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)
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    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 St.
    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 St.
    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 St.
    Chicago, IL
NCT02443298 STU00201582
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Hixon, Jenny Lorraine 312 926 0975
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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1-888-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 St.
    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
The Effect of KNO3 Compared to KCl on Oxygen Uptake in Heart Failure with Preserved Ejection Fraction
This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what the…
This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02840799 STU00202379
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Patel, Harnish H 312 695 4481
Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine testing to deter…
This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine testing to determine the best pumping speed for their LVAD that help guide medical treatment. One routine testing uses echocardiography (ultrasound of the heart) to create heart images and make measurements while gradually increasing the LVAD heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test. The ramp testing may also be performed during a right heart catheterization procedure (insertion of a catheter into a vein or artery in the groin, arm or neck guided to the heart using X-ray imaging). Doctors normally perform this procedure to obtain hemodynamic measurements (measure the pressure and blood flow in the heart). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the LVAD pump. Both of these methods for determining pump speed are accepted as normal, routine care for LVAD patients. In this study participants will be randomly (by chance) assigned (1:1) evenly to one of these two methods of testing. The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for LVAD patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
Rich, JonathanRich, Jonathan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203630
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Crooke, Catherine 312 695 4189
HFN - CHART
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy. We will evaluate how well your heart is working and measure proteins and chemicals in your blood. This study consists of a serie…
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy. We will evaluate how well your heart is working and measure proteins and chemicals in your blood. This study consists of a series of tests that may be completed in one visit or may be divided between two or more visits. We expect up to 20 people here will be in this research study out of approximately 200 people in the entire study nationally.
Inclusion Criteria:
Age >40 years
HIV antibody positive
On HAART for >6 months (HIV positive cohort only)
History of adequate viral suppression as defined by HIV RNA level <200 copies/mL in the past 6 months
LVEF >50%

Exclusion Criteria:
Past EF <50%
Moderate or severe valve stenosis or regurgitation, or past repair or replacement
Percutaneous or surgical revascularization or active angina
Persistent atrial fibrillation
BP>160mmHg SBP or >100mmHg DBP
Comorbid inflammatory disease (e.g. RA or SLE)
Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)
Chronic use of steroids or anti-inflammatory therapy
GFR <30 mL/min
Active in a clinical trial with investigational product
Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)
Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02860156 STU00203898
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Sanchez, Cynthia 312 695 5097
AdreView™ Myocardial Imaging for Risk Evaluation – A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 25%≤LVEF≤35%.
Currently, only about half of all patients with Heart Failure who meet the criteria for an ICD device actually receive one. Also, s…
Currently, only about half of all patients with Heart Failure who meet the criteria for an ICD device actually receive one. Also, some patients who receive an ICD device do not benefit from the device but rather incur the increased risks that are associated with the introduction of devices into the body. The purpose of this study is study is to evaluate if an AdreView™ heart function scan can help identify HF patients who may be more or less likely to benefit from having an ICD device implanted. Some research suggests that an ICD device may not be suitable for all patients with mild to moderate HF and a heart blood-pumping efficiency that is between 30% and 35% (ejection fraction 30-35%). An AdreView™ heart function scan could be used to identify people who have a high or low risk of a fatal event in the next 1 to 2 years. This additional information may make it possible to take a more accurate decision about who would and who would not benefit from an ICD device implantation. We expect that participants in the study will be involved for approximately 2¾ to 3 years and will need to come to clinic for study visits 8-9 times, depending upon if an ICD device is received as part of the patient's standard care or not. All participants involved in this study will receive an AdreView™ heart function scan. This heart function scan uses a radioactive imaging drug, AdreView™, which is already approved in the U.S. and Canada for diagnosing other diseases (e.g., cancers). AdreView™ is already approved in the United States by the U.S. Food and Drug Administration (FDA) for imaging the hearts of people with HF. We expect up to 25 people here will be in this research study out of approximately 2200 people in the entire study internationally.
