University Of Florida

COVID-19: HIGHER EDUCATION EMERGENCY RELIEF FUND-INSTITUTIONAL PORTION

CARES APPLICATION FOR UF

THE LIFE STUDY

TOGETHER: TRANSFORMING AND TRANSLATING DISCOVERY TO IMPROVE HEALTH

FEED THE FUTURE INNOVATION LAB FOR LIVESTOCK SYSTEMS

COMPARISON OF ANTI-COAGULATION AND ANTI-PLATELET THERAPIES FOR INTRACRANIAL VASCULAR ATHEROSTENOSIS - SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS (SICAS) IS A COMMON DISEASE ASSOCIATED WITH A VERY HIGH RISK OF STROKE. ALTHOUGH CLOPIDOGREL + ASPIRIN AND INTENSIVE RISK FACTOR MANAGEMENT ARE CONSIDERED STANDARD CARE FOR SICAS, THE 1-YEAR RATE OF ALL STROKE AND VASCULAR DEATH IN SUBJECTS PRESENTING WITH A SYMPTOMATIC INFARCT AND 70- 99% SICAS WAS 27% WITH THIS THERAPY IN THE SAMMPRIS TRIAL. CLEARLY, WE NEED BETTER TREATMENT. COMBINING TICAGRELOR WITH ASPIRIN MAY BE MORE EFFECTIVE THAN CLOPIDOGREL + ASPIRIN FOR SICAS BECAUSE TICAGRELOR PROVIDES FASTER, GREATER AND MORE CONSISTENT PLATELET INHIBITION THAN CLOPIDOGREL. ADDITIONALLY, TICAGRELOR IS A DIRECT P2Y12 RECEPTOR ANTAGONIST AND MAY BE MORE EFFECTIVE THAN CLOPIDOGREL IN PATIENTS WHO CARRY GENETIC SINGLE-NUCLEOTIDE LOSS-OF-FUNCTION (LOF) POLYMORPHISMS FOR THE CYP2C19 CYTOCHROME P450 ENZYME NECESSARY TO METABOLIZE CLOPIDOGREL TO ITS ACTIVE FORM. THE NOVEL ORAL ANTICOAGULANTS (NOAC) MAY ALSO OFFER POTENTIAL ADVANTAGES IN PATIENTS WITH SICAS. ATHEROSCLEROTIC DISEASE PROGRESSION TO AN UNSTABLE STATE IS CHARACTERIZED BY INCREASED PLATELET ACTIVATION, ELEVATED PROCOAGULANT ACTIVITY AND THROMBIN GENERATION, WHICH PROVIDES THE MECHANISTIC RATIONALE FOR COMBINING ANTICOAGULATION WITH AN ANTIPLATELET AGENT IN PATIENTS WITH ATHEROSCLEROSIS. HOWEVER, COMBINING FULL DOSE ANTICOAGULATION WITH AN ANTIPLATELET AGENT INCREASES THE RISK OF MAJOR HEMORRHAGE, INCLUDING INTRACEREBRAL HEMORRHAGE (ICH). THIS HAS LED TO INTEREST IN COMBINING A LOW DOSE NOAC WITH LOW DOSE ASPIRIN IN PATIENTS WITH ATHEROSCLEROSIS. WE PROPOSE A SEAMLESS PHASE II/III ADAPTIVE, PROSPECTIVE, DOUBLE-BLINDED, 3-ARM CLINICAL TRIAL AT 115 SITES THAT WILL RANDOMIZE 1683 HIGH-RISK SUBJECTS WITH SICAS TO 1 YEAR TREATMENT IN ONE OF THREE ARMS: 1) TICAGRELOR (180 MG LOADING DOSE, THEN 90MG TWICE DAILY), 2) LOW DOSE RIVAROXABAN (2.5MG TWICE DAILY), OR 3) CLOPIDOGREL (600MG LOADING DOSE, THEN 75 MG DAILY). ALL SUBJECTS WILL ALSO RECEIVE ASPIRIN (81MG DAILY) AND INTENSIVE RISK FACTOR MANAGEMENT PER THE SAMMPRIS PROTOCOL. THE 3-ARM PHASE II/III ADAPTIVE DESIGN INCREASES THE EFFICIENCY WITH WHICH WE CAN EVALUATE TWO NEW POTENTIAL THERAPIES FOR SICAS, USING A SHARED CONTROL GROUP AND A SHARED TRIAL INFRASTRUCTURE. THE PHASE II PRIMARY AIM IS TO IDENTIFY AN EXCESS OF ICH OR NON-ICH MAJOR HEMORRHAGE IN THE RIVAROXABAN OR TICAGRELOR ARMS THAT COULD LEAD TO AN EARLY TERMINATION OF ONE OR BOTH OF THOSE ARMS. THE PHASE III PRIMARY AIM IS TO DETERMINE IF THE EXPERIMENTAL ARM(S) (RIVAROXABAN OR TICAGRELOR OR BOTH) THAT PROGRESS FROM PHASE II TO PHASE III ARE SUPERIOR TO THE CLOPIDOGREL ARM FOR LOWERING THE 1-YEAR RATE OF THE PRIMARY ENDPOINT (ISCHEMIC STROKE, ICH, OR VASCULAR DEATH) IN SUBJECTS WITH 70-99% SICAS. THE EXPLORATORY AIM IS TO ESTIMATE THE IMPACT OF CYP2C19 LOF CARRIER STATUS ON ANY BENEFIT THAT THE TICAGRELOR OR LOW DOSE RIVAROXABAN ARMS MAY HAVE IN LOWERING THE PRIMARY ENDPOINT COMPARED WITH THE CLOPIDOGREL ARM. THIS INNOVATIVE TRIAL WILL EVALUATE TWO NEW ANTITHROMBOTIC APPROACHES TO MAXIMIZE THE CHANCE OF ESTABLISHING MORE EFFECTIVE THERAPY FOR SICAS, ONE OF THE MOST COMMON AND HIGH-RISK CEREBROVASCULAR DISEASES WORLDWIDE.

