Northwestern University Feinberg School of Medicine
Department of Medicine
Skip to main content

Clinical Trials

As part of an academic medical center, the Department of Medicine at Northwestern University Feinberg School of Medicine 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
More Info

For more information on this study please contact us:

Hixon, Jenny Lorraine 312 926 0975
Copy
Steroids in Eosinophil Negative Asthma (SIENA)
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 peop…
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
More Info

For more information on this study please contact us:

Hixon, Jenny Lorraine 312 926 0975
Copy
EMPROVE (Evaluation of the Spiration Valve System (SVS) - for EMphysema to ImPROVE Lung Function) A Prospective, Randomized, Controlled, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Single Lobe Treatment of Severe Emphysema
Emphysema is a chron…
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
More Info

For more information on this study please contact us:

Rogowski, Allison 312 695 4828
Copy
A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’(SSc-ILD)
Systemic Sclerosis (SSc) is a devastating disease of unknown eti…
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
More Info

For more information on this study please contact us:

1-888-NU-STUDY
Copy
Beta-Blockers for the Prevention of Acute Exacerbations of COPD
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 Administr…
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
More Info

For more information on this study please contact us:

Rogowski, Allison 312 695 4828
Copy
INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)
We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight…
We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors.
40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02634268 STU00204332
More Info

For more information on this study please contact us:

Hixon, Jenny Lorraine 312 926 0975
Copy
Losartan Effects on Emphysema Progression (LEEP)
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms…
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD. Losartan is a medicine used for treatment of high blood pressure. Losartan has been shown to slow the damage to lungs caused by COPD in animals. We would like to find out if taking Losartan can slow the damage to lungs caused by COPD. We will use images of participants’ lungs taken with high resolution computed tomography (HRCT) to measure changes in the lung. We also want to find out if Losartan has effects on blood and breathing tests.
40 years of age or older with COPD, controlled blood pressure, no flare of COPD in the last 6 weeks or the use of antibiotics or prednisone
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02696564 STU00204797
More Info

For more information on this study please contact us:

Hixon, Jenny Lorraine 312 926 0975
Copy
Anti-TSLP (AMG 157) plus antigen-specific immunotherapy for induction of tolerance in individuals with cat allergy (ITN057AD)
This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TS…
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
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
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.
hemoglobin < 12, ferritin <100 or ferritin <300 w/ TSAT < 20, no active infections, no active use of immunosuppresants
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03106298 STU00201742
More Info

For more information on this study please contact us:

Fox, Patrick 312 503 1887
Copy
The Effect of KNO3 Compared to KCl on Oxygen Uptake in Heart Failure with Preserved Ejection Fraction
KNO3CK-OUT HFpEF: 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 l…
KNO3CK-OUT HFpEF: 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
More Info

For more information on this study please contact us:

Patel, Harnish H 312 695 4481
Copy
Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
Ramp-It-Up: This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine test…
Ramp-It-Up: 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
More Info

For more information on this study please contact us:

Crooke, Catherine 312 695 4189
Copy
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
More Info

For more information on this study please contact us:

Zinn, Sarah 312 926 2828
Copy
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 study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (TH…
This 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. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the 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) 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 the 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 the heart. Study participation will last approximately 10 years. Participants 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.
*Main Inclusion Criteria*
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

*Main 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 is unstable, rocking, or not structurally intact.
Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03003299 STU00204739
More Info

For more information on this study please contact us:

Duquette, Audrey 312 926 7078
Copy
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
More Info

For more information on this study please contact us:

Roshevsky, Daniel Scott 312 695 3264
Copy
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
More Info

For more information on this study please contact us:

Duquette, Audrey 312 926 7078
Copy
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.

