Northwestern University Feinberg School of Medicine
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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
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Hixon, Jenny Lorraine 312 926 0975
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A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.
Wunderink, Richard GWunderink, Richard G
NCT02493764 STU00201672
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1-855-NU-STUDY
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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.

1 year, 2 visits.

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
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Hixon, Jenny Lorraine 312 926 0975
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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
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Hixon, Jenny Lorraine 312 926 0975
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REdefining THerapy IN early COPD

The purpose of this study is toevaluate a drug called indacterol/glycopyrrolate that may help improve yourbreathing. Indacterol/glycopyrrolate is an inhaled medication that is an FDAapproved medication for people who have Chronic Obstructive Pulmonary Disease(COPD)…

The purpose of this study is toevaluate a drug called indacterol/glycopyrrolate that may help improve yourbreathing. Indacterol/glycopyrrolate is an inhaled medication that is an FDAapproved medication for people who have Chronic Obstructive Pulmonary Disease(COPD). It is being used as an investigational drug in this study in people whodo not meet the current criteria for COPD but have respiratory symptoms (suchas coughing and shortness of breath).

12 weeks, 2 visits and 1 phone call.

Age 40-80

Current or former smoker

With symptoms of shortness of breath, chest tightness, cough, wheeze, and limitation in activities. 

Kalhan, RaviKalhan, Ravi
NCT02867761 STU00204372
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Frederick, Alyssa +1 312 695 4828
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xIRB A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis

This study is being done to learn more about the safety ofan experimental drug called ATYR1923 to see if taking this medication willallow people who have…

This study is being done to learn more about the safety ofan experimental drug called ATYR1923 to see if taking this medication willallow people who have pulmonary sarcoidosis to reduce their steroid dose, andto find out more about the effects of different doses of this drug on the lungsof people who have pulmonary sarcoidosis. This study will also look at how thebody responds to the drug. These things will be measured by taking samples ofblood, performing medical examinations, conducting lung function tests andreviewing images of the lungs.

 

In this study, people with pulmonary sarcoidosis willreceive monthly doses of ATYR1923 or Placebo for a total of 6 doses.Participation will last up to 28 weeks. The screening period to see if youqualify for the study may last up to 4 weeks and may require up to 3 visits atthe study site clinic. Participants who enter the study will receive study drugonce a month for 20 weeks. The study drug will be administered by infusion andeach visit will take approximately 6 hours. There are a total of 7 study clinicvisits and 8 telephone contacts during the treatment period.  Finally, there will be a follow-up studyvisit 4 weeks after receiving the last dose of study drug.

To qualify for the study you must be:

1. Diagnosed with pulmonary sarcoidosis for at least 1year 

2. Taking 10 to 25 mg/day of oral prednisone (or oralequivalent), at the same dose for at least 4 weeks before receivingstudy drug.

 

You will not qualify for the study if you have:

1. Cardiac, neurological, gastrointestinal, and/or renalmanifestations of sarcoidosis

2. Received treatment with biological medications (such asinfliximab (REMICADE) or adalimumab (HUMIRA) in the last 6 months

3. Smoked or inhaled (including e-cigarettes ore-vaporizers) any nicotine containing product within 6 months prior toScreening visit.

4. History of or positive results of hepatitis B, hepatitisC, or HIV

5. Jo-1 Antibody levels >7 U/mL, or past history of Jo-1antibody positivity.

Sporn, Peter HSporn, Peter H
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03824392 STU00208847
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Goldberg, Isaac +1 312 503 2157
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A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Fai…
A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

Inclusion:

1.Men or women, > 18 years of age 

2.Confirmed diagnosis of WHO Group 2 Pulmonary Hypertension (PH) with heart failure and preserved ejection fraction (HFpEF). 

3.WHO Group 2 Pulmonary Hypertension subjects with heart failure and preserved ejection fraction as defined by:

  • a. Mean pulmonary arterial pressure (mPAP) > 35 mmHg at rest or with legs up (at baseline right heart catheter/Lead-In)
  • b. Pulmonary capillary wedge pressure (PCWP) ≥ 20 mmHg at rest or with legs up (at baseline right heart catheter/Lead-In) 
  • c. NYHA Class II or III 
  • d. LVEF ≥ 40% by echocardiogram within three months of enrollment with no change in clinical status suggesting the potential for deterioration in systolic function 

4.Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 

5.Ability to walk at least 50 meters, but not more than 550 meters in a six-minute walk test. 

6.Long term oxygen treatment (if applicable) must be stable for 30 days prior to enrollment. 

7.Subjects on a chronic medication or therapy for any underlying cardiac condition must be on a stable dose for ≥30 days prior to randomization, with the exception of diuretics and antihypertensive medication for blood pressure control which may be discontinued if deemed appropriate. 

8.Subjects on chronic medications for any underlying respiratory condition must be on a stable dose for ≥ 30 days prior to randomization 

Exclusion:

1.Previous PCI or cardiac surgery (CABG) unless documented to have a negative stress test within the last 12 months. 

2.Clinically symptomatic mitral or aortic valvular heart disease. 

3.Cardiac index greater than 4.0 L/min/m2 

4.In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH-HFpEF 

5.Congenital heart disease other than surgically corrected pre and post tricuspid shunts for at least 5 years 

6.Symptomatic coronary artery disease based on a positive stress test. 

7.Patients planning lung or heart transplant; or cardiac surgery in the next 4 months 

8.Patients diagnosed with pulmonary hypertension associated with clinically significant lung disease at the time of initial diagnosis, or patients with a congenital defect of the lung. 

  • a. Clinically significant obstructive lung disease is defined as FEV1/FVC <60% of predicted, unless a high resolution chest CT scan shows no more than mild areas of emphysematous changes. 
  • b. Clinically significant restrictive lung disease is defined as a FVC of <60% of predicted, unless a high resolution chest CT scan shows no more than mild areas of interstitial lung disease or pulmonary fibrosis. 

9.Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration) 

10.Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 

11.Liver dysfunction with Child Pugh Class B or C (see Attachment 3) 

12.Evidence of systemic bacterial, systemic fungal, or viral infection in last 2 weeks 

13.Weight >150 kg 

14.Symptomatic low systolic blood pressure (SBP) that cannot be managed to ensure SBP > 100 mmHg at initiation of study drug 

Rich, JonathanRich, Jonathan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03541603 STU00208303
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Roshevsky, Daniel Scott 312 695 3264
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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
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1-855-NU-STUDY
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A Phase IIA, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of CRTh2 Antagonist AZD1981 in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
AZD-1981 is an oral tablet drug, with two pills (20 mg each) taken three times daily (120 mg total). The…
AZD-1981 is an oral tablet drug, with two pills (20 mg each) taken three times daily (120 mg total). The drug is a selective receptor antagonist, meaning AZD-1981 binds to a receptor located on the surface of a cell and blocks other cells from binding there. Without AZD-1981, when that normally open receptor is bound to, inflammation-causing eosinophils accumulate in the area. With AZD-1981 blocking that eosinophil-recruiting binding site, the number of eosinophils at that site should theoretically decrease which should reduce inflammation and therefore improve your nasal polyp symptoms.
In order to qualify for the study you must have at least grade 2 nasal polyps in each nostril, with a total polyp score of at least 4.
Peters, Anju TripathiPeters, Anju Tripathi
NCT02874144 STU00202062
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Hadzic, Amela 312 695 3530
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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
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Dvorak, Stephen 312 695 4481
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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
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Kats, Lauren 312 926 1096
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EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH 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 (Inability of the heart to pump blood with …
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..

  • Age > 18 and < 120 at the screening visit 
  • 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 24 months of enrolment with no change in clinical status suggesting potential for deterioration in systolic function 
  • Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml)
  • Stable medical therapy for heart failure for 15 days as defined by: i. No addition or removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril, beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists ii. No substantial change in dosage (100% or greater increase or decrease from baseline dose) of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists 
  • On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7 days

Khan, SadiyaKhan, Sadiya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03030235 STU00204842
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Roshevsky, Daniel Scott 312 695 3264
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Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Inclusion Criteria:
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03042104 STU00204517
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Kats, Lauren 312 926 1096
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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: 

  • Chronic symptomatic heart failure (HF) documented by the following: 
    • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days 
    • 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 
    • ≥ 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. 
EXCLUSION CRITERIA 

  • 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. 
  • Cardiac resynchronization therapy initiated within the past 6 months 
  • 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 list4.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. 

Ricciardi, MarkRicciardi, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03088033 STU00204899
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Roshevsky, Daniel Scott 312 695 3264
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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
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Carswell, Amy 312 926 7554
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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)
Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccin…
Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are being provided for use in the study by Sanofi Pasteur, which manufactures the vaccines. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses.  The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least65 years old. Thus its use with adults younger than 65 in this study is investigational.
This study is recruiting patients who have had a heart attack or have heart failure.
Mutharasan, R KannanMutharasan, R Kannan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02787044 STU00205380
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Ramirez, Haydee +1 312 695 2928
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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.

Primary Inclusion:

  • 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.  
  • Pulmonary vascular disease or right ventricular dysfunction

Primary Exclusion: 

  • 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) 

Freed, BenjaminFreed, Benjamin
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03153111 STU00205418
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Sanchez, Cynthia 312 695 5097
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Real Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF)

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. 

Furthermore, it aims to address the challenges and feasibility of imple…

The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. 

Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

Female and male subjects with a diagnosis of acute decompensated heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) or

acute decompensated heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) will be enrolled.

Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206315
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Ramirez, Haydee +1 312 695 2928
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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 E. Huron St.
    Chicago, IL
STU00206184
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Roshevsky, Daniel Scott 312 695 3264
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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 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
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Whisler, Cailin 312 926 3356
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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
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McCloskey, Elizabeth 312 926 0840
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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)

The objective of this clinical trial is to determine the safety and efficacy of the CardiAMP cell…

The objective of this clinical trial is to determine the safety and efficacy of the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure.

Primary Inclusion:

  • NYHA II or III
  • A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI)
  • Have an ejection fraction ≥ 20% and ≤ 40% by twodimensional echocardiogram and not in the setting of a recent ischemic event
  • Primary Exclusion:

  • Have a baseline glomerular filtration rate < 30 ml/min /1.73m2
  • Have a hematological abnormality as evidenced by hematocrit < 30%, white blood cell < 4,500/μl or platelet values, <100,000/μl without another explanation
  • Anderson, AllenAnderson, Allen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02438306 STU00206166
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    Roshevsky, Daniel Scott 312 695 3264
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    A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
    A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Fai…
    A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

    Inclusion:

    1.Men or women, > 18 years of age 

    2.Confirmed diagnosis of WHO Group 2 Pulmonary Hypertension (PH) with heart failure and preserved ejection fraction (HFpEF). 

    3.WHO Group 2 Pulmonary Hypertension subjects with heart failure and preserved ejection fraction as defined by:

    • a. Mean pulmonary arterial pressure (mPAP) > 35 mmHg at rest or with legs up (at baseline right heart catheter/Lead-In)
    • b. Pulmonary capillary wedge pressure (PCWP) ≥ 20 mmHg at rest or with legs up (at baseline right heart catheter/Lead-In) 
    • c. NYHA Class II or III 
    • d. LVEF ≥ 40% by echocardiogram within three months of enrollment with no change in clinical status suggesting the potential for deterioration in systolic function 

    4.Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. 

    5.Ability to walk at least 50 meters, but not more than 550 meters in a six-minute walk test. 

    6.Long term oxygen treatment (if applicable) must be stable for 30 days prior to enrollment. 

    7.Subjects on a chronic medication or therapy for any underlying cardiac condition must be on a stable dose for ≥30 days prior to randomization, with the exception of diuretics and antihypertensive medication for blood pressure control which may be discontinued if deemed appropriate. 

    8.Subjects on chronic medications for any underlying respiratory condition must be on a stable dose for ≥ 30 days prior to randomization 

    Exclusion:

    1.Previous PCI or cardiac surgery (CABG) unless documented to have a negative stress test within the last 12 months. 

    2.Clinically symptomatic mitral or aortic valvular heart disease. 

    3.Cardiac index greater than 4.0 L/min/m2 

    4.In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH-HFpEF 

    5.Congenital heart disease other than surgically corrected pre and post tricuspid shunts for at least 5 years 

    6.Symptomatic coronary artery disease based on a positive stress test. 

    7.Patients planning lung or heart transplant; or cardiac surgery in the next 4 months 

    8.Patients diagnosed with pulmonary hypertension associated with clinically significant lung disease at the time of initial diagnosis, or patients with a congenital defect of the lung. 

    • a. Clinically significant obstructive lung disease is defined as FEV1/FVC <60% of predicted, unless a high resolution chest CT scan shows no more than mild areas of emphysematous changes. 
    • b. Clinically significant restrictive lung disease is defined as a FVC of <60% of predicted, unless a high resolution chest CT scan shows no more than mild areas of interstitial lung disease or pulmonary fibrosis. 

    9.Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration) 

    10.Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 

    11.Liver dysfunction with Child Pugh Class B or C (see Attachment 3) 

    12.Evidence of systemic bacterial, systemic fungal, or viral infection in last 2 weeks 

    13.Weight >150 kg 

    14.Symptomatic low systolic blood pressure (SBP) that cannot be managed to ensure SBP > 100 mmHg at initiation of study drug 

    Rich, JonathanRich, Jonathan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03541603 STU00208303
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    Roshevsky, Daniel Scott 312 695 3264
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    Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR)
    The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

    Primary Inclusion Criteria:

  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
  • Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab
  • Left ventricular ejection fraction (LVEF) ≥ 20%
  • Ricciardi, MarkRicciardi, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
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    Brady, Caitlin 312 926 5968
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    CLASP TR EFS: Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study.
    The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not …
    The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure tricuspid regurgitation.  

