NIH_SPENDING_CATS: Brain Disorders;Cerebrovascular;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Neurosciences;Stroke

ORG_CITY: CINCINNATI

ORG_NAME: UNIVERSITY OF CINCINNATI

ORG_STATE: OH

PHR: Project Narrative The FASTEST Trial will test whether treatment with Recombinant Factor VIIa within two hours of onset in appropriately selected patients with spontaneous ICH improves outcome as measured by the ordinal distribution of the modified Rankin Scale (mRS) at 90 days, as compared to placebo. If this trial is positive, it would represent the first scientifically proven treatment for ICH and dramatically change the acute treatment of ICH, as has tPA for acute ischemic stroke.

PI_NAMEs: BRODERICK, JOSEPH PAUL (contact);ELM, JORDAN J.;GROTTA, JAMES C;NAIDECH, ANDREW M

PROJECT_TERMS: Acute;Age;Alteplase;American Heart Association;arm;Australia;Blood Pressure;Brain hemorrhage;Brain imaging;Brain Ischemia;Canada;care systems;Caring;Cerebral hemisphere hemorrhage;Cerebral Infarction;Cessation of life;Country;Dose;Double-Blind Method;Edema;efficacy outcomes;Embolism;Event;Factor VIIa;Favorable Clinical Outcome;Germany;Glasgow Coma Scale;Goals;Growth;Guidelines;Head;Hemorrhage;Hospitals;Hour;Image;improved outcome;Informed Consent;Institution;intraventricular hemorrhage;Ischemia;Ischemic Stroke;Japan;Jordan;Lung;Measurement;Measures;Medical;Myocardial Infarction;National Institute of Neurological Disorders and Stroke;Outcome Measure;outcome prediction;Participant;Patient Recruitments;Patient Selection;Patient-Focused Outcomes;Patients;Pharmaceutical Preparations;Phase;Physiological;Placebos;primary outcome;Principal Investigator;Proliferating;Publishing;Randomized;randomized, clinical trials;Recombinants;recruit;Reporting;safety outcomes;Site;Spain;Stroke;stroke patient;Telephone;Testing;Time;treatment guidelines;Triage;United Kingdom;X-Ray Computed Tomography

PROJECT_TITLE: FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time  (FASTEST) Trial


ADMINISTERING_IC: MD

ARRA_FUNDED: N

ED_INST_TYPE: SCHOOLS OF PUBLIC HEALTH

FUNDING_MECHANISM: OTHER RESEARCH-RELATED

IC_NAME: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Social Determinants of Health

ORG_CITY: ANN ARBOR

ORG_COUNTRY: UNITED STATES

ORG_DEPT: PUBLIC HEALTH & PREV MEDICINE

ORG_FIPS: US

ORG_NAME: UNIVERSITY OF MICHIGAN AT ANN ARBOR

ORG_STATE: MI

PHR: Project Narrative The University of Michigan Minority Health and Health Disparities Research Training Program (UM MHRT) will expand upon over 20 years’ institutional experience as a MHIRT Program awardee to provide rigorous and strongly mentored research and training in the field of health disparities with a special focus on child health utilizing both foreign and domestic sites. Selected pre- and post- doctoral, post-baccalaureate and undergraduate student trainees for UM MHRT will be students underrepresented in the biomedical, behavioral, clinical, and social sciences and will be prepared for research and practice careers in these fields working with under-served populations while also contributing to enhanced diversity of the future biomedical, behavioral, clinical, and social sciences research workforce.

PI_NAMEs: BOULTON, MATTHEW LESTER (contact)

PROGRAM_OFFICER_NAME: OLADEINDE, YEWANDE A

PROJECT_TERMS: Affect;Africa;Americas;Asia;behavioral health;Behavioral Sciences;career;Child;Chile;Clinical Sciences;Collection;Data;design;doctoral student;experience;Faculty;follow-up;Funding;Future;Geographic Locations;Ghana;Health;health determinants;health disparity;health disparity populations;health inequalities;India;Individual;International;low and middle-income countries;Manuscripts;member;Mentors;Michigan;Minority;minority communities;Minority Health and Health Disparities International Research Training;Modeling;Mongolia;Nicaragua;Oral;Peer Review;physical conditioning;poor communities;Postbaccalaureate;Postdoctoral Fellow;pre-doctoral;Preparation;programs;Publications;Qualifying;Research;Research Personnel;Research Project Grants;Site;social culture;Social Sciences;Students;Tobago;Training;training opportunity;Training Programs;Trinidad;Uganda;undergraduate student;Underserved Population;United States;Universities;Vocational Guidance;Writing

PROJECT_TITLE: University of Michigan Minority Health and Health Disparities International Research Training Program


ADMINISTERING_IC: VA

FUNDING_MECHANISM: RESEARCH CENTERS

IC_NAME: Veterans Affairs

ORG_CITY: PORTLAND

ORG_NAME: PORTLAND VA MEDICAL CENTER

ORG_STATE: OR

PHR: Research conducted at the National Center for Rehabilitative Auditory Research (NCRAR) involves the diagnosis and assessment, rehabilitation and prevention of auditory and balance dysfunction. It is highly relevant to Veterans' health care because tinnitus and hearing loss are the number one and number two most prevalent service-connected disabilities, respectively, among all Veteran compensation recipients (Veterans Benefits Administration, 2019). Moreover, balance dysfunction is associated with blast exposure and traumatic brain injury often seen in Veterans of recent conflicts. Additionally, since nearly half of all Veterans are over age 65 (VA Strategic Plan 2018-2024), NCRAR research will remain relevant to Veterans' health because it focuses on the assessment and diagnosis, rehabilitation, and prevention of tinnitus, hearing loss and balance dysfunction, which are all disorders prevalent in aging Veterans.

PI_NAMEs: FEENEY, MARTIN PATRICK (contact);KONRAD-MARTIN, DAWN L

PROJECT_TERMS: Acclimatization;active duty;Adult;Aging;aminoglycoside-induced ototoxicity;Area;Audiology;Auditory;behavior test;Biological Markers;blast exposure;Brain;Brain Injuries;chemotherapy;Clinic;clinical phenotype;Clinical Trials;Cochlea;Cognition;Collaborations;commercialization;Communication;Compensation;Computers;Data;Development;Diagnosis;disability;Disease;Drug Prescriptions;Education and Outreach;Effectiveness;Electrophysiology (science);Epidemiology;equilibration disorder;Equilibrium;Evaluation;externship;Frequencies;Functional disorder;Funding;Genetic Markers;handheld mobile device;Health;Healthcare;Healthcare Systems;Hearing;Hearing Aids;hearing impairment;hearing screening;hidden hearing loss;Home;human old age (65+);improved;Infrastructure;Legal patent;Military Personnel;Modeling;monitoring device;Musculoskeletal Equilibrium;Noise;Noise-Induced Hearing Loss;normal hearing;Older Population;otoacoustic emission;otoprotectant;ototoxicity;Outer Hair Cells;outreach program;Peer Review;Perception;Physiological;Population;portability;Post-Traumatic Stress Disorders;Prevention;primary care setting;Primary Prevention;Psychoacoustics;psychologic;randomized, clinical trials;Rehabilitation Centers;Rehabilitation therapy;Research;Research Personnel;Research Training;Sensory;Sensory Aids;Series;service member;Services;Site;somatosensory;sound;Speech;Strategic Planning;Stream;Students;success;symposium;System;Tablets;Technology;Testing;Time;Tinnitus;Translational Research;Traumatic Brain Injury;United States National Institutes of Health;vestibular system;Veterans;Visual

STUDY_SECTION: RRDC

STUDY_SECTION_NAME: Centers, Research Enhancement Award Program and Consortiums[RRDC]


ORG_CITY: CLEVELAND

ORG_NAME: LOUIS STOKES CLEVELAND VA MEDICAL CENTER

PHR: Functional electrical stimulation (FES) is the use of small electrical currents applied to the nervous system to replace or compensate for the actions of neurons that have been damaged by injury or disease. The Center for Functional Electrical Stimulation (FES Center) maintains a rich environment that promotes new discoveries and provides the critical resources needed for innovation. It develops new, FES-based rehabilitation treatments for Veterans and civilians with neurological disorders such as spinal cord injury, stroke, Parkinson's disease, chronic pain, psychiatric disorders, epilepsy, and internal body functions such as bladder and bowel function, blood pressure, and inflammation. FES Center investigators (1) explore approaches for interfacing with the nervous system, (2) develop new stimulation technologies, (3) establish teams of scientist, engineers, and clinicians who explore the effectiveness and practicality of the FES treatments, and (4) work to move effective new FES treatment into clinical deployment.

PI_NAMEs: KIRSCH, ROBERT F. (contact);RIECHERS, RONALD G

PROJECT_TERMS: Address;Bioethics;Bladder;Blood Pressure;brain health;chronic pain;Clinic;Clinical;Clinical Trials;Collaborations;Communities;community building;community-centered;Compensation;computerized tools;Creativeness;Development;Devices;Disease;Effectiveness;Engineering;Environment;Epilepsy;Equipment;Event;Fostering;functional electrical stimulation;Home;improved;Individual;Industry;Inflammation;Infrastructure;Injury;innovation;Institution;Interdisciplinary Study;interest;Intervention;intervention effect;Intestines;Laboratories;Language;Leadership;Machine Learning;Medical center;Medical Illustration;member;Mental disorders;Mission;models and simulation;Movement;Needs Assessment;Nervous System;Nervous System Disorder;neural;Neurologic;Neurons;Neurophysiology - biologic function;neuroregulation;novel;Pain;Parkinson Disease;patient population;Persons;Physiology;Rehabilitation Outcome;rehabilitation research;Rehabilitation therapy;Research;research and development;Research Personnel;Resource Sharing;Resources;restoration;Scientist;Services;social;Spinal cord injury;Stroke;success;synergism;System;Talents;Techniques;Technology;technology development;translational research program;Translations;United States Department of Veterans Affairs;Universities;University Hospitals;Veterans;Vision;Work

PROJECT_TITLE: VA RR&D Center for Functional Electrical Stimulation (FES)


ADMINISTERING_IC: AG

ED_INST_TYPE: ORGANIZED RESEARCH UNITS

FUNDING_MECHANISM: NON-SBIR/STTR RPGS

IC_NAME: NATIONAL INSTITUTE ON AGING

NIH_SPENDING_CATS: Acquired Cognitive Impairment;Aging;Alzheimer's Disease;Alzheimer's Disease Related Dementias (ADRD);Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD);Behavioral and Social Science;Biomedical Imaging;Brain Disorders;Cerebrovascular;Clinical Research;Clinical Trials and Supportive Activities;Dementia;Neurodegenerative;Neurosciences;Nutrition;Physical Activity;Precision Medicine;Prevention;Vascular Contributions to Cognitive Impairment and Dementia (VCID)

ORG_CITY: BERKELEY

ORG_DEPT: NEUROSCIENCES

ORG_NAME: UNIVERSITY OF CALIFORNIA BERKELEY

ORG_STATE: CA

PHR: Project Narrative The POINTER imaging ancillary study leverages the rare opportunity provided by the ongoing POINTER multidomain lifestyle intervention trial to examine intervention effects on changes in Alzheimer's disease and cerebrovascular pathophysiology, measured with MRI and PET neuroimaging. This study also aims to determine whether these biomarkers at baseline predict cognitive response to the intervention, which could inform precision medicine approaches to healthcare. The proposed study is responsive to the 2018 NIA Research Summit recommendations that encourage rigorous investigations of lifestyle change as a disease- modifying therapeutic strategy to prevent AD and related dementias.

