Active Clinical Trials at CHI Health

Study Name: Oral Bio-Film

Principals: Esther Rathjen, MSN RN, APRN-CCNS and David W. Voigt, MD

Category: Burn/Wound

Study Site: CHI Health St. Elizabeth

Study Name: Correlation Between Chlorhexidine Rinse Regiment and Oral
Bio-Film

Description: The purpose of this research study is to evaluate the
effectiveness of Chlorhexidine in reducing the amount of bacteria that
accumulates in a person's mouth during the day. The researchers are
interested in determining if a more frequent use of Chlorhexidine during
the day, may result in patient's experiencing less health complications
such as Pneumonia.

Study Name: Re-Energize 

Principal: David Voigt, MD    

Category: Burn/Wound

Study Site: CHI Health St. Elizabeth

Study Name: A randomized trial of External Glutamine to minimize thermal injury

Description: Glutamine is a substance normally made by the body and can be found in your diet. This substance is important to the immune system during illness and stress. We hope to determine if increased doses of Glutamine decreases mortality and hospital lengths of stay in burn patients.

Study Name: APPRAISE ATP

Principal: Stephen Ackerman, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.

Study Name: Barostim Therapy for Heart Failure (BeAT-HF)

Principal: Anuj Jain, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The purpose of this trial is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects with heart failure, defined as New York Heart Association (NYHA) functional class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).

Study Name: CLEAR Outcomes 

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

Study Name: Dal-GenE MHICC 2050

Principal: Scott Carollo, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Recent Acute Coronary Syndrome

Description: We are investigating whether a new oral drug can reduce the cardiovascular risk for patients who were recently hospitalized for an acute coronary event and found to have a genetic variant after study lab draw.

Study Name: Early Feasibility Study of the AccuCinch® Ventriculoplasty System

Principal: James Wudel, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventriculoplasty System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy. 

Study Name: Emperor Preserved 

Principal: Joseph Thibodeau, MD; Douglas Kosmicki, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy, CHI Health Nebraska Heart - Lincoln

Study Name: Emperor Preserved 

Description: The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction.. Phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with Heart failure with preserved Ejection Fraction (HFpEF – EF > 40%)

Study Name: GOULD

Principal: Denes Korpas, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.

Study Name: Graft Master

Principal: Scott Carolla, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: JOSTENT Coronary Stent Graft

Study Name: Heart FID

Principal: Venkata Alla, MD

Category: Cardiovascular

Study Sites: CHI Health Creighton University Medical Center - Bergan Mercy, CHI Health Nebraska Heart

Study Name: Heart Failure with Iron Deficiency. 

Description: The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.

Study Name: INVESTED

Principal: Erich Fruehling, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Grand Island

Description: INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. 

Study Name: INTERLUDE

Principal: James Wudel, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Study Name: PARADISE-MI

Principal: Douglas Kosmicki, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy; CHI Health Nebraska Heart - Lincoln; CHI Health Nebraska Heart - Grand Island

Description: The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.

Study Name: PARALLAX

Principal: Anuj Jain, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Study Name: PARTNER 3

Principals: Steven Martin, MD and James Wudel, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Study Name: PIONEER-HF

Principal: Himanshu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Study Name: VICTORIA

Principal: Jeffrey Holmberg, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Heart Failure Study

Description: We are investigating the safety and efficacy of an oral drug on reducing the risk of being admitted to the hospital with worsening heart failure. 

Study Name: VIVO

Principal: Eric Vander Woude, MD

Category: Cardiovascular

Study Site: CHI Health St. Elizabeth

Study Name: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

Description: We are investigating the safety and effectiveness of the Zilver Vena Venous Stent placed in patients with symptomatic venous outflow obstructions in one iliofemoral venous segment. The results of the study will be compared to performance goals derived from the literature.

Study Name: C-TRACT

Principal: Rahul Razdan, MD

Category: DVT(Deep Vein Thrombosis)

Study Site: CHI Health St. Elizabeth

Study Name: Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial) (C-TRACT)

Description: :The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructivepost thrombotic syndrome (DIO-PTS).

Study Name: Humira Legacy- 10 year registry

Principal: Robert Kizer, MD

Category: Digestive Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Active Ulcerative Colitis

Description: We are participating in a registry to collect data on patients with moderate to severe ulcerative colitis that are taking Humira (Adalimumab).  

Study Name: NASH 747-303 REGENERATE

Principal: Sandeep Mukherjee, MD

Category: Digestive Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Liver Disease Study

Description: Nonalcoholic steatohepatitis is when the liver is swollen and damaged from the build up of fat in the liver.  We are investigating the safety and efficacy of an oral drug to delay health-related conditions in patients with nonalcoholic steatohepatitis or evidence of liver fibrosis (damaged or scarred liver tissue).  

Study Name: EDP-305-201

Principal: Sandeep Mukherjee, MD

Category: Gastroenterology

Description: A Phase 2 Dose Ranging, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Study Name: MLN-0002_401 PASS

Principal: Erin Jenkins, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Entyvio (Vedolizumab) long term safety study: An international, observations prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn's Disease

Study Name: M14-431

Principal: Robert Kizer, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Biologic Therapy.

Study Name: M14-433

Principal: Robert Kizer, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Conventional Therapies, but have not Failed Biologic Therapy.

Study Name: M16-135

Principal: Sandeep Mukherjee, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis.

Study Name: Nash 747-304

Principal: Sandeep Mukherjee, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH).

CHI Health participates in over 50 cancer clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use clinical trials to learn more about how to fight cancer. 

Search open cancer clinical trials.

Study Name: LUNAR

Principal: Hadi Zahra, MD

Category: Oncology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure.

Study Name: Waste Tissue II

Principal: Matthew Dilisio, MD

Category: Orthopedics

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Understanding Periarticular Pathophysiology Through Surgical Waste Tissue. 

Study Name: Akebia 6548-CI-0014

Principal: Khalid Bahir, MD

Category: Nephrology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Anemia Due to Chronic Kidney Disease

Description: Anemia (low red blood cell count) is a common health problem in people with chronic (long-term) kidney disease.  We are investigating a new oral drug to treat anemia in patients with chronic kidney disease.

Study Name: Akebia 6548-CI-0015

Principal: Khalid Bashir, MD

Category: Nephrology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Anemia Due to Chronic Kidney Disease

Description: Anemia (low red blood cell count) is a common health problem in people with chronic (long-term) kidney disease.  We are investigating a new oral drug to treat anemia in patients with chronic kidney disease who are currently being treated with an erythropoiesis-stimulating agent (ESA) for anemia.

Study Name: Bayer/FIGARO-DKD

Principal: Khalid Bashir, MD

Category: Nephrology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Cardiovascular Prevention Study in Patients with Type 2 Diabetes and Chronic Kidney Disease

Description: We are investigating the safety and efficacy of a new oral drug to find out if it can offer protection against further worsening of your kidney disease. 

Study Name: Spirit MVT-601-3108 

Principal: John Cote, MD

Category: Women's Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain.

Study Name: LIBERTY1-Myovant

Principal: John Cote, MD

Category: Women's Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Heavy Menstrual Bleeding with Uterine Fibroids

Description: We are investigating the effects of an oral drug on patients with heavy menstrual bleeding associated with uterine fibroids.

Study Name: MVT-601-3003 

Principal: John Cote, MD

Category: Women's Health

Description: LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids.