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Northwestern Scleroderma Program Patient Registry
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
Hinchliff, Monique EHinchliff, Monique E
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00002669
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Carns, Mary 312 503 1137
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ECOG 1105: A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-expressing Metastatic Breast Cancer
This randomized phase III trial is studying first-line chemotherapy and trastuz…
This randomized phase III trial is studying first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.
Gradishar, William JGradishar, William J
NCT00520975 STU00003529
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1 312 695 1102
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NU 05H6: Acute Leukemias and Map Kinase

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

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

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

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

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

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

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

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

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
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Study Coordinator 312 695 1102
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Randomized Conversion of Calcineurin-Inhibitors (Tacrolimus to Sirolimus) at 6-24 Months Post Transplant in a Prednisone-Free Immunosuppression Regimen: Impact on Incidence of Acute Cellular Rejection, Renal Allograft Function and Lymphocytes Function
This study is being done to investi…
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.
Gallon, LorenzoGallon, Lorenzo
NCT00866879 STU00008308
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1-855-NU-STUDY
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HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor …
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic unresponsiveness, and to investigate the safety and efficacy of the treatment regimen including withdrawal of immunosuppression after one year post-transplant for those recipients having received DHSC infusions.
Leventhal, Joseph RLeventhal, Joseph R
NCT00619528 STU00008874
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1-855-NU-STUDY
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Chicago Lupus Database
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number …
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
STU00009193
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312 503 1919
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DERMATOLOGY TISSUE ACQUISITION AND REPOSITORY
Northwestern University’s Department of Dermatology is collecting skin, hair, nail, blood, saliva, skin and/or buccal swabs, and mucous membrane(part of your skin which lines body passages and cavities such as the inside of your mouth or nose), and ot…
Northwestern University’s Department of Dermatology is collecting skin, hair, nail, blood, saliva, skin and/or buccal swabs, and mucous membrane(part of your skin which lines body passages and cavities such as the inside of your mouth or nose), and other tissue samples for use in a biorepository. By operating this biorepository, the Department of Dermatology hopes to develop a better understanding of skin diseases (meaning the knowledge about how cells in the skin behave and react to medical treatments) among researchers at Northwestern University and other approved researchers. This basic knowledge is expected to help the development of more effective patient care and new treatment methods.
-Having specimens collected as part of a standard of care procedure;
-Have a skin disease which researchers want samples of in order to further understand
it; or
-Qualify as a healthy volunteer whose samples researchers can use as control samples
for research.
Rangel, Stephanie MarieRangel, Stephanie Marie
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00009443
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Belback, Madeleine 312 503 5901
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NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be…
Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. 

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

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

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

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

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

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

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

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

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

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

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

Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00013577
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Study Coordinator 1 312 695 1102
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National Parkinson Foundation Patient Registry
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate tre…
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate treatment and ultimately improve patient care.
• Patients diagnosed with idiopathic Parkinson’s Disease
• Must have established care with a movement disorder specialist at Northwestern
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
STU00014255
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Friedeck, Heidi 312 503 1522
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Screening For a Registry (Database) and Future Participation In Asthma and Chronic Obstructive Lung Disease (COPD) Clinical Research Studies
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in la…
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in laboratory studies, the most promising ones are tested in human subjects. At the same time, research is being done on cells and secretions obtained from normal individuals and patients with asthma and COPD to increase our understanding of what causes these diseases and to determine how they can best be treated. You are being asked to take part in an evaluation of your health status in order to determine your eligibility to participate in future clinical research studies. The evaluation will involve assessing your overall medical condition and the status of your asthma, if you have asthma or the status of your COPD, if you have COPD. The evaluation will help determine if you may be eligible for current or future asthma and COPD clinical research studies done at Northwestern University.
18 years of age or older with asthma or COPD(Chronic Obstructive Lung Disease)
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
STU00015972
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Hixon, Jenny Lorraine 312 926 0975
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A Multicenter Group to Study Acute Liver Failure. Long-term Outcomes of Acute Liver Failure Study Group Patients
Data Registry study for acute liver failure.
18-70 yr old adults. Acute Liver Failure (ALF) - INR > 1.5 and hepatic encephalopathy. Acute Liver Injury (ALI) - INR > 2, ALT > 10 x ULN
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00518440 STU00016475
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Gottstein, Jeanne H 312 694 0264
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Mediators of Atherosclerosis in South Asians Living in America
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians r…
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
Kandula, Namratha RKandula, Namratha R
NCT01207167 STU00019837
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1-855-NU-STUDY
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NU 00X3: Pathology Core Facility

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized r…

The main purpose of this project is to collect samples for research. The samples will be stored at the Pathology Core Facility (PCF) of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School (NUMS). PCF serves as the centralized resource that addresses the sample collection needs for the research community. The samples collected can be used by researchers at Northwestern University and third party commercial and non-profit institutions who have approval from their Institutional Review Board (a committee which is responsible for the ethical oversight of the study) for their projects. 

You will be asked to donate a sample of blood. In addition, any extra tissue or fluid from what has been collected from you for your routine care will be used. Examples of samples include but are not limited to tissue, blood, urine, and bone marrow. 

Wei, Jian-JunWei, Jian-Jun
  • Map it 201 E. Huron St.
    Chicago, IL
STU00020989
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Study Coordinator 1 312 695 1102
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RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pacli…
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Some of the eligibility criteria include:

- Participants must be 18 years old or older.
- Participants must have undergone radical hysterectomy prior to entering the study.
- Participants cannot be allergic to carboplatin, paclitaxel and/ or cisplatin.

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
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Study Coordinator 312 695 1102
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Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion (OSR cross referenced as: “Induction of Donor Tolerance in Renal Transplants”)
Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell I…
Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
Leventhal, Joseph RLeventhal, Joseph R
NCT00497926 STU00026088
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1-855-NU-STUDY
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Language in Primary Progressive Aphasia

The observational primary progressive aphasia (PPA) research program at Northwestern University seeks to study individuals living with PPA over time using neuropsychological testing and advanced imaging techniques. Participants are asked to come to…

The observational primary progressive aphasia (PPA) research program at Northwestern University seeks to study individuals living with PPA over time using neuropsychological testing and advanced imaging techniques. Participants are asked to come to Chicago in order to help:

  • better understand progression in PPA and its link to brain changes,
  • increase awareness of PPA and better educate patients, families, and clinicians, and
  • identify biomarkers that will lead to earlier diagnosis and earlier intervention.
  • Participants are compensated for participation and travel expenses and meals are covered for those not local to Chicago.
    You must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet screening criteria which require the patient to be a right-handed, native English speaker and safe to undergo a 3T MRI.
    Mesulam, Marek-MarselMesulam, Marek-Marsel
    NCT00537004 STU00026372
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    Study Coordinator 312 908 9681
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    NU 01CC4: STAR (Survivors Taking Action and Responsibility)

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

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

    You may be eligible for this research study if you are a survivor of childhood cancer. 
    Didwania, AaratiDidwania, Aarati
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00029383
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    Study Coordinator 312 695 1102
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    NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
    RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods …
    RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
    Shulman, Lee PShulman, Lee P
    NCT00005095 STU00005421
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    1-855-NU-STUDY
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    Alzheimer's Disease Core Center
    The purpose of the Northwestern Alzheimer’s Disease Center (NADC) research registry is to 1) provide state-of-the-art care to patients with mild cognitive impairment, Alzheimer’s disease and related disorders, and to 2) support clinical and basic research on memory…
    The purpose of the Northwestern Alzheimer’s Disease Center (NADC) research registry is to 1) provide state-of-the-art care to patients with mild cognitive impairment, Alzheimer’s disease and related disorders, and to 2) support clinical and basic research on memory and aging collecting, storing, and disseminating clinical data, brain imaging, and biological samples from research participants to collaborators.
    For individuals with dementia who wish to participate in studies:

    You must carry a diagnosis of mild cognitive impairment, Alzheimer's disease or other dementia (frontotemporal dementia, primary progressive aphasia, Lewy Body disease and others), established a thorough evaluation prior to enrollment to assure that individuals are eligible to participate. If you think you may have dementia but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research.

    For older individuals without meaningful cognitive decline who wish to participate in studies:
    Must meet screening criteria which exclude illnesses that could interfere with cognitive function, and be able to provide the name of a friend or family member who can answer questions about daily activities and whether or not there are observable symptoms of forgetfulness.
    Vassar, RobertVassar, Robert
    STU00023196
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    Study Coordinator 312 926 1851
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    Neural Mechanisms in Sensory Reception and Processing in the Healthy Adult (VA RR&D Grant # B3302K)
    The measures of treatment effect in the project include reception and processing of sensory stimulation as measured by functional MRI in the severely injured brain. The neural responses to these senso…
    The measures of treatment effect in the project include reception and processing of sensory stimulation as measured by functional MRI in the severely injured brain. The neural responses to these sensory stimuli in the healthy brain have never been identified nor mapped. Therefore, the purpose of this new project is to determine the mechanisms of responses to the same sensory stimuli used in the 597-006 except in the healthy brain, which will allow for comparisons between the healthy and severely injured brains mechanistic responses to sensory input. The rationale is that in order to assert that the neural responses in the injured brain are measured reliably with fMRI over time and that they deviate from normal, a comparable fMRI protocol with healthy brains must be completed because this basic knowledge does not exist in the scientific literature. It is hypothesized that images acquired at rest and contrasted with images acquired during sensory stimulation will identify significant activation in the relevant association areas (i.e., auditory cortex-A1, somatosensory area-S1) as well as the brain stem and thalamus in accordance with receiving and processing sensory stimulation. It is also hypothesized that significant activation will be demonstrated in these areas for each of the 4 imaging sessions (i.e., reliably over time).
    Pape, Theresa L Bender LPape, Theresa L Bender L
    STU00024134
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    1-855-NU-STUDY
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    PACTG 1026s: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL AND RELATED DRUGS DURING PREGNANCY AND POSTPARTUM
    The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmaco…
    The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
    Jao, JenniferJao, Jennifer
    NCT00042289 STU00030724
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    1-855-NU-STUDY
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    NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility

    The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a…

    The purpose of this research study is to help advance the scientific understanding of breast cancer. A portion of breast or skin tissue and a sample of blood, along with clinical information, will be collected and stored in a database for research purposes only. 

    Only tissue or fluid in excess of that required for clinical diagnosis and/or staging will be collected. Specific clinical data will include: treatment for cancer (surgical procedures, chemo or hormone therapy, radiation), cancer outcome (recurrence, metastases, death due to disease, and death without disease, alive, alive with disease). 

    You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
    Wei, Jian-JunWei, Jian-Jun
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00023488
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    Study Coordinator 1 312 695 1102
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    Super Aging Study: Correlates of Active Engagement in Life in the Elderly
    The purpose of this study is to identify factors that contribute to the maintenance of functioning in old age (age 80 and above). We will be looking at a variety of factors including cognition, personality traits, psychosocial …
    The purpose of this study is to identify factors that contribute to the maintenance of functioning in old age (age 80 and above). We will be looking at a variety of factors including cognition, personality traits, psychosocial factors, genetic factors, and brain structure. The second purpose of this study is to look at how performance on these variables changes over time. The study consists of a baseline evaluation and follow-up visits every two years. The baseline evaluation consists of nine hours of testing. All visits will take place at our research lab on Northwestern University’s Chicago campus. Testing is split into three different days of three hours each. During the enrollment visit, participants will complete an MRI scan, a blood draw, and neuropsychological testing. We also ask some demographic and health history questions and request that participants fill out surveys and questionnaires. Following study enrollment, participants are required to complete follow up visits every two years which have the same structure as the initial visit. The follow-up evaluations will only total about six hours of testing.
    For individuals with who wish to participate: You must be over the age of 80 and remain actively engaged in life. All participants must be eligible for an MRI scan and willing to come to our Chicago location for each visit.
    Rogalski, Emily JoyRogalski, Emily Joy
    STU00027225
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    Study Coordinator 312 503 2716
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    The Parkinson’s Progression Markers Initiative (PPMI)
    This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. …
    This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.
    Genetic Cohort-PD Subjects
    • Have at least two of the following: resting tremor, slowness of movement, muscle rigidity
    • Parkinson disease diagnosis for 7 years or less
    • Male or female 18 years or older
    • Confirmation of LRRK2, GBA, or SNCA genetic mutation
    • Willing to undergo genetic testing

    Genetic Cohort-Unaffected Subjects
    • 50 years or older with LRRK2/GBA mutation or first degree relative with LRRK2/GBA mutation
    • Willing to undergo genetic testing
    OR
    • 30 years or older with SNCA mutation or first degree relative with SNCA mutation
    • Willing to undergo genetic testing
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT01141023 STU00031752
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    Friedeck, Heidi 312 503 1519
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    Department of Psychiatry and Behavioral Sciences Research Registry
    Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potenti…
    Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potential research participants who view the Department’s website. This application is not in itself a research project, but only for the establishment of the registry for recruitment. Recruitment will be for studies that have been approved by the Northwestern University Institutional Review Board. Advertising for the research database will be posted on the Department’s website. Our aim is to recruit psychiatric patients, their family members, and healthy controls for research on mood disorders, schizophrenia, and Alzheimer's disease.
    Goldman, Morris BGoldman, Morris B
    STU00034881
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    Jain, Ankit +1 312 503 9092
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    Nulliparous Pregnancy Outcomes Study: Monitoring Mothers to be
    Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might ha…
    Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having their first baby and are carrying only one baby. The women are enrolled early in pregnancy and undergo research assessments four times during their pregnancies. Data are collected through interviews, self-completed data forms, clinical measurements, ultrasound, and collection and storage of blood samples, urine samples, and fluid from the vagina and cervix. Some information comes from medical records. A subset of women may be asked to participate in substudies collecting information on sleep breathing, sleep patterns and quality, or other areas possibly related to birth outcomes. The goal of the research is to find ways to identify women in this group who might develop a problem with their pregnancy and use this information to improve the health of pregnant women and their babies in the future. The study is focusing on pregnancy problems like high blood pressure, babies that are born much too early and very small babies.
    Recruitment closed.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT01322529 STU00030993
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    Rangel, Elizabeth 1 312 503 6287
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    EHR-based Health Literacy Strategy to Promote Medication Therapy Management
    Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based…
    Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies that leverage an electronic health record (EHR) to promote patient understanding, medication reconciliation, medication adherence and disease control among hypertensive patients at safety net clinics. Medication therapy management (MTM) has been described as a set of procedures that include: medication review, assembly of a personal medication record, development of action plans, intervention when necessary, and follow-up. However, evidence showing the effectiveness of general MTM interventions is scant. MTM has often been performed separately from patients’ usual sources of care (i.e., at pharmacies). This could limit its effectiveness since medication-related concerns would be discussed by clinicians who are not aware of the regimen intended by patients’ prescribers. Cost is another barrier to widespread use of MTM. Health information technology in primary care could be leveraged to assist with MTM tasks. We have field tested low literacy MTM tools embedded within an EHR to 1) activate patients to review medications, 2) automate the provision of plain language, medication information, and 3) provide print tools to help patients engage providers, and consolidate their regime. These tools were developed with patient, physician, and pharmacist feedback. For this study, we combine tools to address the range of MTM tasks. In aggregate, we refer to this as an Electronic health record-based Health literacy Medication therapy management Intervention, or ‘EHMI’. We will evaluate the effects of this approach among patients with uncontrolled hypertension treated in federally qualified health centers (FQHCs). This may be a relatively low-cost strategy ideal for safety net practices that use EHRs and whose patients may be at greater risk for limited literacy. It is also possible that the EHMI strategy may not result in a significant change. Therefore, we will also evaluate using a nurse educator to help patients utilize EHMI tools, provide brief counseling, and track progress. This three-arm, clinic-randomized, controlled trial at 12 FQHCs will evaluate the EHMI and EHMI + Nurse Educator interventions compared to usual care. Recruited patients will be followed for 12 months. We will test the impact of these two strategies on blood pressure levels, , powered to detect a 4 mm Hg difference in systolic blood pressure as the primary outcome. We will also assess the impact on HbA1c and LDL cholesterol control in the subgroup with diabetes. We will determine the interventions’ effects on: 1) medication understanding, 2) discrepancies, and 3) adherence. We will specifically examine intervention effects among groups with different literacy levels. We will also assess the fidelity and cost of the interventions to guide future dissemination efforts.
    Persell, Stephen DPersell, Stephen D
    STU00042150
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    1-855-NU-STUDY
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    Transplant Recipients Undergoing Therapy Intended to Achieve Transplant Tolerance
    Improvements in immunosuppression following solid organ allotransplantation have significantly enhanced short-term graft and patient survival. At the same time, long-term graft survival has not significantly improved. T…
    Improvements in immunosuppression following solid organ allotransplantation have significantly enhanced short-term graft and patient survival. At the same time, long-term graft survival has not significantly improved. The combination of long-term inflammatory injury, in part due to incomplete immunosuppression, and drug toxicity from calcineurin inhibitors used in immunosuppression have inhibited long-term graft survival. Further, the cost and side effects of long-term immunosuppression are significant. Some patients do not need ongoing maintenance immunosuppression long-term. In liver transplant recipients, some estimates place this number as high as 20% of recipients. It has not been possible to show similar results in kidney transplantation. However, several interventions have been designed intended to achieve tolerance in the renal transplant population, as well. The status of immune systems in transplant patients has been well-studied. However, given the small number of patients either tolerant or undergoing therapy intended to induce tolerance, less is understood about their immune markers. This project aims to establish a repository of blood and urine taken serially from patients who have either demonstrated some degree of tolerance, or who are undergoing therapy intended to achieve tolerance, such that potential biomarkers – including those not yet identified – can be compared among health controls, transplant recipients not believed to be tolerant, and tolerant or partially tolerant recipients.
    Friedewald, John JFriedewald, John J
    STU00047842
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    1-855-NU-STUDY
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    Peripheral Neuropathy Research Registry (PNRR)
    National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in t…
    National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in the future. The registry aims to help researchers’ access large amounts of information about people with PN. By using this registry, researchers will facilitate both basic and clinical research studies that will bring improved understandings of the etiology (origination) and pathogenesis (development) of PN. They will specifically ask why some patients with peripheral neuropathy develop neuropathic pain and others do not, and what the characteristics of patients with painful peripheral neuropathy are in terms of their symptoms, examination findings, and blood tests. Ultimately this research may result in improved diagnosis, more effective treatments, and possibly prevention.
    Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    STU00048864
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    Joslin, Benjamin 312 503 7504
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    NU 11B04: Breast Tissue Biomarkers of ER- Specific Cancer Risk that Are Valid Across Menstrual and Menopausal Status

