Current Clinical Trials

Every treatment, medication, and procedure available today was once tested as part of a clinical trial. These carefully designed scientific studies are among the last steps in the research process, helping doctors continually improve care. The primary goal of clinical trials is to advance medicine by finding better ways to treat and prevent disease. Clinical trials are available through the Clinical Trials Office and McGlinn Cancer Institute.

We have several open clinical trials that can be reviewed below.

Cardiology

Heart Attack

MiCORE Study

Myocardial Infarction COmbined device, Recovery Enhancement Study

Johns Hopkins Primary Investigator: Seth Martin, MD

Investigator: Eric Elgin, MD

The purpose of this study is to assess readmissions in patients who use a mobile application to assist recovery from acute myocardial infarction.

Learn more about the MiCORE study call the Clinical Trials Office at 484-628-8585.

Heart Failure

GUIDE-HF

"Hemodynamic-GUIDEd Management of Heart Failure"

Investigator: Jared Green, DO

The purpose of this study is to demonstrate the effectiveness of the CardioMEMS™ Heart Failure System in an expanded patient population, including patients with New York Heart Association (NYHA) Class II, III, or IV heart failure with or without a prior hospitalization.

Learn more about the GUIDE-HF trial or call the Clinical Trials Office at 484-628-8585.

REHAB-HF

"A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients"

Investigator: Jared Green, DO

The purpose of this study is to measure the effect of an exercising training program has on physical function, hospital readmission rates and medical costs for people admitted to the hospital with a diagnosis of heart failure.

Learn more about the REHAB-HF trial or call the Clinical Trials Office at 484-628-8585.

HF Biomarkers

"A Blood Collection from Patients Presenting with Suspected New Onset or Exacerbated Heart Failure"

Investigator: Jared Green, DO

The purpose of this study is to validate a blood test used to diagnose and assess the severity of heart failure.

Learn more about the HF Biomarker trial by calling the Clinical Trials Office at 484-628-8585.

CardioMEMS

CardioMEMS Heart Failure System Post Approval Study

Investigator: Jared Green, DO

The purpose of this post-approval study is to educate the use of the CardioMEMS Heart Failure System in qualifying subjects to confirm its safety and effectiveness.

Learn more about the CardioMEMS trial or call the Clinical Trials Office at 484-628-8585.

Colonoscopy

Colon Cancer Screening

Biofilm Epidemiology and Mechanisms of Colon Cancer

Investigators: Louis LaLuna, MD; John Altomare, MD; Ravi Ghanta, MD; Christopher Ibrahim, MD; Nirav Shah, MD

This research is being done to learn more about why people get colon cancer. We are looking to identify specific bacteria in the colon that may be linked to the development of colon cancer, and small biopsies will be taken along with other samples to look for these bacteria.

Learn more about the colonoscopy trial or call the Clinical Trials Office at 484-628-8585.

Emergency Medicine

Anticoagulants and Bleeding

SOAR

Safety of Oral Anticoagulants Registry: A National, Hospital-based Sentinel Surveillance Study of the Clinical and Economic Impact of Bleeding and Bleeding Concerns due to the use of Oral Anticoagulants

Investigator: Adam Sigal, MD

This is a registry study to identify the clinical and economic impact of safety concerns around the use of oral anticoagulants, the evaluation and management in an emergency department or on inpatient units. The data is used to improve approaches to the management and development of a new protocol safety standard.

Learn more about the SOAR trial or call the Clinical Trials Office at 484-628-8585.

Endocrinology and Diabetes

Prediabetes

Sweetch

Effectiveness of a Smartphone-Assisted Coaching System to Improve Glucose Homeostasis in Adults with Prediabetes

Investigator: Brian Kane, MD

The purpose of this study is to test the usefulness of Sweetch, a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

Learn more about the Sweetch trial or call the Clinical Trials Office at 484-628-8585.

Infectious Disease

Candidemia

STRIVE

CD101 Compared to Caspofungin Followed by Oral Step Down Treatment in Subjects with Candidemia

Investigator: Debra Powell, MD

The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

Learn more about the STRIVE trial here or call the Clinical Trials Office at 484-628-8585.

Clostridium difficile

ECOSPOR

A RandomizEd, Double Blind, Placebo COntrolled, Parallel Group Study of SER 109 to Prevent Recurrent ClOstRidium Difficile Infection

Investigator: Debra Powell, MD

This study is recruiting patients who have had at least 3 episodes of C. difficile in the last year, and who have responded to antibiotic treatment.

Learn more about the ECOSPOR trial or call the Clinical Trials Office at 484-628-8585.