    This is an early feasibility study, meaning patients agreeing to participate in this study will be one of the first patients in the USA to undergo repair of their tricuspid valve using this investigational (experimental) device system. The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System’s implant (composed of man-made materials). This study is being conducted in up to 8 US centers and will enroll 15 patients across all sites. 

     

    Participation in this research study will last about 5 years. 

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03745313 STU00208923
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    McCloskey, Elizabeth 312 926 0840
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    Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to m…

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow).  This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS.  The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational.
    This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02661451 STU00208415
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    Kats, Lauren 312 926 1096
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    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
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    1-855-NU-STUDY
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    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
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    1-855-NU-STUDY
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    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
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    Adelman, Daphne T 312 908 9002
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    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
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    1-855-NU-STUDY
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    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 18-50, healthy, non-smoking, overweight/obese
    Neff, Lisa MNeff, Lisa M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03110809 STU00204058
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    Hakamy, Beth +1 312 503 7203
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    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
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    1-855-NU-STUDY
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    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
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    Domanchuk, Kathryn J 312 503 6438
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    Telmisartan Plus Exercise to Improve Functioning in PAD
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performan…
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
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    Domanchuk, Kathryn J 312 503 6438
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    Improving Outpatient Safety of Older Adults through Electronic Patient Portals
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
    Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
    Lindquist, Lee ALindquist, Lee A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00201242
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    Seltzer, Anne Jennifer 312 926 5159
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    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
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    Domanchuk, Kathryn J 312 503 6438
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    Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve card…
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
    We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
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    Domanchuk, Kathryn J 312 503 6438
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    Reducing Assessment Barriers for Patients with Low Literacy
    This study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
    You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation.
    Griffith, James WGriffith, James W
    STU00204308
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    Serrano, Eloisa +1 312 503 6501
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    NU 05H6: Acute Leukemias and Map Kinase

    Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the prod…

    Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

    The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells. 

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), which are cancers of the blood that affect white blood cells. 

    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00004841
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    Study Coordinator 312 695 1102
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    NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

    The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) ti…

    The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research. 

    You may be eligible for this research study if you are visiting the high risk clinic and/or are undergoing surgery to remove a portion of your pancreas. 

    Yang, Guang-YuYang, Guang-Yu
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00007180
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    Study Coordinator 312 695 1102
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    NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be…
    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. 

    This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

    You may be eligible for this research study if you have unresectable cancer primarily in the liver (with the liver being the only site of disease or the dominant site of disease).
    Salem, RiadSalem, Riad
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00530010 STU00011036
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    Study Coordinator 1 312 695 1102
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    A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells m…

    Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. 

    This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.

    You may be eligible for this research study if you have been diagnosed with metastatic disease to the liver. This means your cancer originated from somewhere else in your body and spread to your liver. 

    You cannot be eligible to have surgery to remove the cancerous tissue from your liver.

    Salem, RiadSalem, Riad
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00532740 STU00011037
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    Study Coordinator 312 695 1102
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    NU 09B2: Case Control Study of Biomarkers of Breast Cancer Risk in Benign Biopsy Samples

    This study is being conducted to better understand the causes of breast cancer. Currently, our ability to determine if a particular woman is at higher than average risk for breast cancer is only a little bette…

    This study is being conducted to better understand the causes of breast cancer. Currently, our ability to determine if a particular woman is at higher than average risk for breast cancer is only a little better than flipping a coin. However, there is good reason to believe that we can obtain much more information by focusing directly on breast cells and looking at the biochemical changes that predate cancer. We expect that breast cells present in breast biopsy samples will be a practical place to look for such changes, and that this will help us to predict which women will get breast cancer. In the future, we could then focus on high risk women to offer them methods of breast cancer prevention and also to target them for early diagnosis. It may also mean that we could spare women who are at low risk for breast cancer from treatment that may have side effects, and from unnecessary testing or surgery. The breast tissue changes we will look for may involve alterations in genes or in proteins. If we find changes in genes in the breast, these may be harmless variations (like genes that explain eye color or height), or they may be harmful, possibly promoting the development of cancer. To tell whether the changes were acquired only in the breast, later in life, or whether you were born with them, we will need to compare the breast genes with your bloodline genes. We can do this by collecting a sample of saliva.

    You may be eligible for this research study if you have had breast surgery in the past for either a benign breast problem or breast cancer. 

    Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00013577
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    Study Coordinator 1 312 695 1102
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    NU 01CC4: STAR (Survivors Taking Action and Responsibility)

    The goal of this program is to collect data reflecting past and current medical and behavioral issues related to diagnosis and treatment of childhood cancer. Much is known about the impact up to ten years after cure, but the long-term eff…

    The goal of this program is to collect data reflecting past and current medical and behavioral issues related to diagnosis and treatment of childhood cancer. Much is known about the impact up to ten years after cure, but the long-term effects of the cancer and treatments must be better understood to help both you and future survivors.

    You may be eligible for this research study if you are a survivor of childhood cancer. 
    Didwania, AaratiDidwania, Aarati
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00029383
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    Study Coordinator 312 695 1102
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    NCI 02H2: Signal Transduction of Type I Interferons in Malignant Cells

    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (E…

    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.

    You may be eligible for this research study if you have been diagnosed with a group of diseases called myeloproliferative neoplasms (MPN) and are already scheduled to have

    blood and bone marrow samples taken for routine health monitoring purposes.

    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00006780
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    Study Coordinator 312 695 1102
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    NU 11B04: Breast Tissue Biomarkers of ER- Specific Cancer Risk that Are Valid Across Menstrual and Menopausal Status

    The purpose of this study is to discover predictors of future cancer in the healthy tissue of the opposite breast as compared to tissue from women with no breast disease. 

    <…

    The purpose of this study is to discover predictors of future cancer in the healthy tissue of the opposite breast as compared to tissue from women with no breast disease. 

    If you participate in this study and are having a preventive mastectomy, no extra tissue will be removed for this study. If you are not having a preventive mastectomy, we will perform a needle biopsy of your other breast for research purposes. If you do not have breast cancer, we will use a portion of the healthy tissue removed during your reduction or augmentation surgery for research.

    You may be eligible for this research study if you fit into one of the following categories:

    1. You have been diagnosed with breast cancer and you and your doctor have decided that you will benefit from a preventive mastectomy of your other (non-cancerous) breast, OR

    2. You have been diagnosed with breast cancer on one side and will soon be having surgical or medical treatment for that cancer, OR

    3. You have no evidence of breast disease and are scheduled to undergo either a breast reduction or breast augmentation surgery.

    Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00051134
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    Study Coordinator 1 312 695 1102
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    NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

    In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect …

    In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

    The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

    You may be eligible to take part in this research study if you have been diagnosed with chronic myelogenous leukemia (CML), a chronic form of leukemia, OR if you are a normal individual without any blood disorders.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00039629
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    Study Coordinator 312 695 1102
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    NCI 12H13: The Role of ICSBP in the Pathogenesis of Chronic Myeloid Leukemia

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The p…

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future. 

    You may be eligible for this research study if you have been diagnosed with chronic myeloid leukemia, a cancer of the blood and are scheduled to have a bone marrow biopsy.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00074258
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    Study Coordinator 312 695 1102
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    NUDB 13C03: Northwestern Brain Tumor Institute Research Database

    The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain add…

    The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

    The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

    You may be eligible to take part in the research component of the NBTIDB if you are either a new or returning patient, over the age of 18, who is being seen by one of the clinicians at the NBTI and are or will be entered into the NBTIDB, or a patient who is not coming to the NBTI for evaluation, but would still like to participate in the NBTIDB.

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
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    Study Coordinator 1 312 695 1102
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    ECOG 1910: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults.
    Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview …
    Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview This study is for patients who have recently been diagnosed with a subtype of ALL that is known as BCR-ABL negative B-lineage ALL. Blinatumomab is a new antibody therapy that binds to B cells and recruits T cells to attack leukemia B cells. Patients will be randomized to receive chemotherapy what has traditionally been used to treat this sub-type of ALL alone or chemotherapy with blinatumomab . Studies are being done in ALL and other blood cancers with blinotumomab Blinatumomab has been effective in residual or relapsed B-cell ALL at destroying these specific cells. But it has not yet been proven helpful in combination with chemotherapy in newly diagnosed ALL. Description of Treatment There are several steps of treatment in this study. They are called induction, intensification, consolidation, and maintenance. In these study steps participants will be getting standard chemotherapy treatments that may or may not be combined with a new cancer drug called blinatumomab. Blinatumomab is a drug that is given as a continues infusion. The treatment schedule should be discussed with the study doctor.
    Some of the eligibility criteria include:

    - Participants in this study must have B lineage ALL that is Philadelphia chromosome and BCR/ABL negative. Please discuss this requirement with the study doctor.
    - Participants must be 35-70 years old.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Dinner, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02003222 STU00093458
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    Study Coordinator 312 695 1102
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    A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

    This randomized phase III trial studies how well the study drug (crizotinib, also known …

    This randomized phase III trial studies how well the study drug (crizotinib, also known as XALKORI®) works, and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. 

    It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK mutation. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach.

    The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib will be prescribed for earlier stage disease after the cancer has been surgically removed.

    You are being asked to take part in this research study because you have ALK-positive non-small cell lung cancer, which has been removed by a surgeon. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02201992 STU00102000
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    Study Coordinator 312 695 1102
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    Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying…

    This research trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. The purpose of the study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes. 

    Genetic testing will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is your unique genetic material that carries the instructions for your body’s development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.

    Another purpose of this research study is to learn more about cancer and why treatments may be more effective or even stop working with some tumors or in certain patients. After your tumor tissue is screened, if there is any tissue left, the remainder of your coded tissue samples will be sent to a National Cancer Institute (NCI)-sponsored storage facility, currently known as the Biospecimen Core Resource (BCR).

    You may be eligible for this research study if you have lung cancer that has either been removed or will be removed by a surgeon. As part of your normal treatment, you may receive chemotherapy or radiation therapy to reduce the chance of the cancer coming back.

    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02194738 STU00200150
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    Study Coordinator 312 695 1102
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    RTOG 1216: Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

    This randomized phase III trial studies how well radiation therapy works when …

    This randomized phase III trial studies how well radiation therapy works when given together with cisplatin compared to with docetaxel or cetuximab and docetaxel after surgery in treating patients with squamous cell head and neck cancer. 

    The purpose of this study is to compare the effects, good and/or bad, of the standard treatment (radiation therapy and cisplatin) with a chosen experimental treatment (either radiation therapy and docetaxel, or radiation therapy, cetuximab, and docetaxel) to find out which is a better treatment for head and neck cancer. Subjects will get either the standard treatment or the experimental treatment.

    Cisplatin and docetaxel are standard chemotherapy drugs. They work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 

    Cetuximab is a drug that blocks the epidermal growth factor receptor, a protein that affects cancer growth and many other functions.

    Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. 

    It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

    You may be eligible for this research study if you have head and neck cancer.
    Mittal, Bharat BMittal, Bharat B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01810913 STU00200314
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    Study Coordinator 312 695 1102
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    NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a proble…

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

    The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future. 

    At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study. 

    You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood.

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200435
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    Study Coordinator 312 695 1102
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    ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

    The main purpose of this study is to compare getting more treatment with capecitabine (i.e. on…

    The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery.

    Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV (i.e., metastatic) breast cancers, but are usually not used in patients with early forms of breast cancer. Getting a platinum-based chemotherapy after surgery could reduce the risk of cancer returning (metastatic recurrence) in the breast or at other distant organs, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than using capecitabine chemotherapy. 

    You may be eligible for this research study if you:

    • Have early stage breast cancer. 
    • Have a breast cancer that does not have the estrogen, progesterone or HER2 receptor, and is called triple-negative breast cancer.
    • Have completed all your chemotherapy prior to your surgery.
    • Had ≥ 1 cm worth of cancer in the breast at the time of your surgery.

    Flaum, LisaFlaum, Lisa
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02445391 STU00201173
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    Study Coordinator 312 695 1102
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    NU 15B01: A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort

    The main purpose of this study is to determine the anti-tumor activity of durvalumab (ME…

    The main purpose of this study is to determine the anti-tumor activity of durvalumab (MEDI4736) in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. 

    Both durvalumab and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by binding to a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.

    Both durvalumab and tremelimumab are “investigational” drugs, which means that the drugs are not approved by the Food and Drug Administration. The idea behind developing these types of experimental drugs is that stimulating the immune system could be a different way of killing cancer cells.

    We will be investigating primarily the ability of this drug combination to shrink tumors, or prevent them from growing larger. We will also investigate if this drug combination can increase survival. Finally, we will explore how these drugs affect your immune system and tumor cells by conducting tests on tumor samples before and after the first two months of treatment. This will help us learn if certain types of tumor or immune system features are associated with better responses. The information learned in this study may be helpful in the further development of durvalumab and tremelimumab for the treatment of women with advanced breast cancer.

