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Clinical Trials

Our Clinical Trials Lead to Treatment Innovations

A clinical trial is a clinical research study where participants receive specific interventions —such as a drug or other therapy, a new screening test, a behavior change or procedure — under close medical monitoring and according to the research plan or protocol created by the investigators (often medical doctors). A clinical study involves research that is intended to add to medical knowledge related to the treatment, diagnosis and prevention of diseases or conditions. Without clinical trials, we would not be able to move medicine forward.

Be sure to consult with your physician before participating in a clinical trial.

Throughout our health system, researchers and medical experts are conducting a variety of clinical trials:

  • At Our Lady of the Lake Regional Medical Center in Baton Rouge, which serves as an academic medical center, clinical innovation, medical education and scientific research takes place every day. We participate in a wide range of clinical trials that are used to determine whether new drugs or treatments are both safe and effective.
  • At Our Lady of the Lake Cancer Institute, all cancer patients are evaluated for participation in a clinical trial. If you are interested in participating in one of the clinical trials offered at the Cancer Institute, or if you have questions about clinical research, please reach out to a member of our research team at (225) 765-7659 or via email research@ololrmc.com.
  • At Our Lady of the Lake Children’s Health, which is an academic teaching hospital, our patients have access to the best of the best when it comes to research and evidence-based practice initiatives. Our research team manages several research endeavors, including clinical trials, quality and safety initiatives and projects that improve patient care.
  • At St. Dominic Hospital in Jackson, Mississippi, we take pride in supporting clinical research performed at or in collaboration with St. Dominic Hospital and St. Dominic Medical Associates. St. Dominic’s Office of Research is responsible for managing and overseeing the conduct of the clinical research program. If you are a study participant or would like more information on joining a clinical trial study, a researcher and would like more information, or you would like to become a Principal Investigator, please contact us at (601) 200-6301.

Patient Information for Clinical Trials

  • What is clinical research?

    Clinical research studies are designed to answer specific medical questions. Some clinical research studies test new drugs or new combinations of drugs, new surgical procedures or devices or new ways to use existing treatments. Other research studies might involve long-term observation of patients to better understand how health or diseases progress. The goal of clinical research is to discover better ways to treat, prevent, diagnose or understand human disease.

  • Who participates in clinical trials?

    Both healthy patients and patients with an illness or disease can volunteer to be in a clinical trial. Franciscan Missionaries of Our Lady Health System offers clinical trials for adult and pediatric patients in several of the regions we serve. Patients who decide to participate in a research study usually must complete the informed consent process before they participate in the clinical trial.

    During the informed consent process, patients are provided with the information they need to make their decision about participating in a clinical trial. Members of the research team meet with the patient and provides them with an informed consent form that explains the details of the study, including the purpose, duration, required procedures, potential risks and benefits, and contact information for the research team. Patients are given time to ask questions, consult with their family, or talk to their doctors before they sign the informed consent document. Participating in a clinical trial is voluntary. Patients can refuse to participate or can withdraw from the study at any time without the loss of any medical benefit to which the patient is entitled.

  • How do I join a research study

    You can sign up for a clinical trial by:

    • Physician Referral: Ask your doctor about participating in one of our trials.
    • Phone: In the Baton Rouge area, call our clinical research department at (225) 765-7659.
    • Email: Contact our clinical research department at research@fmolhs.org.

    If you are a patient at a Franciscan Missionaries of Our Lady Health System hospital or clinic, you might be asked to participate in a research study.

  • Who funds the clinical trial?

    Clinical trials are funded by different sources, including pharmaceutical companies, device companies, the National Institutes of Health or other sponsors. FMOLHS is committed to ensuring that financial interests or other conflicts of interest do not compromise the protection of research subjects or the integrity of the research findings.

  • For more information

Clinical Trials by Specialty

  • Blood Disorders

    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Cardiovascular

    Clinical Trials in the Baton Rouge area:


    Title: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease (VICTORION-

    Purpose: Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

    Principle Investigator: Dr. Denzil Moraes

    Contact: For more information, contact Anne Erwin, RN or Betsy Harper, LPN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry

    Purpose: The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

    Principle Investigator: Dr. Kenneth Civello

    Contact: For more information, contact Becky Toler, RN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: AMPLATZER HUD

    Purpose: Humanitarian Device Exemption (HDE) Guidance for Healthcare Providers Requesting the AMPLATZER™ Post-Infarct Muscular VSD Occluder

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, contact Gretchen Figarola, RN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: The ENCIRCLE Trial

    Purpose: This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, contact Gretchen Figarola, RN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

    Purpose: Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, contact Melissa Hughes, LPN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: Product Surveillance Registry (PSR)

    Purpose: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

    Principle Investigator: Dr. Henry Patrick

    Contact: For more information, contact Gretchen Figarola, RN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: CorMatrix Cor TRICUSPID ECM Valve Replacement Study: The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve).

