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Northwestern Scleroderma Program Patient Registry
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00002669
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Carns, Mary 312 503 1137
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Transthyretin-Associated Amyloidosis Outcomes Survey (THAOS): A Global, Multi-Center, Longitudinal, Observational Survey of Patients with Documented Transthyretin (TTR) Mutations or Wild-Type TTR Amyloidosis
THAOS is a global, multi-center, longitudinal observational survey open to all …
THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate. The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease.
Shah, Sanjiv JShah, Sanjiv J
NCT00628745 STU00004191
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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 312 503 1137
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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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312 503 1919
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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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1-855-NU-STUDY
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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 312 503 5901
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NU 1365-001: A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to…
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 liver cancer that cannot be removed by surgery.
Salem, RiadSalem, Riad
NCT00530010 STU00011036
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1-855-NU-STUDY
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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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National Parkinson Foundation Patient Registry
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate tre…
The purpose of this study is to collect registry data to examine the relationship between clinical symptoms and treatment in PD patients. Data collected will be used to describe differences in current treatment practices across many sites to evaluate treatment and ultimately improve patient care.
• Patients diagnosed with idiopathic Parkinson’s Disease
• Must have established care with a movement disorder specialist at Northwestern
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
STU00014255
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Friedeck, Heidi 312 503 1522
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Screening For a Registry (Database) and Future Participation In Asthma and Chronic Obstructive Lung Disease (COPD) Clinical Research Studies
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in la…
Recent advances in understanding asthma and COPD have led to the development of several new forms of treatment. After these new treatments are evaluated in laboratory studies, the most promising ones are tested in human subjects. At the same time, research is being done on cells and secretions obtained from normal individuals and patients with asthma and COPD to increase our understanding of what causes these diseases and to determine how they can best be treated. You are being asked to take part in an evaluation of your health status in order to determine your eligibility to participate in future clinical research studies. The evaluation will involve assessing your overall medical condition and the status of your asthma, if you have asthma or the status of your COPD, if you have COPD. The evaluation will help determine if you may be eligible for current or future asthma and COPD clinical research studies done at Northwestern University.
18 years of age or older with asthma or COPD(Chronic Obstructive Lung Disease)
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
STU00015972
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Hixon, Jenny Lorraine 312 926 0975
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A Multicenter Group to Study Acute Liver Failure. Long-term Outcomes of Acute Liver Failure Study Group Patients
Data Registry study for acute liver failure.
18-70 yr old adults. Acute Liver Failure (ALF) - INR > 1.5 and hepatic encephalopathy. Acute Liver Injury (ALI) - INR > 2, ALT > 10 x ULN
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00518440 STU00016475
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Gottstein, Jeanne H 312 694 0264
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Mediators of Atherosclerosis in South Asians Living in America
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians r…
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
Kandula, Namratha RKandula, Namratha R
NCT01207167 STU00019837
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1-855-NU-STUDY
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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
Hinchcliff, Monique EHinchcliff, Monique E
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00021381
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Thakrar, Anjali 312 503 1120
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RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pacli…
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Some of the eligibility criteria include:

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Donnelly, EricDonnelly, Eric
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
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Study Coordinator 312 695 1102
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Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion (OSR cross referenced as: “Induction of Donor Tolerance in Renal Transplants”)
Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell I…
Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
Leventhal, Joseph RLeventhal, Joseph R
NCT00497926 STU00026088
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1-888-NU-STUDY
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Language in Primary Progressive Aphasia
The Language in Primary Progressive Aphasia (PPA) aims to understand the behavioral, anatomical and physiological changes in people with PPA throughout the course of the illness. The researchers in this study want to increase awareness of PPA, educate others ab…
The Language in Primary Progressive Aphasia (PPA) aims to understand the behavioral, anatomical and physiological changes in people with PPA throughout the course of the illness. The researchers in this study want to increase awareness of PPA, educate others about this unique disorder, and to encourage more research to eventually develop therapies. During the three-day research program, participants will be asked to undergo neuropsychological testing (paper and pencil tests that evaluate cognition), an MRI (a non-invasive brain-imaging procedure), an EEG (another non-invasive procedure that looks at brain waves when you think) and other computer and language testing batteries. Participants may be asked to return every two years to complete the same measures. The study will recruit approximately 15 participants with PPA per year. For participants not living near Chicago, IL, flights and accommodations (for both the person with PPA and their companion) will be covered by the study.
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 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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Coventry, Christina Ann 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 1-888-NU-STUDY
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NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods …
RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
Shulman, Lee PShulman, Lee P
NCT00005095 STU00005421
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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 are 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 memor…
The purpose of the Northwestern Alzheimer’s Disease Center (NADC) research registry are 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 and brain tissue from research participants.
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.
Mesulam, Marek-MarselMesulam, Marek-Marsel
STU00023196
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Study Coordinator 312 926 5103
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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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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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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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Makowski-Woidan, Beth 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 312 503 1519
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Department of Psychiatry and Behavioral Sciences Research Registry
Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potenti…
Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potential research participants who view the Department’s website. This application is not in itself a research project, but only for the establishment of the registry for recruitment. Recruitment will be for studies that have been approved by the Northwestern University Institutional Review Board. Advertising for the research database will be posted on the Department’s website. Our aim is to recruit psychiatric patients, their family members, and healthy controls for research on mood disorders, schizophrenia, and Alzheimer's disease.
Goldman, Morris BGoldman, Morris B
STU00034881
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Voss-Fairchild, Pamela C 312 503 9100
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Nulliparous Pregnancy Outcomes Study: Monitoring Mothers to be
Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might ha…
Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having their first baby and are carrying only one baby. The women are enrolled early in pregnancy and undergo research assessments four times during their pregnancies. Data are collected through interviews, self-completed data forms, clinical measurements, ultrasound, and collection and storage of blood samples, urine samples, and fluid from the vagina and cervix. Some information comes from medical records. A subset of women may be asked to participate in substudies collecting information on sleep breathing, sleep patterns and quality, or other areas possibly related to birth outcomes. The goal of the research is to find ways to identify women in this group who might develop a problem with their pregnancy and use this information to improve the health of pregnant women and their babies in the future. The study is focusing on pregnancy problems like high blood pressure, babies that are born much too early and very small babies.
Recruitment closed.
Grobman, William AGrobman, William A
  • Map it 633 N. St. Clair St
    Chicago, IL
NCT01322529 STU00030993
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Rangel, Elizabeth 1 312 503 6287
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EHR-based Health Literacy Strategy to Promote Medication Therapy Management
Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based…
Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies that leverage an electronic health record (EHR) to promote patient understanding, medication reconciliation, medication adherence and disease control among hypertensive patients at safety net clinics. Medication therapy management (MTM) has been described as a set of procedures that include: medication review, assembly of a personal medication record, development of action plans, intervention when necessary, and follow-up. However, evidence showing the effectiveness of general MTM interventions is scant. MTM has often been performed separately from patients’ usual sources of care (i.e., at pharmacies). This could limit its effectiveness since medication-related concerns would be discussed by clinicians who are not aware of the regimen intended by patients’ prescribers. Cost is another barrier to widespread use of MTM. Health information technology in primary care could be leveraged to assist with MTM tasks. We have field tested low literacy MTM tools embedded within an EHR to 1) activate patients to review medications, 2) automate the provision of plain language, medication information, and 3) provide print tools to help patients engage providers, and consolidate their regime. These tools were developed with patient, physician, and pharmacist feedback. For this study, we combine tools to address the range of MTM tasks. In aggregate, we refer to this as an Electronic health record-based Health literacy Medication therapy management Intervention, or ‘EHMI’. We will evaluate the effects of this approach among patients with uncontrolled hypertension treated in federally qualified health centers (FQHCs). This may be a relatively low-cost strategy ideal for safety net practices that use EHRs and whose patients may be at greater risk for limited literacy. It is also possible that the EHMI strategy may not result in a significant change. Therefore, we will also evaluate using a nurse educator to help patients utilize EHMI tools, provide brief counseling, and track progress. This three-arm, clinic-randomized, controlled trial at 12 FQHCs will evaluate the EHMI and EHMI + Nurse Educator interventions compared to usual care. Recruited patients will be followed for 12 months. We will test the impact of these two strategies on blood pressure levels, , powered to detect a 4 mm Hg difference in systolic blood pressure as the primary outcome. We will also assess the impact on HbA1c and LDL cholesterol control in the subgroup with diabetes. We will determine the interventions’ effects on: 1) medication understanding, 2) discrepancies, and 3) adherence. We will specifically examine intervention effects among groups with different literacy levels. We will also assess the fidelity and cost of the interventions to guide future dissemination efforts.
Persell, Stephen DPersell, Stephen D
STU00042150
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Incidence of post-dural puncture headache following unintentional dural puncture: a randomized trial of intrathecal morphine versus saline.
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrea…
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
Peralta, FeycePeralta, Feyce
NCT01977898 STU00043549
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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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Peripheral Neuropathy Research Registry (PNRR)
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in t…
National Peripheral Neuropathy Research Registry, a collection of different types of information, such as patient medical, family, and social histories and blood samples. The information is carefully maintained so that it can be studied repeatedly in the future. The registry aims to help researchers’ access large amounts of information about people with PN. By using this registry, researchers will facilitate both basic and clinical research studies that will bring improved understandings of the etiology (origination) and pathogenesis (development) of PN. They will specifically ask why some patients with peripheral neuropathy develop neuropathic pain and others do not, and what the characteristics of patients with painful peripheral neuropathy are in terms of their symptoms, examination findings, and blood tests. Ultimately this research may result in improved diagnosis, more effective treatments, and possibly prevention.
Inclusion criteria: 1. Diabetic Peripheral Neuropathy 2. Chemo-therapy Induced Peripheral Neuropathy 3. HIV-induced Peripheral Neuropathy 4. Idiopathic Peripheral Neuropathy; Exclusion criteria: Any other type of Peripheral Neuropathy
Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00048864
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Joslin, Benjamin 312 503 7504
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Microbiomes of Pelvic Pain
Interstitial cystitis/painful bladder syndrome (IC) is characterized by chronic pelvic pain and voiding dysfunction. IC remains an enigma within urology, with no known etiology or widely effective therapies. However, some IC patients suffer bowel co-morbidities, and it …
Interstitial cystitis/painful bladder syndrome (IC) is characterized by chronic pelvic pain and voiding dysfunction. IC remains an enigma within urology, with no known etiology or widely effective therapies. However, some IC patients suffer bowel co-morbidities, and it is well established that the GI tract can influence bladder function and sensation via pelvic organ crosstalk. Like other body sites, the gut harbors a rich microflora. Studies characterizing microbial diversity and relative abundance at a particular body site, the “microbiome,” reveal that microbiomes play critical roles in normal cellular and organ function, and thus this importance is emphasized with the Human Microbiome Project (HMP), an NIH Common Fund initiative. Microbiomes are also dynamic and subject to skewing, and these changes are increasingly associated with diseases including Crohn’s disease, ulcerative colitis, and obesity. Antibiotic therapies alter microbiomes, often causing temporary dysfunction and sometimes resulting in diseases such as colitis. Since IC patients often have a history of urinary tract infection (UTI), they typically receive multiple courses of antibiotics. This therapeutic history of IC patients may have adverse consequences for two reasons. First, potential skewing of the gut microbiome may alter normal sensory and functional homeostatic mechanisms, contributing to pain and voiding dysfunction. Second, an altered gut microbiome may foster uropathogen reservoir expansion, and our preliminary data demonstrate urinary E. coli isolates can induce chronic pelvic pain persisting long after microbial clearance. Together these lines of reasoning raise the provocative possibility that microbiomes contribute to IC directly by supplying uropathogens or indirectly through organ crosstalk dysfunction. Therefore, is an altered gastrointestinal and/or reproductive tract microbiome associated with IC? Our team marries core NIH and NIDDK missions, digestive diseases and kidney/urologic, to address this novel question with synergistic expertise in clinical diagnosis of IC, quantifying GI and reproductive tract microbiomes, and mechanisms of microbe-induced pelvic pain.
Klumpp, DavidKlumpp, David
STU00055668
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Mohammed, Juned Ali Khan 1-888-NU-STUDY
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Chicago Adolescent Longitudinal Study