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

    <…

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

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

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

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

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

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

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

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

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00039629
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    Study Coordinator 312 695 1102
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    Microbiomes of Pelvic Pain
    Interstitial cystitis/painful bladder syndrome (IC) is characterized by chronic pelvic pain and voiding dysfunction. IC remains an enigma within urology, with no known etiology or widely effective therapies. However, some IC patients suffer bowel co-morbidities, and it …
    Interstitial cystitis/painful bladder syndrome (IC) is characterized by chronic pelvic pain and voiding dysfunction. IC remains an enigma within urology, with no known etiology or widely effective therapies. However, some IC patients suffer bowel co-morbidities, and it is well established that the GI tract can influence bladder function and sensation via pelvic organ crosstalk. Like other body sites, the gut harbors a rich microflora. Studies characterizing microbial diversity and relative abundance at a particular body site, the “microbiome,” reveal that microbiomes play critical roles in normal cellular and organ function, and thus this importance is emphasized with the Human Microbiome Project (HMP), an NIH Common Fund initiative. Microbiomes are also dynamic and subject to skewing, and these changes are increasingly associated with diseases including Crohn’s disease, ulcerative colitis, and obesity. Antibiotic therapies alter microbiomes, often causing temporary dysfunction and sometimes resulting in diseases such as colitis. Since IC patients often have a history of urinary tract infection (UTI), they typically receive multiple courses of antibiotics. This therapeutic history of IC patients may have adverse consequences for two reasons. First, potential skewing of the gut microbiome may alter normal sensory and functional homeostatic mechanisms, contributing to pain and voiding dysfunction. Second, an altered gut microbiome may foster uropathogen reservoir expansion, and our preliminary data demonstrate urinary E. coli isolates can induce chronic pelvic pain persisting long after microbial clearance. Together these lines of reasoning raise the provocative possibility that microbiomes contribute to IC directly by supplying uropathogens or indirectly through organ crosstalk dysfunction. Therefore, is an altered gastrointestinal and/or reproductive tract microbiome associated with IC? Our team marries core NIH and NIDDK missions, digestive diseases and kidney/urologic, to address this novel question with synergistic expertise in clinical diagnosis of IC, quantifying GI and reproductive tract microbiomes, and mechanisms of microbe-induced pelvic pain.
    Klumpp, DavidKlumpp, David
    STU00055668
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    Mohammed, Juned Ali Khan 1-855-NU-STUDY
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    A Prospective Review of Excimer Laser-Assisted IVC Filter Removal
    At Northwestern, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques…
    At Northwestern, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques. The rationale for the study is to allow us to prospectively follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.
    Lewandowski, Robert JLewandowski, Robert J
    STU00058721
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    Karp, Jennifer 312 926 5289
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    Northwestern University The Department of Psychiatry and Behavioral Sciences, Clinical Research Program (NU CRP) Recruitment Pipeline
    The recruitment pipeline provides research staff with an organized system of identifying researchsubjects.NU CRP clinical research studies covers a wide spectrum of Ax…
    The recruitment pipeline provides research staff with an organized system of identifying researchsubjects.NU CRP clinical research studies covers a wide spectrum of Axis I Diagnoses such as schizophrenia, depression, anxiety, etc. NU CRP also conducts research studies for patients who are diagnosed with certain neurological diseases such as Alzheimer’s disease, Tourette’s Syndrome, etc. NU CRP conducts basic, translational and clinical research. Personal Health Information (PHI) will not be collected. All information collected in this recruitmentregistry is based on the patient self-report. You will be contacted to answer additional questions by someone in the study staff and to determine your eligibility for the current studies.
    Goldman, Morris BGoldman, Morris B
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    STU00059328
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    Jain, Ankit +1 312 503 9092
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    A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS
    Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
    Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
    Borja-Cacho, DanielBorja-Cacho, Daniel
    NCT01897688 STU00059469
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    1-855-NU-STUDY
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    A Randomized Trial to Prevent Congenital Cytomegalovirus Infection (CMV)
    Cytomegalovirus (CMV) is a common virus that usually presents withfew if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most peopl…
    Cytomegalovirus (CMV) is a common virus that usually presents withfew if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.
    Primary CMV infection in women with singleton pregnancy at less than 24 weeks.
    Grobman, William AGrobman, William A
    NCT01376778 STU00059714
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    Mallett, Gail 312 503 3200
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    A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety
    The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well …
    The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
    Dokucu, Mehmet EDokucu, Mehmet E
    NCT01701284 STU00063218
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    Jain, Ankit +1 312 503 9092
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    The Genetics of Prostate Cancer in Active Surveillance
    Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
    1. Patients diagnosed with prostate cancer
    2. Patients with Gleason ≤ 3+3 prostate cancer
    3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
    4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
    5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
    6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
    Kundu, Shilajit DKundu, Shilajit D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00059221
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    Khawaja, Faizan 312 694 2417
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    ANTLER Pilot Intervention
    ANTLER Pilot Study
    Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
    STU00069201
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    1-855-NU-STUDY
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    Genome Research in African American Scleroderma Patients (GRASP)
    Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain t…
    Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain the different risk in developing scleroderma seen in African American patients compared to other populations. Participants will complete a brief health questionnaire and provide two tubes of blood.
    African American patients who are evaluated at the Northwestern Scleroderma Program and meet criteria for the diagnosis of systemic sclerosis, Age ≥ 18 years old
    Varga, JohnVarga, John
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00069421
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    Carns, Mary 312 503 1137
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    An Observational Study of Hepatitis C Virus in Pregnancy
    This multi-center observational study examines risk factors for HCV transmission from mother to baby.
    Hepatitis C positive women pregnant with one baby who are at least 18 years of age and less than 24 weeks pregant
    Grobman, William AGrobman, William A
    NCT01959321 STU00069248
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    Mallett, Gail 312 503 3200
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    Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
    The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal …
    The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal therapy, and how these brain areas are related to the development of mild cognitive impairment as the results of these treatments. This study involves obtaining pictures of the brain’s size, shape and activity using a Magnetic Resonance Imaging (MRI) device, a machine that uses a powerful magnet to obtain this information without using any radiation. This procedure has been used safely with humans in many different studies. Your part in this study will last for 1 to 2 years.
    Female breast cancer patients between 40-70 years old
    Wang, LeiWang, Lei
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT01949376 STU00069634
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    Fairchild, Melody Dawn +1 312 503 7071
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    Mobile Monitoring for Long Term Behavioral Data Collection in Bipolar Disorder
    This study is being done to evaluate the use of mobile phones interventions to improve patient self-management and increase the effectiveness of psychological interventions to reduce symptoms and prevent relapse in people …
    This study is being done to evaluate the use of mobile phones interventions to improve patient self-management and increase the effectiveness of psychological interventions to reduce symptoms and prevent relapse in people with bipolar disorder. The purpose of prototype testing prior to the main study is to achieve early input on the study design, including the utility of the psychosocial interventions, and user perspectives and experiences with the interface and program content. In order to determine if you are eligible for the study, we will first ask you to complete a brief screening questionnaire either online or during a brief telephone call. This will include questions about your mental health and mental health treatment and will take 5 minutes. If it appears that you may be eligible for the study, you will be scheduled for a longer initial telephone interview which will take approximately 30-60 minutes.
    Goulding, EvanGoulding, Evan
    STU00069725
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    UNKNOWN, UNKNOWN 312 503 9095
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    Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)
    The purpose of this study is to observe mothers with and without epilepsy, along with their children, from pregnancy until age 6 and assess the developmental and neurocognitive influence of anti-epileptic medications.
    Gerard, Elizabeth ErwayGerard, Elizabeth Erway
    NCT01730170 STU00070411
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    Bellinski, Irena Iva 312 926 1672
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    NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00074258
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    Study Coordinator 312 695 1102
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    Liver Transplant Tolerance Enhanced By Sirolimus Therapy
    The significance of this clinical trial lies in its potential to increase the success of immunosuppression (IS) therapy withdrawal in liver transplant (LT) recipients, thus decreasing the negative impact of IS on the…
    The significance of this clinical trial lies in its potential to increase the success of immunosuppression (IS) therapy withdrawal in liver transplant (LT) recipients, thus decreasing the negative impact of IS on their long-term outcomes. Lifetime immunosuppression (IS) with standard agents, the calcineurin inhibitors (CNI) cyclosporine and tacrolimus (TAC), is currently required at clinically recommended doses and trough levels to prevent allograft rejection. However, this occurs at the significant expense of long-term CNI toxicity, i.e. chronic kidney disease (CKD), hypertension, hyperlipidemia, diabetes, infections and malignancy. With improvements in early graft and patient survival, long term adverse IS effects have become increasingly important in this rapidly expanding patient population. The strategies to reduce long term CNI toxicity include dose minimization that still leaves patients on CNI therapy, conversion to non-CNI therapy, or even complete IS withdrawal. The second approach, conversion to non-CNI IS therapy, is attractive in the potential to stabilize or improve renal function and other CNI toxicities. One such non-nephrotoxic IS agent, the mammalian target of rapamycin inhibitor (mTOR-I) SRL, has a different mechanism of IS action and studies have shown that CNI to SRL conversion can stabilize renal dysfunction with a low risk of rejection. Yet even with these possible benefits, patients on SRL are still subject to lifetime IS therapy with side effects and costs, highlighting the need to investigate the strategies that promote full IS withdrawal without rejection (3rd approach), also known as 'operational tolerance'.
    Levitsky, JoshLevitsky, Josh
    NCT02062944 STU00072766
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    1-855-NU-STUDY
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    Communication Bridge: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
    The purpose of this study is to evaluate the effectiveness of speech and language therapy on individuals diagnosed with Primary Progressive Aphasia (PPA) ability to communicate immediately after tr…
    The purpose of this study is to evaluate the effectiveness of speech and language therapy on individuals diagnosed with Primary Progressive Aphasia (PPA) ability to communicate immediately after treatment, 6-months after treatment. We additionally hope to identify the most effective speech and language therapy strategies for persons with these conditions. Lastly, we hope to determine the feasibility of Internet-based video-practice of speech and language therapy for persons with these conditions. The study will involve 11 to 14 session over the course of 6 months. These sessions will all take place over the Internet, using an online study portal.
    For individuals with who wish to participate: You must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet screening criteria which require the patient and care-partner to be comfortable using computers and videoconferencing software. Care-partners of patients must be available to participate for all speech-language therapy sessions and evaluations.
    Rogalski, Emily JoyRogalski, Emily Joy
    NCT02439853 STU00073634
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    Rogers, Elizabeth +1 312 503 4012
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    CENTER FOR BEHAVIORAL INTERVENTION TECHNOLOGIES (CBITs) RESEARCH SUBJECT RECRUITMENT REGISTRY
    WHAT IS THE REGISTRY ABOUT? Becoming a member of this registry allows researchers at Northwestern University to get in touch with you to see if you might be interested in and eligible to participate in diff…
    WHAT IS THE REGISTRY ABOUT? Becoming a member of this registry allows researchers at Northwestern University to get in touch with you to see if you might be interested in and eligible to participate in different research studies at CBITs. The research conducted at CBITs generally involves evaluating different aspects of technology-assisted health interventions. WHAT WILL I BE ASKED TO DO? You will be asked to provide some basic contact and background information, as well as continue on to complete a brief survey. There is no cost to join the registry. You can read more about the current studies and sign up for the registry on our website: http://cbitshealth.northwestern.edu
    If you're an adult (18 years or older), living in the United States, who speaks English, and has Internet access, you may be eligible to join.
    Mohr, David CMohr, David C
    STU00076804
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    Study Coordinator 855 682 2487
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    Non-Invasive Marker of Ovarian Reserve in Women with Epilepsy
    The purpose of this study is to assess and compare AMH hormone levels in women with epilepsy vs. healthy controls, utilizing medical history questionnaires and a finger stick.
    Gerard, Elizabeth ErwayGerard, Elizabeth Erway
    STU00077630
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    Bellinski, Irena Iva 312 926 1672
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    Ketamine Effect on Recovery and Respiratory Outcomes after Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
    Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very…
    Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia. Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events. The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline. The investigators also seek to determine if intraoperative ketamine would decrease the incidence of postoperative hypoxemic events in the same patient population.
    Yilmaz, MeltemYilmaz, Meltem
    NCT01997515 STU00081191
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    1-855-NU-STUDY
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    Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
    This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms a…
    This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).
    Salem, RiadSalem, Riad
    NCT02026908 STU00081296
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    Jenkins, Kimberly 312 695 9327
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    Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder

    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less…

    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust lamotrigine in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

    Participation Involves: 

    • 3 overnight visits during pregnancy and 2 postpartum,
    • expert evaluation, mood assessments, and blood draws, and
    • to compensate for your time and effort, you will receive between $100 and $150 for each completed overnight visit. 

    To qualify for this study you must be: 

    • pregnancy planning or less than 27 weeks pregnant, 
    • between the ages of 18 and 45, and
    • taking lamotrigine (Lamictal) and planning to continue to take it during pregnancy and postpartum. 

    Clark, CrystalClark, Crystal
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT01996293 STU00079810
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    Montiel, Catalina +1 312 695 6010
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    Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa
    This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).
    Apkarian, ApkarApkarian, Apkar
    NCT01951105 STU00081444
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    Hunt, Elizabeth 312 503 6475
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    A Prospective, Double-masked, Placebo Controlled Comparison of Topical 0.15% Ganciclovir Gel (Zirgan®) Versus 0.3% Hypromellose Gel (Genteal Gel®; Placebo) for the Treatment of Herpes Zoster Keratitis While on Oral Anti-viral Treatment
    The purpose of this study is to see if ganciclovir gel (Zirgan…
    The purpose of this study is to see if ganciclovir gel (Zirgan®) will work better than a lubricating gel placebo in the treatment of herpes zoster dendritic keratitis.
    Feder, Robert SFeder, Robert S
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02382588 STU00082890
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    Seddon, Nicole 1-855-NU-STUDY
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    RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (A7007)
    The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practic…
    The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and to evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
    Key Inclusion Criteria:
    -Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
    -Signed a valid, IRB/EC-approved informed consent form
    -18 years of age or older

    Key Exclusion Criteria:
    -Contraindicated for Boston Scientific neurostimulation system
    -Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
    Rosenow, Joshua MRosenow, Joshua M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01719055 STU00083506
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    Amidei, Christina 312 695 9124
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    PERL - Preventing Early Renal Loss in Diabetes: A multicenter clinical trial of allopurinol to prevent GFR loss in type 1 diabetes A multicenter clinical trial of allopurinol to prevent GFR loss in type 1
    Despite improvements during the past 20 years in blood glucose and blood pressure control,diabe…
    Despite improvements during the past 20 years in blood glucose and blood pressure control,diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments} to complement blood glucose and blood pressure control are urgently needed. The goal of this study is to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes. Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, we will be conducting an international clinical trial at eight diabetes centers, enrolling approximately 480 patients with type 1 diabetes who are at increased risk of developing kidney disease.
    Molitch, Mark EMolitch, Mark E
    NCT02017171 STU00076318
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    1-855-NU-STUDY
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    Targeting Siglecs in Disease supported by NIH Grant R01 AI072265 Targeting Siglec-8/-F to treat eosinophil and mast cell related disorders and P01 HL107151 Glycobiology of Inflammatory Lung Diseases: Project 1 and U19 AI136443 Using Siglecs and Their Ligands to Treat Allergic Diseases: Project 1 and Core B.
    The study involves recruiting paid volunteers to donate blood. The goal of the studies is to isolate certain cells from the blood called eosinophils to examine certain proteins and their functions in the laboratory.
    Adults with or without allergies
    Bochner, BruceBochner, Bruce
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00085003
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    Bochner, Bruce 312 503 0068
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    NU 13S02: Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
    The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is fo…
    The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
    Agulnik, MarkAgulnik, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02048722 STU00087654
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    Study Coordinator 312 695 1102
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    NUDB 13C03: Northwestern Brain Tumor Institute Research Database

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

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

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

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

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
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    Study Coordinator 1 312 695 1102
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    Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial
    Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe ne…
    Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe neonatal morbidity and perinatal mortality.
    first time mom, singleton pregnancy in women 18 years of age or older
    Grobman, William AGrobman, William A
    NCT01990612 STU00087536
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    Mallett, Gail 312 503 3200
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    A5320: Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)
    This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepat…
    This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepatitis C medications lasts and whether it affects future hepatitis C treatments. This is an observational study and does NOT provide any Hepatitis C or HIV treatment.
    Persons who were treated with an oral direct acting anti-viral (DAA) therapy for hepatitis C, but did NOT have a successful response to treatment (non-SVR) (enrollment is closed to persons with successful response to treatment); Hepatitis C mono-infected OR Hepatitis C and HIV co-infected;
    Taiwo, Babafemi OTaiwo, Babafemi O
    STU00090304
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    Berzins, Baiba Ingrida 312 695 5012
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    Parkinson’s Disease and Movement Disorders Center Biorepository
    This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the regi…
    This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’s risk for developing them. Samples collected for this biorepository include a blood sample (or a saliva sample) and a skin biopsy. Participants may choose to donate one or both samples.
    • Diagnosis of a movement disorder
    • Male or female 5 years of age or older when diagnosed
    • Genetic mutation related to a movement disorder
    • Family members of patients with movement disorders
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00091585
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    Hernandez, Alejandro +1 312 503 2778
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    A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
    This study is a prospective Phase IV study to determine if the …
    This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
    Kulik, Laura MKulik, Laura M
    NCT02081755 STU00083409
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    Bezler, Laura 312 694 0260
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    RANDOMIZED CONVERSION OF EBV+ KIDNEY TRANSPLANT RECIPIENTS OF LIVING OR STANDARD CRITERIA DONORS AT THREE MONTHS POST TRANSPLANTATION TO BELATACEPT WITH MPA OR BELATACEPT WITH LOW-DOSE TACROLIMUS (50% OF DOSE) COMPARED TO PATIENTS REMAINING ON CENTER SPECIFIC STANDARD THERAPY OF TACROLIMUS AND MPA
    Th…
    This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.
    Gallon, LorenzoGallon, Lorenzo
    NCT02213068 STU00085274
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    Goudy, Leah +1 312 694 0242
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    Thighplasty of transfemoral amputee residual limbs to improve prosthesis fit and patient functional outcomes
    Transfemoral amputees who are obese suffer from a lack of mobility and prosthesis fit and control due to an overly compliant nature of their limb. This study aims to improve the fit and functi…
    Transfemoral amputees who are obese suffer from a lack of mobility and prosthesis fit and control due to an overly compliant nature of their limb. This study aims to improve the fit and function of lower-limb prostheses in transfemoral amputees who are obese using a plastic surgery intervention known as a standard medial thighplasty. We will perform this surgery on up to 3 amputees over 2 years. In Aim 1, we will quantify subcutaneous fat anatomy of residual limb, quantify soft tissue compliance of the residual limb and displacement of the socket wall relative to the femur under mechanical loading, and characterize the functional mobility level of the patients via standard clinical and biomechanical tests. In Aim 2, we will perform a standard medial thighplasty on the transfemoral amputee subjects, consisting of medial excision of excess adipose and cutaneous tissue with circumferential liposuction. In Aim 3, post intervention, we will again quantify subcutaneous fat anatomy of residual limb, quantify soft tissue compliance of the residual limb and displacement of the socket wall relative to the femur under mechanical loading, characterize the functional mobility level of the patients via standard clinical and biomechanical tests.
    Kuiken, Todd AKuiken, Todd A
    STU00090292
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    1-855-NU-STUDY
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    A Phase 1, Single Center Trial of Adoptive Immunotherapy with T-reg Adoptive Cell Transfer (TRACT) to Prevent Rejection in Living Donor Kidney Transplant Recipients
    Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have been demonstrated to bro…
    Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been shown to control immune responsiveness to alloantigens and significantly contribute to operational tolerance in transplantation models (15, 16). However, there have been limited efforts to harness the therapeutic potential of directly isolated CD4+CD25+ Treg cells for controlling graft rejection and inducing transplantation tolerance, such as for kidney transplants. In order for CD4+CD25+ Treg cells to be used as a clinical treatment, the following cell properties could be necessary: ex vivo generation of sufficient numbers of cells, migration in vivo to sites of antigenic reactivity, ability to suppress rejection in an alloantigen-specific manner, and survival/expansion after infusion for a critical, but currently unknown, period of time. Our published work and that of other investigators has demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to downregulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for prevention of allograft rejection in animal models (15,16). We have developed strategies for the ex vivo expansion of naturally occurring human Tregs (nTregs) that allow for the practical employment of this cellular therapy in the clinic. Our central hypothesis is that sufficient human nTreg can be expanded ex vivo and used to both prevent renal transplant rejection and facilitate the reduction and subsequent withdrawal of drug-based immunosuppression. This study will allow for us to define the safety of Treg adoptive cellular transfer (TRACT) in living donor renal transplant recipients that draws upon our extensive preclinical experience with expanded Tregs, as well as our recognized clinical expertise with designing immunosuppressive regimens compatible with this type of therapeutic cell transfer.
    Skaro, Anton ISkaro, Anton I
    NCT02145325 STU00091850
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    1-855-NU-STUDY
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    HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network-A Longitudinal, Observational Study
    The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both …
    The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.
    Levitsky, JoshLevitsky, Josh
    STU00092110
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    1-855-NU-STUDY
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    The Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
    The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN a…
    The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are: 1. To learn more about important problems faced by people living with scleroderma (e.g., fatigue, emotional distress, physical limitations). 2. To develop and test internet-based interventions to support people in their efforts to cope with living with scleroderma. Participants will be asked to complete quality of life questionnaires via the internet every 3 months.
    Diagnosis of scleroderma. Fluent in English. Must have access to the Internet to complete questionnaires.
    Varga, JohnVarga, John
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00092924
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    Carns, Mary 312 503 1137
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    B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
    This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
    This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
    -Pregnant women at least 18 years old.
    -Less than 15 weeks pregnant with a single baby.
    -Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
    Grobman, William AGrobman, William A
    STU00093038
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    Wolfe, Kaitlin A 312 503 3248
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    (LCH) A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Neonates at High Risk of Acquiring HIV-1 Infection. Version 1, December 10, 2012(Lurie Children's # 2014-15720)
    This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (…
    This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (RAL) given to HIV-1-exposed newborns at high risk of acquiring HIV-1 infection. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the appropriate dose of RAL to give to an infant to prevent the infant from getting HIV infection from its mother.
    Chadwick, EllenChadwick, Ellen
    NCT01780831 STU00093680
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    1-855-NU-STUDY
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    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderatel…
    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01848561 STU00094204
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    Arrieta, Rose +1 312 695 5878
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    DRUG ATI001-102: A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
    This research study involves two investigational drugs…
    This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
    Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
    Lesniak, MaciejLesniak, Maciej
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02026271 STU00094296
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    Amidei, Christina 312 695 9124
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    Precision Retrospective Outcomes (PRO)
    This study will evaluate deidentified (anonymous) data in subject medical charts to review the clinical outcomes of spinal cord stimulation.
    Inclusion Criteria:
    -Previously treated with or eligible for implantation with a spinal cord stimulation system
    -18 years of age or older at the start of Baseline
    Rosenow, Joshua MRosenow, Joshua M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01550575 STU00094644
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    Amidei, Christina 312 695 9124
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    Can active elbow extension reduce shoulder loading in C5/C6 quadriplegia?
    The purpose of this study is to determine whether the ability to actively extend the elbow decreases mechanical loading at the shoulder during weight-relief lift in individuals with quadriplegia. If you consent to participa…
    The purpose of this study is to determine whether the ability to actively extend the elbow decreases mechanical loading at the shoulder during weight-relief lift in individuals with quadriplegia. If you consent to participate, you will have small recording electrodes attached to your skin over several muscles. We will also place small reflective markers on a number of anatomical landmarks of your arms and upper body. Your arm will be placed in a rigid cast and you will be asked to push and pull at maximum effort to assess the strength of your arm muscles. These measurements may be repeated with your arm placed in different positions, such as to the side or stretched out in front of you. Next, you will be assisted to transfer to a different chair that is positioned between two adjustable hand rails. Once comfortably seated, you will be asked to perform six weight-relief lift trials. You will be asked to place your hands on the hand rails and lift (or attempt to lift) your body weight off the seat of the chair as high as possible and hold for 3-5 seconds.
    Murray, Wendy M M.Murray, Wendy M M.
    STU00095944
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    1-855-NU-STUDY
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    A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
    A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens…
    A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02065622 STU00096456
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    Arrieta, Rose +1 312 695 5878
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    A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
    A Multicenter, Randomized, Double-Blind Study to Evaluate…
    A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02065570 STU00096539
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    Arrieta, Rose +1 312 695 5878
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    Healthy Control Esophageal Registry and Biorepository
    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biop…
    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
    Must not be:
    - Obese (i.e. BMI ≥30)
    - Known medical illnesses that could affect esophageal function, gene expression or histology
    - Have a diagnosis of an eating disorder
    - Have a diagnosis of an autoimmune disease
    - A current or previous smoker (smoked >100 cigarettes in lifetime)
    - Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
    - Taking antacids and/or proton pump inhibitors for heartburn
    - Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
    - Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
    - Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
    Carlson, DustinCarlson, Dustin
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00096856
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    Masihi, Melina +1 312 695 0330
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    Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease
    This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are …
    This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in the nuMOM2b Study.
    By invitation only. Women who previously participated in the nuMOM2b Study and who are 18+ years old are invited to participate in the nuMOM2b Heart Health Study. These women also consented to be contacted for future research studies and did not previously withdraw from the nuMoM2b cohort.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT02231398 STU00098233
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    Rangel, Elizabeth 312 503 6287
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    NU 14H04: Phase II Study of Romidepsin plus Lenalidomide for Patients with Previously Untreated PTCL
    The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymp…
    The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).
    Some of the eligibility criteria include:

    - Participants must have PTCL.
    - Participants may not have had prior systemic treatment for their PTCL. Treatment with corticosteroids is allowed. Please discuss all treatments with the study doctor.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Pro, BarbaraPro, Barbara
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02232516 STU00097620
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    Study Coordinator 312 695 1102
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    Neural Systems for the Dynamic Use of Memory
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our re…
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our research studies. Depending on your eligibility, you could take part in studies involving cognitive testing or studies involving noninvasive recording of brain function (using EEG, TMS, and MRI). Please contact us if you are interested in participating and we can determine your eligibility and provide additional details. All studies take place in downtown Chicago on the Northwestern University campus. Individuals will receive monetary compensation for participating, ranging from $10-$40 per hour depending on the experiment. Please contact fill out our participant survey if you are interested at https://redcap.nubic.northwestern.edu/redcap/surveys/?s=w7RfNPbxwJ or contact us at lhn@northwestern.edu or 312-503-5613.
    Voss, JoelVoss, Joel
    STU00060723
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    Karp, Erica +1 312 503 5613
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    Noninvasive Manipulation of Hippocampal-Cortical Brain Networks and Memory
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individual…
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our research studies. Depending on your eligibility, you could take part in studies involving cognitive testing or studies involving noninvasive recording of brain function (using EEG, TMS, and MRI). Please contact us if you are interested in participating and we can determine your eligibility and provide additional details. All studies take place in downtown Chicago on the Northwestern University campus. Individuals will receive monetary compensation for participating, ranging from $10-$40 per hour depending on the experiment. Please fill out our participant survey if you are interested at https://redcap.nubic.northwestern.edu/redcap/surveys/?s=w7RfNPbxwJ or contact us at lhn@northwestern.edu or 312-503-5613.
    Voss, JoelVoss, Joel
    STU00070522
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    Karp, Erica +1 312 503 5613
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    A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease (Protocol # CLCI699C2301)
    The study aims …
    The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It is a pivotal trial intended to support the registration of LCI699 for the treatment of patients with Cushing's disease in the EU, Japan, and other countries.
    Molitch, Mark EMolitch, Mark E
    NCT02180217 STU00100063
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    1-855-NU-STUDY
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    Development of a Kidney Cancer Patient Outcomes Database
    Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who …
    Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter information about their disease, treatment, symptoms, health status, and quality of life into an on-line, password-protected database on a regularly scheduled basis. Participants can use the registry to track many of their symptoms and their health status over time and to compare themselves (anonymously) with other groups of people (for example, how their level of fatigue compares with the average level of fatigue reported by other participants in the registry). Participants can also choose to share relevant information about themselves (from the registry) with their health care provider(s), by printing copies of their completed forms. Registry participants will be offered opportunities to join in other research studies when available. Description of Treatment Participants in this study will be asked to do the following for a 1-year trial period: 1) enroll in the on-line registry; 2) complete questionnaires about their health and treatment every 3 months ; and 3) be willing to have MYQOL researchers contact them confidentially about participating in other research studies. This does not mean that participants are obligated to participate in future research studies; only that they agree to be contacted.
    Some of the eligibility criteria include:

    - Participants must have a kidney cancer diagnosis.
    - Participants must be 18 or older.
    - Participants must be able to read English well enough to complete questionnaires.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Cella, DavidCella, David
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00070200
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    Study Coordinator 312 695 1102
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    Application of Targeted Reinnervation for People with Transradial Amputation
    The purpose of this study is to improve prosthesis control for transradial amputees with combining targeted muscle reinnervation surgery (TMR) and pattern recognition control.
    Kuiken, Todd AKuiken, Todd A
    NCT02349035 STU00101444
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    1-855-NU-STUDY
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    A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

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

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

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

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

    You are being asked to take part in this research study because you have ALK-positive non-small cell lung cancer, which has been removed by a surgeon. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02201992 STU00102000
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    Study Coordinator 312 695 1102
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    Behavioral activation and varenicline for smoking cessation in depressed smokers
    The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Beh…
    The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Behavioral activation for smoking cessation + placebo; 3) Standard behavior therapy + varenicline (Chantix); or 4) Behavioral activation for smoking cessation + varenicline (Chantix).
    1. Adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
    2. Lifetime history of clinical depression (Major Depressive Disorder)
    Hitsman, Brian LHitsman, Brian L
    NCT02378714 STU00100303
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    Reyes, Celine 1 877 236 7487
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    (xIRB) An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
    The purpose of this study is to evaluate L…
    The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
    Ganger, Daniel RGanger, Daniel R
    NCT02167945 STU00102262
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    1-855-NU-STUDY
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    Radiographic Markers of Clinical Function in Cervical Spondylotic Myelopathy (CSM)
    Cervical spondylotic myelopathy (CSM), also called “spinal stenosis,” is a common cause of injury to the cervical spinal cord (the neck). CSM can cause pain in the neck and arms, as well as weakness and loss of coo…
    Cervical spondylotic myelopathy (CSM), also called “spinal stenosis,” is a common cause of injury to the cervical spinal cord (the neck). CSM can cause pain in the neck and arms, as well as weakness and loss of coordination in the neck, arms, hands, legs, and feet. Although CSM is common, there is still a question of how findings on imaging such as x-rays or magnetic resonance imaging (MRI) relate to a person’s symptoms. The purpose of this study is to see how the images and symptoms of people with CSM compare to images of healthy people without CSM. We are looking for healthy volunteers to help us gain valuable insight into how medical imaging can help us diagnose CSM.
    Participants must be 21 years of age or older, preferably 40 years of age or older. Participants may not have any previous spine surgeries or chronic neck pain.
    Smith, ZacharySmith, Zachary
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00099367
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    Amidei, Christina 312 695 9124
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    Phase III, Randomized, Double-Blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy (Maintenance Of Remission) And Safety Of Etrolizumab Compared With Placebo In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Naive To Tnf Inhibitors (Protocol GA29102)
    Phase III, Ra…
    Phase III, Randomized, Double-Blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy (Maintenance Of Remission) And Safety Of Etrolizumab Compared With Placebo In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Naive To Tnf Inhibitors (Protocol GA29102)
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02165215 STU00101866
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    Arrieta, Rose +1 312 695 5878
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    rTMS: A Treatment to Restore Function after Severe TBI
    The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiven…
    The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the relationship between neurobehavioral changes and net neural effects, and to identify and define the neural mechanisms related to neurobehavioral improvements by providing 30 active or placebo rTMS sessions.
    Inclusion Criteria:
    -Veteran of any combat era
    -Both Genders
    -20-65 years
    -History of Post Traumatic Amnesia < 1 day for mild TBI; 1 day> x < 7days for moderate TBI))
    -Ability to obtain a Motor Threshold (MT) will be determined during the screening process.
    -If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
    -Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
    -For female participants, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive; Norplant
    -Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.

    Exclusion Criteria:
    -Pregnant or lactating female.
    -Unable to be safely withdraw, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures
    -Have a cardiac pacemaker or a cochlear implant
    -Have an implanted device (deep brain stimulation) or metal in the brain (see standard MRI exclusion criteria including metal screening section in telephone screen, Appendix A).
    -Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
    -Known current psychosis as determined by DSM-IV coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
    -Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake interview)
    -Current amnesic disorders, dementia, mini mental state examination (MMSE) 24 or delirium.
    -Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via AUDIT, within 3 months prior to screening
    -Prior history of seizures
    -Severe TBI or open head injury
    -TBI within last two months or in acute stage
    -Participation in another concurrent clinical trial
    -Patients with prior exposure to rTMS/ECT
    -Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial
    Pape, Theresa L Bender LPape, Theresa L Bender L
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02366754 STU00103966
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    Walsh, Elyse 708 968 0427
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    EFFORT TO REDUCE POSTOPERATIVE BRACHIAL NEUROPRAXIA THROUGH NERVE COMPRESSION
    The purpose of this study is to ultimately prevent injuries to nerves during surgical procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver) patients will rece…
    The purpose of this study is to ultimately prevent injuries to nerves during surgical procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver) patients will receive an arterial line as standard of care. The arterial line helps monitor blood pressure along with the compression of important vessels during surgery. In addition, research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation, neuromuscular monitoring can tell doctors if the nerves being studied are working normally or if they are at risk for injury. This study will help investigators to understand what kind of monitoring is best to prevent nerve injuries during a surgical procedure.
    Ladner, Daniela PLadner, Daniela P
    STU00105002
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    Loftus, Corinne 312 694 0260
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    Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic Efficacy
    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what c…
    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
    • Diagnosis of rheumatoid arthritis (RA).
    • Must have been 18 years of age or older at the time of diagnosis of RA.
    • At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
    Perlman, Harris RPerlman, Harris R
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00104822
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    Carns, Mary 312 503 1137
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    Effect of a Patient-Centered Decision App on TOLAC: An RCT
    Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly one third of births annually. In the last decade, the CD rate has increased by approximately 50%, with almost 1.3 million procedu…
    Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly one third of births annually. In the last decade, the CD rate has increased by approximately 50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been associated with an increase in major maternal morbidity (Silver 2010), with corresponding increases in length of inpatient care following delivery and frequency of hospital readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives have targeted reducing the CD rate as an important public health goal for more than a decade; however, identifying interventions to achieve this goal has proven challenging. Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the combination of a rising rate of primary CD and a decreasing rate of vaginal birth after cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010 (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of debate; the extent to which these changes are driven by patient preferences is not known. An NIH consensus conference statement noted that "the informed consent process for TOLAC and Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and incorporate a strong emphasis on the values and preferences of pregnant women," and recommended "interprofessional collaboration to refine, validate, and implement decision-making and risk assessment tools" to accomplish that goal (Cunningham 2010). Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer TOLAC consider individualized risk assessments, incorporate their values and preferences, and participate in a shared decision making process with their providers to make informed decisions about delivery approach. We are now conducting a randomized study of the effect of a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.
    Ages Eligible for Study: 18 Years and older (Adult, Senior)
    Sexes Eligible for Study: Female
    Accepts Healthy Volunteers: No
    Criteria

    Inclusion Criteria:

    Women with exactly one prior Cesarean Delivery.
    Current singleton pregnancy.
    Gestational age, 16-24 weeks.
    English or Spanish speaker.
    Must be receiving prenatal care at one of the participating centers.

    Exclusion Criteria:

    Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
    Prior VBAC.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT02646423 STU00104496
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    Williams, Brittney 1 312 503 3476
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    HOme-based moNitORed exercise for PAD
    This study will determine the effects of a home based walking exercise intervention on walking ability in people with peripheral artery disease (PAD).
    Peripheral artery disease
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02462824 STU00100697
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    Domanchuk, Kathryn J 312 503 6438
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    Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

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

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

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

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

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

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

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

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

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

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

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

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

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

    You may be eligible for this research study if you have head and neck cancer.
    Mittal, Bharat BMittal, Bharat B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01810913 STU00200314
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    Study Coordinator 312 695 1102
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    NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
    There are two study questions the investigators are asking in this randomized phase II/III trial b…
    There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
    Mittal, Bharat BMittal, Bharat B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02135042 STU00200330
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    Study Coordinator 312 695 1102
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    NU 14S03: A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
    The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The…
    The purpose of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control sarcomas. The safety of this drug combination will also be studied. Pazopanib hydrochloride and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Agulnik, MarkAgulnik, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02357810 STU00200112
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    Study Coordinator 312 695 1102
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    Ex vivo interactions between high-density-like nanoparticles and human blood
    This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Pr…
    This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an in-depth knowledge of the interaction of the HDL-NPs with human blood cells using safe ex vivo experiments.
    Healthy, non-pregnant adult (age >18-75 years) volunteers.
    Thaxton, Colby SThaxton, Colby S
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200368
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    Thaxton, Colby S 312 503 1826
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    NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

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

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

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200435
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    Study Coordinator 312 695 1102
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    Low InTensity Exercise intervention in PAD: The LITE Trial.
    This study is being done to determine whether an exercise intervention that avoids continuous supervision and exercise-related pain in the legs can improve walking ability in people with lower extremity peripheral artery disease (PAD).
    Peripheral artery disease
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02538900 STU00105855
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    Domanchuk, Kathryn J 312 503 6438
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    Advancing Research and Treatment for Frontotemporal Lobar Degeneration
    Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progre…
    Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials. This study is observational and requires a one-time visit, referred to as the Baseline visit. All ARTFL participants will co-enroll into the Alzheimer's Disease Core Center study. 
    1. Between 18 and 85 (inclusive) years of age.2. Able to walk (with assistance) at the time of enrollment.3. Have a reliable study partner who can provide an independent evaluation of functioning.4. Speak fluent English.5. Ability to sit for 4-5 hours to undergo cognitive testing, questionnaires, interviews, and a neurological exam.6. Meet the clinical diagnostic criteria for PSP, semantic PPA, CBS, bvFTD, FTD-ALS, or non-fluent PPA.
    Weintraub, SandraWeintraub, Sandra
    NCT02365922 STU00200202
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    Study Coordinator 312 503 5103
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    Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) P
    Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical managem…
    Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
    Eskandari, MarkEskandari, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02089217 STU00200290
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    Reinkensmeyer, Alexandra 312 695 4189
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    Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332)/ A5333s: Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE/A5361s: Pitavastatin to REduce Physical Function Impairment and Frailty in HIV (PREPARE)
    People infected wi…
    People infected with HIV are at risk for cardiovascular disease (CVD). REPRIEVE is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months. The trial is testing the effect of statin therapy on preventing heart disease and death in HIV-infected persons on HIV medications who do not meet guidelines for starting statins. HIV causes inflammation (irritation) inside the body that may contribute to diseases such as heart disease. HIV medications can lower inflammation, however the levels of inflammation can remain higher compared to people who are not infected with HIV. Statins, such as pitavastatin, are medications that are used to lower the levels of cholesterol and triglycerides (fat in the blood) and have been shown to lower levels of inflammation and heart disease.
    • HIV infected men and women between the ages of 40 and 75
    • On anti-HIV medications for at least 6 months
    • CD4 cell count greater than 100
    • No history of cardiovascular disease, such as heart attack, stroke, etc.
    • No history of cancer in the last 3 years
    • Not currently using a statin drug
    Taiwo, Babafemi OTaiwo, Babafemi O
    NCT02344290 STU00200323
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    Berzins, Baiba Ingrida 312 695 5012
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    The effect of magnesium on maternal mood, cognitive function, and birth experience
    Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less …
    Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.
    Miller, EmilyMiller, Emily
    NCT02454322 STU00200388
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    1-855-NU-STUDY
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    A Phase 3 Multicenter, Randomized, Placebo-Controlled Study to Determine the Efficacy of Topical SGX301 and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
    To evaluate the safety and effectiveness of the topical ointment (cream), SGX301, in combination with light the…
    To evaluate the safety and effectiveness of the topical ointment (cream), SGX301, in combination with light therapy in patients with cutaneous T-cell lymphoma.
    Must be 18 years of age or older, with a clinical diagnosis of Cutaneous T- Cell Lymphoma, Myucosis Fungoides, Stage IA. Stage IB, or Stage IIA, and willing to refrain from sunbathing for duration of the study.
    Guitart, JoanGuitart, Joan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02448381 STU00200530
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    Bagnowski, Katherine +1 312 503 3788
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    Lithium Therapy: Understanding Mothers, Mood and Metabolism
    We are working to understand how physiological changes during pregnancy and postpartum affect lithium blood levels. Changes in metabolism have the potential to lead to high lithium levels that can lead to toxicity or less than therapeutic li…
    We are working to understand how physiological changes during pregnancy and postpartum affect lithium blood levels. Changes in metabolism have the potential to lead to high lithium levels that can lead to toxicity or less than therapeutic lithium levels which may cause an increase in mood symptoms. Participating in this study will help researchers better understand how to adjust lithium dose in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

    Participation involves one overnight visit per trimester and two postpartum. Each visit includes expert evaluation, mood assessments, and blood draws. To compensate for your time and effort you will be eligible to receive up to $750 for your participation in the study. Validation for on-site parking will be provided. 

    To qualify for this study you must be: 

    • pregnancy planning or less than 27 weeks pregnant,
    • between the ages of 18 and 45, and  
    • taking lithium (Lithium Carbonate) and plan to continue taking it during and after pregnancy.

    Clark, CrystalClark, Crystal
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02490241 STU00200026
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    Montiel, Catalina +1 312 695 6010
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    A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
    A5324 is a randomized, double-blinded, placebo-con…
    A5324 is a randomized, double-blinded, placebo-controlled study for HIV-infected individuals with an undetectable HIV viral load who have at least mild neurocognitive impairment. Participants will be randomized to add either maraviroc plus dolutegravir, dolutegravir alone, or placebo to their current anti-HIV medications. The main purpose of the study is to see if intensification with maraviroc and dolutegravir will improve neurocognitive performance and functioning in persons who have at least mild neurocognitive impairment.
    • HIV-1 infected persons at least 18 years of age
    • On current HIV medications for at least 12 months
    • No prior or current use of any integrase inhibitor or maraviroc
    • HIV viral load less than 50 copies
    • Screening neuropsychological tests showing problems with memory, thinking or daily tasks
    Taiwo, Babafemi OTaiwo, Babafemi O
    NCT02519777 STU00200413
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    Berzins, Baiba Ingrida 312 695 5012
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    SPARC: Gene expression profiling in scleroderma to discover therapeutic targets and predict clinical course
    The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match tar…
    The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match targeted treatments to the appropriate patients. The study will also focus on identifying inflammatory and fibrotic molecular pathways that are important in the disease Participants will be asked to give: - Two punch skin biopsies from the forearm (size of a pencil eraser) - Two tubes of blood - Urine collection Participants will be paid $110 for the one-time study visit. We are recruiting both patients with scleroderma and healthy control subjects.
    Participants must be: Over age 18, No chronic skin conditions, No rheumatic autoimmune diagnosis (e.g., lupus, rheumatoid arthritis, scleroderma), Not currently pregnant.
    Varga, JohnVarga, John
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00200631
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    Carns, Mary (312) 503 1137
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    A Prospective Study of Early Stage Breast Cancer Patients with Abnormal Myocardial Deformation treated with Anthracycline and/or Trastuzumab and Pertuzumab-based cancer therapy.
    This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV funct…
    This study will help us to determine if prophylactic beta-blocker therapy, in patients with preclinical changes in LV function, will prevent a worsening of strain, allowing patients to stay on their chemotherapy treatment.

    Main Inclusion:

    • Patients > 18 years of age with HER2-overexpressing early stage breast cancer (Stages I – III)
    • Pathology report must include HER2 expression, estrogen and progesterone receptor status
    • Normal LV function (EF > 53%) on baseline echocardiogram
    • NYHA functional class I-II
    • Scheduled to receive treatment with anthracycline and/or trastuzumab and pertuzumab-based regimens

    Main Exclusion:

    • Pre-existing cardiac disease (moderate-severe coronary artery disease, moderate-severe valvular heart disease, constrictive/restrictive cardiomyopathies)
    • Metastatic breast cancer
    • Prior use of BB/ACE therapy
    • 2nd and 3rd degree AV block, Sick Sinus Syndrome, severe bradycardia (<50 BPM), or severe hypotension (SBP < 85 mmHg)
    • Severe liver dysfunction or moderate-severe asthma
    Akhter, NausheenAkhter, Nausheen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02993198 STU00200675
    More Info

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    Ramirez, Haydee +1 312 695 2928
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    A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis
    Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease …
    Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.
    Flamm, Steven LFlamm, Steven L
    NCT02308111 STU00200837
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    Gottstein, Jeanne H 312 694 0264
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    Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
    This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enr…
    This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
    Schaeffer, Anthony JSchaeffer, Anthony J
    NCT02514265 STU00200928
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    Corona, Maria Eugenia +1 312 503 3585
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    The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
    The aim of this trial is to determine whether midurethral sling (MUS), combined with injections of a prescription medicine used to treat urinary leakage is more effective than MUS alone in improving urinary incontinence sympto…
    The aim of this trial is to determine whether midurethral sling (MUS), combined with injections of a prescription medicine used to treat urinary leakage is more effective than MUS alone in improving urinary incontinence symptoms. The primary outcome of this study is to see if a midurethral sling combined with injections will help mixed urinary incontinence. This study is for women who plan on going midurethral sling surgery for their mixed incontinence.
    The study will include women undergoing mid-urethral sling surgery and have symptoms of both stress and urgency urinary incontinence. Participants that have a history of recurrent UTI's, undergoing concomitant prolapse surgery, and who have had previous bladder injections will not be considered eligible for the study.







    Kenton, KimberlyKenton, Kimberly
    • Map it 250 E. Superior St.
      Chicago, IL
    • Map it 676 N St. Clair Arkes Pavillion Suite 950
      Chicago, IL
    NCT02678377 STU00201249
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    For more information on this study please contact us:

    Tavathia, Meera 312 926 7748
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    Testing the ability of JNJ-18038683, a selective serotonin (5-HT)7 antagonist, to improve cognition and reduce residual depressive symptoms in stable bipolar patients
    This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in …
    This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in people who have bipolar disorder and are taking other medications for their illness. Mental function is how your brain works and includes your mood, memory and how you think and concentrate. An investigational drug is one that is not approved for sale by the US Food and Drug Administration (FDA) or any other regulatory or health agency. This study compares an experimental drug to a placebo. A placebo is an inactive substance made to look/taste like an active medicine. We expect that you will be in this research study for up to 10 weeks, including the screening period.
    Adults 18 to 60 years old with diagnosis of of bipolar disorder
    Meltzer, HerbertMeltzer, Herbert
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT02466685 STU00200919
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    Nikolajuk, Katie M 312 503 9076
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    A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)
    This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent earl…
    This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
    Grobman, William AGrobman, William A
    NCT02518594 STU00200799
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    Mallett, Gail +1 312 503 3200
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    ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

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

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

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

    You may be eligible for this research study if you:

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

    Flaum, LisaFlaum, Lisa
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02445391 STU00201173
    More Info

    For more information on this study please contact us:

    Study Coordinator 312 695 1102
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    An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies
    An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase …
    An Open Label Extension And Safety Monitoring Study Of Moderate To Severe Ulcerative Colitis Patients Previously Enrolled In Etrolizumab Phase II/III Studies
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02118584 STU00200583
    More Info

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    Arrieta, Rose +1 312 695 5878
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    Telmisartan Plus Exercise to Improve Functioning in PAD
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performan…
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
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    Domanchuk, Kathryn J 312 503 6438
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    Optimizing Medication Management for Mothers with Depression (OPTI-MOM)

    The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the

    blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body

    The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the

    blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body

    fluid) during pregnancy and postpartum. Taking the same medication dose when you are pregnant may result in

    an amount of drug in your blood that is different than when you are not pregnant. We will also study the impact

    of genetic factors on the amount of drug in your blood. Drug metabolism (how medications are broken down,

    absorbed, and removed from the body) differs among people because of their unique genetic make-up, which can

    cause medications to be metabolized faster or slower. This means that when two people with different genetic

    backgrounds take the same dose, the concentration of the medicine in their blood can vary dramatically.

    Changes in antidepressant concentrations are important to monitor because a decrease in the blood level of the

    drug may result in the antidepressant becoming ineffective and an increase in mood symptoms or recurrence of

    depression may occur. An increase in antidepressant concentration may lead to side effects. We aim to better

    understand the course of these changes across pregnancy and postpartum and determine how n woman’s genetic

    makeup affects these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of

    pregnant women.