INCLUSION CRITERIA:
• ≥18 years of age
• Females pre-menarchal, surgically sterile, postmenopausal, or negative pregnancy test
• Heart failure NYHA classes II or III for symptoms, ischemic or non-ischemic heart disease, eligible for ICD implantation
• Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration
• 30% ≤ LVEF ≤ 35%
• Clinically stable HF (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor’s office) for the past 30 days

EXCLUSION CRITERIA:
• Existing ICD or indication of ICD implantation for secondary prevention of SCD
• Hospitalized for HF or for acute coronary syndrome in the previous 40 days
• Cardiac resynchronization therapy (CRT) is planned or indicated
• Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing)
• NYHA class I or class IV symptoms
• ACC-AHA class III or class IV (unstable) angina
• Chronic renal insufficiency (serum creatinine ≥ 3 mg/dl or 265.2 μmol/L)
• Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView™ (Iobenguane I123 Injection)
• Use of medication that could interfere with the test: e.g. amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs which inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine
• Medical condition that could interfere with the AdreView™ test (e.g. left ventricular assist device or prior heart transplant)
• Participation in a research study using ionizing radiation in the previous 12 months
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02656329 STU00203156
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Crooke, Catherine 312 695 4189
Exercise in Genetic Cardiovascular Conditions: Lifestyle and Exercise in Hypertrophic Cardiomyopathy: “LIVE-HCM”/ Lifestyle and Exercise in Long QT Syndrome: “LIVE-LQTS”
This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants w…
This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants will be asked to periodically wear pedometers, upload data to a secure website, and complete interviews and questionnaires via telephone or online for up to three years. We expect up to 50 people here will be in this research study out of 4286 people in the entire study nationally.
Choudhury, LubnaChoudhury, Lubna
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02549664 STU00204370
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Zinn, Sarah 312 926 2828
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart …
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. If you agree to participate in this study, the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) and delivery system will be used to replace your failing bioprosthetic aortic valve. The delivery systems are the Commander system (transfemoral access – through the leg) and the Certitude system (transapical and transaortic access through the heart, when a small incision is made in your chest). The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) or any other governmental agency in North America for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. If you agree to participate in this research study and pass the screening tests, your involvement will last approximately 10 years. You will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally
Inclusion Criteria:
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
NYHA Functional Class ≥ II.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
Failing valve is unstable, rocking, or not structurally intact.
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.
Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
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Warzecha, Anna 312 926 0846
EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH TYPE 2 DIABETES OR PRE-DIABETES, AND PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inabil…
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..
Inclusion Criteria:

Documented type 2 diabetes for at least 3 months, or prediabetes. Those with type 2 diabetes must be prescribed a lifestyle intervention alone or in combination with a stable dose(s) of at least one glucose-lowering medication during the 8 weeks prior to the screening visit.
Hemoglobin A1c inclusion criteria as follows: i. Hemoglobin A1c of 6-11% (inclusive) for patients with documented type 2 diabetes receiving metformin monotherapy; ii. Hemoglobin A1c of 6.5-11% (inclusive) for patients with documented type 2 diabetes receiving any type of glucose-lowering medication (except metformin monotherapy); iii. Hemoglobin A1c of 6.0-6.9% (inclusive) for patients with documented type 2 diabetes receiving lifestyle intervention alone; iv. Hemoglobin A1c of > 5.7% and < 6.5 % for patients with pre-diabetes
Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
Ejection fraction (EF) ≥ 45% as determined on imaging study within 18 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
Elevated NT-proBNP ≥ 300 pg/ml or BNP ≥ 100 pg/ml. For patients with permanent atrial fibrillation inclusion thresholds will be BNP ≥ 125 pg/mL or NTproBNP ≥ 500 pg/mL
Stable medical therapy for heart failure for 30 days
On a diuretic ≥30 days prior to screening visit and a stable diuretic therapy for 14 days
At least one of the following: i. Hospitalization for decompensated HF in the last 12 months; ii. Acute treatment for HF with intravenous loop diuretic or hemofiltration in the last 12 months; iii. Mean pulmonary capillary wedge pressure ≥15 mmHg or LV end diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest, or pulmonary capillary wedge pressure or LVEDP ≥25 mmHg documented during catheterization with exercise; iv. Structural heart disease evidenced by at least one of the following echo findings (any local measurement made within the 18 months prior to screening visit): 1) left atrial (LA) enlargement defined by at least one of the following: LA width ≥3.8cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55mL or LA volume index ≥29 mL/m2 2) OR left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm.