The purpose of this study is to evaluate young adults experiencing the initial symptoms of mental disorders. We hope this study will improve our understanding of how different brain areas work together and change over time in young adults experiencing these symp…
The purpose of this study is to evaluate young adults experiencing the initial symptoms of mental disorders. We hope this study will improve our understanding of how different brain areas work together and change over time in young adults experiencing these symptoms. Also, we want to see the effect of substance abuse and other environmental factors on the progression of mental disorders. Your part in this study will last for 2 years and involve 4 or more visits depending on your preference. Today’s visit will last approximately 30 minutes. Each of the following study visits will last about 4 hours. Overall, the study will take approximately 12 hours to complete.
Adolescents and young adults (ages 12 to 26 years old) with changes in thoughts, feelings, and behavior OR drug use.
Reilly, JamesReilly, James
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
STU00055031
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Fairchild, Melody Dawn 312 503 7071
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A Prospective Review of Excimer Laser-Assisted IVC Filter Removal
At Northwestern, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques…
At Northwestern, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques. The rationale for the study is to allow us to prospectively follow our laser-assisted IVC filter retrieval patients. We intend to validate existing literature and scientific findings by publishing our own clinical experience in difficult IVC filter retrievals.
Lewandowski, Robert JLewandowski, Robert J
STU00058721
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Karp, Jennifer 312 926 5289
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Northwestern University The Department of Psychiatry and Behavioral Sciences, Clinical Research Program (NU CRP) Recruitment Pipeline
The recruitment pipeline provides research staff with an organized system of identifying 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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312 503 9100
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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.
Luo, XunrongLuo, Xunrong
NCT01897688 STU00059469
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DRUG TS-102: A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy
The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases …
The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.
Mulcahy, Mary FrancesMulcahy, Mary Frances
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01483027 STU00059821
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Study Coordinator 312 695 1102
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A Randomized Trial to Prevent Congenital Cytomegalovirus Infection (CMV)
Cytomegalovirus (CMV) is a common virus that usually presents withfew if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most peopl…
Cytomegalovirus (CMV) is a common virus that usually presents withfew if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.
Primary CMV infection in women with singleton pregnancy at less than 24 weeks.
Grobman, William AGrobman, William A
NCT01376778 STU00059714
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Mallett, Gail 312 503 3200
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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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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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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 312 503 7071
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Stepped Telemental Health Care Intervention for Depression
TeleHealth Study: Researchers are studying the use of technology to make options for managing depression more affordable and easier for people to access. This study aims to evaluate different methods for addressing symptoms of depression. The…
TeleHealth Study: Researchers are studying the use of technology to make options for managing depression more affordable and easier for people to access. This study aims to evaluate different methods for addressing symptoms of depression. These methods include two different investigative study treatments. Eligible participants will be randomly assigned to receive one of two study interventions: 1) Telephone Administered Cognitive Behavioral Therapy Weekly, 50 minute study therapy sessions over the phone with a trained study clinician; OR… 2) Internet Administered Cognitive Behavioral Therapy Access to a study treatment website plus email and phone support from a trained study clinician. Participants in the iCBT intervention may eventually receive weekly 50 minute telephone study therapy sessions. Study treatment lasts for a maximum of 20 weeks in all interventions. If depression symptoms improve, study treatment may be ended earlier than 20 weeks. Participants will be compensated up to $200 for completing telephone interviews and questionnaires online across an 11-month period.
Individuals who are currently experiencing clinical symptoms of depression, who are at least 18 years old, who speak English, and have access to and familiarity of using the Internet and phones might be a good fit for this study.
Mohr, David CMohr, David C
NCT01906476 STU00064411
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Study Coordinator 855 682 2487
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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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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 312 926 5968
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The Genetics of Prostate Cancer in Active Surveillance
Our study uses saliva samples to detect whether or not active surveillance is the best option for the subject, based on their their genetic makeup and susceptibility to aggressive prostate cancer.
1. Patients diagnosed with prostate cancer
2. Patients with Gleason ≤ 3+3 prostate cancer
3. Patients with fewer than 3 cores involved with cancer. If a patient has 3 or more cores involved with cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
4. Patients with no more than 50% of any 1 core involved with prostate cancer. If a patient has more than 50% of any 1 core involved with prostate cancer but still meets all pathologic criteria and after discussing risks and benefits does not want definitive treatment, he may still be eligible for active surveillance.
5. Patients age > 18. Patients are typically offered AS if they are ≥ 60 years of age. However, if a man meets pathologic criteria and is < 60, he can be entered in AS if, after discussing risks and benefits, does not want definitive treatment.
6. Most patients will have PSA value ≤ 10 ng/ml. However, since PSA is prostate specific and not prostate cancer specific, many patients with elevated PSA levels > 10 ng/ml will not have prostate cancer, and PSA is elevated due to conditions such as BPH or inflammation. If a patient has a PSA value > 10 ng/ml, but still meets all pathologic criteria, he may still be eligible for active surveillance
Kundu, Shilajit DKundu, Shilajit D
  • Map it 201 E. Huron St.
    Chicago, IL
STU00059221
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Khawaja, Faizan 312 694 2417
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ECOG N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
RATIONALE: Drug…
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, 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 alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer. PURPOSE: This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.
Halverson, Amy LHalverson, Amy L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01515787 STU00067473
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Study Coordinator 312 695 1102
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ANTLER Pilot Intervention
ANTLER Pilot Study
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
STU00069201
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1-888-NU-STUDY
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Genome Research in African American Scleroderma Patients (GRASP)
Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain t…
Previous scleroderma studies have found that the risk of developing scleroderma is higher among African Americans than in Caucasians. The purpose of this study is to determine how variations in genes (or inherited traits) may explain the different risk in developing scleroderma seen in African American patients compared to other populations. Participants will complete a brief health questionnaire and provide two tubes of blood.
African American patients who are evaluated at the Northwestern Scleroderma Program and meet criteria for the diagnosis of systemic sclerosis, Age ≥ 18 years old
Varga, JohnVarga, John
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00069421
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Carns, Mary 312 503 1137
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An Observational Study of Hepatitis C Virus in Pregnancy
This multi-center observational study examines risk factors for HCV transmission from mother to baby.
Hepatitis C positive women pregnant with one baby who are at least 18 years of age and less than 24 weeks pregant
Grobman, William AGrobman, William A
NCT01959321 STU00069248
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Mallett, Gail 312 503 3200
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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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1-888-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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Berger, Jessica M 312 503 4995
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Mobile Monitoring for Long Term Behavioral Data Collection in Bipolar Disorder
This study is being done to evaluate the use of mobile phones interventions to improve patient self-management and increase the effectiveness of psychological interventions to reduce symptoms and prevent relapse in people …
This study is being done to evaluate the use of mobile phones interventions to improve patient self-management and increase the effectiveness of psychological interventions to reduce symptoms and prevent relapse in people with bipolar disorder. The purpose of prototype testing prior to the main study is to achieve early input on the study design, including the utility of the psychosocial interventions, and user perspectives and experiences with the interface and program content. In order to determine if you are eligible for the study, we will first ask you to complete a brief screening questionnaire either online or during a brief telephone call. This will include questions about your mental health and mental health treatment and will take 5 minutes. If it appears that you may be eligible for the study, you will be scheduled for a longer initial telephone interview which will take approximately 30-60 minutes.
Goulding, EvanGoulding, Evan
STU00069725
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UNKNOWN, UNKNOWN 312 503 9095
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Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)
The purpose of this study is to observe mothers with and without epilepsy, along with their children, from pregnancy until age 6 and assess the developmental and neurocognitive influence of anti-epileptic medications.
Gerard, Elizabeth ErwayGerard, Elizabeth Erway
NCT01730170 STU00070411
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Bellinski, Irena Iva 312 926 1672
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Institution-wide Registry of Klinefelter Syndrome Patients
The goa 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 thi…
The goa 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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312 695 8146
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Artificial Intelligence in a Mobile Intervention for Depression and Anxiety (AIM)
IntelliCare Study: Researchers are studying the use of smartphone apps to teach mood management skills to people experiencing depression and anxiety. The apps work to target common issues related to depression and anxie…
IntelliCare Study: Researchers are studying the use of smartphone apps to teach mood management skills to people experiencing depression and anxiety. The apps work to target common issues related to depression and anxiety, like feeling down, stressed, or worried. Eligible participants would be asked to download the IntelliCare apps onto their own Android smartphone, and use the apps each day for an 8-week period. Participants will be randomly assigned to either use the apps independently or communicate via phone and through text messages with an IntelliCare coach who will help with the use of the apps. Individuals will participate in the 8 week IntelliCare program, during which, two online assessments will be completed. Follow-up online assessments will be conducted 3 and 6 months after the 8 week program. In sum, the IntelliCare study lasts up to 8 months. Participants may be compensated up to $160 in total for completing the study assessments.
You may be eligible to join if you are an (1) Android smartphone user with a data/text messaging plan, (2) currently experiencing symptoms of depression or anxiety, (3) a United States Citizen/Resident, (4) at least 18 years old, and (5) a new user of IntelliCare apps.
Mohr, David CMohr, David C
STU00074405
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Study Coordinator 855 682 2487
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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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Sleep Disturbance and Metabolic Syndrome
The goal of this study is to determine the ability of auditory stimulation with these sound waves to improve sleep, cardiovascular disease and metabolic function in patients with elevated cardiovascular disease risk factors. The study will involve a home …
The goal of this study is to determine the ability of auditory stimulation with these sound waves to improve sleep, cardiovascular disease and metabolic function in patients with elevated cardiovascular disease risk factors. The study will involve a home sleep test to look for sleep apnea and 7-days of at-home activity monitoring using a wristwatch before the inpatient visit. This study will also include surveys, blood draws, and overnight sleep studies. There is compensation for completing the study.
Need to be overweight, have high blood pressure (130/85 or higher), high blood sugar (110 or higher) in the past month, difficulty falling or staying asleep, and have daytime sleepiness and poor sleep quality. Total time commitment – 2 visits: One outpatient visit (2-3 hours) and one 5-day/4-night inpatient visit for overnight sleep studies at Northwestern Memorial Hospital.
Zee, Phyllis CZee, Phyllis C
STU00074507
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Ortiz, Rosemary J 1-888-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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Saxon, Marie 312 503 4012
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CENTER FOR BEHAVIORAL INTERVENTION TECHNOLOGIES (CBITs) RESEARCH SUBJECT RECRUITMENT REGISTRY
WHAT IS THE REGISTRY ABOUT? Becoming a member of this registry allows researchers at Northwestern University to get in touch with you to see if you might be interested in and eligible to participate in diff…
WHAT IS THE REGISTRY ABOUT? Becoming a member of this registry allows researchers at Northwestern University to get in touch with you to see if you might be interested in and eligible to participate in different research studies at CBITs. The research conducted at CBITs generally involves evaluating different aspects of technology-assisted health interventions. WHAT WILL I BE ASKED TO DO? You will be asked to provide some basic contact and background information, as well as continue on to complete a brief survey. There is no cost to join the registry. You can read more about the current studies and sign up for the registry on our website: http://cbitshealth.northwestern.edu
If you're an adult (18 years or older), living in the United States, who speaks English, and has Internet access, you may be eligible to join.
Mohr, David CMohr, David C
STU00076804
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Study Coordinator 855 682 2487
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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 312 926 1672
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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 312 503 5906
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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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1-888-NU-STUDY
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Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms a…
This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).
Salem, RiadSalem, Riad
NCT02026908 STU00081296
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Jenkins, Kimberly 312 695 9327
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Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder
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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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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Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa
This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).
Apkarian, ApkarApkarian, Apkar
NCT01951105 STU00081444
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Hunt, Elizabeth 312 503 6475
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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.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
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 1-888-NU-STUDY
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RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (A7007)
The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practic…
The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and to evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
Key Inclusion Criteria:
-Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
-Signed a valid, IRB/EC-approved informed consent form
-18 years of age or older

