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Northwestern Scleroderma Program Patient Registry
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00002669
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Carns, Mary
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Predictive Ability of Gene Expression Signatures in Skin as SSc Biomarkers
This study is being done because all therapies for scleroderma are associated with potential side effects. Given this fact, it is essential to be able to predict response to various experimental treatments in order minimize th…
This study is being done because all therapies for scleroderma are associated with potential side effects. Given this fact, it is essential to be able to predict response to various experimental treatments in order minimize the risk of side effects while improving the chance of clinical benefit. Using genomic (DNA expression) information gathered from skin biopsies from patients who respond to individual therapies, and associated clinical information, we hope to be able to accurately predict the likelihood of treatment response for individuals with scleroderma. This study involves skin biopsies at five seperate visits, blood collection, and some health questionnaires.
-Patients >18 years old with a diagnosis of lcSSc, dcSSc, localized scleroderma, or a scleroderma mimic disorder as defined by American College of Rheumatology criteria who will be beginning a new disease-modifying treatment for their disease.
-Must not be currently pregnant or nursing.
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00004428
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Carns, Mary
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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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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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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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Characteristics of the Stretch Reflex Response in Various Joints
Please see IRB-approved consent form (attached).
Perreault, EricPerreault, Eric
STU00009204
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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.
West, Dennis PWest, Dennis P
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00009443
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Pease, David
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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
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass b…
RATIONALE: 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. PURPOSE: 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.
Salem, RiadSalem, Riad
NCT00532740 STU00011037
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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
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NU 09Z3: Evaluation of immune cell responses in blood of patients with colon, rectal, and pancreas cancer – A pilot study

This study is being done because it is not well understood how the immune system controls tumor growth. You will be asked to provide blood samples for this research study.

This study is being done because it is not well understood how the immune system controls tumor growth. You will be asked to provide blood samples for this research study.

You may be eligible for this research study if you have cancer of the colon, rectum or pancreasand are planning to undergo treatment or you are a healthy volunteer who has agreed to donate asmall amount of blood. 
Mulcahy, Mary FrancesMulcahy, Mary Frances
  • Map it 201 E. Huron St.
    Chicago, IL
STU00015014
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Study Coordinator 1 312 695 1102
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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
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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
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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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Alterations in Gene Expression in the Scleroderma Esophagus
The purpose of this study is to learn more about how Scleroderma (SSc) affects the esophagus to cause symptoms such as heartburn and trouble swallowing (dysphagia). We also want to learn whether the problems that cause esophageal symptoms ar…
The purpose of this study is to learn more about how Scleroderma (SSc) affects the esophagus to cause symptoms such as heartburn and trouble swallowing (dysphagia). We also want to learn whether the problems that cause esophageal symptoms are the same as the problems that cause SSc skin tightening and lung disease. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology (achalasia, esophageal stricture, esophageal cancer)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine
Brenner, Darren MBrenner, Darren M
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00021381
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Thakrar, Anjali
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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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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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    Chemokine mechanisms in chronic pelvic pain
    The purpose of this study is to investigate the types of biomarkers, which are measurable indicators of a health condition, present in patients who suffer from chronic pelvic pain syndrome. Biomarker levels will be determined from patient samples of blood, …
    The purpose of this study is to investigate the types of biomarkers, which are measurable indicators of a health condition, present in patients who suffer from chronic pelvic pain syndrome. Biomarker levels will be determined from patient samples of blood, urine, and expressed prostatic secretions.
    Patients who report a response of at least 1 on the pain, pressure or discomfort scale for chronic pelvic pain syndrome (CPPS) and report pain or discomfort in the Male Genitourinary Pain index. Pain must be present for 3 out of the past 6 months. Must be 18 years of age or older.
    Thumbikat, PraveenThumbikat, Praveen
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00030121
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    Thumbikat, Praveen
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    Platelet-Orientated Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
    The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, h…
    The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke.
    Bernstein, Richard ABernstein, Richard A
    STU00023167
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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.
    Sutton, Sarah HSutton, Sarah H
    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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    Development of New MRI Protocols
    This is an ongoing study that recruits subjects for testing out new MRI protocols or functional MRI tasks. You may be asked to perform tasks while being scanned.
    Parrish, Todd BParrish, Todd B
    STU00028086
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    1-855-NU-STUDY
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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
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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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    Voss-Fairchild, Pamela C
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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
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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
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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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    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
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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
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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 research subjects.NU CRP clinical research studies covers a wide spectrum of …
    The recruitment pipeline provides research staff with an organized system of identifying research subjects.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 recruitment registry 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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    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
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    Impact of two prednisone-free maintenance immunosuppressive regimens with reduced dose FK506+Everolimus vs. standard dose FK506+MMF on subpopulation of T and B cells, renal allograft function and gene expression profiles in renal allograft biopsies at 12, 24 and 36 months post-transplant. Prospective single center study in recipients of renal transplant allograft.
    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 a transplanted organ. The primary purpose of this study is to investigate the impact of two maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil (group 2) as their immunosuppression medication. This study will enroll adult patients who are scheduled to receive a kidney transplant. The study is designed to understand the mechanisms of Everolimus in regards to kidney function in transplant recipients. The investigators hypothesis is that decreased exposure to Tacrolimus to the immune system will then translate in better renal allograft function.
    Gallon, LorenzoGallon, Lorenzo
    NCT01653847 STU00058738
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    1-855-NU-STUDY
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    Boehringer Ingelheim Pharmaceuticals, Inc., "Gloria-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment in Patients with Atrial Fibrillation" (Phase II/III)
    In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are…
    In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
    Bernstein, Richard ABernstein, Richard A
    NCT01468701 STU00062959
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    1-855-NU-STUDY
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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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    Fairchild, Melody Dawn
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    Cannabimimetic Treatment of Obstructive Sleep Apnea A Proof of Concept Trial of Dronabinol in OSA
    This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
    Zee, Phyllis CZee, Phyllis C
    NCT01755091 STU00063346
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    1-855-NU-STUDY
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    Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional MR (COAPT) Continued Access Study
    Description of Research Trial: To evaluate (study) the safety and effectiveness of the MitraClip System (“Study Device”) in patients with of mitral…
    Description of Research Trial: To evaluate (study) the safety and effectiveness of the MitraClip System (“Study Device”) in patients with of mitral regurgitation (MR) that are at high risk for mitral valve surgery. The Study Device consists of an implantable clip to repair the mitral valve and a delivery catheter (a thin, flexible tube through which the clip is passed into the body). The Study Device has not been approved by the US Food and Drug Administration (FDA) for use outside of research trials, and is considered experimental in this study. Participant Requirements: The COAPT Trial is recruiting individuals who have moderate-to-severe or severe functional mitral regurgitation (FMR) and have been determined to be at high risk for traditional mitral valve surgery. 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 is a randomized study which means that there is a 50/50 chance (like flipping a coin) of being assigned to receive the study device or not. Subjects assigned to the Control (no Device group) may be eligible to receive the Study Device after their two year study visit. Up to 420 patients at 75 medical centers in North America will participate in this clinical study. We hope to enroll up to 20 participants here at Northwestern. Participation in the study will last up to five years.
    Ricciardi, MarkRicciardi, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01626079 STU00064006
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    Brady, Caitlin
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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
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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
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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
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    Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study
    Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
    Kalhan, RaviKalhan, Ravi
    NCT01608490 STU00069480
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    COPD RePneu

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    1-855-NU-STUDY
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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
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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
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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
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    Institution-wide Registry of Klinefelter Syndrome Patients
    The goal of this study is to better understand the clinical characteristics of our Klinefelter Syndrome patients at Northwestern to better understand the clinical course and treatment outcomes of the condition. We hope that the results of th…
    The goal of this study is to better understand the clinical characteristics of our Klinefelter Syndrome patients at Northwestern to better understand the clinical course and treatment outcomes of the condition. We hope that the results of this research will lead to future research in Klinefelter Syndrome.
    Men ages 18-89 with a confirmed diagnosis of mosaic and non-mosaic Klinefelter Syndrome (47,XXY)
    Brannigan, Robert EBrannigan, Robert E
    STU00071754
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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
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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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    NU 12G11: The Efficacy and Safety of Tivozanib in Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
    This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tiv…
    This phase II trial studies how well tivozanib works in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Tivozanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01853644 STU00073756
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    Study Coordinator 312 695 1102
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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
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    Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients with Psoriasis
    The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vasc…
    The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features. Subjects will receive 6 months of either Humira or Methotrexate.
    18-75 years old with the diagnosis of moderate-to-severe plaque psoriasis; participants must be willing to have taken digital photographs of their plaque lesions and uninvolved skin; participants must not have not taken any systemic psoriatic therapy for at least 4 weeks before the start of the study and/or use of any topical treatments at least 2 weeks prior to start of the study.
    Brieva, Joaquin CBrieva, Joaquin C
    NCT02162472 STU00078102
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    Ali, Yasmeen
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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
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    Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder
    This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration o…
    This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum. Because the concentration of the medication is likely to decrease during pregnancy, it is important for doctors to know how much they should increase a patient's dose in order to prevent worsening of Bipolar symptoms. In this study, the investigators will ask that participants complete up to five overnight visits to our clinical research unit where their blood will be drawn every couple of hours, through an IV catheter, to measure how the concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated for their time.
    Clark, CrystalClark, Crystal
    NCT01996293 STU00079810
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    1-855-NU-STUDY
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    Prospective randomized evaluation of centration of intraocular lens with two laser settings for capsulorhexis with femtosecond laser
    The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centr…
    The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.
    Basti, SurendraBasti, Surendra
    NCT02315456 STU00081388
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    1-855-NU-STUDY
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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
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    NEUROLOGICAL MECHANISMS OF TREATMENT PROJECT (NMT): AN EXAMINATION OF THE NEUROLOGICAL EFFECTS OF COGNITIVE BEHAVIORAL THERAPY ON ADOLESCENTS WITH DEPRESSION
    The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process informati…
    The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process information. We hope to determine if adolescents with depression who have received treatment process information the way adolescents without depression react. Your child is being asked to participate in this study because he/she is age of 13-17 and has been diagnosed of Major Depressive Disorder (MDD). You or your child will be asked to complete 3 assessment days, including today, and 12 weeks of individual Cognitive Behavioral Therapy (CBT). During the assessment days, your child will be asked to complete questionnaires regarding how he/she is feeling and how he/she copes with stressful situations.
    13-17 years old, diagnosed with Major Depressive Disorder
    Breiter, HansBreiter, Hans
    STU00081474
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    O'Dor, Sarah
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    SWOG 1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer, e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.