    Pregnant women ages 18-45 years old less than 18 weeks pregnant with a singleton pregnancy taking sertraline (Zoloft), fluoxetine (Prozac), escitalopram (Lexapro), or citalopram (Celexa) and plan to continue this medication throughout pregnancy and through the first 4 months postpartum. 
    Wisner, KatherineWisner, Katherine
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00201386
    More Info

    For more information on this study please contact us:

    Mesches, Gabrielle +1 312 695 6684
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    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
    A Phase III, Randomized, Double-Blind, Placebo…
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02394028 STU00201257
    More Info

    For more information on this study please contact us:

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

    For more information on this study please contact us:

    Arrieta, Rose +1 312 695 5878
    Copy
    Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)
    Phase III, Double Blind, Pla…
    Phase III, Double Blind, Placebo Controlled, Multicenter Study Of The Efficacy And Safety Of Etrolizumab During Induction And Maintenance In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Refractory To Or Intolerant Of Tnf Inhibitors (Protocol GA28950)
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02100696 STU00200704
    More Info

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    Arrieta, Rose +1 312 695 5878
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    NU 15B01: A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort

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

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

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

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

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

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02536794 STU00200984
    More Info

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    Study Coordinator 312 695 1102
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    Chronic Kidney Disease Research Biorepository
    The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00201546
    More Info

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    Martinez, Carlos 312 503 1808
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    Degenerative Mitral Regurgitation in Intermediate Risk Patients 65 or older: Exercise Echocardiogram and HRQOL Post Surgery Preliminary Analysis
    The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 year…
    The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02604745 STU00201771
    More Info

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    Zinn, Sarah +1 312 926 2828
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    Improving Outpatient Safety of Older Adults through Electronic Patient Portals
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
    Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
    Lindquist, Lee ALindquist, Lee A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00201242
    More Info

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    Seltzer, Anne Jennifer 312 926 5159
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    ITN056ST: Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults
    The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or …
    The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
    Levitsky, JoshLevitsky, Josh
    NCT02533180 STU00201197
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    Kalume, Naomi +1 312 694 0601
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    Midwest Small Practice Care Transformation Research Alliance (MSPCTRA): H3 Healthy Hearts in the Heartland
    This study evaluates the ability of small primary care practices to 1) implement point-of-care and population management quality improvement strategies to improve cardiov…
    This study evaluates the ability of small primary care practices to 1) implement point-of-care and population management quality improvement strategies to improve cardiovascular quality of care (e.g., clinical decision support, patient education and counseling, or referral to smoking quit lines), and 2) implement the PopHealth performance measurement software to evaluate performance on the ABCS (aspirin when appropriate, blood pressure control, cholesterol management, and when applicable, smoking cessation) and allow regional benchmarking. This minimal risk study is a practice-randomized trial to determine a) whether point of care strategies improve ABCS performance measures compared to baseline, and b) whether adding locally tailored population management strategies to POC strategies improves performance on the ABCS measures more than POC strategies alone.
    Kho, Abel NKho, Abel N
    NCT02598284 STU00201720
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    1-855-NU-STUDY
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    Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients
    Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the eff…
    Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls.
    Leventhal, Joseph RLeventhal, Joseph R
    NCT02623075 STU00201741
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    1-855-NU-STUDY
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    High Resolution and Functional MRI Assessment of Intracranial Atherosclerotic Plaque
    Intracranial atherosclerotic disease (ICAD) accounts for 7-10% of cute ischemic stroke with a substantial risk of recurrent stroke in a setting of severe intracranial stenosis, approaching 12-25% over 1-2 years despi…
    Intracranial atherosclerotic disease (ICAD) accounts for 7-10% of cute ischemic stroke with a substantial risk of recurrent stroke in a setting of severe intracranial stenosis, approaching 12-25% over 1-2 years despite medical management. However, a risk stratification scheme is not available to identify this susceptible population for targeted treatment trials when intervention with more aggressive medical management and/or endovascular angioplasty/stenting could limit complications of ischemic stroke. The unmet need that we plan to address is to develop and study MR imaging modalities that may characterize vulnerable inflammatory and/or hemodynamically significant intracranial plaques, stratifying the mechanisms and potential predictors of primary/recurrent ischemic stroke in ICAD. Recently, we have identified unique intracranial plaque characteristics as well as hemodynamic parameters using quantitative MR perfusion techniques to stage cerebrovascular reserve failure that are associated with symptomatic intracranial stenoses. We propose a prospective study to recruit asymptomatic and symptomatic patients with severe ICAD and longitudinally assess them with a comprehensive and novel MRI protocol: high resolution 3T MR imaging, ferumoxytol molecular imaging, dynamic contrast enhanced (DCE) MRI to quantify the transfer constant (Ktrans) of contrast plaque permeability, and dynamic susceptibility contrast (DSC) MR perfusion weighted imaging (MRPWI) using the quantitative SCALE-PWI sequence. Our study hypothesis is that high resolution T1 plaque enhancement, T1/T2 plaque hemorrhage, early ferumoxytol uptake as a marker of macrophage infiltration/inflammation, intraplaque Ktrans permeability, and/or altered qCBF/qCBV perfusion based parameters with vascular territory analysis will assist in stratifying patient risk for thromboembolic versus hypoperfusion related ischemic complications respectively. This project aims to identify specific qualitative and quantitative thresholds with advanced high resolution, molecular, and functional MRI techniques that can be correlated to clinical presentations (asymptomatic, symptomatic, recurrent symptomatic), DWI infarct distributions (perforator, thromboembolic, hypoperfusion related infarcts), inflammatory blood markers, and clinical/imaging outcomes to inform an understanding of differential stroke mechanisms and to improve the selection of high risk ICAD patients who may be susceptible to primary or recurrent ischemic stroke despite aggressive medical management.
    Inclusion:
    1- Severe ICAD>70% confirmed by SOC CTA/MRA/DSA using SAMMPRIS criteria2
    2- AGE 30-80 YEARS
    3- At least one segment of
    a) supraclinoid ICA,
    b) A1-A2 ACA,
    c) M1-M2 MCA,
    d) intracranial vertebral-basilar artery
    e) P1-P2 PCA
    4- Age 30-80 years
    5- Symptomatic patients defined as an association between the intracranial stenosis and hemodynamic impairment of the corresponding vascular territory, based on either neurological exam (TIAs/stroke) and/or acute/subacute infarcts documented on MR-DWI

    Exclusion:
    1- Contraindications to MRI-Fill safety questionnaire day before MRI/Call to ask
    2- GFR70% cervical carotid or vertebral artery proximal stenosis, or tandem intracranial stenoses,
    5- Impaired liver function
    Ansari, Sameer AhmadAnsari, Sameer Ahmad
    STU00201681
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    Muzaffar, Ayesha 312 926 4251
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    Role Functioning Changes in New Onset Symptoms
    Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning. During this study the investigators will …
    Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning. During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. The primary outcome of the study is to correlate Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition. The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan. While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.
    Inclusion Criteria:

    Age 18 to 26 years
    Individuals seeking treatment for psychiatric symptoms in a clinical care setting
    Able to provide informed consent (age 18-26)
    Subjects must consent to a review of the medical records in order to track changes in clinical symptoms
    Fluent in English
    Exclusion Criteria:

    Adults unable to consent
    Individuals who have not reached the age of 18
    Pregnant women
    Prisoners.
    Cronenwett, Will JCronenwett, Will J
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    STU00201133
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    Jain, Ankit 312 503 9092
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    A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease
    The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
    • Subjects with type 2 diabetes mellitus
    • Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on the following criteria: Persistent very high albuminuria defined as urinary albumin-to-creatinine ratio (ACR) of > 300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) 25 - < 75 mL/min/1.73 m² Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months
    • Serum potassium
    Huang, WenyuHuang, Wenyu
    NCT02540993 STU00201605
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    Adelman, Daphne T 312 908 9002
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    DRUG EZH-202: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
    This study uses the investigational drug, tazemetostat (also called EPZ-6438). The sponsor’s research information shows the study d…
    This study uses the investigational drug, tazemetostat (also called EPZ-6438). The sponsor’s research information shows the study drug targets and kills certain cancer cells by stopping a gene called EZH2 from working. EZH2 is also involved in how the gene INI1 works incells. In laboratory studies, the study drug has been shown to slow down the growth of, or kill, cancer cells that are missing the INI1 gene in some way. Studies like this one will help understand more about whether the study drug will be a useful treatment in the future for people with cancer.
    We are asking you to take part in this research study because you may have one of the following specific types of cancers: Rhabdoid tumors, synovial sarcomas, Rare tumors that have an abnormal gene called INI1, other tumors that have an abnormality, also called mutation, in the EZH2 gene. To be part of this study, you must have been given approved therapy for your cancer in the past that did not work or a tumor for which there is no standard therapy available and must have no other options for effective therapy. 
    Agulnik, MarkAgulnik, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02601950 STU00201778
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    Study Coordinator 312 695 1102
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    SMART Weight Loss Management
    SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss…
    SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss and best follow-up approach for those who need more support from a weight loss program
    You are between the ages of 18 - 60 years old.
    You will live in the Chicagoland area for the next 12 months.
    You are NOT currently pregnant, trying to become pregnant, or breastfeeding.
    You do NOT have an unstable medical condition.
    You own an Android or iPhone smartphone.
    You are willing to track your lifestyle behaviors using a smartphone for 3 months.
    Spring, BonnieSpring, Bonnie
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    NCT02997943 STU00202075
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    Scanlan, Laura 312 503 1395
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    A collaborative Study to Evaluate the Efficacy of Prospective Post-Induction Infliximab Dosing Based on Trough Levels at Week 12 and 28 in Subjects with Crohn’s Disease (CD) and Ulcerative Colitis (UC)
    A collaborative Study to Evaluate the Efficacy of Prospective Post-Induction Infliximab Dosing Ba…
    A collaborative Study to Evaluate the Efficacy of Prospective Post-Induction Infliximab Dosing Based on Trough Levels at Week 12 and 28 in Subjects with Crohn’s Disease (CD) and Ulcerative Colitis (UC)
    Bellaguarda, EmanuelleBellaguarda, Emanuelle
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201255
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    Arrieta, Rose 312 695 5878
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    A Phase IIA, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of CRTh2 Antagonist AZD1981 in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
    AZD-1981 is an oral tablet drug, with two pills (20 mg each) taken three times daily (120 mg total). The…
    AZD-1981 is an oral tablet drug, with two pills (20 mg each) taken three times daily (120 mg total). The drug is a selective receptor antagonist, meaning AZD-1981 binds to a receptor located on the surface of a cell and blocks other cells from binding there. Without AZD-1981, when that normally open receptor is bound to, inflammation-causing eosinophils accumulate in the area. With AZD-1981 blocking that eosinophil-recruiting binding site, the number of eosinophils at that site should theoretically decrease which should reduce inflammation and therefore improve your nasal polyp symptoms.
    In order to qualify for the study you must have at least grade 2 nasal polyps in each nostril, with a total polyp score of at least 4.
    Peters, Anju TripathiPeters, Anju Tripathi
    NCT02874144 STU00202062
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    Hadzic, Amela 312 695 3530
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    The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure me…
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
    Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
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    Domanchuk, Kathryn J 312 503 6438
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    Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot Study
    Preeclampsia is a serious medical condition affecting pregnancy. Certain chemicals in your blood may increase your risk of developing preeclampsia. A medicine called pravastatin, which you take by mouth, may decr…
    Preeclampsia is a serious medical condition affecting pregnancy. Certain chemicals in your blood may increase your risk of developing preeclampsia. A medicine called pravastatin, which you take by mouth, may decrease the levels of these chemicals. The purpose of this pilot study is to determine how the body handles Pravastatin during pregnancy and to determine its safety.
    • Are 18 years or older
    • Currently between 12-16 weeks pregnant
    • Have a documented history of prior severe PE, requiring delivery before 35 weeks gestation
    Wisner, KatherineWisner, Katherine
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT01717586 STU00202090
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    Cattan, Minaz 312 695 7190
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    AAD-PEPR: Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
    The purpose of this study is to validate a specific itch tool and its relation to skin disease severity in children ages 5-17 who have symptoms of itch (ie, primary dermatologic conditions: atopic dermatitis, epidermoly…
    The purpose of this study is to validate a specific itch tool and its relation to skin disease severity in children ages 5-17 who have symptoms of itch (ie, primary dermatologic conditions: atopic dermatitis, epidermolysis bullosa, ichthyosis, psoriasis, etc; or other conditions that result in itch such as cancer and pruritic responses to therapy, chronic liver or renal diseases, patients who receive cancer therapy) The study will look at how well Patient Reported Outcomes Measurement Information System (PROMIS) tools uncover meaningful changes in disease status as well as build a list of items relating to pediatric skin diseases and a PRO model for signs and symptoms of skin disease. Surveys can be done remotely.
    Paller, AmyPaller, Amy
    • Map it 676 N. St. Clair St.
      Chicago, IL
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00202292
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    Ramachandran, Divya 312 503 5914
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    Sense2Stop: Mobile Sensor Data to Knowledge
    Sense2Stop is a 15-day smokingcessation research study that involves answering surveys on a study-providedsmartphone, smoking cessation counseling, 3 in-person lab sessions, andwearable sensors to detect smoking, eating, and stress. The aim of this res…
    Sense2Stop is a 15-day smokingcessation research study that involves answering surveys on a study-providedsmartphone, smoking cessation counseling, 3 in-person lab sessions, andwearable sensors to detect smoking, eating, and stress. The aim of this research is to build systems that can recognize when peopleare stressed and then provide them with relaxation prompts in the moment toreduce their likelihood of being stressed, smoking, or overeating in the nearfuture. Using these systems should help smokers be more effective in theirattempts to quit by reducing their tendency to lapse when they are stressed orexperiencing other negative moods or behaviors.
    -Age: 18 to 65 years old ; Smokes 1+ cigarettes/day for past year. ; Willing to try to quit smoking for at least 48 hours during a 15-day quit trial. ; Will not use non-cigarette tobacco products or nicotine replacement
    therapy during the study period ; Not taking or intending to take pharmacological smoking cessation aids
    (e.g., nicotine replacement, bupropion, venlafaxene) during the study
    period
    Spring, BonnieSpring, Bonnie
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03184389 STU00201566
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    Daly, Elyse 312 503 1317
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    A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
    The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxife…
    The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
    Some of the eligibility criteria include:

    - Participants must be postmenopausal women with newly diagnosed DCIS scheduled to undergo surgical therapy.
    - Patients must be able to swallow the oral medication.
    - Patients must be able to understand and the willing to sign a written informed consent document and comply to all procedures.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Kulkarni, SwatiKulkarni, Swati
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02694809 STU00202100
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    Study Coordinator 312 695 1102
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    Left Atrial Appendage Ligation with the LARIAT+® Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
    This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness…
    This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites - Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both stages will be included in the primary analysis.
    Lin, AlbertLin, Albert
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02513797 STU00201623
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    Carswell, Amy 312 926 7554
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    NU 15N01: Head and Neck Tissue Bank

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202162
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    Study Coordinator 312 695 1102
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    The Effect of KNO3 Compared to KCl on Oxygen Uptake in Heart Failure with Preserved Ejection Fraction
    KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and l…
    KNO3CK-OUT HFpEF: This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02840799 STU00202379
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    Dvorak, Stephen 312 695 4481
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    Motivational Interviewing and Physical Activity in Parkinson’s Disease
    We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coac…
    We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coaching style used to help people change their behavior; 2) a web-based application for participants to keep track of their physical activity; 3) a combination of the motivational interviewing and the web-based application; and 4) an educational program on various issues related to Parkinson’s disease.
    Live in the community
    At least 18 years of age
    A diagnosis of Idiopathic Parkinson’s Disease
    Be able to walk for a distance of 50 feet or 10 minutes at a time
    Do NOT currently complete 150 minutes or 2.5 hours of moderate to vigorous physical activity per week
    Currently has and uses a smartphone, tablet, or computer to access the internet
    Ehrlich-Jones, Linda SEhrlich-Jones, Linda S
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT03329833 STU00202265
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    Engel, Edeth 1 312 238 1405
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    A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS
    Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
    Huang, WenyuHuang, Wenyu
    NCT02685709 STU00202258
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    1-855-NU-STUDY
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    Semen quality in males with inflammatory bowel disease: Influence of medication for IBD
    Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
    Bellaguarda, EmanuelleBellaguarda, Emanuelle
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201469
    More Info

    For more information on this study please contact us:

    Arrieta, Rose 312 695 5878
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    A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Subjects with Painful Diabetic Peripheral Neuropathy (Protocol Number: VMDN-003)
    The purpose of this study is to determine the safety and efficacy of bilateral intramuscular inje…
    The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic neuropathy. A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups: Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects Randomization will be stratified by current use of gabapentin and/or pregabalin.
    1. 18-75 years, 2. Type 1 or 2 diabetes, 3. no significant changes to diabetes medication in last 3 months, 4. No new symptoms associated with diabetes for last 3 months, 5. Diagnosis of diabetic peripheral neuropathy in both lower limbs, 6, lower limb pain for at least 6 months, 7. No history of cancer. 8. No active infection or immuno-supression. 9. No amputations due to diabetes. 10. No proliferative diabetic retinopathy.
    Ajroud-Driss, SendaAjroud-Driss, Senda
    NCT02427464 STU00202112
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    Joslin, Benjamin 312 503 7504
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    North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) Study
    This is a non-interventional study (i.e. no study drug)

    NARCRMS is a highly collaborative effort involving investigators, industry, and, mostimportantly, patients. The goal of this effort is to make informati…

    This is a non-interventional study (i.e. no study drug)

    NARCRMS is a highly collaborative effort involving investigators, industry, and, mostimportantly, patients. The goal of this effort is to make information on all aspects of MS availableto all stakeholders in real-time. The feedback that patients will eventually receive will allowthem to evaluate themselves as compared to the whole cohort, and permit themselves to beactive participants towards their care. 

    The NARCRMS database is unique for the following reasons: 

    1. This is the only database in MS that is North American in scope. 

    2. This is the only database that is all encompassing. It examines every aspect of MS;clinical, imaging, biomarkers, pathology, healthcare economics, and pharmacotherapy. 

    3. This is the only database that makes available to all stakeholders in an anonymousformat the entire dataset, including imaging, in real-time.4. This is the only database that allows examination of therapeutic agents in a phase 4setting, after the launch of the agent. 

    Inclusion Criteria:

    • Age 18 to 65 years.
    • Relapsing-Remitting or progressive MS with clear date ofMS onset within 15 years. 
    • EDSS of 6.5 or less. 
    • Evidence of Clinical Isolated Syndrome. 
    • Willingness to participate and contribute data on an ongoing basis

    Exclusion Criteria:

    • Unclear date of onset. Onset with symptoms of fatigue,malaise, pain and other vague symptoms without adefinable neurological symptom-onset date. 
    • Concomitant confounding disorders like neuromyelitisoptica and idiopathic isolated transverse myelitis, and/orknown autoimmune disorders that can cause neurologicaldisorders, etc. 
    • Unwilling to participate for ongoing follow up collection ofdata. 
    • Any other factor that in the opinion of the principalinvestigator will render the individual unsuitable forparticipation. 

    Cohen, Bruce ArnoldCohen, Bruce Arnold
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00201852
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    Joslin, Benjamin
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    Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
    The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through…
    The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia: - Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through the stenotic artery. - Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue perfusion. - Vasomotor reactivity by Transcranial Doppler using the breath-holding technique (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the affected artery; - Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery embolism that reflects plaque instability. Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored. The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period. Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally.
    Inclusion
    1- Symptomatic stroke/TIA due to IAD

    2- Stenosis 70-99% measured on CTA/DSA/MRA as SOC (WASID criteria) and MRA flow gap (send to bay state)


    3-Stroke/TIA diagnosed on CT or MRI

    3- TIA with DWI abnormalities or ≥2 stereotyped events (weakness, aphasia)

    5- IAD-Intracranial Carotid
    MCA, Intracranial Vertebral,
    Basilar

    6- Age >30;
    7- 30-49 also IAD in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).

    8- Enrollment within 21 days of index event

    .
    Exclusion
    1- No ACA No PCA
    2- Other cause of stroke/TIA besides ICAD
    3- Angioplasty/stenting performed or planned on target vessel or on a vessel proximal to it.
    4- Contraindications to MRI,
    5- Pregnancy, lactation, morbid obesity, and severe claustrophobia.
    6- Cr >1.5 mg/dL or GFR
    Ansari, Sameer AhmadAnsari, Sameer Ahmad
    NCT02121028 STU00202274
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    Muzaffar, Ayesha 312 926 4251
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    LiveWell: A Mobile Intervention for Bipolar Disorder
    This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent …
    This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If you are eligible for the study, your participation will last up to 12 months.
    Individuals 18-65 years old who have been diagnosed with bipolar disorder and are currently working with a psychiatrist
    Goulding, EvanGoulding, Evan
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03088462 STU00202860
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    Jonathan, Geneva 1 312 503 9095
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    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for…
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02435992 STU00201568
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    Arrieta, Rose +1 312 695 5878
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    Defining the Skin and Blood Biomarkers of Ichthyosis
    Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper…
    Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper understanding of this disease is required to develop better treatments. There are different types of cells and cell-produced signals (biomarkers) that are being studied in order to help find these new treatments. Looking at biomarkers has been successful in helping us to understand other skin disorders better. The purpose of this study is to determine which blood and skin biomarkers characterize ichthyosis in children.
    Subjects (1 year to 60 years of age) with Autosomal Recessive Congenital Ichthyosis (ARCI), which includes lamellar Ichthyosis, Netherton Syndrome, or other ichthyosis subtypes will be enrolled.
    Healthy control subjects will be enrolled for either a blood sample or skin sample, and/or tape strip samples.
    Paller, AmyPaller, Amy
    • Map it 676 N. St. Clair St.
      Chicago, IL
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    • Map it 1131 Techny Rd.
      Northbrook, IL
    STU00203051
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    Canter, Talia 312 503 5917
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    Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
    Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y prom…
    Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
    (a) ≥ 18 years of age;
    (b) Hispanic/Latino self-identification;
    (c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
    (d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
    (e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
    Miller, GregMiller, Greg
    • Map it 633 N. St. Clair St.
      Chicago , IL
    NCT03344757 STU00203197
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    Pizarro, Edgar 312 503 3949
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    Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve card…
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
    We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
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    Domanchuk, Kathryn J 312 503 6438
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    Defining The Skin and Blood Biomarkers of Pediatric Atopic Dermatitis
    Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. A deeper understanding of this disease is required to develop new and better treat…
    Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. A deeper understanding of this disease is required to develop new and better treatments. There are different types of cells and cell-produced signals (biomarkers) that have been found in adults with AD. Nevertheless, there may be significant differences between AD in children versus adults. The purpose of this study is to determine which blood and skin biomarkers characterize AD in children by looking at the blood and skin biomarkers of children with AD and children without AD.
    This study will enroll children ages 0 months to 17 years to collect blood, skin, saliva and tape strip samples in order to look at biomarkers related to AD. Children who have or have not been diagnosed with AD or an atopic condition, such as allergies or asthma.
    Paller, AmyPaller, Amy
    • Map it 676 N. St. Clair St.
      Chicago, IL
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    • Map it 1131 Techny Rd.
      Northbrook, IL
    STU00203272
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    Canter, Talia 312 503 5917
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    PFF Patient Registry Protocol version 1.0 date 21.Jan.2016
    The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollmen…
    The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research
    Diagnosed with IPF
    Tomic, RadeTomic, Rade
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT02758808 STU00202873
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    Ansari, Adeeb 312 695 6021
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    (CIRB) A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1 (The Confirm Study)
    This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in…
    This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
    Ganger, Daniel RGanger, Daniel R
    NCT02770716 STU00203053
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    Gottstein, Jeanne H 312 694 0264
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    MAST CELLS IN MALE CHRONIC PELVIC PAIN AND LOWER URINARY TRACT DYSFUNCTION
    The purpose of this study is to figure out if drug treatments using cromolyn sodium and cetirizine hydrochloride lessen painful symptoms in patients suffering from chronic pelvic pain syndrome (CPPS).
    Men diagnosed with Category IIIB Chronic Pelvic Pain Syndrome reporting pain or discomfort in any of the 8 domains of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
    Thumbikat, PraveenThumbikat, Praveen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03167216 STU00202831
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    Thumbikat, Praveen 312 503 1050
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    Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

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

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

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

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

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

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02523014 STU00202953
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    Study Coordinator 312 695 1102
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    NU 15U06: A Phase 1 Dose-Escalation Study of Intravesical Pembrolizumab and Bacillus Calmette-Guerin (BCG) in Subjects with High Risk and BCG-Refractory Non-Muscle-Invasive Bladder Cancer
    Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerabili…
    Purpose The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of Pembrolizumab, when given as a single agent in patients with bladder tumors. Another purpose of the study is to see what tumor characteristics are associated with increased efficacy of the Pembrolizumab. Overview Pembrolizumab (MK-3475) is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body‰Ûªs immune system to work against tumor cells. Pembrolizumab is FDA approved for the treatment of advanced melanoma (a type of skin cancer) and some types of lung cancer. It is not yet approved by the USFDA for bladder cancer, hence it is considered an investigational agent for this disease. Description of Treatment All study participants will take the same study drug, Pembrolizumab. Pembrolizumab will be given intravesically through urethra. With intravesical therapy, doctor administers the drug directly into the bladder (through a catheter), rather than giving it by mouth or injecting it into a vein. During the first six weeks of therapy, one will also receive treatment with BCG as a standard of care. We expect that one will receive treatment for up to 1 year or until your disease gets worse (whichever occurs first). After completing treatment, the study team will continue to watch you for side effects for at least 30 days. The study team will also continue to check periodically to see how you are doing until your disease returns.
    Some of the eligibility criteria include:

    - Participants must have a recurrent, high or low risk non-muscle-invasive bladder carcinoma.
    - Participants must (be BCG refractory) have received at least one 6-week course of BCG induction plus 1 maintenance dose, OR 2 full 6-week courses of induction BCG treatment.
    - Participants must be 18 or older.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Meeks, Joshua JMeeks, Joshua J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02808143 STU00202754
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    Study Coordinator 312 695 1102
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    An Exploratory Phase II Study to Determine the Tolerability, Safety, and Activity of a Novel Vasopressin 1a Receptor Antagonist (SRX246) in Irritable Subjects with Huntington's Disease (HD)
    We are doing this research to find out whether a new investigational drug called SRX246, which might be useful …
    We are doing this research to find out whether a new investigational drug called SRX246, which might be useful to Huntington's Disease (HD) patients who sometimes feel irritable, angry, or even aggressive, is well tolerated and safe when it is given two times a day by mouth at doses as high as 160 mg. As part of this study, we will ask participants to complete a number of questionnaires related to mood and behavior in HD because we want to learn how to plan future studies of medicines that may help HD patients with these problems.
    INCLUSION: 1. Male and female Subjects aged 18 years or older; 2. Subjects must have clinical features of HD, which can include motor, cognitive, or
    behavioral symptoms; 3. A confirmatory family history of HD; OR CAG repeat expansion >36; 4. Availability of a responsible Study Partner who has good English skills, is familiar with the
    Subject, and is able and willing to comply with all required study procedures, ensuring that the Subject attends all study visits and takes the study medicine as instructed. The StudyPartner must spend time with the Subject a minimum of 4 times per week on 4 separate days, and must monitor the Subject's compliance and adverse events, participate in Study Partner
    assessments, and use the eDiary; 5. Medications prescribed for mood, behavior, or neurologic symptoms must be stable for 30 days prior to the Baseline Visit
    Bega, DannyBega, Danny
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT02507284 STU00202640
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    Ward, Tina 312 503 2128
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    A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma
    Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the stud…
    Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. In order for tumors to grow they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune (the study device) is also considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study device, Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient‰Ûªs brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed. Description of Treatment Tumor treatment field therapy with Optune will be initiated at the same time as bevacizumab, with both treatments to start within a one-week period of each other. Bevacizumab will be given at current standard central nervous system (CNS) dosing of 10mg/kg q2 weeks in an outpatient setting. After 4 cycles (1 cycle=28days) of therapy (Cycle 5 day 1) patients may choose to switch to bevacizumab at a dose of 15 mg/kg q3 weeks. For patients who chose to make this switch, they have to do it on Day1 of a new cycle. Tumor treatment fields with Optune will be delivered for at least 18 hours a day at a frequency of 200 KHz and intensity of 1-3V/cm. Treatment will be continued until disease progression or up to 1 year.
    "Some of the eligibility criteria include:

    - Patients must be age = 18 years. Both males and females and patients from all

    ethnic backgrounds are eligible.
    - Patients must have a histologic diagnosis of meningioma, WHO grade 2 or 3 (atypical or anaplastic).
    - All patients must have developed recurrent disease/progression after receiving all standard treatments.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial."
    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02847559 STU00203030
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    Study Coordinator 312 695 1102
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    (CIRB)-A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered by Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
    This is a double-masked, randomized, sham-controlled efficacy and safety study th…
    This is a double-masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.

