Northwestern University Feinberg School of Medicine

Department of Medicine

Clinical Trials

As part of an academic medical center, the Department of Medicine at Northwestern University Feinberg School of Medicine (Feinberg) aims to improve the human health through scientific research.

About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.

Department of Medicine Clinical Trials
The following searchable list includes all Department of Medicine clinical trials currently looking for participants.

Contact Us
Please feel free to contact us with inquiries about any of our ongoing research.

Trials
Screening For a Registry (Database) and Future Participation In Asthma and Chronic Obstructive Lung Disease (COPD) Clinical Research Studies
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in la…
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in laboratory studies, the most promising ones are tested in human subjects. At the same time, research is being done on cells and secretions obtained from normal individuals and patients with asthma and COPD to increase our understanding of what causes these diseases and to determine how they can best be treated. You are being asked to take part in an evaluation of your health status in order to determine your eligibility to participate in future clinical research studies. The evaluation will involve assessing your overall medical condition and the status of your asthma, if you have asthma or the status of your COPD, if you have COPD. The evaluation will help determine if you may be eligible for current or future asthma and COPD clinical research studies done at Northwestern University.
18 years of age or older with asthma or COPD(Chronic Obstructive Lung Disease)
Smith, Lewis JSmith, Lewis J
  • Map it 201 E. Huron Street
    Chicago, IL
STU00015972
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Hixon, Jenny Lorraine 312 926 0975
Steroids In Eosinophil Negative Asthma
Most people with asthma have inflammation in their airway. Asthma controller medications, like inhaled corticosteroids, are meant to reduce inflammation in the airway. Reducing airway inflammation should make one's breathing easier. However, many people with …
Most people with asthma have inflammation in their airway. Asthma controller medications, like inhaled corticosteroids, are meant to reduce inflammation in the airway. Reducing airway inflammation should make one's breathing easier. However, many people with asthma don't breathe easier when they take inhaled corticosteroids. We know that there are several types of cells that can cause airway inflammation. However, inhaled corticosteroids mostly target only one cell called the eosinophil. The purpose of this study is to find out if people should take an asthma controller medication based on the type of inflammatory cells present in their airway.
18 year of age or older with asthma
Smith, Lewis JSmith, Lewis J
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02066298 STU00093538
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Hixon, Jenny Lorraine 312 926 0975
Evaluation of the IBV® Valve for Emphysema to Improve Lung Function
Emphysema is a chronic lung disease where lung tissue is destroyed. This destruction causes the lungs to lose their natural elasticity, leaving the emphysema sufferer with an inability to get air out of their lungs. This causes sh…
Emphysema is a chronic lung disease where lung tissue is destroyed. This destruction causes the lungs to lose their natural elasticity, leaving the emphysema sufferer with an inability to get air out of their lungs. This causes shortness of breath which makes it hard to perform many physicial activities. While there is no cure for emphysema, there are various surgical procedures that have been used to treat the symptoms of emphysema, including lung volume reduction surgery (LVRS). LVRS has proven effective in improving survival, health status, exercise capacity and lung functions in treated patients. However, many people with severe emphysema are not eligibile for LVRS due to concerns regarding the risks associated with surgical procedures. As a result, there is a significant medical need to investigate a non-surgical approach to helping patients with severe emphysema, such as the Spiration Valve System, the device of this study.
18 years of age or older and diagnosed with severe COPD
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron Street
    Chicago, IL
NCT01812447 STU00099554
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Rogowski, Allison 312 695 4828
Efficacy and Safety of BI 655066 in Patients With Severe Persistent Asthma.
Many people with severe asthma do not have their symptoms controlled even after taking current therapies that are available, and experience frequent asthma attacks. The purpose of the study is to test the safety and ef…
Many people with severe asthma do not have their symptoms controlled even after taking current therapies that are available, and experience frequent asthma attacks. The purpose of the study is to test the safety and effectiveness of the study drug called risankizumab administered by injections beneath the skin in adults with severe asthma. This study will test whether the study drug will reduce attack frequency, reduce episodes of asthma worsening, improve asthma symptoms, improve lung function, and resolve inflammation in the airways.