*Main 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
Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure
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
Heart attack within 90 days prior to randomization
Left ventricular ejection Fraction (LVEF) <30%
Symptomatic carotid artery disease Resting heart rate >110 bpm
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02879448 STU00204852
More Info

For more information on this study please contact us:

Carswell, Amy 312 926 7554
Copy
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
More Info
heart failure

For more information on this study please contact us:

Roshevsky, Daniel Scott 312 695 3264
Copy
Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by c…
This study will evaluate the safety and effectiveness of the WATCHMAN 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 WATCHMAN 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 WATCHMAN Device itself and the implantation procedure are the same as the FDA approved WATCHMAN. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMAN Device in this study is considered “investigational” because it has not been approved by the FDA for use without short-term OAC therapy. Participants in this study will be in this research study for about 5 years. During this time, participants will be asked to come to clinic for 6-7 study visits, and the study team will contact participants 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:
Documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation. The subject has a calculated CHA2DS2-VASc score of 2 or greater.
Deemed by two study physicians to be unsuitable for oral anticoagulation.
Deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
Able and willing to return for required follow-up visits and examinations.

Exclusion Criteria:
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
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).
Prior stroke (of any cause) or TIA within the 30 days prior to randomization.
Prior bleeding event within the 14 days prior to randomization.
History of atrial septal repair or has an ASD/PFO device.
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%.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02928497 STU00205007
More Info

For more information on this study please contact us:

Carswell, Amy 312 926 7554
Copy
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) requiring treatment with at least one oral diuretic (any type) . Left ventricular ejection fraction (LVEF) ≥ 40% . Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF).
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) Hemoglobin < 100g/L (< 10 g/dl) Significant 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
More Info

For more information on this study please contact us:

Sanchez, Cynthia 312 695 5097
Copy
Microtubule Polymerization of Modulators for Treating LMNA-Related Dilated Cardiomyopathy
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For thi…
This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if it can help improve heart function and reduce irregular heart rhythms in patients with LMNA related DCM
1. Confirmed diagnoses of LMNA cardiomyopathy (confirmed with genetic testing). 2. Evidence of myocardial dysfunction OR cardiac arrhythmia
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
STU00206184
More Info

For more information on this study please contact us:

Pollan, Laura 312 926 7312
Copy
Dilated Cardiomyopathy (DCM) Research Project
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery di…
Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery disease. Other causes include exposure to some drugs, such as cancer chemotherapy. When the cause is unknown, it is called idiopathic DCM. Among individuals with idiopathic DCM, having relatives undergo a cardiac check-up (echocardiogram, ECG) will reveal familial DCM in up to one-third of cases. A high level of suspicion of familial DCM is also raised when family members have had heart failure, a heart transplant, sudden death (without a history of coronary artery disease), or arrhythmias, which sometimes require a pacemaker or defibrillator. WHAT DOES THIS STUDY INVOLVE? IF YOU HAVE IDIOPATHIC DCM: Participation involves inviting all your first-degree relatives (children, parents, siblings) with or without heart disease. If you have other more distant relatives with DCM, they are also welcome to participate. To help with this process, we provide a letter that you can share with your relatives, and a family history questionnaire for you to complete. You may also receive a communication tool to help you invite your family members to the study. Your participation also involves providing cardiovascular information and medical records, completing annual surveys, and a blood draw. FOR FAMILY MEMBERS: Participation of family members involves collecting cardiac information and a blood draw. To better understand the genetic cause of DCM, it is helpful to compare results from family members with and without the condition. Because DCM can be present but silent for years, it is difficult to know with certainty if a family member does or does not have DCM unless a cardiac check-up is performed. Medical guidelines recommend this for 1st degree family members of individuals with DCM. Therefore, we also ask family members who enroll to obtain cardiac screening with both an echocardiogram and an electrocardiogram (ECG) if they have not done so recently.
Inclusion Criteria:

Meeting criteria for dilated cardiomyopathy (DCM) :
Left ventricular ejection fraction <50%
Left ventricular enlargement (A left ventricular end-diastolic dimension > 95%tile population standard based on gender and height).
Detectable causes of cardiomyopathy, except genetic, excluded beyond a reasonable doubt at the time of DCM diagnosis (that is, meeting clinical criteria for idiopathic DCM)
Any age (including children)
Non-Hispanic and Hispanic ethnicity
All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets).
Ability to give informed consent
Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity)
Willingness to participate in a family-based study (patient willing to work with a clinical site and/or OSU to facilitate the recruitment and enrollment of family members to the study).