Key Exclusion Criteria:
-Contraindicated for Boston Scientific neurostimulation system
-Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01719055 STU00083506
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Amidei, Christina 312 695 9124
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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 312 503 3413
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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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Targeting Siglecs in Disease supported by NIH Grant R01 AI072265 Targeting Siglec-8/-F to treat eosinophil and mast cell related disorders and P01 HL107151 Glycobiology of Inflammatory Lung Diseases: Project 1 and U19 AI136443 Using Siglecs and Their Ligands to Treat Allergic Diseases: Project 1 and Core B.
The study involves recruiting paid volunteers to donate blood. The goal of the studies is to isolate certain cells from the blood called eosinophils to examine certain proteins and their functions in the laboratory.
Adults with or without allergies
Bochner, BruceBochner, Bruce
  • Map it 201 E. Huron St.
    Chicago, IL
STU00085003
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Bochner, Bruce 312 503 0068
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NU 13S02: Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is fo…
The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02048722 STU00087654
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Study Coordinator 312 695 1102
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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 312 503 3200
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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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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 312 695 8146
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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 312 503 1137
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EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON SERUM PHOSPHATE AND FGF23 LEVELS IN PATIENTS WITH STAGE 3-4 CHRONIC KIDNEY DISEASE
The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) i…
The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney Disease (CKD) stages 3-4.
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT02258074 STU00089187
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Martinez, Carlos 312 503 1808
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A5320: Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)
This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepat…
This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful hepatitis C treatment on a person’s health over many years. It will also help us understand how long resistance to new hepatitis C medications lasts and whether it affects future hepatitis C treatments. This is an observational study and does NOT provide any Hepatitis C or HIV treatment.
Persons who were treated with an oral direct acting anti-viral (DAA) therapy for hepatitis C, but did NOT have a successful response to treatment (non-SVR) (enrollment is closed to persons with successful response to treatment); Hepatitis C mono-infected OR Hepatitis C and HIV co-infected;
Taiwo, Babafemi OTaiwo, Babafemi O
STU00090304
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Berzins, Baiba Ingrida 312 695 5012
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Parkinson’s Disease and Movement Disorders Center Biorepository
This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the regi…
This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’s risk for developing them. Samples collected for this biorepository include a blood sample (or a saliva sample) and a skin biopsy. Participants may choose to donate one or both samples.
• Diagnosis of a movement disorder
• Male or female 5 years of age or older when diagnosed
• Genetic mutation related to a movement disorder
• Family members of patients with movement disorders
Simuni, TatyanaSimuni, Tatyana
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
STU00091585
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Hernandez, Alejandro +1 312 503 2778
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A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
This study is a prospective Phase IV study to determine if the …
This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
Kulik, Laura MKulik, Laura M
NCT02081755 STU00083409
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Bezler, Laura 312 694 0260
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RANDOMIZED CONVERSION OF EBV+ KIDNEY TRANSPLANT RECIPIENTS OF LIVING OR STANDARD CRITERIA DONORS AT THREE MONTHS POST TRANSPLANTATION TO BELATACEPT WITH MPA OR BELATACEPT WITH LOW-DOSE TACROLIMUS (50% OF DOSE) COMPARED TO PATIENTS REMAINING ON CENTER SPECIFIC STANDARD THERAPY OF TACROLIMUS AND MPA
Th…
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.
Gallon, LorenzoGallon, Lorenzo
NCT02213068 STU00085274
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1-855-NU-STUDY
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SHORT-TERM EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHATE HOMEOSTASIS IN HEALTHY VOLUNTEERS
The study is a Phase 1, double blind, randomized, placebo-controlled, trial in which healthy volunteers (as defined by the study protocol) receive a combination of phosphorus lowering medications…
The study is a Phase 1, double blind, randomized, placebo-controlled, trial in which healthy volunteers (as defined by the study protocol) receive a combination of phosphorus lowering medications and/or placebo for approximately 2 weeks.The objective of this study is to perform a detailed physiologic study of healthy volunteers to assess the short-term effects of nicotinamide alone, lanthanum carbonate alone, or both in combination on phosphate homeostasis. Specifically, the study is looking to determine the short-term effects of lanthanum carbonate and nicotinamide, alone and in combination, on hormonal regulators of mineral metabolism (FGF23 and PTH) and markers of bone turnover (P1NP and CTX).The results from healthy volunteers will provide information needed for optimal design of studies for patients with Chronic Kidney Disease.
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03136705 STU00090161
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Martinez, Carlos 312 503 1808
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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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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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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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The Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN a…
The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are: 1. To learn more about important problems faced by people living with scleroderma (e.g., fatigue, emotional distress, physical limitations). 2. To develop and test internet-based interventions to support people in their efforts to cope with living with scleroderma. Participants will be asked to complete quality of life questionnaires via the internet every 3 months.
Diagnosis of scleroderma. Fluent in English. Must have access to the Internet to complete questionnaires.
Varga, JohnVarga, John
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00092924
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Carns, Mary 312 503 1137
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B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
-Pregnant women at least 18 years old.
-Less than 15 weeks pregnant with a single baby.
-Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
Grobman, William AGrobman, William A
STU00093038
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Wolfe, Kaitlin A 312 503 3248
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(LCH) A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Neonates at High Risk of Acquiring HIV-1 Infection. Version 1, December 10, 2012(Lurie Children's # 2014-15720)
This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (…
This study will evaluate the safety and pharmacokinetics (PKs) of raltegravir (RAL) given to HIV-1-exposed newborns at high risk of acquiring HIV-1 infection. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the appropriate dose of RAL to give to an infant to prevent the infant from getting HIV infection from its mother.
Chadwick, EllenChadwick, Ellen
NCT01780831 STU00093680
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Cardiometabolic outcomes with light exposure during sleep
The overall aim is to determine the impact of light during the sleep period on cardiometabolic outcomes and melatonin. We hypothesize that light at night contributes to circadian and sleep disruptions that may then lead to adverse cardiometabo…
The overall aim is to determine the impact of light during the sleep period on cardiometabolic outcomes and melatonin. We hypothesize that light at night contributes to circadian and sleep disruptions that may then lead to adverse cardiometabolic outcomes. Light pollution, and specifically light at night, has been shown to impact circadian rhythms via changes to melatonin, sleep, and other parameters. Poor sleep, changes in melatonin, and circadian disturbances are known to affect cardiometabolic outcomes. Therefore, it is plausible that light exposure during the sleep period may adversely impact next day cardiometabolic outcomes. Understanding the consequences of light during the sleep period is of great interest considering the high prevalence of light pollution in modern society.
If you are 18-40 years of age with a regular sleeping schedule. Please visit https://www.surveymonkey.com/s/LANstudy
Zee, Phyllis CZee, Phyllis C
STU00094737
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Cheung, Ivy N 1-888-NU-STUDY
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NU SARC14S01: A blanket protocol to study oral regorafenib in patients with selected sarcoma subtypes
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been …
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02048371 STU00094754
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Study Coordinator 312 695 1102
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A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01848561 STU00094204
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Arrieta, Rose +1 312 695 5878
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DRUG ATI001-102: A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
This research study involves two investigational drugs…
This research study involves two investigational drugs, veledimex, an activator ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of INXN-2001 given in combination with oral veledimex.
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 75 years of age. 2. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue. 3. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy. 4. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. 5. Able to undergo standard MRI scans with contrast agent. 6. Karnofsky Performance Status ≥ 70. 7. Adequate bone marrow reserves and liver and kidney function. 8.Male and female subjects must agree to use a highly reliable method of birth control. Exclusion Criteria: 1. Radiotherapy within 4 weeks or less prior to starting first veledimex dose. 2. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures. 3. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections. 4. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection. 5. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug. 6. Other concurrent clinically active malignant disease requiring treatment. 7. Nursing or pregnant females. 8. Prior exposure to veledimex. 9. Presence of any contra-indication for a neurosurgical procedure.
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02026271 STU00094296
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Amidei, Christina 312 695 9124
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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 <40 mg/dL. Enrollment will occur over 3.5 - 4 years.
Prabhakaran, ShyamPrabhakaran, Shyam
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 312 695 9124
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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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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 312 926 0975
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Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life
The aim of this trial is to compare the proportion of vaginal deliveries among women who participate in a before childbirth fitness and education program versus those who do not. Women wil…
The aim of this trial is to compare the proportion of vaginal deliveries among women who participate in a before childbirth fitness and education program versus those who do not. Women will be recruited to start the study in their second trimester and will complete surveys and track their activity.The primary outcome of this study is to compare rates of severe birth trauma and wound complications between groups. This study is for women who have a singleton pregnancy, are in the second trimester, and are delivering at Prentice Women’s Hospital.
The study will include women with a singleton primiparous pregnancy, who are delivering at Prentice Women's Hospital will be considered eligible for the study. Participants that are less than 18, having a required C-section and are currently enrolled in any kind of physical therapy 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
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02334397 STU00095770
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Tavathia, Meera 312 926 7846
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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 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02065622 STU00096456
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Arrieta, Rose +1 312 695 5878
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A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02065570 STU00096539
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Arrieta, Rose +1 312 695 5878
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Healthy Control Esophageal Registry and Biorepository
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biop…
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology
- Have a diagnosis of an eating disorder
- Have a diagnosis of an autoimmune disease
- A current or previous smoker (smoked >100 cigarettes in lifetime)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Taking antacids and/or proton pump inhibitors for heartburn
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
Carlson, DustinCarlson, Dustin
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00096856
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Thakrar, Anjali 312 503 1120
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Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are …
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in the nuMOM2b Study.
By invitation only. Women who previously participated in the nuMOM2b Study and who are 18+ years old are invited to participate in the nuMOM2b Heart Health Study. These women also consented to be contacted for future research studies and did not previously withdraw from the nuMoM2b cohort.
Grobman, William AGrobman, William A
  • Map it 633 N. St. Clair St
    Chicago, IL
NCT02231398 STU00098233
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Rangel, Elizabeth 312 503 6287
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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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1-888-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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1-888-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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A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam compared with Meropenem in Adult Patients with Ventilated Nosocomial Pneumonia
This is a Phase 3, Multicenter, Prospective, Randomized study of IV …
This is a Phase 3, Multicenter, Prospective, Randomized study of IV ceftolozane/tazobactam vs. IV meropenem in the treatment of adult patients with either Ventilator-Associated Bacterial Pneumonia [VABP] or Ventilated Hospital-Acquired Bacterial Pneumonia [HABP].
Wunderink, Richard GWunderink, Richard G
NCT02070757 STU00099685
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Freehand Ultrasound to Evaluate the Scapular Kinematics in Persons with Paraplegia
Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level pa…
Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder during routine daily activities, the onset of pain or injury lead to increased healthcare expenses, limitation in activity, depression, decreased participation, and reduced quality of life. One of the main reasons of shoulder pain is believed to have a altered scapular movement. To clarify the mechanism of the shoulder pain and injury, comprehensive understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture system to evaluate scapular movement was developed and presented favorable results in able-bodied population. The purpose of this study is to compare the FUS and widely used skin-based method against a radiographic based gold standard in people with paraplegia, and to elucidate the relationship among scapular movement and shoulder pain, pathology. This study will also allow us to gain more understanding of how level of injury influences the scapular behavior during functional activities. The investigators believe more severe shoulder pain and pathology will be associated with greater abnormal scapular movement. The investigators also believe that people with high-level paraplegia will have greater scapular abnormality than people with low-level paraplegia during arm elevation and weight relief raise tasks. By completing this study, the investigators will expect to deliver a reliable and valid tool to evaluate scapular movement and gain a better understanding how the altered scapular movement is related to shoulder pain and pathology. The investigators will also learn how the level of injury affects the scapular behavior during functional activities. The results of this study may help the shoulder pain management leading to the improvement in the quality of life of individuals with SCI.
Dhaher, Yasin YDhaher, Yasin Y
NCT02357914 STU00100638
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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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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 312 695 3410
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A Phase III Randomized Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
This randomized phase III trial studies how well crizotinib works and compare…
This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.
Mohindra, NishaMohindra, Nisha
NCT02201992 STU00102000
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Behavioral activation and varenicline for smoking cessation in depressed smokers
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Beh…
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Behavioral activation for smoking cessation + placebo; 3) Standard behavior therapy + varenicline (Chantix); or 4) Behavioral activation for smoking cessation + varenicline (Chantix).
1. Adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
2. Lifetime history of clinical depression (Major Depressive Disorder)
Hitsman, Brian LHitsman, Brian L
NCT02378714 STU00100303
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Reyes, Celine 1 877 236 7487
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(xIRB) An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
The purpose of this study is to evaluate L…
The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Flamm, Steven LFlamm, Steven L
NCT02167945 STU00102262
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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 312 695 4828
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Radiographic Markers of Clinical Function in Cervical Spondylotic Myelopathy (CSM)
Cervical spondylotic myelopathy (CSM), also called “spinal stenosis,” is a common cause of injury to the cervical spinal cord (the neck). CSM can cause pain in the neck and arms, as well as weakness and loss of coo…
Cervical spondylotic myelopathy (CSM), also called “spinal stenosis,” is a common cause of injury to the cervical spinal cord (the neck). CSM can cause pain in the neck and arms, as well as weakness and loss of coordination in the neck, arms, hands, legs, and feet. Although CSM is common, there is still a question of how findings on imaging such as x-rays or magnetic resonance imaging (MRI) relate to a person’s symptoms. The purpose of this study is to see how the images and symptoms of people with CSM compare to images of healthy people without CSM. We are looking for healthy volunteers to help us gain valuable insight into how medical imaging can help us diagnose CSM.
Participants must be 21 years of age or older, preferably 40 years of age or older. Participants may not have any previous spine surgeries or chronic neck pain.
Smith, ZacharySmith, Zachary
  • Map it 201 E. Huron St.
    Chicago, IL
STU00099367
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Amidei, Christina 312 695 9124
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Phase III, Randomized, Double-Blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy (Maintenance Of Remission) And Safety Of Etrolizumab Compared With Placebo In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Naive To Tnf Inhibitors (Protocol GA29102)