Exclusion Criteria:

Decompensated heart failure (hospitalization for heart failure within the 30 days prior to screening)
History of type 1 diabetes
History of diabetic ketoacidosis
Hemoglobin A1c <5.7 or >11% at the screening visit
Estimated glomerular filtration rate (eGFR) < 30 at the screening visit
Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 60 days prior to the screening visit.
Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy, or transcatheter aortic valve replacement) or CRT within the 90 days after the screening visit.
Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within 30 days of the screening visit.
History of hypersensitivity to dapagliflozin
For women of child-bearing potential: Current or planned pregnancy or currently lactating.
Life expectancy <1 year at the screening visit
Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
BNP <100 pg/mL and NTproBNP<300 pg/mL at the screening visit. For patients with permanent atrial fibrillation exclusion thresholds will be BNP<125 pg/mL and NTproBNP<500pg/mL.
Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 12 weeks prior to the screening visit.
Average supine systolic BP <100 mmHg at the screening or randomization visit
Past or current history of bladder cancer
Active Hematuria
Donation of blood or bone marrow 12 weeks prior to the screening visit and no planned donations during the study period
Heart failure due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
Heart failure due to severe aortic or mitral regurgitation
Severe COPD thought to contribute to dyspnea
Isolated right heart failure due to pulmonary disease
Active and significant ischemia thought to contribute to dyspnea
Documentation of previous EF < 40% at any time
Complex congenital heart disease
Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the screening visit
Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
Bariatric surgery within the past 6 months or planned bariatric surgery within the study time course.
CardioMems device implantation within previous 4 weeks or planned CardioMems implantation during study period
For echo substudy only: history of poor echo windows as judged by the investigator
For echo substudy only: patients with ventricular paced rhythm or left bundle branch block on the most recent clinically available 12-lead electrocardiogram.
For echo substudy only: permanent atrial fibrillation
Khan, SadiyaKhan, Sadiya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03030235 STU00204842
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Roshevsky, Daniel Scott 312 695 3264
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Inclusion Criteria:
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03042104 STU00204517
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Warzecha, Anna 312 926 0846
AMPLATZER™ Amulet™ Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the h…
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical signals in your heart are not normal and cause the upper chambers of the heart to beat too fast and irregularly. This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the heart. In the left upper chamber, there is a small pouch called the left atrial appendage (LAA). Slowing of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a mini-stroke. These blood clots can also travel to other parts of the body and block blood vessels. The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the investigational (not yet approved by the FDA for use in the US) Amulet device is safe and effective when compared to an FDA-approved device called the WATCHMAN LAA closure device. We expect up to 25 people here will be in this research study out of 1700 people in the entire study internationally. Participants will be involved in this research study for up to 5 years. After the procedure, participants will be asked to come to clinic for 5 in-person study visits, and will be contacted via telephone by the study team 5 times.
Inclusion Criteria:
18 years of age or older
Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3
Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6)
Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation

Exclusion Criteria:
Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
Indicated for chronic P2Y12 platelet therapy inhibitor
Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
Implanted with a mechanical valve prosthesis
Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
Myocardial infarction (MI) within 90 days prior to randomization
New York Heart Association Class IV Congestive Heart Failure
Left ventricular ejection Fraction (LVEF) <30%
Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis
Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
History of idiopathic or recurrent venous thromboembolism
Left atrial appendage is obliterated or surgically ligated
Resting heart rate >110 bpm
Thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e. anemia as determined by the investigator which would require transfusion)
Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02879448 STU00204852
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Carswell, Amy 312 926 7554
CardioMEMS HF System Post Approval Study
The objective of this Post Approval Study is to demonstrate that data collected related to the use of the CardioMEMS HF System in a commercial setting are comparable with data collected in a controlled clinical trial. The CardioMEMS HF System provides a metho…