UFL TO ESTABLISH THE CONSORTIUM FOR NUCLEAR FORENSICS (CNF), CONSISTING OF 16 UNIVERSITIES (INCLUDING 4 MSIS) AND 7 NATIONAL LABORATORIES (NLS), TO PROVIDE THE RESEARCH, DEVELOPMENT, AND HUMAN CAPITAL NEEDED TO CREATE AND DEVELOP NEW SCIENTIFIC DISCOVERIES, TECHNOLOGIES, AND CAPABILITIES IN SUPPORT OF NNSA'S DEFENSE NUCLEAR NONPROLIFERATION RESEARCH AND DEVELOPMENT (DNN R&D) OFFICE AS RELATED TO NUCLEAR FORENSICS.

IMMUNE FUNCTION AND THE PROGRESSION TO TYPE 1 DIABETES

CYTOSKELETAL REGULATION OF LUNG ENDOTHELIAL PATHOBIOLOGY

CENTER FOR MOLECULAR MAGNETIC QUANTUM MATERIALS

COLLABORATION FOR EFFECTIVE EDUCATOR DEVELOPMENT, ACCOUNTABILITY, AND REFORM (CEEDAR 2.0) CENTER

1FLORIDA ALZHEIMER'S DISEASE RESEARCH CENTER

CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTER (OAIC)

MAGNETIC RESONANCE IMAGING AND BIOMARKERS FOR MUSCULAR DYSTROPHY

COLLABORATION FOR EFFECTIVE EDUCATOR DEVELOPMENT, ACCOUNTABILITY, AND REFORM: CEEDAR CENTER

IDIGBIO: SUSTAINING THE DIGITIZATION, MOBILIZATION, ACCESSIBILITY, AND USE OF BIODIVERSITY SPECIMEN DATA IN U.S. MUSEUM AND ACADEMIC COLLECTIONS

SOUTHEASTERN AND COASTAL CENTER FOR AGRICULTURE SAFETY AND HEALTH (SEC-CAGSH)

MODULATION OF MUSCLE GROWTH FOR THE MUSCULAR DYSTROPHIES

COLLABORATION FOR EFFECTIVE EDUCATOR DEVELOPMENT, ACCOUNTABILITY, AND REFORM CENTER (CEEDAR 3.0)

