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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
Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
This randomized phase II trial is studying radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with recurrent end…
This randomized phase II trial is studying radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with recurrent endometrial cancer. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.
Shahabi, ShohrehShahabi, Shohreh
NCT00492778 STU00002996
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Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibo…
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.
Benson III, Al BBenson III, Al B
NCT00940316 STU00004101
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Transthyretin-Associated Amyloidoses Outcome Survey (THAOS)
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 …
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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Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of a…
The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.
Altman, Jessica KAltman, Jessica K
NCT00590187 STU00004419
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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
Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer …
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET)/computed tomography (CT), may help diagnose if recurrent disease is likely. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma.
Winter, Jane NormaWinter, Jane Norma
NCT00118209 STU00004575
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MULTIETHNIC FINE-MAPPING OF POLYCYSTIC OVARY SYNDROME SUSCEPTIBILITY LOCI (R01 HD085227)
Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive age women worldwide and a leading risk factor for type 2 diabetes mellitus. We are mapping chromosomal regions that have a high…
Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive age women worldwide and a leading risk factor for type 2 diabetes mellitus. We are mapping chromosomal regions that have a high likelihood of containing genes causing PCOS. These findings could also identify novel therapeutic targets and genetic variants conferring substantial risk that could be used for PCOS prediction and prevention.
We are currently recruiting 18-40 year old women with either PCOS (8 or fewer periods per year) or healthy control (regular monthly periods). Also, these women should not be using any type of hormonal birth control (pills, patches or injections).
Dunaif, Andrea EDunaif, Andrea E
  • Map it 303 E. Chicago Ave.
    Chicago, IL
STU00008096
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Akinrotimi, Oludemilade 312 503 4385
Intranasal oxytocins effect on facial affect discrimination in schizophrenia
Our work indicates that schizophrenic patients with water imbalance have enhanced activity of the hypothalamic-pituitary-adrenal (HPA) axis and the antidiuretic hormone (arginine vasopressin: AVP) in response to psychologica…
Our work indicates that schizophrenic patients with water imbalance have enhanced activity of the hypothalamic-pituitary-adrenal (HPA) axis and the antidiuretic hormone (arginine vasopressin: AVP) in response to psychological stress. Furthermore, these findings appear attributable to hippocampal dysfunction, which may in turn be directly related to the underlying psychiatric disorder. The AVP abnormality likely contributes to life threatening water intoxication and the HPA axis abnormality may be part of a more general hippocampal-mediated vulnerability to psychological stress. Our pilot findings indicate that there is also a deficit in the closely related neurohormone, oxytocin, in these patients that may contribute to a particularly virulent form of schizophrenia (i.e. deficit syndrome) characterized by extreme social deficits. The goal of this study is to confirm the putative deficits in oxytocin regulation, and begin to determine the extent that behavioral functions can be restored with oxytocin treatment. Aim I will confirm or disprove that oxytocin levels are lower in patients with water imbalance. Aim II will assess the association between plasma oxytocin versus social deficits and the deficit syndrome. Aim III will assess if intranasal oxytocin normalizes the enhanced AVP and HPA axis responses to stress in patients with water balance. These exploratory studies are innovative and could directly lead to new therapeutic modalities for intractable and virulent features of severe mental illness.
Goldman, Morris BGoldman, Morris B
STU00008154
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Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
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 pri…
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
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 pa…
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
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
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
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
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 …
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
Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
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 m…
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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1-855-NU-STUDY
Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Len…
This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cell. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
Frankfurt, OlgaFrankfurt, Olga
NCT00843882 STU00011947
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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 675 N. St. Clair St. Suite 20-100
    Chicago, IL
STU00014255
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Friedeck, Heidi 312 503 1522
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
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
Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin a…
This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, 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 and other types of radiation to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.
Shahabi, ShohrehShahabi, Shohreh
NCT00942357 STU00018576
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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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S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, …
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.
Winter, Jane NormaWinter, Jane Norma
NCT00822120 STU00020976
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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
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different wa…
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
Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy
This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal ca…
This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.
Donnelly, EricDonnelly, Eric
NCT00769379 STU00021706
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Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
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 …
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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Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor ce…
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma. PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT00978458 STU00026337
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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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Rader, Benjamin 1 312 908 9681
Make Better Choices
The average adult has a poor quality diet and sedentary lifestyle, but the best way to produce sustained healthy change remains unknown. The MBC2 intervention uses handheld technology to help individuals monitor and transmit information about their eati…
The average adult has a poor quality diet and sedentary lifestyle, but the best way to produce sustained healthy change remains unknown. The MBC2 intervention uses handheld technology to help individuals monitor and transmit information about their eating and activity remotely to a behavior coach. The proposed trial tests whether MBC2 intervention improves diet and activity more than a stress management control condition, and whether changing multiple health behaviors is best achieved by changing them all at the same time, or one after another.
Spring, BonnieSpring, Bonnie
NCT01249989 STU00028323
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1-888-NU-STUDY
Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal ti…
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis. (phase II completed as of 8-30-11)
Kalapurakal, John AKalapurakal, John A
NCT00922974 STU00027912
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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
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
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…
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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Carboplatin, Paclitaxel and Gemcitabine With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
This randomized phase III trial is studying giving carboplatin, paclitaxel and gemcit…
This randomized phase III trial is studying giving carboplatin, paclitaxel and gemcitabine together with or without bevacizumab after surgery to see how well it works in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
Shahabi, ShohrehShahabi, Shohreh
NCT00565851 STU00005425
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Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
This randomized phase III trial is studying chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treat…
This randomized phase III trial is studying chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.
Benson III, Al BBenson III, Al B
NCT01004978 STU00022384
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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.
Mendelson, ScottMendelson, Scott
STU00023167
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Alzheimer's Disease Core Center
The Northwestern Alzheimer’s Disease Center (NADC) was established with funding from the National Institute on Aging (NIA) in 1996. The primary goals of the center are to 1) provide state-of-the-art care to patients with Alzheimer’s disease and related disorders, …
The Northwestern Alzheimer’s Disease Center (NADC) was established with funding from the National Institute on Aging (NIA) in 1996. The primary goals of the center are to 1) provide state-of-the-art care to patients with Alzheimer’s disease and related disorders, and 2) support clinical and basic research on memory and aging through the collection and storage of clinical data and brain tissue from research participants. Clinical data and tissue are distributed to collaborators throughout Northwestern, as well as to other Alzheimer Disease Centers. The NADC is comprised of five Cores: Clinical, Administrative, Neuropathology, Data Management and Biostatistics, and Education. Over the past year, the Clinical and Data cores have worked closely with the Education and Neuropathology cores to recruit and enroll subjects, facilitate brain donations, support investigations of dementia and aging, and educate the public on effectively coping with these illnesses.
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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Riley, Michaela 312 503 5103
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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Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
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 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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Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
This randomized phase I trial is studying inositol to see how well it works in preventing colorectal cancer in patients with colitis-associated dysplasia. Chemoprevention is the use of c…
This randomized phase I trial is studying inositol to see how well it works in preventing colorectal cancer in patients with colitis-associated dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent colorectal cancer.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
NCT01111292 STU00024719
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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
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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Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression
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…
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
NCT01141023 STU00031752
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Friedeck, Heidi 312 503 1519
Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
This phase II trial studies how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma. Drugs used in chemotherapy, …
This phase II trial studies how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Kumthekar, PriyaKumthekar, Priya
NCT00823797 STU00033288
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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
Radiation Therapy With or Without Temozolomide in Treating Patients With Anaplastic Glioma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, eith…
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Kumthekar, PriyaKumthekar, Priya
NCT00626990 STU00036280
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Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood fl…
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer. PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.
Sosman, JeffreySosman, Jeffrey
NCT01164228 STU00036017
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Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritorium Cavity Cancer
This randomized phase III trial is studying giving paclitaxel together with carboplatin to see how well it works c…
This randomized phase III trial is studying giving paclitaxel together with carboplatin to see how well it works compared with giving paclitaxel together with ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine, ovarian, fallopian tube, or peritorium cavity cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether paclitaxel is more effective when given together with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritorium cavity cancer.
Shahabi, ShohrehShahabi, Shohreh
NCT00954174 STU00037705
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Alzheimer's Disease Neuroimaging Initiative 2
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Reco…
The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
Rogalski, Emily JoyRogalski, Emily Joy
NCT01231971 STU00038190
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Lipowski, Kristine Lynn 312 503 2486
Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor…
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
Mohindra, NishaMohindra, Nisha
NCT01107626 STU00038892
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Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer
The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because the…
The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the safety and effects of this drug when given directly into the spinal fluid. Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01325207 STU00040150
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BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
RATIONALE: Vaccines may help the body build an effective immune response to kill …
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy 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. Giving vaccine therapy together with bevacizumab after chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine together with bevacizumab after chemotherapy and radiation therapy in treating patients with newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery.
Mohindra, NishaMohindra, Nisha
NCT00828009 STU00040569
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Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to st…
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer. PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
Benson III, Al BBenson III, Al B
NCT01150045 STU00041400
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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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Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work i…
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma. PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
Winter, Jane NormaWinter, Jane Norma
NCT01216683 STU00042588
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Incidence of Headache Following an Unintentional Dural Puncture
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…
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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Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (C…
This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving alemtuzumab together with ofatumumab may kill more cancer cells
Ma, ShuoMa, Shuo
NCT01361711 STU00044115
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Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine…
RATIONALE: Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.
Altman, Jessica KAltman, Jessica K
NCT01041703 STU00044579
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Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably.…
RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer. PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
NCT01242800 STU00046528
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Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previous…
This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.