Phase III, Randomized, Double-Blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy (Maintenance Of Remission) And Safety Of Etrolizumab Compared With Placebo In Patients With Moderate To Severe Active Ulcerative Colitis Who Are Naive To Tnf Inhibitors (Protocol GA29102)

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02165215 STU00101866
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Arrieta, Rose +1 312 695 5878
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ECOG-ACRIN S1400: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assi…
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02154490 STU00100140
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Study Coordinator 312 695 1102
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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 312 695 9124
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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 312 503 1137
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Effect of a Patient-Centered Decision App on TOLAC: An RCT
Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly one third of births annually. In the last decade, the CD rate has increased by approximately 50%, with almost 1.3 million procedu…
Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly one third of births annually. In the last decade, the CD rate has increased by approximately 50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been associated with an increase in major maternal morbidity (Silver 2010), with corresponding increases in length of inpatient care following delivery and frequency of hospital readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives have targeted reducing the CD rate as an important public health goal for more than a decade; however, identifying interventions to achieve this goal has proven challenging. Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the combination of a rising rate of primary CD and a decreasing rate of vaginal birth after cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010 (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of debate; the extent to which these changes are driven by patient preferences is not known. An NIH consensus conference statement noted that "the informed consent process for TOLAC and Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and incorporate a strong emphasis on the values and preferences of pregnant women," and recommended "interprofessional collaboration to refine, validate, and implement decision-making and risk assessment tools" to accomplish that goal (Cunningham 2010). Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer TOLAC consider individualized risk assessments, incorporate their values and preferences, and participate in a shared decision making process with their providers to make informed decisions about delivery approach. We are now conducting a randomized study of the effect of a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
Prior VBAC.
Grobman, William AGrobman, William A
  • Map it 633 N. St. Clair St
    Chicago, IL
NCT02646423 STU00104496
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Williams, Brittney 1 312 503 3476
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Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce drug Exposure (ASPIRE) Study
HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department…
HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02263326 STU00104766
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1-855-NU-STUDY
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COG ARST1321: Pazopanib Neoadjuvunt Trial on Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
This randomized phase II/III trial studies how we…
This randomized phase II/III trial studies how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin hydrochloride, 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. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy works better when given with or without combination chemotherapy and/or pazopanib hydrochloride in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02180867 STU00105700
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Study Coordinator 312 695 1102
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HOme-based moNitORed exercise for PAD
This study will determine the effects of a home based walking exercise intervention on walking ability in people with peripheral artery disease (PAD).
Peripheral artery disease
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02462824 STU00100697
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Domanchuk, Kathryn J 312 503 6438
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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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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study, followed by an Active-Treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects with Active Behçet’s Disease
Behcet's disease, is a rare disorder…
Behcet's disease, is a rare disorder that causes inflammation in blood vessels throughout the body. The signs and symptoms of Behcet's disease may include mouth sores, eye inflammation, skin rashes and lesions, and genital sores that vary from person to person and may come and go on their own. The exact cause of Behcet's is unknown, but it may be an autoimmune disorder, which means the body's immune system mistakenly attacks some of its own healthy cells. This study will test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of oral ulcers in subjects with active Behçet's disease. Other manifestations of the disease will also be assessed, such as, pain and tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also will test how well the body tolerates apremilast. This study is a randomized, placebo-controlled, parallel design. About 204 subjects will participate. The placebo-controlled period will be 12 weeks long and patients will receive apremilast or placebo. After the 12-week placebo-controlled period, all subjects will receive apremilast for 1 year. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
Brown Jr, Calvin RBrown Jr, Calvin R
NCT02307513 STU00200088
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1-888-NU-STUDY
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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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A Phase 3b, Multi center, Open -label Trial to Evaluate the Long Term Safety of Titrated Immediate -release Tolvaptan (OPC 41061, 30 mg to 120 mg/day , Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease
This study's purpose is to evaluate the long-term safety and e…
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Tuazon, Jennifer ATuazon, Jennifer A
NCT00428948 STU00102788
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1-855-NU-STUDY
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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 312 503 1826
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A Phase 2 Study of MM-121 in Combination with Docetaxel or Pemetrexed versus Docetaxel or Pemetrexed alone in Patients with Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to determine whether the combination of MM-121 plus doce…
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to PFS in patients with heregulin-positive NSCLC.
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02387216 STU00200295
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Study Coordinator 312 695 1102
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Low InTensity Exercise intervention in PAD: The LITE Trial.
This study is being done to determine whether an exercise intervention that avoids continuous supervision and exercise-related pain in the legs can improve walking ability in people with lower extremity peripheral artery disease (PAD).
Peripheral artery disease
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02538900 STU00105855
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Domanchuk, Kathryn J 312 503 6438
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Advancing Research and Treatment for Frontotemporal Lobar Degeneration
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progre…
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotemporal dementia (FTD), primary progressive aphasia (PPA), corticobasal degeneration syndrome (CBS) and progressive supranuclear palsy syndrome (PSPS). The goal of this study is to build a FTLD clinical research consortium to support the development of FTLD therapies for new clinical trials.
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 English or Spanish.
5. Meet the clinical diagnostic criteria for PSP, semantic PPA, CBS, vFTD, FTD-ALS, or non-fluent PPA.
Weintraub, SandraWeintraub, Sandra
NCT02365922 STU00200202
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Riley, Michaela 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 312 695 3410
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Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332)/ A5333s: Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE/A5361s: Pitavastatin to REduce Physical Function Impairment and Frailty in HIV (PREPARE)
People infected wi…
People infected with HIV are at risk for cardiovascular disease (CVD). REPRIEVE is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months. The trial is testing the effect of statin therapy on preventing heart disease and death in HIV-infected persons on HIV medications who do not meet guidelines for starting statins. HIV causes inflammation (irritation) inside the body that may contribute to diseases such as heart disease. HIV medications can lower inflammation, however the levels of inflammation can remain higher compared to people who are not infected with HIV. Statins, such as pitavastatin, are medications that are used to lower the levels of cholesterol and triglycerides (fat in the blood) and have been shown to lower levels of inflammation and heart disease.
• HIV infected men and women between the ages of 40 and 75
• On anti-HIV medications for at least 6 months
• CD4 cell count greater than 100
• No history of cardiovascular disease, such as heart attack, stroke, etc.
• No history of cancer in the last 3 years
• Not currently using a statin drug
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02344290 STU00200323
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Berzins, Baiba Ingrida 312 695 5012
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The effect of magnesium on maternal mood, cognitive function, and birth experience
Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less …
Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.
Miller, EmilyMiller, Emily
NCT02454322 STU00200388
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1-855-NU-STUDY
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LURN: Symptoms of Lower Urinary Tract Dysfunction Research Network Prospective Phenotyping Study
Cella, DavidCella, David
NCT02485808 STU00200227
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Tavathia, Meera 312 926 7846
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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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Lipiszko, Olga 312 503 6568
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Permanent versus delayed-absorbable monofilament suture for vaginal graft attachment during minimally-invasive total hysterectomy and sacrocolpopexy: A Randomized Clinical Trial
The aim of this study is to compare permanent stitches to delayed absorbable stitches for attachment of vaginal mesh (net-l…
The aim of this study is to compare permanent stitches to delayed absorbable stitches for attachment of vaginal mesh (net-like implant) in total removal of the uterus and repairing of the pelvic organs. The primary outcome for this study is comparing vaginal mesh and stitches exposure rates.This study is for women who are planning on undergoing surgical treatment for pelvic organ prolapse.
The study will include women with anterior or posterior vaginal prolapse, who have completed childbearing, are seeking surgical management, and are willing to proceed with placement of abdominal mesh. Participants who have had a prior hysterectomy and are not surgical candidates will not be considered eligible for the study.
Kenton, KimberlyKenton, Kimberly
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02277925 STU00200281
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Tavathia, Meera 312 926 7846
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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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Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process
The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conserv…
The hypothesis of this study is that PEMF treatment will improve odontoid fracture healing, compared with standard conservative care, in subjects 50 years of age and over diagnosed with Type II odontoid fractures, and this effect will be evident by 6 months post-injury. Subjects will be assessed for the presence of a Type II odontoid fracture by X-ray, MRI and CT scan. Subjects meeting eligibility criteria will be randomized in a 2:1 ratio (active: placebo control) to either the active or control device for 4 hours a day for 6 months. X-rays will be collected at 6 weeks, and at 3, 6 and 12 months to assess the fracture healing process, with flexion-extension x-rays collected at 3, 6 and 12 months. A CT scan will be performed at 6 months to confirm healing. Quality of Life measures (SF-36, VAS neck pain scale, NDI) will be collected at all visits (6 weeks, 3, 6 and 12 months). Study subjects will receive either an active Orthofix Cervical-Stim Model 2205OD or an inactive (placebo) Orthofix Cervical-Stim Model 2205OD device.
Hsu, Wellington KHsu, Wellington K
NCT02281994 STU00200366
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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 312 695 5012
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SPARC: Gene expression profiling in scleroderma to discover therapeutic targets and predict clinical course
The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match tar…
The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match targeted treatments to the appropriate patients. The study will also focus on identifying inflammatory and fibrotic molecular pathways that are important in the disease Participants will be asked to give: - Two punch skin biopsies from the forearm (size of a pencil eraser) - Two tubes of blood - Urine collection Participants will be paid $110 for the one-time study visit. We are recruiting both patients with scleroderma and healthy control subjects.
Participants must be: Over age 18, No chronic skin conditions, No rheumatic autoimmune diagnosis (e.g., lupus, rheumatoid arthritis, scleroderma), Not currently pregnant.
Varga, JohnVarga, John
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00200631
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Carns, Mary (312) 503 1137
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Protocol AC-055-503, US-based, observation, drug registry of Opsumit®(macitentan) new users in clinical practice (OPUS Registry)
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describ…
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
Cuttica, Michael JCuttica, Michael J
NCT02126943 STU00200762
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1-855-NU-STUDY
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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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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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Crooke, Catherine 312 695 4189
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Bicarbonate Administration to Stabilize eGFR
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in …
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT02521181 STU00200505
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Fox, Patrick 312 503 1887
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Biochronicity Grand Challenge: Human Time Stamp Development, Validation and Prediction
This research is being done to develop a diagnostic test that will determine the time of your internal clock from a single blood draw. We want to determine whether changes to the internal clock, reflected in this …
This research is being done to develop a diagnostic test that will determine the time of your internal clock from a single blood draw. We want to determine whether changes to the internal clock, reflected in this blood test, can predict recovery from traumatic brain injury.
Between the ages of 18-55 and have had a traumatic brain injury.
Zee, Phyllis CZee, Phyllis C
STU00200445
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Gendy, Maged 1-888-NU-STUDY
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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 312 926 2828
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A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination with Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer
The study seeks to assess the efficacy of veliparib (ABT-888) in combination wit…
The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin, with or without the involvement of regional lymph nodes, including ipsilateral and contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular nodes
Chae, Young KwangChae, Young Kwang
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02289690 STU00200750
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Study Coordinator 312 695 1102
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A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease o…
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.
Flamm, Steven LFlamm, Steven L
NCT02308111 STU00200837
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Gottstein, Jeanne H 312 694 0264
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Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enr…
This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
Schaeffer, Anthony JSchaeffer, Anthony J
NCT02514265 STU00200928
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Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)
Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)
Caprio, FanCaprio, Fan
NCT02239120 STU00200255
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1-888-NU-STUDY
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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 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
  • Map it 250 E. Superior St.
    Chicago, IL
NCT02678377 STU00201249
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Tavathia, Meera 312 926 7748
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Testing the ability of JNJ-18038683, a selective serotonin (5-HT)7 antagonist, to improve cognition and reduce residual depressive symptoms in stable bipolar patients
This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in …
This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in people who have bipolar disorder and are taking other medications for their illness. Mental function is how your brain works and includes your mood, memory and how you think and concentrate. An investigational drug is one that is not approved for sale by the US Food and Drug Administration (FDA) or any other regulatory or health agency. This study compares an experimental drug to a placebo. A placebo is an inactive substance made to look/taste like an active medicine. We expect that you will be in this research study for up to 10 weeks, including the screening period.
Adults 18 to 60 years old with diagnosis of of bipolar disorder
Meltzer, HerbertMeltzer, Herbert
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02466685 STU00200919
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Nikolajuk, Katie M 312 503 9076
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PeriOcular and INTravitreal corticosteroids for uveitic macular edema (POINT) Trial
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal t…
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects.
Goldstein, DebraGoldstein, Debra
NCT02374060 STU00201241
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Seddon, Nicole 312 695 0252
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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 312 503 4163
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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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ECOG-ACRIN 1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy
Purpose The main purpose of this study is to compare the usual approach (i.e. capecitab…
Purpose The main purpose of this study is to compare the usual approach (i.e. capecitabine), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (using the drug cisplatin or carboplatin), after surgery - in patients with triple negative breast cancer with residual basal-like disease who have received neoadjuvant chemotherapy. Overview Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV breast cancers, but are usually not used in patients with early forms of breast cancer. The use of a platinum-based chemotherapy could prevent the cancer from returning (metastatic recurrence), 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. Description of Treatment Study participants will be randomly assigned by chance (like the flip of a coin) to one of the two study groups. Group 2 will get a platinum-based chemotherapy treatment for 12 weeks. Participants will receive a 30-minute intravenous infusion of either cisplatin or carboplatin once, every 3 weeks, for 4 doses (total of 12 weeks). Group 3 will get capecitabine treatment for 18 weeks. Participants will take the capecitabine pills twice a day for 2 weeks and then get one week off (called a cycle). There will be six cycles. After finishing treatment, all participants will be followed for about 10 years (every 3 months for the first 2 years from study entry, every 6 months if they are 2-5 years from study entry, every 12 months if they are 5-10 years from study entry).
Some of the eligibility criteria include:

- Participants must have early stage breast cancer.
- Participants must have triple negative breast cancer (ER-, PR- and HER2-).
- 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.
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 II/III Studies

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02118584 STU00200583
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Arrieta, Rose +1 312 695 5878
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Telmisartan Plus Exercise to Improve Functioning in PAD
The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performan…
The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02593110 STU00200954
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Domanchuk, Kathryn J 312 503 6438
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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 1-888-NU-STUDY
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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 312 695 6076
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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-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 +1 312 695 5878
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An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)

An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active 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 +1 312 695 5878
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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, 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 +1 312 695 5878
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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.
Anderson, AllenAnderson, Allen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02892955 STU00200932
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Dreisbach, Alexander 312 926 2671
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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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Chronic Kidney Disease Research Biorepository
The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00201546
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Martinez, Carlos 312 503 1808
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ACUpuncture after HEART Surgery
The purpose of this study is to see if acupuncture after heart surgery can prevent onset of atrial fibrillation (AF) and reduce pain, nausea and symptoms of depression. AF is an irregular heartbeat, which may cause symptoms such as pounding sensations in the chest, diz…
The purpose of this study is to see if acupuncture after heart surgery can prevent onset of atrial fibrillation (AF) and reduce pain, nausea and symptoms of depression. AF is an irregular heartbeat, which may cause symptoms such as pounding sensations in the chest, dizziness, fatigue, chest pain and/or shortness of breath and can cause blood clots to form in the heart. AF is one of the most common complications to occur after heart surgery. Acupuncture involves the insertion of extremely thin needles through the skin at strategic points on the body. Acupuncture has been used in traditional Chinese medicine for thousands of years for a variety of illnesses and has been shown to be effective for the treatment of nausea and vomiting in adults following surgery. Acupuncture seeks to release the flow of the body's vital energy or "chi" by stimulating points along 14 energy pathways. Scientists say the needles cause the body to release endorphins -- natural painkillers -- and may boost blood flow and change brain activity.
Feingold, Kim RFeingold, Kim R
  • Map it 201 E. Huron St.
    Chicago, IL
STU00201408
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Whisler, Cailin 312 926 3356
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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 i…
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 312 926 7554
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A5353: A Study to Evaluate Dolutegravir plus Lamivudine Dual Therapy for the Treatment of Naïve HIV-1-infected Participants
This study is being done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, will …
This study is being done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, will provide a safe, effective, and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended regimens along with a third active drug. Since some HIV medicines have side effects and are costly, there is interest in whether HIV can be successfully controlled with fewer than three HIV drugs.
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02582684 STU00201656
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Improving Outpatient Safety of Older Adults through Electronic Patient Portals
The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
Lindquist, Lee ALindquist, Lee A
  • Map it 675 N. St. Clair St.
    Chicago, IL
STU00201242
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Seltzer, Anne Jennifer 312 926 5159
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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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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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(CIRB) ECOG-ACRIN 6134: A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
This randomized phase III t…
This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
Chandra, SunandanaChandra, Sunandana
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02224781 STU00201842
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Study Coordinator 312 695 1102
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Genomic Medicine at Northwestern: Discovery and Implementation in the eMERGE Network
We are studying how patients and physicians use and value genetic information that resides in the electronic medical record. We plan to recruit and return information on over 100 genes to 3,000 Northwestern patients…
We are studying how patients and physicians use and value genetic information that resides in the electronic medical record. We plan to recruit and return information on over 100 genes to 3,000 Northwestern patients. Most of the genes being analyzed as part of this study have been linked to the development of a disease or condition, such as certain inherited cancers, certain types of inherited heart-related condition, and how our bodies respond to certain medications. There will also be some genes studied where the usefulness still being determined. Only results determined to potentially affect decisions that you and your physician(s) may make regarding your health care management will be placed in the electronic health record (EHR) for use by you and your Northwestern physicians. To participate, individuals need to be over 18 years of age, see a Northwestern physician, sign a consent form and donate approximately 1 table spoon of blood. Participants will also complete a baseline survey, will be given the option to be interviewed after receiving their results, and the option to participate in the NUgene Project, a genetic biobanking project designed to collect and store genetic and health information and provide those samples to researchers studying the genetics of common conditions such as diabetes, cancer, and heart disease.
Any Northwestern Medicine Patient who is 18 years of age or older.
Smith, Maureen ESmith, Maureen E
STU00201671
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Hoell, Christin Jane 312 695 0700
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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 312 694 0255
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A Phase 3, Randomized, Double Blind, Placebo and Active Controlled, Multicenter, Parallel Group Study of the Analgesic Efficacy and Safety of Tanezumab in Adult Subjects with Chronic Low Back Pain
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administer…
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Schnitzer, Thomas JSchnitzer, Thomas J
  • Map it 710 N. Lake Shore Dr. Abbott Hall
    Chicago, IL
NCT02528253 STU00201593
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Swiostek, Irmina 312 503 4163
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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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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- GFR<30
3- Allergy to Gadolinium or Ferumoxytol or Fe or multiple drugs
4- Severe >70% cervical carotid or vertebral artery proximal stenosis, or tandem intracranial stenoses,
5- Impaired liver function
Ansari, Sameer AhmadAnsari, Sameer Ahmad
STU00201681
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Muzaffar, Ayesha 312 926 4251
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Iron Deficiency and FGF23 Regulation in Chronic Kidney Disease and Heart Failure
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iro…
Our research group is currently conducting a 6-week iron deficiency anemia study on healthy individuals, individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iron sucrose therapy can safely and successfully lower FGF23 levels. Iron sucrose has been shown to lower FGF23 in animal models. The short term effects of iron sucrose on FGF23 levels in CKD and CHF are not known. We are conducting this research study to understand the effects of intravenous iron sucrose therapy on blood levels of FGF23 in iron deficiency anemia in healthy individuals, individuals with CHF, individuals with CKD, and individuals with CKD and CHF. The information gained from this study could be used to improve the health of patients with iron deficiency anemia and disease of the kidneys and heart.
hemoglobin < 12, ferritin <100 or ferritin <300 w/ TSAT < 20, no active infections, no active use of immunosuppresants
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03106298 STU00201742
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Fox, Patrick 312 503 1887
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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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Role Functioning Changes in New Onset Symptoms
Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning. During this study the investigators will …
Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning. During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. The primary outcome of the study is to correlate Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition. The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan. While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.
Inclusion Criteria:

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

Adults unable to consent
Individuals who have not reached the age of 18
Pregnant women
Prisoners.
Cronenwett, Will JCronenwett, Will J
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
STU00201133
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Jain, Ankit 312 503 9092
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The SCOUT Study - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation (CLPR-010)
SCOUT: This study is looking for patients who have a “leaky” tricuspid valve in the heart. The leakage of blood is a…
SCOUT: This study is looking for patients who have a “leaky” tricuspid valve in the heart. The leakage of blood is also called regurgitation. The tricuspid valve is located within the right side of the heart. This condition is referred to as functional tricuspid regurgitation (FTR). FTR occurs when the valve itself has been determined to be normal. However, the heart is enlarged and pulls the valve open more than it should be. As the heart works hard to pump blood throughout the body, the leaking valve allows blood to flow backwards in the wrong direction, and therefore the heart cannot pump enough blood through the body. The symptoms that patients may experience are an irregular heartbeat, fatigue, a fluttering discomfort in the neck, right abdominal pain, shortness of breath, swelling in the legs or abdomen, and cold skin. The purpose of the SCOUT study is to learn initial information about the basic safety and function of a new investigational device, the Mitralign system. The Mitralign system is a tricuspid valve repair device which uses catheters placed through two small openings in a vein in the neck to deliver surgical sutures (threads) through the ring (annulus) around the tricuspid valve. These sutures are then pulled together (as is done with threads when sewing) to make the tricuspid valve opening smaller and reduce regurgitation. These sutures are then locked in place with a small stainless steel lock. Implanting this device does not require open-heart surgery. The study valve is an investigational device meaning it has not yet been approved by the US Food and Drug Administration (FDA). This research study plans to enroll approximately 15 study participants at up to 5 sites in the US. We are looking to enroll up to 8 people at Northwestern.
Rich MD, StuartRich MD, Stuart
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02574650 STU00201839
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Warzecha, Anna 312 926 0846
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PRELAPSE – A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment with Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia
Medications for the treatment of schizophrenia come in varied forms. …
Medications for the treatment of schizophrenia come in varied forms. Some are taken one or more times a day; other types are taken once every 2 or 4 weeks. The purpose of the PRELAPSE study is to compare standard treatment with treatment with a version of the medication aripiprazole that is taken only once each month. To allow the aripiprazole to be taken only once a month with current technology, the once monthly aripiprazole is given as an injection (sometimes called a “shot”). We expect that you will be in this research study for 24 months (two years). The study will last for approximately 3.If you choose to participate in the optional MRI sub-study, you will undergo up to 3 MRI sessions; one at the time of your baseline visit, a second that takes place coinciding with your Month 12 visit and a third at the Month 24 visit. Each appointment at the MRI facility should take approximately 1 hour.
Individuals with schizophrenia from 18 to 35 years old
Rado, JeffreyRado, Jeffrey
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02360319 STU00201898
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Jain, Ankit 312 503 9092
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NU WU15S01: A Phase II Study of Pazopanib as Front-Line Therapy in Patients with Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy
Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is …
Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is well tolerated with minimal side effects, the investigators propose a phase II study to evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic disease who are not candidates for cytotoxic chemotherapy.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02300545 STU00201925
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Study Coordinator 312 695 1102
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A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease
The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
• Subjects with type 2 diabetes mellitus
• Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on the following criteria: Persistent very high albuminuria defined as urinary albumin-to-creatinine ratio (ACR) of > 300 mg/g in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) 25 - < 75 mL/min/1.73 m² Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), but not both, for at least 3 months
• Serum potassium
Molitch, Mark EMolitch, Mark E
NCT02540993 STU00201605
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Adelman, Daphne T 312 908 9002
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A 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 312 926 1672
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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 312 926 7846
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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 312 695 8146
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A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)
This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (…
This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment.
Gordon, Leo I IGordon, Leo I I
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02631044 STU00201825
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Study Coordinator 312 695 1102
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SMART Weight Loss Management
SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss…
SMART is a 12-month weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. SMART includes a 3-month weight loss program at no cost. The purpose of this research is to determine the best initial strategy for weight loss and best follow-up approach for those who need more support from a weight loss program
You are between the ages of 18 - 60 years old.
You will live in the Chicagoland area for the next 12 months.
You are NOT currently pregnant, trying to become pregnant, or breastfeeding.
You do NOT have an unstable medical condition.
You own an Android or iPhone smartphone.
You are willing to track your lifestyle behaviors using a smartphone for 3 months.
Spring, BonnieSpring, Bonnie
  • Map it 680 N. Lake Shore Drive Suite 1410
    Chicago, IL
NCT02997943 STU00202075
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Scanlan, Laura 312 503 1395
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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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1-888-NU-STUDY
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Modeling Neuroscience for Enhancing Memory Operations through Non-Invasive Channels (MNEMONIC)
Slow wave sleep, or deep sleep, is important for memory consolidation. Enhancing slow wave or deep sleep may be beneficial for memory performance. We have recently developed a new approach to increase slow …
Slow wave sleep, or deep sleep, is important for memory consolidation. Enhancing slow wave or deep sleep may be beneficial for memory performance. We have recently developed a new approach to increase slow wave sleep by delivering sound waves played through headphones in a specific sequence. When applied during sleep the sound waves increase the total amount and amplitude of deep slow wave sleep. The goal of this study is to determine the ability of these sound waves to improve sleep and memory. We are looking for people who healthy. This study would involve a total of 5 visits (2 inpatient visits and 3 outpatient visits). The first visit is a detailed screening visit which involves informed consent, medical history, physical examination, and surveys. That visit takes place at the Circadian Rhythms and Sleep Research Laboratory in Abbott Hall, located in the Northwestern University Chicago Campus. You will also be given an activity monitor that senses movement and is worn like a watch for 1 week and a home sleep test to look for sleep apnea to wear for 1 night. You will be asked to return the devices either in person or a pre-paid envelope. The second and fourth visit is a 3-day/2-night stay at Northwestern Memorial Hospital and involves sleep studies each night. You will also be given some surveys and brief attention testing. There will be blood draws 2 times each day stay starting after the first night and a few blood draws overnight. You will be randomized (like a coin flip) to one of two groups: the sound wave stimulation or a sham-stimulation (like a placebo). You will not be allowed to know which group you are in. On the 2nd night of each visit, this stimulation or sham stimulation will be applied. Following each inpatient visit your will return 48 hours later to complete 1 hour of memory tasks. For your participation, you will get up to $900 in compensation. If you have questions about the study, you may ask now. You will also get more details and have more time to ask questions at the first study visit if you are interested and are eligible for this study.
18-35 years old
Zee, Phyllis CZee, Phyllis C
STU00202059
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Gendy, Maged 312 503 2519
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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 Based on Trough Levels at Week 12 and 28 in Subjects with Crohn’s Disease (CD) and Ulcerative Colitis (UC)

Bellaguarda, EmanuelleBellaguarda, Emanuelle
  • Map it 201 E. Huron St.
    Chicago, IL
STU00201255
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Arrieta, Rose 312 695 5878
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A Phase IIA, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of CRTh2 Antagonist AZD1981 in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
AZD-1981 is an oral tablet drug, with two pills (20 mg each) taken three times daily (120 mg total). The…
AZD-1981 is an oral tablet drug, with two pills (20 mg each) taken three times daily (120 mg total). The drug is a selective receptor antagonist, meaning AZD-1981 binds to a receptor located on the surface of a cell and blocks other cells from binding there. Without AZD-1981, when that normally open receptor is bound to, inflammation-causing eosinophils accumulate in the area. With AZD-1981 blocking that eosinophil-recruiting binding site, the number of eosinophils at that site should theoretically decrease which should reduce inflammation and therefore improve your nasal polyp symptoms.
In order to qualify for the study you must have at least grade 2 nasal polyps in each nostril, with a total polyp score of at least 4.
Peters, Anju TripathiPeters, Anju Tripathi
NCT02874144 STU00202062
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Hadzic, Amela 312 695 3530
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The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study
The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure me…
The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02676466 STU00201974
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Domanchuk, Kathryn J 312 503 6438
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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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1-888-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 312 695 7190
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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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Rogowski, Allison 312 695 4828
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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo …
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Rinella, Mary EugeniaRinella, Mary Eugenia
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02548351 STU00201580
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Milosevic, Stanislava 312 694 0326
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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 225 E. Chicago Ave.
    Chicago, IL
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00202292
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Ramachandran, Divya 312 503 5914
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An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life among Hispanic Women Completing Active Treatment for Breast Cancer
The purpose of this study is to compare 2 health applications designed to address the wellbeing of Hispanic/Latina breast cancer patients. These hea…
The purpose of this study is to compare 2 health applications designed to address the wellbeing of Hispanic/Latina breast cancer patients. These health applications are delivered through a phone and are designed to help address wellbeing after breast cancer treatment. The applications are interactive and include videos, as well as important resources. Participation consists of completing in 1 in-person meeting, using one of the phone applications for 6 weeks on your own time, and completing 2 follow-up phone interviews. // El propósito de este estudio es comparar 2 aplicaciones de salud enfocadas en el bienestar de pacientes hispanas / latinas después del cáncer de seno. Estas aplicaciones de salud se entregan a través de un teléfono y están diseñadas para abordar el bienestar después del tratamiento del cáncer de mama. Las aplicaciones son interactivas e incluyen videos, así como recursos importantes. Participación consiste en completar 1 cita en persona, usar una aplicación de teléfono por 6 semanas, y hacer 2 entrevistas por teléfono después de usar la aplicación.
You may qualify if you: 1) Identify as Hispanic or Latina, 2) are able to read English or Spanish, 3) have been diagnosed with breast cancer and 4) have completed breast cancer treatment no more than 2 years ago (current hormonal treatment and target therapy allowed). //
Usted podría ser elegible si: 1) se identifica como Hispana/Latina 2) puede leer y escribir en inglés o en español 3) ha sido diagnosticada con cáncer de seno y 4) ha completado su tratamiento, no mas de 2 años atrás (el uso actual de terapia hormonal o terapia localizada es permitido).
Yanez, BetinaYanez, Betina
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00201961
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Buitrago, Diana 312 503 2866
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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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A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
This study will evaluate the effectiveness and long term safety profile of tanezumab 5mg and 10mg treatm…
This study will evaluate the effectiveness and long term safety profile of tanezumab 5mg and 10mg treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain. In addition, this study will evaluate the efficacy of tanezumab compared to placebo for the treatment of chronic low back pain. Tanezumab 5 mg and 10 mg will be administered by subcutaneous injection seven times at 8 week intervals.
Chronic low back pain >3 months, No osteoarthritis, 18 or older
Walega, David RWalega, David R
NCT02528253 STU00201561
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Reynolds, Trista 312 472 6475
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Left Atrial Appendage Ligation with the LARIAT+® Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness…
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites - Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both stages will be included in the primary analysis.
Lin, AlbertLin, Albert
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02513797 STU00201623
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Carswell, Amy 312 926 7554
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Is a Chance to Cut a Chance to Heal? A Pilot Study to Determine the Role of Submucosal Fibroids in Endometrial Gene Expression and Function
The purpose of this study is to understand how the presence of uterine fibroids within the cavity of the uterus (submucosal fibroids) affects the function of the…
The purpose of this study is to understand how the presence of uterine fibroids within the cavity of the uterus (submucosal fibroids) affects the function of the uterus. Fibroids are common benign tumors of smooth muscles that are found in the uterus. Submucosal fibroids are associated with heavy menstrual bleeding, infertility and recurrent miscarriage. Other studies have shown that surgical removal of submucosal fibroids leads to improved bleeding profiles, as well as improved pregnancy rates. However, we do not currently understand why this is the case. We believe that a better understanding of why removing fibroids improves heavy menstrual bleeding, infertility and recurrent miscarriage may lead to better non-surgical treatment options for women with submucosal fibroids.
Women between the ages of 18 and 50 presenting to Northwestern Medicine for gynecologic care who (1) are either scheduled to undergo surgery to remove uterine fibroids (non-cancerous tumors in the uterus), OR (2) are healthy and whose test results can be compared to those of the women undergoing surgery.
Bernardi Wendeln, LiaBernardi Wendeln, Lia
  • Map it 259 E. Erie St. Lavin Pavilion
    Chicago, IL
STU00202001
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1 312 695 2575
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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 312 695 3264
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A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis Patients Who Are Refractory or Intolerant to Current Therapies
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who ha…
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 2 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
Flamm, Steven LFlamm, Steven L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02556372 STU00202224
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Sipich, Kimberly A 312 694 1293
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COAST-1: Clinical Knee Osteoarthritis Symptom Treatment 1 Study A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.
This study…
This study is designed to determine the efficacy and safety of Disodium Zoledronate Tetrahydrate in reducing pain in subjects with knee osteoarthritis. Males of 50 years of age or older and post-menopausal females with knee pain or newly diagnosed osteoarthritis of the knee may be eligible to participate.
Males of 50 years of age or older and post-menopausal women may be eligible to participate.
Schnitzer, Thomas JSchnitzer, Thomas J
  • Map it 710 N. Lake Shore Dr. Abbott Hall
    Chicago, IL
NCT02746068 STU00202310
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Rivera, Natalie 312 503 3806
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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 312 695 4481
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Motivational Interviewing and Physical Activity in Parkinson’s Disease
We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coac…
We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coaching style used to help people change their behavior; 2) a web-based application for participants to keep track of their physical activity; 3) a combination of the motivational interviewing and the web-based application; and 4) an educational program on various issues related to Parkinson’s disease.
Live in the community
At least 18 years of age
A diagnosis of Idiopathic Parkinson’s Disease
Be able to walk for a distance of 50 feet or 10 minutes at a time
Do NOT currently complete 150 minutes or 2.5 hours of moderate to vigorous physical activity per week
Currently has and uses a smartphone, tablet, or computer to access the internet
Ehrlich-Jones, Linda SEhrlich-Jones, Linda S
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT03329833 STU00202265
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Engel, Edeth 1 312 238 1405
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A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
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 in…

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
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Arrieta, Rose 312 695 5878
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Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure. Protocol #: Hybrid-002
The purpose of this research study is to determine if a new investigational device, Thoraflex Hybrid, is saf…
The purpose of this research study is to determine if a new investigational device, Thoraflex Hybrid, is safe and effective for the surgical treatment of damage or disease of the aorta. The aorta is the main artery that takes blood away from the heart and runs through the chest and abdomen. The damage or disease may be due to either a bulge or ballooning in the wall of the aorta (called an aneurysm) or a tear in the wall of the aorta (called a dissection). The Thoraflex Hybrid device is used to treat both aneurysm and dissection of the aorta in the chest. Surgery for aneurysm/dissection involves replacing the weakened section of the vessel with an artificial tube, called a graft. This may be done by either, cutting out the weakened area and replacing with a graft, or by placing a graft inside the weakened blood vessel to act as a lining. The study device combines both these types of procedure in a single device. The Thoraflex Hybrid device has been licensed in Europe since 2012, but is not yet approved by the U.S. Food and Drug Administration (FDA). As the device is not yet approved by the FDA it is classed as an “Investigational” Device. This study will involve about 65-80 people at about 14 different centers in the United States. We hope to enroll up to 10 patients at Northwestern.
Malaisrie, S Chris ChrisMalaisrie, S Chris Chris
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02724072 STU00202483
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Brady, Caitlin 312 926 5968
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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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Woods, Zakary 1-888-NU-STUDY
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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 312 503 7504
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Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through…
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia: - Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through the stenotic artery. - Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue perfusion. - Vasomotor reactivity by Transcranial Doppler using the breath-holding technique (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the affected artery; - Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery embolism that reflects plaque instability. Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored. The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period. Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally.
Inclusion
1- Symptomatic stroke/TIA due to IAD

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


3-Stroke/TIA diagnosed on CT or MRI

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

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

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

8- Enrollment within 21 days of index event

.
Exclusion
1- No ACA No PCA
2- Other cause of stroke/TIA besides ICAD
3- Angioplasty/stenting performed or planned on target vessel or on a vessel proximal to it.
4- Contraindications to MRI,
5- Pregnancy, lactation, morbid obesity, and severe claustrophobia.
6- Cr >1.5 mg/dL or GFR <30 ml/min/1.73 m2;
7- Known allergy to gadolinium.