18 years of age or older with severe asthma
Rosenberg, Sharon ReiflerRosenberg, Sharon Reifler
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02443298 STU00201582
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Hixon, Jenny Lorraine 312 926 0975
Study of N91115 in Patients With CF Homozygous for the F508del-CFTR Mutation
This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of N91115 in adult patients with CF who are h…
This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of N91115 in adult patients with CF who are homozygous for the F508del-CFTR mutation and being treated with lumacaftor/ivacaftor (Orkambi™).
Jain, ManuJain, Manu
NCT02589236 STU00201882
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1-855-NU-STUDY
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the …
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
Dematte DDematte D'Amico, Jane E
NCT02597933 STU00201767
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1-855-NU-STUDY
Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
The purpose of this study is to learn more about the safety and effectiveness of an investigational drug called metoprolol succinate for the treatment of COPD. Metoprolol succinate is already approved by…
The purpose of this study is to learn more about the safety and effectiveness of an investigational drug called metoprolol succinate for the treatment of COPD. Metoprolol succinate is already approved by the U.S. Food and Drug Administration (FDA) to treat patients with heart disease usually after a myocardial infarction (MI), such as a heart attack. Metoprolol succinate is considered "investigational" in this study, because it has not been approved by the FDA to treat COPD. Metoprolol succinate is used to treat chest pain (angina), heart failure, and high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This lowers heart rate, blood pressure, and strain on the heart. This study will test how well once daily metorprolol succinate works to reduce COPD flare-ups.
40 to 84 years of age with a diagnosis of COPD, Currently using oxygen OR had a COPD flare-up OR visited the ER for COPD in the last year, not taking a beta blocker medication
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02587351 STU00202036
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Rogowski, Allison 312 695 4828
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic …
This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin] antibody being co-developed by Amgen and Medimmune) can lead to lasting tolerance to cat allergen.The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
Greenberger, Paul AllenGreenberger, Paul Allen
NCT02237196 STU00088003
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1-855-NU-STUDY
Non-invasive Detection of Right Ventricular Interstitial Fibrosis using MRI in Patients with Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
This study seeks to explore the structural alterations in the right ventricle (RV) of patients with heart failure with preserved ej…
This study seeks to explore the structural alterations in the right ventricle (RV) of patients with heart failure with preserved ejection fraction (HFpEF) by employing cardiac MRI-derived T1 mapping, an indicator of the degree of diffuse fibrosis, that may allow us to answer the following research questions: 1) Does T1 mapping accurately detect diffuse RV fibrosis?; 2) Do pulmonary hypertension (PH) HFpEF patients have increased RV fibrosis compared to controls and/or HFpEF patients without PH?; 3) Does the amount of RV fibrosis correlate with the degree of RV dysfunction?; 4) Does the degree of RV fibrosis vary between various etiologies of PH? Given NMHC's unique and robust HFpEF program and strength in cardiovascular MR research, Northwestern is uniquely suited for this endeavor. The ultimate goal is to provide mechanistic insight into these conditions so that effective, targeted therapies can be developed.
Freed, BenjaminFreed, Benjamin
STU00200134
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1-855-NU-STUDY
PHENOTYPING RARE GENETIC VARIANTS IN PCOS & MULTIETHNIC FINE-MAPPING OF POLYCYSTIC OVARY SYNDROME SUSCEPTIBILITY LOCI (P50 HD044405 / R01 HD085227)
Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive age women worldwide and a leading risk factor for type 2 diabetes me…
Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive age women worldwide and a leading risk factor for type 2 diabetes mellitus. We are mapping chromosomal regions that have a high likelihood of containing genes causing PCOS. These findings could also identify novel therapeutic targets and genetic variants conferring substantial risk that could be used for PCOS prediction and prevention.
We are currently recruiting 18-40 year old women with either PCOS (8 or fewer periods per year) or healthy control (regular monthly periods). Also, these women should not be using any type of hormonal birth control (pills, patches or injections).
Dunaif, Andrea EDunaif, Andrea E
  • Map it 303 E. Chicago Avenue
    Chicago, IL
STU00008096
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Akinrotimi, Oludemilade 312 503 4385
Vitamin D and Type 2 Diabetes Study
Overweight adults, age 30 and above who are at risk for type 2 diabetes, are needed for a research study on a dietary supplement. During the study, participants will obtain information about their health, receive educational information on the prevention of diabete…
Overweight adults, age 30 and above who are at risk for type 2 diabetes, are needed for a research study on a dietary supplement. During the study, participants will obtain information about their health, receive educational information on the prevention of diabetes, and be required to take a dietary supplement daily. Participation in the study will last for up to 4 years. Participants will receive a stipend for completing all study visits. People diagnosed with diabetes, kidney stones, or kidney disease are not eligible. Other exclusions apply. For more information or to see if you qualify, please call 312-503-3413, email d2d@northwestern.edu or visit www.d2dstudy.org. (Sponsored by the National Institutes of Health)
-Adults 30 and older, BMI 24 and above, having pre-diabetes as determined by the following: fasting glucose: 100-125, HbA1c: 5.7-6.4
Neff, Lisa MNeff, Lisa M
STU00078718
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Abou-El-Seoud, Dalya 312 503 7203
LCH_Measuring Human BAT Volume and Activity by Quantitative and Functional MRI (2014-15761)
In this study we will be comparing two different types of body scans and how they reveal fat tissues in the body. Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) will be used to look fo…
In this study we will be comparing two different types of body scans and how they reveal fat tissues in the body. Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) will be used to look for a specific type of metabolically active fat called brown fat (brown adipose tissue or BAT). Understanding more about BAT and how it relates to metabolism could eventually lead to the development of obesity treatments by encouraging weight loss. You may be eligible if you are male, normal weight or obese, healthy, nonsmoking and between the ages of 18-24. The study includes 3-4 separate visits to Northwestern Memorial Hospital and Lurie Children’s, laboratory testing and medical imaging study. Volunteers will receive compensation and reimbursement for participation. Call 312-503-3413 or email jennifer.lewandowski@northwestern.edu for more information.
You may be eligible if you are male, normal weight or obese, healthy, nonsmoking and between the ages of 18-24.
Deng, JieDeng, Jie
STU00099042
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Abou-El-Seoud, Dalya 312 503 7203
Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease
The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It is a pivotal trial intended to support the registration of LCI699 for the treatment of patie…
The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It is a pivotal trial intended to support the registration of LCI699 for the treatment of patients with Cushing's disease in the EU, Japan, and other countries.
Molitch, Mark EMolitch, Mark E
NCT02180217 STU00100063
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1-855-NU-STUDY
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 dia…
The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
• Subjects with type 2 diabetes mellitus
• Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on the following criteria: Persistent very high albuminuria defined as urinary albumin-to-creatinine ratio (ACR) of > 300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) 25 - < 75 mL/min/1.73 m² Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months
• Serum potassium
Molitch, Mark EMolitch, Mark E
NCT02540993 STU00201605
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Adelman, Daphne T 312 908 9002
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated …
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
Molitch, Mark EMolitch, Mark E
NCT02685709 STU00202258
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1-855-NU-STUDY
Low InTensity Exercise Intervention in PAD
This study is being done to determine whether an exercise intervention that avoids continuous supervision and exercise-related pain in the legs can improve walking ability in people with lower extremity peripheral artery disease (PAD).
Peripheral artery disease
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02538900 STU00105855
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Mesyef, Catherine 312 503 4639
Telmisartan Plus Exercise to Improve Functioning in PAD
The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performan…
The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02593110 STU00200954
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Banks, Landan 312 503 3252
Improving Outpatient Safety of Older Adults through Electronic Patient Portals
The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
Lindquist, Lee ALindquist, Lee A
STU00201242
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Seltzer, Anne Jennifer 312 926 5159
The ENRGISE Pilot Study
The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02676466 STU00201974
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Vyas, Riddhi 312 503 4416
Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study
The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve card…
The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02876887 STU00202741
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Banks, Landan 312 503 3252
A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
A5324 is a randomized, double-blinded, placebo-con…
A5324 is a randomized, double-blinded, placebo-controlled study for HIV-infected individuals with an undetectable HIV viral load who have at least mild neurocognitive impairment. Participants will be randomized to add either maraviroc plus dolutegravir, dolutegravir alone, or placebo to their current anti-HIV medications. The main purpose of the study is to see if intensification with maraviroc and dolutegravir will improve neurocognitive performance and functioning in persons who have at least mild neurocognitive impairment.