Gordon, Leo I IGordon, Leo I I
NCT01476410 STU00046908
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Hydrogel Endovascular Aneurysm Treatment Trial
This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coil…
This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of minimally invasive surgery, which is performed on blood vessels. The technique involves the introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found near the groin. The catheter is then maneuvered through the body to the location of the aneurysm in the brain using image guidance. Coils are delivered into the aneurysm through the catheters. Once the coils are delivered in the aneurysm, they are detached from the catheter. This is repeated until enough coils fill the aneurysm, blocking the blood flow to the aneurysm. The body responds by forming blood clots around the coil(s), which helps block the flow of blood into the aneurysm and keeps the vessel from rupturing or leaking. This study will compare the study device to the standard bare platinum coil to see which is better at preventing future rupturing or leaking. The study device is called the HydroCoil Embolization System and this study is a post-market clinical trial. About 600 subjects from multiple institutions will take part in this study.
Ansari, Sameer AhmadAnsari, Sameer Ahmad
NCT01407952 STU00045294
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First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel as first-line therapy for cisplatin-ineligible patients with advanced urothelial car…
The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.
Hussain, MahaHussain, Maha
NCT01215136 STU00047727
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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
Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their m…
The investigators would like to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles. The investigators would also like to determine if Brevail® can reduce breast cancer pre-menopausal women.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
NCT01276704 STU00049144
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as …
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
Hayes, John PHayes, John P
NCT01349322 STU00051796
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Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery
This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how …
This phase I/II trial studies the side effects and best dose of temozolomide and pazopanib hydrochloride when given together and to see how well they work in treating patients with advanced pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth. Giving temozolomide together with pazopanib hydrochloride may be an effective treatment for patients with PNET.
Kircher, SheetalKircher, Sheetal
NCT01465659 STU00053541
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Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas
This phase II trial studies how well giving hypofractionated radiation therapy together with temozolomide and bevacizumab works in treating patients with high-grade glioblastoma multiforme or anap…
This phase II trial studies how well giving hypofractionated radiation therapy together with temozolomide and bevacizumab works in treating patients with high-grade glioblastoma multiforme or anaplastic glioma. Specialized radiation therapy, such as hypofractionated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving hypofractionated radiation therapy together with temozolomide and bevacizumab may kill more tumor cells.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01478321 STU00053636
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Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with…
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.
Frankfurt, OlgaFrankfurt, Olga
NCT01349049 STU00053687
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Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-r…
This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon alfa-2b in treating patients with melanoma.
Chandra, SunandanaChandra, Sunandana
NCT01274338 STU00053937
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Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemothe…
This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer.
Gradishar, William JGradishar, William J
NCT01272037 STU00054693
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Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of …
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
Mittal, Bharat BMittal, Bharat B
NCT01302834 STU00055939
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Ipilimumab and Gemcitabine Hydrochloride in Treating Patients With Stage III-IV or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of ipilimumab when given together with gemcitabine hydrochloride in treating …
This phase I trial studies the side effects and best dose of ipilimumab when given together with gemcitabine hydrochloride in treating patients with stage III-IV or recurrent pancreatic cancer that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to kill tumor cells or stop them from growing. Giving monoclonal antibody therapy together with chemotherapy may kill more tumor cells.
Mulcahy, Mary FrancesMulcahy, Mary Frances
NCT01473940 STU00045323
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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
TK008: Efficacy Study on the Strategy of Herpes Simplex Virus Thymidine Kinase (HSV-Tk) Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
The main objective of this randomized trial is To compare disease-free survival (DFS) in high risk leukemia patients who under…
The main objective of this randomized trial is To compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT
Mehta, JayeshMehta, Jayesh
NCT00914628 STU00058127
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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
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
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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Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients rece…
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.
Kulik, Laura MKulik, Laura M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01556490 STU00059691
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Study Coordinator 312 695 1102
Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer
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 chem…
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
A Randomized Trial to Prevent Congenital Cytomegalovirus (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 people in the U…
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
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
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" …
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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Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzyme…
This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Agulnik, MarkAgulnik, Mark
NCT01462630 STU00061834
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Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways…
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vincristine sulfate, procarbazine hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill cancer cells. It is not yet know whether rituximab and combination chemotherapy are more effective when given with or without radiation therapy in treating patients with primary central nervous system lymphoma. PURPOSE: This randomized phase II trial studies how well giving rituximab and combination chemotherapy with or without radiation therapy works in treating patients with primary central nervous system lymphoma.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01399372 STU00062372
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Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treati…
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.
Donnelly, EricDonnelly, Eric
NCT01414608 STU00062184
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GLORIA-AF Registry Program - Second and Third Phases
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. …
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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PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy
RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phas…
RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.
Benson III, Al BBenson III, Al B
NCT01333033 STU00063249
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S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-Cell Lymphoma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by …
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
Winter, Jane NormaWinter, Jane Norma
NCT01359592 STU00064010
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Repetitive Transcranial Magnetic Stimulation in Breast 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 these two methods of rTMS work in treating cancer-related depression…
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
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
Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
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 Therapy Percutaneous Therapy for High Surgical Risk Patients
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 …
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
A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-1…
This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study.
Ma, ShuoMa, Shuo
NCT01682616 STU00065351
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Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants…
Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.
Wolf, MichaelWolf, Michael
NCT01811264 STU00064228
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A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Be…
This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Pro, BarbaraPro, Barbara
NCT01578499 STU00065910
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HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
The purpose of this study is to evaluate overall survival in patients treated with HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with …
The purpose of this study is to evaluate overall survival in patients treated with HepaSphere/QuadraSphere compared to conventional transarterial chemoembolization with particle PVA.
Lewandowski, Robert JLewandowski, Robert J
NCT01387932 STU00064130
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Methotrexate or Dactinomycin in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in …
This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
Shahabi, ShohrehShahabi, Shohreh
NCT01535053 STU00066779
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Extended Varenicline Treatment for Smoking Among Cancer Patients
The purpose of this study is to compare two different smoking cessation treatments for people who have been diagnosed or been treated for cancer in the past 5 years. Participants will receive either standard varenicline (Chantix) treatm…
The purpose of this study is to compare two different smoking cessation treatments for people who have been diagnosed or been treated for cancer in the past 5 years. Participants will receive either standard varenicline (Chantix) treatment for 12 weeks or extended varenicline (Chantix) treatment for 24 weeks, in combination with brief behavior therapy.
1. 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and non-menthol) per day, on average, for the last 6 months.
2. Current cancer diagnosis (all sites) or diagnosis within the past 5 years.
3. Able to use varenicline safely, based on a medical evaluation including medical history and physical examination, and psychiatric evaluation.
Hitsman, Brian LHitsman, Brian L
NCT01756885 STU00064871
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Maloney, Michael 1 877 236 7487
Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This randomized phase III trial studies diet and physical activity changes to see how well they wor…
This randomized phase III trial studies diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy lifestyle and counseling after treatment may improve progression-free survival in patients with previously treated cancer.
Shahabi, ShohrehShahabi, Shohreh
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00719303 STU00066809
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Study Coordinator 312 695 1102
Response-Based Therapy Assessed By PET Scan in Treating Patients With Bulky Stage I and Stage II Classical Hodgkin Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.…
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving chemotherapy together with radiation therapy may kill more cancer cells. Diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors plan the best treatment. PURPOSE: This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma.
Pro, BarbaraPro, Barbara
NCT01118026 STU00066977
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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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Kundu, Shilajit D 1-888-NU-STUDY
Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the…
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
The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer
The Study Evaluating Efficacy And Tolerability of Velipari…
The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.
Gradishar, William JGradishar, William J
NCT01506609 STU00068228
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Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF
The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary My…
The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)
Stein, Brady LeeStein, Brady Lee
NCT01423851 STU00068449
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Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cel…
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma. PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
Winter, Jane NormaWinter, Jane Norma
NCT01415752 STU00068608
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ANTLER Pilot Intervention
ANTLER Pilot Study
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
STU00069201
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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
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
The purpose of this study is to - compare Progression Free Survival (PFS) after treatment with …
The purpose of this study is to - compare Progression Free Survival (PFS) after treatment with 177Lu-DOTA0-Tyr3-Octreotate plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in patients with inoperable, progressive (as determined by Response Evaluation Criteria in Solid Tumors [RECIST] Criteria), somatostatin receptor positive, well-differentiated neuroendocrine tumours of the small bowel (midgut carcinoid tumours). - compare the Objective Response Rate (ORR) between the two study arms - compare the Overall Survival (OS) between the two study arms - compare the Time to Tumour Progression (TTP) between the two study arms - evaluate the safety and tolerability of 177Lu-DOTA0-Tyr3-Octreotate - evaluate the health related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 questionnaire - explore the correlation of toxicity outcomes and administered radiation doses corrected for body weight and body surface area - explore the correlation of clinical efficacy outcomes with the levels of the biomarkers Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine - evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients - explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake score - explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase (AP)
Benson III, Al BBenson III, Al B
NCT01578239 STU00065623
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A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with s…
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
Altman, Jessica KAltman, Jessica K
NCT01546038 STU00067903
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A Clinical Study Conducted in Multiple Centers Comparing Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Subjects With Brain Metastases From Non Small Cell Lung Cancer (NSCLC)
The primary objective of this study is to evaluate the Overall Survival, Best Tumor…
The primary objective of this study is to evaluate the Overall Survival, Best Tumor Response Rate, Time to Intracranial Progression (radiographic), Time to Clinical Brain Metastasis Progression, safety, and tolerability of veliparib and Whole Brain Radiation Therapy in subjects with brain metastases from Non Small Cell Lung Cancer
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01657799 STU00068212
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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
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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Mild Cognitive Impairment 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 therapy, and how these brain are…
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
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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Adhikari, Krina 312 503 9095
Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure
Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children. The proposed studi…
Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children. The proposed studies will increase our knowledge on multiple levels to improve care and reduce adverse outcomes in these mothers and children. An overall goal of this study is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.
Gerard, Elizabeth ErwayGerard, Elizabeth Erway
NCT01730170 STU00070411
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Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This phase II clinical trial is studying how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblas…
This phase II clinical trial is studying how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
Frankfurt, OlgaFrankfurt, Olga
NCT01256398 STU00070681
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Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy work in different …
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01231906 STU00070869
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Study Coordinator 312 695 1102
Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma
This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocel…
This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly plus sorafenib 200 mg (oral, twice daily).
Kircher, SheetalKircher, Sheetal
NCT01687673 STU00071124
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Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant g…
The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied. The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01266031 STU00071570
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Study of Vitamin D in Untreated Metastatic Colorectal Cancer
The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell death. Vitamin D has been used …
The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colorectal cancer. In this research study, the investigators are comparing standard and higher dose Vitamin D treatment when given in combination with standard treatment for metastatic colorectal cancer. Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and Oxaliplatin (FOLFOX) with bevacizumab.
Kircher, SheetalKircher, Sheetal
NCT01516216 STU00071588
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Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant gliom…
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant glioma. The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can help to control malignant glioma. The safety of this combination will also be studied in both phases.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01434602 STU00071721
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Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
Pro, BarbaraPro, Barbara
NCT01728805 STU00072232
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Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
This randomized phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with metastatic kidney cancer who have no …
This randomized phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with metastatic kidney cancer who have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Sosman, JeffreySosman, Jeffrey
NCT01575548 STU00071950
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Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. T…
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Frankfurt, OlgaFrankfurt, Olga
NCT01696084 STU00072848
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A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study i…
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere with the growth of some types of tumors. The study will also evaluate how safe the study treatment is by observing how many and what kind of adverse events (side effects) participants experience.
Agulnik, MarkAgulnik, Mark
NCT01782313 STU00073826
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Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of …
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
Donnelly, EricDonnelly, Eric
NCT01672892 STU00073668
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Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed By Surgery
This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cance…
This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that is recurrent, metastatic, or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, can interfere with tumor growth by blocking the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.
Agulnik, MarkAgulnik, Mark
NCT01696955 STU00073973
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Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transpla…
The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high risk patients following liver transplantation
Kulik, Laura MKulik, Laura M
NCT01624285 STU00048134
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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
Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer
The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared…
The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared to a placebo. CDB-4124 (also called Proellex) is a medication that works against the hormone, progesterone. The researchers in this study would like to compare changes in breast cancer cells of women who have taken CDB-4124 prior to surgery to those from women who have taken a placebo pill prior to surgery.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
NCT01800422 STU00074599
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SRL (Sirolimus) Withdrawal
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. Lifetim…
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
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
Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma
This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as b…
This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma
Kumthekar, PriyaKumthekar, Priya
NCT01730950 STU00075529
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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
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. Tivozanib may stop the growth of …
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
Cediranib Maleate With or Without Lenalidomide in Treating Patients With Thyroid Cancer
This partially randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with or without lenalidomide and to see how well they work in …
This partially randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with or without lenalidomide and to see how well they work in treating patients with thyroid cancer. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of thyroid cancer by blocking blood flow to the tumor. It is not yet known whether cediranib maleate is more effective when given together with lenalidomide in treating thyroid cancer.
Agulnik, MarkAgulnik, Mark
NCT01208051 STU00078077
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Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator
The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in…
The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.
Frankfurt, OlgaFrankfurt, Olga
NCT01742299 STU00078335
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Videocapillaroscopy Assessment During Systemic Agent Therapy in 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 vascular features.…
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
FTC/RPV/TDF on T-Cell Activation, CD4 Cell Count, Inflammatory Biomarkers and Viral Reservoir
This study is being done with people who are infected with HIV, but do not show any signs of having HIV. They are also feeling well without taking HIV medication and have low or undet…
This study is being done with people who are infected with HIV, but do not show any signs of having HIV. They are also feeling well without taking HIV medication and have low or undetectable levels of the virus in the blood. The purpose of this study is to see if taking HIV medication (antiretroviral therapy [ART]) will reduce immune activation (a signal that the body is fighting an infection) in people who have HIV, but do not show symptoms. Also this study will help determine how safe the drug is and how well people react to the drug. For this study, the following antiretroviral therapy (ART) will be provided in the form of a single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF). These drugs are combined as one tablet which is approved by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV medication provided is one of the recommended treatments for HIV, including people with low viral loads (how much HIV you have in your body) who are taking HIV drugs for the first time. The risks seen with this HIV medication are the same that one would encounter when taking these drugs outside of the study.
Taiwo, Babafemi OTaiwo, Babafemi O
NCT01777997 STU00078481
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Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery
This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with …
This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.
Bloch, OrinBloch, Orin
NCT01814813 STU00079456
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Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in …
To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these subjects.
Bhorade, SangeetaBhorade, Sangeeta
NCT01890265 STU00079406
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Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia
This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cyta…
This randomized phase III trial studies cytarabine and daunorubicin hydrochloride or idarubicin and cytarabine with or without vorinostat to see how well they work in treating younger patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin hydrochloride, idarubicin, and vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells. It is not yet known which combination chemotherapy is more effective in treating acute myeloid leukemia.
Altman, Jessica KAltman, Jessica K
NCT01802333 STU00079895
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Bevacizumab in Pats w/ Recurrent ST Brain Metas Who Have Failed Whole Brain Radiation Therapy
This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease has spread to their brain. This study will not evaluate the effect of bevacizumab on the sy…
This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease has spread to their brain. This study will not evaluate the effect of bevacizumab on the systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab may interfere with the growth of new blood vessels; therefore it might stop tumor growth and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels.
Kumthekar, PriyaKumthekar, Priya
NCT01898130 STU00080404
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A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly dia…
The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01790503 STU00079884
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glioblastoma GBM

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Ketamine Effect 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 often treated with opioids. However …
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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Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer
This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and how well they work in …
This partially randomized phase I/II trial studies the side effects and best dose of veliparib when given together with combination chemotherapy and how well they work in treating patients with IV head and neck cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given with or without veliparib in treating head and neck cancer.
Agulnik, MarkAgulnik, Mark
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01711541 STU00081215
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Study Coordinator 312 695 1102
Prostatic Artery Embolization (PAE) for Treatment 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 attributed to be…
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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Karp, Jennifer 312 926 5289
Pregnant Women Taking Lamictal for 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 of Lamictal in women's blood will de…
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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Evaluation of Centration of Intraocular Lens With Two 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 centration and pupil centration. I…
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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Effect of L-dopa In Subacute Back Pain Population
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
NEUROLOGICAL MECHANISMS OF TREATMENT PROJECT (NMT): AN EXAMINATION OF THE NEUROLOGICAL EFFECTS OF COGNITIVE BEHAVIORAL THERAPY ON ADOLESCENTS WITH DEPRESSION
The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process informati…
The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process information. We hope to determine if adolescents with depression who have received treatment process information the way adolescents without depression react. Your child is being asked to participate in this study because he/she is age of 13-17 and has been diagnosed of Major Depressive Disorder (MDD). You or your child will be asked to complete 3 assessment days, including today, and 12 weeks of individual Cognitive Behavioral Therapy (CBT). During the assessment days, your child will be asked to complete questionnaires regarding how he/she is feeling and how he/she copes with stressful situations.
13-17 years old, diagnosed with Major Depressive Disorder
Breiter, HansBreiter, Hans
STU00081474
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O'Dor, Sarah 312 503 1802
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, …
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
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
Vitamin D and Type 2 Diabetes Study
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 diabete…
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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Abou-El-Seoud, Dalya 312 503 7203
Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
Kumthekar, PriyaKumthekar, Priya
NCT01800695 STU00084903
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GBM

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A Study of the Efficacy of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia With the 17p Deletion
This is a Phase 2, open label, multicenter, study evaluating the efficacy of ABT-199 in approximately 100 relapsed or refractory subjects with CLL harboring …
This is a Phase 2, open label, multicenter, study evaluating the efficacy of ABT-199 in approximately 100 relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion.
Ma, ShuoMa, Shuo
NCT01889186 STU00083476
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Immunotherapy Study in Progressive or Relapsed Non-Small Cell Lung Cancer
The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cance…
The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.
Chae, Young KwangChae, Young Kwang
NCT01774578 STU00083862
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Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containin…
This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing an extract of a person's cancer cells and the immunostimulant interleukin-2 may help the body to build an effective immune response to kill cancer cells.