The objective of this Post Approval Study is to demonstrate that data collected related to the use of the CardioMEMS HF System in a commercial setting are comparable with data collected in a controlled clinical trial. The CardioMEMS HF System provides a method to measure pulmonary artery (PA) pressures by using a small wireless sensor (about the size of a paperclip) implanted into the pulmonary artery (a vessel close to your heart). Once implanted, the sensor communicates through radio frequency to an antenna contained in a pillow connected to an electronic unit and then transmits this valuable information to a secure website for your doctor to review. You will be able to take these PA pressure measurements yourself at home. In addition to these home readings, your PA pressures can also be obtained in the physician’s office, clinic, or hospital. Your doctor can access the secure website to view your measurements allowing him/her to make earlier treatment changes (usually changes in medications) to manage your heart failure remotely. The CardioMEMS HF System was approved by the US Food and Drug Administration (FDA) for commercial use, and is not considered experimental. We expect up to 180 people here will be in this research study out of 1200 people in the entire study nationally. If you agree to participate, we expect that you will be in this research study for two (2) years
Inclusion Criteria:
Diagnosis of NYHA class III heart failure
At least 1 heart failure hospitalization within previous 12 months
Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:
Active infection
History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Inability to tolerate a right heart catheterization
A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
Cardiac resynchronization device (CRT) implanted within previous 3 months
Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Congenital heart disease or mechanical right heart valve
Likely to undergo heart transplantation or VAD within the next 6 months
Known coagulation disorders
Hypersensitivity or allergy to aspirin, and/or clopidogrel
Anderson, AllenAnderson, Allen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02279888 STU00204614
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Crooke, Catherine 312 695 4189
REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
INCLUSION CRITERIA: 1. Chronic symptomatic heart failure (HF) documented by the following:
a. Symptoms of HF requiring current treatment with diuretics for ≥ 30 days
b. New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
c. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
2. Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months.
3. Age ≥ 40 years old
4. Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,
without documented ejection fraction <30% in the 5 years prior to study entry.
5. Site determined elevated PCWP with a gradient compared to right atrial pressure (RAP)
documented by:
a. End-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than
RAP by ≥ 5 mm Hg. OR
b. End-expiratory resting PCWP >15mm Hg, and greater than RAP by ≥ 5 mm Hg.
6. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
a. LA diameter > 4 cm; or
b. Diastolic LA volume > 50, LA volume index > 28 ml/m2 or c. Lateral e’ < 10 cm/s; or
d. Septal e’ < 8 cm/s; or
e. Lateral E/e’ > 10 ; or f. Septal E/e’ > 15
7. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC
8. Subject is willing to comply with clinical investigation procedures and agrees to return for all
required follow-up visits, tests, and exams
9. Trans-septal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator. EXCLUSION CRITERIA 1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
2. Cardiac resynchronization therapy initiated within the past 6 months
3. Advanced heart failure defined as one or more of the below:
a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
b. Cardiac index < 2.0 L/min/m2
c. Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months d. Patient is on the cardiac transplant waiting list
4. Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
5. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain.
6. Unwilling or unable (per PhysIQ protocol) to wear tele-monitoring patch.
7. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
8. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
9. Known clinically significant untreated carotid artery stenosis likely to require intervention.
10. Presence of hemodynamically significant valve disease assessed by the site cardiologist and defined as:
a. Mitral valve disease defined as grade ≥ 3+ MR or > mild MS
b. Tricuspid valve regurgitation defined as grade ≥ 2+ TR;
c. Aortic valve disease defined as ≥ 2+ AR or > moderate AS
11. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue);
or has a documented coagulopathy
13. Atrial fibrillation with resting HR > 100 BPM
14. Resting arterial oxygen saturation < 95% on room air
15. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
16. Right ventricular dysfunction, assessed by the site cardiologist and defined as a. More than mild RV dysfunction as estimated by TTE; OR
b. TAPSE < 1.4 cm; OR
c. RV size ≥ LV size as estimated by TTE; OR
d. Ultrasound or clinical evidence of congestive hepatopathy; OR
e. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%;
17. Resting RAP > 14 mmHg
18. Evidence of significant pulmonary hypertension defined as PVR > 4 Wood units
19. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
20. Hemoglobin <10 g/dl
21. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
22. Life expectancy less than 12 months for known non-cardiovascular reasons
23. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
24. Known or suspected allergy to nickel
25. Fertile women
26. Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
27. Systolic blood pressure >170 mm Hg.
28. Subjects with existing atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded.
29. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (>10 mg prednisone/day).