PI_NAMEs: LANDAU, SUSAN M (contact)

PROGRAM_OFFICER_NAME: MCLINDEN, KRISTINA

PROJECT_TERMS: Adherence;Adult;Aerobic Exercise;Alzheimer's Disease;Alzheimer's disease pathology;Alzheimer's disease related dementia;Amyloid beta-Protein;Ancillary Study;Apolipoprotein E;Biological Markers;Brain;brain health;cardiometabolic risk;cardiovascular health;cardiovascular risk factor;cerebrovascular;Cerebrovascular Circulation;Cerebrovascular Disorders;Characteristics;clinically relevant;clinically significant;Cognition;Cognitive;cognitive benefits;cognitive disability;cognitive function;cognitive training;cohort;Communities;Dementia;dementia risk;design;Diet;dietary;Disease;Education;Elderly;Enrollment;Ensure;ethnic diversity;Exercise;exercise training;Failure;Finland;Functional disorder;Genotype;Geography;good diet;group intervention;Group Meetings;Group Structure;Health;Health Benefit;Health education;Healthcare;healthy lifestyle;Hemorrhage;high risk;Hippocampus;Image;Impaired cognition;improved;Individual;Instruction;Intervention;intervention effect;Intervention Studies;Intervention Trial;Investigation;Life Style;Life Style Modification;lifestyle intervention;Link;Magnetic Resonance Imaging;Measures;Medical;Mediterranean Diet;Memory impairment;Modeling;Monitor;morphometry;Multiple Abnormalities;neuroimaging;older adult;Older Population;Parents;Participant;Pathologic;Pharmacologic Substance;Pharmacological Treatment;Physical Exercise;Positron-Emission Tomography;precision medicine;prevent;Printing;Public Health;racial diversity;Randomized;randomized, clinical trials;Recommendation;Recording of previous events;recruit;Research;Research Design;Resources;response;Risk;Risk Factors;Risk Reduction;Role;Sample Size;Sampling;sedentary lifestyle;Site;social;Structure;success;Support Groups;symposium;tau aggregation;tau Proteins;Testing;Therapeutic;Time;treatment as usual;Unhealthy Diet;Weight;White Matter Hyperintensity;Work

PROJECT_TITLE: US POINTER Neuroimaging Ancillary Study


ORG_CITY: SAN ANTONIO

ORG_NAME: SOUTH TEXAS VETERANS HEALTH CARE SYSTEM

ORG_STATE: TX

PHR: Informal caregivers play a critical role supporting Veterans with functional impairments who choose to remain at home. The COVID-19 pandemic has introduced stressors to an already strained and burdened caregiving system. However, there are no studies focused on how the pandemic has impacted Veteran caregivers. This project would use multiple methods to obtain a broad and deep understanding of caregivers’ experiences. We will survey and interview Veteran caregivers and VA stakeholders in San Antonio, Palo Alto, Miami, Salt Lake City, Durham. We will share preliminary findings with VA program office leaders and explore how programs, like the Caregiver Support Program, are working to address those needs. Finally, we will engage caregivers to set priorities for future Veteran caregiver research and intervention. By identifying caregiver impacts we will be able to inform caregiver-centered service and policy reforms.

PI_NAMEs: PENNEY, LAUREN  (contact)

PROJECT_TERMS: Address;Advisory Committees;Ally;Appointment;Area;burnout;care giving burden;care recipients;Caregiver Burden;caregiver interventions;Caregiver research;caregiver stress;Caregiver support;Caregiver well-being;Caregivers;caregiving;Caring;Chronic;Cities;Clinical;Communicable Diseases;Communication;Communities;Complex;COVID-19;COVID-19 impact;COVID-19 pandemic;COVID-19 pandemic effects;COVID-19 risk;Data;design;Disasters;Disease Management;Ecology;Economics;Ecosystem;Environment;Epidemic;experience;Face;Family;Family Caregiver;Feedback;Feeling;Focus Groups;Friends;Functional impairment;Future;Goals;Health;health care availability;Healthcare Systems;Home;Home Health Aides;Impairment;Inequity;informal care;informal caregiver;innovation;insight;Institution;Internist;Interruption;Intervention;Interview;Learning;Lived experience;Long-Term Care;Long-Term Effects;Marketing;Measures;meetings;Mental Health;Methodology;Methods;Nurses;operation;pandemic disease;pandemic impact;Persons;physical conditioning;Play;Policies;Politics;previous epidemic;Process;programs;Provider;Psychologist;Research;resilience;response;Risk;Role;Sampling;SARS-CoV-2 exposure;SARS-CoV-2 infection;service organization;Services;Shapes;Site;social;Social Distance;Social isolation;Sodium Chloride;Stress;stressor;Structure;Support System;Surveys;Survivors;synergism;System;Time;Uncertainty;Veterans;virtual;Work

PROJECT_TITLE: The Impact of the COVID-19 Pandemic on Veteran Caregivers: A Mixed Methods Study to inform the VA Caregiver Support System

STUDY_SECTION_NAME: HSR-6 Aging, Recovery, and Workforce[HSR6]


ADMINISTERING_IC: CA

ED_INST_TYPE: SCHOOLS OF MEDICINE

IC_NAME: NATIONAL CANCER INSTITUTE

NIH_SPENDING_CATS: Bioengineering;Biomedical Imaging;Cancer;Clinical Research;Clinical Trials and Supportive Activities;Digestive Diseases;Immunotherapy;Lung;Precision Medicine

ORG_DEPT: INTERNAL MEDICINE/MEDICINE

ORG_NAME: OREGON HEALTH & SCIENCE UNIVERSITY

PHR: PROJECT NARRATIVE Drugs designed to harness the immune system, called checkpoint inhibitors, have been shown to work against the tumor and are now used as a treatment for a variety of cancers. However, these immune based treatments are not always effective, and a number of patients receive these drugs and experience their associated side effects without deriving any benefit. In this study, we propose to develop a way to use Positron Emission Tomography (PET) scans to identify patients likely to benefit from this immune therapy.

PI_NAMEs: KUMMAR, SHIVAANI  (contact);MARI APARICI, CARINA ;MITTRA, ERIK S.

PROGRAM_OFFICER_NAME: KIM, BOKLYE

PROJECT_TERMS: Advanced Malignant Neoplasm;Adverse event;Aftercare;analog;Antibodies;Area;Binding;Biological Markers;Biopsy;Blood;cancer therapy;CD4 Positive T Lymphocytes;CD8B1 gene;cell mediated immune response;Cell Physiology;Cells;checkpoint therapy;Clinical;Clinical Trials;Colitis;Complex;Confidence Intervals;Data;Data Reporting;Development;Diarrhea;Disease;Dose;Drug Design;Early treatment;experience;Exposure to;Gastrointestinal tract structure;Head and Neck Cancer;Human;Image;imaging biomarker;imaging probe;Immune;Immune checkpoint inhibitor;Immune response;Immune system;immune-related adverse events;Immunooncology;Immunotherapy;In complete remission;Inflammatory Arthritis;Institution;Label;Laboratories;Lesion;Logistic Regressions;Lung;Malignant Neoplasms;Measures;Melanoma;Metastatic Neoplasm to the Lung;Modeling;mouse model;Multiplexed Ion Beam Imaging;Neck Cancer;Non-Small-Cell Lung Carcinoma;Normal tissue morphology;novel;partial response;patient safety;Patient Selection;patient subsets;Patient-Focused Outcomes;Patients;personalized management;Pharmaceutical Preparations;Positron-Emission Tomography;pre-clinical;Pre-Clinical Model;predictive marker;Prognostic Marker;programmed cell death ligand 1;programmed cell death protein 1;PrP;Pulmonary Inflammation;recruit;response;response biomarker;ROC Curve;Sample Size;Sampling;Scanning;Side;side effect;Signal Transduction;Site;Solid Neoplasm;Spearman Rank Correlation Coefficient;Stable Disease;statistics;study population;T cell infiltration;T-Cell Activation;T-Lymphocyte;Therapeutic;Time;time of flight mass spectrometry;Tissues;Toxic effect;treatment response;tumor;tumor heterogeneity;Tumor-Derived;uptake;Work;X-Ray Computed Tomography

PROJECT_TITLE: [18F]-AraG -PET imaging to evaluate immunological response to checkpoint inhibitor therapy (CKI) in patients with advanced solid tumors

STUDY_SECTION: CTIS

STUDY_SECTION_NAME: Clinical Translational Imaging Science Study Section[CTIS]


ADMINISTERING_IC: ES

IC_NAME: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

NIH_SPENDING_CATS: Basic Behavioral and Social Science;Behavioral and Social Science;Bioengineering;Climate-Related Exposures and Conditions;Clinical Research;Contraception/Reproduction;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Maternal Health;Pediatric;Perinatal Period - Conditions Originating in Perinatal Period;Pregnancy;Preterm, Low Birth Weight and Health of the Newborn;Prevention;Rural Health;Social Determinants of Health;Women's Health Research

ORG_CITY: ATLANTA

ORG_DEPT: BIOSTATISTICS & OTHER MATH SCI

ORG_NAME: EMORY UNIVERSITY

ORG_STATE: GA

PHR: PROJECT NARRATIVE The proposed research investigates effects of extreme heat events on the risk of preterm and early term birth. Results will advance our understanding of the health impacts of these climate-related exposures in order to inform public health warning systems that protect pregnant women and their children.

PI_NAMEs: CHANG, HOWARD H (contact);DARROW, LYNDSEY

PROGRAM_OFFICER_NAME: JOUBERT, BONNIE

PROJECT_TERMS: 37 weeks gestation;access restrictions;adverse birth outcomes;Age Distribution;Air;Air Conditioning;Air Pollutants;Air Pollution;atmospheric sciences;Bayesian Modeling;Birth;Birth Records;California;Characteristics;Child;Cities;climate impact;climate zone;climate-related exposures;climate-related health;Colorado;Communities;community-level factor;Conceptions;County;Data;data centers;Data Set;Data Sources;Databases;Date of birth;economic indicator;Education;Ethnic Origin;Event;Exposure to;extreme heat;Florida;Frequencies;Future;future climate scenario;Geography;Gestational Age;Goals;Health;health warning;Heat Waves;Heterogeneity;High temperature of physical object;Hour;Humidity;Income;Individual;Infant;Infant Mortality;innovation;Investments;Length;Location;Measurement;Measures;Mediating;Mediation;Medical;meteorological data;Meteorology;Methodology;Modeling;Monitor;Morbidity - disease rate;Neighborhoods;Neurological disability;New Jersey;Ohio;Output;Pattern;Planet Earth;pollutant;Population;Poverty;Pregnancy;Pregnant Women;Premature Birth;Prevalence;Principal Investigator;Public Health;Race;regional pollution;Reproductive Health;Research;Research Personnel;Residential Mobility;Resolution;Resources;Risk;Risk Factors;rural area;Sampling;scientific atmosphere;Seasons;Socioeconomic Status;socioeconomics;Source;Statistical Models;Surface;System;Temperature;temporal measurement;Term Birth;Testing;Texas;Time;Uncertainty;United States National Center for Health Statistics;urban area;Urbanicity;Washington;Weather;weather stations;Work

PROJECT_TITLE: Extreme heat events and pregnancy duration: a national study

STUDY_SECTION: IRAP

STUDY_SECTION_NAME: Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions Study Section[IRAP]


ORG_CITY: NORTH LITTLE ROCK

ORG_NAME: CENTRAL ARKANSAS VETERANS HLTHCARE SYS

ORG_STATE: AR

PHR: PROJECT NARRATIVE HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) is a team-based service to manage depression in Veterans Living with HIV (VLWH). This service is more effective for managing depression than the care VLWH usually receive and saves resources. HITIDES is also liked by HIV care providers and VLWH. Despite this, no VA clinics currently offer this service. This study examines two approaches to engage clinics with HITIDES, the resulting effects on VLWH, and the costs of these approaches. The first approach includes recruiting an HIV care provider at the site to help connect with the service and a network of providers to support this person. The second approach uses an additional external expert to facilitate these connections. Understanding how to connect Veterans to the HITIDES service will allow VA to improve depression care for VLWH and save VA resources.

PI_NAMEs: PAINTER, JACOB T (contact)

PROJECT_TERMS: Address;Adherence;Adoption;Anti-Retroviral Agents;Area;arm;Bisexual;budget impact;care providers;Caring;Characteristics;Clinic;Clinical;clinical data warehouse;collaborative care;cost;cost effective;Cost Savings;Coupled;Data;depression model;Depression screen;depressive symptoms;design;Diagnosis;economic evaluation;Economics;Effectiveness;Effectiveness of Interventions;effectiveness outcome;effectiveness/implementation trial;efficacious treatment;Equilibrium;ethnic minority;Evaluation;evidence base;examination questions;experience;Feeling suicidal;Future;Gays;Goals;health care disparity;health disparity;health equity;Health Services Accessibility;Healthcare promotion;Healthcare Systems;Hepatitis C;high risk;high standard;HIV;HIV Seropositivity;Hybrids;Immune system;Impairment;implementation barriers;implementation facilitation;implementation intervention;implementation outcomes;implementation strategy;Improve Access;improved;innovation;Intervention;Investigator-Initiated Research;Investments;Leadership;Learning;Low income;Mediating;Medical;men;Mental Depression;Mental disorders;Mental Health;Mental Health Services;Methodology;mortality;multidisciplinary;multimodality;Nature;novel;Outcome;patient population;Patient-Focused Outcomes;Patients;peer;Persons;Population;Primary Care;primary care patient;primary care setting;programs;Provider;provider networks;Qualifying;Quality of Care;racial minority;racial minority population;Randomized;Randomized, Controlled Trials;Recommendation;recruit;reducing suicide;relative cost;relative effectiveness;Research;Research Design;Resources;Rest;Services;sexual minority;Site;standard of care;success;suicidal;suicide rate;Target Populations;Testing;Time;tool;Translating;treatment as usual;trial design;Update;Veterans;Veterans Health Administration;Vulnerable Populations;Work

PROJECT_TITLE: Implementation of collaborative care for depression in VA HIV clinics: Translating Initiatives for Depression into Effective Solutions (HITIDES)

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


ADMINISTERING_IC: MH

FUNDING_MECHANISM: SBIR-STTR RPGS

IC_NAME: NATIONAL INSTITUTE OF MENTAL HEALTH

ORG_NAME: ADVANCED IMAGING RESEARCH, INC.