• HIV-1 infected persons at least 18 years of age
• On current HIV medications for at least 12 months
• No prior or current use of any integrase inhibitor or maraviroc
• HIV viral load less than 50 copies
• Screening neuropsychological tests showing problems with memory, thinking or daily tasks
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02519777 STU00200413
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Berzins, Baiba Ingrida 312 695 5012
HIV acquisition among African-born US residents
We are doing this study with people who have been diagnosed with HIV infection and were born in Africa. We want to learn about how and where people born in Africa who now live in the U.S. became infected with HIV, and how often and where they were scre…
We are doing this study with people who have been diagnosed with HIV infection and were born in Africa. We want to learn about how and where people born in Africa who now live in the U.S. became infected with HIV, and how often and where they were screened for HIV, so that barriers for HIV diagnosis can be identified. This study involves a one-time in-person interview (30 to 45 minutes) about the participants HIV testing history, risk factors, and sexual behaviors.
Have an HIV diagnosis in 2000 or later year; African country of birth or citizenship, but currently living in the U.S.; Male or Female at least 18 years of age; English-speaking
Taiwo, Babafemi OTaiwo, Babafemi O
STU00200911
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Berzins, Baiba Ingrida 312 695 5012
A Multicenter Group to Study Acute Liver Failure. Long-term Outcomes of Acute Liver Failure Study Group Patients
Data Registry study for acute liver failure.
18-70 yr old adults. Acute Liver Failure (ALF) - INR > 1.5 and hepatic encephalopathy. Acute Liver Injury (ALI) - INR > 2, ALT > 10 x ULN
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron Street
    Chicago, IL
NCT00518440 STU00016475
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Gottstein, Jeanne H 312 694 0264
Alterations in Gene Expression in the Scleroderma Esophagus
The purpose of this study is to learn more about how Scleroderma (SSc) affects the esophagus to cause symptoms such as heartburn and trouble swallowing (dysphagia). We also want to learn whether the problems that cause esophageal symptoms ar…
The purpose of this study is to learn more about how Scleroderma (SSc) affects the esophagus to cause symptoms such as heartburn and trouble swallowing (dysphagia). We also want to learn whether the problems that cause esophageal symptoms are the same as the problems that cause SSc skin tightening and lung disease. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology (achalasia, esophageal stricture, esophageal cancer)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00021381
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Hoffmann, Aileen 312 503 4083
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospita…
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron Street
    Chicago, IL
NCT01966419 STU00085977
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Gottstein, Jeanne H 312 694 0264
Healthy Control Esophageal Registry and Biorepository
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biop…
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology
- Have a diagnosis of an eating disorder
- Have a diagnosis of an autoimmune disease
- A current or previous smoker (smoked >100 cigarettes in lifetime)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Taking antacids and/or proton pump inhibitors for heartburn
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
Hirano, IkuoHirano, Ikuo
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00096856
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Hoffmann, Aileen 312 503 4083
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE).
Hirano, IkuoHirano, Ikuo
NCT02098473 STU00098780
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1-855-NU-STUDY
Phase 3 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibros…
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.
Flamm, Steven LFlamm, Steven L
NCT02308111 STU00200837
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Gottstein, Jeanne H 312 694 0264
A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Patients Who Are Refractory to or Intolerant of TNF Inhibitors
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and …
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of tumor necrosis factor (TNF) inhibitors.
Hanauer, StephenHanauer, Stephen
NCT02100696 STU00200704
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1-855-NU-STUDY
JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatiti…
To evaluate the safety and potential efficacy of two dose levels of JKB-121 (5 mg twice daily and 10 mg twice daily) in reducing liver fat and/or liver biochemistry compared to placebo in patients with biopsy-proven nonalcoholic steatohepatitis
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02442687 STU00201231
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Milosevic, Stanislava 312 694 0326
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patient…
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02548351 STU00201580
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Milosevic, Stanislava 312 694 0326
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02316717 STU00201957
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Milosevic, Stanislava 312 694 0326
Liver Test Study of Using JKB-122 in AIH Patients
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 2 to 10 times the upper limit of normal (ULN) and who have had a f…
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 2 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
Flamm, Steven LFlamm, Steven L
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02556372 STU00202224
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Sipich, Kimberly A 312 694 1293
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
Rapidity of response to treatments in inflammatory bowel diseases is now considered a field of major interest, due to the importance of achieving the highest benefit in the shortest possible tim…
Rapidity of response to treatments in inflammatory bowel diseases is now considered a field of major interest, due to the importance of achieving the highest benefit in the shortest possible time, in order to favor a fast backward step to normal life. There are no previous studies specifically designed to evaluate the rapidity of response to adalimumab therapy in patients with active Crohn's disease. Studies on rapidity of onset of response to adalimumab have, on the other hand, been performed in other diseases such as rheumatoid arthritis (Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis HERO study, Wolfe et al, 2006). This trial will assess the clinical responses occurring earlier than in week 1. This is an open label, one arm, prospective, multicenter, phase IV clinical trial.