Ma, ShuoMa, Shuo
NCT01976520 STU00083074
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Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer…
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
A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes
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. Nove…
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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Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCET…
This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
Pro, BarbaraPro, Barbara
NCT01712490 STU00083869
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Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors
This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with progressive carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells b…
This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with progressive carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Benson III, Al BBenson III, Al B
NCT01841736 STU00083973
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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
The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF)
An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family…
An urgent need exists to find effective treatments for Alzheimer's disease (AD) that can arrest or reverse the disease at its earliest stages. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median population age increases. Current FDA-approved therapies are modestly effective at best. This study will examine a novel therapeutic approach using intranasal insulin (INI) that has shown promise in short-term clinical trials. If successful, information gained from the study has the potential to move INI forward rapidly as a therapy for AD. The study will also provide evidence for the mechanisms through which INI may produce benefits by examining key cerebral spinal fluid (CSF) biomarkers and hippocampal/entorhinal atrophy. These results will have considerable clinical and scientific significance, and provide therapeutically-relevant knowledge about insulin's effects on AD pathophysiology. Growing evidence has shown that insulin carries out multiple functions in the brain, and that insulin dysregulation may contribute to AD pathogenesis. This study will examine the effects of intranasally-administered insulin on cognition, entorhinal cortex and hippocampal atrophy, and cerebrospinal fluid (CSF) biomarkers in amnestic mild cognitive impairment (aMCI) or mild AD. It is hypothesized that after 12 months of treatment with INI compared to placebo, subjects will improve performance on a global measure of cognition, on a memory composite and on daily function. In addition to the examination of CSF biomarkers and hippocampal and entorhinal atrophy, the study aims to examine whether baseline AD biomarker profile, gender, or Apolipoprotein epsilon 4 (APOE-ε4) allele carriage predict treatment response. In this study, 240 people with aMCI or AD will be given either INI or placebo for 12 months, following an open-label period of 6 months where all participants will be given active drug. The study uses insulin as a therapeutic agent and intranasal administration focusing on nose to brain transport as a mode of delivery.
Mesulam, Marek-MarselMesulam, Marek-Marsel
NCT01767909 STU00085066
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Robson, Jordan 312 503 5212
Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
Inclusion Criteria:

-Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (CT, CTA, etc.), with a GCS ≤ 14 or a NIHSS ≥ 6.
-Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method.
-Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
-Ability to randomize between 12 and 72 hours after dCT.
-SBP < 180 mmHg sustained for six hours recorded closest to the time of randomization.
-Historical Rankin score of 0 or 1.
-Age ≥ 18 and older.

Exclusion Criteria:

-Infratentorial hemorrhage.
-Intraventricular hemorrhage requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. EVD to treat ICP is allowed.
-Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
-Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
-Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1 year) hemorrhage diagnosed with radiographic imaging. Patients with unstable mass or evolving intracranial compartment syndrome.
-Platelet count < 100,000, INR > 1.4, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT).
-Any irreversible coagulopathy or known clotting disorder.
-Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but not limited to NovoSeven, FFP, and/or vitamin K).
-Subjects requiring long-term anti-coagulation are excluded. Reversal of anti-coagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation.
-Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
-Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
-Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention.
-Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
-Allergy/sensitivity to rt-PA.
-Prior enrollment in the study.
-Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible.
-Not expected to survive to the day 365 visit due to co-morbidities and/or are DNR/DNI status prior to randomization.
-Any concurrent serious illness that would interfere with safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
-Patients with mechanical} heart valve. Presence of bio-prosthetic valve(s) is permitted.
-Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.
-Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
-Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
-In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rt-PA removal of the ICH.
-Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Jahromi, BabakJahromi, Babak
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01827046 STU00085848
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Yip, Byron K. 312 926 9445
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide works in treati…
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide works in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Winter, Jane NormaWinter, Jane Norma
NCT01856192 STU00085928
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A Phase 2 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer - "BIRCH"
This multicenter, single- arm study will evaluate the efficacy and safety of MPDL3280A in patients with PD-L1-positi…
This multicenter, single- arm study will evaluate the efficacy and safety of MPDL3280A in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer. Patients will receive MPDL3280A 1200 mg intravenously every 3 weeks for a maximum of 16 cycles (or 12 months, whichever occurs first) in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. Patients who complete the initial treatment stage may be eligible fro MPDL3280A re-treatment upon subsequent disease progression during the follow-up period without intervening systemic anti-cancer therapy.
Mohindra, NishaMohindra, Nisha
NCT02031458 STU00087058
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Study of Two Doses of MK-3475 (Pembrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
This study will compare two doses of pembrolizumab versus docetaxel in participants with non-small cell lung cancer (NSCLC) …
This study will compare two doses of pembrolizumab versus docetaxel in participants with non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-containing systemic therapy. Participants will be assigned randomly to receive either Low Dose or High Dose pembrolizumab every three weeks (Q3W), or docetaxel at 75 mg/m^2 Q3W. This study will use an adaptive trial design so that the total number of participants randomized will depend upon demonstration of sufficient objective responses at interim analysis. If the pembrolizumab Low Dose arm is closed, participants may receive pembrolizumab High Dose therapy.
Chae, Young KwangChae, Young Kwang
NCT01905657 STU00087871
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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 for patients who have angiosarcoma that has gotten …
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
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either …
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
Nieves-Neira, WilbertoNieves-Neira, Wilberto
NCT01847274 STU00087845
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A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally …
This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.
Chae, Young KwangChae, Young Kwang
NCT01449058 STU00089683
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ANG1005 in Patients With Recurrent High-Grade Glioma
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokineti…
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
Kumthekar, PriyaKumthekar, Priya
NCT01967810 STU00086859
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A Study of TAK-659 in Adult Patients With Advanced Solid Tumor and Lymphoma Malignancies
This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult patients with advanced solid tumor and lymphoma malignancies. This study will be the first …
This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult patients with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The patient population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 2 dose expansion cohorts in refractory and/or relapsed CLL and DLBCL (Part B) following completion of dose escalation (Part A).
Karmali, ReemKarmali, Reem
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02000934 STU00088167
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Study Coordinator 312 695 1102
BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx
The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating …
The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this study is considered standard treatment for the type of cancer in this study. Participants in this study have already been treated with trastuzumab and chemotherapy in the past, and their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth) that the researchers think may help T-DM1 to work better.
Gradishar, William JGradishar, William J
NCT02038010 STU00087202
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Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone
The purpose of this study is to determine the maximum tolerated dose and the safety profile of MEDI4736 in combination with dabrafenib and trametinib or with trametinib…
The purpose of this study is to determine the maximum tolerated dose and the safety profile of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type BRAF, respectively.
Chandra, SunandanaChandra, Sunandana
NCT02027961 STU00088281
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A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to patients with recurrent GBM, whose tumors demonstrate FGFR amplification, translocation, or activating mutation.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01975701 STU00089428
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An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS…
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
Dinner, ShiraDinner, Shira
NCT02039726 STU00090667
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Treatment for CI-DME in Eyes With Very Good VA Study
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), onl…
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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A Randomized Trial of Induction Versus Expectant Management
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 morta…
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
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
The purpose of the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the "A4 study" for short) is to test whether a new investigational treatment called solanezumab, an anti-amyloid antibody, can slow mem…
The purpose of the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the "A4 study" for short) is to test whether a new investigational treatment called solanezumab, an anti-amyloid antibody, can slow memory loss caused by Alzheimer’s disease. Amyloid is a protein normally produced in the brain that can build up in older people, forming amyloid plaque deposits. Scientists believe this buildup of deposits may play a key role in the eventual development of Alzheimer’s disease-related memory loss. The overall goal of the A4 study is to test whether decreasing amyloid with antibody investigational treatment can help slow the memory loss associated with amyloid buildup in some people. The A4 study invites healthy older individuals (ages 65-85) who have normal thinking and memory function but who may be at risk for memory loss due to Alzheimer’s disease, but have no outward signs of the disease to participate in the study.
- Are 65 to 85 years old
- Have normal thinking and memory abilities
- Have an A4 study partner – someone who has at least weekly contact (at least 10 hours) with you who can answer questions once a year
- Are willing and able to receive monthly infusions of the investigational treatment or placebo for 3 years - Are willing and able to participate in all required procedures for the duration of the A4 study.
- Are willing to have your health monitored throughout the study using assessments such as:
(1) Memory and thinking tests
(2) ECGs (a look at your heart)
(3) PET scan (a way to look for the plaques thought to be associated with AD)
(4) MRI scans (a way to take a picture of your brain)
(5) Blood and urine tests
Weintraub, SandraWeintraub, Sandra
NCT02008357 STU00087736
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1-888-NU-STUDY
Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
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 …
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 1-888-NU-STUDY
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
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
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
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
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects wi…
This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.
Goldstein, DebraGoldstein, Debra
NCT01694186 STU00091161
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A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
This is a 3 arm Phase 3 study to evaluate the safety and…
This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.
Gradishar, William JGradishar, William J
NCT02032277 STU00091377
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ANG1005 in HER2+ Breast Cancer Patients With Progressive/Recurrent Brain Metastases
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in HER2+ breast cancer patients with recurrent brain metastases.
Kumthekar, PriyaKumthekar, Priya
NCT02048059 STU00091395
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Phase I Study of AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation
The purpose of this Phase I, multi-center study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-221 in advanced hematologic malignancies that…
The purpose of this Phase I, multi-center study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-221 in advanced hematologic malignancies that harbor an IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-221 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-221 to further evaluate the safety, tolerability, and clinical activity of the MTD. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Altman, Jessica KAltman, Jessica K
NCT01915498 STU00091898
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Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib
The purpose of this signal seeking study is to determine whether treatment with dovitinib (TKI258) demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic mali…
The purpose of this signal seeking study is to determine whether treatment with dovitinib (TKI258) demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Chae, Young KwangChae, Young Kwang
NCT01831726 STU00092203
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Selinexor (KPT-330) in Older Patients With Relapsed AML
This is a randomized, multicenter, open-label, Phase 2 study of the SINE Selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Patients age ≥ 60 years with relapsed…
This is a randomized, multicenter, open-label, Phase 2 study of the SINE Selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Patients age ≥ 60 years with relapsed/refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
Frankfurt, OlgaFrankfurt, Olga
NCT02088541 STU00092397
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Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer
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…
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
Belatacept 3 Month Post Transplant Conversion Study
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 de…
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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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
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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Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants
The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional inte…
The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a smartphone application; the researchers also want to study the effect that a tRD has on weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to restrict their daily eating to a specific time frame each day. The researchers think that this might be an effective and manageable way to control weight.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
NCT02154984 STU00091568
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Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor…
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.
