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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

A Registry of Interstitial Lung Disease Patients

The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine …
The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine who might be eligible for and interested in participating in future studies related to ILD.

Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis.

  • At least 18 years old
  • Diagnosis of interstitial lung disease (ILD)
  • Receives care at Northwestern's Pulmonary Clinic
Dematte DDematte D'Amico, Jane E
  • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
    Chicago, IL
STU00060593
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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 loss as a possible treatment in current research. We are trying to find …
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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Pathogenic Wnt-beta catenin target genes in macrophages and fibrosis

The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, …
The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.

Patients who participate in this study will:

  • donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
  • give a blood sample
  • give esophageal biopsies (taken during their scheduled endoscopy)
  • as an option, give skin biopsies

  • At least 18 years old
  • Meet criteria for systemic sclerosis
  • Receive care at Northwestern Medicine in Rheumatology, Pulmonary & Critical Care, and/or Gastroenterology scleroderma clinics
  • Plan to undergo a standard of care bronchoscopy or endoscopy at Northwestern or a research bronchoscopy through a separate Northwestern study
Perlman, Harris RPerlman, Harris R
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00207083
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MACITEPH

The purpose of this trial is to see if macitentan 75 mg versus placebo is useful and safe for treating patients with chronic thromboembolic pulmonary hypertension (CTEPH). Macitentan 10 mg once-daily is approved in many countries around the world for the treatment of pulmonary arterial hypertension (PAH). Macitentan at …
The purpose of this trial is to see if macitentan 75 mg versus placebo is useful and safe for treating patients with chronic thromboembolic pulmonary hypertension (CTEPH). Macitentan 10 mg once-daily is approved in many countries around the world for the treatment of pulmonary arterial hypertension (PAH). Macitentan at a dose of 75 mg is not approved for use by any Regulatory Authority in any country. This means that macitentan is an investigational drug, since it is not approved for use in patients with CTEPH, and can only be used in a research study such as this one.

Participants will be in this study for up to 3.5 years. Participants who choose to join the open label part of the study will be in the study between 2.5 and 6 years.

Participants will:

  • Randomly assigned to macitentan 75 mg or placebo
  • Return for study visits at least 10 times for the first 7 months and then every 12 weeks until the end of the double-blind period.
  • Receive a phone call at week 5 and week 9.
  • If continuing in the open-label study, return for 7 visits for the first 6 months and then every 6 months until the end of the open-label period.
  • Study visits may include health questionnaires, physical exam, blood draw, EKG, 6 minute walk test, urine pregnancy test.
  • Monitor body weight at least once per week at home until week 12.
  • Wear a device to monitor sleep and activity until week 28.
  • Complete questionnaires at home on a mobile device provide to you during the double-blind period.
  • Optionally undergo a right heart catheterization at week 28.

Participants will be paid a stipend after completion of each study visit.

  • Age 18 to 80 years old
  • Diagnosis of CTEPH with one of the following:
  • Inoperable due to the localization of the obstruction being surgically inaccessible
  • Persistent/recurrent CTEPH after BPA and deemed inoperable
  • Persistent/recurrent CTEPH after PEA (including PEA followed by BPA)
    • 6 minute walk test distance between 100 and 450 meters
    • Receiving riociguat for standard of care, unless it is contraindicated
    • If a female of childbearing potential, must use a highly effective method of contraception until at least 30 days after the last dose of study drug
    • Additional exclusion criteria apply
    Cuttica, Michael JCuttica, Michael J
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    NCT04271475 STU00212942
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    Molecular Biomarkers to Guide Therapy in the Systemic Sclerosis-Associated Interstitial Lung Disease

    The purpose of this study is to better understand the development and progression of scleroderma-related lung fibrosis (SSc-ILD). We would like to find indicators (biomarkers) that can help us predict which patients will develop SSc-ILD and who might benefit from receiving certain treatments. To do this, we …

    The purpose of this study is to better understand the development and progression of scleroderma-related lung fibrosis (SSc-ILD). We would like to find indicators (biomarkers) that can help us predict which patients will develop SSc-ILD and who might benefit from receiving certain treatments. To do this, we will collect and study your clinical and imaging data and samples (blood, lung fluid, and skin) if you agree to participate in this research.

    SSc Patients

    Inclusion Criteria:

    • Age 18 or older
    • Receiving clinical care at Northwestern Medicine
    • Meet 2013 ACR criteria for diagnosis of SSc

    Exclusion Criteria:

    • Unable to provide informed consent
    • Diagnosis of an overlap syndrome (i.e., SLE, RA, etc.) that is considered clinically significant by the investigators
    • Currently pregnant or nursing
    • Contraindication to the bronchoscopy per the pulmonologist

    Healthy Controls

    Inclusion Criteria:

    • Age 18 or older
    • Not diagnosed with a rheumatic autoimmune disease (i.e., lupus (SLE), rheumatoid arthritis (RA), etc.)