Hanauer, StephenHanauer, Stephen
STU00201469
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1-855-NU-STUDY
A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) Tablet for 12 weeks in Genotype 1 or 4 HCV-Infected Subjects with Renal Insufficiency
To evaluate the safety of Ledipasvir/Sofosbuvir (Harvo…
To evaluate the safety of Ledipasvir/Sofosbuvir (Harvoni) for 12 weeks in patients with renal insufficiency, not yet on dialysis
Flamm, Steven LFlamm, Steven L
  • Map it 201 E. Huron Street
    Chicago, IL
NCT01958281 STU00202407
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Sipich, Kimberly A 312 694 1293
A Study To Confirm Efficacy and Safety of Terlipressin in HRS Type 1
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
Ganger, Daniel RGanger, Daniel R
NCT02770716 STU00203053
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Gottstein, Jeanne H 312 694 0264
(CIRB) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Steatohepatitis
This study will test an experimental drug GS-0976 for the treatment of Nonalcoholic Steatohepatitis (NASH). NASH is an aggres…
This study will test an experimental drug GS-0976 for the treatment of Nonalcoholic Steatohepatitis (NASH). NASH is an aggressive form of Nonalcoholic Fatty Liver Disease (NAFLD) in which the liver becomes fatty, inflamed and liver cells become injured. Scarring of the liver (fibrosis) may also occur.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 633 N. St Clair Street
    Chicago, IL
NCT02856555 STU00203619
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Sipich, Kimberly A 312 694 1293
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)
A study to evaluate the safety and tolerability of GS-9674 in subjects with NASH
Clinical diagnosis of non-alcoholic fatty liver disease (NAFLD) with histological or imaging evidence of fatty liver within the past 2 years.Screening MRI-PDFF with >= 10 % steatosis, screening MRE with liver stiffness >= 2.9 kPa; Platelet count >=150,000/mm3; Albumin >= 3.3 g/dL; Exclusions include: ALT > 5x ULN, other causes of liver disease including autoimmune, viral and alcoholic liver disease, liver cirrhosis.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron Street
    Chicago, IL
NCT02854605 STU00204121
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NASH

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Khan, Noreen Osman 312 694 1295
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Luo, XunrongLuo, Xunrong
NCT01897688 STU00059469
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1-855-NU-STUDY
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney…
The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney Disease (CKD) stages 3-4.
Isakova, TamaraIsakova, Tamara
NCT02258074 STU00089187
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1-855-NU-STUDY
Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Tuazon, Jennifer ATuazon, Jennifer A
NCT00428948 STU00102788
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1-855-NU-STUDY
Chronic Kidney Disease Research Biorepository
The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
Isakova, TamaraIsakova, Tamara
STU00201546
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1-855-NU-STUDY
Northwestern Scleroderma Program Patient Registry
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00002669
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Carns, Mary 312 503 1137
Predictive Ability of Gene Expression Signatures in Skin as SSc Biomarkers
This study is being done because all therapies for scleroderma are associated with potential side effects. Given this fact, it is essential to be able to predict response to various experimental treatments in order minimize th…
This study is being done because all therapies for scleroderma are associated with potential side effects. Given this fact, it is essential to be able to predict response to various experimental treatments in order minimize the risk of side effects while improving the chance of clinical benefit. Using genomic (DNA expression) information gathered from skin biopsies from patients who respond to individual therapies, and associated clinical information, we hope to be able to accurately predict the likelihood of treatment response for individuals with scleroderma. This study involves skin biopsies at five seperate visits, blood collection, and some health questionnaires.
-Patients >18 years old with a diagnosis of lcSSc, dcSSc, localized scleroderma, or a scleroderma mimic disorder as defined by American College of Rheumatology criteria who will be beginning a new disease-modifying treatment for their disease.
-Must not be currently pregnant or nursing.
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00004428
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Carns, Mary 312 503 1137
Chicago Lupus Database
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number …
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
STU00009193
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Lerner, Danielle 312 503 1919
Genome Research in African American Scleroderma Patients (GRASP)
Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain t…
Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain the different risk in developing scleroderma seen in African American patients compared to other populations. Participants will complete a brief health questionnaire and provide two tubes of blood.