Mittal, Bharat BMittal, Bharat B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00956007 STU00091727
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Study Coordinator 312 695 1102
A Phase I, 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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Phase II Pazopanib Plus Topotecan for Recurrent Glioblastoma Multiforme (GBM)
The goal of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control glioblastoma. The safety of this drug combination will also be studied.…
The goal of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control glioblastoma. The safety of this drug combination will also be studied. The study doctor can explain how the study drugs are designed to work.
Raizer, Jeffrey JRaizer, Jeffrey J
NCT01931098 STU00092064
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HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network
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 practi…
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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Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malign…
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where three cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the MTD. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Altman, Jessica KAltman, Jessica K
NCT02074839 STU00092474
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Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
Agulnik, MarkAgulnik, Mark
NCT02049905 STU00092843
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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
Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This randomized phase III trial studies ibrutinib and rituximab to see how well they work compa…
This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab are more effective than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Ma, ShuoMa, Shuo
NCT02048813 STU00093033
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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
Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they…
This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet know whether rituximab with bendamustine hydrochloride is more effective than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
Ma, ShuoMa, Shuo
NCT01886872 STU00093727
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Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme
The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM).
Kumthekar, PriyaKumthekar, Priya
NCT02078648 STU00093962
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Olaparib Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Shahabi, ShohrehShahabi, Shohreh
NCT01844986 STU00094075
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Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at High Risk of Acquiring HIV-1 Infection
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. (Pharm…
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.
Yogev, RamYogev, Ram
NCT01780831 STU00093680
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Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel…
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.
Shahabi, ShohrehShahabi, Shohreh
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02065687 STU00093932
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Study Coordinator 312 695 1102
Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery
This randomized phase II clinical trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma…
This randomized phase II clinical trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.
Chandra, SunandanaChandra, Sunandana
NCT01258855 STU00094690
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Ruxolitinib Prior to Transplant in Patients With Myelofibrosis
The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopo…
The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopoietic stem cells (bone marrow transplantation) will be successful in people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate whether adding the drug Ruxolitinib will further aid in reducing pre-transplant spleen size, improve physical performance levels and reduce adverse events (side effects) related to the transplant. Ruxolitinib is a drug that is approved by the FDA for the treatment of patients with advanced forms of myelofibrosis. Using Ruxolitinib prior to stem cell transplantation is experimental.
Adekola, KehindeAdekola, Kehinde
NCT01790295 STU00092812
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Correlative Biomarker Study in Patients With Myeloproliferative Disorders
Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings will provide norm…
Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings will provide normal material like DNA for comparison with the abnormal material derived from the blood and/or bone marrow. The results of these studies will be correlated with subjects' disease symptoms and response to their experimental treatment. The MPD-RC researchers are interested in studying molecules from the blood and bone marrow, the exact molecules changing over time with the investigators choosing only the most promising for investigation. The investigators are attempting to better understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases. These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments. It is believed that further basic knowledge about these cancer cells as well as the effects of treatment will lead to the improvement of current therapies and the development of entirely new treatments for these diseases. The MPD-RC is hoping to determine if a number of laboratory tests (biomarkers) will allow for the prediction of response in future patients to the treatment they would receive.
Adekola, KehindeAdekola, Kehinde
NCT00665067 STU00093364
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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
A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-like Sarcomas
Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and ph…
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
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as reco…
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
Hanauer, StephenHanauer, Stephen
NCT01848561 STU00094204
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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 Gliomas
This research study involves two investigational drugs, veledimex, an a…
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
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
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 hyperglycemi…
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
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
STU00093458
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Study Coordinator 312 695 1102
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
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 …
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
The Chimerix CMX001 Registry
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA viru…
The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.
Ison, Michael GIson, Michael G
NCT02167685 STU00095440
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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Ca…
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Chandra, SunandanaChandra, Sunandana
NCT01835145 STU00096579
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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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Siurek, Alexis 312 695 7748
Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis
To evaluate safety and efficacy of two dosing regimens in achieving clinical remission at Week 8 in subjects with moderately to severely active Ulcerative Colitis.
Hanauer, StephenHanauer, Stephen
NCT02065622 STU00096456
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Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
This study will evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.
Hanauer, StephenHanauer, Stephen
NCT02065570 STU00096539
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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)
Hirano, IkuoHirano, Ikuo
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00096856
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Thakrar, Anjali 312 503 1120
Ibrutinib With Rituximab in Previously Treated Adults With Waldenstrom's Macroglobulinemia
The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in subjects with previously treated Waldenstrom's Macroglobulinemia.
Ma, ShuoMa, Shuo
NCT02165397 STU00097388
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Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme
This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together w…
This partially randomized phase I/II trial studies the side effects and the best dose of anti-endoglin monoclonal antibody TRC105 when given together with bevacizumab and to see how well they work in treating patients with glioblastoma multiforme that has come back. Monoclonal antibodies, such as anti-endoglin monoclonal antibody TRC105 and bevacizumab, may find tumor cells and help kill them. Giving anti-endoglin monoclonal antibody TRC105 together with bevacizumab may be an effective treatment for glioblastoma multiforme.
Kumthekar, PriyaKumthekar, Priya
NCT01648348 STU00097918
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BKM120 for Patients With PI3K-activated Tumors
The purpose of this signal seeking study is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Chae, Young KwangChae, Young Kwang
NCT01833169 STU00098066
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Effect of Magnesium Threonate (MgT) on Cognitive Enhancement in Schizophrenia
This study is being conducted in order to determine if an investigational drug, MMFS-202-302 improves mental function and are safe in people who have schizophrenia and are taking another medication for their illness. Menta…
This study is being conducted in order to determine if an investigational drug, MMFS-202-302 improves mental function and are safe in people who have schizophrenia and are taking another medication for their illness. Mental function is how your brain works and includes your 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. MMFS-202-302 has been self-affirmed by an expert panel convened by its manufacturer Magceutics as being produced using good manufacturing practices, and fulfilling the FDA’s criteria for GRAS (generally regarded as safe) status If you decide to participate, you will be in this study for up to 9 weeks (63 days) after the screening period. The screening period can last up to 2 weeks (14 days). The total length of your participation is up to 11 weeks (77 days). After the initial screening visit (Visit 1), you will be asked to return to the research site at least 5 more times to take part in additional study procedures.
18-55 years old, Diagnosis of Schizophrenia or Schizoaffective Disorder of at least 1 year
Meltzer, HerbertMeltzer, Herbert
NCT02237235 STU00098144
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Wardell, Cale 312 503 9076
Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the prelimina…
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations.
Frankfurt, OlgaFrankfurt, Olga
NCT02203773 STU00098734
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Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery
This randomized phase II-R/III tria…
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.
Hayes, John PHayes, John P
NCT01013649 STU00099583
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LCH_Measuring Human BAT Volume and Activity by Quantitative and Functional MRI (2014-15761)
In this study we will be comparing two different types of body scans and how they reveal fat tissues in the body. Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) will be used to look fo…
In this study we will be comparing two different types of body scans and how they reveal fat tissues in the body. Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) will be used to look for a specific type of metabolically active fat called brown fat (brown adipose tissue or BAT). Understanding more about BAT and how it relates to metabolism could eventually lead to the development of obesity treatments by encouraging weight loss. You may be eligible if you are male, normal weight or obese, healthy, nonsmoking and between the ages of 18-24. The study includes 3-4 separate visits to Northwestern Memorial Hospital and Lurie Children’s, laboratory testing and medical imaging study. Volunteers will receive compensation and reimbursement for participation. Call 312-503-3413 or email jennifer.lewandowski@northwestern.edu for more information.
You may be eligible if you are male, normal weight or obese, healthy, nonsmoking and between the ages of 18-24.
Deng, JieDeng, Jie
STU00099042
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Abou-El-Seoud, Dalya 312 503 7203
Efficacy, Safety, Tolerability of Carbavance Compared to Best Available Therapy in Serious Infections Due to Carbapenem Resistant Enterobacteriaceae, in Adults
Carbavance™, (meropenem/RPX7009) is being compared to the Best Available Therapy in the treatment of adults with selec…
Carbavance™, (meropenem/RPX7009) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
Wunderink, Richard GWunderink, Richard G
NCT02168946 STU00099080
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LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
Crossover study for patients who were randomized to the Control Group in CLN0009.
Kalhan, RaviKalhan, Ravi
NCT02059057 STU00099240
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Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment (SaNDI)
This study aims to use sensory nerve testing to explain the mechanism by which nerve stimulation affects nerves in patients with dual incontinence (urinary and fecal incontinence). A device will be…
This study aims to use sensory nerve testing to explain the mechanism by which nerve stimulation affects nerves in patients with dual incontinence (urinary and fecal incontinence). A device will be implanted to test these mechanisms. The primary outcome of this study is to see how the device affects the dual incontinence after implantation. This study is for women who have dual incontinence and are planning on undergoing placement of this device.
The study will include women over the age of 18 with idiopathic dual incontinence planning to undergo placement of a sacral nerve modulator if they have at least 5 UUI episodes on a 3-day diary and 2 FI episodes on a 7-day diary. Participants that have any disease that may impair sphincter tone or sensation will not be considered eligible for the study.



Kenton, KimberlyKenton, Kimberly
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
NCT02357784 STU00098840
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Siurek, Alexis 312 695 7748
Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
We are recruiting people motivated to lose weight to participate in a 6 month weight loss intervention study. The purpose of this study is to see what combination of different weight loss program components is t…
We are recruiting people motivated to lose weight to participate in a 6 month weight loss intervention study. The purpose of this study is to see what combination of different weight loss program components is the most effective for overall weight loss. All participants will receive a personal coach who will communicate with them regularly over the telephone throughout the study. All participants must own a personal smartphone and be willing and able to record their food intake on a smartphone application that will be provided. Participants will be randomly assigned to 1 of 16 possible programs that may include a combination of the following weight loss program components: Coaching Calls, Text Messaging, Reports to Primary Care Physician, Buddy Training, Meal Replacement Recommendations. Participants are asked to attend a total of 5 in-person sessions throughout the course of the study, and all appointments will be held on Northwestern University's Chicago campus at 680 N. Lake Shore Drive. Chicago, IL 60611. Free parking vouchers will be provided for those who drive to in-person visits. This study DOES NOT involve medication/drugs.
You may be eligible to participate if you: Are between 18-60 years old; Will be living in the Chicagoland area for the next 6 months; Are NOT currently pregnant, trying to become pregnant, or breastfeeding; Do NOT have an unstable medical condition; Have an Android or iPhone smartphone; Are willing to track your lifestyle behaviors using a smartphone for 6-months
Spring, BonnieSpring, Bonnie
NCT01814072 STU00066546
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Paluch, Amanda 773 234 6711
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the e…
This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in approximately 40 subjects with relapsed or refractory CLL after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
Ma, ShuoMa, Shuo
NCT02141282 STU00100071
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Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
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 lym…
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
(CIRB) A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment with BELVIQ (lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment with BELVIQ (lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Kushner, Robert FKushner, Robert F
NCT02019264 STU00093876
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Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel a…
Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.
Benson III, Al BBenson III, Al B
NCT02181634 STU00100012
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Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,levodopa-responsive bilateral Parkinson's dise…
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
22-75 years old; Diagnosis of bilateral, idiopathic Parkinson's disease
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01839396 STU00094646
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Coffey, Taylor 312 695 0482
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breas…
This randomized trial studies transdermal or oral telapristone acetate in treating patients undergoing surgery to remove the breast (mastectomy). Telapristone acetate may help prevent breast cancer from forming in premenopausal women. Giving telapristone acetate transdermally may be safer and have fewer side effects than oral administration.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02314156 STU00100531
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Study Coordinator 312 695 1102
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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Necessary roles of PFC-MTL interactions in memory tested in humans using TMS
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 individu…
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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Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease
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 patie…
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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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
Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia
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 Ba…
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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Folic Acid and Zinc Supplementation Trial (FAZST)
The goal of this randomized controlled trial is to determine if folic acid and zinc dietary supplementation versus placebo improves semen quality and fertility outcomes (i.e., conception and live birth rates) among couples trying to conceive and seeki…
The goal of this randomized controlled trial is to determine if folic acid and zinc dietary supplementation versus placebo improves semen quality and fertility outcomes (i.e., conception and live birth rates) among couples trying to conceive and seeking assisted reproduction. A couple who enrolls will undergo a baseline study visit, and then the male partner will return for 3 additional study visits every 2 months. Blood, urine, saliva and semen will be collected at each visit. Men will receive a total four semen analyses at no-cost during this study.
Inclusion: 1) Women 18-45 years old, Men 18+ years old; 2) Heterosexual couples; 3) Women not using a gestational carrier; 4) Men using their own sperm; 5) Men without a history of vasectomy/vasectomy reversal or obstructive azoospermia; 6) All other men regardless of prior semen analysis results/findings; 6) Couples who are seeking assisted reproduction with intrauterine insemination (IUI) or in vitro fertilization (IVF)
Robins, JaredRobins, Jared
  • Map it 259 E. Erie St. Lavin Pavilion
    Chicago, IL
NCT01857310 STU00100789
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Posley, Dana 312 472 0289
LDE225 for Patients With PTCH1 or SMO Mutated Tumors
The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study …
The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study
Chae, Young KwangChae, Young Kwang
NCT02002689 STU00100530
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Freehand Ultrasound to Evaluate Scapular Kinematics in People 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 paraple…
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 Endovascular vs. 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 (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowe…
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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Vyas, Riddhi 312 926 4801
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients…
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
Association Between Bolus Rate and Duration of Adequate Labor Analgesia
Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient co…
Administration of anesthetic solution into the epidural space is usually accomplished by a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia [PCEA]). The optimal method for maintaining labor analgesia is unknown. Several studies have demonstrated that timed-intermittent boluses, in combination with patient-controlled epidural analgesia (PCEA), provide superior maintenance of labor analgesia than maintenance with a continuous infusion with PCEA. Epidural infusion pumps capable of delivering timed boluses of local anesthetic with PCEA recently became commercially available. Several infusion rates are available for delivering the timed bolus, and the optimal bolus rate is unknown.
Lange, ElizabethLange, Elizabeth
NCT02340806 STU00100819
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A Study to Evaluate Long-term Outcomes Following Treatment 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
The purpose of this study is to evaluate Long-term Outcomes follo…
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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Evaluation of the IBV® Valve for Emphysema to Improve Lung Function
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 sh…
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
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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Coffey, Taylor 312 695 0482
Gemcitabine Hydrochloride and Cisplatin With or Without Radiation Therapy in Treating Patients With Localized Liver Cancer That Cannot Be Removed By Surgery
This randomized phase III trial compares the effects of gemcitabine hydrochloride and cisplatin with or without radiation t…
This randomized phase III trial compares the effects of gemcitabine hydrochloride and cisplatin with or without radiation therapy to find out which one is better in treating patients with liver cancer that has not spread to nearby lymph nodes or to other parts of the body and cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving gemcitabine hydrochloride and cisplatin is better with or without radiation therapy in treating patients with liver cancer that cannot be removed by surgery.
Hayes, John PHayes, John P
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02200042 STU00102844
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Study Coordinator 312 695 1102
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis Patients Who Are Naive to TNF Inhibitors
This Phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizum…
This Phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are naïve to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.
Hanauer, StephenHanauer, Stephen
NCT02165215 STU00101866
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A Phase 1 Study of MEDI6383 in Adult Subjects With Select Advanced Solid Tumors
To evaluate the tolerability of MEDI6383 in adult subjects with recurrent or metastatic solid tumors.
Chae, Young KwangChae, Young Kwang
NCT02221960 STU00103559
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Lung-MAP: S1400 Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV 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 fo…
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
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic m…
The purpose of this signal seeking study is to determine whether treatment with ceritinib demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Chae, Young KwangChae, Young Kwang
NCT02186821 STU00103423
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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
Assessment of Patient Positioning
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. Th…
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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Effect of a Patient-Centered Decision App on TOLAC
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 perf…
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
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure
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 Heal…
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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Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can be Removed by Surgery
This randomized phase II/III trial studies how well pazopanib hydrochlo…
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
BGJ398 for Patients With Tumors With FGFR Genetic Alterations
The purpose of this signal seeking study is to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant fu…
The purpose of this signal seeking study is to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.
Chae, Young KwangChae, Young Kwang
NCT02160041 STU00104815
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Alendronate to Prevent Loss of Bronchoprotection in Asthma
Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids …
Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.
Smith, Lewis JSmith, Lewis J
NCT02230332 STU00104967
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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
Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
Background: - Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox bin…
Background: - Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results. Objectives: - To see how effective moxetumomab pasudotox is at destroying hairy cell leukemia tumor cells and producing lasting complete remissions. Eligibility: - Individuals at least 18 years of age who have hairy cell leukemia that has not responded to or relapsed at least twice after standard therapy. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and heart and lung function tests will also be performed. - Participants will have 28-day cycles of treatment. They will receive the study drug on days 1, 3, and 5 of every cycle. Each dose will take about 30 minutes. - Treatment will be monitored with frequent blood and urine tests and imaging studies. - The study will focus on the results from the first 6 months of treatment. However, participants will continue to take the study drug for as long as it is effective and the side effects are not severe. - After stopping the study drug, participants will have frequent follow-up visits to monitor the outcome of the treatment.
Dinner, ShiraDinner, Shira
NCT01829711 STU00105706
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Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery
This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery…
This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
Mohindra, NishaMohindra, Nisha
NCT02194738 STU00200150
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Phase IIB TL + YCWP + DC in 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…
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
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behcet's Disease
Behcet's disease, is a rare disorder that causes inflammation in blood vessels throughout the body. The signs and symptoms of Behcet's di…
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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Radiation Therapy With Cisplatin, Docetaxel, or Cetuximab After Surgery in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or c…
This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.
Mittal, Bharat BMittal, Bharat B
NCT01810913 STU00200314
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Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
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)…
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
Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD
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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Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic 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 safety of this dr…
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
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
STU00200145
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Study Coordinator 312 695 1102
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
Carboplatin/Nab-Paclitaxel and MK-3475 in NSCLC
This is a phase I/II study for previously untreated patients with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I and will be treated with carbopla…
This is a phase I/II study for previously untreated patients with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I and will be treated with carboplatin, nab-paclitaxel and MK-3475 and evaluated for safety and tolerability after 2 cycles of therapy. If needed, a second cohort of twelve participants will be enrolled. Following successful completion of the dose-finding/safety run-in cohort, the study will proceed to phase II. Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all participants (only if adequate archived samples are unavailable). Mandatory tumor biopsies will be obtained in the phase II part of the study after 4 cycles or at the time of progression, whichever comes first. The phase II part of the study is a single arm study. All participants will be treated with carboplatin, nab-paclitaxel, and MK-3475 at the recommended phase II dose (RP2D) in 21-day cycles for up to 4 cycles. Participants will be evaluated for response every 2 cycles (6 weeks). For participants without progression of disease after Cycle 4, MK-3475 will continue every 3 weeks for up to 2 years or until unacceptable toxicity.