30. Severe obstructive sleep apnea not treated with CPAP or other measures
31. Severe depression and/or anxiety
32. In the opinion of the investigator, the subject is not an appropriate candidate for the study

Ricciardi, MarkRicciardi, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03088033 STU00204899
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Roshevsky, Daniel Scott 312 695 3264
Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
This study will evaluate the safety and effectiveness of the WATCHMANTM Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by…
This study will evaluate the safety and effectiveness of the WATCHMANTM Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMANTM Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMANTM Device itself and the implantation procedure are the same as the FDA approved WATCHMANTM. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMANTM Device in this study is considered “investigational” because the WATCHMANTM Device has not been approved by the FDA for use without short-term OAC therapy. If you agree to participate in this study, we expect that you will be in this research study for about 5 years. During this time, you will be asked to come to clinic for 6-7 study visits, and the study team will contact you by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
Inclusion Criteria:
The subject is of legal age to participate in the study per the laws of their respective geography.
The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
The subject has a calculated CHA2DS2-VASc score of 2 or greater.
The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.
The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:
The subject is unable or unwilling to return for required follow-up visits and examinations.
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
The subject has a history of atrial septal repair or has an ASD/PFO device.
The subject has an implanted mechanical valve prosthesis in any position.
The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
The subject has LVEF < 30%.
The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
The subject has a life expectancy of less than two years.
The subject has a known or suspected hypercoagulable state.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02928497 STU00205007
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Carswell, Amy 312 926 7554
A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding Phase II trial to study the efficacy, safety, pharmacokinetics and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure and preserved ejection fraction
This study is recruiting patients who have heart failure with normal ejection fraction (a measurement of the percentage of blood leaving the heart each time it pumps). The purpose of this study is to look at the efficacy and safety of the “Study Drug” neladenoson bialanate (BAY 1067197), and to learn more about how the body processes it. The study is considered research, because the Study Drug is under development and has not been approved by the US Food and Drug Administration (FDA) for use outside of a clinical study setting. Participants will be assigned at random (by chance) by a computer to receive one of five different doses of the Study Drug (5, 10, 20, 30, or 40 mg) or a placebo (a pill that looks like the Study Drug but has no active ingredient in it). There is a 3 in 4 chance of receiving some dose of the Study Drug and a 1 in 4 chance of receiving placebo. Participants will need to take the study tablets as the study doctor instructs and record doses in a diary. Additionally, at start of the study, and during the 1st, 8th, and 19th week of the treatment period, participants’ heart activity will be recorded for seven days using a device called AVIVO. A patch will be placed on the chest and connected wirelessly to a mobile device (size of a cell phone) that must be carried. The patch is waterproof and therefore it is possible to take a shower while wearing it. Taking a bath or swimming is not allowed because the patch can’t be submerged in water. After each period of 7 days the patch is to be removed and both the patch and the mobile device must be returned at the next study visit. Participation in the study will last approximately 27 weeks. Participants will be asked to attend 7 study visits to clinic and receive 3 telephone “visits” from the study team. We expect about 5 people here will be in this research study out of 288 people in the entire study internationally.
Inclusion Criteria:
Men or women aged 45 years and older
Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

Exclusion Criteria:
Acute decompensated heart failure within the past 4 weeks
Inability to exercise
Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)
Khan, SadiyaKhan, Sadiya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03098979 STU00205396
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Pohlman, Neal 312 926 2884
A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease
The purpose of this study is to find out whether a drug called “macitentan” works and is…
The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease. There are several drugs available to manage heart failure symptoms, but to date, no treatments have been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. Macitentan may reduce unwanted effects of a chemical substance in the body called endothelin, which has been detected in increased amounts in patients with heart failure. Endothelin causes blood vessels to narrow and results in overgrowth of the muscle in the walls of the lung blood vessels and also of the heart. By blocking the action of endothelin, macitentan lowers the blood pressure in the pulmonary arteries, may slow down overgrowth of the heart muscle and may therefore improve your condition. Macitentan has been tested and approved in the U.S. for other diseases, but is considered experimental for the use in this study. We expect participants will be in this research study for 70 weeks, and will need to come to clinic for study visits 13 times. We expect up to 5 people here will be in this research study out of 300 people in the entire study internationally.