    You may be eligible for this research study if you have metastatic breast cancer that has not responded to or stopped responding to at least one line of standard-of-care chemotherapy.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02536794 STU00200984
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    Study Coordinator 312 695 1102
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    x(CIRB) NRG-BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
    This randomized phase II/III trial studies how well standard of care therapy with stereotac…
    This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02364557 STU00201769
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    Study Coordinator 312 695 1102
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    NU 15N01: Head and Neck Tissue Bank

    Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be a…

    Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

    You may be eligible to take part in our head and neck specimen banking study if you have one of the following conditions:

    a) You have a tumor or an abnormal area in the head and neck area, suspicious for cancer, or pre-cancerous condition or other pathology of interest, and you’re scheduled to have biopsy and/or surgery at Northwestern Memorial Hospital.

    b) You will receive treatment and/or regular follow up for further management for your head and neck cancer or precancerous condition, or other pathology at Northwestern Memorial Hospital and/or Northwestern Medicine Developmental Therapeutics Institute (NMDTI).

    Matsangou, MariaMatsangou, Maria
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202177
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    Study Coordinator 312 695 1102
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    The Role of Hormone Receptors in Breast Cancer Development in BRCA1/2 Mutation Carriers

    The purpose of this research study is to determine how the hormones estrogen, progesterone, and cortisone may work through their receptor proteins to help breast cancers to develop in women with BRCA1 and BRCA2…

    The purpose of this research study is to determine how the hormones estrogen, progesterone, and cortisone may work through their receptor proteins to help breast cancers to develop in women with BRCA1 and BRCA2 mutations. At the moment, the only proven way to prevent breast cancer for women with BRCA mutations is bilateral mastectomy (removal of both breasts). In this study, we will test the effects of selective hormone receptor modulators on breast cells derived from BRCA1 and BRCA2 mutation carriers. If this works in the way we think it will, we may then be able to develop new ways of preventing cancers in BRCA mutation carriers.

    Participation will consist of a one-time questionnaire, blood draw, and tissue collection at the time of your scheduled surgery.

    You may be eligible for this research study if you fit into one of the following categories: 

    1) you have been diagnosed with breast cancer and you and your doctor have decided that you will benefit from a preventive mastectomy of your other (non-cancerous) breast, or 

    2) you are a BRCA1 or BRCA2 mutation carrier with no evidence of breast cancer and are scheduled to undergo a preventive mastectomy of both breasts, or 

    3) you have no evidence of breast disease and are scheduled to undergo breast reduction surgery.

    Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202331
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    Study Coordinator 1 312 695 1102
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    NU 15N02: Northwestern Head and Neck Cancer Registry

    The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct…

    The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

    You may be eligible to take part in this research study if you are being treated or have been treated for a tumor or cancer of the head and neck. 

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202162
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    Study Coordinator 312 695 1102
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    DRUG C-500-01: A Phase 1 Open-label, Multicenter Study To Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884), and to Estimate the Maximum Tolerated Dose in Subjects With Advanced or Refractory Cancer

    This study will be testing a thera…

    This study will be testing a therapy called AGEN1884, an immune therapy that targets the immune cells to block a protein called CTLA-4. This therapy is designed to improve the ability of the immune system to fight your cancer. 

    The FDA (the U.S. Food and Drug Administration) has not approved AGEN1884 as a treatment for any disease. This is the first time that AGEN1884 will be given to humans.

    The purpose of the study is to evaluate the safety of AGEN1884 and determine the most appropriate dose for use in future studies.

    You may be eligible for this research study if you have advanced cancer.

    You have already been treated with other therapies that are commonly used for your cancer, and your cancer has recurred or not responded to those treatments.

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02694822 STU00202198
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    Study Coordinator 312 695 1102
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    Alliance A091302: Randomized phase II study of sorafenib with or without everolimus in patients with radioactive iodine refractory Hürthle cell thyroid cancer

    The purpose of this study is to compare any good and bad effects of using everolimus along with sorafenib versus sorafenib alone in treat…

    The purpose of this study is to compare any good and bad effects of using everolimus along with sorafenib versus sorafenib alone in treating patients with advanced radioactive iodine refractory thyroid cancer. The addition of everolimus to the usual sorafenib might cause more shrinkage of the cancer and might prevent it from growing but it could also cause more side effects than sorafenib alone. This study will allow the researchers to know whether this treatment with 2 drugs is better, the same, or worse than the usual approach (which is sorafenib alone). 

    You may be eligible for this research study if you have an advanced Hürthle cell thyroid cancer that does not respond to radioactive iodine. 

    Matsangou, MariaMatsangou, Maria
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02143726 STU00202628
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    Study Coordinator 312 695 1102
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    Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

    This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegi…

    This phase II trial studies how well two drugs, vismodegib and GSK2256098, work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.  

    The purpose of this study is to test good and bad effects of these two different drugs against meningioma tumors with altered (or mutated) genes. Altered genes can cause a tumor to grow. The study drugs, vismodegib and GSK2256098, target these genes. The study drugs could shrink the cancer, or the cancer could stay the same size or grow. They may cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-half compared to its present size. 

    Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients.

    You may be eligible for this research study if you have a meningioma which has gotten bigger or grew back after treatment. 

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02523014 STU00202953
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    Study Coordinator 312 695 1102
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    NRG GY005-A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)

    This Phase III st…

    This Phase III study will be done to confirm the effectiveness of the combination of cediranib and olaparib to the standard chemotherapy. Also cediranib alone will be compared with standard chemotherapy for effectiveness. There is no placebo in this study.

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for recurrent platinum-resistant or –refractory ovarian cancer. The usual approach is defined as care most people get for recurrent platinum-resistant or –refractory ovarian cancer.

    Cediranib is an experimental drug that may help keep cancer cells from growing by affecting their blood supply. Olaparib is a drug that may stop cancer cells from growing abnormally. Olaparib by itself has been approved by the Food and Drug Administration (FDA) for use in women with advanced ovarian cancer with BRCA1 and BRCA2 mutations who had prior chemotherapy. The combination of olaparib and cediranib is investigational. These drugs have been used in other research studies in ovarian cancer, and information from those other research studies suggest that they may help to keep cancer from growing. The addition of cediranib to olaparib could shrink the cancer but it could also cause side effects.

    Another purpose of this study is for researchers to learn if a biomarker test is helpful to decide whether or not a patient’s tumor will respond to the study drug(s). Tissue from your surgery will be used for the biomarker test. Extra tubes of blood will be drawn for the biomarker test also. Researchers do not know if using the biomarker test is better, the same, or worse than if you enrolled in this study without using the biomarker test.

    You may be eligible for this research study if you have recurrent platinum-resistant or –refractory ovarian, primary peritoneal, or fallopian tube cancer defined as cancer that returned within 6 months of completion of platinum-containing chemotherapy, or continued to get worse during platinum-containing chemotherapy.

    Tanner, EdwardTanner, Edward
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02502266 STU00203140
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    Study Coordinator 312 695 1102
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    NRG-GY006: A Randomized phase II trial of radiation therapy and cisplatin alone or in combination with intravenous triapine in women with newly diagnosed bulky stage IB2, or stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer.

    The purpose of this study is to compare …

    The purpose of this study is to compare any good or bad effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, compared to using cisplatin chemotherapy and radiation therapy alone. Triapine is an experimental drug being tested in the treatment of cervical cancer to improve the effects of standard radiotherapy with concurrent chemotherapy. The addition of triapine to the usual chemotherapy and radiation therapy could shrink your tumor and increase the length of time till the cancer returns, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

    You may be eligible for this research study if you have newly diagnosed cervical or vaginal cancer for which surgical treatment is not possible. 

    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02466971 STU00203105
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    Study Coordinator 312 695 1102
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    NU 16B06: Blood Based Prognostic Biomarkers of Breast Cancer Patients – Characterization of clustered CTCs to eliminate Breast Cancer Metastasis

    This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer …

    This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

    You may be eligible for this research study if you have advanced stage (III/IV)breast cancer.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203283
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    Study Coordinator 312 695 1102
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    Phase II Multicenter Study of Natalizumab Plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

    This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids …

    This research trial is designed to study the safety and effectiveness of adding the drug, Natalizumab (Tysabri®) to the standard treatment (which consist in the use of steroids such as prednisone i.e., a corticosteroid), as a new treatment for acute graft versus host disease (GVHD). 

    GVHD is the most common serious complication after bone marrow transplant. GVHD occurs when the donor cells (the graft) treat the recipient’s body as “foreign” and attack the cells in the recipient’s body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. GVHD can be severe and potentially fatal to the transplant recipient. The only proven effective treatment for patients with acute GVHD is steroids. Patients who do not respond to steroid treatment are at high risk for death.  

    We want to test whether we can improve steroid response and prevent death from GVHD by blocking the donor cells from getting to the intestine and causing damage. 

    The study drug, Natalizumab (Tysabri®), is a drug that works by blocking the signals that cause donor cells to travel to the intestine or brain. Natalizumab is FDA-approved in adults to treat Crohn’s disease, a chronic condition where immune cells cause damage to the digestive system (such as the stomach, intestines). It is also used to treat multiple sclerosis where immune cells cause damage to the nervous system in the brain. Its intended use is for patients whose disease has not responded to the standard treatment or if they cannot tolerate the side effects from standard treatments. Natalizumab has never been used for treating GVHD. It is an experimental drug for this study, because we are investigating a new use for the drug as a GVHD treatment.

    The goal of this research is to develop safer and more effective treatments for GVHD, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.

    You may be eligible for this research study if you have been diagnosed with acute graft-versus-host disease (GVHD) of the GI tract.

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02133924 STU00203346
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    Study Coordinator 312 695 1102
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    An Open Label Phase II Trial of Guadecitabine and Pembrolizumab in Platinum Resistant Recurrent Ovarian Cancer

    The purpose of this study is to look at how patients respondto treatment with guadecitabine and pembrolizumab. The researchers will also belooking at the amount of time it takes for cance…

    The purpose of this study is to look at how patients respondto treatment with guadecitabine and pembrolizumab. The researchers will also belooking at the amount of time it takes for cancer to get worse when participantstake the study drugs.

    All participants will be treated with guadecitabine andpembrolizumab. Guadecitabine is a drug that acts on the cancer cells' DNA. DNAis present inside all cells and guides how proteins are made. Guadecitabineinterferes with the cancer cells' DNA and can increase the production ofcertain proteins, making cancer cells more recognizable by the immune system.Pembrolizumab helps your immune system to kill cancer cells. Thus thecombination of guadecitabine and pembrolizumab may increase the ability of theimmune system to eliminate cancer cells. 

    This study will help researchers to find out whether thecombination of guadecitabine and pembrolizumab is effective in treatingovarian, primary peritoneal, or fallopian tube cancer that has not responded totraditional chemotherapy.

    You may be eligible for this research study if you have a particular type of ovarian, primary peritoneal, or fallopian tube cancer that has not responded adequately to prior therapy or that we know will not respond to existing therapies.

    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02901899 STU00203494
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    Study Coordinator 312 695 1102
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    DRUG AG-221-AML-005: A phase 1B/2 open-label, randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant targeted therapies plus azacitidine: oral AG-120 plus subcutaneous azacitidine and oral AG-221 plus SC azacitidine in subjects with newly diagnosed acute myeloid leukemia harboring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive induction chemotherapy

    The purpose of this study, which involves research, is to determine a safe and tolerable dose of the investigational combination of AG-120 plus azacitidine or AG-221 plus azacitidine (Phase 1b) as well as the effectiveness of AG-221 plus azacitidine in treating this disease, when compared to azacitidine alone (Phase 2). AG-120 is not currently approved for the treatment of any type of AML and its use in this study is investigational. Recently AG-221, also known as

    enasidenib (IDHIFA®), was approved in the United States (US) for the treatment of adult patients with relapsed or refractory AML with an Isocitrate dehydragenase 2 (IDH2) mutation as detected by an FDA-approved test. The use of enasidenib in this study is investigational. Enasidenib is not currently approved in other countries for the treatment of any type of AML. Azacitidine (Vidaza®) is approved in Canada for the treatment of AML for patients with 20 - 30% bone marrow blast and multi lineage dysplasia, according to WHO classification, who are not candidates to receive hematopoietic stem cell transplantation.

    - Adults at least 18 years of age

    - Newly diagnosed, primary (i.e., de novo) or secondary (Progression of MDS or myeloproliferative neoplasms [MPN], or therapy-related) AML according to WHO classification with at least 20% leukemic blasts in the bone marrow

    - Have an IDH1 or IDH2 gene mutation

    - Not candidates to receive intensive IC.

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02677922 STU00203231
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    Study Coordinator 312 695 1102
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    Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) – A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
    The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer…
    The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body's immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in this type of cancer. 
    You may be eligible if you have non-small cell lung cancer, which has been removed by a surgeon. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02595944 STU00203600
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    Study Coordinator 1 312 695 1102
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    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

    The purpose of the study is to gather information about your cancer and the t…

    The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

    We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

    The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

    If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

    You may be eligible for this research study if you have a diagnosis of cancer and are being treated at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
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    Study Coordinator 1 312 695 1102
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    NU 16L04: Parallel proof of concept phase 2 study of nivolumab and metformin combination treatment in advanced non-small cell lung cancer with and without prior treatment with PD-1/PD-L1 inhibitors
    The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non…
    The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We will also be looking at the safety of the combination. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by the US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is being used to treat cancer. This use is not approved by the FDA; therefore, in this study, it is considered experimental. Experimental means the U.S. FDA has not approved the drug for use in your type of cancer. All study participants will get the same study intervention. All study participants will get the study drugs Nivolumab and Metformin.
    You may be eligible for this research study if you have an advanced non-small cell lung cancer, and are age 18 or older. 
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03048500 STU00204354
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    Study Coordinator 312 695 1102
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    NU 16MH03: Phase I/Ib Study of Nivolumab and Veliparib in Patients with Advanced Solid Tumors and Lymphoma with and without Alterations in Selected DNA Repair Genes

    This study is being done to evaluate a drug called veliparib that will be given together with nivolumab for the potential treatment o…

    This study is being done to evaluate a drug called veliparib that will be given together with nivolumab for the potential treatment of cancer in subjects with selected advanced solid tumors or lymphoma.

    Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body’s immune system to work against tumor cells. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer.

    Veliparib inhibits an enzyme in your body known as polyadenosine 5'-diphosphoribose polymerase (PARP). PARP is a naturally occurring protein made by your body that may help cancer cells overcome injury or damage caused by radiation and certain types of anti-cancer drugs, making these treatments less effective (don't work well). Veliparib inhibits (blocks) the activity of PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Veliparib is not yet approved for use in the United States, and is considered experimental. Experimental means the U.S. Food and Drug Administration (FDA) has not approved the drug for use in the type of cancer in this study. 

    The purpose of this study is to find the highest and safest dose of the experimental drug veliparib when combined with nivolumab. We will also study how safely this combination of medication can be given in advanced cancer and lymphoma and benefits of receiving this therapy.

    You may be eligible for this research study if you have an advanced solid tumor or lymphoma. 

    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03061188 STU00204250
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    Study Coordinator 312 695 1102
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    NU UP16M02 The BAMM Trial: BRAF, Autophagy and MEK inhibition in Metastatic Melanoma: A Phase I/II Open Label Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients with Advanced BRAF Mutant Melanoma

    This is a research study involving the use of the drugs hydroxychloroquine (Plaquenil)…

    This is a research study involving the use of the drugs hydroxychloroquine (Plaquenil), dabrafenib (Tafinlar®Novartis), and trametinib (Mekinist®Novartis). Hydroxychloroquine is FDA approved for select non-cancer disorders at lower doses, but is not FDA approved for the treatment of cancer, and therefore is considered “investigational” as used in this study. Dabrafenib and trametinib are FDA-approved for the treatment of mutant melanoma. All three drugs have each been given to more than 10,000 patients each worldwide as separate agents, but, all three have not yet been approved when combined together. In this trial hydroxychloroquine is being studied as a potential anticancer medicine. The reasons for combining these three drugs is that dabrafenib and trametinib together effectively block a protein called BRAF, which drives the growth of melanoma. In response, the melanoma cells activate a stress response called autophagy. Autophagy provides resistance to dabrafenib and trametinib treatment over time making it less effective. We are using hydroxychloroquine, which may impair autophagy and therefore block this key resistance mechanism, to increase the number of dead cancer cells when combined with dabrafenib and trametinib.

    The purpose of this study is to:

    • Determine the maximum tolerated dose of hydroxychloroquine which can be safely combined with dabrafenib and trametinib
    • Determine how effective this three drug combination is in shrinking tumors
    • Perform laboratory based tests to assist in understanding how these drugs work in patients with advanced melanoma

    You may be eligible for this research study if you have advanced metastatic melanoma, a type of malignant skin cancer.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02257424 STU00204561
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    Study Coordinator 1 312 695 1102
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    Melanoma and Skin Cancer Tissue Repository

    The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine…

    The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

    You may be eligible to take part in the research component of the Northwestern Melanoma and Skin Cancer Tissue Repository if you are either a new or returning patient and have a skin cancer or pre-cancer lesion. 

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
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    Study Coordinator 1 312 695 1102
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    BTCRC GYN15-013: Phase II Study of Pembrolizumab in Combination with Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
    The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and ca…
    The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and carboplatin chemotherapy.
    Participants will be adults with cancer in the lining of the uterus (endometrium) that has spread to other parts of the body or has returned after initial treatment.
    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02549209 STU00204968
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    Study Coordinator 312 695 1102
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    NU 16B14: I-CURE-1: A Phase II, single arm study of Pembroluzimab combined with carboplatin in patients with circulating tumor cells (CTCs) positive Her-2 negative metastatic breast cancer (MBC)

    Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence,&n…

    Previous studies have indicated that in triple negative breast cancer patients with tumor recurrence, those tumors are more resistant to chemotherapy and may be associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells.

    This drug has been found effective in other type of cancer and already approved by FDA for those indications, but the efficacy in breast cancer is still unknown. Pembrolizumab will be combined with chemotherapy, a drug called carboplatin, to increase the cancer cell killing. There is no control or placebo treatment in this study. Use of Pembrolizumab in this study is considered investigational, meaning that the drug is not approved for the indication under investigation.

    You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03213041 STU00205013
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    Study Coordinator 312 695 1102
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    DRUG CA209-816: Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
    The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the …
    The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the drug works) of nivolumab in combination with ipilimumab and nivolumab in combination with plantinum doublet chemotherapy in subjects with non-small cell lung cancer.
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02998528 STU00205030
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    Study Coordinator 312 695 1102
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    BTCRC-GI15-015: A Phase II Study of FOLFOX combined with Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

    This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen…

    This study is being done to find out if a drug called nab-paclitaxel plus a combination chemotherapy regimen called FOLFOX have any effect on stomach cancer or cancer where the esophagus and the stomach meet. The study drugs could shrink your cancer but it could also cause side effects.

    Nab-paclitaxel is a new formulation of a chemotherapy called paclitaxel. Regular paclitaxel is made with stabilizers that cause allergic reactions in many patients. Nab-paclitaxel does not use these stabilizers which means more of the drug can be given with fewer allergic reactions. Nab-paclitaxel (Abraxane®) is approved by the U.S. Food and Drug Administration (FDA) to treat breast, lung, and pancreas cancers. 

    FOLFOX stands for a combination of three drugs: oxaliplatin, leucovorin, and 5-fluorouracil. Oxaliplatin is a chemotherapy approved by the FDA to treat colon and rectal cancer. Leucovorin is not a chemotherapy. It is form of folic acid and it is given with 5-fluorouracil to help increase the anti-cancer effects of 5-fluorouracil. It is approved by the FDA to be given with fluorouracil in patients with advanced colorectal cancer. 5-fluorouracil is approved by the FDA to treat cancers of the breast, stomach, colon, rectum, and pancreas.

    Combining nab-paclitaxel with FOLFOX should be considered investigational. Investigational means that the FDA has not approved this combination of drugs for stomach cancer or cancer where the esophagus and the stomach meet.

     

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03283761 STU00205558
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    Study Coordinator 1 312 695 1102
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    DRUG PCYC-1145-LT: Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials

    Pharmacyclics Switzerland GmbH is conducting this protocol to provide long term access to ibrutinib for subjects who have been enrolled in ibrutinib studie…

    Pharmacyclics Switzerland GmbH is conducting this protocol to provide long term access to ibrutinib for subjects who have been enrolled in ibrutinib studies that are being closed and are actively receiving treatment with ibrutinib and deriving benefit. 

    Ibrutinib is a type of drug called a “kinase inhibitor”. Ibrutinib (IMBRUVICA®) has been approved in many regions, including the US and EU for indications covering the treatment of patients with: 1) mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, 2) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) including CLL/SLL patients with a 17p deletion and 3) Waldenstrom’s macroglobulinemia (WM). 

    You may be eligible for this research study if you are, 1) participating in an ibrutinib clinical trial which will end soon, 2) deriving clinical benefit from treatment with ibrutinib in the opinion of your treating physician and 3) do not have adequate access to commercial ibrutinib within your region.

    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03229200 STU00205716
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    Study Coordinator 312 695 1102
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    DRUG CA209-914: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

    The purpose of this study is to test the effectiveness (how well…

    The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return. 

    Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. 

    OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung, in multiple countries including the United States, the European Union, and Japan. Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. The combination of nivolumab (Opdivo™) and ipilimumab (Yervoy™) is also approved by the US FDA for the treatment of advanced kidney cancer that has spread to other parts of the body and by the US FDA and the EMA for the treatment of metastatic melanoma.

    You may be eligible for this research study if you have kidney cancer and have had your tumors completely removed but are at risk of having your cancer return.

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03138512 STU00205491
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    Study Coordinator 312 695 1102
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    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
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    Study Coordinator 312 695 1102
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    ALLIANCE A021501 PREOPERATIVE EXTENDED CHEMOTHERAPY VS. CHEMOTHERAPY PLUS HYPOFRACTIONATED RADIATION THERAPY FOR BORDERLINE RESECTABLE ADENOCARCINOMA OF THE HEAD OF THE PANCREAS
    The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiati…
    The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.
    You may be eligible for this study if you have pancreatic cancer that cannot be removed by surgery at this time.
    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02839343 STU00205727
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    Study Coordinator 1 312 695 1102
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    NU 16B19: Automated system for creating custom three-dimensional radiofrequency ablation lesion geometries in post-lumpectomy margin ablation breast cancer treatment

    When a lumpectomy or excisional biopsy is performed to remove cancer, the surgeon attempts to create a cancer-free zone or “margin…

    When a lumpectomy or excisional biopsy is performed to remove cancer, the surgeon attempts to create a cancer-free zone or “margin” around the removed area. In order to create this margin or safety zone, heat can be used to kill pre-cancerous or cancerous cells in the zone around where the cancer once existed. This process is called “ablation”. We wish to test an ablation method that can be added to future breast cancer surgeries. To do this, we need donated breast tissue from people who have mastectomies performed.

    The heat source being investigated in this study is radiofrequency ablation (RFA). In this study a new RFA device design will be tested. These devices have a spacing applicator to form fit to the tissue around a lumpectomy for optimal treatment. These devices are in the development phase and have not yet been approved by the Food and Drug Administration (FDA), however, because the procedure is done on tissue that has been removed from the body, there is not a physical risk from the use of the device. This study will allow us to analyze the effectiveness of the devices and improve their use and design before they are used to treat breast cancer patients who receive lumpectomy.

    You may be eligible for this research study if you are scheduled to undergo a mastectomy on one or both of your breasts. 

    Bethke, KevinBethke, Kevin
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206005
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    Study Coordinator 1 312 695 1102
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    DRUG 2401BT-002P: A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) with Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma

    In this study, there are two study drugs: DNX-2401 and pembrolizumab. The study drug (DNX-2401), when injected…

    In this study, there are two study drugs: DNX-2401 and pembrolizumab. The study drug (DNX-2401), when injected into a brain tumor, may shrink or slow the growth of the tumor. The addition of the study drug intravenous (IV) pembrolizumab may also shrink or slow the growth of the tumor and could allow DNX-2401 to work better inside the tumor. They will both act against cancer in ways that involve the body's immune defense system. 

    The purpose of this research study is to:

    • find out how much DNX-2401 is best to give once into the brain tumor when followed by intravenous (IV) pembrolizumab infusions;
    • learn whether or not the study drug (DNX-2401) followed by IV pembrolizumab will shrink brain tumors compared to their present size as assessed by regular MRI (magnetic resonance imaging);
    • find out whether DNX-2401 given into the brain tumor followed by IV pembrolizumab infusions every 3 weeks will change the way the virus DNX-2401 behaves in the brain tumor cells as it is attacking the tumor;
    • find out what effects DNX-2401 and pembrolizumab, used together, have on general health over time by testing urine and blood.

    This is an investigational study. The Food and Drug Administration (FDA) has allowed DNX2401 to be used for research purposes only, so it is considered experimental. Pembrolizumab (KEYTRUDA®) is approved for other types of cancer but it has not been approved for use in people with brain cancer, and is considered experimental when used as it is used in this study. Using them together in the same study is a new experimental approach. It is not possible to predict whether the anticancer effects will be stronger when these two experimental study drugs are used together.

    You may be eligible for this research study if youhave a malignant brain tumor called glioblastoma or gliosarcoma that is recurrent, or has comeback following initial surgery and treatment. 

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02798406 STU00204494
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    Study Coordinator 312 695 1102
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    PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
    This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
    This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
    Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
    Schaeffer, EdwardSchaeffer, Edward
    NCT03392181 STU00205957
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    Khawaja, Faizan 312 694 2417
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    BMT CTN-1506: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML

    The main purpose of this study is to learn if it is safe and effective (works…

    The main purpose of this study is to learn if it is safe and effective (works well) to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. We want to know if this drug works better than a placebo (pill that contains no drug, like a sugar pill) to stop the AML from coming back after allogeneic transplant. We also want to know if there are side effects when gilteritinib is given to people with FLT3/ITD AML.

    Gilteritinib is an experimental drug that is being studied to treat FLT3/ITD AML. It is being tested in clinical trials and has not been approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities to treat any disease.

    You may be able to take part in this research study if you have acute myeloid leukemia (AML) with a genetic mutation (change in your DNA) called FLT3/ITD, and you are planning to have an allogeneic stem cell transplant.
    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02997202 STU00205841
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    Study Coordinator 312 695 1102
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    AN OPEN-LABEL, PHASE 2 STUDY OF NERATINIB IN PATIENTS WITH SOLID TUMORS WITH SOMATIC HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR, HER2, HER3) MUTATIONS OR EGFR GENE AMPLIFICATION

    Neratinib is an experimental drug in this study and is being studied as a potential new treatment for patients with ca…

    Neratinib is an experimental drug in this study and is being studied as a potential new treatment for patients with cancers which carry specific mutations in genes of the ERBB family of growth factor receptors (EGFR, ERBB2, ERBB3, or ERBB4 also referred to as HER1, HER2, HER3, or HER4).  Growth factor receptors are proteins present on the cell surface that receive signals on when to divide and grow. These mutations are believed to have a role in abnormal growth of cells that can lead to oncogenesis, which is the transformation of a normal cell to a cancer cell.  An experimental or investigational drug means it has not been approved by the US Food and Drug Administration (USFDA) for these indications.

     

    This study will enroll patients who have any solid tumors that have mutations in EGFR mutations, ERBB2 or ERBB4 including but not limited to bladder/urinary tract cancer, biliary tract, gastroesophageal (includes esophageal, gastro-esophageal and gastric cancers), breast, solid tumors not otherwise specified (ERBB2 and ERRB4), cervical, lung, colorectal and ovarian cancer. The reason why neratinib is being tested in patients with these types of cancers is because it is believed that when an ERBB2, ERBB 4 or EGFR mutation occurs in a tumor, it will help the tumor grow and neratinib may decrease the effect of these mutations on cancer growth.

     

    The purpose of this study is to find out what effects, good and/or bad, neratinib, either by itself (monotherapy) or in combination with other drugs has in solid tumors harboring somatic EGFR mutations, ERBB2 or ERBB4 mutations.

    Some of the eligibility criteria include:

    • Participants must be 18 or older.
    • Patient must have the ability to understand and sign an approved informed consent form (ICF).
    • Patient must have a confirmed diagnosis of cancers with mutations in ERBB family
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT01953926 STU00206494
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    Study Coordinator 312 695 1102
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    Phase Ib, open label, combination study of nintedanib with 5- azacitidine in acute myeloid leukemia characterized by HOX gene overexpression, that are not candidates of intensive chemotherapy
    The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with aza…
    The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant’s response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant’s leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.

    You may be eligible for this research study if you have a specific type of disease of the blood cells and bone marrow called acute myeloid leukemia, and you have declined standard intensive chemotherapy or it has been medically determined not to be in your best interest. It may also be that your disease has returned after initial treatment and disappearance of evidence of cancer, or you may not have responded to treatment during initial therapy. You may be eligible to receive treatment on this trial if your leukemia cells have overexpression (abnormal amount) of HOX genes. 

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03513484 STU00206525
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    Study Coordinator 1 312 695 1102
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    A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

    This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses…

    This study tests the combination of an investigational drug, called VRx-3996, along with an antiviral (fights viruses) drug called valganciclovir. “Investigational” means the drug being tested (VRx-3996) has not been approved by the United States Food and Drug Administration (FDA). The antiviral drug, valganciclovir, has been FDA-approved to prevent and treat certain types of viral infections. Some people may already have received or are currently taking the antiviral drug, valganciclovir, for their disease.

    The primary purpose of this study is to determine how safe is it to take the investigational drug (VRx-3996) along with valgaciclovir and find the maximal dose that can be taken safely. The study will also determine if the cancer responds to treatment with the drug combination. The study will also evaluate how much of the study drug is present in your blood at different time points.

    You may be eligible for this research study if you have a cancer, called lymphoma, that tested positive for Epstein-Barr Virus (EBV). 

    Karmali, ReemKarmali, Reem
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03397706 STU00206699
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    Study Coordinator 312 695 1102
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    DRUG KCP-330-020: A Phase 2-3, Multicenter, Randomized, Double-Blind Study of Selinexor (KPT-330) Versus Placebo in Patients with Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

    The purpose of this research study is to see if selinexor has any effects against advanced unresectable dediff…

    The purpose of this research study is to see if selinexor has any effects against advanced unresectable dedifferentiated liposarcoma (DDLS). 

    Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. In cancer cells one or more of these control mechanisms has failed, or been tempered with, leading to uncontrollable growth. One specific way cancer cells continue to grow is by getting rid of certain proteins called “tumor suppressor proteins” that would normally cause cancer cells to die. Selinexor works by trapping “tumor suppressing proteins” within the nucleus of the cells and thus causing the cancer cells to die or stop growing. 

    Selinexor has previously been tested in humans to define a safe dose to be administered. It is not known at this time if selinexor will treat your cancer. Selinexor (also known as KPT-330) is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). This study will examine the effects of selinexor on your cancer and on your body including any side-effects that you may experience.

    You may be eligible for this research study if you have been diagnosed with an advanced unresectable dedifferentiated liposarcoma (DDLS), your previous treatment(s) have not been successful and your cancer is progressing.

    Agulnik, MarkAgulnik, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02606461 STU00206790
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    Study Coordinator 312 695 1102
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    PCCTC-c16-170: IRONMAN: International Registry for Men with Advanced Prostate Cancer
    This is a registry study. The purpose of the study is to learn more about prostate cancer and

    • to describe the use of different therapies for advanced prostate cancer internationally;
    • to desc…
    This is a registry study. The purpose of the study is to learn more about prostate cancer and

    • to describe the use of different therapies for advanced prostate cancer internationally;
    • to describe specific treatment patterns and whether they are associated with differences in outcomes such as hospitalizations;
    • to identify associations between treatment sequences or combinations and overall survival;
    • to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment;
    • to identify clinical and molecular disease subtypes that may predict for a reduction in cancer from individual treatments, combinations, or sequences.

    You may be eligible for this IRONMAN Registry research study if you have been diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) or nonmetastatic (M0) / metastatic (M1) castration-resistant prostate cancer (CRPC). If you have prostate cancer that has spread to another part of your body and you have not received hormonal therapy, then you have mHSPC. If you have already been treated with androgen deprivation therapy and your disease is now growing despite a low testosterone level, you have CRPC.

    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206648
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    Study Coordinator 312 695 1102
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    DRUG NLG0705: Long Term Follow-Up Study for Subjects Previously Treated with Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

    The purpose of this clinical study is to determine if there are any long term safety risks for research subjects who have received the investigational algenpantucel-L im…

    The purpose of this clinical study is to determine if there are any long term safety risks for research subjects who have received the investigational algenpantucel-L immunotherapy (DRUG NLG-0205 or DRUG NLG-0405) in a clinical trial for pancreatic cancer. 

    You may be eligible for this study if you were treated with the investigational algenpantucel-L (HyperAcute-Pancreas) immunotherapy in a clinical trial for pancreatic cancer (DRUG NLG-0205 or DRUG NLG-0405). 

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206880
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    Study Coordinator 312 695 1102
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    NU MGH17C01: A single arm phase 2 study of the dual mTORC1/mTORC2 inhibitor AZD2014 provided on an intermittent schedule for patients with grade I-III meningiomas that recur or progress after surgery and radiation
    The goal of this clinical research study is to learn if the study drug can shrink or sl…
    The goal of this clinical research study is to learn if the study drug can shrink or slow the growth of meningioma. Treatment of meningioma cells in the laboratory has resulted in decreased survival of tumor cells. As such, the purpose of this research is to see whether treating your meningioma with the study drug will result in tumor size stabilization or shrinkage. The safety of the study drug will also be studied. Your physical state, your symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if the study drug is safe and effective in participants with your condition.
    You may be eligible for this research study if you have one or more meningiomas which have grown or not responded to standard treatment.
    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03071874 STU00206421
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    Study Coordinator 1 312 695 1102
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    Palbociclib after CDK and Endocrine Therapy (PACE): A Randomized Phase II study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

    This research study is studying three combinations of drugs as treatments for this type of cancer:

    • Ar…

    This research study is studying three combinations of drugs as treatments for this type of cancer:

    • Arm A: fulvestrant 
    • Arm B: fulvestrant with palbociclib 
    • Arm C: fulvestrant with palbociclib and avelumab 

    This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied and the researchers are trying to find out more about it— for example, the side effects it may cause, and the activity of a drug, or combination of drugs, against a cancer. 

    In this research study, we are evaluating the activity of fulvestrant alone, fulvestrant and palbociclib, or fulvestrant, palbociclib, and avelumab in participants with metastatic hormone receptor positive breast cancer that has previously stopped responding to prior palbociclib therapy, or another medication in the class of therapy called CDK 4/6 inhibitors.

    You may be eligible for this research study if you have breast cancer that has spread to other parts of your body (metastatic cancer) and your cancer is hormone receptor positive. This study is designed for patients who have previously had exposure to the medication palbociclib, or another medication in the class of therapy called CDK 4/6 inhibitors.

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03147287 STU00207256
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    Study Coordinator 1 312 695 1102
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    NU UC18B01: PHASE IB/II OPEN-LABEL SINGLE ARM STUDY TO EVALUATE SAFETY AND EFFICACY OF TUCATINIB IN COMBINATION WITH LETROZOLE AND PALBOCICLIB IN SUBJECTS WITH HORMONE RECEPTOR POSITIVE AND HER2-POSITIVE METASTATIC BREAST CANCER

    This study plans to learn more about the combination therapy of tucat…

    This study plans to learn more about the combination therapy of tucatinib with palbociclib and letrozole and how these drugs work together to treat HR+/HER2+ metastatic breast cancer. The purpose of the study is to evaluate the safety and how well the study drugs are tolerated when given in combination.

    Letrozole has been approved as standard treatment for metastatic breast cancer by the U.S. Food and Drug Administration (FDA). Palbociclib has been approved by the FDA for treatment of hormone receptor positive (HR+) metastatic breast cancer, but has not yet been approved for patients with HR+ and HER2+ metastatic breast cancer. Tucatinib has not been approved for treatment in metastatic breast cancer patients. This is considered an “investigational” study because this combination of drugs has not been approved by the FDA. 

    You may be eligible for this research study if you have been diagnosed withHR+/HER2+ metastatic breast cancer. 
    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03054363 STU00207287
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    Study Coordinator 312 695 1102
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    DRUG GRN-1201-002: A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with Non-Small Cell Lung Cancer with High PD-L1 Expression

    This is the first study of GRN-1201/sargramostim in combination with pembrolizumab in humans. The researchers want to fin…

    This is the first study of GRN-1201/sargramostim in combination with pembrolizumab in humans. The researchers want to find out what effects, good or bad, this combination has on people with newly diagnosed metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 and whose tumor biopsy samples express PD-L1. 

    The study drug, GRN-1201, is a type of cancer vaccine made up of four peptides (short chains of amino acids) that can cause an immune system response against cancer cells. The study drug is being tested when it is added to another drug called pembrolizumab, an approved medicine to treat NSCLC which has spread (metastatic), because it may cause a response by the immune system against the tumor. GRN-1201 is considered an "investigational" drug. An investigational drug is one that is not approved by the Food and Drug Administration (FDA) for use or sale in the United States. Each dose of GRN-1201 will be 3.0 mg of each peptide given together with a low dose (75 mcg) of another drug called rhGM-CSF (sargramostim, also called Leukine®). Sargramostim is an FDA approved drug which may enhance (increase) your body's immune response to GRN-1201. GRN-1201/sargramostim in combination with pembrolizumab has not been tested before and is not FDA approved. 

    You may be eligible for this research study if you have newly diagnosed metastatic non-small cell lung cancer (NSCLC) with high levels of PD-L1. 
    Villaflor, VictoriaVillaflor, Victoria
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03417882 STU00206591
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    Study Coordinator 1 312 695 1102
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    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 the study drug, Avelumab (anti-PDL-1, also called MS…

    The purpose of this study is to find out how the study drug, Avelumab (anti-PDL-1, also called MSB0010718C), 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. 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.

    Avelumab is an antibody. An antibody is a type of protein thought to work by helping the immune system fight against cancer cells. In this study, we want to compare the study product to placebo (like normal saline) to learn if the study drug might keep your cancer from coming back after you have had surgery and radiation to remove it. We are using a placebo to make sure that the information we collect is not biased or “skewed”. This is considered acceptable because no drug is known to keep your cancer from coming back. If you join this study, you would receive either avelumab or placebo. You would not get both.

    You may be eligible for this research study if you have Merkel Cell Carcinoma (MCC) that has traveled to your lymph nodes. You must have completed treatment that included surgical removal of the cancer.
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03271372 STU00207190
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    Study Coordinator 312 695 1102
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    A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

    The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause n…

    The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause normal and cancerous cells to grow and multiply. While sorafenib is an effective drug for treating HCC, there is evidence suggesting that combining sorafenib therapy with pembrolizumab may be more effective than sorafenib by itself. 

    Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat HCC. Pembrolizumab works by helping the immune system to fight cancer. However, pembrolizumab can also cause the immune system to attack normal organs and tissues in the body and can affect the way they work, which can result in side effects that may become serious or life-threatening, and in some cases, may lead to death. 

    The purpose of this study is to test the safety of giving pembrolizumab in combination with sorafenib, and to look at the effect that this combination has on HCC and how it responds to this treatment.

    You may be eligible for this research study if you have hepatocellular carcinoma (HCC), which is the most common type of liver cancer and usually occurs with chronic liver disease. 

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03211416 STU00207399
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    Study Coordinator 312 695 1102
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    A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) plus Chemotherapy (XP or FP) versus Placebo plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585).
    The purpose of this s…
    The purpose of this study is to test the safety, efficacy, and tolerability of the research study drug, pembrolizumab (MK-3475) in combination with cisplatin and capecitabine or 5- fluorouracil (5-FU).

    You may be eligible for this research study if you have gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03221426 STU00207611
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    Study Coordinator 1 312 695 1102
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    Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination with R-CHOP in a Cohort of Patients with DLBCL/tFL/ high grade B-NHL

    The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffu…

    The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffuse large B-cell lymphoma (DLBCL). 