Ansari, Sameer AhmadAnsari, Sameer Ahmad
NCT02121028 STU00202274
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Muzaffar, Ayesha 312 926 4251
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LiveWell: A Mobile Intervention for Bipolar Disorder
This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent …
This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If you are eligible for the study, your participation will last up to 12 months.
Individuals 18-65 years old who have been diagnosed with bipolar disorder and are currently working with a psychiatrist
Goulding, EvanGoulding, Evan
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03088462 STU00202860
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Jonathan, Geneva 1 312 503 9095
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02435992 STU00201568
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Arrieta, Rose +1 312 695 5878
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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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Rivera, Natalie 312 503 3806
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A5350: Safety, Tolerability, and Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome and Immune Activation Markers in HIV-Infected Participants on Suppressive Antiretroviral Therapy: A Phase II Study/A5352s: Effects of the Probiotic Visbiome Extra Strength on Epithelial Barrier Function and Inflammation in HIV-Infected Participants on Suppressive Antiretroviral Therapy: A Substudy of A5350
A5350 is a phase II randomized, double-blind, two-arm study to evaluate whether there is a change in gut immunity after 24 weeks of probiotic therapy in HIV-infected participants on stable HIV therapy.
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02706717 STU00202434
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1-855-NU-STUDY
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Alliance A091305: A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination with Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer
This randomized phase II trial studies how well efatutazone with paclitaxel compared to paclitaxel alone works in treating patie…
This randomized phase II trial studies how well efatutazone with paclitaxel compared to paclitaxel alone works in treating patients with advanced anaplastic thyroid cancer. Drugs used in chemotherapy, such as efatutazone 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 efatutazone in combination with paclitaxel is more effective than paclitaxel alone in treating patients with advanced anaplastic thyroid cancer.
Matsangou, MariaMatsangou, Maria
NCT02152137 STU00202641
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1-855-NU-STUDY
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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 312 926 0846
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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 312 503 1137
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Defining the Skin and Blood Biomarkers of Ichthyosis
Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper…
Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper understanding of this disease is required to develop better treatments. There are different types of cells and cell-produced signals (biomarkers) that are being studied in order to help find these new treatments. Looking at biomarkers has been successful in helping us to understand other skin disorders better. The purpose of this study is to determine which blood and skin biomarkers characterize ichthyosis in children.
Subjects (1 year to 60 years of age) with Autosomal Recessive Congenital Ichthyosis (ARCI), which includes lamellar Ichthyosis, Netherton Syndrome, or other ichthyosis subtypes will be enrolled.
Healthy control subjects will be enrolled for either a blood sample or skin sample, and/or tape strip samples.
Paller, AmyPaller, Amy
  • Map it 1131 Techny Rd.
    Northbrook, IL
  • Map it 225 E. Chicago Ave.
    Chicago, IL
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00203051
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Canter, Talia 312 503 5917
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A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity
The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achiev…
The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
NCT02725515 STU00202463
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1-888-NU-STUDY
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(xIRB) NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
This randomized phase III trial …
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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 doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
Gradishar, William JGradishar, William J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02488967 STU00203129
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Study Coordinator 312 695 1102
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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 1131 Techny Rd.
    Northbrook, IL
  • Map it 225 E. Chicago Ave.
    Chicago, IL
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00203185
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Rangel, Stephanie Marie 312 503 5944
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Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y prom…
Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
(a) ≥ 18 years of age;
(b) Hispanic/Latino self-identification;
(c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
(d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
(e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
Miller, GregMiller, Greg
  • Map it 633 N. St. Clair St.
    Chicago , IL
NCT03344757 STU00203197
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Pizarro, Edgar 312 503 3949
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Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study
The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve card…
The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02876887 STU00202741
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Domanchuk, Kathryn J 312 503 6438
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Defining The Skin and Blood Biomarkers of Pediatric Atopic Dermatitis
Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. A deeper understanding of this disease is required to develop new and better treat…
Atopic dermatitis (AD), also called eczema, is a disease in which the skin is dry and scaly with severe itching that may continue despite treatment. A deeper understanding of this disease is required to develop new and better treatments. There are different types of cells and cell-produced signals (biomarkers) that have been found in adults with AD. Nevertheless, there may be significant differences between AD in children versus adults. The purpose of this study is to determine which blood and skin biomarkers characterize AD in children by looking at the blood and skin biomarkers of children with AD and children without AD.
This study will enroll children ages 0 months to 17 years to collect blood, skin, saliva and tape strip samples in order to look at biomarkers related to AD. Children who have or have not been diagnosed with AD or an atopic condition, such as allergies or asthma.
Paller, AmyPaller, Amy
  • Map it 1131 Techny Rd.
    Northbrook, IL
  • Map it 225 E. Chicago Ave.
    Chicago, IL
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00203272
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Canter, Talia 312 503 5917
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PFF Patient Registry Protocol version 1.0 date 21.Jan.2016
The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollmen…
The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research
Diagnosed with IPF
Bhorade, SangeetaBhorade, Sangeeta
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
NCT02758808 STU00202873
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Ansari, Adeeb 312 695 6021
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(CIRB) A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1 (The Confirm Study)
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in…
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.
Ganger, Daniel RGanger, Daniel R
NCT02770716 STU00203053
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Gottstein, Jeanne H 312 694 0264
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MAST CELLS IN MALE CHRONIC PELVIC PAIN AND LOWER URINARY TRACT DYSFUNCTION
The purpose of this study is to figure out if drug treatments using cromolyn sodium and cetirizine hydrochloride lessen painful symptoms in patients suffering from chronic pelvic pain syndrome (CPPS).
Men diagnosed with Category IIIB Chronic Pelvic Pain Syndrome reporting pain or discomfort in any of the 8 domains of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
Thumbikat, PraveenThumbikat, Praveen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03167216 STU00202831
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Thumbikat, Praveen 312 503 1050
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Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bi…
This phase II trial studies how well vismodegib and focal adhesion kinase (FAK) inhibitor GSK2256098 work in treating patients with meningiomas that may have gotten bigger or grew back after treatment. Vismodegib and FAK inhibitor GSK2256098 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Participants must be 18 years or older and have a meningioma which has gotten bigger or grew back after treatment.
Kumthekar, PriyaKumthekar, Priya
NCT02523014 STU00202953
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Study Coordinator 1-888-NU-STUDY
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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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RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy
The purpose of this study is to evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonom…
The purpose of this study is to evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out).
• 18 years or older and able to stand (with or without limited assistance)
• Clinical diagnosis of symptomatic orthostatic hypotension
Zadikoff, CindyZadikoff, Cindy
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02586623 STU00202923
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Rutkowski, Anna 1-888-NU-STUDY
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A Phase 3 Multicenter, Randomized, Double-Blind, Extension Study to Evaluate the Safety of Daily Oral Dosing of Tafamidis Meglumine (PF-06291826) 20 mg or 80 mg in Subjects Diagnosed With Transthyretin Cardiomyopathy (TTR-CM)

This is a study designed to obtain additional safety data for tafamidis …

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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Mkrdichian, Hamorabi +1 312 926 2773
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An Exploratory Phase II Study to Determine the Tolerability, Safety, and Activity of a Novel Vasopressin 1a Receptor Antagonist (SRX246) in Irritable Subjects with Huntington's Disease (HD)
We are doing this research to find out whether a new investigational drug called SRX246, which might be useful …
We are doing this research to find out whether a new investigational drug called SRX246, which might be useful to Huntington's Disease (HD) patients who sometimes feel irritable, angry, or even aggressive, is well tolerated and safe when it is given two times a day by mouth at doses as high as 160 mg. As part of this study, we will ask participants to complete a number of questionnaires related to mood and behavior in HD because we want to learn how to plan future studies of medicines that may help HD patients with these problems.
INCLUSION: 1. Male and female Subjects aged 18 years or older; 2. Subjects must have clinical features of HD, which can include motor, cognitive, or
behavioral symptoms; 3. A confirmatory family history of HD; OR CAG repeat expansion >36; 4. Availability of a responsible Study Partner who has good English skills, is familiar with the
Subject, and is able and willing to comply with all required study procedures, ensuring that the Subject attends all study visits and takes the study medicine as instructed. The StudyPartner must spend time with the Subject a minimum of 4 times per week on 4 separate days, and must monitor the Subject's compliance and adverse events, participate in Study Partner
assessments, and use the eDiary; 5. Medications prescribed for mood, behavior, or neurologic symptoms must be stable for 30 days prior to the Baseline Visit
Bega, DannyBega, Danny
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT02507284 STU00202640
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Ward, Tina 312 503 2128
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A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the stud…
Purpose The purpose of this research study is to determine the effects (good and bad) bevacizumab (the study drug) combined with Optune (the study device) tumor treatment field therapy has on meningiomas. Overview Bevacizumab (the study drug) is considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study drug is a medication that blocks the growth of new blood vessels. In order for tumors to grow they need to have a blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. It is thought that the study drug may interfere with the growth of new blood vessels and therefore might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Optune (the study device) is also considered investigational because the US Food and Drug Administration (FDA) has not approved its use for the treatment of meningiomas. The study device, Optune is a device that the patient will wear and use for at least 18 hours of each day. It delivers alternating electrical current to the patient‰Ûªs brain tumor and by doing so interrupts a process called mitosis. Mitosis needs to occur in order for cell division to occur and allows tumors to grow. By slowing this process, we hypothesize that meningioma growth may also be slowed. Description of Treatment Tumor treatment field therapy with Optune will be initiated at the same time as bevacizumab, with both treatments to start within a one-week period of each other. Bevacizumab will be given at current standard central nervous system (CNS) dosing of 10mg/kg q2 weeks in an outpatient setting. After 4 cycles (1 cycle=28days) of therapy (Cycle 5 day 1) patients may choose to switch to bevacizumab at a dose of 15 mg/kg q3 weeks. For patients who chose to make this switch, they have to do it on Day1 of a new cycle. Tumor treatment fields with Optune will be delivered for at least 18 hours a day at a frequency of 200 KHz and intensity of 1-3V/cm. Treatment will be continued until disease progression or up to 1 year.
"Some of the eligibility criteria include:

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial."
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02847559 STU00203030
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Study Coordinator 312 695 1102
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The association between the urinary microbiome and response to sacral neuromodulation in women with urgency urinary incontinence
This study aims to identify urinary bacteria which may predict a successful response to nerve stimulation. The primary outcome of this study is to see if patients with cert…
This study aims to identify urinary bacteria which may predict a successful response to nerve stimulation. The primary outcome of this study is to see if patients with certain urinary bacteria respond better to nerve stimulation and if the nerve stimulation changes the normal urinary bacteria. This study is for women who are planning to undergo nerve stimulation for overactive bladder.
The study will include women over the age of 18 with UUI planning to undergo SNM implantation will be included if they have at least 2 UUI episodes on a baseline 3-day bladder diary. Participants that have neurologic disease or have recurrent UTI will not be considered eligible for the study.


Mueller, MargaretMueller, Margaret
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02833402 STU00202669
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Tavathia, Meera 312 926 7846
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Effects of Intravenous Ferric Carboxymaltose on Phosphorus and FGF23 Levels
Our research group is currently conducting a 6-8 -week study on patients with iron deficiency anemia to determine the effect of treating iron deficiency anemia with intravenous ferric carboxymaltose therapy on FGF23 and phosp…
Our research group is currently conducting a 6-8 -week study on patients with iron deficiency anemia to determine the effect of treating iron deficiency anemia with intravenous ferric carboxymaltose therapy on FGF23 and phosphorus levels. A single dose of ferric carboxymaltose has been shown to increase FGF23 levels in the short-term, but the long-term effects of ferric carboxymaltose on FGF23 levels in iron deficient patients are not known. We are conducting this research study to understand the effects of intravenous ferric carboxymaltose therapy on blood levels of FGF23 in individuals with iron deficiency anemia. The information gained from this study could be used to improve the health of patients with iron deficiency anemia.
Receiving 2 doses of injectafer from Bleeding clinic
Mehta, RupalMehta, Rupal
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00203065
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Hodakowski, Alexander 312 503 3901
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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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Lipiszko, Olga 312 503 6568
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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 312 694 1293
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AHA Strategically Focused Research Network: mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health-Study 2
NUYou is a two year cardiovascular health study using a mobile app.
The study is closed to recruiting. To test whether a health intervention in the form of a mobile phone
application will preserve or improve heart healthy behaviors (nonsmoking, healthy diet, physical
activity, healthy weight) and cardiovascular health biomarkers (blood pressure, and fasting
cholesterol and glucose) in college students between their freshman and junior year.
Spring, BonnieSpring, Bonnie
STU00202845
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Hood, Susan 312 503 0945
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Multidisciplinary Treatment for Obstructive Sleep Apnea and Insomnia
The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be rand…
The MATRICS Study - This study aims to investigate the effectiveness of different combinations and sequences of evidence-based treatment strategies for people with both Obstructive Sleep Apnea and Insomnia. Participants will be randomly assigned to one of three treatment conditions using a medical device known as CPAP, or using this device in combination with a behavioral treatment to improve sleep.
Inclusion Criteria:
Males and Females age 18 and older;
Meets criteria for Obstructive Sleep Apnea;
Meets criteria for an Insomnia Disorder; Able to make around 15 in-person visits over 7-9 months.
Exclusion Criteria:
Comorbid medical condition that requires immediate treatment of OSA;
Severe cases of OSA that require immediate treatment;
Psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment;
Comorbid sleep disorders that require treatment outside of the study protocol;
Other sleep-related breathing disorder besides OSA;
Excessive daytime sleepiness that requires immediate treatment or presents significant risk;
CPAP use or formal CBT for insomnia within the past 6 months.
Ong, Jason COng, Jason C
NCT01785303 STU00203478
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Yap, Bonnie 312 503 6627
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A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1
INOvation-1: This study is enrolling participants…
INOvation-1: This study is enrolling participants with pulmonary arterial hypertension (PAH) that are currently taking at least 1 PAH drug treatment approved by the Food and Drug Administration (FDA). The drug being studied is “inhaled nitric oxide” and the device being studied is called the “INOpulse.” Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. However, inhaled nitric oxide, in combination with the INOpulse delivery device, is an investigational treatment of PAH and is not currently approved by the FDA or Health Canada. “Investigational” means that the drug-and-device combination tested in this study has not been approved by the FDA or any other health authority. The purpose of this study is to determine if inhaled nitric oxide (study drug), when given and breathed through the INOpulse (investigational device), may help treat PAH.
Rich MD, StuartRich MD, Stuart
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02725372 STU00202892
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Crooke, Catherine 312 695 4189
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A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively redu…
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Key Inclusion Criteria:
-At least 18 years old
-Traumatic lower extremity amputation(s)
-Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:
-Change of prescribed medications affecting pain within the past 4 weeks
-Compromised immune system based on medical history
-Implanted electronic device
-Bleeding disorder
-History of valvular heart disease
-Confounding central nervous system injuries and disorders
-History of recurrent skin infections
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01996254 STU00202359
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Amidei, Christina 312 695 9124
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Northwestern Scleroderma Twins Registry and Biorepository
The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonuclei…
The purpose of this research is to study twin pairs, in which at least one twin has been diagnosed with systemic sclerosis (SSc). In about 95% of twins with SSc, only one twin has been diagnosed with SSc. Since the DNA (i.e., deoxyribonucleic acid, the genetic information that contains your genes) is nearly identical in twins, we are interested in studying what happens to change how the genes are read in the twin with SSc (epigenetics), when compared to how the same genes are read in the twin without SSc. Identifying these changes may help us to better understand why SSc occurs and to identify targets for treatment.
• Age ≥ 18 years
• At least one twin meets the 2013 American College of Rheumatology (ACR) criteria for the diagnosis of systemic sclerosis (affected twin)
• Both twins agree to participate in the research study
Varga, JohnVarga, John
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00203621
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Carns, Mary 312 503 1137
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Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase Disorder
This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will i…
This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity monitoring.
Individuals with delayed sleep-wake phase disorder and healthy controls
Abbott, SabraAbbott, Sabra
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203647
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Abbott, Sabra 312 503 3561
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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 Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn’s Disease Who Are Receiving Vedolizumab Therapeutically