RESEARCH IN THEORETICAL AND EXPERIMENTAL ELEMENTARY PARTICLE PHYSICS

GENOMIC MEDICINE IMPLEMENTATION: THE PERSONALIZED MEDICINE PROGRAM

DIGITIZATION: IDIGBIO: INTEGRATED DIGITIZED BIOCOLLECTIONS PHASE 2

UNIVERSITY TRANSPORTATION CENTERS

ISCHEMIA-INTENSIVE MEDICAL TREATMENT REDUCES EVENTS IN WOMEN WITH NONOBSTRUCTIVE CAD

PHARMACOGENOMIC EVALUATION OF ANTIHYPERTENSIVE RESPONSES

INSTITUTE ON AGING CLINICAL TRANSLATIONAL RESEARCH BUILDING

RESEARCH IN HIGH ENERGY EXPERIMENTAL PHYSICS USING THE CMS DETECTOR AT THE LARGE HADRON COLLIDER, CERN, GENEVA

THROUGH A STRONG ACADEMIA-INDUSTRY PARTNERSHIP, AND AN INTEGRATED RESEARCH, EXTENSION, AND EDUCATION PROGRAM, THIS PROPOSAL AIMS TO DEVELOP A RESILIENT BRASSICA CARINATA (CARINATA) BASED BIOFUEL AND BIOPRODUCT SUPPLY CHAIN IN THE SOUTHEAST: FROM FEEDSTOCK DEVELOPMENT TO DISTRIBUTION TO END USER. SPECIFICALLY WE WILL: 1) IDENTIFY AND DEPLOY REGIONALLY ADAPTED CARINATA GENOTYPES FOR MAXIMUM PRODUCTIVITY AND RESOURCE USE EFFICIENCY; ENHANCE PRODUCTION ECONOMICS AND ENVIRONMENTAL SUSTAINABILITY THROUGH IMPROVING CROPPING SYSTEM FIT OF CARINATA; 2) PROVIDE AN ECONOMIC AND ENVIRONMENTAL FEASIBILITY ANALYSIS OF CARINATA BASED FUEL AND COPRODUCT DEVELOPMENT AND DISTRIBUTION; 3) CREATE VALUE ALONG THE CARINATA SUPPLY CHAIN THROUGH RESEARCH AND ADDRESS STAKEHOLDER NEEDS BY AUDIENCE-APPROPRIATE DISSEMINATION OF INFORMATION, AND TRAINING. THE STRENGTH OF THE PROPOSAL LIES IN THE EXTENSIVE BACKGROUND DATA WE HAVE COLLECTED ON CARINATA AGRONOMICS AND MANAGEMENT, A PROVEN CONVERSION PROCESS FOR FUELDEVELOPMENT WITH CONSEQUENT INTEREST FROM MILITARY AND COMMERCIAL AVIATION SECTORS, AND DEMONSTRATED MARKET DEMAND FOR NUMEROUS FUEL COPRODUCTS AND BIOPRODUCTS FROM CARINATA SEED MEAL. RESEARCH, EXTENSION, AND EDUCATION PROPOSED ON THIS GRANT WILL FOCUS ON SUSTAINABLE COMMERCIALIZATION OF CARINATA IN THE SOUTHEAST IN CONJUNCTION WITH DEVELOPMENT OF A TRAINED WORKFORCE TO SUPPORT A CARINATA BASED BIOECONOMY IN THE REGION. TO ENSURE SUCCESS, WE WILL EVALUATE STRENGTH OF OBJECTIVES AND VALIDITY OF APPROACH THROUGH CONSTANT COMMUNICATION AND FEEDBACK AMONG THE ADVISORY BOARD, STAKEHOLDER AND PROJECT TEAM MEMBERS.

NONCODING RNAS IN GAMMA-HERPESVIRUS BIOLOGY AND AIDS MALIGNANCIES

UF CLINICAL AND TRANSLATIONAL SCIENCE AWARD

GRAVITATIONAL REFERENCE ADVANCED TECHNOLOGY TEST IN SPACE (GRATTIS)

RFA: SUPPORT TO AGRICULTURAL RESEARCH AND DEVELOPMENT PROGRAM

PURPOSE: THE PURPOSE OF THIS AWARD IS TO PROVIDE SUPPORT TO CONTINUE A BAROTRAUMA REDUCTION PROGRAM DEVELOPED AND IMPLEMENTED DURING THE FY 2020 2023 PERIOD THOUGH THE FY 2024 2027 PERIOD AS PART OF POST-DEEPWATER HORIZON OIL SPILL FISHERIES RESTORATION EFFORTS. ACTIVITIES TO BE PERFORMED: THE PROGRAM BLENDS SCIENCE, MARKETING, AND COMMUNICATIONS WITH AN INTERACTIVE ON LINE LEARNING PLATFORM AND THE DISTRIBUTION OF FREE FISH DESCENDING GEAR TO INSPIRE AND EMPOWER ANGLERS TO TAKE AN ACTIVE AND LASTING ROLE IN SUSTAINING GULF OF MEXICO REEF FISH RESOURCES. UF/FLORIDA SEA GRANT WILL PROVIDE: A COMMUNICATIONS MANAGER TO SERVE AS PRINCIPAL PROGRAM PLANNER, ORGANIZER AND REPORTING AGENT; A MARKETING SERVICES MANAGER TO SUPPORT WEBSITE MANAGEMENT, GRAPHIC DESIGN AND OUTREACH PRODUCT DEVELOPMENT, DIGITAL AND SOCIAL MEDIA CONTENT DEVELOPMENT AND IMPLEMENTATION, MARKET PLACEMENT AND PROGRAM ADVERTISING, AND OVERSIGHT OF THE PROCUREMENT, WAREHOUSING AND SHIPPING OF FISH DESCENDING DEVICES; AND

ETHNIC DIFFERENCES IN RESPONSES TO PAINFUL STIMULI

DIGITIZATION HUB: A COLLECTIONS DIGITIZATION FRAMEWORK FOR THE 21ST CENTURY

MYOTONIC DYSTROPHY: MOLECULAR PATHOPHYSIOLOGY AND CNS EFFECTS

MODEL STATE-SUPPORTED AREA HEALTH EDUCATION CENTERS

VIVO: ENABLING NATIONAL NETWORKING OF SCIENTISTS

UF CLINICAL AND TRANSLATIONAL SCIENCE AWARD

OPTIMIZING COMBINATION THERAPY TO ACCELERATE CLINICAL CURE OF TUBERCULOSIS

GRADUATE RESEARCH FELLOWSHIP PROGRAM (GRFP) -THE NATIONAL SCIENCE FOUNDATION (NSF) GRADUATE RESEARCH FELLOWSHIP PROGRAM (GRFP) IS A HIGHLY COMPETITIVE, FEDERAL FELLOWSHIP PROGRAM. GRFP HELPS ENSURE THE VITALITY AND DIVERSITY OF THE SCIENTIFIC AND ENGINEERING WORKFORCE OF THE UNITED STATES. THE PROGRAM RECOGNIZES AND SUPPORTS OUTSTANDING GRADUATE STUDENTS WHO ARE PURSUING RESEARCH-BASED MASTER'S AND DOCTORAL DEGREES IN SCIENCE, TECHNOLOGY, ENGINEERING, AND MATHEMATICS (STEM) AND IN STEM EDUCATION. THE GRFP PROVIDES THREE YEARS OF FINANCIAL SUPPORT FOR THE GRADUATE EDUCATION OF INDIVIDUALS WHO HAVE DEMONSTRATED THEIR POTENTIAL FOR SIGNIFICANT RESEARCH ACHIEVEMENTS IN STEM AND STEM EDUCATION. THIS AWARD SUPPORTS THE NSF GRADUATE FELLOWS PURSUING GRADUATE EDUCATION AT THIS GRFP INSTITUTION. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.