    The standard chemotherapy regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is called “R-CHOP” and includes the drugs: Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O) and Prednisone (P). The new drug, nivolumab, works by targeting the immune system and increasing the effect of immune cells against the cancer cells. 

    The purpose of the study is to determine if the combination of nivolumab with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth, and whether or not it improves symptoms and quality of life in those who participate in the study. 

    Nivolumab is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer. However, it has been studied and approved by the FDA for other types of cancer.

      You may be eligible for this research study if you have been diagnosed with aggressive diffuse large B-cell lymphoma (DLBCL) or another form of aggressive B-cell non-Hodgkin lymphoma, and you have not been treated for this type of cancer.

      Karmali, ReemKarmali, Reem
      • Map it 201 East Huron Street Suite 12-160​
        Chicago, IL
      NCT03704714 STU00207793
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      Study Coordinator 312 695 1102
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      (xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
      The first purpose of this study is to te…
      The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
      You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
      Dinner, ShiraDinner, Shira
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03150693 STU00208162
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      Study Coordinator 312 695 1102
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      A phase 1 study of R-CHOP plus SYK inhibitor TAK-659 for the front-line treatment of high-risk diffuse large B cell lymphoma (DLBCL)

      We are performing a clinical trial that will combine 1 new drug, TAK-659, with a standard treatment regimen for diffuse large B-cell lymphoma (DLBCL). The stand…

      We are performing a clinical trial that will combine 1 new drug, TAK-659, with a standard treatment regimen for diffuse large B-cell lymphoma (DLBCL). The standard treatment regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is a chemotherapy combination called R-CHOP (Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O), Prednisone (P)). The new drug, TAK-659, inhibits the activity of a protein called Syk, which is known to function abnormally in this type of cancer. 

      The purpose of the study is to make sure that the combination of TAK-659 with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth and improving your symptoms. 

      TAK-659 is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer.

      You may be eligible for this research study if you have been diagnosed with diffuse large B-cell lymphoma (DLBCL), you have not been treated for your cancer, and your doctor plans to treat you with the R-CHOP chemotherapy regimen.

      Karmali, ReemKarmali, Reem
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03742258 STU00207880
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      Study Coordinator 312 695 1102
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      A Study To Estimate the Anti-Tumor Activity And Identify Potential Predictors of Response in Patients with Advanced Mucosal or Acral Lentiginous Melanoma Receiving Standard Nivolumab in Combination with Ipilimumab followed by Nivolumab Monotherapy.

      This is a study to learn more about mucosal and a…

      This is a study to learn more about mucosal and acral lentiginous melanoma therapy. We are collecting blood and tissue samples from people who will receive nivolumab in combination with ipilimumab treatment for their mucosal and acral lentiginous melanoma. The nivolumab and ipilimumab combination is approved by the U.S. Food and Drug Administration for the treatment of patients with advanced melanoma and therefore is considered a standard treatment of this disease.

      However, the disease we call melanoma can present in different fashions, which may influence its behavior and response to therapy. Melanomas that start on mucous membranes are called mucosal and those that develop on the palms and soles of the feet are designated “acral lentiginous.” These rare subtypes of melanoma may behave differently from the more common melanomas that begin on sun exposed skin surfaces. Research on blood, tissues, and medical information is one way to learn more about diseases. We can learn how different people respond to different cancer treatments.

      The purpose of this study is to determine which participants with melanoma respond best to nivolumab and ipilimumab treatment and to identify tumor and blood based markers that may predict response to the combination. To do this, participants will be asked to submit tumor tissue samples from initial tumor specimen and blood samples before and during treatment with nivolumab and ipilimumab for their advanced melanoma. By collecting participant information on response to therapy and correlating it with analyses of blood and tumor samples we hope to determine which patients are most appropriate for this treatment and potentially factors that might suggest patients should be considered for a different treatment.

      You may be eligible for this research study if you have been diagnosed with mucosal and/or acral lentiginous melanoma.

      Chandra, SunandanaChandra, Sunandana
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02978443 STU00207669
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      Study Coordinator 1 312 695 1102
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      DRUG D6070C00004: A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC

      This study is being conducted to test 2 experimental drugs, oleclumab (MEDI9447) and osimertinib, given in combination (tog…

      This study is being conducted to test 2 experimental drugs, oleclumab (MEDI9447) and osimertinib, given in combination (together), to treat advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC). 

      Oleclumab is a laboratory-made antibody that binds to a molecule called CD73. Naturally occurring, antibodies are proteins, made by the immune system, that fight infections and other diseases. The immune system can recognize cancer cells, and in some circumstances control or even eliminate tumors. In the body, CD73 produces a molecule called adenosine. Too much adenosine can suppress the activity of the immune system. Oleclumab binds to CD73, reducing CD73’s ability to produce adenosine. This reduction in adenosine may boost the activity of the immune system, and prevent cancer growth. Additionally, it has been shown that patients with EGFRm NSCLC have higher levels of the CD73 protein in their tumors compared to patients with lung cancer that lacks the mutation in the EGFR gene. Osimertinib blocks the actions of a protein in the body called tyrosine kinase. It has been approved by the United States Food and Drug Administration (FDA) for the treatment of a type of EGFRm NSCLC that is linked to a specific change in the EGFR gene called the T790M mutation. The use of osimertinib is “experimental” in this study because the use of osimertinib combined with oleclumab as a cancer treatment has not been approved by any authority that regulates new medicines. This means that treatment with osimertinib is not standard care for treating this type of cancer. 

      The study will look at whether this combination of oleclumab and osimertinib, because of the way they work, may improve the outcome in subjects with your type of cancer. The purposes of this study are to find the doses of oleclumab and osimertinib, given in combination, which are safe and well tolerated, to determine what side effects may occur and to confirm how well the treatment works for EGFRm NSCLC. The study will also measure the amount of oleclumab and osimertinib in your blood at various times, whether or not your body makes antibodies against oleclumab, and the effect oleclumab combined with osimertinib has on your cancer. Antibodies against oleclumab could reduce the active level of the study drugs in your blood and reduce the effects of the study drugs on your cancer.

      You may be eligible for this research study if you have advanced epidermalgrowth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and your cancer is advanced and is worsening despite previous treatments that have included a medicine whichworks to block the EGFR gene.
      Chae, Young KwangChae, Young Kwang
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03486314 STU00207982
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      Study Coordinator 1 312 695 1102
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      A Phase 1, First in Human, Open Label, Dose Escalation Study of AMV564, a CD33 x CD3 Tandem Diabody in Patients with Relapsed or Refractory Acute Myeloid Leukemia

      This is the first in human study to test an investigational drug called AMV564. AMV564 has not been approved by the Food and Drug Admin…

      This is the first in human study to test an investigational drug called AMV564. AMV564 has not been approved by the Food and Drug Administration (FDA) in the United States or any health or regulatory authority in other countries. 

      The purpose of this clinical research study is to find the highest tolerable dose of this drug that can be given to subjects with acute myeloid leukemia (AML), and to recommend a dose to be used in future studies. Another purpose of the study is to learn more about the safety of this drug and how the body processes the drug. For example, the study will look at how long the drug can be measured in the blood, and how the drug affects AML cancer cells and other blood cells.

      You may be eligible for this research study if you have acute myeloid leukemia(AML), a blood cancer that has either returned, worsened or is resistant to treatment.

      Altman, Jessica KAltman, Jessica K
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03144245 STU00207464
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      Study Coordinator 312 695 1102
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      Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)

      The purpose of this study is to:

      - See how well the study drug, pembrolizumab, works compared to placebo in keeping your cancer from coming back …

      The purpose of this study is to:

      - See how well the study drug, pembrolizumab, works compared to placebo in keeping your cancer from coming back or spreading. A placebo looks like the study drug but has no medicine in it.

      - Test the safety of the study drug

      - See how your body handles the study drug.

      - Male/female patients at least 18 years of age who have surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma

      - Patients must not have been previously treated for melanoma beyond complete surgical resection of the current primary melanoma lesion

      - Patients must be able to start study treatment no more than 12 weeks after full surgical resection.

      Chandra, SunandanaChandra, Sunandana
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03553836 STU00208266
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      Study Coordinator 312 695 1102
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      DRUG CX-839-008: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination with Cabozantinib (CB-Cabo) vs. Placebo with Cabozantinib (Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

      The purpose of this study is to determine i…

      The purpose of this study is to determine if CB-839 (an “investigational” drug), given together with cabozantinib (an “approved” drug), is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than cabozantinib alone. This study will also look at any possible effect that CB-839 in combination with cabozantinib may have on your cancer.

      "Investigational" means that CB-839 has not been approved by the United States Food and Drug Administration (FDA) or any other health authority in the world for use outside of research studies. “Approved” means that cabozantinib has been tested and approved for sale by the FDA (and other health authorities) and can be prescribed by doctors. The combination of CB-839 together with cabozantinib is also investigational.

      You may be eligible for this research study if you have kidney cancer. 
      Sosman, JeffreySosman, Jeffrey
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03428217 STU00208112
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      Study Coordinator 312 695 1102
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      DRUG ASTX660-01: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

      The purpose of the study is to test the safety of the study drug ASTX660 and to see if this drug has an effect on treating your cancer. The dru…

      The purpose of the study is to test the safety of the study drug ASTX660 and to see if this drug has an effect on treating your cancer. The drug that will be given to you in this study is investigational, meaning that it has not yet been approved for treatment of any disease, including cancer.

      Cancer is a disease involving the uncontrolled growth of human cells. Normal cell growth is controlled by many mechanisms. Cancer cells escape these mechanisms and grow uncontrollably. One of the ways that cancer cells continue to grow is by producing proteins called "Inhibitors of apoptosis proteins (IAPs)" that block the normal cell death pathway of human cells. The study drug may interfere with the function of these inhibitory proteins and thus cause the cancer cells to die or stop growing.

      You may be eligible for this research study if you have an advanced cancer that is either a solid tumor or blood cancer and it has not responded to treatment with other therapies.

      Matei, DanielaMatei, Daniela
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02503423 STU00208005
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      Study Coordinator 312 695 1102
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      A multicenter Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of the combination of rogaratinib and copanlisib in patients with FGFR-positive, locally advanced or metastatic solid tumors

      There are two con…

      There are two consecutive parts to this study, a dose escalation part and a dose expansion part.

      The purpose of the escalation part is to determine the highest dose that can be safely given of the study drugs (Rogaratinib) in combination with Copanlisib to treat follicular lymphoma that has come back to participants with locally advanced or metastatic solid tumors. The aim of this part of the study is to determine the appropriate dose of Rogaratinib to be used in combination with Copanlisib. Approximately 15 patients may be treated during this first part of the study.

      Once the appropriate dose of Rogaratinib and Copanlisib in combination has been defined, the expansion part of the study will start and approximately up to 30 additional patients will be treated. The purpose of this part is to assess whether or not the selected dose of the combination is safe and shows activity in treating participants with locally advanced or metastatic urothelial carcinoma (a type of cancer that occurs in the urinary system, including bladder, urethra, ureter or renal pelvis).

      Rogaratinib is an investigational drug, which means that it has not been approved by any country’s health authority and it is only available to people who are in research studies. It is made and studied by Bayer for the treatment of cancer that belongs to a new class of medication called tyrosine kinase inhibitors. A tyrosine kinase inhibitor targets certain key structures called proteins in or on the surface of your cells that are needed for the survival of the cancer cells. The study drug targets a class of tyrosine kinases called fibroblast growth factor receptors (FGFR). Therefore, these drugs work by stopping the cell growth of cancer cells in a specific way and may even reduce the size of the tumor.

      The test drug Copanlisib has already been approved by the FDA (Food and Drug Administration) in the US for the treatment of adult patients with relapsed follicular lymphoma, but not other type of cancers. Copanlisib works by inhibiting the cell growth of the cancer via a specific pathway. This drug blocks the enzyme Phospho-Inositol-3-Kinase (PI3K), which stimulates the growth of tumor cells. 

      Concomitant administration of study test drugs Rogaratinib with Copanlisib has never been used before this study. 

      You may be eligible for this research study if you have been diagnosed with locally advanced or metastatic solid tumors.

      Fibroblast Growth Factor Receptor (FGFR; a protein found abnormally present on the surface of some cancer cells) testing (tissue test) is required to see if you qualify for the study.

      Mahalingam, DevalingamMahalingam, Devalingam
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03517956 STU00208211
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      Study Coordinator 312 695 1102
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      A Phase 2, Randomized, Biomarker-driven, Clinical Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML and Exploratory Arms with Varying Levels of MCL-1 Dependence

      The purpose of this research study is to …

      The purpose of this research study is to determine the effectiveness (how well something works) and safety of an “investigational” compound called alvocidib when used in a combination chemotherapy regimen in patients with acute myeloid leukemia (AML) who have varying levels of MCL-1 (human gene) dependency. “Investigational” means that the Food and Drug Administration (FDA) has not yet approved this drug as a prescription medicine; it is only available through research studies like this. 

      Alvocidib was previously known as flavopiridol. Alvocidib is an investigational product being developed by Tolero Pharmaceuticals in AML. Alvocidib will be one of three drugs used in the combination chemotherapy treatment regimen. The other drugs are cytarabine and mitoxantrone. Both cytarabine (also known as Ara-C) and mitoxantrone are standard of care for the treatment of patients with AML. However, the three-drug combination of alvocidib with cytarabine and mitoxantrone (abbreviated “ACM”) is an experimental combination. (ACM has also been referred to as FLAM).