Mohindra, NishaMohindra, Nisha
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02382406 STU00105339
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Study Coordinator 312 695 1102
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
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…
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
A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma
The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin. The safety and tolerability of these drugs will be studie…
The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin. The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met. Screening is required within 21 days prior to first dose.
Agulnik, MarkAgulnik, Mark
NCT02326025 STU00200062
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Low InTensity Exercise Intervention in PAD
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
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma …
This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
Kumthekar, PriyaKumthekar, Priya
NCT02152982 STU00200312
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Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
Frontotemporal Lobar Degeneration (FTLD) is the neuropathological term for a collection of rare neurodegenerative diseases that correspond to four main overlapping clinical syndromes: frontotem…
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. The consortium, referred to as Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL), will be headquartered at UCSF and will partner with six patient advocacy groups to manage the consortium. Participants will be evaluated at 14 clinical sites throughout North America and a genetics core will genotype all individuals for FTLD associated genes.
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
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
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…
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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Vyas, Riddhi 312 926 4801
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
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 tria…
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
To Evaluate the Impact of SBI on C. Difficile in Hospitalized UC Patients
The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations: I. Hospitalized ulcerative colitis (UC) p…
The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations: I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are receiving vancomycin. II. Hospitalized UC patients who tested negative for C. difficile at time of admission.
Hanauer, StephenHanauer, Stephen
NCT02730325 STU00200335
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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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Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
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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Serrano, Linda 312 503 5903
Observational US Study Assessing Outcomes, Treatment Patterns, AEs, QOL in MF-CTCL Patients and Treated With Valchlor
The purpose of this study is to better understand: the use of Valchlor®; the disease of MF-CTCL; the health outcomes in patients treated with Valchlor® under care by your doctor.
Adult patients currently being treated with Valchlor®, for the treatment of mycosis fungoides cutaneous T-cell lymphoma (MF-CTCL) and able to sign an informed consent form without assistant from others.
Guitart, JoanGuitart, Joan
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02296164 STU00200362
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Serrano, Linda 312 503 5903
A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild Alzheimer's Disease
AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, th…
AZD0530 is an inhibitor of Src and Abl family kinases1. It has been developed as treatment for malignancies because these kinases play a role in tumor invasion and proliferation. However, the Src family kinases (SFKs) are highly expressed in brain and have major effects on synaptic plasticity. Moreover, the investigators have recently shown that a specific SFK, namely Fyn, is aberrantly activated by specific conformations of the Amyloid Beta (Aß) peptide from Alzheimer's disease (AD). Genetic deletion of Fyn rescues AD deficits in preclinical models. This clinical trial will test the potential benefit of AZD0530 for Alzheimer's disease modification.
Bonakdarpour, BornaBonakdarpour, Borna
NCT02167256 STU00200256
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Lipowski, Kristine Lynn 312 503 5212
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
Beraprost-314d Added-on to Tyvaso® (BEAT)
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. …
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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Investigation of how nulliparous women make decisions regarding epidural use for labor analgesia
The purpose of this study is to understand the decision-making process that first-time mothers go through when deciding whether to use epidural analgesia for labor. First, we will interview pregnant women…
The purpose of this study is to understand the decision-making process that first-time mothers go through when deciding whether to use epidural analgesia for labor. First, we will interview pregnant women about what information sources they rely on to make this decision and assess whether they have accurate information about risks and benefits. Next, we will use medical records to determine whether epidural was used during labor and then follow up by phone to assess women's perspectives about their choice of receiving an epidural/no epidural during labor.
Toledo, PalomaToledo, Paloma
STU00200581
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Odontoid Fracture Study Treated With Pulsed Electromagnetic Fields
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 …
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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A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 With Tremelimumab or Tremelimumab Alone in Head and Neck Cancer
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, ph…
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab or tremelimumab alone in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.
Agulnik, MarkAgulnik, Mark
NCT02262741 STU00200513
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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
Fibroids and Urinary Symptoms Study (FUSS) Survey
This study aims to better understand and characterize pelvic floor and urinary symptoms in a cohort of women with uterine fibroids. The primary outcome of this study will be comparing differences in dynamic MRI imaging in a subset of women with and wi…
This study aims to better understand and characterize pelvic floor and urinary symptoms in a cohort of women with uterine fibroids. The primary outcome of this study will be comparing differences in dynamic MRI imaging in a subset of women with and without pelvic floor symptoms and fibroids. This study is for either women affected by uterine fibroids or pelvic floor symptoms or women wanting to participate in women’s health research on uterine fibroids and pelvic floor symptoms.
The study will include women that are between the ages of 25 and 55 years old, English speaking and currently have uterine fibroids. Participants should not have any contraindication to the MRI such as pacemakers, magnetic implants, etc, or they will not be considered eligible for the study.
Kenton, KimberlyKenton, Kimberly
  • Map it 676 N St. Clair Arkes Pavillion Suite 950
    Chicago, IL
STU00200796
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Siurek, Alexis 312 695 7748
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
OPsumit USers Registry
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 …
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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Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma
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 combinat…
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
MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzum…
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients who have received prior treatment with rastuzumab any setting and who have either progressed or are intolerant to each of pertuzumab and ado-trastuzumab emtansine in the metastatic or locally advanced setting. Patients must not have been previously treated with anthracycline in any setting.
Flaum, LisaFlaum, Lisa
NCT02213744 STU00200503
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1-888-NU-STUDY
MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ
This clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio…
This clinical trial studies magnetic resonance imaging (MRI) and gene expression in diagnosing patients with abnormal cells in the breast duct that have not spread outside the duct. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. MRI may help find and diagnose patients with breast cancer. It may also help doctors predict a patient's response to treatment and help plan the best treatment. Genetic studies may help doctors predict the outcome of treatment and the risk for disease recurrence. Performing MRI with genetic studies may help determine the best treatment for patients with breast cancer in situ.
Khan, Seema Ahsan AhsanKhan, Seema Ahsan Ahsan
NCT02352883 STU00200436
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1-855-NU-STUDY
Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study…
The purpose of this study is to evaluate the safety of alisertib and its effect, bad and/or good, on acute megakaryoblastic leukemia (AMKL) or myelofibrosis (MF). The study drug, alisertib, is an investigational drug. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). Alisertib has shown evidence in the lab that it may have an effect on a type of cell that produces platelets. This cell is called a megakaryocyte and it is known to be defective (doesn't work well) in both AMKL and MF.
Some of the eligibility criteria include:

- Participants must be 18 or older.
- Participants must have an estimated life expectancy of at least 6 months.
- Participants must have a confirmed diagnosis of one of the following (as defined by the World Health Organization criteria):

a. Relapsed/refractory acute megakaryoblastic leukemia (AMKL)

b. Myelofibrosis (MF), including primary and post-essential/post- polycythemic myelofibrosis

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.
Stein, Brady LeeStein, Brady Lee
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02530619 STU00200682
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Study Coordinator 312 695 1102
Genomic Response Analysis of 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 Lopressor (als…
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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heart failure

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Crooke, Catherine 312 695 4189
Exemestane With or Without Entinostat in Treating Postmenopausal Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane …
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating postmenopausal patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Gradishar, William JGradishar, William J
NCT02115282 STU00200791
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1-855-NU-STUDY
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received at Least Three Previous Chemotherapy Regimens
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received at least three previo…
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received at least three previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
Nieves-Neira, WilbertoNieves-Neira, Wilberto
NCT02354586 STU00200818
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1-855-NU-STUDY
HIV acquisition among African-born US residents
We are doing this study with people who have been diagnosed with HIV infection and were born in Africa. We want to learn about how and where people born in Africa who now live in the U.S. became infected with HIV, and how often and where they were scre…
We are doing this study with people who have been diagnosed with HIV infection and were born in Africa. We want to learn about how and where people born in Africa who now live in the U.S. became infected with HIV, and how often and where they were screened for HIV, so that barriers for HIV diagnosis can be identified. This study involves a one-time in-person interview (30 to 45 minutes) about the participants HIV testing history, risk factors, and sexual behaviors.
Have an HIV diagnosis in 2000 or later year; African country of birth or citizenship, but currently living in the U.S.; Male or Female at least 18 years of age; English-speaking
Taiwo, Babafemi OTaiwo, Babafemi O
STU00200911
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Berzins, Baiba Ingrida 312 695 5012
Pembrolizumab Alone and In Combination With ACP-196 in Subjects With Advanced Non-small Cell Lung Cancer
Pembrolizumab alone and in combination with ACP-196 in subjects with advanced non-small cell lung cancer.
Mohindra, NishaMohindra, Nisha
NCT02448303 STU00200814
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1-888-NU-STUDY
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their scr…
The LEARN study a multicenter, observational study will that will evaluate the rate of cognitive change in approximately 500 clinically normal older individuals who "screen-fail" for the A4 trial on the basis of their screening PET imaging not demonstrating evidence of elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility criteria. This study will leverage the A4 infrastructure and maximize the data acquired in screening a large number of well-characterized older adults for the A4 trial. The LEARN observational cohort will provide a critical comparison group for the A4 placebo arm, and future trials in preclinical AD. Although accumulating longitudinal data suggest that older individuals with elevated Aβ burden are at increased risk of cognitive decline, it is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen fail" for the A4 trial. The LEARN study will follow 500 of these individuals, matched as closely as possible to the two treatment arms, in this observation cohort. The LEARN study may selectively recruit from a specific range of SUVr that fall below the threshold for "elevated amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent cognitive change and amyloid accumulation. The observational cohort will be followed for 168 weeks with identical clinical/cognitive testing performed every 24 weeks, running parallel to the A4 treatment study.