    Key Inclusion Criteria:

    • Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure
    • Best corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure.
    • Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination

    Key Exclusion Criteria:

    • Present use or history of any treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine
    • Prior episode of NAION in the study eye only
    • Present use of drugs known to cause optic nerve or retinal toxicity at Day 1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
    • Any medical condition, concomitant therapy, or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye only
    • Clinical evidence of temporal arteritis
    Volpe, NicholasVolpe, Nicholas
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT02341560 STU00202830
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    Santillanes, Crystal 312 472 3627
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    NRG GY005-A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)

    This Phase III st…

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

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

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

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

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

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

    The purpose of this study is to compare…

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

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

    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02466971 STU00203105
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    Study Coordinator 312 695 1102
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    A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
    The main goal of …
    The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF.
    21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
    Guitart, JoanGuitart, Joan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02811783 STU00203078
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    Bagnowski, Katherine +1 312 503 3788
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    NU 16B06: Blood Based Prognostic Biomarkers of Breast Cancer Patients – Characterization of clustered CTCs to eliminate Breast Cancer Metastasis

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

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

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

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

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

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

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

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

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

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

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02133924 STU00203346
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    Study Coordinator 312 695 1102
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    Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
    The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be rand…
    The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be randomly assigned to one of three treatment conditions using a medical device known as CPAP, or using this device in combination with a behavioral treatment to improve sleep.
    Inclusion Criteria:
    Males and Females age 18 and older;
    Meets criteria for Obstructive Sleep Apnea;
    Meets criteria for an Insomnia Disorder; Able to make around 15 in-person visits over 7-9 months.
    Exclusion Criteria:
    Comorbid medical condition that requires immediate treatment of OSA;
    Severe cases of OSA that require immediate treatment;
    Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment;
    Comorbid sleep disorders that require treatment outside of the study protocol;
    Other sleep-related breathing disorder besides OSA;
    Excessive daytime sleepiness that requires immediate treatment or presents significant risk;
    CPAP use or formal CBT for insomnia within the past 6 months.
    Ong, Jason COng, Jason C
    NCT01785303 STU00203478
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    Yap, Bonnie 312 503 6627
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    Northwestern Scleroderma Twins Registry and Biorepository
    The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonuclei…
    The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonucleic acid, the genetic information that contains your genes) is nearly identical in twins, we are interested in studying what happens to change how the genes are read in the twin with SSc (epigenetics), when compared to how the same genes are read in the twin without SSc. Identifying these changes may help us to better understand why SSc occurs and to identify targets for treatment.
    • Age ≥ 18 years
    • At least one twin meets the 2013 American College of Rheumatology (ACR) criteria for the diagnosis of systemic sclerosis (affected twin)
    • Both twins agree to participate in the research study
    Varga, JohnVarga, John
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00203621
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    Carns, Mary 312 503 1137
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    Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase Disorder
    This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will i…
    This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity monitoring.
    Individuals with delayed sleep-wake phase disorder and healthy controls
    Abbott, SabraAbbott, Sabra
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203647
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    Abbott, Sabra 312 503 3561
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    DRUG AG-221-AML-005: A phase 1B/2 open-label, randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant targeted therapies plus azacitidine: oral AG-120 plus subcutaneous azacitidine and oral AG-221 plus SC azacitidine in subjects with newly diagnosed acute myeloid leukemia harboring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive induction chemotherapy

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

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

    - Adults at least 18 years of age

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

    - Have an IDH1 or IDH2 gene mutation

    - Not candidates to receive intensive IC.

    Frankfurt, OlgaFrankfurt, Olga
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02677922 STU00203231
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    Study Coordinator 312 695 1102
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    A wearable myoelectric-computer interface to reduce muscle co-activation in acute and chronic stroke
    We are conducting a study investigating the use of small wearable devices, called myoelectric computer interfaces, to reduce abnormal arm muscle coordination in individuals with impaired arm movement …
    We are conducting a study investigating the use of small wearable devices, called myoelectric computer interfaces, to reduce abnormal arm muscle coordination in individuals with impaired arm movement from a stroke. Training will take place predominantly at home, with some sessions in the lab as well. This study could potentially lead to improved arm function for stroke survivors who have abnormal arm coordination. 

    At  least 18 years of age

    - Had a stroke more than 6 months ago

    - No large impairment in vision (glasses), memory, language or concentration

    - Not currently participating in another research study on the arm

    Slutzky, Marc WSlutzky, Marc W
    • Map it 320 E. Superior Ave. Searle 11
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    STU00203644
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    Hung, Na-Teng 312 503 4816
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    ACTG A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
    This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away …
    This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.
    • Men and women, at least 18 years old
    • Have certain lab tests done that confirm very early HIV infection (ie. before the blood shows that antibodies have been made, or just at the time antibodies are starting to be found in the blood)
    • Be willing to take drugs to treat HIV right away.
    Taiwo, Babafemi OTaiwo, Babafemi O
    NCT02859558 STU00203124
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    Berzins, Baiba Ingrida 312 695 5012
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    Alzheimer’s Disease Neuroimaging Initiative 3
    The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through …
    The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios. This is a non-randomized natural history non-treatment study. Participants will need to be 55 - 90 years, otherwise healthy with no neurologic disease such as Alzheimer's disease. Approximately 1070 - 2000 participants will be enrolled at approximately 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts. Subjects will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.
    - No history of major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia.
    - Must be between the ages of 55-90 years (inclusive).
    - Must have a study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol.
    - Must have visual and auditory acuity adequate for neuropsychological testing.
    - Must be in good general health with no diseases expected to interfere with the study.
    - For females only: Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
    - Must be willing and able to participate in a longitudinal imaging study lasting up to 5 years.
    - Must have completed six grades of education or has a good work history (sufficient to exclude mental retardation).
    - Must speak English fluently.
    - Must be willing to undergo repeated MRIs (3Tesla) and at least two PET scans - must not have any MRI contraindications (i.e. pacemaker, claustrophobia)
    - Must agree to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking.
    - Must agree to collection of blood for biomarker testing.
    - Must agree to at least one lumbar puncture for the collection of CSF.
    - Must agree to share genomic data and biomarker samples.
    Rogalski, Emily JoyRogalski, Emily Joy
    NCT02854033 STU00203359
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    Muse, Brittanie +1 312 503 5674
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    Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
    Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have hear…
    Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin every day. That way, we can learn which is better in terms of reducing the risk of heart attacks, strokes, bleeding, and death. We expect up to 15,000 subjects with heart disease from across the U.S. will take part in ADAPTABLE.
    Criteria


    Inclusion Criteria:
    • Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
    • Age ≥ 18 years
    • No known safety concerns or side effects considered to be related to aspirin, including
    • No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
    • No history of significant GI bleed within the past 12 months
    • Significant bleeding disorders that preclude the use of aspirin
    • Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
    • Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
    • Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
    • Female patients who are not pregnant or nursing an infant
    • Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
    • Age > 65 years
    • Serum creatinine > 1.5 mg/dL
    • Diabetes mellitus (Type 1 or Type 2)
    • 3-vessel coronary artery disease
    • Cerebrovascular disease and/or peripheral arterial disease
    • Left ventricular ejection fraction (LVEF) < 50%
    • Current cigarette smoker
    • Chronic systolic or diastolic heart failure
    • SBP > 140 (within past 12 mos)
    • LDL > 130 (within past 12 mos)

    Exclusion Criteria:
    • There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
    • Patients and sites interested in participating must be part of the listed health systems collaborators.
    Kho, Abel NKho, Abel N
    • Map it 675 N. St. Clair St.
      Chicago, IL
    NCT02697916 STU00203465
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    Nodal, Mercedes 312 503 4260
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    Stellate Ganglion Blockade for the Management of Vasomotor Symptoms
    This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot flashes in post menopausal women. You will be asked to come downtown for 5 visits over …
    This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot flashes in post menopausal women. You will be asked to come downtown for 5 visits over the period of 7 months. During this time, you will keep a daily diary, wear a hot flash monitor for 24 hrs at three time points, a sleep and activity watch for 72hrs at 3 time points, and complete memory testing. You will be given a parking pass and compensation for your participation. If you're interested and would like to learn more, please click on the buttons to the right to call or email our study team.
    female, post-menopausal (no menstrual periods), 40-65 years old, moderate to severe hot flashes
    Walega, David RWalega, David R
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02907983 STU00203490
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    Oldaker, Kelsey 312 472 6754
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    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

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

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

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

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

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

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
    More Info

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    Study Coordinator 1 312 695 1102
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    Early Feasibility Study of the Edwards EVOQUE Mitral Valve Replacement System for the Treatment of Moderate to Severe Mitral Regurgitation, Study 2013-05C
    This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart su…
    This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. Mitral regurgitation, MR, is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that is simpler than traditional open-heart procedure and may be safer for patients who are at a higher risk from open-heart surgery. The new device is called the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transseptal and Transapical Delivery Systems). The CardiAQ™ TMVI system is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transseptal) or through an incision in the chest between the ribs (transapical). The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 8 scheduled study visits after discharge from the hospital at 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
    Patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. General Criteria:
    1. Greater than or equal to 18 years of age.
    2. New York Heart Associate Classification ≥ II
    3. Left Ventricular Ejection Fraction ≥ 30%.
    4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe) where EROA ≥ 0.30 cm2 or VC width ˃ 0.7 cm.
    5. Patient is determined to be high surgical risk but operable as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). Inclusion of a heart failure specialist is strongly recommended.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02718001 STU00204104
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    Brady, Caitlin 312 926 5968
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    The effects of capsinoids on brown adipose tissue recruitment and activation in obesity
    This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in in…
    This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in individuals with excess weight. Previous studies have suggested that chronic consumption of capsinoids may be able to generate new brown fat in thin individuals. Capsinoids may also have a small positive effect on metabolism (increased calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more treatment options for people with excess weight.
    Male, between ages 18-50, healthy, non-smoking, overweight/obese
    Neff, Lisa MNeff, Lisa M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03110809 STU00204058
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    Hakamy, Beth +1 312 503 7203
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    Improve PAD PERformance with METformin: The PERMET Trial
    The purpose of this study is to establish whether metformin improves walking ability in people with PAD.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03054519 STU00203784
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    Domanchuk, Kathryn J 312 503 6438
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    Reducing Assessment Barriers for Patients with Low Literacy
    This study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
    You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation.
    Griffith, James WGriffith, James W
    STU00204308
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    Serrano, Eloisa +1 312 503 6501
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    OT-15-001: A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
    Purpose The purpose of this study i…
    Purpose The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Overview Elfornithine is an experimental drug. An experimental drug means that the United States Food and Drug Administration (FDA) has not approved it for use. This drug will be used with another drug called Lomustine that is approved by the FDA in the United States for patients with anaplastic astrocytoma. Description of Treatment This study has two study groups. Patients will be randomly placed in one of the 2 groups.
    Some of the eligibility criteria include:

    - Participants must be 18 years of age or older.

    - Patients must have surgical or biopsy proven diagnosis of WHO grade 3 Anaplastic Astrocytoma

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02796261 STU00203957
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    Study Coordinator 312 695 1102
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    NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
    Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
    Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
    Some of the eligibility criteria include:

    - participants must have been diagnosed with prostate cancer that is metastatic (has spread outside of the prostate region) and castration-resistant (means the cancer is still growing even when testosterone levels are close to zero)
    - participants must be males 18 years of age or above

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03012321 STU00203960
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    Study Coordinator 312 695 1102
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    NU 16C01: A Phase 0 first-in-human study using NU-0129: a spherical nucleic acid (SNA) gold nanoparticle targeting BCL2L12 in recurrent glioblastoma multiforme or gliosarcoma patients
    Purpose The purpose of this research study is to evaluate the safety of NU-0129 SNA gold nanoparticle infusion in …
    Purpose The purpose of this research study is to evaluate the safety of NU-0129 SNA gold nanoparticle infusion in patients with recurrent glioblastoma multiforme or gliosarcoma Overview This is a first-in-human trial to determine the safety of NU-0129. The study drug is composed of a small gold nanoparticle that has spherical nucleic acid attached to it. This small particle allows NU-0129 to cross the blood brain barrier (a filtering mechanism that carry blood to the brain). Once within the tumor, the nucleic acid component is able to target a gene called Bcl2L12 that is present in glioblastoma multiforme, and is associated with tumor growth. This gene prevents tumor cells from apoptosis, which is the process of programmed cell death, thus promoting tumor growth. Researchers think that targeting the Bcl2L12 gene with NU-0129 will help stop cancer cells from growing. Description of Treatment All study participants will receive the same study drug, NU-0129, given through vein one time over 20 minutes as an inpatient. Within two days of getting this drug, participants will have a tumor resection surgery, recommended by their doctor. The study team will continue to watch for any side effects for at least 4 weeks with clinic visits and lab tests done each week. The study team will also continue to check how the subjects are doing with a clinic visit at least every 3 months for up to 2 years or until their disease comes back.
    Some of the eligibility criteria include:

    - Patients should have a diagnosis of recurrent glioblastoma multiforme (GBM) or gliosarcoma (GS) after failing prior therapy.
    - Eligible patients must be surgical candidates where surgery is felt to be an appropriate treatment option.
    - Patients must be 18 or older.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03020017 STU00203790
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    Study Coordinator 312 695 1102
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    NU 16H07: Phase II Trial of Pembrolizumab in Combination with ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma
    The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regim…
    The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called “ICE” and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently FDA approved for the treatment of melanoma, but has not yet been investigated in Relapsed/Refractory Hodgkin Lymphoma. The ‘ICE’ regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. This is a phase II study of these drugs used in combination. For patients who have a relapse of their Hodgkin’s lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure. Research continues to find for the best regimen to obtain a complete remission in this setting.
    Some of the eligibility criteria include:
    • Patients must have a histologically confirmed diagnosis of classical Hodgkin lymphoma.
    • Patients must have relapsed/refractory disease, with at least one line of prior chemotherapy, but not more than 2 prior lines of treatment, for Hodgkin lymphoma.
    • Patients 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.
    Winter, Jane NormaWinter, Jane Norma
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03077828 STU00203658
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    Study Coordinator 312 695 1102
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    A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND)
    Levodopa and Carbidopa are registered and widely used by Parkinson’s disease su…
    Levodopa and Carbidopa are registered and widely used by Parkinson’s disease subjects. The medication is given as pills, whilst the study drug is given as a solution in a continuous subcutaneous infusion. This study is based on the assumption that treatment which will enable the administration of levodopa to the brain in a more continuous way compared to the current standard treatment could constitute a more effective treatment for Parkinson’s subjects, with less of the known side effects of this treatment.
    Must be individual with Parkinson's disease on stable doses of Levodopa/carbidopa >4/day or Rytary >3/day with "OFF" periods ≥ 2.5 hours per day.
    Simuni, TatyanaSimuni, Tatyana
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT02726386 STU00203747
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    Poon, Cynthia 312 503 8216
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    A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
    EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. T…
    EGFR inhibitors are biologic agents used to treat certain cancers including non-small cell lung, colorectal, head and neck, and pancreatic carcinomas. These agents often have a side effect of an acne like rash that in some cases can be quite severe. This rash has been shown to be inflammatory in origin but is currently treated with antibiotics if it appears. The main goal of this study is to test if patients treated with steroid cream, (added) which is an anti-inflammatory medication, (added) before a rash develops have a less severe rash than patients who do not use a steroid cream before a rash develops.
    Must be 18 years of age or older with a diagnosis of cancer and starting an (changed from 'and') EGFR inhibitor. During the study you must be willing to fill out a daily diary, use sunscreen and cream daily, and fill out 2 questionnaires and have photographs taken every 2 weeks for 4 visits.
    Choi, JenniferChoi, Jennifer
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03115567 STU00203631
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    Erickson, Maia 312 503 4347
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    Prevalence of aneuploidy in ectopic pregnancies
    The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectop…
    The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectopic pregnancies may implant outside of the uterus because they are chromosomally abnormal. The tissue from the ectopic pregnancy, called products of conception, that was removed at the time of your surgery will undergo genetic testing to identify if the pregnancy implanted in the wrong place due to a genetic abnormality with the fetus. Results of the genetic analysis of your ectopic pregnancy tissue will be made available to you. You and the biological father of the ectopic pregnancy will also be required to provide a cheek swab sample for analysis.
    Inclusion: 1) Women with previous ectopic pregnancy that required surgery while under care at Northwestern Memorial Hospital; 2) Biological father of ectopic pregnancy willing and able to participate; 3) English-speaking.
    Feinberg, EveFeinberg, Eve
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203775
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    Feinberg, Eve
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    Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort
    The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers wil…
    The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find new treatments for the disease. People from many countries contribute to Enroll-HD.
    Individuals 18 yrs or older affected by Huntington's Disease (HD) or from a HD family or are a "community control" (a person who does not carry the HD genetic mutation that causes Huntington's disease and is not part of an HD family, but would like to participate in the study). Research visits are conducted yearly and will consists of a collection of medical and family history and biological samples.
    Bega, DannyBega, Danny
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    STU00203021
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    Brown, ZsaZsa 312 503 4121
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    ELUCDITATING THE MOLECULAR MECHANISMS UNDERLYING CYP2D6 INDUCTION DURING PREGNANCY
    We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimest…
    We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimesters. Drug metabolism is controlled by certain genes in the body. This study will be examining the up-regulation of a certain enzyme in the liver called CYP2D6, which helps the body process many different drugs. We will measure compounds related to vitamin A, which we think might be involved in the process that speeds up the enzyme activity, from blood samples. The primary goal of our research is to understand how drug metabolism changes across pregnancy. The secondary goal is to define how the activity of enzymes in the liver are up-regulated (increased) during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.
    • Are 18-45 years of age
    • Are currently at or less than 13 weeks pregnant
    • Speak English
    • Singleton Gestation (not pregnant with twins)
    • Able to present for blood sampling between 8am-noon once per each month of pregnancy, and for two months postpartum
    Wisner, KatherineWisner, Katherine
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00204600
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    Mesches, Gabrielle 1 312 695 6127
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    Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
    This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening i…
    This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2. A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture. 3. Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture. 4. A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture. 5. A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening condition The study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
    Primary Inclusion Criteria: 

    • Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.  
    • Age ≥18 years at time of informed consent signature Subject is capable of complying with protocol requirements, including follow-up Informed Consent Form (ICF) is signed by Subject or legal representative 
    • Must have appropriate proximal aortic landing zone
    • Must have appropriate target branch vessel landing zone For patients with aneurysm/isolated lesion 
    • Must have appropriate distal aortic landing zone. 
    Primary Exclusion Criteria: 

    • Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair 
    • Previous endovascular repair of the ascending aorta 
    • Previous endovascular repair of the DTA with a non-Gore device 
    • Surgery within 30 days prior to enrollment 
    • Myocardial infarction within 6 weeks prior to treatment 
    • Stroke within 6 weeks prior to treatment. 

    Hoel, AndrewHoel, Andrew
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02777593 STU00203850
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    Reinkensmeyer, Alexandra 312 695 4189
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    INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)
    We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight…
    We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors.

    1 year, 2 visits.

    40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02634268 STU00204332
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    Hixon, Jenny Lorraine 312 926 0975
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    (xIRB) DRUG 2215-CL-0201: A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
    Purpose The purpose of the study is to see if a medicine called ASP2215 given alone or in combination with azacitidine is both effective and safe as a treatment for AML patients with mutations in the FLT3 gene when compared to being treated with azacitidine alone. Overview ASP2215 is a drug that is designed to slow down the growth of leukemic cells by blocking FLT3 protein on those cells. ASP2215 is an experimental drug that is being studied to treat AML. It is being tested in clinical trials and has not been approved by U.S. Food and Drug Administration (FDA) and/or any other regulatory authorities for any indication. Description of Treatment Participants will be randomly (like flipping a coin) assigned to one of three treatment groups: * Group A: ASP2215 given alone; * Group AC: ASP2215 given in combination with azacitidine chemotherapy; * Group C: azacitidine chemotherapy given alone. During the treatment period, the study is divided into periods of time called cycles. Each cycle lasts 28 days. Participants will come into the clinic each cycle for visits to get more study drug and to evaluate AML and other related health assessments.
    Some of the eligibility criteria include:

    - Participant is at least 18 years old.
    - Subject has a diagnosis of previously-untreated AML.
    - Subject is positive for FLT3 mutation (ITD or TKD [D835/I836] mutation) in bone marrow or whole blood.

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Dinner, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02752035 STU00203834
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    Study Coordinator 312 695 1102
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    The Role of Circadian Dysfunction in Hepatic Encephalopathy in Patients with Cirrhosis
    Individuals with advanced liver disease (cirrhosis) often report new or worsening sleep problems. 
    1) Diagnosis of end-stage liver disease or cirrhosis; 2) being evaluated for liver transplant; 3) Age >=18yo; 4) fluent in English; 5) no severe kidney disease (for example, patients currently on dialysis are not eligible)
    Kim, MinjeeKim, Minjee
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204423
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    Menzel-Smith, Julia 312 503 3781
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    Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)
    The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurolo…
    The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
    • Age 18 and older
    • Presence of symptoms and signs of ataxia
    • Molecular diagnosis of SCA 1, 2, 3, 6 either in the participant or an affected family member
    • Willingness to participate in the study and ability to give informed consent.
    Opal, PuneetOpal, Puneet
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT01060371 STU00204294
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    Brown, ZsaZsa 312 503 4121
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    The Molecular Markers of Bladder Cancer
    Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
    Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
    Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
    Meeks, Joshua JMeeks, Joshua J
    STU00204352
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    312 695 8146
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    Losartan Effects on Emphysema Progression (LEEP)
    This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms…
    This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD. Losartan is a medicine used for treatment of high blood pressure. Losartan has been shown to slow the damage to lungs caused by COPD in animals. We would like to find out if taking Losartan can slow the damage to lungs caused by COPD. We will use images of participants’ lungs taken with high resolution computed tomography (HRCT) to measure changes in the lung. We also want to find out if Losartan has effects on blood and breathing tests.
    40 years of age or older with COPD, controlled blood pressure, no flare of COPD in the last 6 weeks or the use of antibiotics or prednisone
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02696564 STU00204797
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    Hixon, Jenny Lorraine 312 926 0975
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    REdefining THerapy IN early COPD

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

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

    12 weeks, 2 visits and 1 phone call.