Exclusion Criteria:

Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery)
Primary valvular disease
Adriamycin or other cardiotoxic drug exposure
Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
Congenital heart disease
Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
Other active multi-system disease that may cause DCM (e.g., active connective tissue disease).
Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment).
However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
Wilcox, Jane ElizabethWilcox, Jane Elizabeth
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03037632 STU00205850
More Info

For more information on this study please contact us:

Whisler, Cailin 312 926 3356
Copy
Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve recons…
This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ). The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation. Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03382457 STU00207338
More Info

For more information on this study please contact us:

Christensen, Lyndsay 312 694 0661
Copy
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
More Info

For more information on this study please contact us:

Akinrotimi, Oludemilade 312 503 4385
Copy
Vitamin D and type 2 diabetes
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…
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
More Info

For more information on this study please contact us:

Arroyo, Esperanza 312 503 3413
Copy
PERL - Preventing Early Renal Loss in Diabetes: A multicenter clinical trial of allopurinol to prevent GFR loss in type 1 diabetes A multicenter clinical trial of allopurinol to prevent GFR loss in type 1
Despite improvements during the past 20 years in blood glucose and blood pressure control,diabe…
Despite improvements during the past 20 years in blood glucose and blood pressure control,diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments} to complement blood glucose and blood pressure control are urgently needed. The goal of this study is to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes. Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, we will be conducting an international clinical trial at eight diabetes centers, enrolling approximately 480 patients with type 1 diabetes who are at increased risk of developing kidney disease.
Molitch, Mark EMolitch, Mark E
NCT02017171 STU00076318
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
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
More Info

For more information on this study please contact us:

Abou-El-Seoud, Dalya 312 503 7203
Copy
A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease (Protocol # CLCI699C2301)
The study aims …
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
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of 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 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
More Info

For more information on this study please contact us:

Adelman, Daphne T 312 908 9002
Copy
A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS
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
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
The effects of capsinoids on brown adipose tissue recruitment and activation in obesity
This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in in…
This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in individuals with excess weight. Previous studies have suggested that chronic consumption of capsinoids may be able to generate new brown fat in thin individuals. Capsinoids may also have a small positive effect on metabolism (increased calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more treatment options for people with excess weight.
Male, between ages 18-45, healthy, non-smoking, overweight/obese
Neff, Lisa MNeff, Lisa M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03110809 STU00204058
More Info

For more information on this study please contact us:

Abou-El-Seoud, Dalya 312 503 7203
Copy
Mediators of Atherosclerosis in South Asians Living in America
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians r…
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
Kandula, Namratha RKandula, Namratha R
NCT01207167 STU00019837
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
Low InTensity Exercise intervention in PAD: The LITE Trial.
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
More Info

For more information on this study please contact us:

Domanchuk, Kathryn J 312 503 6438
Copy
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
More Info

For more information on this study please contact us:

Domanchuk, Kathryn J 312 503 6438
Copy
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
More Info

For more information on this study please contact us:

Seltzer, Anne Jennifer 312 926 5159
Copy
The ENabling Reduction of low-Grade Inflammation in SEniors) 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 me…
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
More Info

For more information on this study please contact us:

Domanchuk, Kathryn J 312 503 6438
Copy
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
More Info

For more information on this study please contact us:

Domanchuk, Kathryn J 312 503 6438
Copy
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.
Receiving 2 doses of injectafer from Bleeding clinic
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00203065
More Info

For more information on this study please contact us:

Hodakowski, Alexander 312 503 3901
Copy
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
More Info

For more information on this study please contact us:

Study Coordinator 312 695 1102
Copy
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
More Info

