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A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

The purpose of this study is to see if filgotinib can be safe and useful in the long-term treatment of RA. During this study, you will be assigned to one of two study drug dose groups as…

Investigator
Gurjit Kaeley
IRB Number
20180717
Sexes
All
Location
Jacksonville

Uptravi® (SelexiPag): tHe usErs dRug rEgistry (SPHERE) Registry Uptravi® (Selexipag) Users Registry PROTOCOL: AC-065A402

The purpose of this Study is to better understand the demographic and clinical characteristics of PAH patients treated with Uptravi, to learn about the dosing and titration patterns of Uptravi…

Investigator
Vandana Seeram
IRB Number
20162037
Location
Jacksonville

OPEN ENROLLMENT
Pragmatic evaluation of events and benefits of Lipid-lowering in older adults (PREVENTABLE)

The PREVENTABLE trial aims to find out if a drug called atorvastatin (brand name Lipitor) can help older adults 75 years or older live well for longer by preventing dementia, disability, or heart…

Investigator
Arshag Mooradian
IRB Number
CED000000393
Ages
75 Years – 100 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of Asapiprant in Hospitalized Adults With COVID-19

Individuals diagnosed with COVID-19 are being asked to take part in a research study of an investigational drug called Asapiprant (BGE 175). This drug is being tested for the…

Investigator
Carmen Isache
IRB Number
20210252
Location
Jacksonville

OPEN ENROLLMENT
VANTAGE study

The purpose of this clinical research study is to learn more about the use of the investigational study drug, volixibat, for the treatment of pruritus (itching) associated with PBC….

Investigator
Neha Agrawal
IRB Number
1328153
Ages
18 Years – NA
Sexes
All
Location
Jacksonville

A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis. (20222253)

A study to test whether different doses of BI 1291583 help people with bronchiectasis. This study is being done to test the study drug, BI 1291583, for safety, effectiveness, and side effects, when…

Investigator
Mehdi Mirsaeidi
IRB Number
1332722
Location
Jacksonville

OPEN ENROLLMENT
An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease (20212063)

This study is investigating long-term treatment with a drug called inhaled treprostinil (brand name Tyvaso®) in people with Idiopathic Pulmonary Fibrosis (IPF). In the study, you will receive…

Investigator
Vandana Seeram
IRB Number
1334674
Ages
40 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (20210052)

In general, what is the purpose of the research, how long will you be involved? You are being asked to be in this research study because you have idiopathic pulmonary fibrosis (IPF). …

Investigator
Vandana Seeram
IRB Number
1319137
Ages
40 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
The ABCD-Gene Prospective Study

This investigation will be a prospective cohort study conducted in a population of 500 patients with stable CAD undergoing elective PCI treated with standard of care clopidogrel. By integrating…

Investigator
Francesco Franchi
IRB Number
IRB202200298
Ages
18 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
TAILOR BLEED

The purpose of this study is to evaluate the feasibility of switching patients from the standard dual antiplatelet therapy (DAPT) to single therapy of Ticagrelor or Prasugrel only or DAPT with…

Investigator
Dominick Angiolillo
IRB Number
IRB202202835
Location
Jacksonville

OPEN ENROLLMENT
Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI)

Multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and…

Investigator
Francesco Franchi
IRB Number
1318659
Ages
18 Years
Sexes
All
Location
Jacksonville

A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT) (20216310)

This study is being done to find out if the investigational study treatment, called inclisiran, can help prevent cardiovascular events (such as heart attacks, strokes, and cardiovascular-related…

Investigator
Francesco Franchi
IRB Number
1331797
Ages
40 Years
Sexes
All
Location
Jacksonville

Ocean(a)

This study is being done to learn more about olpasiran (AMG 890) in people with cardiovascular disease and elevated Lp(a). It will see if olpasiran (AMG 890) reduces cardiovascular events, lowers…

Investigator
Francesco Franchi
IRB Number
1347686
Ages
18 Years – 85 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
EVOLVE-MI

This study is being done to learn whether regular healthcare, combined with early treatment with a cholesterol lowering drug called evolocumab (Repatha®) reduces heart attack, stroke,…

Investigator
Francesco Franchi
IRB Number
1348573
Ages
18 Years
Sexes
All
Location
Jacksonville

CGUARD

This clinical trial is being done to help evaluate a new investigational device to treat narrowing of the carotid arteries in the neck. The device is called the CGUARD Prime Carotid Stent…

Investigator
Daniel Soffer
IRB Number
1334311
Ages
18 Years
Sexes
All
Location
Jacksonville

A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™)

A study to test whether different doses of BI 1291583 help people with bronchiectasis. If you join this study, you may receive the study drug being tested, BI 1291583, and/or placebo. The study drug…

Investigator
Mehdi Mirsaeidi
IRB Number
1397-0012
Ages
18 Years – 100 Years
Sexes
All
Location
Jacksonville

Comparative effectiveness of early vs. late initiation of dialysis in chronic kidney disease stage 5 with eGFR = 10

A large multicenter randomized-controlled multi-level effectiveness-implementation emphasis pragmatic trial to evaluate the comparative effectiveness of early initiation of dialysis with eGFR at 10…

Investigator
Alaa Awad
IRB Number
N/A
Ages
18 Years – 100 Years
Sexes
All
Location
Jacksonville

A 52-week study assessing exacerbation rate, asthma control and safety in adult severe eosinophilic asthmatics treated with depemokimab compared with mepolizumab or benralizumab

This is a multi-centre, randomised, double-blind, double-dummy, parallel group noninferiority trial of GSK3511294 (depemokimab) 100 mg SC compared with continuation of mepolizumab or benralizumab…

Investigator
Vandana Seeram
IRB Number
20204289
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
The TwoPlus Study-Comparative Effectiveness of an Individualized Model of Hemodialysis vs. Conventional Hemodialysis

The purpose of this study is to compare clinical outcomes and health-related quality of life between an individualized hemodialysis prescription and conventional hemodialysis prescription in…

Investigator
Alaa Awad
IRB Number
CED000000872
Ages
18 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE

The purpose of this program is to assess the safety and efficacy of upadacitinib compared with placebo (fake drug) for the treatment of signs and symptoms in adults with moderately to severely…

Investigator
Gurjit Kaeley
IRB Number
20233520
Ages
18 Years – 63 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE)

The POETYK SLE-1/SLE-2 (IM011-246/247) studies are two identical studies. If eligible, you will be enrolled in only one of these two studies. Participation may last between approximately 14 and 38…

Investigator
Gurjit Kaeley
IRB Number
20232025
Ages
18 Years – 75 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare

The main purpose of this study is to see how well dapansutrile reduces joint pain and other joint symptoms (such as tenderness and swelling) because of an acute gout flare compared with placebo. A…

Investigator
Gurjit Kaeley
IRB Number
20224812
Ages
18 Years – 100 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
SAGE-PsA Study Sex- And Gender-based analysis of the Effectiveness of advanced therapies in Psoriatic Arthritis

The purpose of this study is to understand how sex and gender influence response to advanced therapies (also known as “biologic treatments”) in Psoriatic Arthritis (PsA). We hope to…

Investigator
Gurjit Kaeley
IRB Number
202300383
Ages
18 Years – 100 Years
Sexes
All
Location
Jacksonville

MAESTRO-NASH Outcomes Study

The main purpose of this study is to learn whether treatment with resmetirom compared with placebo for several years can benefit participants by slowing further disease progression and delaying…

Investigator
Neha Agrawal
IRB Number
1353535
Ages
18 Years – NA
Sexes
All
Location
Jacksonville

Effects of NNC0194-0499, cagrilintide, and semaglutide alone or in combinations on liver damage and alcohol use in people with alcohol-related liver disease

We are doing this study to look at the effects of NNC0194-0499 (alone and in fixed-dose combination with semaglutide), cagrilintide (alone and in fixed-dose combination with semaglutide called…

Investigator
Neha Agrawal
IRB Number
1380458
Ages
21 Years – NA
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home – a multi-center randomized controlled trial

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization in patients with chronic obstructive pulmonary disease (COPD). You…

Investigator
Mehdi Mirsaeidi
IRB Number
20216340
Ages
30 Years – NA
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Patients Hospitalized for Viral Lung Infection Requiring Supplemental Oxygen

The purpose of this study is to find out if the experimental drug called tozorakimab is safe and effective in treating severe viral lung infections with Acute Respiratory Failure (ARF), and also to…

Investigator
Tracy Ashby
IRB Number
D9185C00001
Ages
18 Years – NA
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Study of the Efficacy and Safety of Treatment With MNKD-101 When Added to GBT in Participants with Pulmonary Nontuberculous Mycobacterial Infection

The purpose of this study is to find out if a new investigational drug called Clofazimine Inhalation Suspension can help treat people with NTM lung disease.  Part A of the study is made up of…

Investigator
Mehdi Mirsaeidi
IRB Number
20242988
Ages
18 Years – 85 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
The American Lung Association (ALA) Lung Health Cohort (LHC)

The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease.  The overarching…

Investigator
Vandana Seeram
IRB Number
IRB00236497
Ages
25 Years – 35 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Hypothyroidism: Efficacy and Safety of Armour Thyroid Treatment in Subjects with Primary Hypothyroidism

The purpose of this study is to evaluate if Armour Thyroid is safe and effective in the treatment of hypothyroidism. This study will compare the effect of Armour Thyroid on…

Investigator
Joe Chehade, Christian Koch, Payal Shooliz
IRB Number
P0335962
Ages
18 Years – 75 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Non-invasive vagal nerve stimulation and sleep

This study is investigating if using a stimulation devise can improve quality of sleep for veterans suffering from PTSD. …

Investigator
Mariam Louis
IRB Number
201700541
Ages
18 Years – 55 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
RECOVER-ENERGIZE: A Platform Protocol for Evaluation of Interventions for Exercise Intolerance in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

RECOVER-ENERGIZE is studying possible treatments, also called study interventions, for exercise intolerance and post-exertional malaise (PEM) related to Long COVID. These studies will include…

Investigator
Carmen Isache, Jorge Verdecia
IRB Number
CED000000942
Ages
18 Years – 80 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Recover SLEEP

Researchers are studying possible treatments for adults who have Long COVID, which is when a person has symptoms months after getting COVID. Symptoms can include trouble breathing, a cough, trouble…

Investigator
Carmen Isache
IRB Number
CED000000937
Ages
18 Years – 75 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis

The purpose of this study is to measure clinical safety and efficacy of oral brepocitinib in adult participants with cutaneous…

Investigator
Mehdi Mirsaeidi
IRB Number
PVT-2201-203
Ages
18 Years – 75 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (JOURNEY)

This study will investigate the efficacy and safety of Tezepelumab as add-on treatment to inhaled maintenance therapy in a COPD population with a history of exacerbations. This study will compare…

Investigator
Michael Schweitzer Barrios
IRB Number
D5241C00007
Ages
40 Years – 80 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Phase III, randomized, double-blind, placebo-controlled study to assess BI 1291583 2.5 mg once daily for up to 76 weeks in patients with bronchiectasis

The aim of this study is to evaluate the efficacy, safety, and tolerability of BI 1291583 2.5 mg compared to placebo in participants with bronchiectasis. The ability of the study drug (BI 1291583…

Investigator
Mehdi Mirsaeidi, Michael Schweitzer Barrios
IRB Number
BI 1397-0014
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
The Bridging Antiplatelet Therapy with Cangrelor 2 (BRIDGE 2) Study: A Pilot Prospective Cohort, Pharmacodynamic Study of Tailored Cangrelor Bridging Dosing Regimens

This study is to determine rates of patients with optimal platelet reactivity range when using a PFT-guided titration of cangrelor infusion rate (cangrelor…

Investigator
Dominick Angiolillo, Luis Ortega Paz
IRB Number
BRIDGE 2
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Switching from Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention: TAILOR-BLEED-2 study

Studies have shown that the blood-thinning effects of clopidogrel can be influenced by your genetics and clinical characteristics. A scoring system called the ABCD-GENE score is used to assess…

Investigator
Dominick Angiolillo, Luis Ortega Paz
IRB Number
IRB202401774
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Use of AC through Provider Prompting about Oral AC Therapy for AF (SUPPORT-AF) IV

This study is multifaceted and has multiple aims.  1. Discover what role religiosity and spirituality play in anticoagulant (AC) use in non-white older adults with atrial…

Investigator
Luis Ortega Paz
IRB Number
CED000000646
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
ABCD Gene Substudy

Blood thinning medications prevent cells in the body called platelets from sticking together that would lead to a clot and subsequent heart attacks. Dual blood thinning therapy with aspirin and…

Investigator
Francesco Franchi
IRB Number
IRB202302083
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
A Study of Contrast-induced Acute Kidney Injury Prediction Using the RENISCHEM L-FABP Assay at the Point-of-Care (SAKURA-POC)

The purpose of this research is to help doctors and scientists learn about an investigational test called RENISCHEM L-FABP Test.  This test looks for a substance in urine that can help doctors…

Investigator
Dominick Angiolillo
IRB Number
20212233
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
SWAP 7

You are being asked to participate in this study because you have a stent in your heart artery for at least 90 days and you are currently taking blood-thinning medications as part of your standard of…

Investigator
Francesco Franchi
IRB Number
IRB202401578
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
SWAP 8

People are being asked to participate in this study because they have a stent in their heart artery and are currently taking blood-thinning medications as part of standard of care. In particular,…

Investigator
Luis Ortega Paz
IRB Number
IRB202401735
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
SWAP 9

People are considered for participation in this trial when. they are taking two blood-thinning medications, which include baby aspirin plus either Prasugrel (Effient) or Ticagrelor (Brilinta)….

Investigator
Luis Ortega Paz
IRB Number
IRB202400929
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System

In patients with left heart failure, elevations in left atrial pressures can also cause pressure elevations in blood vessels between the left atrium and the lungs resulting in a condition called…

Investigator
Dominick Angiolillo
IRB Number
20181035
Ages
18 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
Dal-Gene-2

Events such as myocardial infarction (heart attack) or the need for a revascularization procedure (implantation of a stent in a coronary artery) are signs of severe arterial disease. Events such as…

Investigator
Dominick Angiolillo
IRB Number
20233015
Ages
45 Years – 99 Years
Sexes
All
Location
Jacksonville

OPEN ENROLLMENT
AMPLITUDE

This study is being done to learn more about the safety and effectiveness of the investigational drug VX-147 in participants with APOL1-Mediated Chronic Kidney Disease. People of recent…

Investigator
Dominick Angiolillo
IRB Number
20233313
Ages
18 Years – 65 Years
Sexes
All
Location
Jacksonville