PHR: MRI is a safe, non-invasive diagnostic imaging tool and can be used to obtain detailed anatomical, vascular, biochemical and functional information from the brain, spine, heart, major organs such as liver, kidney etc. including bones and joints. But effective diagnosis depends on the quality of the MR image, which can be improved by going to high magnet field strengths or by increasing the number of receiver channels, both are expensive and are approaching their limits. We propose to use supplementary technologies aimed at maximizing MRI image quality with the intention of alleviating the burden placed on high cost, high magnet field based MRI systems.

PI_NAMEs: SRINIVASAN, RAVI  (contact)

PROGRAM_OFFICER_NAME: DURKIN, JACLYN MARIE

PROJECT_TERMS: Address;Adult;Advanced Development;Anatomy;Biochemical;Blood Vessels;bone;Brain;brain magnetic resonance imaging;Clinical;clinical diagnosis;Communication;cost;cryogenics;Deposition;design;Detection;Diagnosis;diagnostic tool;disease diagnosis;effectiveness evaluation;Frequencies;Funding;Gases;Gel;Goals;Head;Heart;Housing;Human;human model;Image;Imaging Device;improved;Industrialization;innovation;Intention;Joints;Kidney;Liver;magnetic field;Magnetic Resonance Imaging;Mechanics;Medical;Methods;Military Personnel;Miniaturization;Modeling;neuroimaging;new technology;next generation;Nitrogen;Noise;noninvasive diagnosis;novel;Organ;Patients;Pediatric Hospitals;Performance;Phase;Physiologic pulse;Population;Procedures;prototype;Radar;radio frequency;Refrigeration;Research;Resolution;Safety;Scanning;Signal Transduction;simulation;soft tissue;Solid;Specific qualifier value;Structure;System;Technology;Temperature;Testing;transmission process;United States National Institutes of Health;Validation;Vertebral column;Work

PROJECT_TITLE: ADVANCED NEXT GEENRATION RADIO FREQUENCY COILS FOR MAGNETIC RESONANCE IMAGING


ORG_CITY: BEDFORD

ORG_NAME: EDITH NOURSE  ROGERS MEMORIAL VETERANS HOSPITAL

ORG_STATE: MA

PHR: Type 2 Diabetes is a common, complex health condition which can result in many serious and costly health complications if not treated and controlled properly. Overall, 24% of Veterans are diagnosed with Type 2 Diabetes. Vulnerable Veterans, such as minority, low-income, or rural Veterans, and Veterans with comorbid mental health diagnoses, are disproportionately affected and are less likely to have their diabetes under control. One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. This study seeks to leverage “Annie”, a new VA texting system. The study will seek input from vulnerable Veteran groups living with diabetes to help develop DD-TXT, a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. It will compare DD- TXT with another education-only texting intervention called DSE that is based on a diabetes skills workbook.

PI_NAMEs: SHIMADA, STEPHANIE LEAH (contact)

PROJECT_TERMS: Address;Adherence;Affect;African American;Appointment;Area;Behavior;Blood Glucose;blood pressure control;Blood Pressure Monitors;Cellular Phone;Chicago;Chronic Disease;comorbidity;comparative effectiveness;comparative effectiveness trial;Complex;complex chronic conditions;connected care;coping;cost;Data;design;Development;diabetes control;diabetes distress;Diabetes Mellitus;diabetes self-management;diabetic;Diagnosis;digital divide;Disease;Disparity;Education;Effectiveness;effectiveness evaluation;Emotional;empowerment;Evaluation;experience;Feedback;field study;Future;future implementation;General Population;Glycosylated hemoglobin A;Goals;Guidelines;Health;health care availability;Health Care Costs;health equity;Health Expenditures;Health Services Accessibility;Healthcare;Heart;Heterogeneity;Hybrids;implementation strategy;implementation trial;Improve Access;improved;individual patient;Informatics;information gathering;innovation;Intervention;Lead;Libraries;literacy;Logic;Low income;Low-Density Lipoproteins;medical complication;medication compliance;Medication Management;Medicine;member;Mental Health;Methodology;Minority;Modality;Monitor;Morbidity - disease rate;mortality;Motivation;multidisciplinary;Names;Non-Insulin-Dependent Diabetes Mellitus;Nurses;nutrition;Outcome;Ownership;Participant;patient engagement;Patient Preferences;Patient Selection;Patient Self-Report;Patient-Centered Care;Patients;Pharmaceutical Preparations;Physical activity;Physiological;population health;preference;Preventive care;primary care practice;primary outcome;Problem Solving;Process;protocol development;Protocols documentation;Provider;Randomized;Recommendation;Research Priority;Resources;Risk Factors;Rural;Safety;secondary outcome;Self Efficacy;Self Management;self-management program;skills;social health determinants;sociodemographics;Subgroup;success;System;Technology;technology platform;Testing;Text;Text Messaging;text messaging intervention;texting support;Time;treatment as usual;treatment effect;Veterans;virtual;virtual healthcare;Weight maintenance regimen;Woman;Women's Health;Work

PROJECT_TITLE: Diabetes Disparities: Texting to Extend Treatment (DD-TXT)

STUDY_SECTION_NAME: HSR-3 Healthcare Informatics[HSR3]


ORG_CITY: CANANDAIGUA

ORG_NAME: VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF

ORG_STATE: NY

PHR: The risk for suicide increases by nearly 50% in the first year that service members transition from the military to civilian life underscoring the need for effective strategies to facilitate help seeking among Veterans vulnerable to self-directed violence. Yet despite a great need for treatment, more than half of returning Veterans at risk for suicide do not initiate mental health services. VA has embarked on the regular use of communication campaigns as part of a public health approach designed to reach the larger Veteran population with messages promoting help seeking. However, what types of messages effectively change beliefs and behaviors for at-risk Veterans resistant to seek treatment is unclear. The main objective of this study is to develop and test the use of public messaging to increase treatment seeking among Veterans at risk for suicide and resistant to seek mental health care following separation from military service. This represents the first study to systematically develop public messaging strategies for populations at risk for suicide.

PI_NAMEs: KARRAS, ELIZABETH  (contact)

PROJECT_TERMS: 18 year old;2 arm randomized control trial;active duty;Audience Research;Behavior;behavioral response;Belief;Cellular Phone;Communication;Consent;Control Groups;cost;Data;Data Collection;design;Eligibility Determination;evidence base;Evidence based treatment;Exclusion Criteria;experience;Feeling suicidal;follow-up;Funding;Future;Goals;Head;help-seeking behavior;high risk;high risk population;Impairment;improved;inclusion criteria;Individual;innovation;Institutionalization;Intervention;Interview;iterative design;Life;Measures;Mental Health;Mental Health Services;Methodology;Methods;Military Personnel;military service;military veteran;Minority;mobile application;Observational Study;outreach;Ownership;Participant;peer;Performance;Planning Theory;Populations at Risk;portability;Predisposition;prevent;Process;Public Health;Randomized;recruit;repository;Research;Resistance;Risk;Sampling;screening;Self Direction;service member;service utilization;Services;smartphone application;suicidal behavior;suicidal risk;Suicide;Suicide prevention;suicide rate;Target Populations;Telephone;Testing;treatment services;verbal;Veterans;Violence;Waiting Lists;Woman;Work

PROJECT_TITLE: Public messaging to increase treatment seeking among Veterans at risk for suicide during transition from military service


ADMINISTERING_IC: DA

IC_NAME: NATIONAL INSTITUTE ON DRUG ABUSE

NIH_SPENDING_CATS: Biotechnology;Clinical Research;Drug Abuse (NIDA only);Genetics;HIV/AIDS;Infectious Diseases;Microbiome;Neurosciences;Substance Misuse

ORG_CITY: CHICAGO

ORG_DEPT: NEUROLOGY

ORG_NAME: NORTHWESTERN UNIVERSITY AT CHICAGO

ORG_STATE: IL

PHR: The proposed research is relevant to public health because it will have an important positive impact on our understanding of the role of the Virome in HIV/AIDS and the pathogenesis associated with drug use. Thus, the proposed research is relevant to the part of NIDA’s mission that pertains to developing fundamental knowledge to alleviate the burdens of drug use.

PI_NAMEs: KORALNIK, IGOR J. (contact)

PROGRAM_OFFICER_NAME: BORGMANN, KATHLEEN RUTH

PROJECT_TERMS: Academic Medical Centers;Achievement;Acquired Immunodeficiency Syndrome;Address;Area;Autopsy;Biological Assay;Blood;Brain;Clinical;co-infection;cohort;Collection;comorbidity;Data;deep sequencing;Department chair;detection platform;DNA Viruses;Drug usage;druggable target;experience;Formalin;Freedom;Genomic DNA;Genomics;HIV;HIV/AIDS;Human;interest;Intervention;Investigation;Knowledge;metabolomics;Mission;Names;National Institute of Drug Abuse;neuroimmunology;Neurology;Neurovirology;next generation sequencing;novel;novel therapeutics;Nucleic Acids;Paraffin Embedding;Pathogenesis;Patients;Pattern;Positioning Attribute;programs;Public Health;Research;RNA;RNA Viruses;Role;Sampling;stem;Systems Biology;therapeutic target;transcriptomics;Variant;Viral;virome;Virus;Virus Diseases;Zambia

PROJECT_TITLE: Contribution of the Virome to HIV/AIDS pathogenesis


ORG_CITY: RESEARCH TRIANGLE PARK

ORG_NAME: RESEARCH TRIANGLE INSTITUTE

ORG_STATE: NC

PHR: Project Narrative The Human Health Exposure Analysis Resource (HHEAR) Hub will use existing resources and infrastructure developed under the NIH Common Fund Metabolomics Program and the NIEHS-Children’s Health Exposure Analysis Resource (CHEAR) Program to facilitate exposome research, and we will expand our methods for identification of even more compounds that comprise the exposome. Deriving links between environmental exposures and biological responses in humans through understanding metabolic perturbations is critical to the development of intervention strategies.