      You may be eligible for this research study if you have acute myeloid leukemia (AML) that has come back after initial treatment (relapsed) or because you did not get a complete response from your initial treatment (refractory) or you have been newly diagnosed with highrisk (NDHR) AML. As part of the initial pre-screening process, you had a bone marrow aspirate performed and tested that showed you have AML that expresses a protein that may predict whether you will respond to treatment with ACM (an experimental combination).

      Frankfurt, OlgaFrankfurt, Olga
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02520011 STU00208084
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      Study Coordinator 312 695 1102
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      NU C18C01: A Phase I Study of Safety and Tolerability of Acetazolamide with Temozolomide in Adults with Newly Diagnosed MGMT Promoter-Methylated Malignant Glioma

      This study is being done to learn more about a combination of two drugs called acetazolamide and temozolomide given to persons who have …

      This study is being done to learn more about a combination of two drugs called acetazolamide and temozolomide given to persons who have an aggressive form of glioma (either grade III or IV). We aim to explore whether it is possible to add acetazolamide to a standard treatment regimen of temozolomide and radiotherapy. Specifically, the study will explore whether the study drug combination (the addition of acetazolamide to the temozolomide regime) will cause negative side effects that would not be seen in someone just receiving temozolomide alone. Some subjects on the trial may experience important or serious side effects. If certain side effects are seen, the study drug combination will be stopped.

      Temozolomide and acetazolamide given together is experimental in this study and is not FDA approved. It is thought that acetazolomide may make the standard temozolomide chemotherapy more effective in a subset of patients.

      You may be eligible for this research study if you have newly diagnosed glioma, a form of brain cancer.

      Lukas, RimasLukas, Rimas
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03011671 STU00208331
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      glioma

      For more information on this study please contact us:

      Study Coordinator 1 312 695 1102
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      DRUG E7080-G000-604: An open-label, multi-center, roll-over study to assess long term safety of lenvatinib monotherapy or lenvatinib combination regimen or comparator treatment arm to cancer patients in Eisai sponsored lenvatinib trials

      The purpose of this study is to gather long term safety on le…

      The purpose of this study is to gather long term safety on lenvatinib as either monotherapy or in combination therapy. If you received comparator drug in the previous study you will continue to receive that drug at the same dose. This will allow you to continue at your current dose of the study drug(s) until loss of clinical benefit or until disease progression as confirmed by your doctor, unacceptable toxicity, withdrawal by your own request, consent withdrawal, or study termination by the sponsor. Monitoring of hematology, blood chemistry, and urine values, and performance of physical examinations will be performed per standard of care or as clinically indicated.

      You may be eligible for this research study if you have been diagnosed with cancer and you have participated in a clinical trial in which you have received the study drug lenvatinib. The current study that you are participating in, called the parent study, will be ending and this new study will allow you to continue to receive the drug you received previously in addition to following any side effects that may occur in the future.

      Agulnik, MarkAgulnik, Mark
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03477175 STU00207974
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      Study Coordinator 312 695 1102
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      DRUG GC P#05.01.020: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
      The main purpose of this study…
      The main purpose of this study is to determine whether NiCord® transplants are better than transplants with standard, unmanipulated cord blood units.
      You may be eligible for this study if you have a blood cancer that is being treated with allogeneic stem cell transplantation. 
      Frankfurt, OlgaFrankfurt, Olga
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00208388
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      Study Coordinator 312 695 1102
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      An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

      This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Prog…

      This research study is a type of treatment program called an Expanded Access Program sponsored by Incyte Corporation. The purpose of the Program is to give access to the investigational drug, ruxolitinib, to graft-versus-host disease (GVHD) patients in the United States who are not eligible or able to participate in clinical trials. 

      A second objective is to monitor the safety of ruxolitinib in GVHD patients. 

      Ruxolitinib is an investigational drug that is being studied for use in the treatment of GVHD. “Investigational” means that ruxolitinib has not been approved by the FDA (Food and Drug Administration) for use as a prescription or over-the-counter medication.

      You may be eligible for this research study if you have acute or chronic graft-versus-host disease (GVHD) but are not eligible or able to obtain ruxolitinib by participating in clinical trials.

      Frankfurt, OlgaFrankfurt, Olga
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03147742 STU00208471
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      Study Coordinator 312 695 1102
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      (xIRB NCI CIRB) Alliance A011401: Randomized Phase III Trial Evaluating The Role Of Weight Loss In Adjuvant Treatment Of Overweight And Obese Women With Early Breast Cancer
      This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have fou…
      This study is being done to see if losing weight may help prevent breast cancer from coming back. Previous studies have found that women who are overweight or obese when their breast cancer is found have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether or not losing weight will reduce the risk of breast cancer returning. This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost. It is important to note that we do not know how much weight would need to be lost to lower the risk of breast cancer recurrence, or whether this strategy would work for all women. This study willhelp to show researchers whether weight loss programs should be a part of breast cancer treatment.

      This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost.

       

      Donnelly, EricDonnelly, Eric
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00208895
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      Study Coordinator 312 695 1102
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      Utilization of Clinomic Outcomes, Patient-Derived Xenografts (Avatars), and Next Generation Sequencing Data for the Identification of Alternative Actionable Targets and Therapeutic Response Prediction in Cholangiocarcinoma

      The purpose of this study is to gather information about your cancer and th…

      The purpose of this study is to gather information about your cancer and the genetic makeup of your tumor tissue. In this study, we are looking for specific biomarkers using genetic testing and animal models. We are interested in learning about the relationship between your cancer and the different types of genetic markers in your tumor tissue to identify possible new treatment methods in the future. 

      A portion of your tumor will be sent for routine genomic analysis. The tests known as next generation sequencing or “NGS” are being done on your cancer tissue samples as part of your routine clinical care. These routine tests will be performed whether you participate in this study or not. Another small portion of that tumor will be placed in a mouse to grow (xenograph or “avatar”) from which more genetic analyses will be performed. 

      You may be eligible for this research study if you have a diagnosis of a type of cancer called cholangiocarcinoma, and you are planning to have either a surgical resection or a biopsy of your tumor at Northwestern University, in which you agree to have a portion of your tumor sent for routine genomic analysis to potentially help you and your physician make treatment decisions now or in the future. 

      Benson III, Al BBenson III, Al B
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00208589
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      Study Coordinator 1 312 695 1102
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      A Phase 1/2, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome
      This study involves research about the…
      This study involves research about the study drug MGD006. MGD006 is similar to an antibody - a substance in the blood that helps remove foreign substances. MGD006 is made to attach to your cancer cells and to T-cells - a part of your immune system - that may help your immune system kill the malignant cells. MGD006 is an investigational drug which means it has not been approved by the Unites States Food and Drug Administration (FDA) for the treatment of AML or any other cancers. MGD006 has been tested in animals, but this is the first time it will be given to humans to be tested as a possible treatment for AML. The purpose of this study is to find the answers to these research questions:

      • What are the side effects of MGD006?
      • What is the highest dose of MGD006 that can be given safely?
      • How long does MGD006 stay in the blood?
      • How long does it take for MGD006 to leave the body?
      • Is MGD006 a possible treatment for AML?

      • Patients must have a confirmed diagnosis of primary or secondary AML or MDS with a risk category of Intermediate-2 or High Risk
      • Patients must be unlikely to benefit from recommended standard of care defined by any one of the following criteria:
        • leukemia refractory to at least 2 induction attempts,
        • leukemia in 1st relapse with initial CR duration < 6 months
        • leukemia in 1st relapse following at least 1 unsuccessful salvage attempt
        • leukemia in 2nd or higher relapse
        • prior treatment failure with at least four cycles of a hypomethylating agent
      • Patients with MDS must have experienced treatment failure with induction therapy or at least one cycle of hypomethylating therapy and have at least 10% bone marrow blasts.
      Altman, Jessica KAltman, Jessica K
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00208838
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      Study Coordinator 312 695 1102
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      DRUG JZP963-201: A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

      Allogeneic hema…

      Allogeneic hematopoietic stem cell transplant (HSCT) involves the receipt of healthy bone marrow or stem cells from a donor in order to replace damaged bone marrow stem cells. A common complication of allogeneic stem cell transplant is acute Graft versus Host Disease (abbreviated as aGvHD). It occurs in close to 40–59% of patients who receive allogeneic HSCT, and it may be life threatening. The donated tissue you will receive contains healthy cells that will repopulate your marrow and produce healthy blood cells. The donor graft tissue also contains immune cells which help to recognize and destroy the few, if any, remaining leukemia or preleukemic cells remaining in your body. But these donor immune cells can also sometimes attack your body because the immune cells from the donor graft are different from yours and they recognize your cells (called ‘the host’) as foreign. The immune cells from the graft start an immune reaction which can affect multiple organs in your body. This is what happens in aGvHD. All patients who undergo allogeneic HSCT receive medicine to try to prevent aGvHD. These prophylactic treatments work by suppressing (decreasing) the activity of the immune cells, and they are therefore called immunosuppressive regimens or immunoprophylaxis. Most of the prophylactic treatments that are used prevent some, but not all, aGvHD. Despite the use of immunosuppressive regimens, aGvHD remains the most important and life-threatening complication after HSCT.

      This clinical research study will test a study drug designed to prevent acute Graft-versus-HostDisease (aGvHD) by adding this new medicine to the usual medicines your doctor will give you for prevention of aGvHD. Everyone who participates in the study will receive treatment to prevent aGvHD, but some of the participants will also receive defibrotide, the study drug being studied in this trial, while some of the participants will not receive the study drug. 

      The study is being done to learn if adding defibrotide to the standard medicines for prevention of aGvHD, which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. In GvHD, when the immune cells from the graft begin to recognize a patient’s tissue as foreign and start to attack normal tissue, it is because they have been sent a signal to do so by certain chemicals in the body called inflammatory cytokines. Defibrotide has been shown to reduce the levels of some inflammatory cytokines. It has a protective effect on cells lining the blood vessels, and might have the potential to prevent early immune reactions after stem cell transplantation.

      Defibrotide is used in adults and children to treat liver Veno Occlusive Disease (VOD) when there is also kidney or lung dysfunction (also known as severe VOD) following HSCT. Defibrotide has been approved for this treatment in Europe, Israel, South Korea, the United States, and Canada with the brand name Defitelio®. The study drug has not been approved for the prevention of aGvHD in patients undergoing HSCT. Its use in this study is experimental.

      You may be eligible for this research study if you have been diagnosed with acute leukemia or with myelodysplastic syndrome (MDS), and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). To be eligible, study participants must be identified to be at high risk for developing acute graft-versus-host disease (abbreviated as aGvHD), a common complication of allogeneic stem cell transplant. 

      Adekola, KehindeAdekola, Kehinde
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03339297 STU00208805
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      For more information on this study please contact us:

      Study Coordinator 312 695 1102
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      DRUG PSMA-617: VISION: An International, Prospective, Open-Label, Multicenter, Randomized Phase 3 Study Of 177Lu-PSMA-617 In The Treatment Of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (MCRPC)

      The therapy we will be using in this study is called “radi…

      The therapy we will be using in this study is called “radionuclide therapy” and is an approach for the treatment of cancer that uses chemical compounds we sometimes refer to as “tumor-targeting agents” to deliver radiation directly to tumors to kill the tumor. The amount of radiation is selected in order to damage and destroy the tumor. The compound and the radiation reach tumor cells throughout the body by travelling through the bloodstream. The idea is that the compound which carries the radiation will target the tumor cells and not healthy normal tissue.

      Many cells contain a protein called prostate-specific membrane antigen (PSMA). There is a cancer called metastatic, castration resistant prostate cancer (mCRPC) that affects men and which often has the PSMA protein on the surface of cells of this cancer. The normal cells in the prostate do not normally express as much PSMA protein on their surface as do cancer cells.

      The compound that we are using in this study to seek and find the PSMA protein is called 177Lu-PSMA-617 (also called Lu-PSMA) and it is a radionuclide therapy. It delivers lutetium 177 (a radioactive metal) to cancers of the prostate which have PSMA proteins on the cell surface. Lu-PSMA is an experimental (investigational) radionuclide therapy, meaning that it has not been approved in the United States by the Food and Drug Administration (U.S. FDA) or any other regulatory authority, and it is not commercially available. It is too early to know whether treatment with Lu-PSMA will provide benefit to patients with prostate cancer, and the results of this study may help answer that question.

      The potential benefit from treatment with Lu-PSMA will be determined by comparing overall survival (how long patients live) in patients with progressive PSMA-positive mCRPC who receive Lu-PSMA in addition to best supportive/best standard-of-care to patients treated with best supportive/best standard-of-care alone.

      The study will also measure how well prostate cancer responds to Lu-PSMA, the safety of the treatment (by measuring the frequency and severity of side effects), whether pain improves or worsens, how long you live without your prostate cancer getting worse, and your quality of life.

      You may be eligible for this research study if you have been diagnosed with recurrent metastatic, castration-resistant prostate cancer.