For more information on this study please contact us:

Study Coordinator 312 695 1102
Copy
A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
This research study is investigating a drug (that is called IMCgp100) in patients with a…
This research study is investigating a drug (that is called IMCgp100) in patients with advanced uveal melanoma. Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the immune system, known as immunotherapies. In this research study, IMCgp100 will be compared to three representative standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug targeting a protein called CTLA-4), or pembrolizumab (an immunotherapy drug targeting a protein called PD-1). This research study is being done to assess the efficacy and safety of the IMCgp100 in patients with uveal melanoma in comparison to these standard treatments.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00000418 STU00205550
More Info

For more information on this study please contact us:

Study Coordinator 312 695 1102
Copy
A multicenter, randomized, double-blinded, placebo-controlled, phase 3 trial of adjuvant Avelumab (anti-PD-L1 antibody) in Merkel cell carcinoma patients with clinically detected lymph node metastases
The purpose of this study is to find out how Avelumab works in subjects who have Merkel Cell Carcino…
The purpose of this study is to find out how Avelumab works in subjects who have Merkel Cell Carcinoma (MCC) that has traveled to lymph nodes. Avelumab is being tested to see if it is given after surgery and radiation, if it might prevent the cancer from coming back. We are studying avelumab (anti-PDL-1, also called MSB0010718C). Avelumab is currently approved by the Food and Drug Administration for the treatment of advanced and metastatic MCC. This FDA approval of avelumab for patients with advanced MCC was granted on the basis of a phase II study showing activity when given after progression of disease on chemotherapy. However, avelumab is an experimental drug in this study and it has NOT been approved for treatment of MCC that has traveled to the lymph nodes (node-positive, non-metastatic MCC) that has been removed with surgery. Avelumab has not been tested in this setting before. Participants will be randomly assigned to be given either avelumab or a placebo. The avelumab and placebo will be given by intravenous (IV) infusion. In the study, the avelumab or placebo will be given every 2 weeks for the first 4 months (Induction Phase 1), then once a month for 4 months (Induction Phase 2), and then once every 3 months for up to 2 years (Maintenance Phase). Participants will continue to receive treatment depending on how they tolerate the study drug and how their cancer responds. After completing all study treatments or after the study has been stopped for other reasons, participants will be asked to continue with follow-up visits to monitor for potential benefits or side effects they may be experiencing from study treatment. Participants may be followed for up to 3 years after finishing study treatment.
Participants must be at least 18 years of age or older. Participants must have Merkel Cell Carcinoma metastases in lymph node(s). Participants must have completed treatment that included surgical removal of the MCC metastases.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207190
More Info

For more information on this study please contact us:

Study Coordinator 312 695 1102
Copy
A5320: Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)
This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepat…
This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepatitis C medications lasts and whether it affects future hepatitis C treatments. This is an observational study and does NOT provide any Hepatitis C or HIV treatment.
Persons who were treated with an oral direct acting anti-viral (DAA) therapy for hepatitis C, but did NOT have a successful response to treatment (non-SVR) (enrollment is closed to persons with successful response to treatment); Hepatitis C mono-infected OR Hepatitis C and HIV co-infected;
Taiwo, Babafemi OTaiwo, Babafemi O
STU00090304
More Info

For more information on this study please contact us:

Berzins, Baiba Ingrida 312 695 5012
Copy
Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332)/ A5333s: Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE/A5361s: Pitavastatin to REduce Physical Function Impairment and Frailty in HIV (PREPARE)
People infected wi…
People infected with HIV are at risk for cardiovascular disease (CVD). REPRIEVE is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months. The trial is testing the effect of statin therapy on preventing heart disease and death in HIV-infected persons on HIV medications who do not meet guidelines for starting statins. HIV causes inflammation (irritation) inside the body that may contribute to diseases such as heart disease. HIV medications can lower inflammation, however the levels of inflammation can remain higher compared to people who are not infected with HIV. Statins, such as pitavastatin, are medications that are used to lower the levels of cholesterol and triglycerides (fat in the blood) and have been shown to lower levels of inflammation and heart disease.
• HIV infected men and women between the ages of 40 and 75
• On anti-HIV medications for at least 6 months
• CD4 cell count greater than 100
• No history of cardiovascular disease, such as heart attack, stroke, etc.
• No history of cancer in the last 3 years
• Not currently using a statin drug
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02344290 STU00200323
More Info