Inclusion Criteria:
Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment with at least one oral diuretic (any type)
Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)
Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
HF hospitalization within 12 months prior to Screening and/or cardiac catheterization performed within 6 months prior to Screening showing PAWP or LVEDP > 15 mmHg
Elevated NT-proBNP
Pulmonary vascular disease or right ventricular dysfunction

Exclusion Criteria:
Any prior measurement of LVEF < 40%.
Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg during Screening
Body mass index (BMI) ≥ 45 kg/m2
Hemoglobin < 100g/L (< 10 g/dl) at Screening.
Significant parenchymal lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2
Severe hepatic impairment, e.g., Child Pugh Class C.
Freed, BenjaminFreed, Benjamin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03153111 STU00205418
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Study Coordinator 312 695 5097
MULTIETHNIC FINE-MAPPING OF POLYCYSTIC OVARY SYNDROME SUSCEPTIBILITY LOCI (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 mellitus. We are mapping chromosomal regions that have a high…
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 Ave.
    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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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 St.
    Chicago, IL
NCT02538900 STU00105855
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Domanchuk, Kathryn J 312 503 6438
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 St.
    Chicago, IL
NCT02593110 STU00200954
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Domanchuk, Kathryn J 312 503 6438
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
  • Map it 675 N. St. Clair St.
    Chicago, IL
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 St.
    Chicago, IL
NCT02676466 STU00201974
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Domanchuk, Kathryn J 312 503 6438
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 St.
    Chicago, IL
NCT02876887 STU00202741
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Domanchuk, Kathryn J 312 503 6438
Effects of Intravenous Ferric Carboxymaltose on Phosphorus and FGF23 Levels
Our research group is currently conducting a 6-8 -week study on patients with iron deficiency anemia to determine the effect of treating iron deficiency anemia with intravenous ferric carboxymaltose therapy on FGF23 and phosp…
Our research group is currently conducting a 6-8 -week study on patients with iron deficiency anemia to determine the effect of treating iron deficiency anemia with intravenous ferric carboxymaltose therapy on FGF23 and phosphorus levels. A single dose of ferric carboxymaltose has been shown to increase FGF23 levels in the short-term, but the long-term effects of ferric carboxymaltose on FGF23 levels in iron deficient patients are not known. We are conducting this research study to understand the effects of intravenous ferric carboxymaltose therapy on blood levels of FGF23 in individuals with iron deficiency anemia. The information gained from this study could be used to improve the health of patients with iron deficiency anemia.
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00203065
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Hodakowski, Alexander 312 503 3901
BTCRC GYN15-013: Phase II Study of Pembrolizumab in Combination with Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and ca…
The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and carboplatin chemotherapy.
Participants will be adults with cancer in the lining of the uterus (endometrium) that has spread to other parts of the body or has returned after initial treatment.
Matei, DanielaMatei, Daniela
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02549209 STU00204968
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Study Coordinator 312 695 1102
DRUG CA209-816: Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the …
The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the drug works) of nivolumab in combination with ipilimumab and nivolumab in combination with plantinum doublet chemotherapy in subjects with non-small cell lung cancer.
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02998528 STU00205030
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Study Coordinator 312 695 1102
A Phase 3, Randomized Study of Adjuvant Immunotherapy with Nivolumab Combined with Ipilimumab Versus Nivolumab Monotherapy after Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of two …
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of two investigational drugs called nivolumab and ipilimumab in subjects with late stage skin cancer that have had their tumors completely removed, but are likely to have their cancer return.
All participants must be aged 18 years or older. Participants must have histologically confirmed melanoma that has been surgically removed.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03068455 STU00205248
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Study Coordinator 312 695 1102
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 St.
    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 St.
    Chicago, IL
STU00021381
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Hoffmann, Aileen 312 503 4083
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 St.
    Chicago, IL
STU00096856
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Thakrar, Anjali 312 503 1120
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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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 St.
    Chicago, IL
NCT02548351 STU00201580
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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 St.
    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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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 St.
    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
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 St.