African American patients who are evaluated at the Northwestern Scleroderma Program and meet criteria for the diagnosis of systemic sclerosis, Age ≥ 18 years old
Varga, JohnVarga, John
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00069421
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Carns, Mary 312 503 1137
A Prospective Study to Identify Risk Factors for Progressive Calcinosis in Patients with Systemic Sclerosis: A Scleroderma Clinical Trials Consortium Study
This study is being done in order to help researchers learn more about calcinosis that affect patients with systemic sclerosis. Calcinosis cutis …
This study is being done in order to help researchers learn more about calcinosis that affect patients with systemic sclerosis. Calcinosis cutis is a rare disorder characterized by calcium deposition in skin and subcutaneous tissues. We will develop a prospective database of SSc patients with calcinosis in order to better understand the natural history, clinical associations, and pathophysiology of this condition.
Must have a diagnosis of Scleroderma. Must not have an overlap connective tissue disease or a diagnosis of mixed connective tissue disease. Must be over the age of 18.
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00088949
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Carns, Mary 312 503 1137
The Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN a…
The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are: 1. To learn more about important problems faced by people living with scleroderma (e.g., fatigue, emotional distress, physical limitations). 2. To develop and test internet-based interventions to support people in their efforts to cope with living with scleroderma. Participants will be asked to complete quality of life questionnaires via the internet every 3 months.
Diagnosis of scleroderma. Fluent in English. Must have access to the Internet to complete questionnaires.
Varga, JohnVarga, John
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00092924
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Carns, Mary 312 503 1137
SPARC: Gene expression profiling in scleroderma to discover therapeutic targets and predict clinical course
The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match tar…
The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match targeted treatments to the appropriate patients. The study will also focus on identifying inflammatory and fibrotic molecular pathways that are important in the disease Participants will be asked to give: - Two punch skin biopsies from the forearm (size of a pencil eraser) - Two tubes of blood - Urine collection Participants will be paid $110 for the one-time study visit. We are recruiting both patients with scleroderma and healthy control subjects.
Participants must be: Over age 18, No chronic skin conditions, No rheumatic autoimmune diagnosis (e.g., lupus, rheumatoid arthritis, scleroderma), Not currently pregnant.
Varga, JohnVarga, John
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00200631
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Carns, Mary (312) 503 1137
Molecular Biomarkers of Improvement for Patients with Systemic Sclerosis
The purpose of this study is to identify a method to predict disease course for each individual patient with scleroderma. We will identify gene expression signatures in skin (i.e., the genes that are being “read” to make pr…
The purpose of this study is to identify a method to predict disease course for each individual patient with scleroderma. We will identify gene expression signatures in skin (i.e., the genes that are being “read” to make proteins) in patients with scleroderma compared to healthy people. Signatures will be determined by measuring RNA (i.e., ribonucleic acid, the genetic information that codes for proteins) and DNA (i.e., deoxyribonucleic acid, the genetic information that contains your genes) in your skin. We will also identify serum protein signatures in blood. The goal is to develop a model that includes gene expression in skin and serum proteins in blood that can predict scleroderma disease course (improvement or worsening in skin, lung, esophageal, and/or heart disease). Participants will complete a questionnaire, give one tube of blood, and one skin biopsy.
• ≥18 years old
• Able to provide informed consent in English
• Meet 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (for patients)
• No chronic skin conditions or diagnosis of a rheumatic autoimmune disease (i.e., SLE, RA) (for healthy controls)
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00202756
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Carns, Mary 312 503 1137
Northwestern Scleroderma Twins Registry and Biorepository
The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonuclei…
The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonucleic acid, the genetic information that contains your genes) is nearly identical in twins, we are interested in studying what happens to change how the genes are read in the twin with SSc (epigenetics), when compared to how the same genes are read in the twin without SSc. Identifying these changes may help us to better understand why SSc occurs and to identify targets for treatment.
• Age ≥ 18 years
• At least one twin meets the 2013 American College of Rheumatology (ACR) criteria for the diagnosis of systemic sclerosis (affected twin)
• Both twins agree to participate in the research study
Varga, JohnVarga, John
  • Map it 633 N. St Clair Street
    Chicago, IL
STU00203621
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Carns, Mary 312 503 1137