    Age 40-80

    Current or former smoker

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

    Kalhan, RaviKalhan, Ravi
    NCT02867761 STU00204372
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    Frederick, Alyssa +1 312 695 4828
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    A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with an Acute, Complicated Type B Aortic Dissection
    This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissect…
    This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissection. One way to repair an acute, complicated type B aortic dissection is with an endovascular stent-graft. A stent-graft is a polyester fabric tube (graft) sewn onto metal springs (stent). The stent-graft is compressed inside a narrow plastic tube called a delivery system, which is inserted into the blood vessels in the groin area (femoral/iliac artery) and then threaded through the blood vessels to be placed at the area of the dissection inside the aorta.This research study will assess and evaluate safety and performance of an endovascular stent graft called the RelayPro Thoracic Stent-Graft System (the “Study Device”). The Study Device is investigational, which means it is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.We expect that participants will be in this research study for approximately 5 years after their endovascular repair procedure. Participants will return to clinic at 1-month, 6-months, and 1-year, and then annually out to 5 years. These visits are considered part of standard care, and the results of test done at these visits will be recorded for the study.We expect up to 5 people here will be in this research study out of 80 people in the entire study nationally.
    Inclusion Criteria: 

    • Subject must have an acute (symptom onset to diagnosis within 2 weeks) or 
    • Subacute, complicated type B aortic dissection 
    • Proximal and distal aortic neck with diameter between 19 mm and 42 mm. 
    Exclusion Criteria: 

    • Diagnosis of traumatic injury or transection of the descending thoracic aorta. 
    • Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device. 
    • Planned coverage of left carotid or celiac arteries; or anatomic variants that would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization. 
    • Prior endovascular or surgical repair in the descending thoracic aorta.

    Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03033043 STU00204570
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    Brady, Caitlin 312 926 5968
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    A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
    This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (TH…
    This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally.
    *Main Inclusion Criteria*
    Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

    *Main Exclusion Criteria*
    Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
    Severe regurgitation (>3+) or stenosis of any other valve.
    Failing valve is unstable, rocking, or not structurally intact.
    Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03003299 STU00204739
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    Kats, Lauren 312 926 1096
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    Long-Term Nicotine Treatment of Mild Cognitive Impairment
    The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been …
    The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function. The study will enroll participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.
    Inclusion Criteria:
    1. Subject must have a subjective memory concern as reported by subject, study partner, or clinician
    2. Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:
    - less than or equal to 11 for 16 or more years of education
    - less than or equal to 9 for 8 - 15 years of education
    - less than or equal to 6 for 0 - 7 years of education
    3. Mini-Mental State Exam score between 24 and 30, inclusive
    4. Clinical Dementia Rating (CDR) Global = 0.5. Memory Box score must be at least 0.5
    5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the time of the screening visit
    6. Age 55-90 (inclusive)
    7. Stable permitted medications for 4 weeks or longer as specified in Section 6, including: • Memantine is allowable if stable for 12 weeks prior to screen
    8. No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4
    9. Geriatric Depression Scale score of less than or equal to 9
    10. Study Partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject
    11. Adequate visual and auditory acuity to allow neuropsychological testing
    12. Good general health with no additional diseases/disorders expected to interfere with the study
    13. ECG without clinically significant abnormalities that would be expected to interfere with study participation
    14. Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
    15. Completed six grades of education or has a good work history
    16 Must speak English fluently
    Exclusion Criteria:

    1. Regular use of tobacco products within the past year, such as smoking (cigarettes, pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes, nicotine patches, gum, sprays, etc.).
    2. Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
    3. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
    4. History of schizophrenia (DSM V criteria)
    5. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
    6. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
    7. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
    8. Clinically significant abnormalities in B12 or TFTs (Thyroid Function Tests) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
    9. Clinically significant abnormalities in screening laboratories or ECG.
    10. Residence in skilled nursing facility.
    11. Use of any excluded medication as described in the protocol, including:
    12. Use of cholinesterase inhibitors or centrally acting cholinergic drugs
    13. Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
    14. For CSF sub-study participants, a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT (partial thromboplastin time) at screening
    15. For MRI sub-study participants, contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
    16. Patients whom the Site PI deems to be otherwise ineligible.
    Grant, IanGrant, Ian
    • Map it 676 N. St. Clair St. Suite 945
      Chicago, IL
    NCT02720445 STU00204222
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    Muse, Brittanie +1 312 503 5674
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    A Randomized Trial of Pessary in Singleton Pregnancies with a Short Cervix (TOPS)
    Eligible and consented women who are pregnant with one baby and have a short cervix when measured during an ultrasound performed between 16 week - 23 weeks are assigned to pessary placement or standard of care (no pes…
    Eligible and consented women who are pregnant with one baby and have a short cervix when measured during an ultrasound performed between 16 week - 23 weeks are assigned to pessary placement or standard of care (no pessary).
    cervical length less than or equal to 20 mm when measured between 16 weeks -23 weeks of singleton pregnancy
    Grobman, William AGrobman, William A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT02901626 STU00204650
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    Mallett, Gail 312 503 3200
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    NU UP16M02 The BAMM Trial: BRAF, Autophagy and MEK inhibition in Metastatic Melanoma: A Phase I/II Open Label Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients with Advanced BRAF Mutant Melanoma

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

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

    The purpose of this study is to:

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

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

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02257424 STU00204561
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    Study Coordinator 1 312 695 1102
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    Enhancing Maneuverability Following Incomplete Spinal Cord Injury
    Participants in this study will: • Complete several clinical tests of balance and walking function • You will walk on a treadmill either with or without balance assistance and challenges that are created by the rehabilitation rob…
    Participants in this study will: • Complete several clinical tests of balance and walking function • You will walk on a treadmill either with or without balance assistance and challenges that are created by the rehabilitation robotic device
    • Age 18 to 70 years

    • No history of significant neurological, orthopedic, cardiorespiratory, or metabolic disease which may limit walking ability

    • Ability to walk continuously without assistance for 10 minutes.

    Gordon, Keith EdwardGordon, Keith Edward
    STU00204732
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    Woodward, Jane 312 503 7081
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    Multicenter, randomized, double-blind, placebo controlled study to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of GZ/SAR402671 in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant.
    A study to assess an experimental oral d…
    A study to assess an experimental oral drug (GZ/SAR402671) in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant. There are 2 parts to this trial. Part 1 will be conducted to decide what will be the best dose of the study drug to use in Part 2 of this trial. The total expected duration of this study will be approximately 11 months for Part 1 and 12 months for Part 2.
    Male or female subjects with a diagnosis of PD and who are heterozygous carriers of a GBA mutation.
    Simuni, TatyanaSimuni, Tatyana
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT02906020 STU00204431
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    Poon, Cynthia 312 503 8216
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    A PHASE I STUDY OF NEURAL STEM CELL BASED VIROTHERAPY IN COMBINATION WITH STANDARD RADIATION AND CHEMOTHERAPY FOR MALIGNANT GLIOMA
    Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Bas…
    Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diganosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.
    Inclusion Criteria:
    •Patients must have presumed malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of stereotactic biopsy or resection prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
    •Tumor must be accessible for injection and must not be located in the brainstem, or contained within the ventricular system.
    •Planning to undergo standard radiation/chemotherapy
    •18 years of age or older.
    •Performance status must be KPS ≥ 70
    •SGOT (AST) < 3x upper limit of normal
    •Serum creatinine < 2mg/dl
    •Platelets > 100,000/mm3 and WBC > 3000/mm3

    Exclusion Criteria:
    •Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection.
    •Immunosuppressive drugs (with exception of corticosteroid).
    •Known HIV+ patients.
    •Acute infections (viral, bacterial or fungal infections requiring therapy).
    •Pregnant or breast-feeding patients.
    •Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
    •Prior radiation therapy to the brain or prior treatment for brain tumor Other serious co-morbid illness or compromised organ function
    Lesniak, MaciejLesniak, Maciej
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03072134 STU00203933
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    Amidei, Christina 312 695 9124
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    Corrona Psoriasis Registry
    The main purpose of the Corrona Psoriasis registry is to learn more about psoriasis, how doctors treat psoriasis, how well medications and treatments work, and the safety of those treatments.
    To be eligible, you need to be 18 years of age or older, have been diagnosed with psoriasis by a dermatologist, and have started on or switched to a systemic biologic psoriasis treatment within the previous 12 months by a Northwestern dermatologist.
    Amin, AhmadAmin, Ahmad
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00203552
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    psoriasis

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    Paiva Costa TeixeiraFigueiredo, Anna Carolina 312 503 5909
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    EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)
    This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with …
    This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..

    • Age > 18 and < 120 at the screening visit 
    • Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea 
    • Ejection fraction (EF) ≥ 45% as determined on imaging study within 24 months of enrolment with no change in clinical status suggesting potential for deterioration in systolic function 
    • Elevated NT-proBNP (≥ 225 pg/ml) or BNP (≥ 75 pg/ml)
    • Stable medical therapy for heart failure for 15 days as defined by: i. No addition or removal of ACE, angiotensin receptor blockers (ARBs), valsartan/sacubitril, beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists ii. No substantial change in dosage (100% or greater increase or decrease from baseline dose) of ACE, ARBs, beta-blockers, CCBs or aldosterone antagonists 
    • On a diuretic ≥15 days prior to screening visit and a stable diuretic therapy for 7 days

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

    Exclusion Criteria:
    Patient is symptomatic.
    Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
    Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
    Aortic valve is a unicuspid, bicuspid, or is non-calcified.
    Severe aortic regurgitation (>3+).
    Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03042104 STU00204517
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    Kats, Lauren 312 926 1096
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    Physical activity and DNA methylation among women with high breast density
    The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy p…
    The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being physically active are believed to be important for preventing cancer. It may be particularly important for women with high breast density, and may help reduce risk for breast cancer. However, we do not understand what physical activity changes within the body to alter risk of breast cancer. DNA methylation is a biological process that may help explain the relationship between physical activity and cancer risk.
    Generally healthy women with a history of heterogeneously or extremely dense breasts, aged 40-74 with no history of cancer (other than non-melanoma skin cancer), diabetes, and cardiovascular disease.
    Hibler, ElizabethHibler, Elizabeth
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00204639
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    Hibler, Elizabeth 312 503 1178
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    NCI 2015-06-04 Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
    Phase IIB trial of neoadjuvant oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
    Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT02993159 STU00204804
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    Xu, Yanfei 1 312 472 0595
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    Gene Expression and Biomarker Profiling of Keloid Skin Sub-Study: A Pilot Trial of Keloid Genomic Profiling Using RNAseq
    Northwestern’s Department of Dermatology is performing a research study to better understand the causes of keloid scars. Keloid scars are solid tissue overgrowths that tend to d…
    Northwestern’s Department of Dermatology is performing a research study to better understand the causes of keloid scars. Keloid scars are solid tissue overgrowths that tend to develop after trauma to the skin.
    Subjects who are 18 years of age or older. Have no history of keloids or have a keloid on the earlobe or on another area of your body that either has not been treated or if treated, the treatment took place more than 6 months ago.
    Kundu, Roopal VashiKundu, Roopal Vashi
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03228693 STU00203462
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    keloid

    For more information on this study please contact us:

    Ali, Yasmeen 312 503 5906
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    Melanoma and Skin Cancer Tissue Repository

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

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

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

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
    More Info

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    Study Coordinator 1 312 695 1102
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    Morning Light Treatment at Home to Improve Glucose Metabolism in People at Increased Risk for Type 2 Diabetes
    The study is titled “Morning Light Treatment.” We think there may be a relationship between sleep and diabetes, and morning light treatment delivered through a head worn light device coul…
    The study is titled “Morning Light Treatment.” We think there may be a relationship between sleep and diabetes, and morning light treatment delivered through a head worn light device could improve glucose metabolism in people with prediabetes.
    We are looking for people ages 40-65, who are overweight or obese, do not currently have diabetes, and are in good health. The study involves screening blood tests, at-home apnea test, 5 weeks of wrist actigraphy, a 4 week period where you would wear a light device for one hour in the morning, and 2 overnight laboratory sessions that include saliva, urine, and blood samples. You will be compensated up to $525, $50 for the screening and $95 for each week of participation.
    Knutson, KristenKnutson, Kristen
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204710
    More Info

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    Knutson, Kristen
    Copy
    BTCRC GYN15-013: Phase II Study of Pembrolizumab in Combination with Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
    The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and ca…
    The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and carboplatin chemotherapy.
    Participants will be adults with cancer in the lining of the uterus (endometrium) that has spread to other parts of the body or has returned after initial treatment.
    Matei, DanielaMatei, Daniela
    • Map it 250 E. Superior St. Fourth Floor
      Chicago, IL
    NCT02549209 STU00204968
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    Gavrilescu, Andreea 312 695 1102
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    REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
    The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
    The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
    INCLUSION CRITERIA: 

    • Chronic symptomatic heart failure (HF) documented by the following: 
      • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days 
      • New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND 
      • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months. 
    • 2.Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months. 
    • 3.Age ≥ 40 years old 
    • 4.Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,without documented ejection fraction <30% in the 5 years prior to study entry. 
    EXCLUSION CRITERIA 

    • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months. 
    • Cardiac resynchronization therapy initiated within the past 6 months 
    • Advanced heart failure defined as one or more of the below: 
      • a.ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF; 
      • b.Cardiac index < 2.0 L/min/m2 
      • c.Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months 
      • d.Patient is on the cardiac transplant waiting list4.Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m 
    • 5.The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain. 

    Flaherty, James DFlaherty, James D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03088033 STU00204899
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    Roshevsky, Daniel Scott 312 695 3264
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    A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness
    This is a study ( http://enlightenstudy.com/ ) to evaluate the effect of the investigational drug comp…
    This is a study ( http://enlightenstudy.com/ ) to evaluate the effect of the investigational drug compared to Olanzapine on body Weight in young adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder who are Early in their Illness. Participation will last up to 20 weeks. Before starting the study, each participant will be evaluated to determine his or her eligibility to participate. Each participant who qualifies will receive study-related tests, investigational medication and study-related care at no cost. Qualifying participants may be compensated for time and travel. If eligible, they will start the 12 week program where they are randomly assigned (like flipping a coin) to take one of two treatments. No one will know which type of treatment they are taking. During the 12 weeks, qualified participants will return for clinic visits where they will meet with the study doctor or staff and complete the following procedures: Interviews about symptoms, medical and psychiatric history, and general quality of life.Answer questions about the treatments they receive and how they are doing Measure their weight, blood pressure,

    Ages Eligible for Study: 18 Years to 40 Years
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No
    Criteria
    Inclusion Criteria:
    Has less than 10 weeks previous treatment with antipsychotics (cumulative; lifetime)
    Has less than 4 years elapse since the initial onset of active-phase of symptoms
    Have a body mass index (BMI) of 18.0 to
    Rado, JeffreyRado, Jeffrey
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03187769 STU00205116
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    Jain, Ankit 312 503 9092
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    NCI 2015-06-03 Statin Therapy to Reduce Disease Progression from Liver Cirrhosis to Cancer
    The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg d…
    The purpose of this study is to compare the safety and effects of simvastatin in people with liver cirrhosis who are at an increased risk for liver cancer. In this study, you will get either simvastatin 40 mg daily or placebo daily, a pill that looks like simvastatin 40 mg but contains no medication. Simvastatin is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk for heart attack, stroke, and chest pain in patients who have heart disease or risk factors for heart disease such as smoking, high blood pressure, low high-density lipoprotein (HDL), or family history of early heart disease. It is also approved to lower the risk for heart attack or stroke in patients with type 2 diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure. However, simvastatin is not approved by the FDA to decrease the risk of liver cancer. Simvastatin is considered “investigational” (a study drug) in this study. Studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. We believe that this anti-inflammatory effect of simvastatin may help patients with liver cirrhosis.
    Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy
    Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
    Leukocytes >= 2,500/microliter
    Absolute neutrophil count >= 1,500/microliter
    Platelets >= 50,000/microliter
    Hemoglobin >= 10 g/dL
    Total bilirubin =< 3 x institutional upper limit of normal (ULN)
    Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN
    Creatinine =< 1.5 x institutional ULN
    Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women >= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
    Women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
    Ability to understand and the willingness to sign a written informed consent document and medical release
    Willing and able to comply with trial protocol and follow-up
    Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 7 months
    Kulik, Laura MKulik, Laura M
    • Map it 675 N. St. Clair St.
      Chicago, IL
    NCT02968810 STU00204992
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    Sipich, Kimberly A 312 694 1293
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    (xIRB) S1418/BR006 A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy.
    The purpose of this study…
    The purpose of this study is to compare the usual approach (i.e. no moretreatment or additional post-operative chemotherapy), to any effects, goodand/or bad, of the experimental drug MK-3475 (also called pembrolizumab)after surgery. This study will allow the researchers to know whether treatmentwith MK-3475 (pembrolizumab) is better, the same, or worse than the usualapproach.

    This study has two study groups (also called study “arms”). A computer willby chance assign you to one of the two study arms. This is calledrandomization. This is done by chance because no one knows if one studyarm is better, the same, or worse than the other arm. Once you are put on onearm, you cannot switch to the other arm. Neither you nor your doctor canchoose which arm you will be in.

     Some of the eligibility criteria include: Participants must be 18 years of age or older; Participants must have “triple-negative” breast cancer. This is the typeof breast cancer that doesn’t have receptors for estrogen, progesterone,or the protein HER2, that are found in some other types of breastcancer
    Gradishar, William JGradishar, William J
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT02954874 STU00205340
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    Study Coordinator 1 312 695 1102
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    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies…
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Hanauer, StephenHanauer, Stephen
    NCT02914561 STU00205056
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    Arrieta, Rose 312 695 5878
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    Alliance A221405 Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer

    The purpose of this study is to determine whether having a child after temporarily stopping endocrine treatment is feasible and safe in patients with a hormone receptor-positive …

    The purpose of this study is to determine whether having a child after temporarily stopping endocrine treatment is feasible and safe in patients with a hormone receptor-positive early breast cancer. Specifically, the study will investigate whether a temporary interruption of endocrine therapy, with the goal of permitting pregnancy and then resuming endocrine therapy to complete a standard course, is associated with a higher risk of breast cancer recurrence. 

    The best available evidence suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a recurrence from her breast cancer. The most recent data also suggest that this is true in women with a hormone receptorpositive breast cancer. While delivery complications have been reported, available information does not suggest an increased risk for delivery complications or for newborns. This new study aims to clarify these results and to help determine how long a woman should wait before trying to become pregnant after breast cancer diagnosis and treatment.

    Some of the eligibility criteria include:

    • Study participants must be at least 18 years old.

    • Study participants must have been diagnosed with and treated for hormone receptor-positive early breast cancer.

    • Study participants are currently taking endocrine therapy.

    • Study participants must have expressed interest in getting pregnant.

    Participants will temporarily stop current endocrine therapy and attempt to become pregnant. They must have taken at least 18, and not more than 30, months of endocrine treatment before stopping; and they must wait three to five months after stopping endocrine treatment before attempting to become pregnant. Whether they become pregnant or not, they should resume endocrine therapy within 2 years after the endocrine therapy interruption and complete five to ten years of treatment, according to individual risk and preference, as planned with their treating oncologist. 

    Flaum, LisaFlaum, Lisa
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02308085 STU00205165
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    Study Coordinator 1 312 695 1102
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    Geometric Surrogates for Clinical Management of Abdominal Aortic Aneurysms
    An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monit…
    An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at least semi-annual evaluations are performed using imaging methods such as a computed tomography (CT) scan. Magnetic Resonance Imaging (MRI) is another method of creating pictures of the same vessels seen on a CT scan. MRI is a method for producing extremely detailed pictures of blood vessels without the need for x-rays. Radio waves, along with the magnetic field of a large magnet within the MRI machine, are used to make the pictures. MR images are used to detect and aid in the diagnosis of heart disorders and blood vessel diseases. For the purpose of this research, along with the routine CT scan, an additional scan called a ECG-gated MRI exam will be performed. This MRI exam does not involve any contrast, a dye used to make tissues, abnormalities or diseases processes more visible. This one-time MRI exam will be performed prior to anticipated elective AAA repair or during the course of periodic surveillance for AAA. This research study plans to enroll approximately 200 study participants at approximately 3 sites, including approximately 100 people at Northwestern.
    Participants may be eligible for this study if they have been diagnosed with an Abdominal Aortic Aneurysm and either have been recommended to undergo elective repair or are currently under periodic surveillance for AAA.
    Eskandari, MarkEskandari, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00205143
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    Reinkensmeyer, Alexandra 312 695 4189
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    Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial
    The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethas…
    The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

    Inclusion criteria:

    Patient level inclusion criterion

  • 18 years of age or older;

    Eye level inclusion criteria - at least one eye must meet all of the following conditions

  • Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as ≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
  • Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection);

    Greater than 300 μm for Zeiss Cirrus Greater than 320 μm for Heidelberg Spectralis Greater than 300 μm for Topcon 3DOCT

  • Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;
  • Best corrected visual acuity (BCVA) 5/200 or better;
  • Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, e.g., Combigan, are counted as two IOP-lowering medications);
  • Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.
  • Exclusion criteria:

    Patient level exclusion criteria

  • History of infectious uveitis in either eye;
  • History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion -see #13 below);
  • History of keratitis (with the exception of keratitis due to dry eye) in either eye;
  • History of central serous retinopathy in either eye;
  • Active infectious conjunctivitis in either eye;
  • Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
  • Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
  • Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
  • Known allergy or hypersensitivity to any component of the study drugs;
  • For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;

    Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions

  • History of infectious endophthalmitis;
  • History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
  • History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment);
  • Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface);
  • Torn or ruptured posterior lens capsule
  • Presence of silicone oil;
  • Ozurdex administered in past 12 weeks;
  • Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
  • Fluocinolone acetonide implant (Retisert) placed in past 3 years.
  • Koreishi, AnjumKoreishi, Anjum
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT02623426 STU00205049
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    Santillanes, Crystal 312 472 3627
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    A phase 3 randomized, open-label (sponsor-blind), activecontrolled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
    This is a phase III study …
    This is a phase III study in non-dialysis subjects with anemia associated chronic kidney disease to evaluate the safety and efficacy of an investigational drug, Daprodustat when compared to darbepoetin alfa.
    Inclusion Criteria:
    1. Men or Women 18 to 99 years of age.
    2. Chronic Kidney Disease Stages 3, 4, or 5
    3. Acceptable if on Erythropoietin-Stimulating Agents
    4. Hemoglobin between 8 to 12 g/dL
    5. Willingness to participate and capable of giving signed informed consent.
    Exclusion Criteria:
    1. Currently receiving dialysis
    2. Planned kidney transplant within 1 year
    3. Iron deficient
    4. Other causes of anemia (pernicious anemia, thalassemia major, sickle cell, myelodysplastic syndrome)
    5. Uncontrolled high blood pressure
    6. History of malignancy within 2 years
    7. Unstable liver disease
    8. Chronic Class IV heart failure
    Ghossein, CybeleGhossein, Cybele
    NCT02876835 STU00203935
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    Napoli, Sara 312 503 3865
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    Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
    This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by c…
    This study will evaluate the safety and effectiveness of the WATCHMAN Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMAN Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMAN Device itself and the implantation procedure are the same as the FDA approved WATCHMAN. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMAN Device in this study is considered “investigational” because it has not been approved by the FDA for use without short-term OAC therapy. Participants in this study will be in this research study for about 5 years. During this time, participants will be asked to come to clinic for 6-7 study visits, and the study team will contact participants by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
    Inclusion Criteria:
    Documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation. The subject has a calculated CHA2DS2-VASc score of 2 or greater.
    Deemed by two study physicians to be unsuitable for oral anticoagulation.
    Deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
    Able and willing to return for required follow-up visits and examinations.