    This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

    The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic (cancer that has spread to other parts of the body) kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients. Investigational or experimental means that the study drug is currently being tested in breast cancer patients and is not approved for sale in the United States by the Food and Drug Administration (FDA). In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

    You may be eligible for this research study if you are a woman/man with hormone responsive breast cancer that has already been removed by surgery and you have completed any required chemotherapy or radiation.

    Flaum, LisaFlaum, Lisa
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01674140 STU00082264
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    Study Coordinator 312 695 1102
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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
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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
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    Vitamin D and type 2 diabetes
    Overweight adults, age 30 and above who are at risk for type 2 diabetes, are needed for a research study on a dietary supplement. During the study, participants will obtain information about their health, receive educational information on the prevention of diabetes, and…
    Overweight adults, age 30 and above who are at risk for type 2 diabetes, are needed for a research study on a dietary supplement. During the study, participants will obtain information about their health, receive educational information on the prevention of diabetes, and be required to take a dietary supplement daily. Participation in the study will last for up to 4 years. Participants will receive a stipend for completing all study visits. People diagnosed with diabetes, kidney stones, or kidney disease are not eligible. Other exclusions apply. For more information or to see if you qualify, please call 312-503-3413, email d2d@northwestern.edu or visit www.d2dstudy.org. (Sponsored by the National Institutes of Health)
    -Adults 30 and older, BMI 24 and above, having pre-diabetes as determined by the following: fasting glucose: 100-125, HbA1c: 5.7-6.4
    Neff, Lisa MNeff, Lisa M
    STU00078718
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    Arroyo, Esperanza
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    RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
    This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer
    Donnelly, EricDonnelly, Eric
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01872975 STU00083782
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    Study Coordinator 312 695 1102
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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
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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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    DRCR V - Treatment for Central-Involved Diabetic macular Edema in Eyes with Very Good Visual Acuity
    Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with cen…
    Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens. The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF. Secondary objectives include: - Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity - For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment - Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness - Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups - Comparing safety outcomes between treatment groups - Comparing associated treatment and follow-up exam costs between treatment groups
    Lyon, A ThayerLyon, A Thayer
    NCT01909791 STU00086556
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    1-855-NU-STUDY
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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
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    Anti-TSLP (AMG 157) plus antigen-specific immunotherapy for induction of tolerance in individuals with cat allergy (ITN057AD)
    This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TS…
    This trial will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP [thymic stromal lymphopoietin] antibody being co-developed by Amgen and Medimmune) can lead to lasting tolerance to cat allergen.The objective of the study is to determine whether one year of immunotherapy combined with MEDI9929/AMG 157 can induce tolerance to cat allergen.
    Greenberger, Paul AllenGreenberger, Paul Allen
    NCT02237196 STU00088003
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    1-855-NU-STUDY
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    Epigenetic Markers of Bladder Cancer Progression
    The purpose of this study is to better understand the expression of certain genes and genetic changes that occur in bladder tumors.
    Male or female patients aged 40-89 identified to have a bladder lesion or mass concerning for urothelial carcinoma based on cystoscopy or imaging who are scheduled to undergo transurethral resection of bladder tumor (TURBT).
    Meeks, Joshua JMeeks, Joshua J
    STU00088853
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    Meeks, Joshua J
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    A Prospective Study to Identify Risk Factors for Progressive Calcinosis in Patients with Systemic Sclerosis: A Scleroderma Clinical Trials Consortium Study
    This study is being done in order to help researchers learn more about calcinosis that affect patients with systemic sclerosis. Calcinosis cutis …
    This study is being done in order to help researchers learn more about calcinosis that affect patients with systemic sclerosis. Calcinosis cutis is a rare disorder characterized by calcium deposition in skin and subcutaneous tissues. We will develop a prospective database of SSc patients with calcinosis in order to better understand the natural history, clinical associations, and pathophysiology of this condition.
    Must have a diagnosis of Scleroderma. Must not have an overlap connective tissue disease or a diagnosis of mixed connective tissue disease. Must be over the age of 18.
    Hinchcliff, Monique EHinchcliff, Monique E
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00088949
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    Carns, Mary
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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
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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
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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
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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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    1-855-NU-STUDY
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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
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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
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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
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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
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    Stroke Hyperglycemia Insulin Network Effort
    The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischem…
    The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL -130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as
    Mendelson, ScottMendelson, Scott
    NCT01369069 STU00095011
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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
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    ECOG 1910: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults.
    Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview …
    Purpose This study in being done to determine what affects (good and bad) the therapy blinatumomab has on acute lymphoblastic leukemia (ALL). Overview This study is for patients who have recently been diagnosed with a subtype of ALL that is known as BCR-ABL negative B-lineage ALL. Blinatumomab is a new antibody therapy that binds to B cells and recruits T cells to attack leukemia B cells. Patients will be randomized to receive chemotherapy what has traditionally been used to treat this sub-type of ALL alone or chemotherapy with blinatumomab . Studies are being done in ALL and other blood cancers with blinotumomab Blinatumomab has been effective in residual or relapsed B-cell ALL at destroying these specific cells. But it has not yet been proven helpful in combination with chemotherapy in newly diagnosed ALL. Description of Treatment There are several steps of treatment in this study. They are called induction, intensification, consolidation, and maintenance. In these study steps participants will be getting standard chemotherapy treatments that may or may not be combined with a new cancer drug called blinatumomab. Blinatumomab is a drug that is given as a continues infusion. The treatment schedule should be discussed with the study doctor.
    Some of the eligibility criteria include:

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Dinner, ShiraDinner, Shira
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02003222 STU00093458
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    Study Coordinator 312 695 1102
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    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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    Steroids in Eosinophil Negative Asthma (SIENA)
    Most people with asthma have inflammation in their airway. Asthma controller medications, like inhaled corticosteroids, are meant to reduce inflammation in the airway. Reducing airway inflammation should make one's breathing easier. However, many peop…
    Most people with asthma have inflammation in their airway. Asthma controller medications, like inhaled corticosteroids, are meant to reduce inflammation in the airway. Reducing airway inflammation should make one's breathing easier. However, many people with asthma don't breathe easier when they take inhaled corticosteroids. We know that there are several types of cells that can cause airway inflammation. However, inhaled corticosteroids mostly target only one cell called the eosinophil. The purpose of this study is to find out if people should take an asthma controller medication based on the type of inflammatory cells present in their airway.
    18 year of age or older with asthma
    Smith, Lewis JSmith, Lewis J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02066298 STU00093538
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    Hixon, Jenny Lorraine
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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
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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
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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
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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
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    PneumRx, Inc. LVRC IDE Crossover Study (Crossover from IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, IDE G110066)
    Crossover study for patients who were randomized to the Control Group in CLN0009.
    Kalhan, RaviKalhan, Ravi
    NCT02059057 STU00099240
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    1-855-NU-STUDY
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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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    1-855-NU-STUDY
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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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    1-855-NU-STUDY
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    A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease (Protocol # CLCI699C2301)
    The study aims …
    The study aims to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It is a pivotal trial intended to support the registration of LCI699 for the treatment of patients with Cushing's disease in the EU, Japan, and other countries.
    Molitch, Mark EMolitch, Mark E
    NCT02180217 STU00100063
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    1-855-NU-STUDY
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    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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    BEST-CLI Trial: Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia
    The BEST-CLI study This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (C…
    The BEST-CLI study This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowed or blocked by plaque buildup (atherosclerosis). CLI can cause pain in the foot or leg even when sitting or lying at rest; it also can cause foot and leg ulcerations, and can sometimes lead to gangrene and loss of the leg. CLI is usually treated by operations or procedures that increase blood flow to the leg and foot, in order to relieve these symptoms, heal the ulcers, and preserve the limb. There are two different ways to increase the blood flow in CLI. One is with open surgery, which creates a bypass around the blockage. The other is with endovascular treatment (often called angioplasty), a minimally invasive procedure that opens the blocked arteries directly. Angioplasty is performed with balloons and other tools that clear plaque, and sometimes permanent implantation of small, mesh-like metal tubes called “stents”. Both types of treatment – open surgery and angioplasty - are considered reasonable and appropriate for patients with CLI. Half of the participants in this study will have open surgery and half will have endovascular treatment. The assignment of treatment is random, meaning purely by chance (50:50, just like a coin toss). The purpose of the study is to learn about which therapy is more suitable for those patients who are candidates for both open surgery and endovascular treatment, and to provide information regarding cost effectiveness of the two different types of treatment. We expect 2100 participants to enroll from approximately 120 different study centers across the United States, Canada, and possibly other countries. We hope to enroll up to 20 participants at Northwestern.
    Eskandari, MarkEskandari, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02060630 STU00101601
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    Toaspern, Lillian
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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
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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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    EMPROVE (Evaluation of the Spiration Valve System (SVS) - for EMphysema to ImPROVE Lung Function) A Prospective, Randomized, Controlled, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Single Lobe Treatment of Severe Emphysema
    Emphysema is a chron…
    Emphysema is a chronic lung disease where lung tissue is destroyed. This destruction causes the lungs to lose their natural elasticity, leaving the emphysema sufferer with an inability to get air out of their lungs. This causes shortness of breath which makes it hard to perform many physicial activities. While there is no cure for emphysema, there are various surgical procedures that have been used to treat the symptoms of emphysema, including lung volume reduction surgery (LVRS). LVRS has proven effective in improving survival, health status, exercise capacity and lung functions in treated patients. However, many people with severe emphysema are not eligibile for LVRS due to concerns regarding the risks associated with surgical procedures. As a result, there is a significant medical need to investigate a non-surgical approach to helping patients with severe emphysema, such as the Spiration Valve System, the device of this study.
    18 years of age or older and diagnosed with severe COPD
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01812447 STU00099554
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    Rogowski, Allison
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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
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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
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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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    Amidei, Christina
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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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    1-855-NU-STUDY
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    Rheumatoid Arthritis Synovial tissue Network
    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression …
    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
    • Diagnosis of rheumatoid arthritis (RA).
    • Must have been 18 years of age or older at the time of diagnosis of RA.
    • At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
    Perlman, Harris RPerlman, Harris R
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00104822
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    Carns, Mary
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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
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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
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    A prospective, randomized, blinded, placebo-controlled, phase IIb trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine vs unloaded YCWP + DC in stage III and stage IV (resected) melanoma to prevent recurrence
    The majority of melanoma…
    The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.
    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02301611 STU00200122
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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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    Alliance A081105: Randomized Study of Erlotinib vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
    Purpose The purpose of this study is to compare any good and bad effects patients may have when treated with the st…
    Purpose The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). Overview This study is for patients with early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). Researchers are trying to find out if this mutation could help doctors make decisions about which type of treatment is best for people with this type of cancer. People not in a research study are usually not treated with anything after they finish their chemotherapy although some of them may receive radiation therapy. Description of Treatment This study has two study groups. Group 1 will get the study drug called erlotinib. The erlotinib will be taken once a day. Group 2 will get the placebo, which looks just like the erlotinib but does not have any active ingredients. The placebo will be taken once a day.
    Some of the eligibility criteria include:

    - Participants must have NSCLC.
    - Participants must EGFR mutant and ALK rearrangement, which is detected by genetic testing performed through the study doctor's office.
    - 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.
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02193282 STU00200145
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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
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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
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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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    Toaspern, Lillian
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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
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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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    Jimenez, Javier
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    A multicenter, double-blind, randomized, placebo-controlled, Phase 3 study to assess the efficacy and safety of oral BPS-314d-MR addedon to treprostinil, inhaled (Tyvaso®) in subjects with pulmonary arterial hypertension version date 15.Oct.2014
    This is a multicenter, double-blind, ran…
    This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 study, to assess the efficacy and safety of BPS-314d-MR when added-on to inhaled treprostinil (Tyvaso®)in patients with pulmonary arterial hypertension. Patients new to Tyvaso, will enter a run-in period on inhaled treprostinil until 90 days of experience is achieved to ensure drug tolerability before enrolling in the study. Treatment groups consist of one active and one placebo group. Subjects will be randomly allocated in a 1:1 ratio to one of the two treatment groups.
    Cuttica, Michael JCuttica, Michael J
    NCT01908699 STU00200387
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    1-855-NU-STUDY
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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
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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
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    NU 14H09: A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients with MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen
    The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it…
    The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.
    Some of the eligibility criteria include:

    - Participants must have diffuse large B-cell lymphoma (DLBCL) or other aggressive B-cell lymphoma that has an MYC-rearrangement. This is determined with special laboratory testing.
    - Participants may not have had more than one prior cycle of chemoimmunotherapy for their lymphoma. All treatments should be discussed with the study doctor.
    - 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.
    Pro, BarbaraPro, Barbara
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02481310 STU00200596
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    Study Coordinator 312 695 1102
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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
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    Brady, Caitlin
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    Genomic Analysis of Enhanced Receptors to Heart Failure Therapy in African Americans
    Congestive heart failure often results in shortness of breath or fatigue with exertion. Medical treatment for this problem usually consists of medications such as Lisinopril (also called ACE inhibitors or ARBs) and L…
    Congestive heart failure often results in shortness of breath or fatigue with exertion. Medical treatment for this problem usually consists of medications such as Lisinopril (also called ACE inhibitors or ARBs) and Lopressor (also called beta blockers). It is believed that a fixed dose combination of Isosorbide Dinitrate and Hydralazine (FDC I/H) works better in African Americans with heart failure when compared to their white counterparts. Despite the possible benefits, the drug is prescribed in only 25% of African Americans. It is believed that the positive response to this drug may be a difference in the genetic make-up of African Americans. “DNA”, “gene”, or “genetic make-up” is inherited information (a blueprint) about the structure and function of cells in the human body that make up the color of our hair and eyes and may influence the way our bodies respond to certain stimuli such as smoking, an illness, or infections.FDC I/H is FDA (Food and Drug Administration) approved for self-designated African Americans with heart failure. The goal of the current study is to see if a genetic blood test would indicate who within the African American group would show a positive response to the study medication. We are asking 500 self-designated African Americans who are 18 years old and older with congestive heart failure to participate. Up to 50 subjects will be asked to participate at Northwestern; the study duration is approximately 24 months.
    Anderson, AllenAnderson, Allen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02305095 STU00200297
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    Mkrdichian, Hamorabi
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    SUSTAIN-IT: Sustaining quality of life of the aged: Heart transplant or mechanical support?
    This study is looking for patients, 60-80 years of age, who are scheduled to receive a mechanical circulatory support (MCS) device for long-term treatment or listed with the United Network for Organ Sharing (U…
    This study is looking for patients, 60-80 years of age, who are scheduled to receive a mechanical circulatory support (MCS) device for long-term treatment or listed with the United Network for Organ Sharing (UNOS) for heart transplant (HT). This study is also enrolling the caregivers of these patients. The purpose of this study is to compare the health-related quality of life (HRQOL), symptoms, thinking and adverse events between these two patient groups. This study will also evaluate the HRQOL of these patients’ caregivers. Approximately 40 patients and 40 caregivers will be enrolled in the study at Northwestern.
    Grady, Kathleen L L.Grady, Kathleen L L.
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02568930 STU00200851
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    Zinn, Sarah
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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
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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
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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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    Tavathia, Meera
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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
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    A Phase 3 Randomized, Double-Blind, Active-Controlled, Multicenter Study of the Long-Term Safety and Efficacy of Subcutaneous Administration of Tanezumab in Subjects with Osteoarthritis of the Hip or Knee; A4091058
    The purpose of this study is to compare the long-term joint safety and e…
    The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.
    Schnitzer, Thomas JSchnitzer, Thomas J
    NCT02528188 STU00201068
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    Swiostek, Irmina
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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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    1-855-NU-STUDY
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    ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

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

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

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

    You may be eligible for this research study if you:

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

    Flaum, LisaFlaum, Lisa
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02445391 STU00201173
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    Study Coordinator 312 695 1102
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    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
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    Arrieta, Rose
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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
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    Circadian rhythms and epilepsy: a prospective study
    This study is to further understand the link between epilepsy, sleep and circadian rhythms. We propose to characterize sleep-wake and circadian rhythm patterns in patients with epilepsy (PWE). To assess the interactions between circadian function an…
    This study is to further understand the link between epilepsy, sleep and circadian rhythms. We propose to characterize sleep-wake and circadian rhythm patterns in patients with epilepsy (PWE). To assess the interactions between circadian function and sleep quality with seizure frequency and timing by data from self- reported sleep and circadian chronotype questionnaires, sleep diaries, seizure type and frequency as reported by the subjects’ primary physician, and objective sleep (actigraphy) and circadian rhythm measures.
    Adults (18 years of age and older) with generalized seizures and focal seizures.
    Patients are allowed to remain on their usual regimen of antiepileptic medications.