    Chicago, IL
NCT02854605 STU00204121
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Khan, Noreen Osman 312 694 1295
Transplant Recipients Undergoing Therapy Intended to Achieve Transplant Tolerance
Improvements in immunosuppression following solid organ allotransplantation have significantly enhanced short-term graft and patient survival. At the same time, long-term graft survival has not significantly improved. T…
Improvements in immunosuppression following solid organ allotransplantation have significantly enhanced short-term graft and patient survival. At the same time, long-term graft survival has not significantly improved. The combination of long-term inflammatory injury, in part due to incomplete immunosuppression, and drug toxicity from calcineurin inhibitors used in immunosuppression have inhibited long-term graft survival. Further, the cost and side effects of long-term immunosuppression are significant. Some patients do not need ongoing maintenance immunosuppression long-term. In liver transplant recipients, some estimates place this number as high as 20% of recipients. It has not been possible to show similar results in kidney transplantation. However, several interventions have been designed intended to achieve tolerance in the renal transplant population, as well. The status of immune systems in transplant patients has been well-studied. However, given the small number of patients either tolerant or undergoing therapy intended to induce tolerance, less is understood about their immune markers. This project aims to establish a repository of blood and urine taken serially from patients who have either demonstrated some degree of tolerance, or who are undergoing therapy intended to achieve tolerance, such that potential biomarkers – including those not yet identified – can be compared among health controls, transplant recipients not believed to be tolerant, and tolerant or partially tolerant recipients.
Friedewald, John JFriedewald, John J
STU00047842
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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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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 Disease (CKD) stages 3-4.
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT02258074 STU00089187
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Martinez, Carlos 312 503 1808
SHORT-TERM EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHATE HOMEOSTASIS IN HEALTHY VOLUNTEERS
The study is a Phase 1, double blind, randomized, placebo-controlled, trial in which healthy volunteers (as defined by the study protocol) receive a combination of phosphorus lowering medications…
The study is a Phase 1, double blind, randomized, placebo-controlled, trial in which healthy volunteers (as defined by the study protocol) receive a combination of phosphorus lowering medications and/or placebo for approximately 2 weeks.The objective of this study is to perform a detailed physiologic study of healthy volunteers to assess the short-term effects of nicotinamide alone, lanthanum carbonate alone, or both in combination on phosphate homeostasis. Specifically, the study is looking to determine the short-term effects of lanthanum carbonate and nicotinamide, alone and in combination, on hormonal regulators of mineral metabolism (FGF23 and PTH) and markers of bone turnover (P1NP and CTX).The results from healthy volunteers will provide information needed for optimal design of studies for patients with Chronic Kidney Disease.
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03136705 STU00090161
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Martinez, Carlos 312 503 1808
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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The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chr…
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT02521181 STU00200505
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Fox, Patrick 312 503 1887
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
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00201546
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Martinez, Carlos 312 503 1808
Iron Deficiency and FGF23 Regulation in Chronic Kidney Disease and Heart Failure
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iro…
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iron sucrose therapy can safely and successfully lower FGF23 levels. Iron sucrose has been shown to lower FGF23 in animal models. The short term effects of iron sucrose on FGF23 levels in CKD and CHF are not known. We are conducting this research study to understand the effects of intravenous iron sucrose therapy on blood levels of FGF23 in iron deficiency anemia in healthy individuals, individuals with CHF, individuals with CKD, and individuals with CKD and CHF. The information gained from this study could be used to improve the health of patients with iron deficiency anemia and disease of the kidneys and heart.
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03106298 STU00201742
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Hodakowski, Alexander 312 503 3901
A Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Patients With Kidney Transplant
To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipie…
To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) within 6 months.
Friedewald, John JFriedewald, John J
NCT02547220 STU00201572
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Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
Inclusion Criteria
• Type 1 and 2 Diabetes by ADA criteria (see appendix )
• Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
• Able to provide informed consent
• Adult participants (no age restriction)
• Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
Exclusion Criteria
• ESRD, defined as chronic dialysis or kidney transplant
• History of receiving dialysis for more than 30 days
• Institutionalized
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Less than 3-year life expectancy
• Known alcohol or substance abuse
• Unable to provide informed consent
• No evidence of active cancer other than non-melanoma skin cancer
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02986984 STU00204808
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Martinez, Carlos 312 503 1808
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 St.
    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 St.
    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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lupus

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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 St.
    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 St.
    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 St.
    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 St.
    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 St.
    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 St.
    Chicago, IL
STU00203621
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For more information on this study please contact us:

Carns, Mary 312 503 1137