For more information on this study please contact us:

Berzins, Baiba Ingrida 312 695 5012
Copy
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
More Info

For more information on this study please contact us:

Berzins, Baiba Ingrida 312 695 5012
Copy
ACTG A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away …
This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.
• Men and women, at least 18 years old
• Have certain lab tests done that confirm very early HIV infection (ie. before the blood shows that antibodies have been made, or just at the time antibodies are starting to be found in the blood)
• Be willing to take drugs to treat HIV right away.
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02859558 STU00203124
More Info

For more information on this study please contact us:

Berzins, Baiba Ingrida 312 695 5012
Copy
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
More Info

For more information on this study please contact us:

Gottstein, Jeanne H 312 694 0264
Copy
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
More Info

For more information on this study please contact us:

Thakrar, Anjali 312 503 1120
Copy
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients wit…
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01848561 STU00094204
More Info

For more information on this study please contact us:

Clark, Amanda 312 695 6688
Copy
A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
This study will evaluate the efficacy and safety of two a…
This study will evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.
Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02065570 STU00096539
More Info

For more information on this study please contact us:

Clark, Amanda 312 695 6688
Copy
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)
Carlson, DustinCarlson, Dustin
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00096856
More Info

For more information on this study please contact us:

Thakrar, Anjali 312 503 1120
Copy
(CIRB) An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
The purpose of this study is to evaluate L…
The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Flamm, Steven LFlamm, Steven L
NCT02167945 STU00102262
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease o…
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
More Info

For more information on this study please contact us:

Gottstein, Jeanne H 312 694 0264
Copy
Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)
This phase III…
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
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02100696 STU00200704
More Info

For more information on this study please contact us:

Clark, Amanda 312 695 6688
Copy
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo …
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
More Info

For more information on this study please contact us:

Milosevic, Stanislava 312 694 0326
Copy
A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis Patients Who Are Refractory or Intolerant to Current Therapies
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 ha…
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
More Info

For more information on this study please contact us:

Sipich, Kimberly A 312 694 1293
Copy
Semen quality in males with inflammatory bowel disease: Influence of methotrexate treatment.
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 …
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
  • Map it 201 E. Huron St.
    Chicago, IL
STU00201469
More Info

For more information on this study please contact us:

Arrieta, Rose 312 695 5878
Copy
(CIRB) A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1 (The Confirm Study)
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in…
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
More Info

For more information on this study please contact us:

Gottstein, Jeanne H 312 694 0264
Copy
(CIRB) A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
treatment for HCV using FDA approved drugs
Hepatitis C, Child pugh C
Flamm, Steven LFlamm, Steven L
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02994056 STU00204620
More Info
Hepatitis C

For more information on this study please contact us:

Gottstein, Jeanne H 312 694 0264
Copy
(CIRB) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known …
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS-4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and cirrhosis
Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study.
1) Willing and able to give informed consent prior to any study specific procedures being
performed
2) Liver biopsy consistent with NASH (defined as the presence of at least grade 1 steatosis,
hepatocellular ballooning, and lobular inflammation according to the NAFLD Activity Score
[NAS]) and cirrhosis (F4 fibrosis) according to the NASH CRN classification, in the opinion
of the central reader.
a) A historical liver biopsy within 12 months of the Screening visit may be accepted as the
Screening biopsy if the sample is deemed acceptable for interpretation by the central
reader.
b) If the subject is deemed ineligible for this study, the liver biopsy, if performed according
to protocol specifications and is within 6 months of the Screening visit, may be used to
determine eligibility for study GS-US-384-1943.
3) Subject has the following laboratory parameters at the Screening visit, as determined by the
central laboratory:
a) ALT ≤ 8 x ULN
b) CLcr ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation
c) HbA1c ≤ 9.5%
4) Body Mass Index (BMI) ≥ 18 kg/m2 at Screening
5) Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based
on the date of the Screening visit
6) Females of childbearing potential (as defined in Appendix 3) must have a negative pregnancy
test at Screening and Day 1
7) Male subjects and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception as described in
Appendix 3.
Rinella, Mary EugeniaRinella, Mary Eugenia
NCT03053063 STU00204671
More Info