    Zee, Phyllis CZee, Phyllis C
    STU00201284
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    Erlikh, Natanie
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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 fluid) dur…
    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, as decreases in drug levels may cause the antidepressant to become ineffective and result in an increase in mood symptoms or recurrence of depressive episodes. Increases in antidepressant concentration may lead to increased side effects. We are hoping to better understand the course of these changes across pregnancy and postpartum and how an individual’s genetic makeup impacts these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of pregnant women
    Are 18 years of age or older
    Are currently at or less than 18 weeks pregnant
    Speak English or Spanish
    Have received a diagnosis of depression
    Take sertraline (Zoloft), fluoxetine (Prozac), citalopram (Celexa), or escitalopram (Lexapro) and plan to continue it during pregnancy and postpartum
    Wisner, KatherineWisner, Katherine
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02519790 STU00201386
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    O'Shea, Kelly
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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
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    Arrieta, Rose
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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
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    Arrieta, Rose
    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
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    Arrieta, Rose
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    The MOMENTUM 3 Clinical Trial - Multicenter study of MagLev technology in patients undergoing MCS therapy with HeartMate 3
    The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for…
    The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

    Primary Inclusion:

    • NYHA Class III with dyspnea upon mild activity or NYHA IV 
    • Inotrope dependent OR on optical medical management for 45/60 days failing to respond, OR advanced HF for at least 14 days and dependent on IABP for at least 7 days
    • LVEF ≤ 25%

     

    Primary Exclusion:

    • Presence of a mechanical aortic valve that will not be converted to bioprothesis or oversewn at implant
    • Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
    • Existence of ongoing MCS other than IABP
    Anderson, AllenAnderson, Allen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02892955 STU00200932
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    Dreisbach, Alexander
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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 MEDI4…
    The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 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 inhibiting 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.
    Cristofanilli, MassimoCristofanilli, Massimo
    NCT02536794 STU00200984
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    1-855-NU-STUDY
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    Chronic Kidney Disease Research Biorepository
    The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00201546
    More Info

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    Martinez, Carlos
    Copy
    Medtronic AdaptResponse Study
    The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated…
    The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
    Lin, AlbertLin, Albert
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02205359 STU00201470
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    Carswell, Amy
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    Improving Outpatient Safety of Older Adults through Electronic Patient Portals
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
    Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
    Lindquist, Lee ALindquist, Lee A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00201242
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    Seltzer, Anne Jennifer
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    A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
    This is a Phase 3, multicenter, ope…
    This is a Phase 3, multicenter, open-label, rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in Studies 103 (NCT02070744), 106 (NCT02347657), 107 (NCT02516410), 108 (NCT02392234), 109 (NCT02412111), and 111 (NCT02508207). The study is designed to evaluate the safety and efficacy of long term treatment of VX-661 in combination with ivacaftor. This study consists of a Treatment Cohort and an Observational Cohort. The Treatment Cohort and the Observational Cohort will be open to enrollment in parallel.
    Jain, ManuJain, Manu
    NCT02565914 STU00201585
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    1-855-NU-STUDY
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    x(CIRB) NRG-BR002: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
    This randomized phase II/III trial studies how well standard of care therapy with stereotactic…
    This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
    Strauss, Jonathan BStrauss, Jonathan B
    NCT02364557 STU00201769
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    1-855-NU-STUDY
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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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    Bryan, Cassandra
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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
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    A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
    This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.
    Wunderink, Richard GWunderink, Richard G
    NCT02493764 STU00201672
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    1-855-NU-STUDY
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    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
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    A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease
    The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
    • Subjects with type 2 diabetes mellitus
    • Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on the following criteria: Persistent very high albuminuria defined as urinary albumin-to-creatinine ratio (ACR) of > 300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) 25 - < 75 mL/min/1.73 m² Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months
    • Serum potassium
    Molitch, Mark EMolitch, Mark E
    NCT02540993 STU00201605
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    Adelman, Daphne T
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    A double-blind, randomize, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy
    This study is looking at generalize toni…
    This study is looking at generalize tonic-clonic (GTC) seizure control for generalized epilepsies using Lacosamide. We are recruiting participants with generalized epilepsies over the age of 18, who are experiencing at least 2 GTCs per month.
    Macken, Micheal PMacken, Micheal P
    NCT02408523 STU00201161
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    Bellinski, Irena Iva
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    VESPR: Vaginal Electrical Stimulation for Postpartum neuromuscular Recovery
    The aim of this study is to compare and assess women who sustain a severe tear during their first pregnancy. They will be randomized to either vaginal electrical stimulation 1 week postpartum or to no stimulation. The primary…
    The aim of this study is to compare and assess women who sustain a severe tear during their first pregnancy. They will be randomized to either vaginal electrical stimulation 1 week postpartum or to no stimulation. The primary outcome of this study will be to assess and compare complications associated with this tear via questionnaires and an ultrasound. This study is for women who sustained a tear during their first pregnancy.
    The study will include women who sustained a severe tear during their first pregnancy will be considered eligible for the study. Participants that have wound breakdown or infection, and have an implanted electrical device will not be considered eligible for the study.
    Gaupp, Christina LewickyGaupp, Christina Lewicky
    • Map it 676 N St. Clair Arkes Pavillion Suite 950
      Chicago, IL
    NCT02701413 STU00201026
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    Tavathia, Meera
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    A Single-Center Pilot Study of the Role of Transurethral Ultrasound in Staging Bladder Cancer in Patients Scheduled to Undergo Transurethral Resection of Bladder Tumor
    This study aims to determine if ultrasound is effective in the staging of bladder cancer.
    Patients with bladder cancer who will be undergoing cystoscopy and/or cystectomy.
    Kundu, Shilajit DKundu, Shilajit D
    STU00201635
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    Kundu, Shilajit D
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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
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    SHP616-302: A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of Cinryze (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection in kidney transplant recipients
    To evaluate the efficacy of Cinryze® given for the treatment of acute a…
    To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) within 6 months.
    Friedewald, John JFriedewald, John J
    NCT02547220 STU00201572
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    1-855-NU-STUDY
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    A 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
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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
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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
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    A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’(SSc-ILD)
    Systemic Sclerosis (SSc) is a devastating disease of unknown eti…
    Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
    Dematte DDematte D'Amico, Jane E
    NCT02597933 STU00201767
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    1-855-NU-STUDY
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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
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    Beta-Blockers for the Prevention of Acute Exacerbations of COPD
    The purpose of this study is to learn more about the safety and effectiveness of an investigational drug called metoprolol succinate for the treatment of COPD. Metoprolol succinate is already approved by the U.S. Food and Drug Administr…
    The purpose of this study is to learn more about the safety and effectiveness of an investigational drug called metoprolol succinate for the treatment of COPD. Metoprolol succinate is already approved by the U.S. Food and Drug Administration (FDA) to treat patients with heart disease usually after a myocardial infarction (MI), such as a heart attack. Metoprolol succinate is considered "investigational" in this study, because it has not been approved by the FDA to treat COPD. Metoprolol succinate is used to treat chest pain (angina), heart failure, and high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This lowers heart rate, blood pressure, and strain on the heart. This study will test how well once daily metorprolol succinate works to reduce COPD flare-ups.
    40 to 84 years of age with a diagnosis of COPD, Currently using oxygen OR had a COPD flare-up OR visited the ER for COPD in the last year, not taking a beta blocker medication
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02587351 STU00202036
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    Frederick, Alyssa
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    A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
    The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo …
    The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
    Rinella, Mary EugeniaRinella, Mary Eugenia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02548351 STU00201580
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    Milosevic, Stanislava
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    AAD-PEPR: Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
    The purpose of this study is to validate patient-reported outcomes (PRO) measures in three existing asthma intervention trials as well as a large group of itch-specific pediatric skin conditions, primarily focusing on a…
    The purpose of this study is to validate patient-reported outcomes (PRO) measures in three existing asthma intervention trials as well as a large group of itch-specific pediatric skin conditions, primarily focusing on atopic dermatitis (AD, or eczema). 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.
    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
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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
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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
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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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    A randomized, subject and investigator-blind, placebo-controlled study of CLR325 in chronic stable heart failure patients
    CLR325X2202: The purpose of the study is to determine if an investigational drug called CLR325 (“the study drug”) is safe and tolerable in heart failure patients. “Investig…
    CLR325X2202: The purpose of the study is to determine if an investigational drug called CLR325 (“the study drug”) is safe and tolerable in heart failure patients. “Investigational” means the study drug has not been approved the FDA for the treatment of people with heart failure. The study drug is currently not “on the market” (available for prescription for and/or to buy) in any country. This is the first time it will be studied in patients with heart failure. Participants will receive a single infusion of either the study drug or a single infusion of placebo. A placebo is a dummy drug with no active medicine inside and is used to make sure that the changes reported are not just happening by chance. The placebo used will be a saline (salt water) solution. Study participation will last for about 1 month. During this time participants will be asked to come to the hospital once and the outpatient clinic 3 times. We expect to enroll up to 8 people here out of 40 people in the entire study nationally.
    Inclusion Criteria: 1) Male and female patients >18 years of age. 2) Patients with a cardiac ejection fraction of ≤45% assessed within the last 6 months. 3) Patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization. EXCLUSION CRITERIA: 1) Patient with known significant valvular heart disease including severe aortic stenosis or severe mitral stenosis 2) Patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days. 3) Patients who have received an intravenous infusion of a cardiac inotrope (e.g., dobutamine or milrinone) in the last 24 hours prior to randomization.
    Wilcox, Jane ElizabethWilcox, Jane Elizabeth
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02696967 STU00202187
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    Roshevsky, Daniel Scott
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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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    Patel, Harnish H
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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
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    A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS
    Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
    Molitch, Mark EMolitch, Mark E
    NCT02685709 STU00202258
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    1-855-NU-STUDY
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    Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
    Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201469
    More Info

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    Arrieta, Rose
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    Attention Bias: Testing a Potential Marker for the Diagnosis of Atypical Movement Disorders
    The purpose of this study is to determine whether problems with attention lead to abnormal movements. The study involves a few thinking tests to determine if certain patterns of thinking or focusing can be ass…
    The purpose of this study is to determine whether problems with attention lead to abnormal movements. The study involves a few thinking tests to determine if certain patterns of thinking or focusing can be associated with abnormal movements.
    • Adult patients with a clinically established or documented psychogenic movement disorder
    • Adult patients with a diagnosis of benign familial/ essential tremor as made by a movement disorder specialist
    • Healthy adults who do not have any suspected or known neurologic movement disorders

    Bega, DannyBega, Danny
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    STU00202673
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    Hernandez, Alejandro
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    NU 15B08: A Phase II Single Arm Study of Palbociclib in Patients with Metastatic HER2-positive Breast Cancer with Brain Metastasis
    Purpose The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to d…
    Purpose The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain. And to determine the overall radiographic response rate in the CNS. Overview Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as triple negative and HER2 positive breast cancer. The study drug palbociclib is a small molecule and can penetrate the meninges. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have triple negative and HER2-positive breast cancer. Description of Treatment All study participants will get the study drug in the form of a pill that will be taken once a day for 21 days followed by a 7 day break. These 28 days is considered as one cycle. The participants with HER2-positive breast cancer may also receive trastuzumab (standard of care) concurrently.
    Some of the eligibility criteria include:

    - Participants who have been diagnosed with triple negative or HER2-positive metastatic breast cancer.
    - Participants must have been treated previously with more than two lines of chemotherapy for metastatic disease.
    - 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.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02774681 STU00202582
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    Study Coordinator 312 695 1102
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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
    Copy
    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
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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
    Copy
    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
    Copy
    A PHASE 3 RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLED STUDY TO EVALUATE THE LONG-TERM SAFETY AND THE EFFICACY OF FASINUMAB IN PATIENTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE OR HIP
    Approximately 10,000 patients will participate in this study to further characterize the safety profil…
    Approximately 10,000 patients will participate in this study to further characterize the safety profile of fasinumab and provide data on long-term exposure to provide efficacy data. In addition to their participation in the main study, approximately 800 patients will participate in a sub-study to characterize the onset of pain relief by fasinumab.
    At least 18 yrs of age, BMI 39 or less, Osteoarthritis of the knee or hip, taking either Acetaminophen/Tylenol, NSAIDs or opioids at least 4 days a week over last month, fails (either inadequate pain relief, unable to take or refuses to take) Acetaminophen/Tylenol, NSAIDs, and opioids, no rheumatoid arthritis, no fibromyalgia, no symptoms of carpal tunnel syndrome in last 6 months, able to undergo an MRI, is not scheduled for a joint replacement in the next 1.5 yrs, no HIV, no Hepatitis, no sickle cell disease, no S-C disease, no S-beta thalassemia, no heart block, no cancer in last 5 yrs, no hospitalization for depression in last 5 yrs, no alcohol or substance abuse in last 5 yrs, no marijuana use for pain relief in last 6 months, if a female must not become pregnant or breastfeed during the study, and if a female of child-bearing potential must be willing to use contraception during study.
    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT02683239 STU00202672
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    Sutkus, Loretta
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    A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
    This research study will evaluate the safety and effectivenes…
    This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems in patients with symptomatic, severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR). Low operative risk means that patients may have less than a 2% chance of death 30 days after open-heart surgery. The delivery system is the Commander system, which uses transfemoral access (through a blood vessel in the leg) to place the valve in the heart. Patients agreeing to participate in this investigational (experimental) study will have a 50/50 chance of receiving the study device or surgical aortic valve replacement (SAVR). Participation in this research study 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 no more than 120 people will be enrolled at Northwestern The study expects to enroll up to 1228 people at up to 50 sites nationally
    Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02675114 STU00202604
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    Warzecha, Anna
    Copy
    Molecular Biomarkers of Improvement for Patients with Systemic Sclerosis
    The purpose of this study is to identify a method to predict disease course for each individual patient with scleroderma. We will identify gene expression signatures in skin (i.e., the genes that are being “read” to make pr…
    The purpose of this study is to identify a method to predict disease course for each individual patient with scleroderma. We will identify gene expression signatures in skin (i.e., the genes that are being “read” to make proteins) in patients with scleroderma compared to healthy people. Signatures will be determined by measuring RNA (i.e., ribonucleic acid, the genetic information that codes for proteins) and DNA (i.e., deoxyribonucleic acid, the genetic information that contains your genes) in your skin. We will also identify serum protein signatures in blood. The goal is to develop a model that includes gene expression in skin and serum proteins in blood that can predict scleroderma disease course (improvement or worsening in skin, lung, esophageal, and/or heart disease). Participants will complete a questionnaire, give one tube of blood, and one skin biopsy.
    • ≥18 years old
    • Able to provide informed consent in English
    • Meet 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (for patients)
    • No chronic skin conditions or diagnosis of a rheumatic autoimmune disease (i.e., SLE, RA) (for healthy controls)
    Hinchcliff, Monique EHinchcliff, Monique E
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00202756
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    Carns, Mary
    Copy
    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
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    Joint Complaints in Children with Harlequin Ichthyosis: A Study to Assess for Comorbidity
    The goal of this study is to understand the pattern of joint pain and what pain management options or treatments have worked for individuals with joint disease related to Harlequin Ichthyosis (HI). Participatio…
    The goal of this study is to understand the pattern of joint pain and what pain management options or treatments have worked for individuals with joint disease related to Harlequin Ichthyosis (HI). Participation in the study will involve completing a one-time survey administered through letter mailing, emailing, link using an online survey, or in person at the Lurie Children’s Dermatology Clinic. The survey will take about 15-30 minutes.
    Confirmed diagnosis of Harlequin Ichthyosis (HI) and have complaints of joint pain, difficulty walking, swelling or other similar issues with your muscles and bones.
    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
    STU00203185
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    Erickson, Taylor
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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
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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
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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
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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
    Bhorade, SangeetaBhorade, Sangeeta
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT02758808 STU00202873
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    Ansari, Adeeb
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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
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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
    Copy
    NU 16I01: Phase I/Ib study of nivolumab in combination with Therasphere (yttrium-90) in patients with advanced hepatocellular carcinoma.
    Purpose The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unaccept…
    Purpose The purpose of this study is to identify maximum tolerated dose (MTD), that is, the highest dose of the study drug nivolumab that does not cause unacceptable side effects, for combination treatment of nivolumab and Y-90. Also, to evaluate the efficacy (the effect of drug on your tumor) and the tolerability (the effect of the drug on your body) of nivolumab, when given with standard of care Y-90 (Therasphere). Overview Nivolumab is currently FDA approved for other cancers, but has not yet been investigated in advanced or refractory hepatocellular carcinoma. Nivolumab 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. Y-90 is currently FDA approved for the treatment of hepatocellular carcinomas, but has not yet been investigated in combination with nivolumab for this disease. This is a phase I study of 2 drugs used in combination: nivolumab and Y-90. We think the combination of these drugs may be more effective against your cancer. Description of Treatment All study participants will get the same study intervention. All study participants will get the study drug Nivolumab. You will receive induction treatment with Y-90, and then approximately four weeks after, you will receive Nivolumab once every 2 weeks (given through the vein over 30 minutes). After you finish your treatment with nivolumab, the study team will continue to watch you for side effects for up to 30 days from your last treatment. If you discontinue from the study for any reason, the study team will continue to check how you are doing every 2 weeks for up to 24 weeks from the start of your treatment.
    Some of the eligibility criteria include:

    - Patients must have a diagnosis of hepatocellular carcinoma.
    - Patients must have advanced disease that is not amenable to transplant or resection.
    - Patients may be treatment naÌøve or have received any number of prior therapies

    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.
    Kalyan, AparnaKalyan, Aparna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02837029 STU00203003
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    Study Coordinator 312 695 1102
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    A Phase 3 Multicenter, Open-Label Study to Evaluate the Safety of Daily Oral Dosing of Tafamidis Meglumine (PF-06291826-83) 20 mg or 80 mg [ or Tafamidis (PF-06291826-00) 61 mg]in Subjects Diagnosed With Transthyretin Cardiomyopathy (ATTR-CM)

    This is a study designed to obtain additional safety da…

    This is a study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects, diagnosed with thransthyretin cardiomyopathy (ATTR-CM), with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR-CM via prescription, whichever occurs first. 

    • Documentation of the genetic testing for transthyretin amyloidosis (ie, original laboratory result, or copy)
    • Documentation of diagnosis of ATTR and criteria used 
    • Evidence of NYHA classification I, II, III, or IV
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02791230 STU00202870
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    Gold, Sheano G
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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
    Copy
    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
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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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    Jimenez, Javier
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    A Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis
    The purpose of this study is to assess whether treatment with emricasan compared to matching placebo in subjects with N…
    The purpose of this study is to assess whether treatment with emricasan compared to matching placebo in subjects with NASH fibrosis improves fibrosis on liver biopsy by at least one stage without worsening of steatohepatitis using the NASH Clinical Research Network (CRN) Histologic Scoring System.
    Rinella, Mary EugeniaRinella, Mary Eugenia
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02686762 STU00202605
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    Sipich, Kimberly A
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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
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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
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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
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    An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically
    An Open-Label, Multicenter and Open…
    An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically
    Stein, AdamStein, Adam
    NCT02559713 STU00202916
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    Arrieta, Rose
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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. 