    Exclusion Criteria:

    • Unable to provide informed consent
    • Currently pregnant or nursing
    • Current smoker or former smoker (> 10 pack years)
    • Lung disease, uncontrolled congestive heart failure, cancer or history of cancer, HIV, or chronic liver disease
    • Contraindication to the bronchoscopy per the pulmonologist
    Misharin, AlexanderMisharin, Alexander
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00218939
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    Targeting Siglecs in Disease

    The study involves recruiting paid volunteers to donate blood. The goal of the studies is to isolate certain cells from the blood called eosinophils to examine certain proteins and their functions in the laboratory.
    Adults with or without allergies
    OO'Sullivan, Jeremy A.
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00085003
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    Partner 3 AVIV Registry

    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 …
    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.
    Malaisrie, S. ChrisMalaisrie, S. Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03003299 STU00204739
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    Quantitative Detection of Coronary Microvascular Dysfunction in Long COVID Patients Using a Comprehensive, Rapid, Free-Breathing Cardiovascular MRI

    This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effectsof COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand thedifferent ways that it may effect the body. There is some evidence that individuals with COVID-19 are …

    This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effects

    of COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand the

    different ways that it may effect the body. There is some evidence that individuals with COVID-

    19 are at higher risk for heart complications. The purpose of this study is to use recently

    developed MRI techniques to compare heart health of individuals with COVID-19 to people who

    were asymptomatic or are healthy. The new MRI techniques used in this experiment may also allow researchers and health care providers to take clearer pictures of the heart in other

    individuals.

    • No kidney disease (eGFR is greater than 45)
    • Does not have severe claustrophobia
    Kim, DanielKim, Daniel
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00205520
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    AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation

    To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
    Primary Inclusion Criteria:
    • Patients ≥ 18 years old
    • Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
    • Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

    Primary Exclusion Criteria:

    • Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
    • Previous catheter or surgical ablation for AF
    • Contraindication to MRI
    • Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
    • History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities
    Passman, Rod SPassman, Rod S
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207885
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    CLASP IID/IIF

    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 …
    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%
  • Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
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    RV Ischemia & Fibrosis in CTEPH

    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time …
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.

    For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

    Freed, Benjamin HowardFreed, Benjamin Howard
    • Map it 201 E. Huron St. Suite 12 160​
      Chicago, IL
    STU00210998
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    Davis, Lucia
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    REPAIR-MR

    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less …
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

    Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

    The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
    • Subject is at least 75 years of age

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198870 STU00211557
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    Cardio-TTRansform (ION-682884-CS2)

    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which …
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04136171 STU00211443
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    TRISCEND II

    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if …
    This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04482062 STU00213338
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    Precision MRI of Left Atrial Fibrosis for Patients with Atrial Fibrillation

    To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure…

    To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure

    Primary Inclusion Criteria:

    • Patients ≥ 18 years old
    • Patients with paroxysmal or persistent AF undergoing routine pulmonary vein isolation (PVI)
    • Patients undergoing a cardiac MRI prior to AF ablation

    Primary Exclusion Criteria:

    • Contraindication to MRI
    • Abnormal renal function (eGFR < 60 mL/min/1.73 m2)

    Kim, DanielKim, Daniel
    • Map it 710 N. Fairbanks Ct. Olson Pavilion
      Chicago, IL
    • Map it 710 N. Fairbanks Court
      Chicago, IL
    STU00213834
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    CY6022

    A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM)

    • Completion of a Cytokinetics study investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
    • LVEF ≥ 55%
    Choudhury, LubnaChoudhury, Lubna
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT04848506 STU00214844
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    HCM
    Yang, Jason
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    PROTECT IV Trial

    This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function.  The purpose of this study is to assess …
    This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function.  The purpose of this study is to assess if using an Impella device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function, and health after the heart procedure compared to the current standard of care.  
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04763200 STU00214880
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    LUX-Dx TRENDS

    This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM).  Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the …
    This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM).  Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the body needs.  Sensors have been added to the ICM to determine whether they can provide doctors who treat patients with similar conditions with additional information to help analyze their heart failure condition.  The study will gather information about the sensors.  
    Okwuosa, Ike StanleyOkwuosa, Ike Stanley
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04790344 STU00214908
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    RADIANCE Continued Access Protocol (RADIANCE CAP)

    RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.…

    RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

    Benzuly, Keith HBenzuly, Keith H
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05017935 STU00216609
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    REBIRTH

    The study will enroll women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery.

  • Presentation with a new diagnosis of peripartum cardiomyopathy
  • Post-delivery and within the first 5 months post-partum.
  • Clinical assessment of an LVEF < 0.35 within 2 weeks of consent
  • Freaney, Priya M.Freaney, Priya M.
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05180773 STU00217144
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    RESPONDER-HF

    Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

    • Chronic symptomatic heart failure (HF)
    • Ongoing stable GDMT HF management and management of comorbidities according to the 2022 ACC/AHA Guidelines for the Management of Heart Failure.
    Flaherty, James DFlaherty, James D
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05425459 STU00217812
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    REACT-AF

    Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation

    • Documented history of symptomatic or asymptomatic paroxysmal or persistent AF
    • CHA2DS2-VASC score of 1-4 without prior stroke or TIA
    • Participant is on a DOAC at time of screening
    Passman, Rod SPassman, Rod S
    • Map it 1000 N. Westmoreland Road Main Entrance
      Lake Forest, IL
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05836987 STU00219005
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    CY 6032

    A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO METOPROLOL IN ADULTS WITH SYMPTOMATIC OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY

    Diagnosed with oHCM per study criteria by cardiac magnetic resonance imaging (CMR) or echocardiography

    Choudhury, LubnaChoudhury, Lubna
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT05767346 STU00219019
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    HCM
    Yang, Jason
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    SEISMIC-HF I

    Non-invasive Seismocardiogram In Cardiovascular monitoring for Heart Failure I

    • History of heart failure or suspected heart failure
    • Scheduled to undergo a right heart catheterization (RHC) procedure
    • Willing to wear the CardioTag device during their RHC procedure
    Tibrewala, AnjanTibrewala, Anjan
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT00000000 STU00215330
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    CY 6033 ACACIA

    TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NONOBSTRUCTIVE

    HYPERTROPHIC CARDIOMYOPATHY

    Choudhury, LubnaChoudhury, Lubna
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT06081894 STU00219608
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    Yang, Jason
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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 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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    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 McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02538900 STU00105855
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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 performance more than telmisartan alone and more than supervised treadmill exercise alone. …
    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 McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
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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 and health care providers. …
    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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    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 medicine) have an effect on walking ability.…
    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 McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
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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 cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability …
    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 McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
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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 production of other normal cells and …

    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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    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) tissue. Tissues from patients (with cancer as well as from those …

    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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    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 them.The purpose of this study is to learn about how CML leukemia cells …

    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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    NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in 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 purpose of this study is to understand how these new drugs stop …

    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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    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 additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it …

    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, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
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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 problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to …

    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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    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 about how genes affect the …

    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).

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202177
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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 studies to learn more about the subtypes of head and neck cancers and determine …

    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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    NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell Clusters

    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 …

    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.

    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203283
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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 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 …

    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.

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
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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, and fecal samples (collectively called “tissue”) for research studies to …

    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, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
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    BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma

    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. …
    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
    You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
    Lorch, Jochen Hanns-MartinLorch, Jochen Hanns-Martin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03942653 STU00210435
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    DRUG KO-MEN-001: A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

    The main purpose of this study is to determine the tolerability and the potential safety of a new drug called KO-539 in treating your cancer. 
    You may be eligible to take part in this research study if you have a type of cancer called acute myeloid leukemia (AML) that has not responded to standard therapy.
    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04067336 STU00211062
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    Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only …

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

    Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212975
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    (xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors

    The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may …

    The purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse

    in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body.

    A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future.

    If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371

    analysis for up to 3 years from enrollment into the study.

    Participants 18 years of age or older who have germ cell cancer will be enrolled.

    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04435756 STU00213585
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    Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort Study

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to …

    The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

    Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy.

    Strauss, Jonathan BStrauss, Jonathan B
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212971
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    (xIRB) NCI CIRB ECOG-ACRIN 8191: Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence

    The purpose of this study is to compare the usual treatment alone to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment. We want to see if we can provide a more targeted treatment to this type of cancer by treating …

    The purpose of this study is to compare the usual treatment alone

    to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

    We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

    specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

    whether adding apalutamide and directed radiation works better than the usual approach to help treat

    prostate cancer that has returned after surgery.

    This study will help the study doctors find out if this different approach is better than the usual

    approach. To decide if it is better, the study doctors will be looking to see if the study approach

    increases the time before cancer growth or if the cancer causes major additional symptoms.

    This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

    depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

    continue to follow your condition for up to 10 years and watch you for side effects and monitor the

    progression of your cancer.

    Group 1 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

    cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

    Group 2 (Negative for Extra Pelvic-Metastases)

    If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

    to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

    for 6 months.

    Group 3 (Positive for Extra Pelvic-Metastases)

    If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

    You will get planned SOC RT + STAD + apalutamide for 6 months.

    Group 4 (Positive for Extra Pelvic-Metastases)

    If you are in this group, your cancer has spread to areas outside of your pelvis.

    You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

    where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

    which will take place about one year after starting treatment or if clinically necessary at an

    earlier time point.

    Male participants 18 years of age or older who have prostate cancer that has come back after surgery

    will be enrolled into this study.

    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04423211 STU00214021
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    Social Correlates Of Variation In Intestinal And Oral Microbiome Among Hematopoietic Stem Cell Transplant Patients: A Geographic Exploration In The City Of Chicago

    This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a …

    This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

    You may be eligible for this study if you have been diagnosed with a hematologic malignancy (also known as a blood cancer) and are being considered for an allogeneic hematopoietic stem cell transplantation (sometimes also referred to as a bone marrow transplant).

    Moreira, JonathanMoreira, Jonathan
    STU00213358
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    DRUG Q702-ONC-P1-US001 A Phase 1 Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic, Pharmacokinetic Study of Q702 with a Cohort Expansion at the RP2D in Patients with Advanced Solid Tumors

    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is …
    The major purpose of this study is to determine the highest dose of Q702 that does not result in severe side effects, the dose that is tolerated, and once this dose is found, if it has any effect against the cancer in patients with solid cancer tumors. This study is being done:

    • To test the safety of Q702 and see what effects (good and bad) it has on you and your cancer.
    • To find the highest dose of Q702 that can be given without causing serious side effects when treatment is given every day for 7 days, followed by 7 days of no treatment, repeated two times during a 28-day cycle.
    • To find the dose of Q702 that should be used in future studies.
    • To evaluate what the human body does and how the body reacts to Q702.

    This research is being performed because improvements are needed in the treatment of patients with cancer.

    We are asking you to take part in this research study because you have cancer that has continued to grow despite the treatments you have already received. Either the standard drugs and therapies used to treat your disease are no longer working or there are no known treatments which work because your tumor cells may be resistant to available treatments or you are not a candidate for or intolerant of available treatment. Your cancer had been confirmed by a pathologist (a person who studies the causes and effects of diseases).

    This clinical trial tests a study drug, Q702. The study drug, Q702, targets certain molecules present in cancer cells that may help activate your body's immune system to fight the cancer. The study drug, Q702, is not approved for sale by the FDA.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04648254 STU00213510
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    (xIRB) NCI CIRB NRG BN009: Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer that has spread to the brain and come back in other areas of the brain after earlier treatment …

    The purpose of this study is to compare the usual treatment of SRS alone to SRS plus HA-WBRT

    (whole brain radiation therapy with hippocampus avoidance) and memantine for patients with cancer

    that has spread to the brain and come back in other areas of the brain after earlier treatment with SRS.

    The addition of HA-WBRT and memantine to the usual treatment could better control your brain cancer.

    This study will help the study doctors find out if this different approach is better, the same,

    or worse than the usual approach.

    Memantine is FDA approved for treating dementia and is commonly used off-label

    (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain

    radiation therapy for cancer that has spread to the brain.

    This study has 2 study groups. You will be told which group you are in.

    Group 1

    If you are in this group, you will get the usual treatment, SRS. In addition to the usual

    SRS treatment, you will also receive HA-WBRT. You will also be given the drug memantine,

    which has also been shown to preserve memory function. Memantine will be taken for up to 6 months.

    Group 2

    If you are in this group, you will get the usual treatment of SRS.

    After you finish your treatment, your doctor and study team will watch you for side effects and

    follow your condition. They will check you every 2 to 3 months for at least 1 year after you finish

    SRS. If you are receiving memantine, your doctor will continue to see you in the clinic as needed.

    Participants age 18 years or older who have receivedstereotactic radiosurgery to treat cancer that spread to the brain, and now thecancer has returned in other areas of the brain will be enrolled into thisstudy.

    Lukas, Rimas VincasLukas, Rimas Vincas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04588246 STU00214371
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    (xIRB) NCI CIRB ETCTN 10285: Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination with Dual BRAF/MEK Inhibition in Patients with BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

    Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled. This study has two phases. Phase 1 and Phase 2. The purpose of Phase 1 …

    Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

    This study has two phases. Phase 1 and Phase 2.

    The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

    All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

    The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

    Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

    Patient must be ≥18 years.

    Patient must have a diagnosis of BRAFV600E/K-mutated metastatic melanoma.

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04557956 STU00214795
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    (xIRB) NCI CIRB SWOG 1925: Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

    The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or …

    The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

    The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

    Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

    After treatment is finished, participants will be followed for up to 10 years after enrollment.

    Participants ages 18 years or older who have chronic lymphocytic leukemia or small lymphocytic lymphoma and who do not have symptoms and do not need to start treatment now will be enrolled into this study.

    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04269902 STU00214799
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    (xIRB) NCI CIRB Alliance A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients …

    The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

    Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

    After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

    Participants age 18 years or older who have HER2-positive breast cancer, and who have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed by a surgeon, will be enrolled into this study.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04457596 STU00214807
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    NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion …

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

    Key eligibility criteria include:

    • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
    • Able to self-administer topical interventions or has available another person who can apply the topical agents
    • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
    • Age of at least 18 years old

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    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.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04469075 STU00213944
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    NU 21B01: Volumetric Lumpectomy Specimen Image Visualization for Intraoperatively Directing Cavity Shaves, a Phase II Study (VIVID)

    The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.If you are undergoing …

    The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.

    If you are undergoing breast conservation surgery and meet all criteria, the 3D imaging device, VSI, will be used to guide and assist the surgeon in identifying and removing all positive margins while in the operating room. The lumpectomy procedure will be performed per standard practice.

    If eligible, the lumpectomy procedure will be performed per standard practice. Promptly after excision, the tumor specimen will be imaged using the VSI device to take additional 3D images of the removed tissue during the standard of care surgery.

    During surgery, after the tumor has been removed, the investigators will use the VSI device to identify the margins on the main sample. The surgeon will use this information to remove additional tissue from the cavity. The surgeon will then complete the standard of care surgery according to standard of care practices which may include additional shaves of the remaining issue. The amount of tissue removed as a result of VSI-directed shaving will not be more than the amount that your surgeon would normally remove as part of standard of care.

    Participants will be asked to come for a post-operative visit as per standard of care and will be followed-up up to 2 months after surgery.

    Note: This is only a partial description of the study procedures. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Age 18 or older

    · Must have histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component

    · Planning to undergo breast conservation surgery with planned localization and intraoperative imaging for the management of invasive breast cancer

    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.

    Kulkarni, SwatiKulkarni, Swati
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05545150 STU00214652
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    NU 22H01: Serial Monitoring of Circulating Plasma Cells and Plasma Cell Components in Adults with Plasma Cell Disorders

    This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand …

    This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

    This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

    You may be eligible for this research study if you have a plasma cell disorder.

    Singhal, SeemaSinghal, Seema
    STU00216869
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    (xIRB NCI CIRB) NRG GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

    This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center …

    This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Participants must have a diagnosis of histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma

    · Participants must be 18 or older

    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.

    Mulcahy, Mary FrancesMulcahy, Mary Frances
    NCT05174169 STU00217884
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    (xIRB NCI IRB) ETCTN 10522: A Phase I Clinical Trial of CA-4948 in Combination with Gemcitabine and Nab-Paclitaxel in Metastatic or Unresectable Pancreatic Ductal Carcinoma

    This phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be …

    This phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable).

    • Participants must have a diagnosis of pancreatic ductal adenocarcinoma.
    • Participants must be 18 or older
    Mulcahy, Mary FrancesMulcahy, Mary Frances
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05685602 STU00219528
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    A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation.  …
    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation. 

    Hospitalized adults (>18 years) with symptoms suggestive of COVID-19

    Illness of any duration and laboratory-confirmed SARS-CoV-2 infection within 14 days

    Requires low or high flow oxygen devices or non-invasive mechanical ventilation

    Has not received 5 or more doses of remdesivir as treatment for COVID-19

    Has not receive 6mg or more of dexamethasone in one day, on more than one day in the past 7 days

    Taiwo, Babafemi OTaiwo, Babafemi O
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04280705 STU00212207
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    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 Moderately to Severely Active Ulcerative Colitis (LEGACY)…
    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, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01848561 STU00094204
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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 biopsies (small pieces of tissue) to be used for several studies.…
    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, Dustin AllanCarlson, Dustin Allan
    STU00096856
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    Semen quality in males with inflammatory bowel disease: Influence of medication for IBD

    Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201469
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    Northwestern TIPS Research Study

    ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their …
    ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

    Undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement

    Subjects over the age of 18 able to provide consent or have a legally authorized representative to provide consent in the event the subject is unable to consent due to a transient clinical condition

    Boike, Justin RichardBoike, Justin Richard
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03973372 STU00208288
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    Treatment for Pruitis in Primary Biliary Cholangitis (PBC).

    Volixibat is an experimental treatment, meaning that it has not been approved by the US Food and Drug Administration (FDA) or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels (the amount of certain chemicals that are produced by the liver and are present in …

    Volixibat is an experimental treatment, meaning that it has not been approved by the US Food and Drug Administration (FDA) or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels (the amount of certain chemicals that are produced by the liver and are present in the blood) that are believed to lead to the itching in patients with PBC. There are no other medicines approved to treat itching in patients with PBC.

    • Male or female, age ≥18 years
    • Primary Biliary Cholangitis
    • Pruitis
    • History of Elevated Alkaline Phosphatase
    Boike, Justin RichardBoike, Justin Richard
    • Map it 675 N. Saint Clair St.
      Chicago, IL
    NCT05050136 STU00218351
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    Investigational drug for NASH cirrhosis

    Treatment for subjects with NASH and cirrhosis

    adults 18-75 year old with NASH and cirrhosis

    Cheung, Amanda Ching-WunCheung, Amanda Ching-Wun
    • Map it 675 N. Saint Clair St.
      Chicago, IL
    NCT05500222 STU00219506
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    Measuring copper parameters in Wilson's Disease using a novel assay

    The purpose of this study is to find out if a new test for patients with Wilson’s disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Ceruloplasmin is a protein that helps transport copper from the liver and deliver copper to …

    The purpose of this study is to find out if a new test for patients with Wilson’s disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Ceruloplasmin is a protein that helps transport copper from the liver and deliver copper to the rest of your body to maintain your health. In Wilson’s disease, ceruloplasmin levels are low and free copper levels are higher than normal, which can be controlled by taking your Wilson’s disease medications regularly. There is currently no approved test to measure NCC. Your doctor may use a combination of tests including a blood test to measure ceruloplasmin in order to calculate the NCC, but this is not accurate or reliable. Having a more reliable and accurate measurement of NCC may help your doctor, in the future, make better informed decisions about your treatment, including the dose of your medicine.

    Inclusion:

    1. Willing and able to give informed consent for participation in the study

    2. Male or female patients, aged 18 years or older as of signing the Informed Consent Form (ICF)

    3. Able and willing to comply with study procedures and requirements, as judged by the treating physician

    4. Established diagnosis of Wilson’s Disease (Leipzig score >4)

    5. Either newly diagnosed or with elevated liver enzymes (defined as ALT, AST ≥1.5xULN) or 24-hour urinary copper excretion outside of recommended ranges [chelation range 200-500mcg/24 hr; zinc < 100mcg/24 hr]

    6. Adequate venous access to allow collection of blood samples

    Cheung, Amanda Ching-WunCheung, Amanda Ching-Wun
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT05783687 STU00219339
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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 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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    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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    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 blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that …
    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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    Evaluation of Renal Microvascular Perfusion by Contrast Enhanced Ultrasound

    Contrast Enhanced Ultrasound Study:The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants …

    Contrast Enhanced Ultrasound Study:

    • The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)
    • Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants only complete the first 2 study visits)
    • Study procedures consist of measuring height, weight, and vital signs, answering questions about demographics and medical history, a blood draw and urine collection at every visit, and undergoing the contrast-enhanced ultrasound (only at visit 2)
    INCLUSION CRITERIA:
    • ≥ 18 years of age
    • Patient is able to provide written informed consent
    • Meet criteria for one of following patient populations:
    • CKD
    • eGFR ≥30 and <90 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation17 (with or without history of hypertension)
    AND
    • Urine albumin to creatinine ratio (UACR) ≥ 30mg/g creatinine
    OR
    • eGFR <30 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation (with or without history of hypertension AND with no UACR requirement)
    • ESRD
    • Currently receiving dialysis (hemodialysis or peritoneal dialysis)
    • No eGFR or UACR requirement
    • Healthy volunteer
    • No prior history of kidney disease (as defined by eGFR >60 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation and UACR <30 mg/g creatinine, based on Screening Visit lab results or average between local lab results (collected within 3 months from the date of the Screening Visit) and lab results from Screening Visit.
    • No self-reported history of hypertension, diabetes mellitus, liver disease, or cardiovascular disease

    • CKD-Biopsy
    • eGFR <90 ml/min/1.73m2 by CKD EPI equation
    OR
    • Urine albumin to creatinine ratio (UACR) ≥30 mg/g creatinine
    AND
    • Undergoing a clinically indicated renal biopsy
    • Transplant Kidney Biopsy
    • Kidney transplant recipient undergoing a protocol surveillance transplant kidney biopsy

    EXCLUSION CRITERIA:

    • Known hypersensitivity to sulfur hexafluoride lipid or to any component of Lumason®
    • Known severe pulmonary hypertension (pulmonary artery pressure > 75mmHg)
    • Active cardiac disease including any of the following:
    • Unstable angina
    • Myocardial infarction within 48 hours prior to date of proposed Lumason® administration
    • Severe arrhythmia (ventricular tachycardia, uncontrolled atrial fibrillation with rapid ventricular response, torsades de pointes)
    • Escalating vasopressor requirements in prior 24 hours
    • Recent neurological compromise (i.e. cerebrovascular accident including transient ischemic attacks within 3 months of Lumason® administration)
    • Emergency cardiac surgery
    • BMI ≥ 35 kg/m2
    • Clinical signs of acute rejection as the indication for transplant kidney biopsy
    • Inability for patient or patient’s surrogate to provide informed consent
    • Pregnancy
    • Incarcerated individuals

    Mehta, Rupal CMehta, Rupal C
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206894
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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

    (ACTIVE, NOT RECRUITING) 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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    Pathogenesis of Heart Failure with Preserved Ejection Fraction in Chronic Kidney Disease

    Heart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes.Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early …

    Heart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes.

    Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early changes in cardiac function and poor knowledge of CKD-specific mechanisms for both HF and heart failure with preserved ejection fraction (HFpEF).

    Inclusion Criteria:

    Inclusion criteria for all: >18 years of age

    Inclusion criteria for CKD: eGFR 20-60 ml/min/1.73m2 on stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker, unless contraindicated.

    Inclusion criteria for the non-CKD group: eGFR >60 ml/min/1.73m2 and UACR <30 mg/g.

    Exclusion Criteria:

    Exclusion criteria for all: presence or history of diabetes, coronary revascularization within the last 6 months, hemodynamically significant valvular disease, significant lung disease requiring home oxygen, angina, non-revascularized myocardial ischemia, systolic BP <100 or >180 mmHg, pregnancy, clinical HF symptoms, history of systemic disease processes that can cause HFpEF, such as amyloidosis or sarcoidosis, any musculoskeletal or chronic condition that will interfere with completion of cardiac testing, or active cancer, immunosuppressive therapy. Participants will also be excluded from continuing in the study if the pre-exercise echocardiogram demonstrates a reduced ejection fraction ≤50% or hemodynamically significant valvular disease at the baseline study visit.

    Exclusion criteria for the non-CKD group: eGFR <60 ml/min/1.73m2 and UACR >30 mg/

    Exclusion criteria for CKD: currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy, SGLT2i hypersensitivity, liver disease, ALT/AST> 3x normal, history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months.

    Mehta, Rupal CMehta, Rupal C
    STU00210997
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    Cure Glomerulonephropathy

    Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.…

    Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.

    Biopsy-proven Membranous, Minimal Change, FSGS, or IgAN within 5 years of study enrollment

    Wadhwani, ShikhaWadhwani, Shikha
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212470
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    Immune checkpoint inhibitor-associated acute kidney injury

    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, …
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
    Aggarwal, VikramAggarwal, Vikram
    STU00212602
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    Northwestern Scleroderma Program 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 course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn …
    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.
    Richardson, CarrieRichardson, Carrie
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00002669
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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 of research studies designed to help us …
    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
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00009193
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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 contributes to the disease progression of RA and why some people respond to RA therapy, …
    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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    LIFT: Lupus Intervention for Fatigue Trial

    This study is designed to evaluate the effectiveness of one-on-one counseling sessions on reducing symptoms of fatigue in persons with lupus by providing them with individualized coaching on increasing physical activity and improving diet.
    Have lupus and experience fatigue as a result.

    At least 18 years old.

    Can participate in physical activity.

    Live in the Chicago area.

    Be able to speak and read English.

    Be able to consent to being in the study.

    Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT02653287 STU00201960
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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 genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms …
    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 one tube 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)
    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00206908
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    The Collaborative, National Quality and Efficacy Registry (CONQUER)

    The CONQUER Registry will enable researchers to:Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waitingEvaluate the response in the real world (…

    The CONQUER Registry will enable researchers to:

  • Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).
    • Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waiting
  • Evaluate the response in the real world (as opposed to the controlled and constrained setting of a clinical trial) to therapeutic agents and to combinations of therapeutic agents.
    • Drive more personalized and effective therapy for patients
    • Develop insights into drug toxicities that are unique to scleroderma patients (e.g. underlying heart disease due to pulmonary vascular disease)
    • Understanding patient satisfaction/issues with the current Standard of Care
  • Collect biosamples for future analyses (e.g. genetic factors contributing to disease)
  • Establish and support a collaborative network for U.S. scleroderma investigators
  • Support the critical infrastructure for future scleroderma studies, including trials for novel therapeutics
  • Patients must:

    1. Be 18 years of age and older

    2. Have a confirmed diagnosis of systemic sclerosis (meeting the 2013 SSc ACR/EULAR criteria)

    3. Have had symptoms of SSc for less than 5 years (other than Raynauds - it is okay if this has been going on for greater than 5 years)

    Richardson, CarrieRichardson, Carrie
    • Map it 633 N. St. Clair St.
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00207506
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    CPIRA-2

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will …

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors that lead to the development of pain centralization, so that in future studies we can learn more about how to prevent the development of this kind of chronic pain in RA.

    Participants will complete a total of 3 study visits (baseline, 3 months and 12 months). At each study visit, participants will have a physical exam, have blood drawn, answer questionnaires, and undergo quantitative sensory testing to assess responses to pressure and coldness. A subset of patients who are interested and eligible will undergo a brain MRI at baseline and the 12-month study visit. Participants will receive $50 for the completion of each study visit and an additional $100 for completing each MRI.

    Study participants must be 18 years or older with active Rheumatoid Arthritis and symptoms starting no more than one year prior to study participation.  Participants taking pain medications must be on a stable dose for at least 3 months.  Patients with Raynauds requiring treatment are not eligible to participate.  Participants must refrain from taking prednisone (greater than 10 mg) or opioids within 24 hours of their study visit.  
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 710 N. Fairbanks Ct. Olson Pavilion
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211593
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    NP-SLE

    This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what …

    This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what goes wrong in systemic lupus. Then, we hope to develop treatments that will target these factors.

    Inclusion Criteria:

    • Meet 4 of 11 American College of Rheumatology (ACR) criteria for systemic lupus (SLE) or meet 3 of 11 ACR criteria for SLE and meet SLICC criteria
    • 18 years or older
    • Positive ANA or positive dsDNA

    Exclusion Criteria:

    • Currently pregnant or nursing
    • Active or chronic infections (such as hepatitis, pneumonia, pyelonephritis, HIV, sepsis)
    • Diagnosed with another chronic autoimmune disease or chronic neurodegenerative condition
    • CKD > 2 and/or GFR < 60
    • AST and/or ALT ≥ 3 times the upper limit of normal
    • Current electrolyte disturbance (hyponatremia or hypernatremia)
    • Current signs or symptoms of acute systemic vascultis
    Cuda, Carla MarieCuda, Carla Marie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00211615
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    xIRB Consortium of Early Arthritis Cohorts USA (CATCH-US) -- A prospective cohort study of adults with new onset inflammatory arthritis symptoms to understand predictors of optimal outcomes

    This is an observational research study to provide data to better understand what characteristics and treatment approaches predict an optimal outcome (i.e., remission and no joint damage) in real world patients with new onset RA. We want to learn more about the factors that predict how patients’ disease might …

    This is an observational research study to provide data to better understand what characteristics and treatment approaches predict an optimal outcome (i.e., remission and no joint damage) in real world patients with new onset RA. We want to learn more about the factors that predict how patients’ disease might progress over time and what their response to treatment might be.

    Participation involves approximately 10 study visits: every 3 months for the first year, every 6 months until the end of year 2, and at year 3, year 4 and year 5. These visits will be at the time of routinely scheduled visits with the participant's Northwestern rheumatologist. Research procedures include collection of questionnaires and clinical information collected from the patient's rheumatologist at each visit.

    If participating in the optional biological specimen and genetic testing study component, participants may be asked to give research blood (during standard of care blood draws) and leftover joint fluid collected at the time of standard of care joint aspirations.