    Purpose: This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

    Principle Investigator: Dr. Terrence Stelly

    Contact: For more information, contact Betsy Harper, LPN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: DIAMOND. Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure

    Purpose: The purpose of this study is to determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.

    Principle Investigator: Dr. Tara Jarreau

    Contact: For more information, contact Gretchen Figarola, RN, BSN at (225) 765-7659

    Open to Enrollment

    Title: GUIDE-HF. Hemodynamic-GUIDEd Management of Heart Failure

    Purpose: The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality. The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH). The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

    Principle Investigator: Dr. David Moll

    Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659

    Opening to Enrollment

    Title: Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease

    Purpose: The purpose of this study is to improve knowledge about the epidemiology of Lp(a) in patients with established cardiovascular disease (CVD).

    Principle Investigator: Dr. Denzil Moraes

    Contact: For more information, contact Julie Doyle at (225) 765-7660

    Open to Enrollment

    Title: Lp(a)HORIZON. Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD

    Purpose: Study TQJ230A12301 is a pivotal phase 3 study designed to test the hypothesis that treatment with TQJ230 80 mg s.c QM will significantly reduce the risk of CV deaths, nonfatal myocardial infarction (MI), non-fatal stroke and urgent coronary re-vascularization in patients with established CVD and elevated levels of Lp(a) who are treated for CV risk factors other than Lp(a) according to local guidelines for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a). TQJ230 is a N-acetyl galactosamine (GalNAc) conjugated 2 ́-O-(2-methoxyethyl) (2 ́-MOE) chimeric second-generation antisense oligonucleotide (ASO) drug targeted to apolipoprotein(a), [apo(a)].

    Principle Investigator: Dr. Denzil Moraes

    Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659

    Opening Soon

    Title: PARAGLIDE-HF. Changes in NT-proBNP and Outcomes, Safety, and Tolerability in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization and Initiated In-hospital or Within 30 Days Post-discharge

    Purpose: The purpose of this study is to assess the effect of sacubitril/valsartan (LCZ696) vs. valsartan on changes in NT-proBNP and outcomes, safety and tolerability in patients with HFpEF (left ventricular ejection fraction (LVEF) > 40%) who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post discharge. Initial dose for patients randomized to sacubitril/valsartan (LCZ696) will be determined by patient's previous dose of ACEi/ARB immediately prior to hospital admission for acute decompensated heart failure. Study treatment will be titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3). Patients will be randomized in a 1:1 ratio of sacubitril/valsartan to valsartan for up to approximately 20 months of double-blind treatment.

    Principle Investigator: Dr. Denzil Moraes

    Contact: For more information, contact Anne Erwin, BSN, RN, CCRP at (225) 765-7659

    Open to Enrollment

    Title: PSR. Product Surveillance Registry

    Purpose: The purpose of the registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use.

    Principle Investigator: Dr. Henry Patrick

    Contact: For more information, contact Gretchen Figarola, RN, BSN at (225) 765-7659

    Open to Enrollment

  • COVID-19

    Clinical Trials in the Baton Rouge area:


    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Critical Care

    Clinical Trials in the Baton Rouge area:


    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Diabetes

    Clinical Trials in the Baton Rouge area:


    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Gastroenterology

    Clinical Trials in the Baton Rouge area:


    Title: MODIFYIII. Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI)

    Purpose: The purpose of this study is to determine the safety and effectiveness of the monoclonal antibody bezlotoxumab in children ages 1 to 17 who have a Clostridium difficile infection.

    Principal Investigator: Dr. Michael Bolton

    Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073

    Open to enrollment

  • Genetic Diseases

    There are no genetic studies open at this time.

  • Infectious Diseases

    Clinical Trials in the Baton Rouge area:


    Title: Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)

    Purpose: A randomized, open label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised adults (PRIOH-1)

    Principle Investigator: Dr. Hollis O’Neal Jr.

    Contact: For more information, contact Jen Daigle, RN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


    Title: Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Adults (PRIOH-1)

    Purpose: This is a randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.