INNERVATION OF THE KNEE AND TMJ - THE OVER-ARCHING GOAL FOR THE RE-JOIN CONSORTIUM IS TO DEFINE HOW THE NEURONS THAT MEDIATE CHRONIC JOINT PAIN INNERVATE DIFFERENT ARTICULAR AND PERI-ARTICULAR TISSUES, WITH A FOCUS ON THE KNEE AND TEMPOROMANDIBULAR JOINT (TMJ). WITH AN IMPROVED UNDERSTANDING OF HOW DIFFERENT NEURAL SUBTYPES DISTRIBUTE THROUGH THE JOINT AND HOW THESE SUBTYPES CHANGE WITH AGE AND DISEASE, NEW THERAPIES CAN BE DEVELOPED TO REDUCE THE HEAVY BURDEN OF CHRONIC JOINT PAIN. TO ACHIEVE THIS GOAL, OUR TEAM WILL FOCUS ON ADVANCING OUR UNDERSTANDING OF PATHOLOGY-PAIN RELATIONSHIPS IN THE KNEE AND TMJ BY COMBINING EXPERTISE IN NEURAL TRACING, 3-DIMENSIONAL IMAGING, AND EVALUATIONS OF CHRONIC JOINT PAIN AND DISABILITY. OUR PROPOSAL BRINGS TOGETHER A HIGHLY COLLABORATIVE TEAM THAT SPANS BASIC SCIENCE AND CLINICAL RESEARCH WITH EXTENSIVE EXPERIENCE IN BOTH THE KNEE AND TMJ, ALLOWING US TO EVALUATE SHARED VS. JOINT-SPECIFIC SHIFTS IN INNERVATION NETWORKS AND THE DEVELOPMENT OF CHRONIC JOINT PAIN. SPECIFICALLY, OUR TEAM WILL FIRST USE NEURAL TRACING DYES TO IDENTIFY THE CELL BODIES IN THE DORSAL ROOT GANGLIA AND TRIGEMINAL GANGLIA THAT PROJECT TO THE MUSCLE, BONE, OR INTRA-ARTICULAR JOINT TISSUES. THESE NEURONS WILL THEN BE EVALUATED FOR THEIR FUNCTION USING ELECTROPHYSIOLOGIC TESTS AND THEIR TRANSCRIPTOME USING SINGLE CELL RNA-SEQ. BY OVERLAPPING NEURAL FUNCTION WITH GENE EXPRESSION, WE WILL IDENTIFY PROMOTER TARGETS AND DESIGN ADENO-ASSOCIATED VIRUS (AAV) VECTORS TO PRODUCE FLUORESCENT LABELS ALONGSIDE THE EXPRESSION OF THESE TARGETS. IMPORTANTLY, THIS APPROACH WILL ALLOW US TO DEVELOP AAV-BASED TRACERS FOR SPECIFIC FUNCTIONAL NEURAL SUBTYPES, AS WELL AS COMBINE TRADITIONAL MARKERS OF FUNCTIONAL SUBTYPES WITH ANY NEWLY IDENTIFIED MARKERS THAT DESCRIBE HOW THE NEURON CHANGES WITH AGE, SEX, AND OSTEOARTHRITIS (OA) SEVERITY. USING THESE TRACERS, WE WILL THEN EVALUATE THE DISTRIBUTION OF FUNCTIONAL NEURAL SUBTYPES THROUGHOUT THE JOINT (INCLUDING BONE, CARTILAGE, SYNOVIUM, JOINT CAPSULE, LIGAMENT, TENDON, FASCIA, AND MUSCLE) AND HOW THESE INNERVATION NETWORKS CHANGE WITH AGE, SEX, AND OA SEVERITY. MOREOVER, THESE TRACERS WILL BE USED TO EVALUATE HOW JOINT INNERVATION ADAPTS FOLLOWING THE APPLICATION OF TWO NEURAL ABLATION TECHNIQUES FOR PAIN RELIEF IN THE KNEE AND TMJ. TO EVALUATE THE CLINICAL SIGNIFICANCE OF OUR PRECLINICAL STUDIES, INNERVATION CHANGES WILL BE ASSESSED IN TISSUES COLLECTED FROM PATIENTS UNDERGOING TOTAL JOINT REPLACEMENT OF THE KNEE OR TMJ. IN ALL OF OUR STUDIES, JOINT INNERVATION WILL BE PAIRED WITH DETAILED ANALYSES OF JOINT PAIN AND DISABILITY. IN RODENTS, THESE ANALYSES WILL INCLUDE DETAILED BEHAVIORAL CHARACTERIZATIONS; IN PATIENTS, THESE ANALYSES WILL INCLUDE QUANTITATIVE SENSORY TESTS AND OTHER ASSESSMENTS OF JOINT FUNCTION. COMBINED, THIS APPROACH WILL ALLOW US TO EVALUATE PATHOLOGY-PAIN RELATIONSHIPS RELATED TO JOINT INNERVATION FROM THE PRECLINICAL MODEL TO THE CLINIC.