      Morgans, AliciaMorgans, Alicia
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03511664 STU00209123
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      Study Coordinator 312 695 1102
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      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

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      Berzins, Baiba Ingrida 312 695 5012
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      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
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      Berzins, Baiba Ingrida 312 695 5012
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      A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
      A5324 is a randomized, double-blinded, placebo-con…
      A5324 is a randomized, double-blinded, placebo-controlled study for HIV-infected individuals with an undetectable HIV viral load who have at least mild neurocognitive impairment. Participants will be randomized to add either maraviroc plus dolutegravir, dolutegravir alone, or placebo to their current anti-HIV medications. The main purpose of the study is to see if intensification with maraviroc and dolutegravir will improve neurocognitive performance and functioning in persons who have at least mild neurocognitive impairment.
      • HIV-1 infected persons at least 18 years of age
      • On current HIV medications for at least 12 months
      • No prior or current use of any integrase inhibitor or maraviroc
      • HIV viral load less than 50 copies
      • Screening neuropsychological tests showing problems with memory, thinking or daily tasks
      Taiwo, Babafemi OTaiwo, Babafemi O
      NCT02519777 STU00200413
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      Berzins, Baiba Ingrida 312 695 5012
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      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
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      Berzins, Baiba Ingrida 312 695 5012
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      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

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      Gottstein, Jeanne H 312 694 0264
      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)
      A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderatel…
      A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT01848561 STU00094204
      More Info

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      Arrieta, Rose +1 312 695 5878
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      A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
      A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens…
      A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02065622 STU00096456
      More Info

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      Arrieta, Rose +1 312 695 5878
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      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
      A Multicenter, Randomized, Double-Blind Study to Evaluate…
      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
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02065570 STU00096539
      More Info

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      Arrieta, Rose +1 312 695 5878
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      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:

      Masihi, Melina +1 312 695 0330
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      (xIRB) 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
      Ganger, Daniel RGanger, Daniel R
      NCT02167945 STU00102262
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      1-855-NU-STUDY
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      A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis
      Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease …
      Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.
      Flamm, Steven LFlamm, Steven L
      NCT02308111 STU00200837
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      Gottstein, Jeanne H 312 694 0264
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      An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies
      An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase …
      An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02118584 STU00200583
      More Info

      For more information on this study please contact us:

      Arrieta, Rose +1 312 695 5878
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      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
      A Phase III, Randomized, Double-Blind, Placebo…
      A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02394028 STU00201257
      More Info

      For more information on this study please contact us:

      Arrieta, Rose +1 312 695 5878
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      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active …
      An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02403323 STU00201259
      More Info

      For more information on this study please contact us:

      Arrieta, Rose +1 312 695 5878
      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)
      Phase III, Double Blind, Pla…
      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)
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02100696 STU00200704
      More Info

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      Arrieta, Rose +1 312 695 5878
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      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
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      Milosevic, Stanislava 312 694 0326
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      Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
      Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      STU00201469
      More Info

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      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
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      Gottstein, Jeanne H 312 694 0264
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      An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically
      An Open-Label, Multicenter and Open…
      An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically
      Stein, AdamStein, Adam
      NCT02559713 STU00202916
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      Arrieta, Rose 312 695 5878
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      (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

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      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

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      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
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      Sipich, Kimberly A 312 694 1293
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      Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
      Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies…
      Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
      Hanauer, StephenHanauer, Stephen
      NCT02914561 STU00205056
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      Arrieta, Rose 312 695 5878
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      Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
      Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled …
      Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
      Hanauer, StephenHanauer, Stephen
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02914522 STU00205250
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      Arrieta, Rose +1 312 695 5878
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      Transplant Recipients Undergoing Therapy Intended to Achieve Transplant Tolerance
      Improvements in immunosuppression following solid organ allotransplantation have significantly enhanced short-term graft and patient survival. At the same time, long-term graft survival has not significantly improved. T…
      Improvements in immunosuppression following solid organ allotransplantation have significantly enhanced short-term graft and patient survival. At the same time, long-term graft survival has not significantly improved. The combination of long-term inflammatory injury, in part due to incomplete immunosuppression, and drug toxicity from calcineurin inhibitors used in immunosuppression have inhibited long-term graft survival. Further, the cost and side effects of long-term immunosuppression are significant. Some patients do not need ongoing maintenance immunosuppression long-term. In liver transplant recipients, some estimates place this number as high as 20% of recipients. It has not been possible to show similar results in kidney transplantation. However, several interventions have been designed intended to achieve tolerance in the renal transplant population, as well. The status of immune systems in transplant patients has been well-studied. However, given the small number of patients either tolerant or undergoing therapy intended to induce tolerance, less is understood about their immune markers. This project aims to establish a repository of blood and urine taken serially from patients who have either demonstrated some degree of tolerance, or who are undergoing therapy intended to achieve tolerance, such that potential biomarkers – including those not yet identified – can be compared among health controls, transplant recipients not believed to be tolerant, and tolerant or partially tolerant recipients.
      Friedewald, John JFriedewald, John J
      STU00047842
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      1-855-NU-STUDY
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      A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS
      Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
      Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
      Borja-Cacho, DanielBorja-Cacho, Daniel
      NCT01897688 STU00059469
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      1-855-NU-STUDY
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      Chronic Kidney Disease Research Biorepository
      The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
      Isakova, TamaraIsakova, Tamara
      • Map it 633 N. St. Clair St.
        Chicago , IL
      STU00201546
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      Martinez, Carlos 312 503 1808
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      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
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      1-855-NU-STUDY
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      A phase 3 randomized, open-label (sponsor-blind), activecontrolled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
      This is a phase III study …
      This is a phase III study in non-dialysis subjects with anemia associated chronic kidney disease to evaluate the safety and efficacy of an investigational drug, Daprodustat when compared to darbepoetin alfa.
      Inclusion Criteria:
      1. Men or Women 18 to 99 years of age.
      2. Chronic Kidney Disease Stages 3, 4, or 5
      3. Acceptable if on Erythropoietin-Stimulating Agents
      4. Hemoglobin between 8 to 12 g/dL
      5. Willingness to participate and capable of giving signed informed consent.
      Exclusion Criteria:
      1. Currently receiving dialysis
      2. Planned kidney transplant within 1 year
      3. Iron deficient
      4. Other causes of anemia (pernicious anemia, thalassemia major, sickle cell, myelodysplastic syndrome)
      5. Uncontrolled high blood pressure
      6. History of malignancy within 2 years
      7. Unstable liver disease
      8. Chronic Class IV heart failure
      Ghossein, CybeleGhossein, Cybele
      NCT02876835 STU00203935
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      Napoli, Sara 312 503 3865
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      Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
      This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
      This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
      Inclusion Criteria
      • Type 1 and 2 Diabetes by ADA criteria (see appendix )
      • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
      • Able to provide informed consent
      • Adult participants (no age restriction)
      • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
      Exclusion Criteria
      • ESRD, defined as chronic dialysis or kidney transplant
      • History of receiving dialysis for more than 30 days
      • Institutionalized
      • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
      • Less than 3-year life expectancy
      • Known alcohol or substance abuse
      • Unable to provide informed consent
      • No evidence of active cancer other than non-melanoma skin cancer
      Isakova, TamaraIsakova, Tamara
      • Map it 633 N. St. Clair St.
        Chicago , IL
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02986984 STU00204808
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      Martinez, Carlos 312 503 1808
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      A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
      C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two for…
      C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
      Inclusion Criteria:
      1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, within 12 weeks prior to screening or during screening:
      2. Male or female subjects, aged at least 18 years
      3. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion;
      4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
      5. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments.
      Exclusion Criteria:
      1. Pregnant or nursing;
      2. Secondary C3 disease
      3. History or presence of any form of cancer within the 5 years prior to screening,
      4. Currently on dialysis or will require dialysis wtihin 7 days of screening
      5. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
      6. Evidence of tuberculosis
      7. Evidence of liver disease
      Ghossein, CybeleGhossein, Cybele
      NCT03301467 STU00206182
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      Napoli, Sara 312 503 3865
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      A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis
      This is a randomized, multicenter, double-blind, parallel, a…
      This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).
      Inclusion Criteria:
      1. Primary FSGS
      2. Male or Female aged 18-75 years
      3. Urine protein/creatinine ratio ≥ 1.5 g/g
      4. Estimated glomerular filtration rate (eGFR) ≥ 30
      5. Blood pressure criteria:  ≥100/60 mmHg and ≤160/100 mmHg
      6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
      Exclusion Criteria:
      1. Secondary FSGS
      2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
      3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
      4. Body Mass Index (BMI) > 40
      3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
      Ghossein, CybeleGhossein, Cybele
      NCT03493685 STU00206193
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      Napoli, Sara 312 503 3865
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      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
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      Martinez, Carlos 312 503 1808
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      EMPA-KIDNEY Trial - A multicentre international randomized parallel group double-blind placebocontrolled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease
      EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardio…
      EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardiovascular health and progression of chronic kidney disease. This research is studying patients with chronic kidney disease (both with and without diabetes). The study involves taking the study medication every day for about 3-4 years. Additionally, the study team will ask participants to come for study visits, with 3 visits in the first 6 months and then one visit every 6 months until the end of the study. Visits will include surveys, blood and urine collection, and distribution of study medication.
      Age is ≥ 18 years at Screening;

      There is evidence of chronic kidney disease at risk of kidney disease progression;

      A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT -1/2 inhibitor), nor that such treatment is inappropriate;

      none of the exclusion criteria apply

      Isakova, TamaraIsakova, Tamara
      • Map it 633 N. St. Clair St.
        Chicago , IL
      NCT03594110 STU00208411
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      Martinez, Carlos +1 312 503 1808
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      Northwestern Scleroderma Program Patient Registry
      The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
      The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
      Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
      Hinchcliff, Monique EHinchcliff, Monique E
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00002669
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      Carns, Mary 312 503 1137
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      Chicago Lupus Database
      Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number …
      Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
      Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
      Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
      STU00009193
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      lupus

      For more information on this study please contact us:

      312 503 1919
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      Genome Research in African American Scleroderma Patients (GRASP)
      Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain t…
      Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain the different risk in developing scleroderma seen in African American patients compared to other populations. Participants will complete a brief health questionnaire and provide two tubes of blood.
      African American patients who are evaluated at the Northwestern Scleroderma Program and meet criteria for the diagnosis of systemic sclerosis, Age ≥ 18 years old
      Varga, JohnVarga, John
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00069421
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      Carns, Mary 312 503 1137
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      The Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
      The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN a…
      The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are: 1. To learn more about important problems faced by people living with scleroderma (e.g., fatigue, emotional distress, physical limitations). 2. To develop and test internet-based interventions to support people in their efforts to cope with living with scleroderma. Participants will be asked to complete quality of life questionnaires via the internet every 3 months.
      Diagnosis of scleroderma. Fluent in English. Must have access to the Internet to complete questionnaires.
      Varga, JohnVarga, John
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00092924
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      Carns, Mary 312 503 1137
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      Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic Efficacy
      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 c…
      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.
      Perlman, Harris RPerlman, Harris R
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00104822
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      Carns, Mary 312 503 1137
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      SPARC: Gene expression profiling in scleroderma to discover therapeutic targets and predict clinical course
      The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match tar…
      The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match targeted treatments to the appropriate patients. The study will also focus on identifying inflammatory and fibrotic molecular pathways that are important in the disease Participants will be asked to give: - Two punch skin biopsies from the forearm (size of a pencil eraser) - Two tubes of blood - Urine collection Participants will be paid $110 for the one-time study visit. We are recruiting both patients with scleroderma and healthy control subjects.
      Participants must be: Over age 18, No chronic skin conditions, No rheumatic autoimmune diagnosis (e.g., lupus, rheumatoid arthritis, scleroderma), Not currently pregnant.
      Varga, JohnVarga, John
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00200631
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      Carns, Mary (312) 503 1137
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      Northwestern Scleroderma Twins Registry and Biorepository
      The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonuclei…
      The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonucleic acid, the genetic information that contains your genes) is nearly identical in twins, we are interested in studying what happens to change how the genes are read in the twin with SSc (epigenetics), when compared to how the same genes are read in the twin without SSc. Identifying these changes may help us to better understand why SSc occurs and to identify targets for treatment.
      • Age ≥ 18 years
      • At least one twin meets the 2013 American College of Rheumatology (ACR) criteria for the diagnosis of systemic sclerosis (affected twin)
      • Both twins agree to participate in the research study
      Varga, JohnVarga, John
      • Map it 633 N. St. Clair St.
        Chicago, IL
      STU00203621
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      Carns, Mary 312 503 1137
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      A multi-centre, randomized, double-blind (sponsor open), placebo-controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis
      GlaxoSmithKline (GSK…
      GlaxoSmithKline (GSK) is developing a new medicine (GSK2330811) for the treatment of systemic sclerosis. GSK2330811 is an antibody which blocks the activity of a substance in the body called Oncostatin M (OSM). Blocking OSM is expected to have a beneficial effect on some of the disease processes in systemic sclerosis (such as fibrosis and inflammation). GSK2330811 is not yet approved for doctors to treat patients with systemic sclerosis. The purpose of this study is to test GSK2330811 in patients with systemic sclerosis. This is the first time GSK2330811 has been tested in people with systemic sclerosis. Some people in this study will be randomly assigned to take GSK2330811 and others will be randomly assigned to take a placebo. The effects of the drug, both good and bad, will be compared to people who are not taking the drug. The drug will be administered as an injection under the skin, and additional research tests and procedures will be performed. The study involves 11 visits to the clinic over 8-9 months.
      • Diagnosis of diffuse systemic sclerosis for less than 5 years
      • Skin score of at least 10
      • Worsening skin disease
      • Stable dose of current medications
      Varga, JohnVarga, John
      • Map it 633 N. St. Clair St.
        Chicago, IL
      NCT03041025 STU00205162
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      Carns, Mary 312 503 1137
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      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
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      Carns, Mary 312 503 1137
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