    - Be 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 researchstudy on the arm

    Slutzky, Marc WSlutzky, Marc W
    • 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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    Park, Sangsoo
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    A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone
    The E4 Freedom study is investigating a new Combined Oral Contraceptive pill. In the study, we hope to find out how safe and e…
    The E4 Freedom study is investigating a new Combined Oral Contraceptive pill. In the study, we hope to find out how safe and effectiev this pill is at preventing pregnancy, and what periods are like during the menstrual cycle while taking the pill. We will also monitor your well-being throughout the study. The study will last about one year. During the study, participants that meet the study requirements will be asked to take the study pill once a day and to come to the study site at least 7 times for visits.
    Age 18-50, heterosexually active females requiring contraception to prevent pregnancy, in good physical and mental health. If over age 35, must be a non-smoker.
    Shulman, Lee PShulman, Lee P
    NCT02817841 STU00203509
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    Romero, Denise S
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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
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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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    Study Coordinator 312 503 5212
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    The REFLECT Trial: A Randomized Evaluation oF the TriGuard™ HDH Cerebral Embolic Protection Device and the TriGUARD 3 Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation
    Transcatheter aortic valve implantation (TAVI) is a…
    Transcatheter aortic valve implantation (TAVI) is a procedure used to treat a disease of the aortic valve called aortic stenosis, which is a narrowing of the aortic valve. One of the risks of the TAVI procedure is that particles of calcium, blood clots, atherosclerotic plaque (fatty material in blood vessel walls) or other debris (known as emboli) could break off from inside the aortic valve or blood vessels during the procedure and travel to the brain. If the embolism travels to the blood vessels that supply the brain, it could cause a stroke or other more subtle forms of brain injury with symptoms such as memory loss or diminished ability to process information. The purpose of the REFLECT study is to evaluate whether a new device, TriGuard HDH, is effective in preventing or reducing the number of these small particles or emboli from entering the blood vessels of the brain in patients undergoing TAVI as measured by an imaging study of the brain called a magnetic resonance imaging (MRI) study. Patients in this study will be randomized to one of two study groups: Treatment Group: Standard TAVI procedure with the TriGuard HDH deflection device Or Control Group: Standard TAVI procedure without the TriGuard HDH deflection device Randomization for this study is 2:1, which means patients are twice as likely to be assigned to the Treatment Group. The TriGuard HDH device is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States.
    Flaherty, James DFlaherty, James D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02536196 STU00203648
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    Duquette, Audrey
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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
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    Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) – A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
    The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer…
    The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body's immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in this type of cancer. 
    You may be eligible if you have non-small cell lung cancer, which has been removed by a surgeon. 
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02595944 STU00203600
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    Study Coordinator 1 312 695 1102
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    SMART: A prospective, multi-center registry assessing the embolization of neurovascular lesions using the Penumbra SMART COIL® System
    The purpose of this registry is to collect data on the “real world” experience of these devices. The registry will be used to evaluate the effectiveness of these…
    The purpose of this registry is to collect data on the “real world” experience of these devices. The registry will be used to evaluate the effectiveness of these systems in treating aneurysms that will include; 1. The amount of aneurysm filling 2. Time of treatment 3. Results of subject follow-up This type of treatment by “coiling” is currently the standard of care worldwide for aneurysms. The knowledge gained from this registry may help to advance medical treatments for this disease. The devices used in this registry have been cleared by the United States Food and Drug Administration (FDA) for standard treatment of aneurysm, AVM or AVF.
    Inclusion:Patients enrolled in this registry must sign the Informed Consent Form and be treated
    according to the cleared indications for Smart, PC 400, and POD, which include the embolization of:

    1. Intracranial aneurysms
    2. Other neurovascular abnormalities such as arteriovenous malformations and
    arteriovenous fistulae
    Exclusion:1. Life expectancy less than one year
    2. Smart, PC 400, or POD account for less than 75% of total number of coils implanted
    3. Patient previously enrolled in the SMART Registry
    4. Participation in another clinical investigation that could confound the
    evaluation of the registry device
    Hurley, MichaelHurley, Michael
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02729740 STU00203952
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    Muzaffar, Ayesha
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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
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    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

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

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

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

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

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

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
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    Study Coordinator 1 312 695 1102
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    Early Feasibility Study of the Edwards EVOQUE Transcatheter 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…
    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
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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
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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
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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
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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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    Prospective Phase II Study of Cytochrome C Oxidase Activity as a Novel Biomarker In Subjects With Newly Diagnosed Primary Glioblastoma Multiforme
    This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (time intervals from dates of diagnosis to death from a…
    This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (time intervals from dates of diagnosis to death from any cause) of a subject with newly diagnosed primary GBM tumors, treated by standard of care (SOC), is a function of the CcO enzymatic activity in the tumor.
    Patients older than 21 years of age with an MRI that is consistent with primary GBM may be eligible for this clinical trial. This biomarker study will require patients to consent (pre-resection) for their tumor tissue to be collected and analyzed for enzymatic activity.
    Kumthekar, PriyaKumthekar, Priya
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203783
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    Coffey, Taylor
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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
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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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    Kosche, Cory
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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
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    Dapagliflozin EFfect on symptoms and bIomarkers iN patiEnts with Heart Failure (DEFINE-HF)
    The purpose of this study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure. To do this, dapagliflozin will be compared with pl…
    The purpose of this study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure. 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 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 250 people in the entire study nationally.
    Mutharasan, R KannanMutharasan, R Kannan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02653482 STU00204141
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    Ritz, Michaela
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    NU 16L04: Parallel proof of concept phase 2 study of nivolumab and metformin combination treatment in advanced non-small cell lung cancer with and without prior treatment with PD-1/PD-L1 inhibitors
    The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non…
    The purpose of this study is to find the benefits of combining nivolumab with metformin in advanced non-small cell lung cancer with and without prior treatment with immunotherapy. We will also be looking at the safety of the combination. Nivolumab is currently approved in certain cancers such as melanoma, lung cancer and kidney cancer. Metformin is approved by the US Food and Drug Administration (FDA) to treat diabetes. In this study, Metformin is being used to treat cancer. This use is not approved by the FDA; therefore, in this study, it is considered experimental. Experimental means the U.S. FDA has not approved the drug for use in your type of cancer. All study participants will get the same study intervention. All study participants will get the study drugs Nivolumab and Metformin.
    You may be eligible for this research study if you have an advanced non-small cell lung cancer, and are age 18 or older. 
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03048500 STU00204354
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    Study Coordinator 312 695 1102
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    Exercise in Genetic Cardiovascular Conditions: Lifestyle and Exercise in Hypertrophic Cardiomyopathy: “LIVE-HCM”/ Lifestyle and Exercise in Long QT Syndrome: “LIVE-LQTS”
    This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants w…
    This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants will be asked to periodically wear pedometers, upload data to a secure website, and complete interviews and questionnaires via telephone or online for up to three years. We expect up to 50 people here will be in this research study out of 4286 people in the entire study nationally.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204370
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    Zinn, Sarah
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    MOLECULAR BASIS OF ALTERED DRUG METABOLISM DURING PREGNANCY (STUDY 2: DEFINING FACTORS RESPONSIBLE FOR TEMPORAL CHANGES IN CYP3A4-MEDIATED DRUG METABOLISM DURING PREGNANCY)
    The purpose of this research is to understand changes in a woman’s body during pregnancy, specifically how the body processes …
    The purpose of this research is to understand changes in a woman’s body during pregnancy, specifically how the body processes medication 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 trimesters. Drug metabolism is sometimes controlled by certain genes in the body. This study will be examining the up-regulation, or “speeding up” of a certain gene called CYP3A4, a gene that helps the body process Nifedipine, a drug commonly used to treat high blood pressure. The primary goal of our research is to understand how drug metabolism changes across pregnancy. The secondary goal for this research is to define how enzymes in the liver act to up-regulate CYP3A4 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)
    • Are currently taking extended release Nifedipine for treatment of high blood pressure during pregnancy
    Wisner, KatherineWisner, Katherine
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00204599
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    Mesches, Gabrielle
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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
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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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    Toaspern, Lillian
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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.
    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
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    Phase II study of nivolumab and ipilimumab for treatment of advanced adenoid cystic carcinoma and non-adenoid cystic carcinoma
    Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combinati…
    Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combination in participants with this type of cancer. Another purpose of the study is to see which tumor markers (proteins in the blood that the body produces in response to the cancer) lead to better results in participants treated with the study drugs. Overview Nivolumab and ipilimumab are antibodies, which are human proteins that recognize and attach to a part of the tumor and/or body‰Ûªs immune cells. They work in slightly different ways to activate the immune system and help the body‰Ûªs immune system to work against tumor cells. The combination of these drugs is already approved by the FDA to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are investigational because they are not approved by the FDA to be used for the type of cancer being studied. Description of Treatment All study participants will receive the same study drugs, nivolumab/ipilimumab combination, over periods called cycles (1 cycle = 12 weeks / 84 days). Nivolumab will be given through a vein over 30 minutes once every 2 weeks for the first 16 weeks. It will then be given over 60 minutes once every 4 weeks for as long as participants are benefitting. Ipilimumab will be given through a vein over 90 minutes every 6 weeks (twice each cycle). Participants will take part in the study as long as they are benefitting from the study drugs.
    Some of the eligibility criteria include:

    - Participants must be > 18 years old.
    - Participants must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands

    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.
    Matsangou, MariaMatsangou, Maria
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03146650 STU00204579
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    Study Coordinator 312 695 1102
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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
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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
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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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    Home sleep and circadian phase: mediators of racial disparities in diabetes risk
    Screening includes overnight stay with a full sleep study and morning blood tests. If you qualify full study includes 1 week of wrist actigraphy at home, saliva collectioning at home for one evening, home visit by study …
    Screening includes overnight stay with a full sleep study and morning blood tests. If you qualify full study includes 1 week of wrist actigraphy at home, saliva collectioning at home for one evening, home visit by study staff, and second overnight stay with blood tests the next morning.
    Age 21-50. African American or Caucasian. Healthy adult.
    Knutson, KristenKnutson, Kristen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01786564 STU00204605
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    Brenner-Jedwabnik, Matthew
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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
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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
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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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    Duquette, Audrey
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    (CIRB) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
    The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known …
    The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS-4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and cirrhosis
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this
    study.
    1) Willing and able to give informed consent prior to any study specific procedures being
    performed
    2) Liver biopsy consistent with NASH (defined as the presence of at least grade 1 steatosis,
    hepatocellular ballooning, and lobular inflammation according to the NAFLD Activity Score
    [NAS]) and cirrhosis (F4 fibrosis) according to the NASH CRN classification, in the opinion
    of the central reader.
    a) A historical liver biopsy within 12 months of the Screening visit may be accepted as the
    Screening biopsy if the sample is deemed acceptable for interpretation by the central
    reader.
    b) If the subject is deemed ineligible for this study, the liver biopsy, if performed according
    to protocol specifications and is within 6 months of the Screening visit, may be used to
    determine eligibility for study GS-US-384-1943.
    3) Subject has the following laboratory parameters at the Screening visit, as determined by the
    central laboratory:
    a) ALT ≤ 8 x ULN
    b) CLcr ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation
    c) HbA1c ≤ 9.5%
    4) Body Mass Index (BMI) ≥ 18 kg/m2 at Screening
    5) Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based
    on the date of the Screening visit
    6) Females of childbearing potential (as defined in Appendix 3) must have a negative pregnancy
    test at Screening and Day 1
    7) Male subjects and female subjects of childbearing potential who engage in heterosexual
    intercourse must agree to use protocol specified method(s) of contraception as described in
    Appendix 3.
    Rinella, Mary EugeniaRinella, Mary Eugenia
    NCT03053063 STU00204671
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    Sipich, Kimberly A
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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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    Study Coordinator 312 503 5212
    Copy
    (CIRB) A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
    The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as…
    The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis.
    1) Liver biopsy consistent with NASH (defined as the presence of at
    least grade 1 steatosis, hepatocellular ballooning, and lobular
    inflammation according to the NAFLD Activity Score [NAS]) and
    bridging (F3 fibrosis) according to the NASH CRN classification, in
    the opinion of the central reader.
    a) A historical liver biopsy within 6 months of the Screening visit
    may be accepted as the Screening biopsy if the sample is deemed
    acceptable for interpretation by the central reader.
    b) If the subject is deemed ineligible for this study, the liver biopsy,
    if performed according to protocol specifications and is within
    12 months of the Screening visit, may be used to determine
    eligibility for study GS-US-384-1944
    2) Subject has the following laboratory parameters at the Screening
    visit, as determined by the central laboratory:
    a) Alanine aminotransferase (ALT) ≤ 8 x ULN
    b) Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as
    calculated by the Cockcroft-Gault equation
    c) HbA1c ≤ 9.5%
    d) Total bilirubin ≤ 1.5 x ULN
    Rinella, Mary EugeniaRinella, Mary Eugenia
    NCT03053050 STU00204672
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    Sipich, Kimberly A
    Copy
    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
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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
    Copy
    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
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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
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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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    Sadowsky, Lauren
    Copy
    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
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    Expanded Access Protocol of Patisiran for Patients with Hereditary Transthyretin-Mediated Amyloidosis (hATTR Amyloidosis) With Polyneuropathy
    This Expanded Access Program (EAP) is intended to provide greater access to patisiran (a drug currently being investigated by the FDA) for patients with sympto…
    This Expanded Access Program (EAP) is intended to provide greater access to patisiran (a drug currently being investigated by the FDA) for patients with symptomatic hATTR amyloidosis with polyneuropathy. It is not a clinical trial. Interested patients will be consented, screened, and their redacted information will be reviewed by an independent adjudication committee to determine study eligibility. If found to be eligible, patients will enroll in the EAP for as long as the drug is being investigated by the FDA. Research patients will receive patisiran infusions every 3 weeks. Before the infusion, research patients will receive pre-medications to prevent a reaction to the study drug. Patisiran is administered as an IV infusion over 70-minutes. Research patients will be asked to remain at the study site for 1-hour after the infusion for monitoring. Research patients will not be compensated for their participation but receive patisiran free of charge for the duration of the study. During the EAP, research patients will also be asked to provide blood and urine samples and answer questionnaires.
    Eligible patients include patients who are 18 years of age or older, with a documented TTR mutation and a confirmed diagnosis of symptomatic hATTR amyloidosis with polyneuropathy established through neurologic consultation, Karnofsky Performance Status ≥50%, and a PND score I to III.
    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT02939820 STU00204718
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    Joslin, Benjamin
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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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    Duquette, Audrey
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    AMPLATZER™ Amulet™ Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial
    This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the h…
    This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical signals in your heart are not normal and cause the upper chambers of the heart to beat too fast and irregularly. This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the heart. In the left upper chamber, there is a small pouch called the left atrial appendage (LAA). Slowing of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a mini-stroke. These blood clots can also travel to other parts of the body and block blood vessels. The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the investigational (not yet approved by the FDA for use in the US) Amulet device is safe and effective when compared to an FDA-approved device called the WATCHMAN LAA closure device. We expect up to 25 people here will be in this research study out of 1700 people in the entire study internationally. Participants will be involved in this research study for up to 5 years. After the procedure, participants will be asked to come to clinic for 5 in-person study visits, and will be contacted via telephone by the study team 5 times.
    Inclusion Criteria:
    18 years of age or older
    Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
    At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3
    Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
    Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation.

    *Main Exclusion Criteria*
    Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
    Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
    Indicated for chronic P2Y12 platelet therapy inhibitor
    Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
    Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
    Implanted with a mechanical valve prosthesis
    Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure
    Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
    Heart attack within 90 days prior to randomization
    Left ventricular ejection Fraction (LVEF) 110 bpm
    Knight, Bradley PaulKnight, Bradley Paul
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02879448 STU00204852
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    Carswell, Amy
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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
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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
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    Evaluation of the Safety and Performance of The Twelve Intrepid™ Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Twelve Intrepid™ TMVR Pilot Study
    The research project is testing a new treatment for mitral regurgitation. The…
    The research project is testing a new treatment for mitral regurgitation. The new treatment is a mitral valve replacement with a new investigational device called the Twelve Transcatheter Mitral Valve Replacement (TMVR) System. This research study is an early feasibility study, which is done to study a device that has not been used in many people. Mitral valve regurgitation (MR) occurs when the two leaflets of the mitral valve do not close correctly and blood leaks backward with each heartbeat. If left untreated, there is a risk that the heart may begin to fail and patients may have symptoms such as shortness of breath or tiredness. One treatment for MR is open-heart surgery to replace a leaky mitral valve with an artificial heart valve. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open and requires 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 and stopping the heart.
    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02322840 STU00204922
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    Brady, Caitlin
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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

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    Ali, Yasmeen
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    Effect of MD1003 in Progressive Multiple Sclerosis: a Randomized Double Blind Placebo Controlled Study
    SPI2 is a Phase III clinical trial investigating the safety and efficacy of MD1003 (high dose biotin) in patients with primary or secondary progressive MS. Research patients will be randomly placed …
    SPI2 is a Phase III clinical trial investigating the safety and efficacy of MD1003 (high dose biotin) in patients with primary or secondary progressive MS. Research patients will be randomly placed into one of two groups; a study drug and placebo (a sugar pill that is not the study drug). The first part of the study will last for at least 15 months, followed by an extension period of up to 12 months where both groups will get the study drug. Throughout the study, both groups of research patients will be asked to provide blood and urine samples, complete MRIs, and answer questionnaires.
    (1) Signed and dated written informed consent, (2) Patient aged 18-65 years old, (3) Diagnosis of primary or secondary progressive MS, (4) Documented evidence of clinical disability progression within the 2 years prior to inclusion, (5) EDSS at inclusion from 3.5 to 6.5, (6) TW25 < 40 seconds, (7) Kurtzke pyramidal functional subscore ≥2 defined as “minimal disability
    Cohen, Bruce ArnoldCohen, Bruce Arnold
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT02936037 STU00204784
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    Joslin, Benjamin
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    Melanoma and Skin Cancer Tissue Repository

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

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

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

    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
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    Study Coordinator 1 312 695 1102
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    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
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    Brenner-Jedwabnik, Matthew
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    BTCRC GYN15-013: Phase II Study of Pembrolizumab in Combination with Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma
    The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and ca…
    The purpose of this study is to test the good and bad effects of the study drug, pembrolizumab, in combination with routine care using paclitaxel and carboplatin chemotherapy.
    Participants will be adults with cancer in the lining of the uterus (endometrium) that has spread to other parts of the body or has returned after initial treatment.
    Matei, DanielaMatei, Daniela
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02549209 STU00204968
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    Study Coordinator 312 695 1102
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    REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
    The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
    The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
    INCLUSION CRITERIA: 

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

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

    Ricciardi, MarkRicciardi, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03088033 STU00204899
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    Roshevsky, Daniel Scott
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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 to evaluate the effect of the investigational drug compared to Olanzapine on body Weight in youn…
    This is a study 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
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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
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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
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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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    Toaspern, Lillian
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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
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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
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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
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    A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip
    Approximately 3,640 patients will participate in this study to evaluate the efficacy of fasinumab compa…
    Approximately 3,640 patients will participate in this study to evaluate the efficacy of fasinumab compared to placebo for the treatment of osteoarthritis pain.
    At least 18 yrs of age, BMI 39 or less, Osteoarthritis of the knee or hip, taking NSAIDs at least 4 days a week over last month, fails (either inadequate pain relief, unable to take or refuses to take) Acetaminophen/Tylenol, NSAIDs, and opioids, must be able to take naproxen, no rheumatoid arthritis or other inflammatory joint disease, no fibromyalgia, no symptoms of carpal tunnel syndrome in last 6 months, able to undergo an MRI, is not scheduled for a joint replacement in the next 1.5 yrs, no HIV, no Hepatitis, no sickle cell disease, no S-C disease, no S-beta thalassemia, no heart block, no cancer in last 5 yrs, no hospitalization for depression in last 5 yrs, no alcohol or substance abuse in last 5 yrs, no marijuana use for pain relief in last 6 months, if a female must not become pregnant or breastfeed during the study, and if a female of child-bearing potential must be willing to use contraception during study.
    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03161093 STU00205258
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    Sutkus, Loretta
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    A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson’s Disease (PD)

    What will I have to do throughout …

    What will I have to do throughout the study?

    — Nilotinib is a capsule that will be taken orally on a daily basis.— The study will include 11 in person study visits. 8.5-9 months duration. — Clinical assessments and questionnaires will be completed— Several blood samples will be collected throughout the study— Certain visits will require a Lumbar Puncture (LP)

    Participants must meet certain criteria. Some are:— You must be between the ages of 40 and 79— You must have been diagnosed with Parkinson’s disease (PD) for more than 5 years— You need to be on a stable regimen of PD medications that includes levodopa for at least 30 days prior to screening visit
    Simuni, TatyanaSimuni, Tatyana
    STU00205407
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    Ward, Tina
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    (xIRB NCI CIRB) SWOG 1609 DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
    Purpose The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. Overview…
    Purpose The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. Overview The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-quarter compared to its present size. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin. Description of Treatment All study participants will get the same study drugs: ipilimumab and nivolumab. Participants will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and they will receive nivolumab through a vein every 2 weeks. Participants will continue to receive study drugs until their disease gets worse or they experience bad side effects from the study drugs or their study doctor decides that they are not benefiting from the study drugs.
    Some of the eligibility criteria include:

    - Participants must be at least 18 years of age or older.

    No other prior malignancy is allowed except for the following:

    1. Adequately managed Stage I or II cancer from which the participant is currently in complete remission

    2. Any other cancer from which the participant has been disease free for one year.

    3. Adequately managed Stage I or II follicular thyroid or prostate cancer is also eligible, in which the participant is not required to be in complete remission

    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.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02834013 STU00205572
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    Study Coordinator 1 312 695 1102
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    A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Non-healing Foot Ulcers in Diabetic Patients with Concomitant Peripheral Arterial Disease (PAD)
    A Study to Assess the Safety and Efficacy of VM202 to Treat Chronic …
    A Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients with Concomitant Peripheral Arterial Disease (PAD)
    • Documented symptomatic peripheral arterial disease (PAD)
    • Documented history of Type I or II diabetes with current treatment control and currently on oral medication, inject-able medication and/or insulin
    • At Screening, subject has one ulcer on the target foot
    Ho, KarenHo, Karen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02563522 STU00204945
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    Toaspern, Lillian
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    Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide The C.L.O.T. Investigation System
    The purpose of this research study is to find out if PerClot is safe and effective as a part of surgery to stop bleeding. Pe…
    The purpose of this research study is to find out if PerClot is safe and effective as a part of surgery to stop bleeding. PerClot is a device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot. This kind of device (topical hemostat) is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, or other conventional procedures is ineffective or impractical. PerClot is left in your body after surgery. In animal studies, it has been found that PerClot is absorbed by the body in a few days after surgery. This has not been demonstrated in humans and can vary depending on the amount of device applied. This can also depend where it is applied. This research study will collect follow-up data after PerClot is used. PerClot is an investigational device in the United States. This means it has not been approved by the Food and Drug Administration (FDA). PerClot has been an approved medical device in Europe since 2008. This research study plans to enroll approximately 324 study participants at approximately 25 U.S. sites, including approximately 10 people from this institution. We expect that participants will be in this research study for approximately 6 weeks; however, if you currently have, or are diagnosed with cancer during the study, you will be contacted by the study coordinator on the telephone at 24 months after your surgery to ask questions about your general health. Research Trial Contact Information: For more information, participants and clinicians may contact the research team at (312) 926-4000 or heartresearch@northwestern.edu.

    Primary Inclusion:

    • Undergoing an open elective cardiac procedure
    • Bleeding at the specified area after conventional means for hemostasis are attempted

     Primary Exclusion:

    • Known sensitivity to starch or starch-derived materials
    • Clinically significant coagulation disorder or disease
    • Corticosteroids within 6 weeks prior to surgery
    • Poor blood glucose control
    Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02359994 STU00205144
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    hemostasis

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    Brady, Caitlin
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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
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    INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)
    Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccin…
    Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are being provided for use in the study by Sanofi Pasteur, which manufactures the vaccines. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses.  The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least65 years old. Thus its use with adults younger than 65 in this study is investigational.
    This study is recruiting patients who have had a heart attack or have heart failure.
    Mutharasan, R KannanMutharasan, R Kannan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02787044 STU00205380
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    Reinkensmeyer, Larissa
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    Breaking Down Financial Barriers: A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In vitro Maturation in Low Resource Populations
    A feasibility and acceptability study of in vitro maturation (IVM) in low income couples, in which we will determine the feasibility, acceptan…
    A feasibility and acceptability study of in vitro maturation (IVM) in low income couples, in which we will determine the feasibility, acceptance, and cost-benefit of IVM as compared to in vitro fertilization (IVF) in low income populations.
    Women aged 18-35 years with a male partner aged 18-45 years; current Illinois resident; no insurance coverage for infertility treatment; low income; English-speaking
    Robins, JaredRobins, Jared
    • Map it 259 E. Erie St. Lavin Pavilion
      Chicago, IL
    STU00204879
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    Okeigwe, Ijeoma
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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 ofcom…
    This research is being done to test the effectiveness (anti-tumor activity) and safety ofcombining enzalutamide with LY2157299 for the treatment of men with advanced castrateresistant prostate cancer. 
    Morgans, AliciaMorgans, Alicia
    NCT00000417 STU00205208
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    Study Coordinator 1-855-NU-STUDY
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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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    DRUG CA209-816: Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
    The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the …
    The main purpose of this study is to look at the safety, tolerability, and overall effectiveness (how well the drug works) of nivolumab in combination with ipilimumab and nivolumab in combination with plantinum doublet chemotherapy in subjects with non-small cell lung cancer.
    Mohindra, NishaMohindra, Nisha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02998528 STU00205030
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    Study Coordinator 312 695 1102
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    Comparison of the efficacy between Cryolipolysis versus ATX-101 (Deoxycholic acid) for the treatment of upper back fat: a prospective randomized controlled pilot study
    The purpose of this study is to compare the effectiveness of cryolipolysis and ATX-101 (Deoxycholic acid)for the treatment of upper b…
    The purpose of this study is to compare the effectiveness of cryolipolysis and ATX-101 (Deoxycholic acid)for the treatment of upper back fat. Cryolipolysis, also known as fat freezing, is the treatment used to destroy fat cells by cooling the skin causing cell death of fat tissue without damaging overlying skin. ATX-101 an injectable that can destroy fat cells.
    Patients with mild to moderate upper back fat and currently living in the Chicago metropolitan area.
    Alam, MuradAlam, Murad
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03284034 STU00205070
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    Weil, Alexandra
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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
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    NU UW16B13: A Phase II Study of Neratinib Alone and in Combination with Fulvestrant in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
    Certain types of breast cancer test positive for overexpression HER2 (a protein involved in normal cell growth) and some test negative. Some patients may …
    Certain types of breast cancer test positive for overexpression HER2 (a protein involved in normal cell growth) and some test negative. Some patients may have HER2-negative breast cancer with mutations in HER2. Neratinib is an investigational drug - meaning that it has not been approved by the U.S. Food and Drug Administration [FDA] - shown to be effective for treating HER2-positive breast cancer in clinical trials. An additional routine treatment involves a drug called Fulvestrant, which blocks the effects of estrogen in breast tissue. In this study, the uses of neratinib alone or in combination with Fulvestrant, will be studied, to see how the cancer responds to these treatments in each population.
    Diagnosis with metastatic breast cancer at the time of screening
    Diagnosis of metastatic breast cancer that is HER2-negative, but found to have a mutation in HER2 at the time of enrollment
    Age of at least 18 years
    Completion of radiation therapy and be at least 1 week from the last administration before starting study treatment
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01670877 STU00205349
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    Study Coordinator 312 695 1102
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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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    Amaravadi, Sankhya
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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
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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.

    You may be eligible for this research study if you have stomach cancer or cancer where the esophagus and the stomach meet, if you have not had any previous chemotherapy treatment, and if your cancer cannot be cured by surgery.

    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
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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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    Brady, Caitlin
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    Clinical Database of Nephrectomy at Northwestern University
    The goal of this study is to determine the current clinical outcomes of our nephrectomy patients at Northwestern (such as complications and survival). We hope to keep track of patients for the first 5-years following radical or partial nep…
    The goal of this study is to determine the current clinical outcomes of our nephrectomy patients at Northwestern (such as complications and survival). We hope to keep track of patients for the first 5-years following radical or partial nephrectomy in order to better understand the long-term behavior of the disease.
    Patients ages 18-89 with a diagnosis of kidney cancer.
    Nadler, Robert BNadler, Robert B
    STU00205973
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    kidney cancer

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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
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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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    A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent"
    The purpose of this study is to compare any good and bad effects of using ipilimumab in combination with nivolumab to th…
    The purpose of this study is to compare any good and bad effects of using ipilimumab in combination with nivolumab to the usual approach of using ipilimumab alone when treating melanoma that cannot be removed by surgery. The combination treatment of ipilimumab and nivolumab could stop a participant's melanoma from getting worse, 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. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating melanoma. This study has two treatment groups, Group 1 and Group 2. Participants in Group 1 will receive ipilimumab once every three weeks for up to four times. Participants in Group 2 will receive nivolumab and ipilimumab once every three weeks for up to four times.
    Participants must be at least 18 years of age. Participants must have melanoma that cannot be removed by surgery. Participants have received an immunotherapy drug (a drug that helps the body’s immune system destroy cancer cells), and their cancer got worse while receiving that.
    Sosman, JeffreySosman, Jeffrey
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03033576 STU00205856
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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
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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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    Ward, Tina
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    Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
    Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled …
    Combined Phase 2b/3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis
    Hanauer, StephenHanauer, Stephen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02914522 STU00205250
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    Arrieta, Rose
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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
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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 i