FY 2010--FY 2013 SEA GRANT OMNIBUS SUBMISSION

PICS: A NEW HORIZON FOR SURGICAL CRITICAL CARE

INSIGHTS - INNOVATIVE NEXT STEPS IN GAINING HEALTH IMPROVEMENTS THROUGH TRANSLATIONAL SCIENCE - FLORIDA IS THE THIRD LARGEST STATE WITH UNIQUE HEALTH CHALLENGES. THE UNIVERSITY OF FLORIDA (UF) AND FLORIDA STATE UNIVERSITY (FSU) CTSA HUB, WITH OVER 14 YEARS OF PRIOR COLLABORATIVE EXPERIENCE, WILL WORK WITHIN THIS DYNAMIC ENVIRONMENT TO IMPROVE HUMAN HEALTH BY ACCELERATING THE TRANSLATION OF SCIENTIFIC DISCOVERIES AND IMPLEMENTING EVIDENCE-BASED BEST PRACTICES. THROUGH PIVOTAL LEADERSHIP IN CATALYZING RESEARCH WITHIN AND ACROSS THE HUB’S UNIVERSITIES, AFFILIATED HEALTH CARE SETTINGS, AND COMMUNITIES, THE UF-FSU CTSA HUB WILL TARGET SIGNIFICANT BARRIERS IN TRANSLATION. THE UF-FSU CTSA HUB ALIGNS FSU’S DISTRIBUTED MEDICAL EDUCATION MODEL WITH UF’S COUNTY EXTENSION REACH AND EXTENSIVE ONEFLORIDA+ CLINICAL RESEARCH NETWORK AND DATA TRUST TO BRING HEALTH RESEARCH OPPORTUNITIES TO FLORIDA’S RURAL AND URBAN COMMUNITIES. APPLYING CLINICAL AND TRANSLATIONAL SCIENCE (CTS) PRACTICES AND PRINCIPLES IN THIS CONTEXT LENDS SUBSTANTIAL OPPORTUNITIES FOR ENHANCING RESEARCH EFFICIENCY AND IMPROVING HEALTH OUTCOMES. THE UF- FSU CTSA HUB IS OPTIMALLY POSITIONED TO DRIVE THE INTEGRATION OF CTS PRINCIPLES AND PRACTICES INTO THE ROUTINE CONDUCT OF BIOMEDICAL RESEARCH AND HEALTH CARE DELIVERY. OVER THE NEXT 7 YEARS, SUCH INTEGRATION WILL DRIVE THE CONTINUED MATURATION OF OUR LEARNING HEALTH SYSTEM INITIATIVE, WHICH WILL EVOLVE INTO A LEARNING HEALTH COMMUNITY ENGAGING STATE, REGIONAL, AND NATIONAL COLLABORATORS. THE GOAL OF THIS APPLICATION IS TO CATALYZE CROSS-DISCIPLINARY TRANSLATIONAL SCIENCE ACTIVITIES THAT RESULT IN MEANINGFUL GAINS IN HEALTH FOR THE HUB’S COMMUNITIES. FURTHERMORE, THE UF-FSU CTSA HUB AIMS TO SERVE AS AN EFFECTIVE IMPLEMENTATION AND DISSEMINATION HUB OF BEST TRANSLATIONAL SCIENCE PRACTICES FOR TURNING DISCOVERIES INTO IMPROVED OUTCOMES. TOWARD THAT END, THE UF-FSU CTSA HUB WILL PURSUE FOUR LONG-TERM STRATEGIC GOALS: 1) CULTIVATE A DYNAMIC TRAINING ECOSYSTEM TO SPEED TRANSLATION THROUGH CONTINUOUS LEARNING AND SKILL DEVELOPMENT, 2) ADVANCE THE SCIENCE OF TRANSLATION TO OVERCOME PERSISTENT CHALLENGES IN THE CONDUCT OF CLINICAL AND TRANSLATIONAL RESEARCH AND TRANSLATION OF BEST EVIDENCE TO PATIENTS AND COMMUNITIES THROUGH INNOVATIONS IN CLINICAL TRIAL DESIGN AND ARTIFICIAL INTELLIGENCE AND DIGITAL HEALTH SOLUTIONS, 3) DEEPEN STAKEHOLDER COLLABORATIONS TO MORE EFFECTIVELY ADDRESS STAKEHOLDER HEALTH PRIORITIES AND REDUCE HEALTH RISKS THROUGH STRATEGIC PARTNERSHIPS, AND 4) CREATE A SCALABLE LEARNING HEALTH COMMUNITY TO EXPAND THE REACH, SUSTAINABILITY, AND IMPACT OF TRANSLATIONAL ADVANCES THROUGH MATURATION OF A LEARNING HEALTH SYSTEM. AS A CENTRAL FACILITATOR FOR IMPLEMENTING CHANGE, BROADENING ACCESS TO RESEARCH, AND TRANSLATING DISCOVERIES INTO PRACTICE, THE UF-FSU CTSA HUB IS POISED TO IMPACT THE SIGNIFICANT HEALTH CHALLENGES IN NORTHERN AND CENTRAL FLORIDA, STATEWIDE, AND BEYOND.