PI_NAMEs: DU, XIUXIA ;FENNELL, TIMOTHY RAYMOND (contact);SUMNER, SUSAN J

PROGRAM_OFFICER_NAME: CUI, YUXIA

PROJECT_TERMS: Acetaminophen;acylcarnitine;Amines;Amino Acids;Aromatic Polycyclic Hydrocarbons;Big Data Methods;Biological;Carboxylic Acids;Cardiovascular Diseases;case control;Chemicals;Child Health;Client;cohort;Collaborations;Communication;Communication Methods;comparative;Coupled;Data;Data Analyses;Data Reporting;data resource;Detection;Development;Diabetes Mellitus;Disease;drug of abuse;Ensure;Environment;Environmental Exposure;Environmental Health;epidemiology study;evidence base;experience;Exposure to;Fatty Acids;Feces;Food;Funding;Gas Chromatography;Goals;Grant;Health;health goals;Health Promotion;Heroin;high throughput analysis;Human;improved;Infrastructure;Ingestion;inorganic phosphate;Intervention;ion mobility;Kidney Diseases;Knowledge;Laboratories;Leadership;Libraries;Link;lipidomics;Liquid Chromatography;Lysophospholipids;Mass Spectrum Analysis;Maternal and Child Health;Measures;Metabolic;metabolic phenotype;Metabolism;metabolomics;metabolomics resource;Metformin;Methods;Modeling;Morphine;multiple reaction monitoring;National Institute of Environmental Health Sciences;Nuclear Magnetic Resonance;Nucleosides;Nutrient;Obesity;Ontology;Opioid;Outcome;outreach;Parabens;Pesticides;Pharmaceutical Preparations;Phenols;Phenotype;phthalates;Plasma;polyphenol;Procedures;Process;programs;Protocols documentation;public database;Publications;quality assurance;Quality Control;Reporting;Reproducibility;Research;Resolution;Resources;response;Running;sample collection;Sampling;Serum;Services;Signal Transduction;skills;success;sugar;System;Technology;therapy development;Time;tobacco products;Translating;treatment response;United States;United States National Institutes of Health;Urine;volatile organic compound;Work

PROJECT_TITLE: Human Health Exposure Analysis Resource Core: Untargeted Analysis


NIH_SPENDING_CATS: Bioengineering;Data Science

PI_NAMEs: SUMNER, SUSAN J (contact)

PROJECT_TERMS: Acetaminophen;acylcarnitine;Amines;Amino Acids;Aromatic Polycyclic Hydrocarbons;Big Data Methods;Budgets;Carboxylic Acids;Chemicals;Child Health;Client;Code;Collaborations;Communication;Consult;Consultations;cost effectiveness;Coupled;Data;data acquisition;Data Analyses;data repository;data standards;data submission;Detection;detection method;Development;drug of abuse;Ensure;Environment;Fatty Acids;Food;Funding;Gas Chromatography;Health;Heroin;Human;Ingestion;inorganic phosphate;Institution;instrument;ion mobility;Laboratories;Laboratory Research;Libraries;lipidomics;Liquid Chromatography;liquid chromatography mass spectrometry;Lysophospholipids;Mass Spectrum Analysis;member;Metabolic;metabolic phenotype;metabolomics;Metformin;method development;Methods;Morphine;multiple reaction monitoring;North Carolina;Nuclear Magnetic Resonance;Nucleosides;Ontology;Opioid;Parabens;Performance;Pesticides;Pharmaceutical Preparations;Phenols;Phenotype;phthalates;polyphenol;Preparation;Procedures;Process;programs;Protocols documentation;public database;quality assurance;Quality Control;Reporting;Reproducibility;Research;Resolution;Resources;Sampling;Science;Services;Signal Transduction;Speed;Statistical Data Interpretation;Statistical Models;sugar;System;Time;timeline;tobacco products;United States National Institutes of Health;Update;volatile organic compound;web site;Work

PROJECT_TITLE: Untargeted Analysis Resource


NIH_SPENDING_CATS: Data Science;Natural Products

PI_NAMEs: FENNELL, TIMOTHY RAYMOND (contact)

PROJECT_TERMS: Big Data Methods;Biological;Biological Markers;biomarker development;Chemical Exposure;Chemicals;Collaborations;Coupled;data acquisition;Detection;detection method;Development;drug of abuse;Ensure;Environment;Environmental Exposure;epidemiology study;experience;Feces;Food;Gas Chromatography;Health;Human;in vivo;Ingestion;Institution;Laboratories;Libraries;liquid chromatography mass spectrometry;Liquid substance;Mass Fragmentography;mass spectrometer;Mass Spectrum Analysis;Measures;Metabolism;Methods;multiple reaction monitoring;Natural Products;novel strategies;Pesticides;Pharmaceutical Preparations;Plants;Plasma;polybrominated diphenyl ether;Polychlorinated Biphenyls;polyphenol;Procedures;Protocols documentation;Reference Standards;Resolution;Resources;Saliva;sample collection;Sampling;Schedule;Serum;Services;Signal Transduction;Source;Testing;Tissues;Toxic effect;Toxicology;Translating;U-Series Cooperative Agreements;Urine;Work;working group

PROJECT_TITLE: Development Core


PROJECT_TERMS: analytical method;Budgets;Child Health;Client;Clinical Laboratory Information Systems;Communication;Communities;Consultations;Contracts;Data;data acquisition;Data Analyses;data repository;data submission;Deposition;Development;Ensure;Epidemiology;experience;Food;Funding;Guidelines;Health;Human;Information Dissemination;Infrastructure;International;Knowledge;Laboratories;Measures;meetings;member;Metabolism;metabolomics;metabolomics resource;method development;Methods;National Institute of Environmental Health Sciences;Needs Assessment;novel strategies;Occupational activity of managing finances;operation;outreach;Persons;Phase;Preparation;Procedures;programs;Progress Reports;Protocols documentation;quality assurance;Quality Control;Reporting;Research;Research Design;Research Personnel;Resources;Role;sample collection;Sampling;Science;Scientist;Self Assessment;Services;skills;symposium;timeline;Training;United States National Institutes of Health;Voting;web site;Work;working group;Writing

PROJECT_TITLE: Administrative Core


NIH_SPENDING_CATS: Climate-Related Exposures and Conditions;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Effects of Household Energy Combustion;Health Effects of Indoor Air Pollution;Prevention;Social Determinants of Health;Tobacco;Tobacco Smoke and Health

PHR: PROJECT NARRATIVE Georgia (GE) is an LMIC significantly impacted by air pollution and secondhand smoke (SHS), having the 3rd highest mortality index attributed to ambient and indoor air pollution in the world and 42% of GE adults experiencing daily SHS exposure. This application, the Emory-Georgia Clean Air Research and Education (EG-CARE) program, represents a uniquely strategic collaboration among Emory University and key educational and public health agencies in GE that leverage several ongoing collaborations and efforts; its long-term goal is to enhance capacity in GE to conduct research related to NCDs and environmental health (EH) and ultimately inform policy and practice to reduce NCDs. The overall objective of this application is to develop and implement a training program involving training, mentorship, and applied research opportunities to provide a foundation to reach the long-term goal; the program team is uniquely positioned to implement EG-CARE and enhance research capacity related to NCDs and EH in the next 5 years and in the long term.

PI_NAMEs: BERG, CARLA J;CAUDLE, WILLIAM MICHAEL (contact);STURUA, LELA

PROGRAM_OFFICER_NAME: HUMBLE, MICHAEL C

PROJECT_TERMS: Address;Adult;Affect;Air;Air Pollution;ambient air pollution;Applied Research;attributable mortality;burden of illness;Centers for Disease Control and Prevention (U.S.);Cessation of life;Child;Collaborations;Country;Education;Environment;environmental agent;Environmental Exposure;Environmental Hazards;Environmental Health;environmental tobacco smoke;environmental tobacco smoke exposure;Funding;global health;Goals;Grant;Health;indexing;Indoor Air Pollution;Infrastructure;Institution;Joints;knowledge translation;low and middle-income countries;Medical;men;Mentors;Mentorship;Molecular;Morbidity - disease rate;mortality;National Institute of Environmental Health Sciences;Policies;Pollution;Population;Positioning Attribute;programs;Public Health;public health priorities;Reporting;Research;research data dissemination;Research Priority;Research Training;smoke-free policy;smoking prevalence;statistics;Training;training opportunity;Training Programs;Universities;Western Asia Georgia;Woman

PROJECT_TITLE: Emory-Georgia Clean Air Research & Education (CARE) Program

STUDY_SECTION_NAME: International and Cooperative Projects - 1 Study Section[ICP1]


ORG_CITY: PALO ALTO

ORG_NAME: VETERANS ADMIN PALO ALTO HEALTH CARE SYS

PHR: Suicide and suicide attempts among U.S. Veterans remain a serious concern, as more than 6,000 Veterans die by suicide every year and many more attempt suicide. Current VHA suicide prediction models do not incorporate the rich information relevant to suicide from clinical progress notes. The proposed study will use natural language processing to make this information available for suicide prediction models. The study sets itself apart from other studies in this area by employing the state-of-the-art 3-step Theory of Suicide, which aims to distinguish high-risk Veterans who will attempt suicide from high-risk Veterans who will not attempt suicide. Enhancing VHA's ability to identify Veterans who are most likely to attempt suicide ensures that limited intervention resources can focus on Veterans with the highest needs, before they attempt suicide or die by suicide. The proposed study is well-aligned with priorities for HSR&D research and with VA strategic goals for 2018 – 2024 set out by VA leadership, who listed suicide prevention as “VA's highest clinical priority.”

PI_NAMEs: SOX-HARRIS, ALEX  (contact)

PROJECT_TERMS: Age;Area;Attention;Automated Annotation;Caring;Clinical;clinical encounter;clinical practice;concept mapping;Data;Data Collection;data repository;Data Science;data warehouse;design;Detection;Development;Electronic Health Record;Ensure;Event;Feeling hopeless;Feeling suicidal;Female;Gender;Goals;hands-on learning;high risk;implementation facilitation;improved;Information Retrieval;innovation;Intervention;Knowledge;Language;Leadership;Linguistics;Machine Learning;machine learning algorithm;machine learning model;Maps;Medical;Medicine;Mental Health;Methodology;Methods;Modeling;Natural Language Processing;Nomenclature;novel;Ontology;Pain;Patient Selection;Patients;Performance;Persons;phrases;predictive modeling;psychologic;random forest;Readability;reducing suicide;Research;Resources;Risk Assessment;Risk Factors;risk prediction model;Signal Transduction;Structure;structured data;suicidal behavior;suicidal morbidity;suicidal risk;Suicide;Suicide attempt;suicide mortality;Suicide prevention;suicide rate;support vector machine;System;Target Populations;Text;text searching;theories;tool;Translating;Veterans;Veterans Health Administration

PROJECT_TITLE: Can suicide theory-guided natural language processing of clinical progress notes improve existing prediction models of Veteran suicide mortality?


NIH_SPENDING_CATS: Anorexia;Behavioral and Social Science;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Comparative Effectiveness Research;Dissemination and Implementation Research;Eating Disorders;Health Disparities Research;Health Disparities and Racial or Ethnic Minority Health Research;Health Services;Mental Health;Mental Illness;Nutrition;Pediatric;Serious Mental Illness;Social Determinants of Health

ORG_CITY: PITTSBURGH

ORG_DEPT: PSYCHIATRY

ORG_NAME: UNIVERSITY OF PITTSBURGH AT PITTSBURGH

ORG_STATE: PA

PHR: PROJECT NARRATIVE Anorexia nervosa (AN) is a pernicious psychiatric illness that affects 1% of adolescents in the community and is associated with high risk for serious medical complications, psychiatric comorbidities, and suicide. Family- based treatment (FBT) is an efficacious intervention for AN in both the short- and long-term, but it is not accessible to many families, particularly those from under-represented sociodemographic groups. This pilot effectiveness trial aims to assess outcome, implementation, and mechanisms of FBT adapted for the home setting, delivered in the context of community-based mental health agencies, which will help guide research efforts towards better understanding how to tailor FBT for delivery in non-traditional treatment settings, in the context of “real world” community-based agencies, and for populations that are otherwise at risk for receiving suboptimal or no care for AN.

PI_NAMEs: GOLDSCHMIDT, ANDREA BETH (contact)

PROGRAM_OFFICER_NAME: BURSTEIN, MARCY ELLEN

PROJECT_TERMS: Address;Adherence;Adolescent;Affect;Ambulatory Care;Anorexia Nervosa;barrier to care;Behavior Therapy;behavioral health;Body mass index;Caregivers;caregiving;Caring;Clinical;Collaborations;Communities;community setting;Competence;Country;Data;Dedications;Development;Disease;Distress;Dose;DSM-V;Eating;Eating Disorders;Effectiveness;effectiveness evaluation;effectiveness research;effectiveness trial;effectiveness-implementation RCT;efficacious intervention;empowerment;Enrollment;Environment;ethnic diversity;ethnic minority;Evidence based treatment;Exposure to;Extinction;Failure;Family;Family Practice;Family psychotherapy;feeding;follow-up;Food;food environment;Fright;Goals;Health Personnel;high risk;Home;Hour;Hybrids;implementation evaluation;implementation outcomes;improved;Individual;innovation;Intervention;Investigation;Knowledge;Language;Longterm Follow-up;Low income;Low Income Population;lower income families;Manuals;Measures;medical appointment;medical complication;medical specialties;Mental disorders;Mental Health;Mental Health Services;Modeling;Monitor;Morbidity - disease rate;mortality;Outcome;Outcome Assessment;outcome prediction;Outpatients;Patients;Population;Preparation;Process;Proctor framework;Provider;psychiatric comorbidity;Psychopathology;Public Health;racial diversity;racial minority;Randomized;Research;Resources;response;Risk;Sampling;Schools;Scientific Advances and Accomplishments;Self Efficacy;Service setting;Services;skill acquisition;skills;sociodemographic group;sound;Standardization;Starvation;Stimulus;Structure;Suicide;Supervision;Testing;Third-Party Payer;Training;Transportation;treatment as usual;Treatment Cost;Treatment outcome;Underserved Population;uptake;Weight;Weight Gain;weight restoration;Work

PROJECT_TITLE: Implementation, Outcome and Mechanisms of Family-Based Treatment for Adolescent Anorexia Nervosa Adapted for the Home Setting: A Pilot Effectiveness Trial


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

PHR: PROJECT NARRATIVE The aim of this project is to measure and describe the social networks of a nationally representative sample of family caregivers of people with Alzheimer’s disease, a group of caregivers at particularly high risk of poor health and social isolation. We will examine common network typologies and their associations with a variety of measures of caregiver physical, mental, and social well-being. We will also test for potential mediating factors, including the caregiving context and care recipient health. Finally, we will examine change in caregivers’ social networks and how it may be associated with caregiver health over the caregiving cycle.