For more information on this study please contact us:

Sipich, Kimberly A 312 694 1293
Copy
(CIRB) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as…
The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis.
1) Liver biopsy consistent with NASH (defined as the presence of at
least grade 1 steatosis, hepatocellular ballooning, and lobular
inflammation according to the NAFLD Activity Score [NAS]) and
bridging (F3 fibrosis) according to the NASH CRN classification, in
the opinion of the central reader.
a) A historical liver biopsy within 6 months of the Screening visit
may be accepted as the Screening biopsy if the sample is deemed
acceptable for interpretation by the central reader.
b) If the subject is deemed ineligible for this study, the liver biopsy,
if performed according to protocol specifications and is within
12 months of the Screening visit, may be used to determine
eligibility for study GS-US-384-1944
2) Subject has the following laboratory parameters at the Screening
visit, as determined by the central laboratory:
a) Alanine aminotransferase (ALT) ≤ 8 x ULN
b) Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as
calculated by the Cockcroft-Gault equation
c) HbA1c ≤ 9.5%
d) Total bilirubin ≤ 1.5 x ULN
Rinella, Mary EugeniaRinella, Mary Eugenia
NCT03053050 STU00204672
More Info

For more information on this study please contact us:

Sipich, Kimberly A 312 694 1293
Copy
NCI 2015-06-03 Statin Therapy to Reduce Disease Progression from Liver Cirrhosis to Cancer
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg d…
The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg daily or placebo daily, a pill that looks like simvastatin 40 mg but contains no medication. Simvastatin is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk for heart attack, stroke, and chest pain in patients who have heart disease or risk factors for heart disease such as smoking, high blood pressure, low high-density lipoprotein (HDL), or family history of early heart disease. It is also approved to lower the risk for heart attack or stroke in patients with type 2 diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure. However, simvastatin is not approved by the FDA to decrease the risk of liver cancer. Simvastatin is considered “investigational” (a study drug) in this study. Studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. We believe that this anti-inflammatory effect of simvastatin may help patients with liver cirrhosis.
Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Leukocytes >= 2,500/microliter
Absolute neutrophil count >= 1,500/microliter
Platelets >= 50,000/microliter
Hemoglobin >= 10 g/dL
Total bilirubin =< 3 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN
Creatinine =< 1.5 x institutional ULN
Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
Women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Ability to understand and the willingness to sign a written informed consent document and medical release
Willing and able to comply with trial protocol and follow-up
Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 7 months
Kulik, Laura MKulik, Laura M
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02968810 STU00204992
More Info

For more information on this study please contact us:

Sipich, Kimberly A 312 694 1293
Copy
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
More Info

For more information on this study please contact us:

1-888-NU-STUDY
Copy
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
More Info

For more information on this study please contact us:

1-888-NU-STUDY
Copy
EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON SERUM PHOSPHATE AND FGF23 LEVELS IN PATIENTS WITH STAGE 3-4 CHRONIC KIDNEY DISEASE
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) i…
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
More Info

For more information on this study please contact us:

Martinez, Carlos 312 503 1808
Copy
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
More Info

For more information on this study please contact us:

Martinez, Carlos 312 503 1808
Copy
A Phase 3b, Multi center, Open -label Trial to Evaluate the Long Term Safety of Titrated Immediate -release Tolvaptan (OPC 41061, 30 mg to 120 mg/day , Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease
This study's purpose is to evaluate the long-term safety and e…
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
More Info