CENTER FOR COMPRESSIBLE MULTIPHASE TURBULENCE (CCMT)

2/3 FLORIDA-CALIFORNIA CANCER RESEARCH, EDUCATION AND ENGAGEMENT (CARE2) HEALTH EQUITY CENTER

REGIONAL ADVANCEMENTS AND CAPABILITY ENHANCEMENT (RACE) PROGRAM OFFEROR'S TECHNICAL PROPOSAL ENTITLED "REGIONAL ADVANCEMENT AND CAPABILITY ENHANCEM

OMNIBUS 2018-2021_FLORIDA SEA GRANT PROPOSAL

PTERYGOPALATINE FOSSA (PPF) BLOCK AS AN OPIOID SPARING TREATMENT FOR ACUTEHEADACHE IN ANEURYSMAL SUBARACHNOLD HEMORRHAGE - SEVERE HEADACHE IS UBIQUITOUS IN SUBARACHNOID HEMORRHAGE (SAH), PRESENT IN 90% OF PATIENTS AFTER ICTUS BLEED. DESPITE STEADY CONSUMPTION OF ANALGESICS, THE DEGREE OF PAIN CONTROL IN SAH PATIENTS IS REMARKABLY POOR. IN SPITE OF THIS HIGH PREVALENCE, A DEARTH OF DATA GUIDES OPTIMAL MANAGEMENT OF POST-SAH HEADACHE. OPIOIDS ARE THE MOST PRESCRIBED PAIN MEDICATION FOR SEVERE POST-SAH HEADACHE. HOWEVER, OPIOID-BASED ANALGESIA PRESENTS CONSIDERABLE RISKS: DEPRESSED LEVEL OF CONSCIOUSNESS AND RESPIRATORY DRIVE, HYPOTENSION, SLOW GASTROINTESTINAL TRANSIT, AND HIGH FREQUENCY OF TOLERANCE AND ADDICTION. FURTHERMORE, IT IS URGENT AND CRITICAL TO IDENTIFY NOVEL STRATEGIES TO ALLEVIATE THE EXCRUCIATING AND NEARLY UNIVERSAL HEADACHE POST-SAH, WHILE MITIGATING CONSEQUENCES OF OPIOID USE. THIS UNMET THERAPEUTIC NEED REFLECTS A KEY KNOWLEDGE GAP IN A CONDITION AFFLICTING NEARLY 30,000 INDIVIDUALS EACH YEAR IN THE US. WE PRESENT AN INEXPENSIVE, OPIOID-SPARING STRATEGY FOR POST-SAH HEADACHE, USING A NERVE-BLOCK INTO THE PTERYGOPALATINE FOSSA (PPF) TO IMPROVE PAIN CONTROL AND LESSEN OPIOID NEEDS. A GROWING BODY OF LITERATURE ON THE USE OF NERVE-BLOCKS IN ACUTE AND CHRONIC HEADACHE DISORDERS SUPPORTS OUR OVERARCHING HYPOTHESIS THAT PPF-BLOCK PROVIDES RAPID, OPIOID-SPARING ANALGESIA, IS SAFE AND WELL-TOLERATED, AND HOLDS PROMISE TO ADEQUATELY TREAT POST-SAH HEADACHE. THE PATHOPHYSIOLOGY OF THESE HEADACHES IS COMPLEX AND