Stein, AdamStein, Adam
NCT02559713 STU00202916
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Arrieta, Rose 312 695 5878
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A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Patients with Ichthyoses Sub-Study: A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Maintenance Dosing Period to Evaluate the Efficacy and Safety of Secukinumab in Patients with Ichthyoses
This is a year-long study which will require monthly visits to the study site. The first four months will be double blind (you may receive either the study medication or placebo), then the remainder of the year participants will receive monthly injections of study medication.
Participants must be 18 years of age or older, with a confirmed diagnosis of Autosomal Recessive Congential Ichthyosis (Lamellar Ichthyosis, Congential Ichthyosiform Erythroderma), Epidermolytic Ichthyosis, or Netherton's Syndrome, and at least moderate redness of the skin.
Paller, AmyPaller, Amy
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT03041038 STU00202022
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Abu Zayed, Hajar 312 503 5944
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A Longitudinal Evaluation of Disease & Fibrosis Biomarkers in Different Groups of Heart Failure Patients to Enhance the Early Clinical Development of Compounds with Anti-fibrotic Activity in the Heart
CV002-004: Heart failure is the number one reason for hospitalizations in elderly adults in the US. …
CV002-004: Heart failure is the number one reason for hospitalizations in elderly adults in the US. Acute decompensated heart failure (ADHF) occurs when heart failure symptoms suddenly become worse, including difficult breathing, swollen legs and feet, and fatigue. 30-50% of patients hospitalized for ADHF die or are re-hospitalized for heart failure within 6 months post discharge. Therefore, new treatment options are needed for these patients. Biomarkers are measured indicators of disease and play an important role in the discovery and development of new drugs, e.g. to treat heart failure. The purpose of this study is to gain further understanding of blood and imaging biomarkers (imaging biomarker is a feature or characteristic detectable in an image, such as a thickening of the heart wall) in different heart failure populations (stable or acutely decompensated) and to compare to subjects without heart failure. There are no experimental drugs in this study. All patients will be on standard of care treatment for heart failure. However, participants will receive an approved gadolinium-based contrast agent, called gadobutrol (Gadavist®, Gadovist®), as part of the MRI procedure. MRI contrast will be given two times during the study; Day 1 and Week 24. We expect that participants will be in this research study for 1 year, which includes 3 to 4 clinical visits over 24 weeks (6 months) and a follow up phone visit at 1 year.
Shah, Sanjiv JShah, Sanjiv J
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203033
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Mkrdichian, Hamorabi 312 926 2773
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Understanding Outcomes with the EMBLEM™ S-ICD in Primary Prevention Patients with Low Ejection Fraction
This study is recruiting individuals that are scheduled to have Boston Scientific’s S-ICD System implanted to manage a heart condition, when it is programmed with specific settings. Since the …
This study is recruiting individuals that are scheduled to have Boston Scientific’s S-ICD System implanted to manage a heart condition, when it is programmed with specific settings. Since the entire device system is already approved by local regulatory authorities, there is nothing investigational about either the device system or the implant procedure. Specific device settings available in the approved device will be tested. The S-ICD System will be programmed to detect only very fast ventricular heart rhythms that are considered life threatening. This should allow participants to avoid receiving a shock from their device for fast heart rates that do not require a shock to terminate, and to avoid shocks that are considered inappropriate (fast signals that are not originating in the ventricle, but the device would wrongly classify as ventricular arrhythmia and deliver a shock). The follow-up visits and information collected during the conduct of the study are typical and routinely done a physician. This study provides Boston Scientific CRM with additional data about the long-term performance of the implanted device system and the optimal way to program the device to allow avoiding unnecessary and uncomfortable shocks. We expect that participants will be in this research study for up to 18 months after their S-ICD implant procedure. Participants will not need to attend any extra clinic visits for the study. Information will be recorded before and during the S-ICD implant procedure, at the time of discharge from the hospital, and thereafter during regular 6-month, 12-month, and 18-month follow-up visits that are part of standard care after an implant procedure. Approximately 1,100 participants will be enrolled in the study at up to 200 sites worldwide. We expect up to 20 people will take part here at Northwestern.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02433379 STU00203207
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Pollan, Laura 312 926 7312
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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 312 503 1804
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ACTG A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away …
This study will include people who have very recently been infected with HIV and will start them on anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.
• Men and women, at least 18 years old
• Have certain lab tests done that confirm very early HIV infection (ie. before the blood shows that antibodies have been made, or just at the time antibodies are starting to be found in the blood)
• Be willing to take drugs to treat HIV right away.
Taiwo, Babafemi OTaiwo, Babafemi O
NCT02859558 STU00203124
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Berzins, Baiba Ingrida 312 695 5012
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Postpartum GRANulation Tissue: The GRANT Study
The aim of this study is to evaluate women who develop scar tissue following an obstetric tear. The properties of the tissue will be studied to determine the role of estrogen. The objective is to find a non-surgical treatment option for women who develop…
The aim of this study is to evaluate women who develop scar tissue following an obstetric tear. The properties of the tissue will be studied to determine the role of estrogen. The objective is to find a non-surgical treatment option for women who develop granulation tissue after childbirth. This study is for women who had an obstetric tear and developed scar tissue during postpartum recovery.
The study will include women who have sustained an obstetric laceration that develop perineal and/or vaginal granulation tissue during postpartum recovery. Participants who are pregnant, unable to consent 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
  • Map it 250 E. Superior St.
    Chicago, IL
STU00203501
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Tavathia, Meera 312 926 7846
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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
  • Map it 320 E. Superior Ave. Searle 11
    Chicago, IL
NCT02854033 STU00203359
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Robson, Jordan 312 503 5212
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Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have hear…
Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin every day. That way, we can learn which is better in terms of reducing the risk of heart attacks, strokes, bleeding, and death. We expect up to 15,000 subjects with heart disease from across the U.S. will take part in ADAPTABLE.
Criteria


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

Exclusion Criteria:
• There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
• Patients and sites interested in participating must be part of the listed health systems collaborators.
Kho, Abel NKho, Abel N
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02697916 STU00203465
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Nodal, Mercedes 312 503 4260
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Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
Ramp-It-Up: This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine test…
Ramp-It-Up: This study is enrolling patients with a recently implanted left ventricular assist device (LVAD) device. Patients with an LVAD undergo routine testing to determine the best pumping speed for their LVAD that help guide medical treatment. One routine testing uses echocardiography (ultrasound of the heart) to create heart images and make measurements while gradually increasing the LVAD heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test. The ramp testing may also be performed during a right heart catheterization procedure (insertion of a catheter into a vein or artery in the groin, arm or neck guided to the heart using X-ray imaging). Doctors normally perform this procedure to obtain hemodynamic measurements (measure the pressure and blood flow in the heart). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the LVAD pump. Both of these methods for determining pump speed are accepted as normal, routine care for LVAD patients. In this study participants will be randomly (by chance) assigned (1:1) evenly to one of these two methods of testing. The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for LVAD patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
Rich, JonathanRich, Jonathan
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203630
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Crooke, Catherine 312 695 4189
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A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Purpose This is a Phase III study to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS) Overview This study will allow the researchers to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy Description of Treatment This study has two study groups. Group 1 will receive a placebo in the form of a tablet that looks like the study drug but contains no medication, and Group 2 will receive the study drug olaparib in the form of a tablet. A computer will by chance assign patients to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other.
Some of the eligibility criteria include:

- Female or Male participants must be 18 years of age or older.

a) For patients who underwent initial surgery and received adjuvant chemotherapy

-TNBC patients must have been axillary node-positive (>/= pN1, any tumor

size) or axillary node negative (pN0) with invasive primary tumor

pathological size > 2 cm (>/= pT2).

-ER and/or PgR positive/HER 2 negative patients must have had >/= 4 pathologically confirmed positive lymph nodes.

b) For patients who underwent neoadjuvant chemotherapy followed by surgery

-TNBC patients must have residual invasive breast cancer in the breast and/or

resected lymph nodes (non-pCR)

-ER and/or PgR positive/HER2 negative patients must have residual invasive

cancer in the breast and/or the resected lymph nodes (non-pCR) AND a CPS&EG score >/= 3.

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.

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
NCT02032823 STU00203491
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Study Coordinator 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 312 926 4251
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Stellate Ganglion Blockade for the Management of Vasomotor Symptoms
This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot flashes in post menopausal women. You will be asked to come downtown for 5 visits over …
This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot flashes in post menopausal women. You will be asked to come downtown for 5 visits over the period of 7 months. During this time, you will keep a daily diary, wear a hot flash monitor for 24 hrs at three time points, a sleep and activity watch for 72hrs at 3 time points, and complete memory testing. You will be given a parking pass and compensation for your participation. If you're interested and would like to learn more, please click on the buttons to the right to call or email our study team.
female, post-menopausal (no menstrual periods), 40-65 years old, moderate to severe hot flashes
Walega, David RWalega, David R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02907983 STU00203490
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Oldaker, Kelsey 312 472 6754
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Early Feasibility Study of the CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV) System For the Treatment of Moderate to Severe Mitral Regurgitation
This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surger…
This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. Mitral regurgitation, MR, is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that is simpler than traditional open-heart procedure and may be safer for patients who are at a higher risk from open-heart surgery. The new device is called the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transseptal and Transapical Delivery Systems). The CardiAQ™ TMVI system is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transseptal) or through an incision in the chest between the ribs (transapical). The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 8 scheduled study visits after discharge from the hospital at 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
Patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. General Criteria:
1. Greater than or equal to 18 years of age.
2. New York Heart Associate Classification ≥ II
3. Left Ventricular Ejection Fraction ≥ 30%.
4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe) where EROA ≥ 0.30 cm2 or VC width ˃ 0.7 cm.
5. Patient is determined to be high surgical risk but operable as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). Inclusion of a heart failure specialist is strongly recommended.
Davidson, Charles JDavidson, Charles J
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02718001 STU00204104
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Brady, Caitlin 312 926 5968
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The effects of capsinoids on brown adipose tissue recruitment and activation in obesity
This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in in…
This research study is being done to determine whether taking a dietary supplement called capsinoids, derived from sweet peppers, can activate brown fat that is already present or even generate new brown fat in individuals with excess weight. Previous studies have suggested that chronic consumption of capsinoids may be able to generate new brown fat in thin individuals. Capsinoids may also have a small positive effect on metabolism (increased calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more treatment options for people with excess weight.
Male, between ages 18-45, healthy, non-smoking, overweight/obese
Neff, Lisa MNeff, Lisa M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03110809 STU00204058
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Abou-El-Seoud, Dalya 312 503 7203
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Improve PAD PERformance with METformin: The PERMET Trial
The purpose of this study is to establish whether metformin improves walking ability in people with PAD.
We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
McDermott, Mary McGrae DouglasMcDermott, Mary McGrae Douglas
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03054519 STU00203784
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Domanchuk, Kathryn J 312 503 6438
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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects with Crohn’s Disease (CD) Receiving Anti-TNF Therapy (PIONEER-CD)
Crohn’s disease is a chronic inflammatory disorder with …
Crohn’s disease is a chronic inflammatory disorder with a multifactorial etiology. It is postulated that patients who have achieved clinical benefit from the use of an anti-TNF agent, but continue to have ongoing gastrointestinal inflammation, have underlying nutritional deficits in specific amino acids at the tissue level. Providing key nutrients through the oral administration of CROWN, a unique medical food, will facilitate in the tissue repair process. To test this hypothesis, approximately 240 adults who have recently been started on induction therapy with an anti-TNF agent (within 24 weeks of initiation of induction therapy prior to randomization) and have demonstrated some clinical benefit but continue to have inflammation on endoscopy will be enrolled in this trial. This trial will test the effectiveness of a nutritional intervention to support the repair and maintenance of the intestinal mucosal health in patients with CD undergoing standard care with biologic therapy. Randomized subjects will be given either CROWN or placebo to take twice daily for 24 weeks.
Inclusion Criteria: Adults between the ages 18-75 with a known history of symptomatic Crohn’s Disease, Initiation of induction of infliximab or adalimumab therapy within 24 weeks prior to Day 1 of study as part of standard care, Ability to consume oral nutrition for up to 24 weeks consisting of two 4 oz (120 ml) servings daily, Must agree to use a reliable form of contraception throughout the duration of the study
Exclusion Criteria: Female subjects who are pregnant or planning to become pregnant during the study period, Anticipated need for gastrointestinal surgical therapy in the next 6 months, or Diagnosis of celiac disease
Hanauer, StephenHanauer, Stephen
NCT02793778 STU00204040
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Arrieta, Rose 1 312 695 5878
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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 312 503 1819
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NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
Some of the eligibility criteria include:

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

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03020017 STU00203790
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Study Coordinator 312 695 1102
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NU 16H07: Phase II Trial of Pembrolizumab in Combination with ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regim…
The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called “ICE” and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently FDA approved for the treatment of melanoma, but has not yet been investigated in Relapsed/Refractory Hodgkin Lymphoma. The ‘ICE’ regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. This is a phase II study of these drugs used in combination. For patients who have a relapse of their Hodgkin’s lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure. Research continues to find for the best regimen to obtain a complete remission in this setting.
Some of the eligibility criteria include:
• Patients must have a histologically confirmed diagnosis of classical Hodgkin lymphoma.
• Patients must have relapsed/refractory disease, with at least one line of prior chemotherapy, but not more than 2 prior lines of treatment, for Hodgkin lymphoma.
• Patients must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
Winter, Jane NormaWinter, Jane Norma
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03077828 STU00203658
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Study Coordinator 312 695 1102
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A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND)
Levodopa and Carbidopa are registered and widely used by Parkinson’s disease su…
Levodopa and Carbidopa are registered and widely used by Parkinson’s disease subjects. The medication is given as pills, whilst the study drug is given as a solution in a continuous subcutaneous infusion. This study is based on the assumption that treatment which will enable the administration of levodopa to the brain in a more continuous way compared to the current standard treatment could constitute a more effective treatment for Parkinson’s subjects, with less of the known side effects of this treatment.
Must be individual with Parkinson's disease on stable doses of Levodopa/carbidopa >4/day or Rytary >3/day with "OFF" periods ≥ 2.5 hours per day.
Simuni, TatyanaSimuni, Tatyana
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT02726386 STU00203747
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Poon, Cynthia 312 503 8216
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Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas.
Purpose The purpose of this study is to compare the effects (good and bad) of the study drugs temozolomide and cap…
Purpose The purpose of this study is to compare the effects (good and bad) of the study drugs temozolomide and capecitabine to cisplatin and etoposide, the drugs used for usual chemotherapy treatment for advanced G3 non-small cell gastroenteropancreatic neuroendocrine carcinomas. Overview Cisplatin and etoposide is usually the first treatment given for neuroendocrine cancer. The chemotherapy drugs temozolomide and capecitabine may be used are also used to treat this disease but usually not until the first treatment, cisplatin and etoposide, stops working. It is not known if this is the best approach or if the temozolomide and capecitabine should be given first instead. Researchers are trying to determine if one chemotherapy combination is better than another for neuroendocrine cancers. Description of Treatment Study participants will be randomly assigned by chance (like the flip of a coin) to one of the two study groups. Group 1 will receive the study drugs temozolomide and capecitabine. Group 2 will receive the usual approach for this cancer; cisplatin and etoposide. Study visits will be grouped into cycles. The number of cycles of study treatment depends on how well each participant is tolerating treatment and how well the cancer responds to it. Group 1 will take the study drug capecitabine by mouth twice a day for 14 days in a row. During the last five days of the 14 days of taking capecitabine, participants will take temozolomide by mouth once a day as well. After the 14 days of treatment participants will have 14 days off from treatment before any further treatment is started. This 28-day period is one cycle for Group 1. Group 2 will receive cisplatin and etoposide through a vein. This treatment will be given at a clinic visit once a day for three days in a row, and then participants will have 18 days off before any further treatment is received. This 21-day period is one cycle for Group 2.
Some of the eligibility criteria include:

- Participants must have a locally advanced and unresectable or metastatic gastroenteropancreatic G3 neuroendocrine carcinoma of the GI tract.
- Participants must have pathologically/histologically confirmed tumor of non-small cell histology.
- Participants must be at least 18 years of age

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.
Benson III, Al BBenson III, Al B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02595424 STU00204209
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Study Coordinator 312 695 1102
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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 312 503 5944
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Prevalence of aneuploidy in ectopic pregnancies
The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectop…
The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectopic pregnancies may implant outside of the uterus because they are chromosomally abnormal. The tissue from the ectopic pregnancy, called products of conception, that was removed at the time of your surgery will undergo genetic testing to identify if the pregnancy implanted in the wrong place due to a genetic abnormality with the fetus. Results of the genetic analysis of your ectopic pregnancy tissue will be made available to you. You and the biological father of the ectopic pregnancy will also be required to provide a cheek swab sample for analysis.
Inclusion: 1) Women with previous ectopic pregnancy that required surgery while under care at Northwestern Memorial Hospital; 2) Biological father of ectopic pregnancy willing and able to participate; 3) English-speaking.
Feinberg, EveFeinberg, Eve
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203775
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Feinberg, Eve
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Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort
The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers wil…
The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find new treatments for the disease. People from many countries contribute to Enroll-HD.
Individuals 18 yrs or older affected by Huntington's Disease (HD) or from a HD family or are a "community control" (a person who does not carry the HD genetic mutation that causes Huntington's disease and is not part of an HD family, but would like to participate in the study). Research visits are conducted yearly and will consists of a collection of medical and family history and biological samples.
Bega, DannyBega, Danny
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00203021
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Brown, ZsaZsa 312 503 4121
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Open-label safety trial of intravenous neridronic acid in subjects with complex regional pain syndrome (CRPS)
This study is designed to test the safety and effectiveness of neridronic acid in patients with complex regional pain syndrome (CRPS). This study is an "open label" trial so all participants …
This study is designed to test the safety and effectiveness of neridronic acid in patients with complex regional pain syndrome (CRPS). This study is an "open label" trial so all participants will receive treatment. There is no placebo involved. Males or females of 18 years or older that has been diagnosed with complex regional pain syndrome (CRPS), with moderate to severe pain in one limb (arm or leg) may be eligible. Participants must not have any planned invasive dental procedures (eg. tooth extractions) or history of significant dental issues or peridontal disease.
Male or female of 18 years or older that has been diagnosed with complex regional pain syndrome (CRPS), with moderate to severe pain in one limb (arm or leg). Participants must not have any planned invasive dental procedures (eg. tooth extractions) or history of significant dental issues or peridontal disease.
Schnitzer, Thomas JSchnitzer, Thomas J
  • Map it 710 N. Lake Shore Dr. Abbott Hall
    Chicago, IL
NCT02972359 STU00204323
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Rivera, Natalie 312 503 3806
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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 312 926 2884
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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.
Participants ages 18 or older. Participants who have an advanced non-small cell lung cancer.
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
NCT02549664 STU00204370
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Zinn, Sarah 312 926 2828
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Asteria
If you are between 19-40 years old, you may be eligible for a research study at Northwestern University. Researchers are investigating the effects of sleep on performance. Study Requirements: • Ages 19 – 40 Total time commitment – 4 visits: • 1 outpatient visit (1-2 hours) • …
If you are between 19-40 years old, you may be eligible for a research study at Northwestern University. Researchers are investigating the effects of sleep on performance. Study Requirements: • Ages 19 – 40 Total time commitment – 4 visits: • 1 outpatient visit (1-2 hours) • 3 separate 24-hour inpatient visits at our downtown location For screening purposes the study will involve 7-days of at-home activity monitoring using a wristwatch. If eligible the same device will be worn throughout the study. The study will also include surveys, cognitive testing, and overnight sleep studies. Each inpatient visit will last approximately 24 hours. The study is being conducted by faculty in the Northwestern University Feinberg School of Medicine. If interested please complete the following survey: https://redcap.nubic.northwestern.edu/redcap/surveys/?s=YXNC3YNE9N
Zee, Phyllis CZee, Phyllis C
STU00204417
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Urban, Claudia 312 503 3781
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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 1 312 695 6127
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ELUCDITATING THE MOLECULAR MECHANISMS UNDERLYING CYP2D6 INDUCTION DURING PREGNANCY
We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimest…
We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimesters. Drug metabolism is controlled by certain genes in the body. This study will be examining the up-regulation of a certain enzyme in the liver called CYP2D6, which helps the body process many different drugs. We will measure compounds related to vitamin A, which we think might be involved in the process that speeds up the enzyme activity, from blood samples. The primary goal of our research is to understand how drug metabolism changes across pregnancy. The secondary goal is to define how the activity of enzymes in the liver are up-regulated (increased) during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.
• Are 18-45 years of age
• Are currently at or less than 13 weeks pregnant
• Speak English
• Singleton Gestation (not pregnant with twins)
• Able to present for blood sampling between 8am-noon once per each month of pregnancy, and for two months postpartum
Wisner, KatherineWisner, Katherine
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00204600
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Mesches, Gabrielle 1 312 695 6127
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REDO-FIRM - Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation with Focal Impulse and Rotor Modulation Guided Procedures
Patients with Atrial Fibrilation (AF) can have a fast and irregular heart rate which can cause fainting, chest pain, shortness of breath and other symptoms. T…
Patients with Atrial Fibrilation (AF) can have a fast and irregular heart rate which can cause fainting, chest pain, shortness of breath and other symptoms. This study is enrolling participants that are scheduled to undergo an electrophysiologic (EP) procedure to treat AF. This procedure looks at the heart’s electrical activity to find the area in the heart muscle that causes the heart rate to increase. It is not easy to find the site that causes AF. Therefore, multiple sites on the heart may have to be scarred (ablated). This is done to stop the fast heartbeats from spreading to other parts of the heart. The purpose of this research is to compare this standard ablation procedure to FIRM (Focal Impulse and Rotor Modulation) guided procedure. The FIRM procedure uses software and probes to find the sites of AF. Both the standard ablation and FIRM guided ablation are approved by the US Food and Drug Administration to treat arrhythmias (irregular heartbeats). We expect up to 15 people at Northwestern will be in this research study out of 268 people in the entire study internationally.
Knight, Bradley PaulKnight, Bradley Paul
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02799043 STU00204252
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Dreisbach, Alexander 312 926 2671
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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.
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.

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.
Patient has a systemic infection and may be at increased risk of endovascular graft infection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of study enrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
Mycotic aneurysm
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
Hoel, AndrewHoel, Andrew
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02777593 STU00203850
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Toaspern, Lillian 312 695 3410
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BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity
This is a randomized, 56-week trial comparing the clinical efficacy of BI 695501 versu…
This is a randomized, 56-week trial comparing the clinical efficacy of BI 695501 versus TNF-alpha blocker, adalimumab (Humira) in patients with moderately to severely active CD. Currently, BI 695501 is an antibody being developed as a biosimilar drug to adalimumab, and phase I clinical trials have shown that there were no notable differences between those who took Bi 695501 vs Humira with respect to safety, tolerability, and immunogenicity. This study will recruit about 286 individuals to undergo up to 27 visits (including 13 trial medication administration only visits) over the duration of the trial (56 weeks). The doses of BI 695501 and EU-approved Humira selected for this trial will follow the standard of care dosing schedule of Humira for the treatment of CD (a loading dose of 160 mg, followed 2 weeks later by a dose of 80 mg, then 2 weeks later and subsequently every 2 weeks by 40 mg, all by subcutaneous injection).
Inclusion criteria: Males and females aged >=18 and =<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), must be anti-TNF naive or patients who have been previously treated with any other anti TNF agent (EXCEPT adalimumab) must have initially responded then have grown intolerant or non-responsive, and must be on contraceptives for the duration of the study; Exclusion criteria: Patients who are diagnosed with ulcerative colitis or indeterminate colitis, have an ostomy or ileoanal pouch, have surgical bowel resection performed within 6 months of Screening, or have previously used infliximab and have never clinically responded
Hanauer, StephenHanauer, Stephen
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02871635 STU00204343
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Arrieta, Rose +1 312 695 5878
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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 312 926 0975
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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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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
Pur…
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. Additionally, cirrhosis increases
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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Kim, Minjee 312 695 7976
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Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)
The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurolo…
The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
• Age 18 and older
• Presence of symptoms and signs of ataxia
• Molecular diagnosis of SCA 1, 2, 3, 6 either in the participant or an affected family member
• Willingness to participate in the study and ability to give informed consent.
Opal, PuneetOpal, Puneet
  • Map it 675 N. St. Clair St. Suite 20-100
    Chicago, IL
NCT01060371 STU00204294
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Brown, ZsaZsa 312 503 4121
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The Molecular Markers of Bladder Cancer
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
Meeks, Joshua JMeeks, Joshua J
STU00204352
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312 695 8146
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(CIRB) A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
treatment for HCV using FDA approved drugs
Hepatitis C, Child pugh C
Flamm, Steven LFlamm, Steven L
  • Map it 675 N. St. Clair St.
    Chicago, IL
NCT02994056 STU00204620
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Hepatitis C

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Gottstein, Jeanne H 312 694 0264
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METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (the study device) in part…
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (the study device) in participants with brain metastases (tumors) as a result of non-small cell lung cancer (NSCLC). This study will test the efficacy, safety and neurocognitive outcomes of advanced NSCLC participants, following stereotactic radiosurgery (SRS) for brain metastases, treated with NovoTTF-100M and supportive treatment when compared to being treated with supportive treatment alone. This is a research study to test a study device, NovoTTF-100M, which is an investigational device and has not been approved by the FDA to treat this type of cancer and therefore is being considered investigational. This study has two study groups. Participants will be randomly placed into one of the two following groups; Supportive care only group OR NovoTTF-100M group.
Participants must be 18 years of age or older. Participants who have non-small cell lung cancer that has spread to the brain (brain metastases).
Kumthekar, PriyaKumthekar, Priya
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02831959 STU00204448
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Study Coordinator 312 695 1102
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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 312 503 4965
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Losartan Effects on Emphysema Progression (LEEP)
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms…
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD. Losartan is a medicine used for treatment of high blood pressure. Losartan has been shown to slow the damage to lungs caused by COPD in animals. We would like to find out if taking Losartan can slow the damage to lungs caused by COPD. We will use images of participants’ lungs taken with high resolution computed tomography (HRCT) to measure changes in the lung. We also want to find out if Losartan has effects on blood and breathing tests.
40 years of age or older with COPD, controlled blood pressure, no flare of COPD in the last 6 weeks or the use of antibiotics or prednisone
Kalhan, RaviKalhan, Ravi
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02696564 STU00204797
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Hixon, Jenny Lorraine 312 926 0975
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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 (entire dissection is distal to