    Exclusion Criteria:
    The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
    Planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
    Prior stroke (of any cause) or TIA within the 30 days prior to randomization.
    Prior bleeding event within the 14 days prior to randomization.
    History of atrial septal repair or has an ASD/PFO device.
    An implanted mechanical valve prosthesis in any position.
    The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
    The subject has LVEF < 30%.
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02928497 STU00205007
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    Carswell, Amy 312 926 7554
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    Pharmacokinetics of Risperidone and Similarly Metabolized Second Generation Antipsychotics Across Pregnancy
    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as aripiprazole, lurasidone, quetiapine, and r…
    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as aripiprazole, lurasidone, quetiapine, and risperidone. Changes in the metabolism of these medications have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust mood-stabilizing medications in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

    Participation Involves: 

    • PK protocol: 2 overnight visits during pregnancy and 1 postpartum, plus one checkup postpartum.
    • CS protocol: 2 checkups during pregnancy and 2 checkups postpartum. 
    • Each visit includes expert evaluation, mood assessments, and blood draws. 
    • To compensate for your time and effort, you will receive $50 for each completed checkup and $200 for each completed overnight visit. 

    To qualify for this study you must be: 

    • pregnancy planning or less than 22 weeks pregnant,
    • between the ages of 18 and 45, and  
    • taking aripiprazole (Abilify), lurasidone (Latuda), quetiapine (Seroquel), or risperidone (Risperdal), and plan to continue taking it during and after pregnancy.
    Clark, CrystalClark, Crystal
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00205640
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    Montiel, Catalina +1 312 695 6010
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    NU 16B14: I-CURE-1: A Phase II, single arm study of Pembroluzimab combined with carboplatin in patients with circulating tumor cells (CTCs) positive Her-2 negative metastatic breast cancer (MBC)

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

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

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

    You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03213041 STU00205013
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    Study Coordinator 312 695 1102
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    (xIRB NCI CIRB) ECOG-ACRIN 8143 A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
    Nivolumab is a drug that may help stimulate one’s immune system to attack any cancer cells that may rem…
    Nivolumab is a drug that may help stimulate one’s immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent cancer from returning but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for kidney cancer that has been removed but is at risk for coming back. The study drug, nivolumab, is already FDA-approved for participants who have kidney cancer that has spread outside of the kidney to other organs or lymph nodes. The use of nivolumab in this study is investigational (not approved by the FDA) for early stages of cancer where we do not know for sure if the disease has spread outside of the kidney. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long participants are able to live without any signs or symptoms of cancer compared to the usual approach.
    • Participants must have Renal Cell Cancer 
    • Participants must be 18 or older
    • Participants must have disease confirmed by biopsy
    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03055013 STU00205209
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    Study Coordinator 312 695 1102
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    A multi-centre, randomized, double-blind (sponsor open), placebo-controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis
    GlaxoSmithKline (GSK…
    GlaxoSmithKline (GSK) is developing a new medicine (GSK2330811) for the treatment of systemic sclerosis. GSK2330811 is an antibody which blocks the activity of a substance in the body called Oncostatin M (OSM). Blocking OSM is expected to have a beneficial effect on some of the disease processes in systemic sclerosis (such as fibrosis and inflammation). GSK2330811 is not yet approved for doctors to treat patients with systemic sclerosis. The purpose of this study is to test GSK2330811 in patients with systemic sclerosis. This is the first time GSK2330811 has been tested in people with systemic sclerosis. Some people in this study will be randomly assigned to take GSK2330811 and others will be randomly assigned to take a placebo. The effects of the drug, both good and bad, will be compared to people who are not taking the drug. The drug will be administered as an injection under the skin, and additional research tests and procedures will be performed. The study involves 11 visits to the clinic over 8-9 months.
    • Diagnosis of diffuse systemic sclerosis for less than 5 years
    • Skin score of at least 10
    • Worsening skin disease
    • Stable dose of current medications
    Varga, JohnVarga, John
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT03041025 STU00205162
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    Carns, Mary 312 503 1137
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    NU JH17U01: Overcoming drug resistance in metastatic castration-resistant prostate cancer with novel combination of TGF-β receptor inhibitor LY2157299 and enzalutamide: a randomized multi-site phase II study

    This research is being done to test the effectiveness (anti-tumor activity) and safety of…

    This research is being done to test the effectiveness (anti-tumor activity) and safety of combining enzalutamide with LY2157299 for the treatment of men with advanced castrate-resistant prostate cancer. 

    Enzalutamide blocks testosterone production in the body to slow or stop the growth of prostate cancer cells. Enzalutamide (Xtandi®) is approved by the FDA for the treatment of patients with advanced castrate resistant prostate cancer who have received chemotherapy. 

    LY2157299 is an investigational drug that inhibits a growth factor that is believed to play a role in the spread of the cancer. The use of LY2157299 in this research study is investigational. The word “investigational” means that LY2157299 is not approved for marketing by the Food and Drug Administration (FDA).

    You may be eligible for this research study if you are a man with advanced castrate resistant prostate cancer.

    Morgans, AliciaMorgans, Alicia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00000417 STU00205208
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    Study Coordinator 312 695 1102
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    A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN2034 in Subjects with Metastatic or Locally Advanced Solid Tumors, with Expansion to Select Solid Tumors
    AGEN2034 is an investigational drug tha…
    AGEN2034 is an investigational drug that blocks a protein called PD-1 expressed on immune cells, which results in reduction in the anti-tumor activity of the immune cells. Drugs that block PD-1 can activate the immune cells to help clear the cancer cells. ‘Investigational’ means the drug has not yet been approved by the FDA for treatment. This trial is intended to find whether AGEN2034 is safe and effective to treat patients with advanced tumors which have not responded to conventional treatment.

    • Have histologically confirmed advanced solid tumors
    • Able to understand the nature of this trial and provide written informed consent
    • Participants must be 18 or older.

    Matei, DanielaMatei, Daniela
    NCT03104699 STU00205408
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    Study Coordinator 312 695 1102
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    MY PATHWAY: AN OPEN-LABEL PHASE IIA STUDY EVALUATING TRASTUZUMAB/PERTUZUMAB, ERLOTINIB, VEMURAFENIB/COBIMETINIB, VISMODEGIB, ALECTINIB, AND ATEZOLIZUMAB IN PATIENTS WHO HAVE ADVANCED SOLID TUMORS WITH MUTATIONS OR GENE EXPRESSION ABNORMALITIES PREDICTIVE OF RESPONSE TO ONE OF THESE AGENTS
    Trastuzumab…
    Trastuzumab/Pertuzumab combination, Erlotinib, Vemurafenib/Cobimetinib combination, Vismodegib, Alectinib and Atezolizumab are agents that target specific proteins that cause or contribute to the growth and spread of cancers. These targeted therapy agents have been tested and approved by the US FDA to treat some types of cancer but not others. The purpose of this research study is to evaluate whether these targeted drugs is safe and effective for the treatment of other types of cancers. Many cancers contain molecular abnormalities that cause or contribute to their ability to grow and spread. These molecular and genetic changes can be detected in the laboratory tests. By blocking the effects of these abnormalities, the growth of cancer may be stopped or slowed down. Many new cancer drugs work in this way. Because they block the effects of specific molecular abnormalities within the cancer, they are known as “targeted” agents. Patients are now able to have molecular tests done on their tumor tissue (“molecular profiling”), in order to identify potential molecular abnormalities that may be treated with targeted drugs. Some of these targeted drugs have been approved by the US FDA to treat certain types of cancer but not others. The purpose of this study is to evaluate if these targeted drugs is safe and effective for the treatment of other types of cancers.
    Some of the eligibility criteria include:1) Molecular testing results from a certified lab showing an abnormality that can be targeted with any of the above agents; 2) Able to understand the nature of this trial and provide written informed consent; 3) Participants must be 18 or older.
    Villaflor, VictoriaVillaflor, Victoria
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02091141 STU00205235
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    Study Coordinator 312 695 1102
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    A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with a 52 Week Blinded Extension (PASADENA)
    This is a multicenter, Phase II study to evaluate the effect of IV administrat…
    This is a multicenter, Phase II study to evaluate the effect of IV administration of RO7046015 in participants with early stage Parkinson's Disease (PD). Participants will be eligible if they have PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD and are either untreated or treated with Azilect or Selegiline. The study will consist of two parts: a 52-week, treatment period of the study medication vs placebo (Part 1) after which eligible participants will continue into an all-participants-on-treatment (RO7046015) blinded to dose extension for an additional 52 weeks (Part 2).
    *Men and women, aged 40 to 80 years inclusive, early PD , who were recently (< 2 years) diagnosed, and either untreated or treated with Azilect or Selegiline
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03100149 STU00205125
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    Poon, Cynthia 312 503 8216
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    D-Cycloserine for the Treatment of Chronic, Refractory Low Back Pain
    The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain. This study will last for 26 weeks and will require approx…
    The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain. This study will last for 26 weeks and will require approximately 6 visits to the study clinic. There will be two groups in this study. You will have an equal chance of being in either group. One group will receive D-cycloserine in capsule form and one group will receive placebo in capsule form. All participants have to take two capsules every day, one in the morning and one in the evening. There will be a 1 in 2 chance of receiving placebo.
    Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
    Male or female, age 18 years or older
    Must be in generally stable health
    Must have a smartphone that will allow downloading of the pain app
    Must be willing to abstain from drinking alcohol during the course of the study.
    If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue during the course of the study.
    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03535688 STU00205398
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    Taira, Ethan 312 503 3806
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    Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
    Inclusion Criteria
    • Type 1 and 2 Diabetes by ADA criteria (see appendix )
    • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
    • Able to provide informed consent
    • Adult participants (no age restriction)
    • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
    Exclusion Criteria
    • ESRD, defined as chronic dialysis or kidney transplant
    • History of receiving dialysis for more than 30 days
    • Institutionalized
    • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
    • Less than 3-year life expectancy
    • Known alcohol or substance abuse
    • Unable to provide informed consent
    • No evidence of active cancer other than non-melanoma skin cancer
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02986984 STU00204808
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    Martinez, Carlos 312 503 1808
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    BTCRC-GI15-015: A Phase II Study of FOLFOX combined with Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

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

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

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

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

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

     

    Benson III, Al BBenson III, Al B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03283761 STU00205558
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    Study Coordinator 1 312 695 1102
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    LIBERTY 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
    Our goal is to evaluat…
    Our goal is to evaluate the effectiveness and safety of investigational medicines for heavy bleeding associated with uterine fibroids. The study drugs will be compared to an inactive substance (called a placebo) to see if the new study drugs are working. There is an entry period for up to 13 weeks (up to 4 study visits) to determine eligibility, which includes: transvaginal ultrasound, endometrial biopsy, menstrual blood collection, bone density scan and a mammogram. There will be a randomization visit followed by 6 monthly treatment visits. The treatment period will take place over 24 weeks. During treatment, participants will take two study drugs or placebo by mouth throughout the treatment period. After the end of treatment, participants will be followed for 30 days to assess effectiveness and safety after stopping treatment. In total, participants will be in the research study for up to 10 months. All research related medications, supplies, procedures and lab work are at no cost to participants. Participants will be compensated for time and travel related to this study.
    Inclusion criteria: 1) Women aged 18-50 years; 2) Heavy menstrual bleeding associated with uterine fibroids, as diagnosed by a physician; 3) English-speaking
    Robins, JaredRobins, Jared
    • Map it 259 E. Erie St. Lavin Pavilion
      Chicago, IL
    NCT03103087 STU00205214
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    Posley, Dana 312 472 0289
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    Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A prospective, multicenter, randomized, controlled pivotal trial to assess transcatheter mitral valve repair with Edwards Cardioband System and guideline directed medical therapy (GDMT) compared to GDMT alone in patients with functional mitral regurgitation (FMR) and heart failure.
    This study is enrolling patients with moderate-to-severe or severe functional mitral regurgitation (FMR). FMR occurs when the two 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 has to pump more blood with each beat to push the same amount of blood forward. This can lead to shortness of breath and make the heart weaker because it cannot pump enough blood for the body’s needs. The purpose of this study is to evaluate a new device to treat patients who might benefit from repair of their mitral heart valve due to functional mitral regurgitation. The device is called the Edwards Cardioband System (“Edwards Cardioband System”). The device is investigational, which means it is not yet approved by the U.S. FDA for sale in the United States. This device is placed without the need for an open-heart procedure and without the need for a heart and lung machine. Instead, the device is delivered using a less invasive approach where the Cardioband System is inserted through a vein in the groin and threaded to the heart using a delivery catheter (small plastic tube). For this study patients will be “randomized” or assigned by chance to one of two study groups: Device group or the Control group. Patients will be randomized 2:1, which means each patient has a 2 to 1 chance of being assigned to the Device group (twice as likely to be in the Device group as the Control group). Subjects assigned to the Control Group may be eligible to receive the Study Device after their 1 year study visit. Participation in this study will last for approximately 5 years. Both Device and Control Group participants will be asked to return for visits at 1 month, 6 months, and 1, 2, 3, 4 and 5 years. This study is being conducted in up to fifty (50) hospitals in the United States, Canada, and/or Europe and plans to enroll up to 525 participants, including approximately 10 people from this institution
    Inclusion: 

    • Functional MR (≥3+ by echo) 
    • Patient hospitalized due to heart failure during 12 months prior to enrollment OR BNP >400 pg/ml or NT‐BNP >1500 pg/ml 
    • LVEF >20% and LVEDD ≤70mm 
    • NYHA Class II‐IVa heart failure symptoms despite medical therapy 
    Exclusion: 

    • Degenerative MR including mixed degenerative/functional MR
    • Severe mitral annular calcification
    • Hypertrophic cardiomyopathy
    • Severe tricuspid regurgitation

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016975 STU00205575
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    Christensen, Lyndsay 312 694 0661
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    Genetic causes and pathogenic mechanisms of adult epilepsies
    The purpose of this study is to look at genetic markers of epilepsy in patients and their families using blood, saliva, skin, and brain tissue analysis.
    Gerard, Elizabeth ErwayGerard, Elizabeth Erway
    STU00205877
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    Bellinski, Irena Iva 312 926 1672
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    A Phase 2 Study of Regn2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
    The purpose of this study i…
    The purpose of this study is to test the effects of cemiplimab (also known as REGN2810) in patients with advanced basal cell cancer (BCC). Specifically, this study is being done to test if cemiplimab can reduce tumor size by helping the immune system destroy the tumor. This study is also being done to test the safety of cemiplimab in BCC patients. Participant's whose BCC has been treated with a Hedgehog Pathway Inhibitor (HHI) will be enrolled.  The HHI therapies that have been approved by the United States Food and Drug Administration (FDA) are Erivedge (vismodegib) and Odomzo (sonidegib).  HHI therapy causes many BCCs to shrink (become smaller) quickly in the first few months of therapy. We expect that participants will be in this research study for about 2 and a half years.
    Participants 18 years and older who have been diagnosed with basil cell cancer.
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03132636 STU00205219
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    Study Coordinator 312 695 1102
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    DRUG CA209-914: A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

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

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

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

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

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

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03138512 STU00205491
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    Study Coordinator 312 695 1102
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    (xIRB NCI-CIRB) SWOG 1512: A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unsectable Desmoplastic Melanoma (DM)
    The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembr…
    The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab). MK-3475 (pembrolizumab) could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will cause the cancer to at least temporarily disappear in more than twenty percent of patients with melanoma that is not surgically removable. In patients with melanoma that is surgically removable, researchers also hope to learn if the study drug will cause the surgery to be more effective and avoid repeated surgery.
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02775851 STU00205551
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    Study Coordinator 312 695 1102
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    Alterations of Sleep and Circadian Timing in Aging
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have…
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.
    Eligibility Criteria:Men and women age 55-75 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
    Zee, Phyllis CZee, Phyllis C
    NCT03490825 STU00206014
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    Gendy, Maged +1 312 503 2519
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    cIRB: Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)
    This is a 96-week placebo-controlled trial of topiramate at a target dose of 100 mg daily (50 mg twice daily) as a potentially disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy
    INCLUSION: 1. Age 18-75; 2. Diagnosis of confirmed cryptogenic symptomatic distal symmetric peripheral polyneuropathy; 3. Prediabetes based on American Diabetes Association; 4. No history of prior therapy with topiramate; 5. Waist circumference >102 cm for men, >88 cm for women
    Menichella, DanielaMenichella, Daniela
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT02878798 STU00206049
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    Casale, Connie
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    A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
    This research study is investigating a drug (that is called IMCgp100) in patients with a…
    This research study is investigating a drug (that is called IMCgp100) in patients with advanced uveal melanoma. Uveal melanoma is generally treated with either chemotherapy or drugs that work by activating the immune system, known as immunotherapies. In this research study, IMCgp100 will be compared to three representative standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug targeting a protein called CTLA-4), or pembrolizumab (an immunotherapy drug targeting a protein called PD-1). This research study is being done to assess the efficacy and safety of the IMCgp100 in patients with uveal melanoma in comparison to these standard treatments.
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00000418 STU00205550
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    Study Coordinator 312 695 1102
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    A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease
    The purpose of this study is to find out whether a drug called “macitentan” works and is…
    The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease. There are several drugs available to manage heart failure symptoms, but to date, no treatments have been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. Macitentan may reduce unwanted effects of a chemical substance in the body called endothelin, which has been detected in increased amounts in patients with heart failure. Endothelin causes blood vessels to narrow and results in overgrowth of the muscle in the walls of the lung blood vessels and also of the heart. By blocking the action of endothelin, macitentan lowers the blood pressure in the pulmonary arteries, may slow down overgrowth of the heart muscle and may therefore improve your condition. Macitentan has been tested and approved in the U.S. for other diseases, but is considered experimental for the use in this study. We expect participants will be in this research study for 70 weeks, and will need to come to clinic for study visits 13 times. We expect up to 5 people here will be in this research study out of 300 people in the entire study internationally.

    Primary Inclusion:

    • Signs or symptoms of Heart Failure (HF) requiring treatment with at least one oral diuretic (any type). 
    • Left ventricular ejection fraction (LVEF) ≥ 40% 
    • Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF). 
    • HF hospitalization within 12 months prior to Screening and/or cardiac catheterization performed within 6 months prior to Screening.  
    • Pulmonary vascular disease or right ventricular dysfunction

    Primary Exclusion: 

    • Any prior measurement of LVEF < 40%. 
    • Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia) 
    • Hemoglobin < 100g/L (< 10 g/dl) 

    Freed, BenjaminFreed, Benjamin
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03153111 STU00205418
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    Sanchez, Cynthia 312 695 5097
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    NIH All of Us Research Program Precision Medicine Initiative® Precision Medicine Initiative Cohort Program Healthcare Provider Organization Enrollment Centers
     Research Program in Illinois. The mission of this ambitious National Institutes of Health (NIH) initiative is to speed up health resear…
     Research Program in Illinois. The mission of this ambitious National Institutes of Health (NIH) initiative is to speed up health research and medical breakthroughs. To do this, the All of Us Research Program is asking one million people to lead the way to provide the types of information that can help us create individualized prevention, treatment, and care for all of us. Visit nm.org/joinallofus to learn more and enroll.

    WHATARE THE BENEFITS OF JOINING?

    ·      ·      ·       

    WHATWOULD I NEED TO DO?

    ·      ·      ·      Visit an All of Us Participant Center for physical measurements (bloodpressure, height, weight, waist/hip, & heart rate) and biosamples (blood& urine)

    Participants receive a $25 payment for completing all researchcomponents.You will also receive a voucher for free parking.

    - 18 years of age or older- Currently live in the United States
    Greenland, PhilipGreenland, Philip
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204480
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    Rodriguez, Monica 312 695 6077
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    Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
    This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the inter…
    This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous) through a vein. About 12 people are expected to participate in this research study here at Northwestern University out of 160 people in the entire study nationally.
    Some of the eligibility criteria include:
    • Participants must be 18 or older.
    • Patient must have the ability to understand and sign an approved informed consent form (ICF).
    • Patient must have a confirmed diagnosis of advanced Renal Cell Carcinoma (RCC).
    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.
    Sosman, JeffreySosman, Jeffrey
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03117309 STU00205969
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    Study Coordinator 312 695 1102
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    Clinical Database of Percutaneous Nephrolithotomy (PCNL)
    The goal of this study is to examine the characteristics of individuals undergoing the procedure as well as patient outcomes after the procedure, such as complications of surgery or improvements in symptoms.
    Patients age 18-89 with a confirmed diagnosis of kidney stones treated with percutaneous nephrolithotripsy at Northwestern.
    Nadler, Robert BNadler, Robert B
    STU00206010
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    kidney stones

    For more information on this study please contact us:

    312 695 8146
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    Clinical Database of Prostate Cancer at Northwestern University
    The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
    Men ages 18-89 years daignosed with prostate cancer.
    Schaeffer, EdwardSchaeffer, Edward
    STU00206270
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    Khawaja, Faizan 312 694 2417
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    REVAMP Study (REmodeling the Left Ventricle with Atrial Modulated Pacing)
    REVAMP: The purpose of this study is to see if pacing the right atrium of the heart at a higher rate for periods of time can help the left ventricle (LV) pump blood better, and if it improves exercise capacity and quality of li…
    REVAMP: The purpose of this study is to see if pacing the right atrium of the heart at a higher rate for periods of time can help the left ventricle (LV) pump blood better, and if it improves exercise capacity and quality of life for patients who have HFpEF, normal to small LV chambers, and evidence of thickened walls. This study will be conducted with patients who have a market-released Medtronic dual chamber pacemaker with a Sleep Function, and have had this pacemaker for at least 6 months. Any Medtronic dual chamber pacemaker with the Sleep Function will qualify.In patients with HFpEF, the chamber of the heart that pumps blood out to the body tends to be stiff with thickened walls, reducing the amount of blood that can be pumped with each heartbeat. Previous research suggests that raising the heart rate may reduce the thickness of the heart chamber walls and increase the amount of blood pumped with each heartbeat.This research study plans to enroll approximately 40 study participants at approximately 5 sites, including approximately 15 people from this institution.

    • Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 6 months 
    • Subject is stable on current medications 
    • Subject has dyspnea with exertion
    • Subject has had a prior Echo in past 6 months with: EF ≥ 50% and Diastolic volume <80 ml/m2 
    • Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m2, women 95 g/m2 or indexed to height: men 49.2 g/m2.7 , women 46.7 g/m2.7 ) or Relative Wall thickness >0.42, or Wall Thickness>1.2cm (posterior wall)

    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03210402 STU00205515
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    Sanchez, Cynthia +1 312 695 5097
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    (xIRB) A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non infectious Uveitis
    The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfecti…
    The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.