INVOLVES MENINGEAL IRRITATION FROM BLOOD PRODUCTS, RELEASE OF INFLAMMATORY CYTOKINES, VASOMOTOR INSTABILITY, AND CENTRAL PAIN SENSITIZATION. THROUGH SELECTIVE MODULATION, PPF-BLOCKS ADDRESS PAIN MECHANISMS AT THEIR ORIGIN, TARGETING THE MAXILLARY NERVE AND SPHENOPALATINE GANGLION, INCLUDING THEIR BRANCHES. WE PROPOSE A MULTICENTER PHASE II, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY WITH SEQUENTIAL PARALLEL COMPARISON DESIGN OF BILATERAL PPF-INJECTIONS OVER 4 DAYS AT 12 CENTERS. FOLLOWING ANEURYSM TREATMENT, 195 ADULTS HOSPITALIZED WITH ANEURYSMAL SAH, WHO ARE EXPERIENCING SEVERE HEADACHES AND CAN VERBALIZE PAIN SCORES, WILL BE RANDOMIZED TO ONCE DAILY ACTIVE (ROPIVACAINE + DEXAMETHASONE) OR SHAM (SALINE) OR PPF-INJECTIONS DURING THE FIRST 2 CONSECUTIVE DAYS OF THE INTERVENTION PERIOD (DAY 1/STAGE 1, DAY 2/STAGE 2). THE OPEN-LABEL PHASE SPANS THE SUBSEQUENT 2 DAYS (DAYS 3-4), DURING WHICH SUBJECTS MAY OPT TO RECEIVE AN ACTIVE PPF-BLOCK. THIS TWO-STAGE DESIGN LEVERAGES INCREASED EFFICIENCY IN DATA GENERATION FROM THE POOLED SEQUENTIAL BLINDED STAGES (I.E., STAGES 1 & 2) AND REDUCED IMPACT OF SHAM RESPONSES, AND THUS, ALLOWS FOR SMALLER SAMPLE SIZE WITHOUT COMPROMISING STATISTICAL POWER. OUR PRIMARY OBJECTIVE IS TO DEMONSTRATE THE OPIOID-SPARING ANALGESIC EFFECT OF PPF-BLOCKS VS SHAM. OUR SECONDARY OBJECTIVE IS TO ASSESS THE TOLERABILITY OF PPF-INJECTIONS AS MEASURED BY RATES OF ACCEPTANCE OF SECOND INJECTION ON DAY 2, AND THEIR SAFETY AS MEASURED BY VASOSPASM RATES AT THE END OF THE OPEN-LABEL PERIOD IN PATIENTS WITH SAH. WE WILL ALSO EXPLORE THE POTENTIAL INTERPLAY OF SEX AND RACIAL DISPARITIES IN PAIN EXPERIENCES AND BOTH PPF- BLOCK TOLERABILITY AND EFFICACY. THIS INITIATIVE MERGES OUR EXPERTISE IN NEUROSURGERY, NEUROCRITICAL CARE, AND ACUTE- PAIN-ANESTHESIOLOGY TO TACKLE A HISTORICALLY NEGLECTED ASPECT OF THE CRITICAL CARE MANAGEMENT OF SAH.