For more information on this study please contact us:

1-855-NU-STUDY
Copy
Bicarbonate Administration to Stabilize 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 chronic kidney disease. However, the dose to prescribe in …
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
More Info

For more information on this study please contact us:

Fox, Patrick 312 503 1887
Copy
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
More Info

For more information on this study please contact us:

Martinez, Carlos 312 503 1808
Copy
SHP616-302: A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of Cinryze (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection in kidney transplant recipients
To evaluate the efficacy of Cinryze® given for the treatment of acute a…
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
More Info

For more information on this study please contact us:

1-888-NU-STUDY
Copy
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
More Info

For more information on this study please contact us:

Martinez, Carlos 312 503 1808
Copy
Protocol Dialysis Outcomes and Practice Patterns Study 2
The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning…
The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning to receive) chronic Peritoneal Dialysis (PD). The overarching goal of the study is to extend patient survival and improving quality of life for PD patients. There is no intervention being utilized as part of this research, participants will not incur charges as a result of study participation, and participants will not receive any financial compensation for participation in the study. Study participation consists of completing a patient questionnaire that asks about how kidney disease affects well-being and overall quality of life and extraction of data , by the study team, from a participant's medical record to complete other questionnaires associated with overall health. The duration of study participation is approximately 3 years and includes 4 study visits. The study visits consist of completing the an optional patient questionnaire on a yearly basis. The questionnaire will be completed when participants are seen in the dialysis clinic. Individuals can still choose to participate without having to complete the patient questionnaire.
Inclusion Criteria
• 18 years of age or older
• Treated at a Peritoneal Dialysis facility
• Receiving chronic, maintenance Peritoneal Dialysis provided by the facility but independent of the facility (for example., at home or a nursing home facility)
• Incident patients must have initiated Peritoneal Dialysis within 60 days of the first Peritoneal Dialysis treatment at home/nursing home

Exclusion Criteria
• Less than 18 years of age
• Receiving Peritoneal Dialysis for acute renal failure
• Receiving concomitant Peritoneal Dialysis and Hemodialysis (hybrid therapy) *
• Adults unable to consent/Cognitively impaired
• Pregnant women
• Prisoners or other detained individuals
* Hybrid therapy will be excluded from sampling for incident patients only but will be included in prevalent patient sampling
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 201 E. Huron St.
    Chicago, IL
STU00207081
More Info

For more information on this study please contact us:

Martinez, Carlos 312 503 1808
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
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
More Info
lupus

For more information on this study please contact us:

312 503 1919
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
Rheumatoid Arthritis Synovial tissue Network
We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression …
We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
• Diagnosis of rheumatoid arthritis (RA).
• Must have been 18 years of age or older at the time of diagnosis of RA.
• At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
Pope, Richard MPope, Richard M
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00104822
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary (312) 503 1137
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
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
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
xIRB A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum (an expe…
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum (an experimental drug) for the treatment of diffuse cutaneous systemic sclerosis (dcSSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks. The study will involve 12 study visits to Northwestern over the course of one year.
Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc), disease duration < 6 years, skin score greater than 15 if disease duration is more than 3 years, no new or increased doses of immunosuppresive medications within 8 weeks
Varga, JohnVarga, John
  • Map it 633 N. St. Clair St.
    Chicago, IL
NCT03398837 STU00206445
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol
The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover…
The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating two tubes of blood for the collection of genetic information (DNA) at one study visit.
- Giant Cell Arteritis
- Takayasu’s Arteritis
- Polyarteritis Nodosa
- Granulomatosis with Polyangiitis (Wegener’s)
- Microscopic Polyangiitis
- Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
Archer, AmyArcher, Amy
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00206908
More Info

For more information on this study please contact us:

Carns, Mary 312 503 1137
Copy
Back to top