    Principal Investigator: Dr. Bud O'Neal

    Contact: For more information, contact Jennifer Daigle, BSN at (225) 939-0779

    Open to enrollment

    Title: A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin In Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection

    Purpose: The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics of lefamulin after a single IV dose in pediatric subjects (birth to < 18 years) who are receiving systemic antibiotic therapy for the prevention or treatment of a confirmed or suspected bacterial infection.

    Principal Investigator: Dr. Michael Bolton

    Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073

    Open to Enrollment

    Title:Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia

    Purpose: This is a multicenter, multinational, open label single dose pharmacokinetic (PK) study enrolling at least 32 subjects. The study aims to characterize the pharmacokinetics (PK) of a single intravenous dose of CAZ AVI in pediatric subjects aged 3 months to less than 18 years who are receiving systemic antibiotic therapy for suspected or confirmed nosocomial pneumonia, including ventilator associated pneumonia.

    Principal Investigator: Dr. Michael Bolton

    Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073

    Open to Enrollment

    Title: Lamprene Multiple Patient Program

    Purpose: Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.

    Principal Investigator: Dr. Maria Reyes

    Contact: For more information, contact Katie Vance, PhD at (225) 765-4365

    Open to Enrollment
  • Neurological

    Clinical Trials in the Baton Rouge area:


    Title: A Prospective, Multicenter study to Evaluate the Performance and Safety of the CerebroFlo® EVD Catheter

    Purpose: The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).

    Principle Investigator: Dr. Allen Joseph

    Contact: For more information, contact Becky Toler, RN at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment

  • Surgical

    Clinical Trials in the Baton Rouge area:


    Title: The Evaluation of Post-operative Pain Control with a TAP Block Using Exparel vs. Marcaine for Hernia Repairs

    Purpose: While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.

    Principle Investigator: Dr. Karl LeBlanc and Dr. Danielle Cobb

    Contact: For more information, contact Leslie Son, PhD at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment


  • Otolaryngology

    Clinical Trials in the Baton Rouge area:


    Title: TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality

    Purpose: The goal of this interventional study is to compare the efficacy (surgical field quality and intra-operative blood loss) or cost of TIVA alone to general inhalational anesthetics with intravenous TXA in patient participants who are undergoing endoscopic sinus surgery.

    The main questions the study aims to answer are:

    • Is the surgical field quality better when using TIVA alone compared to general inhalational anesthetics with intravenous TXA?
    • Is one method more financially advantageous to the participant and the institution compared to the other method?

    Participants will be randomized into one of the two anesthesia cohorts prior to sinus surgery. One group will be given total intravenous anesthesia (TIVA) alone and the other will be given intravenous tranexamic acid (TXA) followed by general inhalational anesthesia.

    Researchers will compare the TIVA group to the TXA group to see if one group exhibits a better surgery field viewing quality through a subjective evaluation and measurement of blood loss and also which anesthesia regimen is most cost effective upon conducting a cost analysis.

    Principle Investigator: Dr. Stephen Hernandez

    Contact: For more information, contact Leslie Son, PhD at (225) 765-7650 or research@fmolhs.org

    Open for Enrollment

Oncology Clinical Trials

Pediatric Clinical Trials by Specialty

Past Clinical Trials by Specialty

  • COVID-19 Trials

    Past Clinical Trials in the Baton Rouge Area:

    • Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults (PassItOn)
    • Study of Efficacy and Safety of MAS825 in Patients With COVID-19 (MAS-COVID)
    • Dociparstat for the Treatment of Sever COVID-19in Adults at High Risk of Respiratory Failure
  • Diabetes Trial

    Past Clinical Trials in the Baton Rouge area:

    • Natural History of the Development of Type 1 Diabetes
  • Cardiovascular

    Past Clinical Trials in the Baton Rouge area:

    • CONVERGE, Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF
    • GREAT, Global Registry for Endovascular Aortic Treatment Outcomes Evaluation
    • LEOPARD, Looking at Endovascular Abdominal Aortic Aneurysm Repair (EVAR) Outcomes by Primary Analysis of Randomized Data
    • PARADISE-MI, Prospective ARNI vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI
  • Critical Care

    Past Clinical Trials in the Baton Rouge area:

    • A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin In Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection
  • Surgical

    Past Clinical Trials in the Baton Rouge area:

    • Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
    • A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair
  • Oncology

    Past Clinical Trials in the Baton Rouge area:

    Breast

    • Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
    • A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

    Pancreas

    • Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs