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.
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A Registry of Interstitial Lung Disease PatientsThe 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. |
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
NCT02634268 STU00204332 |
Pathogenic Wnt-beta catenin target genes in macrophages and fibrosisThe 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:
STU00207083 |
Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertensionThe 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:
Participants will be paid a stipend after completion of each study visit.
NCT04271475 STU00212942 |
Molecular Biomarkers to Guide Therapy in the Systemic Sclerosis-Associated Interstitial Lung DiseaseThe 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:
Exclusion Criteria:
Healthy Controls Inclusion Criteria:
Exclusion Criteria:
STU00218939 |
Targeting Siglecs in DiseaseThe 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. |
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic ValveThis 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. |
Clinical Study of the Edwards Cardioband™ Tricuspid Valve Reconstruction SystemThis study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and … This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ).
The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation.
Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure. |
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablationTo improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF Primary Inclusion Criteria:
Primary Exclusion Criteria:
STU00207885 |
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitationThe 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:
NCT03706833 STU00208635 |
Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). … The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational. This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
NCT02661451 STU00208415 |
Right Ventricular Ischemia and Fibrosis in Chronic Thromboembolic Pulmonary Hypertension (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). |
Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (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.
NCT04198870 STU00211557 |
A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)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. |
Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with TocilizumabThis study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) … This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational. |
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel DeviceThis 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. |
iCLAS™ for Persistent Atrial FibrillationThis study is enrolling patients who have an irregular heartbeat(arrhythmia) and have been scheduled for an ablation (procedure that destroys small area of heart tissue that causes an arrhythmia) to treat the arrhythmia. This irregular heart rhythm is also known as atrial fibrillation, or AF. There are several forms … This study is enrolling patients who have an irregular heartbeat(arrhythmia) and have been scheduled for an ablation (procedure that destroys small area of heart tissue that causes an arrhythmia) to treat the arrhythmia. This irregular heart rhythm is also known as atrial fibrillation, or AF. There are several forms of AF. Persistent AF is when the irregular heart rate become continuous and lasts for at least 7-days but no more than 12 months. Once it has lasted continuously for more than one-year it is referred to as long-standing persistent AF. AF may be treated with medicines, electrical shock(cardioversion), or the ablation for which the patient has been scheduled. The purpose of this study is to demonstrate the safety and effectiveness of the Adagio Medical iCLAS System when used in the treatment of persistent atrial fibrillation. The device is a new type of ablation technology that uses very low freezing temperatures. |
(xIRB) DEFINE AFibThis study is recruiting patients who have a Medtronic Reveal LINQ or LINQ II (or other market-released model) Insertable Cardiac Monitor (ICM) device to monitor their Atrial Fibrillation (Afib). The study will be collecting data entered from the Medtronic Discovery App, data from the LINQ ICM device, and, … This study is recruiting patients who have a Medtronic Reveal LINQ or LINQ II (or other market-released model) Insertable Cardiac Monitor (ICM) device to monitor their Atrial Fibrillation (Afib). The study will be collecting data entered from the Medtronic Discovery App, data from the LINQ ICM device, and, if allowed, data from the Apple Health app on your iPhone. The purpose of this study is to both better understand how certain factors affect patterns of Afib; and how each patient's Afib impacts their daily life, quality of life, Afib symptoms, and healthcare usage. |
AN EXPLORATORY, OPEN-LABEL, PROOF-OF-CONCEPT, PHASE 2A STUDY OF MAVACAMTEN (MYK-461) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF) AND CHRONIC ELEVATION OF CARDIAC BIOMARKERSThis study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” … This study is recruiting patients who have been diagnosed with Heart Failure with Preserved Ejection Fraction. The study will test whether a drug called mavacamten can lower blood levels of cardiac troponin (a marker of heart muscle injury) and/or NT-proBNP (a marker of heart wall stress). These “biomarkers” are increased in the blood of some people with HFpEF. Additionally, the main research study will provide preliminary information regarding tolerability and safety of mavacamten treatment in HFpEF. Mavacamten is an investigational drug. This means that it has not been approved by the Food and Drug Administration (FDA) or any regulatory agency for routine clinical use, including the treatment of HFpEF. |
An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Participants with Primary Dilated Cardiomyopathy due to either MYH7 or TTN Variants or Other CausalitiesThis study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the … This study is recruiting patients aged 18-80 years and who have been diagnosed with dilated cardiomyopathy due to a mutation in either MYH7 or TTN, both of which are genes involved in the function of heart muscle. The purpose of Part A of this study is to evaluate the safety, tolerability, and cardiac pharmacodynamics (the effect of the drug on your heart) of the study drug, danicamtiv, when administered by mouth twice a day for approximately one to two weeks. Once you complete Part A of the study, you will have the option to continue onto Part B of the study and receive study drug for approximately another 96 weeks. Danicamtiv is being developed to improve the pumping function of the heart muscle for subjects with large hearts that do not pump blood as well as normal hearts, known as dilated cardiomyopathy, and heart failure with reduced ejection fraction (the heart cannot pump enough blood to meet the body's needs). |
A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients with Non-obstructive Hypertrophic CardiomyopathyThis study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test. The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect … This study is recruiting patients with a diagnosis of hypertrophic cardiomyopathy (HCM) who are able to perform a treadmill cardiopulmonary exercise test. The safety and tolerability of investigative study drug IMB-1018972 is being studied in patients with non-obstructive hypertrophic cardiomyopathy. This study will also exmaine the effect of IMB-1018972 on exercise capacity and how the heart uses energy. |
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV TrialThis 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. |
Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications. The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to … The purpose of this study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications. The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat patients who are experiencing symptoms of heart failure due to a dilated (enlarged) left ventricle (heart chamber which pumps blood). |
LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical StudyThis 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. |
RADIANCE Continued Access Protocol (RADIANCE CAP) A study of the ReCor Medical Paradise System in Clinical HypertensionRADIANCE 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.
NCT05017935 STU00216609 |
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.
NCT01207167 STU00019837 |
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). More Info |
Telmisartan Plus Exercise to Improve Functioning in PADThe 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.
NCT02593110 STU00200954 |
Improving Outpatient Safety of Older Adults through Electronic Patient PortalsThe 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).
STU00201242 |
The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot StudyThe 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.
NCT02676466 STU00201974 |
Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD StudyThe 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.
NCT02876887 STU00202741 |
Reducing Assessment Barriers for Patients with Low LiteracyThis study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information. You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation. NCT03584490 STU00204308 |
NU 05H6: Acute Leukemias and Map KinaseNormally, 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. |
NCI 02X3: SPORE in Pancreatic Cancer Tissue CoreThe 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. |
NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid MalignancyIn 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. |
NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid LeukemiaIn 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. |
NUDB 13C03: Northwestern Brain Tumor Institute Research DatabaseThe 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.
STU00087359 |
NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia SuppressorResearchers 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. |
NU 15N01: Head and Neck Tissue BankResearchers 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).
STU00202177 |
NU 15N02: Northwestern Head and Neck Cancer RegistryThe 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. |
NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell ClustersThis 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. |
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 MalignanciesThe 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. |
Melanoma and Skin Cancer Tissue RepositoryThe 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. |
(xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast CancerIn addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, … In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
NCT03488693 STU00208897 |
(xIRB NCI CIRB) NRG GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer.This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the … This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the usual approach? The purpose of this study is to compare any good and bad effects of using experimental study drugs cediranib alone, olaparib alone, or a combination of cediranib and olaparib. These drugs could shrink your cancer but they could also cause side effects. This study will allow the researchers to know whether one of these approaches is better, the same, or worse than the usual approach. The usual approach is defined as care most people get for endometrial cancer. You may be eligible for this research study if you have endometrial cancer which has grown or has returned after earlier treatment.
NCT03660826 STU00208995 |
(xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast CancerThe purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) … The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) for use in ovarian, fallopian tube, peritoneal cancer, andgBRCA mutated her2-negative metastatic breast cancer, however olaparib is notapproved for inflammatory breast cancer. inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancer
NCT03598257 STU00209490 |
BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinomaThis 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.
NCT03942653 STU00210435 |
(xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance ProgramsThe purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1Participants in this group willget less frequent monitoring. Participants … The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1 Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound. Group 2 Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst. Participants will be enrolled forup to five years.
Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study.