Cdiffense

Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection

Investigator: Debra Powell, MD

This study is recruiting patients who are age 50 or older and planning an upcoming hospitalization of more than 72 hours for a surgical procedure OR who have had at least two hospital stays and have received antibiotics in the past year.

Learn more about the Cdiffense trial or call the Clinical Trials Office at 484-628-8585.

HIV

Egrifta

A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects with HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (tesamorelin for injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®

Investigator: Kathleen McElwee, MD

This study is a long-term observational study comparing subjects with HIV-associated belly fat who take the medicine, EGRIFTA with subjects of a similar group that haven's taken Egrifta.

Learn more about the Egrifta trial or call the Clinical Trials Office at 484-628-8585.

Influenza A

FLU-IGIV

Exploring Safety & Clinical Benefit of Anti-Influenza Immune Globulin Intravenous in Hospitalized Adults With Influenza A

Investigator: Debra Powell, MD

This study aims to evaluate a treatment for people who are hospitalized with the flu.

Learn more about the FLU-IGIV trial here by calling the Clinical Trials Office at 484-628-8585.

Lyme

SLICE

Sex-based differences in the immunobiology and natural history of acute and convalescent Lyme disease (JHIRB00071455)

Johns Hopkins Primary Investigator: John Aucott, MD

Investigator: Debra Powell, MD

The purpose of this study is to examine sex-based differences in immune response and clinical outcomes in participants with Lyme disease.

Learn more about the SLICE trial by calling the Clinical Trials Office at 484-628-8585.

Neurology

Stroke

ARAMIS

Management of Acute Stroke Patients on Treatment with New Oral Anticoagulants: Addressing Real-world Anticoagulant Management Issues in Stroke Registry

Investigator: Karen Hoerst, MD

This study is designed to provide important and timely insight into the management of acute stroke patients who are on new oral anticoagulants.

Learn more about the ARAMIS trial or call the Clinical Trials Office at 484-628-8585.

Oncology

Lung Cancer Screening

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer

Investigator: Uday Dasika, MD

The purpose of this study is to develop a blood-based gene expression signature to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected.

Learn more about the Lung Cancer Biomarker by calling the Clinical Trials Office at 484-628-8585.

Orthopedics

Hip Fracture

REGAIN

A Randomized Controlled Trial of Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

Investigator: Karen Troxell, MD

The purpose of this study is to determine whether spinal anesthesia, when used as a primary anesthetic technique for hip fracture surgery is associated with improved functional recovery and decreased risk of adverse postoperative outcomes compared to general anesthesia.

Learn more about the REGAIN trial or call the Clinical Trials Office at 484-628-8585.

Weight Loss

Obesity

STEP 1

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Investigator: Stephen Fehnel, MD

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight.

Learn more about the STEP 1 trial here or call the Clinical Trials Office at 484-628-8585.

Women's Health

Endometriosis

SPIRIT 1

Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

Investigator: Stephen Fehnel, MD

This study is to determine the benefit and safety of relugolix 40 mg once daily, co-administered with low-dose estradiol and norethindrone acetate compared with placebo, on dysmenorrhea and on nonmenstrual pelvic pain.

Learn more about the SPIRIT 1 trial here or call the Clinical Trials Office at 484-628-8585.

HPV

Pap Screens & HPV

Longitudinal Clinical Evaluation of the HPV Assay on the BD Viper LT System with Cervical Specimens

Investigator: Stephen Fehnel, MD

This study collects cervical specimens to test for HPV using an experimental test. These test results will then be compared to the current standards of testing for HPV and diagnosing cervical disease. This study is enrolling by invitation only.

Learn more about the Pap Screens & HPV trial or call the Clinical Trials Office at 484-628-8585.

Sterilization

POET

Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

Investigator: Stephen Fehnel, MD

This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization.

Learn more about the POET trial here or call the Clinical Trials Office at 484-628-8585.


Uterine Fibroids

Elagolix & Heavy Menstrual Bleeding

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding associated with Uterine Fibroids in Premenopausal Women

Investigator: Stephen Fehnel, MD

This study seeks to evaluate the efficacy, safety and tolerability of the drug elagolix alone and in combination with estradiol/norethindrone acetate or placebo for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Learn more about the Elagolix trial or call the Clinical Trials Office at 484-628-8585.

Uterine Fibroids

LIBERTY 2

An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids

Investigator: Stephen Fehnel, MD

The purpose of this study is to determine the benefit of relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

Learn more about the LIBERTY 2 trial here or call the Clinical Trials Office at 484-628-8585.