    • Age > 18 years at time of referral, AND

    • Joint symptoms for ≤12 months, AND

    • At least one of the following (summarized in checklist below):

    o two (2) or more swollen joints OR

    o one (1) swollen metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint and any one (or more) of the following:

    • (+) Rheumatoid Factor (RF)
    • (+) anti-CCP antibody (anti cyclic Citrullinated peptide antibody)
    • Morning (am) stiffness ≥ 45 minutes,
    • Response to NSAID
    • (+) metatarsophalangeal joint (MTP) squeeze test

    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00213564
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    NAV3-32: A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)

    This trial is being done to determine the ability of technetium Tc 99m tilmanocept (study drug) to find inflammatory cells in the joints of patients with rheumatoid arthritis (RA) via imaging. The imaging results will also be compared to the different types of cells present in the joints affected by …
    This trial is being done to determine the ability of technetium Tc 99m tilmanocept (study drug) to find inflammatory cells in the joints of patients with rheumatoid arthritis (RA) via imaging. The imaging results will also be compared to the different types of cells present in the joints affected by RA. The goal is to determine if imaging can be used to better characterize inflammation for rheumatoid arthritis patients, which may be helpful in diagnosing and treating patients.

    Patients who participate will attend 3 clinic visits and 2 phone calls over 45 days and will complete the following:

    • Receive an investigational drug one time through an IV in the arm
    • Have pictures taken of their hands and wrists to look at the inflammatory cells in the joints
    • Have a physical exam
    • Undergo an ultrasound of their hands and wrists
    • Have a synovial (joint) tissue biopsy of the hand or wrist
    • Give blood and urine samples
    • Answer questions about their RA and health

    A stipend will be offered to participants for each completed study visit.

    • Meet criteria for rheumatoid arthritis (RA) and have active disease.
    • At least 18 years of age or older at the time of RA diagnosis.
    • Hand or wrist joint with swelling.
    • Use adequate birth control measures for the duration of the study.
    • If receiving traditional DMARDs, must be on therapy for at least 90 days and at a stable dose for at least 30 days.
    • If receiving biologic DMARDs, must be on a stable dose for at least 60 days.
    • If receiving NSAIDS or steroids, must be on a stable dose for at least 28 days and not be receiving more than 10 mg prednisone per day.
    • Additional exclusion criteria apply.
    Ruderman, Eric MRuderman, Eric M
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04078191 STU00213603
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    IMPACT-Pain-RA

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. People living with RA commonly report persisting pain which on average is 30% more intense than the general population. Previous research has found that this ongoing pain may in part be …

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. People living with RA commonly report persisting pain which on average is 30% more intense than the general population. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will examine the relationship between immune cells (cells that are part of the immune system, that help the body fight infections and other diseases) and pain centralization. This study will also search for biomarkers (substances that can be measured in the blood) that may be associated with pain centralization, so that we can determine who may be at at risk for developing this kind of chronic pain and how to treat and/or prevent it in the future.

    Participants will be in this research study for one study visit, lasting about 2 hours. Participants will undergo a physical examination to assess joint inflammation, complete questionnaires, undergo quantitative sensory testing (QST) assessments, and provide blood samples.

    Key Criteria:

    • Meet the ACR/EULAR 1987 or 2010 criteria for RA
    • On a DMARD for RA
    • Swollen joint count ≤ 1
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00215712
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    PROMOTER

    Finding a way to reduce pain is consistently named one of the top priorities for patients with RA. People living with RA commonly report persisting pain which, on average, is 30% more intense than the general population. Previous research has found that this ongoing pain may, in part, be caused …

    Finding a way to reduce pain is consistently named one of the top priorities for patients with RA. People living with RA commonly report persisting pain which, on average, is 30% more intense than the general population. Previous research has found that this ongoing pain may, in part, be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors associated with pain centralization, so that, in future studies, we can learn more about how to prevent the development of chronic pain in RA. This study will also identify biomarkers that could provide insight into targeted therapies for future clinical trials.

    This study includes two in-person study visit to complete quantitative sensory testing (QST), blood draws, joint counts, blood pressure assessment, and patient-reported outcome (PRO) questionnaires. If participants are unsure of their height and/or weight off-at the time of the visits, they may also have height and/or weight assessed. The first visit will occur at baseline within 3 weeks of the patient starting their DMARD. The second visit will occur 12 weeks (+/- 3 weeks) after starting their new DMARD.

    Key Eligibility Criteria

    • Have had at least one joint with definite swelling
    • Meet the ACR/EULAR 1987 or 2010 criteria for RA
    • Starting a DMARD for treatment of active RA
    Lee, Yvonne ClaireLee, Yvonne Claire
    STU00216431
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    RESET-RA

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).…

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).

    Inclusion Criteria:

    • 22-75 years of age at screening
    • Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
    • Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
    • Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

    Exclusion Criteria:

    • Untreated or poorly controlled psychiatric illness or history of substance abuse
    • Significant immunodeficiency due to underlying illness
    • History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
    • Clinically significant cardiovascular disease
    • Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
    • Uncontrolled fibromyalgia
    • History of left or right carotid surgery
    • History of unilateral or bilateral vagotomy, partial or complete splenectomy
    • Recurrent vasovagal syncope episodes
    • Current, regular use of tobacco products
    Ruderman, Eric MRuderman, Eric M
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    NCT04539964 STU00213547
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