NCT04239573 STU00213102 |
(xIRB) NCI CIRB ECOG-ACRIN 2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)The purpose of this study is to determine whether Gemcitabine and Nab-paclitaxel or 5-Fluorouracil,Leucovorin, and Liposomal Irinotecan are more effective treatments for vulnerable patients over the age of 70 with newly diagnosed metastatic pancreatic cancer (mPCA). These drugs are already approved by the FDA for use in … The purpose of this study is to determine whether Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan are more effective treatments for vulnerable patients over the age of 70 with newly diagnosed metastatic pancreatic cancer (mPCA). These drugs are already approved by the FDA for use in pancreatic cancer. But, it is unknown which combination is the most effective for vulnerable mPCA patients over the age of 70. This study will help the study doctors find out which approach is better at prolonging the life of patients over 70 with mPCA. To determine this, the study doctors will be looking to see which of the two approaches shows better results. Participants who participate will be randomized to either get Gemcitabine and Nab-paclitaxel every other week or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan every other week. This study has 2 study groups. Group 1 (Arm A) Participants in this group will get the combination treatment of Gemcitabine and Nab-paclitaxel. Group 2 (Arm B) Participants in this group will get the combination treatment of 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan. Your doctor will continue to follow your condition for up to 2 years after you start the study, and watch you for side effects and monitor your cancer. Vulnerable patients over the age of 70 with newly diagnosed metastaticpancreatic cancer (mPCA).
NCT04233866 STU00213326 |
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.
STU00212975 |
(xIRB) DRUG 209626: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants with Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Renal Function (DREAMM 12)The purpose of this study is to find out the relationship between kidney function and safety and pharmacokinetics of the study drug. Pharmacokinetics means study of the movement of drug through the body, and this study will be looking to see if kidney disease affects that movement. Patients with well-… The purpose of this study is to find out the relationship between kidney function and safety and pharmacokinetics of the study drug. Pharmacokinetics means study of the movement of drug through the body, and this study will be looking to see if kidney disease affects that movement. Patients with well-functioning kidneys will be invited into the study as well as patients with kidneys that do not work well (or not at all). This is a study in people with relapsed (returning)and/or refractory (not responding to treatment) multiple myeloma (RRMM) with normal or reduced kidney function to test how the study drug belantamab mafodotin impacts kidney function. There are 2-parts to the study. Participants with RRMM from 4 groups based on how well your kidneys work will be enrolled. The study will include three phases. A Screening phase, a Study Treatment phase, and a Follow-up phase.
The screening assessment will be performed within 21 days before the first dose. After your screening period, if you are eligible, you will need to visit the study site repeatedly (at least every 3 weeks) to receive the study treatment and take part in additional exams, tests, or procedures. Study drug will be infused through a vein over approximately 30 minutes. Study visits will take as little as 3 hours or as much as 12 hours of your time.
Participants who are at least 18 years of age or older who have been diagnosed with relapsed or refractory multiple myeloma and who have impaired renal function will be enrolled into this study.
NCT04398745 STU00213490 |
(xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid LeukemiaThe purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study … The purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods. Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy. This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2 Group 1 Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy. Group 2 Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy. Participants between the ages of 18 and 75 who have newly diagnosed AML willbe enrolled into this study.
NCT04214249 STU00213544 |
(xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell TumorsThe 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.
NCT04435756 STU00213585 |
Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort StudyThe 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. |
NU 20H07: Social Correlates of Variation in Intestinal and Oral Microbiome Among Hematopoietic Stem Cell Transplant Patients: A Geographic Exploration in the City of ChicagoThis 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). STU00213358 |
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 TumorsThe 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:
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.
NCT04648254 STU00213510 |
(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/YearThe 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.
NCT04588246 STU00214371 |
(xIRB) NCI CIRB ECOG-ACRIN 2176: A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer PatientsThe purpose of this study is to compare the usual treatment (chemotherapy) alone to using nivolumab plus the usual treatment. This study will help the study doctors find out if this different treatment (chemotherapy plus nivolumab) is better, the same, or worse than the usual approach of chemotherapy alone. To … The purpose of this study is to compare the usual treatment (chemotherapy) alone to using nivolumab plus the usual treatment. This study will help the study doctors find out if this different treatment (chemotherapy plus nivolumab) is better, the same, or worse than the usual approach of chemotherapy alone. To decide if it is better, the study doctors will be looking to see if nivolumab when given with the usual treatment will slow the progression of cancer. The study drug nivolumab, is already approved by the FDA for use in different types of cancer, including lung, skin (melanoma), kidney, bladder, colorectal, and some types of liver cancers. Participants who decide to take part in this study will either get chemotherapy for up to 6 months or get chemotherapy plus a drug called nivolumab for 6 months. After the 6 months of chemotherapy, participants will continue to receive nivolumab until their cancer gets worse or up to 2 years. All of these treatments have been approved by the Food and Drug Administration (FDA), but the use of nivolumab with chemotherapy to treat this type of cancer is considered investigational. After treatment, participants will be followed for up to 2 years to check for side effects. Participants will visit the clinic once every 3 months for the first year, then every 6 months for the second year. Participants ages 18 years or olderwho have anal canal cancer that has spread to some other areas in the body willbe enrolled into this study.
NCT04444921 STU00214628 |
(xIRB) NCI CIRB ETCTN 10384: A Phase 1b/2 Study of Hu5F9-G4 (Magrolimab) in Combination with Mogamulizumab in Relapsed/Refractory Treated T-Cell LymphomaThe purpose of phase 1 of this study is to test the safety of a drug called Hu5F9-G4 (magrolimab) in combination with mogamulizumab. This combination of drugs has been tested in animals, but has not been tested in people and is not approved by the FDA for treatment of … The purpose of phase 1 of this study is to test the safety of a drug called Hu5F9-G4 (magrolimab) in combination with mogamulizumab. This combination of drugs has been tested in animals, but has not been tested in people and is not approved by the FDA for treatment of this type of cancer. This study tests different doses of Hu5F9-G4 (magrolimab) to see which dose is safer for people when given together with mogamulizumab.
Participants enrolled into phase 1will get the study drug Hu5F9-G4 (magrolimab) in combination with mogamulizumab for up to 1 year or until the side effects become too severe or their cancergets worse.
The purpose of phase 2of this study is to compare mogamulizumab alone to using Hu5F9-G4 (magrolimab) plus mogamulizumab. This study will help the study doctors find out if this different approach is better than the usual approach. The study drug, Hu5F9-G4 (magrolimab) is not approved by the FDA for treatment of this type of cancer. Mogamulizumab is approved by the FDA for treatment of this type of cancer.
Phase 2 has two study groups:
Group 1 – participants in this group will get the usual drug used to treat this type of cancer, mogamulizumab, plus a study drug called Hu5F9-G4 (magrolimab).
Group 2 – participants in this group will get the usual drug used to treat this type of cancer, mogamulizumab. In both phases, after the last treatment, participants will be followed for 2years until their cancer gets worse, or until the start of any significant treatment. This study has two phases. In phase1, participants ages 18 years or older who have T-cell (a type of immune cell) lymphoma that has returned after or does not respond to treatment will be enrolled. In phase 2, participants ages 18 years or older who have T-cell lymphoma affecting the skin that has returned after or does not respond to treatment will be enrolled. Participants will participate in either phase 1 or phase 2.
NCT04541017 STU00214653 |
(xIRB) NCI CIRB ECOG-ACRIN 8185: Phase 2 Study of Bladder-SparIng ChemoradiatioN with MEDI4736 (Durvalumab) in Clinical Stage 3, Node PosItive BladdeR CancEr (INSPIRE)The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine if this different approach is better than the usual approach. To decide if it is better, the study doctors will be … The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. This study will help determine 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 life of patients compared to the usual approach. This immunotherapy drug,MEDI4736 (durvalumab), is already approved by the FDA for use in metastatic bladder cancer.
Participants who decide to take part in this study will either get chemotherapy and radiation for 6-8weeks, or will get MEDI4736 (durvalumab) immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. Participants in the MEDI4736(durvalumab) Group 1 whose bladder cancer has responded (shrunk, gone away or remained stable) to treatment with chemotherapy, radiation and MEDI4736(durvalumab) will be offered more treatments with MEDI4736 (durvalumab) alone for up to 9 months.
Participants who are in the arm with chemotherapy and radiation, and whose cancer has responded, will be watched closely without any additional chemotherapy and radiation treatments. Participants whose cancer has not responded, may be offered surgery or some other treatment.
After study treatment is finished, participants will be followed by the study doctor for up to 3 years. Participants ages 18 years or older who have bladder cancer that has spread from the bladder to the lymph nodes will be enrolled into this study.
NCT04216290 STU00214716 |
(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 TherapyParticipants 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.
NCT04557956 STU00214795 |
(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 StudyThe 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.
NCT04269902 STU00214799 |
(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 TucatinibThe 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.
NCT04457596 STU00214807 |
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 FieldsStudyparticipants 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:
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.
NCT04469075 STU00213944 |
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.
NCT05545150 STU00214652 |
NU 22H01: Serial Monitoring of Circulating Plasma Cells and Plasma Cell Components in Adults with Plasma Cell DisordersThis 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. STU00216869 |
(xIRB NCI CIRB) NRG GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)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. NCT05174169 STU00217884 |
MACS/WIHS Combined Cohort StudyThis is a long term study to look at the comprehensive health and well-being of men who have sex with men (MSM) |
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized AdultsACTT-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
NCT04280705 STU00212207 |
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) |
Healthy Control Esophageal Registry and BiorepositoryThis 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) STU00096856 |
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)… An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145) |
Semen quality in males with inflammatory bowel disease: Influence of medication for IBDSemen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment. |
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s DiseaseCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease… Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease NCT02914561 STU00205056 |
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.
NCT01897688 STU00059469 |
Chronic Kidney Disease Research BiorepositoryThe 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 |
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 NCT02986984 STU00204808 |
Evaluation of Renal Microvascular Perfusion by Contrast Enhanced UltrasoundContrast 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:
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
STU00206894 |
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. NCT03493685 STU00206193 |
A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE – Protocol 402-C-1808FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Approximately 300 patients, at 75 study centers, will be enrolled in FALCON around the world.… FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Approximately 300 patients, at 75 study centers, will be enrolled in FALCON around the world. 18 to 70 years of age Diagnosed with ADPKD
NCT03918447 STU00209870 |
Pathogenesis of Heart Failure with Preserved Ejection Fraction in Chronic Kidney DiseaseHeart 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. STU00210997 |
Cure GlomerulonephropathyCure 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. |
Immune checkpoint inhibitor-associated acute kidney injurySince 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. STU00212602 |
Northwestern Scleroderma Program Patient RegistryThe 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.
STU00002669 |
Chicago Lupus DatabaseEstablishing 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. |
Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic EfficacyWe 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. |
LIFT: Lupus Intervention for Fatigue TrialThis 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.
NCT02653287 STU00201960 |
Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA ProtocolThe 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. |
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:
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) STU00207506 |
Large Vessel Vasculitis Tissue Registry and Repository (LVVRR)The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become … The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become inflamed, commonly causing headaches, joint pain, facial pain, fever, and difficulties with vision. We will study the gene expression (i.e., the genes that are being "read" to make proteins) in these immune cells, with a special focus on macrophages (one type of cell in the immune system). We will compare the gene expression in patients with vasculitis to the gene expression in people without vasculitis to determine what goes wrong in patients with this condition. If we can identify the molecular pathways that are affected in vasculitis, we can begin to develop treatments that will target these pathways. This may help us predict which patients will respond to treatment in the future. Patients who participate in this research will:
Participants will be given a stipend after the samples (blood and biopsy) have been collected. For Vasculitis Patients:
For Controls:
STU00210635 |
CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain TransitionFinding 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. STU00211593 |
Microglia-Specific Transcriptional Signatures in Patients with Neuropsychiatric Manifestations of Systemic Lupus ErythematosusThis 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:
Exclusion Criteria:
STU00211615 |
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 outcomesThis 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:
STU00213564 |
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:
A stipend will be offered to participants for each completed study visit.
NCT04078191 STU00213603 |
Investigating immunophenotypic and transcriptional heterogeneity as biomarkers of pain centralization in rheumatoid arthritis: IMPACT-Pain-RAFinding 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. |
Transcriptional Profiles of Circulating Monocytes and their Association with Pain Centralization and DMARD response in Rheumatoid ArthritisFinding 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
STU00216431 |
Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA StudyThis 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:
Exclusion Criteria:
NCT04539964 STU00213547 |