PI_NAMEs: FRIEDMAN, ESTHER M. (contact)

PROGRAM_OFFICER_NAME: NGUYEN, EMERALD THAI HAN

PROJECT_TERMS: Adult;Adverse event;adverse outcome;Age;aged;Alzheimer's Disease;Alzheimer's disease related dementia;Anxiety;baby boomer;Basic Science;Bathing;care burden;care coordination;care providers;care recipients;Caregiver Burden;Caregiver support;Caregivers;caregiving;Caring;Characteristics;Church;Communication;cost;Country;Data;Dementia;Dementia caregivers;Development;Distant;Drops;Eating;Emotional;Exhibits;Face;Family;Family Caregiver;Family member;follow-up;Frequencies;Friends;Grooming;Health;Health Care Costs;high risk;Impairment;improved;Individual;Intervention;Life;Literature;Loneliness;Measures;Mediating;member;Mental Depression;Modeling;novel;older adult;Outcome;Pattern;Perception;Personal Satisfaction;Persons;Policy Maker;poor health outcome;Population;Preparation;Psyche structure;Research;Research Personnel;Resources;Risk;Role;Sampling;Services;Social isolation;Social Network;social network intervention;Social outcome;Social Well-Being;sociodemographics;Spouses;stem;Sterile coverings;Structure;support network;Support System;technology intervention;Testing;Time;Transportation;trend;Typology;United States;United States National Institutes of Health;Visualization;Work

PROJECT_TITLE: Health, Wellbeing, and the Social Networks of Family Caregivers of People with Alzheimer's Disease

STUDY_SECTION: CMPC

STUDY_SECTION_NAME: Clinical Management of Patients in Community-based Settings Study Section[CMPC]


ADMINISTERING_IC: AI

IC_NAME: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

ORG_CITY: HOUSTON

ORG_NAME: METHODIST HOSPITAL RESEARCH INSTITUTE

PHR: PROJECT NARRATIVE – PUBLIC HEALTH RELEVANCE Vancomycin-resistant enterococci (VRE), extended spectrum β-lactamase producing/carbapenem-resistant En- terobacteriaceae (ESBL-E/CRE) and Clostridiodes difficile are major multidrug-resistant and recalcitrant hospi- tal-associated pathogens affecting critically ill patients. These organisms are highly associated with initial colonization of the intestines. We plan to dissect the clinical and genomic epidemiology and population dy- namics of colonizing/infected isolates focusing our translational host-microbiome-pathogen interaction studies in two prospective cohorts of severely ill patients that are at high-risk of developing colonization/infection by these organisms. We aim to develop novel tools for the prevention, diagnosis and treatment of gut-derived multidrug- resistant pathogens that affect critically ill and immunocompromised patients.

PI_NAMEs: ARIAS, CESAR AUGUSTO (contact);SAVIDGE, TOR C.;SHELBURNE, SAMUEL A

PROGRAM_OFFICER_NAME: HUNTLEY, CLAYTON C

PROJECT_TERMS: Affect;Antibiotic Resistance;antimicrobial;Antimicrobial Resistance;Bacteria;carbapenem-resistant Enterobacteriaceae;Clinical;clinical epidemiology;clinical risk;Clostridium difficile;cohort;Collaborations;combat;commensal microbes;Communities;Critical Illness;Data;Development;Diagnosis;Disease;drug resistant pathogen;Extended-spectrum β-lactamase;Functional disorder;Gastrointestinal tract structure;Genome;genomic epidemiology;Genomics;Goals;gut colonization;gut microbiota;high risk;Hospitals;host microbiome;host microbiota;Immunocompromised Host;Individual;Infection;Institution;Intensive Care Units;Intervention;Intestines;Investigation;Knowledge;Longitudinal Studies;Mediating;Medical center;member;Metagenomics;metaproteomics;microbial;microbiome;microbiome composition;microbiome research;microbiota;Multi-Drug Resistance;multi-drug resistant pathogen;Multiple Bacterial Drug Resistance;Names;Nature;novel;novel diagnostics;Organism;pathobiont;pathogen;Patient Admission;patient population;patient subsets;Patients;Population Dynamics;Positioning Attribute;Predisposition;Prevention;Preventive;programs;Prospective cohort;public health priorities;public health relevance;Recording of previous events;Resistance;Resources;Ribosomal RNA;Risk;Role;Sampling;Signal Transduction;Site;Stem cell transplant;stool sample;System;Texas;Therapeutic;tool;trait;United Nations;Vancomycin Resistance;Vancomycin resistant enterococcus

PROJECT_TITLE: Dynamics of Colonization and Infection by Multidrug-resistant Pathogens in Immunocompromised and Critically Ill Patients (DYNAMITE)


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Biotechnology;Digestive Diseases;Emerging Infectious Diseases;Infectious Diseases;Microbiome

PI_NAMEs: ARIAS, CESAR AUGUSTO (contact)

PROJECT_TERMS: Acceleration;Accountability;Address;Admission activity;Advisory Committees;Agriculture;Antibiotic Resistance;Antibiotics;Antimicrobial Resistance;Benchmarking;Budgets;carbapenemase;Clinical;Clinical Data;clinical practice;Clostridium difficile;Collaborations;Combating Antibiotic Resistant Bacteria;commensal microbes;Communication;conflict resolution;Critical Illness;Data;data management;data sharing;Decision Making;Dedications;Development;diagnostic strategy;Disease Progression;Disputes;Effectiveness;Ensure;Enterobacteriaceae;Extended-spectrum β-lactamase;functional genomics;gastrointestinal;Genomics;Goals;Government;gut colonization;gut microbiota;high risk;Home;Human Resources;Immunocompromised Host;improved outcome;Industrialization;Infection;insight;Institution;Intensive Care Units;Leadership;Life;Liquid substance;Logistics;Mediating;Medical;Medical center;meetings;metabolomics;microbiota;microorganism;Minor;Modern Medicine;Monitor;mortality;multi-drug resistant pathogen;novel;Online Systems;operation;Organism;outcome prediction;pathogen;Pathogenicity;Patients;Persons;Phenotype;Positioning Attribute;Process;Productivity;Program Reviews;programs;Progress Reports;Proteomics;Public Health;Quality Control;Regimen;Research;Research Activity;Research Personnel;Research Project Grants;Resolution;sample collection;Sampling;success;synergism;System;Techniques;Texas;Therapeutic;Translating;treatment strategy;United Nations;United States National Institutes of Health;Vancomycin resistant enterococcus;Work

PROJECT_TITLE: P01 Administrative Core


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Digestive Diseases;Emerging Infectious Diseases;Genetics;Infectious Diseases;Microbiome

PI_NAMEs: HAAG, ANTHONY  (contact)

PROJECT_TERMS: 16S ribosomal RNA sequencing;Adopted;Affect;Antibiotics;Antimicrobial Resistance;Back;Bacterial Chromosomes;bacterial genome sequencing;Bar Codes;bioinformatics infrastructure;bioinformatics pipeline;Biological;Biometry;Cancer Center;carbapenemase;Clinical;Clostridium difficile;cohort;Complex;computerized data processing;Coupled;Critical Illness;Data;Data Analyses;data format;Data Storage and Retrieval;Databases;Development;Disease;Disease Progression;Disease susceptibility;DNA;DNA sequencing;Documentation;drug resistant pathogen;dysbiosis;Electronics;Enterobacteriaceae;Equipment and supply inventories;Extended-spectrum β-lactamase;Feces;Foundations;functional genomics;Generations;Genes;Genome;genome sequencing;Genomics;Goals;gut colonization;gut microbiome;Hospitalization;Hospitals;Immunocompromised Host;Individual;Infection;Institution;Intensive Care Units;interest;Laboratories;Maintenance;Maps;Medical center;Metabolic;metabolome;metabolomics;metagenomic sequencing;Metagenomics;metaproteomics;microbial;microbiome;microbiota;Modeling;multi-drug resistant pathogen;Multiomic Data;multiple omics;novel;Outcome;pathogen;Patients;Plasmids;Positioning Attribute;Predisposition;Process;Program Research Project Grants;programs;Protein Analysis;Proteins;Public Health;Resources;Risk Factors;Sampling;Sampling Studies;Shotgun Sequencing;Shotguns;Site;small molecule;Societies;Source;Statistical Methods;Stem cell transplant;stool sample;Texas;tool;United States National Institutes of Health;University of Texas M D Anderson Cancer Center;Vancomycin resistant enterococcus;whole genome

PROJECT_TITLE: Functional Genomics Core


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Biotechnology;Clinical Research;Digestive Diseases;Emerging Infectious Diseases;Infectious Diseases;Microbiome

PROJECT_TERMS: Admission activity;Affect;Algorithms;Antibiotic Resistance;Antibiotic Therapy;Antibiotics;antimicrobial;Antimicrobial Resistance;beta-Lactam Resistance;carbapenem-resistant Enterobacteriaceae;carbapenemase;Caring;Categories;Characteristics;Clinical;clinical epidemiology;Clostridium difficile;cohort;Communicable Diseases;Critical Illness;Data;Development;Disease;Disease Progression;Disease susceptibility;drug resistant pathogen;dysbiosis;Elements;Enterobacteriaceae;Event;Evolution;Extended-spectrum β-lactamase;gastrointestinal;Gastrointestinal tract structure;Genome;genome sequencing;genomic epidemiology;genomic signature;genomic variation;Genomics;gut colonization;Hematologic Neoplasms;high risk;Hospitals;host microbiome;Immune system;Immunocompromised Host;Individual;Infection;insight;Intensive Care Units;Intestines;Mass Spectrum Analysis;Medical;Medical center;metabolomics;Metagenomics;metaproteomics;Microbe;microbiota;Monitor;mortality;mouse model;Multi-Drug Resistance;multi-drug resistant pathogen;Nature;Nosocomial Infections;novel;Organism;Outcome;pathobiont;pathogen;Pathogenesis;Patients;Plasmids;Play;Population;Population Dynamics;Predisposition;prevent;priority pathogen;Process;programs;prospective;Prospective cohort;Proteomics;Public Health;public health priorities;Reaction;Role;Severity of illness;Source;Stem cell transplant;Structure;Techniques;Technology;Texas;Time;translational approach;translational study;Transplant Recipients;Transplantation;Vancomycin resistant enterococcus;Virulence;World Health;World Health Organization

PROJECT_TITLE: Project 1: Genomics of Pathobionts and Transition From Colonization to Infection


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Clinical Research;Digestive Diseases;Emerging Infectious Diseases;Infectious Diseases;Microbiome

PI_NAMEs: SHELBURNE, SAMUEL A (contact)

PROJECT_TERMS: Address;Animal Model;antimicrobial;Antimicrobial Resistance;antimicrobial resistant infection;antimicrobial resistant pathogen;Area;carbapenem-resistant Enterobacteriaceae;Characteristics;Classification;Clinical;Clinical Data;Clinical Research;Clostridium difficile;cohort;Cohort Studies;colonization resistance;commensal microbes;Communicable Diseases;Critical Illness;Data;Data Analyses;deep sequencing;Development;drug resistant pathogen;Elements;Extended-spectrum β-lactamase;Feces;Functional disorder;Genomics;Goals;gulf coast;gut colonization;gut microbiome;gut microbiota;Health;Hematopoietic Stem Cell Transplantation;high risk;Hospitals;Human;Human Microbiome;Immunocompromised Host;indexing;Infection;insight;Intensive Care Units;Intestines;Knowledge;Length of Stay;Longitudinal Studies;Mediating;Medical center;Metagenomics;microbiome;microbiome analysis;microbiome composition;microbiota;microbiota profiles;multi-drug resistant pathogen;Mus;Nature;new technology;novel;Organism;pathogen;Pathogenesis;patient population;patient subsets;Patients;Physicians;Predisposition;Preventive;programs;Protocols documentation;Public Health;Publishing;Research;resident commensals;Resistance;Ribosomal RNA;Risk;risk stratification;Sampling;Scientist;Scourge;Signal Transduction;Site;stool sample;synergism;System;Systems Biology;Testing;Texas;Therapeutic;tool;Transplant Recipients;Vancomycin resistant enterococcus;Work

PROJECT_TITLE: Project 2: Leveraging Metagenomics of the Microbiome to predict colonization/infection by antimicrobial-resistant pathogens


NIH_SPENDING_CATS: Antimicrobial Resistance;Biodefense and Related Countermeasures;Emerging Infectious Diseases;Infectious Diseases;Microbiome;Patient Safety

PI_NAMEs: SAVIDGE, TOR C. (contact)

PROJECT_TERMS: Achievement;Address;Admission activity;Adult;Algorithms;Antibiotic Therapy;Antibiotics;antimicrobial;Antimicrobial Resistance;Bacteria;bacteriocin;carbapenem resistance;Cessation of life;Child;Clinical;Clinical Management;Clostridium difficile;cohort;combat;Communicable Diseases;Communities;Critical Illness;Data;design;Development;Disease;Disease Outcome;Disease Progression;Disease susceptibility;effective therapy;Emerging infection;Extended-spectrum β-lactamase;functional genomics;Goals;gut colonization;gut microbiota;hazard;Healthcare;high risk;Hospitalization;host microbiota;Immune response;Immunocompromised Host;immunosuppressed;Indigenous;Individual;Infant;Infection;infection management;infection risk;infectious disease model;innovation;insight;Intensive Care Units;Link;Medical;Metabolic;Metabolic Pathway;Metagenomics;metaproteomics;microbiome;microbiota;Modern Medicine;multi-drug resistant pathogen;Nosocomial Infections;novel strategies;novel therapeutics;Organism;Outcome;pathogen;pathogenic bacteria;Patients;permissiveness;Physicians;Population;Predisposition;prevent;priority pathogen;prospective;Public Health;Publishing;Resistance;resistant Klebsiella pneumoniae;resistome;Risk;Risk Factors;Shotguns;Signal Transduction;Stem cell transplant;Structure;System;technology platform;Testing;Therapeutic Intervention;trait;Transplant Recipients;treatment planning;Vancomycin resistant enterococcus;Virulence

PROJECT_TITLE: Project 3: Functional Microbiome and Host Signatures in Transition from Commensal to pathogen


ADMINISTERING_IC: NS

IC_NAME: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

NIH_SPENDING_CATS: Biotechnology;Brain Cancer;Brain Disorders;Cancer;Cancer Genomics;Clinical Research;Genetics;Human Genome;Immunization;Immunotherapy;Neurosciences;Orphan Drug;Rare Diseases;Vaccine Related

ORG_CITY: BOSTON

ORG_NAME: MASSACHUSETTS GENERAL HOSPITAL

PHR: PROJECT NARRATIVE The powerful convergence of cancer genome sequencing and immunotherapy has led to the cancer immunogenomics concept and its application to identify mutations in cancer that can be recognized by the immune system and targeted therapeutically. We have applied this approach to identify neoantigens for mechanistic studies in preclinical models of glioblastoma (GBM), to study how cDC1 innate cells present these neoantigens to the immune system, and to develop novel clinical trial programs aimed at targeting these epitopes therapeutically in combination with checkpoint blockade in patients with GBM. Our proposed work will expand our insights into the use of vaccines to target neoantigens in GBM, how the immune system against these tumor-specific targets is primed, and provide critical translational understanding of the immune responses generated in patients enrolled in a novel neoantigen vaccine trial supplemented with checkpoint blockade immunotherapy.

PI_NAMEs: DUNN, GAVIN PETER (contact)

PROGRAM_OFFICER_NAME: KOTLIAROVA, SVETLANA

PROJECT_TERMS: Adaptive Immune System;Address;Anatomy;anti-CTLA4;anti-PD-1;anti-tumor immune response;Antigen Presentation;Antigen Targeting;Antigen-Presenting Cells;antigen-specific T cells;Antigens;Area;Brain;brain cell;Brain Neoplasms;cancer genome;cancer genomics;cancer type;Cancer Vaccines;CD8B1 gene;Cells;Central Nervous System;Cephalic;Cervical lymph node group;Clinical;clinical trial protocol;Clinical Trials;Computational Biology;Conduct Clinical Trials;Dendritic cell tumor;Dendritic Cells;design;Development;Diagnosis;effective therapy;effectiveness evaluation;efficacy evaluation;Epitopes;experimental study;Genome;genome sequencing;Genomics;Glioblastoma;Goals;Histocompatibility;Immune;immune checkpoint blockade;immune resistance;Immune response;Immune system;Immune Targeting;Immunobiology;immunogenic;immunogenicity;Immunogenomics;Immunologics;Immunology;Immunooncology;Immunotherapeutic agent;Immunotherapy;improved;in vivo;Infiltration;insight;Investigation;ipilimumab;Link;Location;Lymphocyte;Malignant neoplasm of brain;Malignant Neoplasms;Methodology;MHC Class II Genes;Modeling;Mus;mutant;Mutation;neoantigen vaccination;neoantigen vaccine;neoantigens;neoplastic cell;Newly Diagnosed;Nivolumab;Normal Cell;novel;Outcome;participant enrollment;Patients;Peptide Vaccines;personalized cancer vaccines;Physiologic pulse;Polyvalent Vaccine;Population;pre-clinical;Pre-Clinical Model;Process;programs;Recurrent tumor;Reporter;response;Role;Somatic Mutation;standard of care;success;T cell response;T-Lymphocyte;targeted treatment;Testing;Therapeutic;Therapeutic Effect;therapeutic vaccine;trafficking;Treatment Efficacy;tumor;Tumor Antigens;Tumor Immunity;tumor microenvironment;Vaccination;vaccine efficacy;vaccine response;vaccine trial;Vaccines;Work;XCR1 gene

PROJECT_TITLE: Targeting Neoantigens in Glioblastoma

STUDY_SECTION: CNBT

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


NIH_SPENDING_CATS: 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;Health Services;Infectious Diseases;Networking and Information Technology R&D (NITRD);Racial and Ethnic Minority Health Research;Social Determinants of Health;Telehealth

ORG_CITY: WEST COVINA

ORG_NAME: SENTIENT RESEARCH, INC.

PHR: PROJECT NARRATIVE Our Virtual Support System (VSS) is an app and mobile website that provides information and social support to help young Black men who have sex with men (YBMSM) living with HIV achieve better HIV care continuum outcomes and overall well-being. In this Phase II SBIR project, we will fully build out and test VSS in a randomized controlled trial and qualitative evaluation. We will also create a plan to deploy VSS nationally to organizations that provide HIV testing and care services to YBMSM, to ultimately reduce HIV-related disparities in this population.

PI_NAMEs: MONTOYA, JORGE ALEJANDRO (contact)

PROGRAM_OFFICER_NAME: PADGETT, LYNNE SLAUGHTER

PROJECT_TERMS: Acquired Immunodeficiency Syndrome;Address;Adherence;Age;antiretroviral therapy;arm;Black AIDS;black men who have sex with men;Black Populations;care outcomes;care systems;Caring;Case Management;Centers for Disease Control and Prevention (U.S.);Chronic stress;Client;Collaborations;commercialization;Communities;Consultations;Continuity of Patient Care;cost;dashboard;design;Development;Disparity;disparity reduction;dosage;Effectiveness;Elements;Ensure;experience;Foundations;Health;Healthcare;Hispanic;HIV;HIV anti-retroviral;HIV diagnosis;HIV disparities;HIV/AIDS;holistic approach;Hour;human centered design;Human immunodeficiency virus test;improved;innovation;Intervention;Interview;Latino;Latino Population;Letters;Marketing;Measures;men who have sex with men;Mental Health;mHealth;mhealth interventions;Outcome;Participant;peer;peer support;Personal Satisfaction;Persons;Phase;Population;programs;prototype;Provider;Public Health;Qualitative Evaluations;Quality of life;Randomized, Controlled Trials;Research;Research Personnel;Resources;satisfaction;service organization;service providers;Services;Site;Small Business Innovation Research Grant;social health determinants;social stigma;Social support;substance use;Support System;Surveys;syndemic;System;Technology;Testing;testing services;theories;tool;transmission process;treatment arm;United States;uptake;usability;Viral;virtual;virtual assessment;Voice;web site;Work

PROJECT_TITLE: A Video-Based mHealth Program to Support People Living with HIV Across the HIV Care Continuum


ADMINISTERING_IC: FD

IC_NAME: FOOD AND DRUG ADMINISTRATION

ORG_NAME: UNIVERSITY OF TX MD ANDERSON CAN CTR

PHR: Project Narrative: Approximately 30-40% of children with brain cancer do not survive, and current therapies including surgery, chemotherapy and radiation are very damaging to the developing brain of a child resulting in long-term disability in survivors of childhood brain cancer. Engineered herpes simplex virus (HSV) therapy is an innovative treatment approach designed to target and kill tumor cells while sparing normal brain cells and to stimulate the patient’s immune system to attack the tumor. The goal of the proposed study is to determine the safety of engineered HSV G207 alone and when combined with a single low dose of radiation in children with refractory cerebellar brain tumors; The information gained from this trial will be used to advance G207 to target pediatric brain tumors.

PI_NAMEs: FRIEDMAN, GREGORY K (contact)

PROGRAM_OFFICER_NAME: JOHNSON, LLOYD

PROJECT_TITLE: Ph1 Study of HSV G207 in Pediatric Malignant Cerebellar Tumors IND 16294 01/05/18.


ADMINISTERING_IC: HL

IC_NAME: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

NIH_SPENDING_CATS: Cardiovascular;Congenital Heart Disease;Congenital Structural Anomalies;Heart Disease;Pediatric;Rare Diseases;Stem Cell Research;Stem Cell Research - Induced Pluripotent Stem Cell;Stem Cell Research - Induced Pluripotent Stem Cell - Human

ORG_DEPT: ANATOMY/CELL BIOLOGY

PHR: Project Narrative This project proposes to generate four-chambered cardiac organoids with valves and septum through organoid fusions to model and treat congenital heart defects.

PI_NAMEs: LI, GUANG  (contact)

PROGRAM_OFFICER_NAME: THAKAR, RAHUL GAUTAM

PROJECT_TERMS: Anatomy;Cardiac;cardiogenesis;Cell Line;congenital heart abnormality;Congenital Heart Defects;Defect;Development;Diagnosis;Disease;disease model;Disease Progression;Generations;Genetic;Goals;Heart;Heart Atrium;Heart Septum;Heart Valves;Human;human induced pluripotent stem cells;improved;Live Birth;Methods;Modeling;Mus;Mutation;novel;Organoids;Patients;prevent;Process;species difference;Structure;success;Techniques;Tissues;Ventricular

PROJECT_TITLE: Generation of four-chambered hearts through organoid fusions


ORG_CITY: Aurora

ORG_NAME: VA EASTERN COLORADO HEALTH CARE SYSTEM

ORG_STATE: CO

PHR: VA developed the Life Sustaining Treatment Decisions Initiative (LSTDI) to elicit, document, and honor the values, goals, and preferences of Veterans with serious illness. The LSTDI is important to Veterans because it ensures they can express their preferences for life sustaining treatments (e.g., cardiopulmonary resuscitation, breathing machine, artificial nutrition) and have them honored. However, across VA nationally, only 39% of LSTDI conversations occur in the outpatient setting; the majority occur in the inpatient setting often close to death. At this late stage, Veterans are often not able to make their preferences known because they are so ill. Decisions fall to surrogates who may be uncertain about what the Veteran would have wanted. This study will examine ways to increase LSTDI conversations among Veterans and their health care providers earlier in illness in the outpatient setting.

PI_NAMEs: BEKELMAN, DAVID B. (contact);WALLING, ANNE M

PROJECT_TERMS: Academy;Address;Breathing;Cardiopulmonary Resuscitation;Caregivers;Caring;Cessation of life;Characteristics;Chronic Disease;Chronic Obstructive Pulmonary Disease;Collaborations;Colorado;COVID-19;COVID-19 morbidity;COVID-19 mortality;Data;data warehouse;decision-making capacity;Dementia;Documentation;effectiveness evaluation;end of life care;Ensure;Ethics;Evaluation;evidence base;experience;Failure;falls;Family;Fostering;Foundations;Goals;Health;Health Personnel;Health system;Healthcare;Healthcare Systems;Heart failure;high risk;Hospitalization;implementation strategy;improved;innovation;Inpatients;interest;Interview;Kidney Diseases;Learning;Life;Liver diseases;Los Angeles;Lung Diseases;Malignant Neoplasms;Mechanical ventilation;Medical;Medical center;Medicine;meetings;member;Methodology;Methods;Needs Assessment;nutrition;operation;Outpatients;Palliative Care;Participant;Patients;Personal Satisfaction;Persons;Policies;population based;preference;Primary Care;prognostic;Provider;Randomized;Recommendation;Research;research and development;Research Design;Resources;Resuscitation;Risk;Sequential Multiple Assignment Randomized Trial;Site;success;Surveys;telehealth;Testing;Time;Training;Veterans;Visit;web site

PROJECT_TITLE: Improving Implementation of Outpatient Goals of Care Conversations for Veteranswith Serious Illness


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

ORG_CITY: DALLAS

ORG_DEPT: BIOCHEMISTRY

ORG_NAME: UT SOUTHWESTERN MEDICAL CENTER

PHR: PROJECT NARRATIVE The resolution revolution of cryo-electron microscopy has revealed that a given amyloid precursor can form structurally different assemblies, or polymorphs, that seem to associate with distinct disease. However, the association of these specific assemblies with the biology and pathology of an amyloid disease is still unclear. I aim to establish a multidisciplinary high-risk program to obtain atomic information about amyloid fibrils using cryo-electron microscopy, to analyze their pathological role in a co-culture cell system to be developed in my laboratory, and to design structure-specific tools to use in the clinic.

PI_NAMEs: SAELICES GOMEZ, LORENA  (contact)

PROGRAM_OFFICER_NAME: DANTHI, NARASIMHAN

PROJECT_TITLE: Closing the gap between structural biology and translational science for amyloid diseases


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

ORG_NAME: COGNITION THERAPEUTICS, INC.

PHR: Project Narrative Despite universal recognition of a desperate need for effective disease modifying therapy for Alzheimer’s disease (AD) there has been no successful development of such a drug, however, advances in AD therapeutic research have set the stage for effective treatment of sporadic AD at early stages. Available evidence points to accumulation of the Aβ 42 protein, and its self- association into toxic oligomers that cause synaptic dysfunction and loss as a central feature of AD. This Phase 2 clinical trial will test the ability of CT1812, a novel anti-oligomer small molecule therapeutic to halt or slow cognitive decline in early AD patients. If successful, this trial will inform the design and methods of subsequent Phase 3 trials of CT1812, a drug candidate with the potential to significantly alleviate the suffering of millions of AD patients.

PI_NAMEs: AISEN, PAUL S.;CAGGIANO, ANTHONY O (contact);VAN DYCK, CHRISTOPHER H

PROJECT_TERMS: abeta accumulation;Abeta clearance;abeta oligomer;absorption;Adverse event;Affect;Alzheimer's Disease;Alzheimer's disease patient;Alzheimer's disease therapeutic;Alzheimer's disease therapy;Amyloid beta-Protein;antagonist;assault;Binding;Biological Markers;Brain;brain volume;Cerebrospinal Fluid;Clinical Trials Cooperative Group;Cognition;Cognitive;cognitive function;Complex;design;Development;Disease;Disease Progression;Disinhibition;Dose;Double-Blind Method;drug candidate;effective therapy;Fumarates;functional decline;Functional disorder;Growth;Headache;healthy volunteer;Hippocampus;Impaired cognition;improved;Ligands;Lipids;lipophilicity;Magnetic Resonance Imaging;Measures;Methods;Modification;Nerve Degeneration;neurogranin;Neurons;novel;Oral Administration;Outcome;Patients;Pharmaceutical Preparations;Pharmacodynamics;Phase;phase I trial;Phase II Clinical Trials;phase II trial;phase III trial;Placebo Control;Placebos;Plasma;preclinical study;primary outcome;progression marker;protein oligomer;Proteins;Randomized;receptor;Reporting;restoration;Role;Safety;safety assessment;Serum;sigma-2 receptor;Site;small molecule;small molecule therapeutics;Sodium Chloride;Synapses;synaptic function;Synaptic Receptors;synaptotagmin;targeted biomarker;tau Proteins;Testing;Therapeutic;Therapeutic Research;Time;treatment duration

PROJECT_TITLE: Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease over 18 Months


ORG_CITY: NORTH CHARLESTON

ORG_NAME: EXPANSE BIO LLC

ORG_STATE: SC

PHR: There is a need and opportunity to improve the lives of the 150,000 young cancer patients each year in the US, who face infertility and low endocrine function, resulting in lifelong side-effects including profound sexual dysfunction, depression, and increased risk of osteoporosis and heart disease due to the profoundly damaging effects that radiation and chemotherapy has on reproductive organs. Fertility preservation was recently recognized by the American Society of Clinical Oncology and the American Society of Reproductive Medicine as one of the most prominent survivorship issues for patients. Our comprehensive approach for banking whole human ovaries brings a totally new capabliity to the oncofertility field and helps solve many of these problems cancer survivors face; and while this Phase 2 project focuses on primarily on the impact whole ovary banking has on the $1 billion oncofertility and $5.4 billion infertility markets, the $30 billion vital organ banking market can, in extension, be addressed through the same technology platform.

PI_NAMEs: BISCHOF, JOHN C;WEEGMAN, BRADLEY P (contact)

PROGRAM_OFFICER_NAME: WEBER, PATRICIA A

PROJECT_TERMS: Address;American;American Society of Clinical Oncology;Area;Autologous Transplantation;Biological;biomaterial compatibility;Biomedical Research;Cancer Patient;Cancer Survivor;cancer therapy;Cell model;Cells;chemotherapy;Chemotherapy and/or radiation;Childhood;Clinic;Clinical;clinical practice;commercialization;Complex;Computer Models;Continuance of life;Cryopreservation;Cryopreserved Tissue;Cryoprotective Agents;Crystallization;Data;Development;Endocrine;Equilibrium;Equipment;Evaluation;expectation;experience;Face;Fertility;fertility preservation;Formulation;Foundations;Fracture;Freezing;Future;Genitourinary system;Glass;Growth;Heart Diseases;high throughput screening;Hormone imbalance;Hormones;Human;Ice;improved;In Vitro;in vivo;Individual;Infertility;Interdisciplinary Study;iron oxide nanoparticle;Leadership;Letters;Magnetic Resonance Imaging;Malignant Neoplasms;Marketing;Mental Depression;Methods;minimally invasive;Modeling;Mus;nanoparticle;nanowarming;next generation;nonhuman primate;novel;novel strategies;Nude Mice;oncofertility;Organ;Organ Transplantation;Osteoporosis;Ovarian Tissue;Ovary;Patients;Perfusion;Phase;phase 1 study;phase 2 study;pre-clinical;preconditioning;preservation;prevent;Primates;Procedures;programs;protocol development;Protocols documentation;Public Health;radiation effect;Radiation therapy;radio frequency;Recovery;Regenerative Medicine;reproductive;Reproductive Medicine;reproductive organ;Research;Research Priority;Rewarming;Risk;Scientist;screening;Sexual Dysfunction;side effect;Societies;success;Surgical Replantation;System;Technology;technology platform;Testing;Testis;Tissue Engineering;Tissue imaging;Tissue Transplantation;Tissue Viability;Tissues;tool;Toxic effect;Translations;transplant model;Transplantation;trauma care;United States National Institutes of Health;Uterus;Validation;Vascular Graft;Vascularization;Work;working group;Xenograft Model;Xenograft procedure;young adult;young cancer survivor

PROJECT_TITLE: Type-7: Fertility Protection in Cancer: Recovery of Whole Ovaries enabled by Next Gen Perfusion, Cryoprotection, and Nanowarming


ORG_NAME: VETERANS HEALTH ADMINISTRATION

PHR: The proposed research will leverage VA’s unique data resources to develop new information about the prevalence and prediction of postoperative Loss of Independence (LOI) and how this information can be operationally implemented to support shared decisions about surgical treatment that are better aligned with patients’ goals and values. The proposal is responsive to multiple VA research priorities to optimize long-term care and aging and transform VA data into a national resource. It also aligns with the operational priorities of the National Surgery Office and Geriatrics and Extended Care to empower patients and families to be involved in health care decisions, especially with an aging population. A reliable, operationalized long-term LOI prognosis will provide VA and key stakeholders with critical evidence about the kind of recovery frail patients can experience after surgery and inform a subsequent implementation trial aimed at aligning shared decisions about surgery with patients’ goals and values.

PI_NAMEs: RODRIGUEZ, KERI LYN (contact)

PROJECT_TERMS: Acute;Address;Aging;aging population;Calibration;Caregivers;Clinical;Communication;Data;Data Files;data resource;Databases;Decision Aid;Decision Making;Development;Electronic Health Record;Emergency Situation;empowerment;experience;Family;Focus Groups;frailty;functional status;Geriatrics;Goals;health care service utilization;Healthcare;Healthcare Systems;Heterogeneity;Home;hospital readmission;implementation trial;improved;indexing;informal caregiver;innovation;Inpatients;Institutionalization;Interview;Investments;Knowledge;Link;Long-Term Care;Measures;Methods;Modeling;mortality;Office Surgery;Operative Surgical Procedures;Outcome;Outpatients;patient oriented;Patient-Focused Outcomes;Patients;Pattern;Perioperative;Physiological;point of care;Postoperative Period;postoperative recovery;predictive modeling;preference;preservation;Prevalence;Procedures;Prognosis;programs;Quality of life;Recording of previous events;Recovery;Registries;Rehabilitation therapy;Research;Research Priority;Resources;response;Risk;Risk Factors;Sampling;Skilled Nursing Facilities;stakeholder perspectives;Stress;Structure;Surgeon;Surveys;Time;treatment planning;Veterans;Work

PROJECT_TITLE: Improving surgical decision-making by measuring and predicting long-term loss of independence after surgery


NIH_SPENDING_CATS: Amyotrophic Lateral Sclerosis (ALS);Assistive Technology;Behavioral and Social Science;Bioengineering;Brain Disorders;Clinical Research;Clinical Trials and Supportive Activities;Drug Abuse (NIDA only);Neurodegenerative;Neurosciences;Rare Diseases;Rehabilitation;Substance Misuse

ORG_CITY: BALTIMORE

ORG_NAME: JOHNS HOPKINS UNIVERSITY

ORG_STATE: MD

PHR: This first-in-human early feasibility clinical trial (NCT03567213, ClinicalTrials.gov) will enroll up to 5 subjects to test the safety and efficacy of the CortiCom System, an implantable brain-computer interface (BCI) that is designed to restore communication to patients with Locked-In Syndrome (LIS). LIS is a devastating, often irreversible, neurological condition in which cognition is intact but nearly all motor output from the brain is interrupted, effectively cutting off communication with the outside world. This study will explore the potential capabilities of large, high density arrays of non-penetrating electrodes, implanted on the brain surface, to restore motor output and communication to patients with LIS and other severe motor impairments.

PI_NAMEs: CRONE, NATHAN E (contact);RAMSEY, NICOLAS FRANCISCUS

PROGRAM_OFFICER_NAME: WU, GUANGYING

PROJECT_TERMS: Academic Medical Centers;Amendment;Amyotrophic Lateral Sclerosis;Anatomy;arm;Articulators;Back;Blinking;Brain;brain computer interface;Brain Stem;Caregivers;Classification;Clinical Trials;Cognition;cognitive load;Communication;Complex;density;design;Detection;Devices;Diameter;Electrocorticogram;Electrodes;Electroencephalography;Enrollment;Epilepsy;Eye;Eye Movements;Face;Fatigue;feasibility testing;feasibility trial;Fingers;first-in-human;Freedom;Frequencies;Gestures;Hand;Home;Home environment;Hybrids;Implant;Institutional Review Boards;Interruption;Intuition;Investigation;Joints;Learning;Left;Lesion;Locked-In Syndrome;Love;Microelectrodes;microsystems;Modeling;Motor Cortex;Motor disability;motor impairment;Motor output;Movement;Muscle;neural;neural implant;Neurodegenerative Disorders;Neurologic;Neurons;neuroregulation;neurotransmission;operation;Oral cavity;Paper;Patients;phrases;Population;portability;Prosthesis;prosthesis control;Reporting;Research Personnel;Resolution;response;Risk;robot control;Safety;safety testing;Secure;Self-Help Devices;Signal Transduction;Speech;Stroke;success;Supervision;Surface;System;temporal measurement;Testing;Time;Tissues;Training;tumor;Universities;Upper limb movement;Vocabulary;wireless implant

PROJECT_TITLE: Investigation of the Cortical Communication (CORTICOM) System


NIH_SPENDING_CATS: Brain Disorders;Clinical Research;Genetics;Huntington's Disease;Neurodegenerative;Neurosciences;Pediatric;Prevention;Rare Diseases

ORG_CITY: IOWA CITY

ORG_NAME: UNIVERSITY OF IOWA

ORG_STATE: IA

PHR: NARRATIVE This proposal is a competitive renewal for a unique study that measures the volume, function, and development of striatal-cerebellar circuity in subjects at risk for Huntington's Disease (HD). Degeneration is a key component in the disease process, yet our program evaluates the crucial component of abnormal development as a key part of the disease process. The current proposal is designed to expand and extend our sample to a multi-site (5) program that evaluates growth and development of striatal-cerebellar circuitry from age 6-30, modeling the full extent of brain maturation.

PI_NAMEs: NOPOULOS, PEGGY C (contact)

PROGRAM_OFFICER_NAME: MILLER, DANIEL L

PROJECT_TERMS: Acceleration;Age;Age Years;Antisense Oligonucleotide Therapy;autosome;Behavioral;Biological Markers;Blood;Brain;brain abnormalities;CAG repeat;California;Cerebellum;Child;Childhood;Cognition;Cognitive;cognitive development;Corpus striatum structure;Data;Degenerative Disorder;design;Development;Diffusion Magnetic Resonance Imaging;Disadvantaged;Disease;DNA;early childhood;frontal lobe function;Funding;Genes;Genotype;Globus Pallidus;grandparent;Grant;Growth;Growth and Development function;Human;Huntington Disease;Huntington gene;Hypertrophy;Iowa;knock-down;Length;Light;longitudinal design;Magnetic Resonance Imaging;Measures;Modeling;Motor;mutant;Neurodegenerative Disorders;neurofilament;Neuronal Dysfunction;novel;Parents;Participant;Pathology;Patients;Pediatric Hospitals;Pennsylvania;Phase;phase 3 study;Philadelphia;prevent;Preventive therapy;Process;programs;Puberty;putamen;Research Support;Rest;Risk;Sample Size;Sampling;Shapes;Signal Transduction;Site;Structure;Study Subject;Symptoms;Texas;Trinucleotide Repeats;Universities;verbal

PROJECT_TITLE: Growth and development of Striatal-Cerebellum circuitry in subjects at risk for Huntington’s Disease

STUDY_SECTION: CNN

STUDY_SECTION_NAME: Clinical Neuroscience and Neurodegeneration Study Section[CNN]


FUNDING_MECHANISM: OTHERS

ORG_NAME: VA BOSTON HEALTH CARE SYSTEM

PHR: This research proposal seeks to create screening approaches for aggressive melanoma specific to Veterans, who as a population, are more likely to develop melanoma than civilians. We will use data from the national VA healthcare system and the Million Veteran Program to create a tool that can identify those at greatest risk of developing aggressive melanoma using clinical and genetic risk factors. This tool can subsequently be used by clinicians to identify Veteran patients who will benefit most from melanoma screening. This proposal directly aligns with two of the four stated VA strategic research priorities, including to “increase the substantial real- world impact of VA research” as the risk prediction model can be trialed as a clinical decision support tool and to “put VA data to work for Veterans” by using the rich VA dataset to obtain information that will benefit both Veterans and the nation.

PI_NAMEs: HARTMAN, REBECCA IVY (contact)

PROJECT_TERMS: Accounting;Age;agent orange;Altitude;Award;Big Data;big-data science;biobank;cancer epidemiology;Candidate Disease Gene;career;Case Study;Cessation of life;Chronic;Clinical;clinical application;clinical decision support;clinical predictive model;clinical risk;Clinical Trials;cohort;comorbidity;Cutaneous Melanoma;Data;Data Analyses;Data Set;data warehouse;demographics;Dermatologist;Dermatology;Detection;Development;Diagnosis;diagnostic strategy;Disease;Early Diagnosis;Electronic Health Record;Environmental Exposure;Environmental Risk Factor;epidemiologic data;Epidemiology;epidemiology study;Ethnic Origin;Future;General Anesthesia;genetic analysis;genetic association;genetic epidemiology;Genetic Risk;genetic risk factor;genome wide association study;genomic data;Goals;hazard;Health;health care service utilization;Health Services Research;Healthcare Systems;high risk;human old age (65+);Immunosuppression;improved;Information Centers;insight;Ionizing radiation;Knowledge;Logistic Regressions;Machine Learning;male;Malignant Neoplasms;Massachusetts;Melanoma;Melanoma patient;Mentors;Mentorship;Military Personnel;Modeling;Nevus;novel;novel therapeutics;Oncology;oncology program;Operative Surgical Procedures;Outcome;Outpatients;Patient risk;Patient Selection;Patients;Performance;Pharmaceutical Preparations;Phenotype;Photosensitizing Agents;polygenic risk score;Population;precision oncology;predictive tools;Predisposition;primary care provider;Prognosis;Program Description;programs;prospective;prospective test;Race;Recording of previous events;Regression Analysis;Research;Research Design;Research Personnel;Research Priority;Research Proposals;Retrospective cohort study;Risk;Risk Assessment;Risk Factors;risk prediction model;risk stratification;ROC Curve;Sample Size;screening;screening guidelines;Sentinel Lymph Node Biopsy;Services;Severities;sex;Single Nucleotide Polymorphism;skills;Skin Cancer;Sun Exposure;support tools;Testing;Therapeutic;tool;Training;Training Programs;Treatment Cost;treatment strategy;Triage;tumor;Tumor stage;Ultraviolet Rays;Veterans;Work

PROJECT_TITLE: Risk Factors for Clinically Aggressive Melanoma in Veterans

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 ONCB-A (01)]


ORG_CITY: PORTLAND

ORG_NAME: PORTLAND VA MEDICAL CENTER

PHR: Prostate cancer treatment options are historically based on clinical stage, prostate specific antigen (PSA) blood test, and grade, or appearance of the tumor under the microscope. Recent scientific advances in molecular research have shown that a common finding in high-risk cancers prostate cancers that are surgically removed is loss of the phosphatase and tensin homologue (PTEN) gene, which leads to increased activity of the AKT gene. PTEN loss is associated with higher rates of prostate cancer recurrence, spread to other organs, and death from cancer. This study will change standard treatment by combining common prostate cancer drugs that target male hormones (abiraterone and leuprolide) with an investigational AKT inhibitor (capivasertib) prior to surgical removal of the prostate. The goal is that early precision treatment of aggressive disease will result minimal residual or no cancer at the time of prostatectomy, and subsequently improved cancer outcomes.

PI_NAMEs: KOPP, RYAN PATRICK (contact)

PROJECT_TERMS: 3-Phosphoinositide Dependent Protein Kinase-1;abiraterone;AKT inhibition;AKT Signaling Pathway;androgen deprivation therapy;androgen independent prostate cancer;Androgen Receptor;Androgens;antagonist;Appearance;arm;Biological Markers;biomarker discovery;Biopsy;Blood Tests;Cancer Etiology;Cancer Patient;cancer recurrence;cancer surgery;Cell model;Cessation of life;Clinical;cohort;Combined Modality Therapy;Data;deprivation;Development;Disease;Disease Progression;DNA sequencing;Drug Targeting;efficacy evaluation;enzalutamide;Excision;Feedback;Gene Activation;Genes;Goals;high risk;High-Risk Cancer;Hormones;Human;improved;Infrastructure;inhibitor;inhibitor therapy;Institution;Investigation;Knock-out;Knowledge;Laboratory Research;Lead;Leuprolide;Maintenance;male;Malignant neoplasm of prostate;Malignant Neoplasms;men;Metastatic Prostate Cancer;Methods;Microscope;Molecular;molecular imaging;Molecular Profiling;molecular scale;mortality;mouse model;Mutation;Neoadjuvant Therapy;Neoplasm Metastasis;Nonmetastatic;novel;oncology program;oncology trial;Operative Surgical Procedures;Organ;Outcome;Pathologic;Pathology;Pathway interactions;Patients;phase 2 study;phase I trial;phase II trial;phase III trial;Phosphatidylinositols;Phosphotransferases;Play;pre-clinical;Pre-Clinical Model;precision oncology;Precision therapeutics;Prognosis;Progression-Free Survivals;Prostate;prostate cancer cell;prostate cancer progression;prostate cancer risk;Prostate Cancer therapy;Prostate-Specific Antigen;Prostatectomy;Proto-Oncogene Proteins c-akt;Protocols documentation;PTEN gene;Radical Prostatectomy;Receptor Cross-Talk;Receptor Signaling;Regulation;Research;Residual Cancers;Residual Neoplasm;Residual state;Resistance;resistance mechanism;response;Role;Running;Safety;Scientific Advances and Accomplishments;Signal Transduction;standard care;Systemic Therapy;targeted agent;targeted treatment;Testing;therapy resistant;Time;Tissues;Translational Research;treatment response;treatment trial;tumor;Tumor Suppressor Genes;United States;Up-Regulation;Xenograft Model

PROJECT_TITLE: Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer with PTEN Loss

STUDY_SECTION_NAME: Special Emphasis Panel[ZRD1 SPLP-Y (01)]


NIH_SPENDING_CATS: Biomedical Imaging;Cancer;Cancer Genomics;Clinical Research;Clinical Trials and Supportive Activities;Genetics;Human Genome;Precision Medicine;Prostate Cancer;Radiation Oncology;Urologic Diseases

ORG_CITY: CLEVELAND

ORG_DEPT: RADIATION-DIAGNOSTIC/ONCOLOGY

ORG_NAME: CASE WESTERN RESERVE UNIVERSITY

PHR: Project Narrative The current standard of care treatment for men with newly diagnosed oligometastatic prostate cancer (PCa) is non-curative and this disease remains near uniformly fatal. The use of metastasis-directed therapy (MDT) in combination with systemic therapy and treatment of the primary has the potential to cure a subset of these men, but currently there is no biomarker to identify which men may benefit from this approach. The lack of imaging and molecular biomarkers to address this problem is a critical unmet need, and by leveraging the first phase 3 randomized trial assessing the benefit of MDT as part of the international STAMPEDE trial, we plan to quantify the benefit of MDT, and produce predictive imaging and molecular biomarkers to personalize treatment decisions and maximize each individual’s treatment response to MDT.

PI_NAMEs: SPRATT, DANIEL EIDELBERG (contact);SUN, YILUN

PROGRAM_OFFICER_NAME: VIKRAM, BHADRASAIN

PROJECT_TERMS: Ablation;Address;African American;Aftercare;American;Androgen Receptor;arm;Bioinformatics;Biological Markers;biomarker signature;Biometry;Biopsy;Biopsy Specimen;Blood;Blood Cells;bone imaging;burden of illness;Cancer Etiology;Castration;cell free DNA;Cessation of life;chemotherapy;Clinical;clinical center;Clinical Management;Clinical Trials;Collection;Country;Data;Diagnosis;Disease;Enrollment;exome;experience;Extramural Activities;Failure;feature extraction;FOLH1 gene;Genomics;Goals;Heterogeneity;Histologic;Image;imaging biomarker;imaging modality;imaging program;improved;Incidence;Individual;inhibitor;inhibitor therapy;International;Intramural Research Program;liquid biopsy;Malignant neoplasm of prostate;Malignant Neoplasms;men;Metastatic Prostate Cancer;Modeling;Molecular;molecular imaging;molecular marker;Molecular Profiling;molecular subtypes;Neoplasm Circulating Cells;Neoplasm Metastasis;Newly Diagnosed;next generation;North America;novel;patient biomarkers;Patients;Pattern;personalized medicine;PET/CT scan;Phase;phase II trial;phase III trial;Positron-Emission Tomography;predicting response;predictive marker;primary endpoint;Prognostic Marker;prospective;prostate biopsy;Prostatectomy;Quality of life;Radiation therapy;Radical Prostatectomy;radiomics;Randomized;randomized trial;Randomized, Controlled Trials;Receptor Signaling;Recording of previous events;Research;Resistance;Resources;response;response biomarker;Sampling;Site;Specimen;standard of care;Systemic Therapy;Testing;Therapeutic Trials;Time;Tissues;transcriptome;Translations;treatment response;United Kingdom;United States National Institutes of Health;Validation;Work;X-Ray Computed Tomography

PROJECT_TITLE: Quantifying and Personalizing the Clinical Benefit of Metastasis-Directed Therapy in Men with De Novo Oligometastatic Prostate Cancer