    Criteria

    Key Inclusion Criteria:

    • Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
    • Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:

      • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
      • ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria
      • ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria
    • No evidence of active tuberculosis (TB), history of prior TB or latent TB meeting the screening criteria

    Key Exclusion Criteria:

    • Elevated intraocular pressures and/or severe glaucoma at screening
    • Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
    • Adults in whom anti-tumor necrosis factor (TNF) therapy has failed in controlling uveitis (as determined by the investigator) or previous exposure to any biologic therapy (except intravitreal anti-vascular endothelial growth factor (VEGF) therapy) with a potential therapeutic impact on noninfectious uveitis within 90 days of Day 1/ Baseline are not eligible to participate

    Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

    Koreishi, AnjumKoreishi, Anjum
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT03207815 STU00205424
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    Santillanes, Crystal 312 472 3627
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    NU 16B19: Automated system for creating custom three-dimensional radiofrequency ablation lesion geometries in post-lumpectomy margin ablation breast cancer treatment

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

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

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

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

    Bethke, KevinBethke, Kevin
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206005
    More Info

    For more information on this study please contact us:

    Study Coordinator 1 312 695 1102
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    Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasia

    The Communication Bridge study is an internet-based, speech therapy intervention for individuals with Primary Progressive Aphasia and their Communication Partner. A Communicati…

    The Communication Bridge study is an internet-based, speech therapy intervention for individuals with Primary Progressive Aphasia and their Communication Partner. A Communication Partner can be a spouse, relative, or close friend that will participate in the study along with the individual with PPA. The goal of the study is to understand how speech-language therapy affects communication abilities in people living with PPA. All study visits take place over the Internet in your home. We will provide you with a computer for the length of the study. We will connect through a video-chat program on the computer. The study lasts about one year. You will complete 5 evaluations with a certified speech-language therapist, 15 one-hour speech therapy sessions with a certified speech-language therapist, and home exercises on the computer we provide you.

    For individuals with who wish to participate: You must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet the following eligibility criteria:

    • Have a diagnosis of PPA with mild impairment
    • Be English speaking
    • Have a communication partner (e.g., spouse, relative, friend) who is willing to participate in all aspects of the study
    • Have adequate experience with a computer and sufficient internet connection
    Additionally, participants are not permitted to participate in any outside speech-language therapy during the course of the study

    Rogalski, Emily JoyRogalski, Emily Joy
    STU00206086
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    Rogers, Elizabeth 312 503 4012
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    DRUG 2401BT-002P: A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) with Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma

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

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

    The purpose of this research study is to:

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

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

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

    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02798406 STU00204494
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    Study Coordinator 312 695 1102
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    Real Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF)

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

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

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

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

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

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

    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206315
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    Ramirez, Haydee +1 312 695 2928
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    Strengthening Circadian Signals to Enhance Cardiometabolic Functions
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circ…
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.
    Eligibility Criteria:Men and women age 40-54 who  have no diagnosis of diabetes or sleep disorders may be eligible for this study.
    Zee, Phyllis CZee, Phyllis C
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT03490864 STU00206038
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    Gendy, Maged +1 312 503 2519
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    NU 17U19: Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer

    This study will help researchers understand what men go through when being treated for their cancer. Specifically, the purpose of this study is to:

    1. Assess the way men think during treatme…

    This study will help researchers understand what men go through when being treated for their cancer. Specifically, the purpose of this study is to:

    1. Assess the way men think during treatment for prostate cancer during specific treatments for prostate cancer.

    2. Follow the thinking process during prostate cancer treatment over time.

    3. Identify genetic variations that might make men more or less sensitive to thinking changes during treatment for prostate cancer. Genes are the instruction manual for your body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person’s risk for certain diseases and how they will respond to treatment. 

    You may be eligible for this research study if you have prostate cancer and are interested in helping researchers understand what men go through when being treated for their cancer. 
    Morgans, AliciaMorgans, Alicia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03016741 STU00206082
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    Study Coordinator 1 312 695 1102
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    APOLLO Trial Clinical Investigation Plan - Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation
    This study is enrolling subjects with severe symptomatic mitral regurgitation to test a new investigational device for …
    This study is enrolling subjects with severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart.
    INCLUSION: 1) Subject has severe symptomatic mitral regurgitation as defined by the ASE. 2) Patient is a candidate for bioprosthetic mitral valve replacement EXCLUSION: 1) Prior mitral valve surgery including previously implanted mitral valve, ring, or band. 2) Heart Team agrees predicted risk of operative mortality is
    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03242642 STU00206197
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    Christensen, Lyndsay 312 694 0661
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    Microburst VNS Therapy Feasibility Study in Subjects with Refractory Epilepsy
    The purpose of this study is for patients with first-time implants of a Vagus Nerve Stimulator (VNS) to have the new Microburst stimulation settings optimized using fMRI scans.
    Macken, Micheal PMacken, Micheal P
    NCT01281293 STU00206259
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    Bellinski, Irena Iva 312 926 1672
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    PET/MRI using [18F]-DCFPyL for the Staging of Newly Diagnosed Prostate Cancer
    This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and ti…
    This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
    Men with biopsy-proven prostate cancer and a diagnosis of high risk, very high risk or locally advanced prostate cancer per NCCN guidelines.
    Schaeffer, EdwardSchaeffer, Edward
    NCT03392181 STU00205957
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    Khawaja, Faizan 312 694 2417
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    Microtubule Polymerization of Modulators for Treating LMNA-Related Dilated Cardiomyopathy
    This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For thi…
    This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if it can help improve heart function and reduce irregular heart rhythms in patients with LMNA related DCM
    1. Confirmed diagnoses of LMNA cardiomyopathy (confirmed with genetic testing). 2. Evidence of myocardial dysfunction OR cardiac arrhythmia
    Wilcox, Jane ElizabethWilcox, Jane Elizabeth
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206184
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    Roshevsky, Daniel Scott 312 695 3264
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    Shared Decision Making in Advanced Prostate Cancer
    This study will help researchers understand what men go through when makingdecisions for treating their cancer. Specifically, the purpose of the study is to: 

    1. Assess the treatment decision making process of men with advanced prostate cancer…

    This study will help researchers understand what men go through when makingdecisions for treating their cancer. Specifically, the purpose of the study is to: 

    1. Assess the treatment decision making process of men with advanced prostate cancer. 

    2. Determine whether the amount of patient participation in decisions affects patientoutcomes, such as quality of life and satisfaction with the decision. 

    3. Help researchers learn how to make treatment decision-making easier and lessconfusing for men with prostate cancer.

    You may be eligible for this research study if you have prostate cancer and are interested in helping researchers understand what men go through when making decisions for treating their cancer.

    Morgans, AliciaMorgans, Alicia
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206080
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    Study Coordinator 1 312 695 1102
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    A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve

    The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue.…

    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 failing valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. 

    We expect that participation in this study will last approximately 10 years. Participants will have the study device implanted, and will need to come to clinic for 13 planned study visits.

    This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined)
    Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03193801 STU00205381
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    Kats, Lauren 312 926 1096
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    A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
    C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two for…
    C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
    Inclusion Criteria:
    1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, within 12 weeks prior to screening or during screening:
    2. Male or female subjects, aged at least 18 years
    3. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion;
    4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
    5. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments.
    Exclusion Criteria:
    1. Pregnant or nursing;
    2. Secondary C3 disease
    3. History or presence of any form of cancer within the 5 years prior to screening,
    4. Currently on dialysis or will require dialysis wtihin 7 days of screening
    5. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
    6. Evidence of tuberculosis
    7. Evidence of liver disease
    Ghossein, CybeleGhossein, Cybele
    NCT03301467 STU00206182
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    Napoli, Sara 312 503 3865
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    Dilated Cardiomyopathy (DCM) Research Project
    Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery di…
    Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery disease. Other causes include exposure to some drugs, such as cancer chemotherapy. When the cause is unknown, it is called idiopathic DCM. Among individuals with idiopathic DCM, having relatives undergo a cardiac check-up (echocardiogram, ECG) will reveal familial DCM in up to one-third of cases. A high level of suspicion of familial DCM is also raised when family members have had heart failure, a heart transplant, sudden death (without a history of coronary artery disease), or arrhythmias, which sometimes require a pacemaker or defibrillator. WHAT DOES THIS STUDY INVOLVE? IF YOU HAVE IDIOPATHIC DCM: Participation involves inviting all your first-degree relatives (children, parents, siblings) with or without heart disease. If you have other more distant relatives with DCM, they are also welcome to participate. To help with this process, we provide a letter that you can share with your relatives, and a family history questionnaire for you to complete. You may also receive a communication tool to help you invite your family members to the study. Your participation also involves providing cardiovascular information and medical records, completing annual surveys, and a blood draw. FOR FAMILY MEMBERS: Participation of family members involves collecting cardiac information and a blood draw. To better understand the genetic cause of DCM, it is helpful to compare results from family members with and without the condition. Because DCM can be present but silent for years, it is difficult to know with certainty if a family member does or does not have DCM unless a cardiac check-up is performed. Medical guidelines recommend this for 1st degree family members of individuals with DCM. Therefore, we also ask family members who enroll to obtain cardiac screening with both an echocardiogram and an electrocardiogram (ECG) if they have not done so recently.
    Inclusion Criteria:

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

    Exclusion Criteria:

    Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery)
    Primary valvular disease
    Adriamycin or other cardiotoxic drug exposure
    Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
    Congenital heart disease
    Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
    Other active multi-system disease that may cause DCM (e.g., active connective tissue disease).
    Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment).
    However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
    Wilcox, Jane ElizabethWilcox, Jane Elizabeth
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03037632 STU00205850
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    Whisler, Cailin 312 926 3356
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    DRUG C-145-03 A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
    The purpose of this study is to find out if a drug named LN-…
    The purpose of this study is to find out if a drug named LN-145 is safe and beneficial in the treatment of patients with recurrent and/or metastatic head and neck cancer when previous treatment has not worked. LN-145 is also called "tumor infiltrating lymphocytes" and is made up of specialized white blood cells called lymphocytes or "T-cells" grown from your tumor. These T cells were made by your body to attack your tumor. 
    You are eligible to participate in this study because you have Squamous Cell Carcinoma of the Head and Neck cancer that has come back after treatment (recurrent) or has spread (metastatic) after the previous treatment. 
    Villaflor, VictoriaVillaflor, Victoria
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03083873 STU00206171
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    Study Coordinator 312 695 1102
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    cIRB: AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic Stroke
    ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of u…
    ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
    Inclusion Criteria:

    1) Age ≥ 45 years.
    2) Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
    3) Modified Rankin Scale (MRS) score ≤ 4.
    4) Ability to be randomized within 3 to 120 days after stroke onset.
    5) ESUS, defined as all of the following:
    Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/
    Caprio, FanCaprio, Fan
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03192215 STU00206251
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    Garcia-Canga, Blas +1 312 503 0492
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    (xIRB) DRUG 201973: A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer
    The purpose of this study is to evaluate the safety of the investiga…
    The purpose of this study is to evaluate the safety of the investigational drug, GSK525762, and how well it works when taken with fulvestrant, a drug that is a standard treatment for estrogen receptor positive breast cancer. Researchers will test 2 dose levels of GSK525762 and fulvestrant. There will be 2 groups of subjects at each dose level. If dose level 1 is shown to be tolerated without serious side effects, a small number of consenting participants will be enrolled and start a second, higher dose level (dose level 2) of GSK252762. If DL1 is not safe, a lower dose will be given. If the small number of subjects completes DL2 and it is shown to be safe, additional subjects will be randomly assigned to receive either DL1 or DL2.
    • Diagnosis of advanced or metastatic estrogen receptor-positive breast cancer (ER+BC) that hasn’t responded to previous endocrine treatment.
    • Age of at least 18 years
    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02964507 STU00206335
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    Study Coordinator 312 695 1102
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    AN OPEN-LABEL, PHASE 2 STUDY OF NERATINIB IN PATIENTS WITH SOLID TUMORS WITH SOMATIC HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR, HER2, HER3) MUTATIONS OR EGFR GENE AMPLIFICATION

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

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

     

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

     

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

    Some of the eligibility criteria include:

    • Participants must be 18 or older.
    • Patient must have the ability to understand and sign an approved informed consent form (ICF).
    • Patient must have a confirmed diagnosis of cancers with mutations in ERBB family
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT01953926 STU00206494
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    Study Coordinator 312 695 1102
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    (xIRB) NCI 9767: An Open Label, Multicenter, Single arm Phase II study to evaluate the Activity and Tolerability of the novel mTOR Inhibitor, MLN0128 (TAK-228), in patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the urothelial tract whose tumors harbor a TSC1 and/or TSC2 mutation.
    The purpose of this study is to test any good and bad effects of the study drug called MLN0128 (TAK-228). This study is being done to see if MLN0128 (TAK-228) is effective in treating this type of cancer.
    • Participants must be 18 years or older
    • Participants must have a urinary tract cancer that has spread because the cancer has a mutation in TSC1 and/or TSC2 genes.
    • Participants must have already been treated with chemotherapy, but their disease is still growing
    Morgans, AliciaMorgans, Alicia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03047213 STU00206603
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    Study Coordinator 312 695 1102
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    Environmental Influences on Child Health Outcomes (ECHO) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies
    Understanding the effects of environmental exposures on child health and development is a priority for the National Institutes of Healt…
    Understanding the effects of environmental exposures on child health and development is a priority for the National Institutes of Health. To advance knowledge in this area, NIH has launched a new seven-year initiative called the Environmental influences on Child Health Outcomes (ECHO) program. ECHO will support multiple, synergistic, longitudinal studies using existing study populations, called cohorts, to investigate environmental exposures — including physical, chemical, biological, social, behavioral, natural and built environments — on child health and development. The studies will focus on four key pediatric outcomes that have a high public health impact: Upper and Lower Airway, Obesity, Pre-, peri-, and Postnatal Outcomes, Neurodevelopment. (Source: https://www.nih.gov/echo)
    By invitation only. Women who previously participated in the NICHD Fetal Growth Study are being invited to participate.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    STU00206857
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    Rangel, Elizabeth 1 312 503 6287
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    Synthetic Lipoprotein Nanoparticles as Biosensors for Rapid Ex Vivo Assessment of Lecithin: Cholesterol Acyltransferase Activity
    The purpose of this study is to utilize a new technology developed in the Thaxton Laboratory to measure molecular changes that occur in a person’s blood as a result of ex…
    The purpose of this study is to utilize a new technology developed in the Thaxton Laboratory to measure molecular changes that occur in a person’s blood as a result of exercise. Research shows that high-density lipoproteins (HDL), particles made up of multiple proteins that transport fat molecules around the body, are broken down during exercise. Comparing the levels of HDLs before and after exercise may provide a way for individuals to monitor their individual response to exercise. Furthermore, the levels may change based upon the time exercised, the intensity of exercise and the type of exercise. We will utilize blood samples taken from individuals before and after exercise in order to test a device that examines differences between HDL levels before and after exercise.
    Healthy, non-pregnant adults ages 18-75 years.
    Thaxton, Colby SThaxton, Colby S
    STU00206658
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    Thaxton, Colby S 312 503 1826
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    A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2

    Brief Summary:

    This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants w…

    Brief Summary:

    This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the Renexus® implants in participants with macular telangiectasia type 2.

    Ages Eligible for Study:  21 Years to 80 Years   (Adult, Older Adult)Sexes Eligible for Study:  AllAccepts Healthy Volunteers:  No

    Criteria

    Key Inclusion Criteria:

    • Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
    • Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2
    • Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

    Key Exclusion Criteria:

    • Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
    • Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy for neovascular disease complicating MacTel in either eye
    • Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study
    • Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months
    • Participant is pregnant or breastfeeding
    • Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications

    Fawzi, AmaniFawzi, Amani
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT03319849 STU00206919
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    Thakkar, Priya 312 695 2573
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    Phase Ib, open label, combination study of nintedanib with 5- azacitidine in acute myeloid leukemia characterized by HOX gene overexpression, that are not candidates of intensive chemotherapy
    The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with aza…
    The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. “Investigational” means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant’s response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant’s leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.

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

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03513484 STU00206525
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    Study Coordinator 1 312 695 1102
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    (xIRB) The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States

    The purpose of this study is to collect information to help us understand how doctors treat and manage pe…

    The purpose of this study is to collect information to help us understand how doctors treat and manage people with severe asthma and how the health of people with severe asthma changes with those treatments.

    At least 75 doctors in  the United States will provide information on their patients for the study. There will be at least 1500 patients in this study. The length of each patient's participation will vary but the goal is to have patients involved for 3 or more years.

    18 years of age or older

    Diagnosis of asthma for at least 12 months

    Frequent, current symptoms of asthma

    Taking a daily asthma medication

    In the last 12 months has gone to ER or hospital or had prednisone for a flare

    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206953
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    Frederick, Alyssa +1 312 695 4828
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    Clinical Trial Readiness for SCA1 and SCA3
    Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain…
    Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain scan) and not weigh over 300 lbs.
    Subjects aged 18 to 65 with presence of symptomatic ataxic disease or asymptomatic mutation carrier or subjects with definite molecular diagnosis of SCA1 or SCA3 or another affected family member or Subjects of age >18 with previous diagnosis of early stage SCA1 and SCA3. Subjects must not make changes in physical/occupational therapy status within two months prior to enrollment. Subjects must not weigh over 300 lbs.
    5) 6) No changes in sical/occupational therapy status within two months prior to enrolment
    Opal, PuneetOpal, Puneet
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00206988
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    Brown, ZsaZsa 312 503 4121
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    A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

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

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

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

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

    Karmali, ReemKarmali, Reem
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03397706 STU00206699
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    Study Coordinator 312 695 1102
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    Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol
    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover…
    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating two tubes of blood for the collection of genetic information (DNA) at one study visit.
    - Giant Cell Arteritis
    - Takayasu’s Arteritis
    - Polyarteritis Nodosa
    - Granulomatosis with Polyangiitis (Wegener’s)
    - Microscopic Polyangiitis
    - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
    Archer, AmyArcher, Amy
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00206908
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    Carns, Mary 312 503 1137
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    (xIRB) Alliance A221505: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction
    Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. Radiation treatments are given daily over a treatmen…
    Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. Radiation treatments are given daily over a treatment course of 5 to 6 weeks. This study will examine whether a shorter course of radiation therapy (3 to 4 weeks) are safe and effective, will lower treatment costs, and improve patient satisfaction.This study has two study groups:  Group 1 will get the usual 5 to 6 weeks radiation therapy used for this type of cancer.  Group 2 will get a shortened course with 3 to 4 weeks radiation therapy for this type of cancer. Participants will be assessed during and after completing radiation, similar to usual care and the study doctor may recommend chemotherapy drugs or anti-estrogen medications that are commonly used before or after radiation therapy.
     Diagnosis with stage 2 or stage 3 breast cancer
     Age of at least 18 years
    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03414970 STU00207162
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    Study Coordinator 312 695 1102
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    xIRB A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men with Osteoporosis
    A 12 month study to see if abaloparatide (an investigational medication) is safe and effective in treating osteoporosis in …
    A 12 month study to see if abaloparatide (an investigational medication) is safe and effective in treating osteoporosis in men.
    Men 40-85 years old

    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03512262 STU00207208
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    Tse, Darwin +1 312 503 4535
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    PCCTC-c16-170: IRONMAN: International Registry for Men with Advanced Prostate Cancer
    This is a registry study. The purpose of the study is to learn more about prostate cancer and

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

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

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

    Morgans, AliciaMorgans, Alicia
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206648
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    Study Coordinator 312 695 1102
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    The Gut and Skin Microbiome in Vitiligo Disease Progression

    Volunteers are needed for a study on the microbiome of subjects with and without vitiligo. For patients with vitiligo and without vitiligo, the study will include an initial visit, at which time swab or tape strip samples of the skin and …

    Volunteers are needed for a study on the microbiome of subjects with and without vitiligo. For patients with vitiligo and without vitiligo, the study will include an initial visit, at which time swab or tape strip samples of the skin and swab samples of stool will be collected. All subjects will be asked to complete questionnaires about their skin care regimen and dietary habits. Subjects with vitiligo will be required to follow up for additional specimen collection and questionnaire completion after six months and one year.

    Volunteers over the age of 18 are eligible to participate. Study is recruiting those with and without vitiligo. 
    Le Poole, IsabelleLe Poole, Isabelle
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00206844
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    Belback, Madeleine 312 503 5901
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    Longitudinal Functional MRI Study of Transcranial Electrical Stimulation in Chronic Tinnitus

    Volunteers with chronic tinnitus are invited to participate in a brain research study at NorthwesternUniversity. Our research group uses brain scans to understand and improve neuromodulation techniques. Th…

    Volunteers with chronic tinnitus are invited to participate in a brain research study at NorthwesternUniversity. Our research group uses brain scans to understand and improve neuromodulation techniques. This study involves transcranial electrical stimulation (tES), a neuromodulation technique that delivers mild electrical current between electrodes placed on the scalp to study brain networks in healthy individuals and people with brain conditions. The study includes questionnaires, perception tests, two brain scans, and ten tES sessions at the Center for Translational Imaging atNorthwestern. These procedures will be at no cost to you and will occur during12 study visits over 10 weeks. The first visit will last 4 hours, and all other visits will last 1 hour or less. Participants will be compensated up to $225.

    • 18 - 55 years old
    • able to have an MRI scan
    • chronic subjective tinnitus for at least one year
    • no developmental, neurological, or psychiatric disorders
    • available to attend 12 study visits over 10 weeks at NU Chicago Campus
    Leaver, AmberLeaver, Amber
    • Map it 710 N. Fairbanks Ct. Olson Paivlion
      Chicago, IL
    NCT03544359 STU00207056
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    tinnitus mri

    For more information on this study please contact us:

    Leaver, Amber +1 312 694 2966
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    A Phase 3, Randomized, Rater-Blinded, Multi-Center Study to Evaluate the Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Patients with Wilson Disease Aged 12 Years and Older with an Extension Period of Up to 60 Months
    The primary objective of this study is to eval…
    The primary objective of this study is to evaluate the efficacy of the drug WTX101 administered for 48 weeks, compared to standard of care (SoC), on copper (Cu) control in subjects with Wilson's disease aged 18 and older.
    Diagnosis of Wilson's Disease, Treatment for >28 days with chelation therapy, Zn therapy or a combination of chelator and Zn; willing to avoid the use of vitamins and/or minerals containing CU, Zn or Mo throughout the study, willing to undergo > 48-hour washout from current WD treatment
    Bega, DannyBega, Danny
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03403205 STU00206921
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    Brown, ZsaZsa 312 503 4121
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    Functional MRI Study of Transcranial Electrical Stimulation in Major Depression
    Volunteers with major depression are invited to participate in a brain research study at Northwestern University. Our research group uses brain scans to understand and improve neuromodulation techniques. This study involv…
    Volunteers with major depression are invited to participate in a brain research study at Northwestern University. Our research group uses brain scans to understand and improve neuromodulation techniques. This study involves transcranial electrical stimulation (tES), a neuromodulation technique that delivers mild electrical current between electrodes placed on the scalp to study brain networks in healthy individuals and people with brain conditions. The study includes questionnaires, perception tests, and a brain scan at the Center for Translational Imaging at Northwestern. These procedures will be at no cost to you and will occur during 2 study visits. The 1st study visit will last approximately 1 hour, and the 2nd visit will last approximately 2 hours. Participants will be compensated up to $75.

    • 18-55 years old
    • able to have an MRI scan
    • diagnosed mild/moderate depression (unipolar, no suicidal thoughts)
    • no developmental, neurological, or other psychiatric disorders

    Leaver, AmberLeaver, Amber