Weintraub, SandraWeintraub, Sandra
NCT02488720 STU00200681
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Lipowski, Kristine Lynn 312 503 2486
PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.
Cuttica, Michael JCuttica, Michael J
NCT02382016 STU00200753
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1-855-NU-STUDY
The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (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 chr…
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
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
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
Nivolumab in Treating Patients With Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal
This phase II trial studies how well nivolumab works in treating patients with squamous cell carcinoma of the anal canal that has not responded to previous treatment (refractory) a…
This phase II trial studies how well nivolumab works in treating patients with squamous cell carcinoma of the anal canal that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
Kircher, SheetalKircher, Sheetal
NCT02314169 STU00201069
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1-888-NU-STUDY
Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis
This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop …
This randomized phase III trial compares the effects, good and/or bad, of sorafenib tosylate in treating patients with desmoid tumors or aggressive fibromatosis. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the proteins needed for cell growth.
Agulnik, MarkAgulnik, Mark
NCT02066181 STU00201073
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Treating verbal memory deficits following chemotherapy for breast cancer
This is a treatment study testing a computerized therapy used at home to help with memory for words and to help with slowed mental processing speed. The study takes place over a 6 week period and there is a one-month follow ass…
This is a treatment study testing a computerized therapy used at home to help with memory for words and to help with slowed mental processing speed. The study takes place over a 6 week period and there is a one-month follow assessment after that. Participants will be randomized to receive treatment right away or will be given the option to receive treatment after 6 weeks.
Women between the ages of 65 and 90 years who have had chemotherapy treatment for early stage breast cancer. Ineligible if breast cancer diagnosis more than one time or any history of other cancer.
Cherney, Leora RCherney, Leora R
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00200767
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Diane F. Morean, Ph.D. F. 847 644 2594
Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation
One in eight women will develop breast cancer in her lifetime, and many of these women undergo mastectomy followed by breast reconstruction by insertion of a tissue expander below the pectoralis major muscle. Wo…
One in eight women will develop breast cancer in her lifetime, and many of these women undergo mastectomy followed by breast reconstruction by insertion of a tissue expander below the pectoralis major muscle. Women undergoing breast reconstruction have been shown to have a significantly higher level of acute postoperative pain and postoperative narcotic requirement compared to women who undergo mastectomy alone without reconstruction. In addition to the inherently worthwhile end of providing patient comfort in the immediate postoperative period, decreased narcotic use carries with it the potential benefit of decreasing the incidence of other adverse effects such as nausea, vomiting, allergic reaction, and respiratory depression. Importantly, the intensity of pain in the immediate postoperative period has been implicated as an important factor predisposing patients to the development of chronic postoperative pain. Chronic pain following mastectomy is a significant and disabling problem, affecting up to 49% of patients in some series. Though breast reconstruction has been shown not to be an independent predictor of the development of chronic breast pain, improved control of acute pain in the immediate postoperative period carries significant promise in decreasing the incidence of this disabling condition for all breast cancer survivors treated with mastectomy. In addition, improving management of acute postoperative pain can shorten hospital stay, expedite return to daily normal activities and increase patient satisfaction. A variety of other adjuncts for pain control have been attempted in studies of variable methodological rigor, including injection of botulinum toxin into the pectoralis muscle, indwelling pain catheters, paravertebral blocks under ultrasound guidance, or simple irrigation of the general area of dissection during breast surgery with a solution containing local anesthestic. While each of these adjuncts has demonstrated some success, none has been widely adopted. Problems with these methods include cost, risk of adverse events, as well as anatomically incomplete or non-selective application. During mastectomy all breast tissue is removed, leaving the patient with denervated skin flaps. For breast reconstruction, a tissue expander is placed in a subpectoral pocket dissected between the pectoralis major and minor muscles. At the end of the procedure the pectoralis major muscle is placed under variable degree of tension depending on the amount of fluid placed inside the expander. This muscle stretch believed to be at least partially responsible for postoperative pain. In addition cut nerve endings in the superficial fascia likely contribute as well. The anatomy of nerves supplying the breast and involved muscles are well-described in rigorous cadaver studies. In this study we hypothesize that performing a block of the intercostal nerves responsible for innervating the breast tissue and skin and the pectoral nerves innervating the pectoralis major muscle should optimize immediate postoperative pain control in this patient population. Of adjuncts described in the literature, paravertebral blocks are the most anatomically targeted, but drawbacks include the need for a separate procedure preoperatively while the patient is awake by an anesthesiologist with facility performing these blocks as well as the risk of pneumothorax. Advantages of our proposed method include lack of pain as the patient is asleep, easy and speed of application, a decreased risk of pneumothorax as the injections are under direct visualization, as well as a decrease in cost and improved efficiency as the only a single provider (i.e. the operative surgeon) is required. Precedent for our technique has been described in the context of breast augmentation and breast lift, with a favorable safety profile and providing adequate analgesia to perform these procedures without the use of a general anesthetic.
Alghoul, MohammedAlghoul, Mohammed
NCT02525718 STU00200903
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Assessment Pain

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1-888-NU-STUDY
Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer
The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in parti…
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
Phase 3 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibros…
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
Association of Donor Age With Recipient Outcomes in Kidney Transplant
This is a single center study that seeks to study the impact of donor age on recipient outcomes in older kidney transplant recipients.
Gallon, LorenzoGallon, Lorenzo
NCT02514733 STU00200153
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1-855-NU-STUDY
Trans-MAPP 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), enriched with pre-defined subgroups, with …
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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SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in …
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.
Simuni, TatyanaSimuni, Tatyana
NCT02258152 STU00200019
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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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1-855-NU-STUDY
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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Siurek, Alexis 312 695 7748
Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce 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 people who have bipolar disorder and are taking othe…
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
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to find out if the mitral valve can be safely implanted using a procedure that is simpler than the open-heart procedure being used today and may be safer for patients who are at a higher risk from convent…
The purpose of this study is to find out if the mitral valve can be safely implanted using a procedure that is simpler than the open-heart procedure being used today and may be safer for patients who are at a higher risk from conventional open-heart surgery. The new device is called the Neovasc Tiara Mitral Valve System. It includes the Neovasc Tiara Mitral Transcatheter Heart Valve and the Tiara Transapical Delivery System. The device being studied would be implanted without the need for an open-heart procedure and without the need for a heart and lung machine. This is the first research study for this device that will be carried out in a small number of subjects. This study will include 30 subjects (10 in the US, 5 in Canada, and 15 in Europe) at up to 8 sites world-wide.
McCarthy, Patrick MMcCarthy, Patrick M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02276547 STU00201002
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Brady, Caitlin 312 926 5968
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcino…
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
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an invest…
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
Bega, DannyBega, Danny
NCT02274766 STU00201174
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1-888-NU-STUDY
Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
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 inf…
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
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
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 …
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
STU00201173
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Study Coordinator 312 695 1102
Sorafenib for Hepatopulmonary Syndrome
The main purpose of this clinical trial is to determine the safety and effects of the study drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effec…
The main purpose of this clinical trial is to determine the safety and effects of the study drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood and the function of the lung vessels.
Levitsky, JoshLevitsky, Josh
NCT02021929 STU00201153
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A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)
This is a study for participants with advanced gastric or gastroe…
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
Benson III, Al BBenson III, Al B
NCT02370498 STU00200986
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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
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
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
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors. …
The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.
Benson III, Al BBenson III, Al B
NCT01916447 STU00201281
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A Study of the Efficacy and Safety of Etrolizumab in Ulcerative Colitis Patients Who Are Refractory to or Intolerant of TNF Inhibitors
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and …
This phase III, double blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission in patients with moderately to severely active ulcerative colitis (UC) who are refractory to or intolerant of tumor necrosis factor (TNF) inhibitors.
Hanauer, StephenHanauer, Stephen
NCT02100696 STU00200704
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1-855-NU-STUDY
MOMENTUM 3 IDE Clinical Study Protocol
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. …
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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Nooruddin, Mohammed 312 695 1806
MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer
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…
The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.
Cristofanilli, MassimoCristofanilli, Massimo
NCT02536794 STU00200984
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1-855-NU-STUDY
Pertuzumab With High-Dose Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
This study will examine the safety and efficacy of pertuzumab in combination with high-dose …
This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.
Kumthekar, PriyaKumthekar, Priya
NCT02536339 STU00201462
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1-888-NU-STUDY
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
Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation
This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced solid tumors, including gliomas, that harb…
This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in advanced solid tumors, including gliomas, that harbor an IDH1 and/or IDH2 mutation.
Altman, Jessica KAltman, Jessica K
NCT02481154 STU00201350
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1-855-NU-STUDY
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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Patel, Ruchi 312 926 5585
Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL)
This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been geneticall…
This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on the cell surface. The study will determine if these modified T cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this treatment on survival.
Dinner, ShiraDinner, Shira
NCT02535364 STU00200524
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1-855-NU-STUDY
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis.…
This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
Singhal, SeemaSinghal, Seema
NCT02312206 STU00201418
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A Phase 3 Study to Examine the Efficacy, Safety and Tolerability of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patie…
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.
Zadikoff, CindyZadikoff, Cindy
NCT02469090 STU00201467
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AdaptResponse Clinical Trial
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 in…
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
Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with adva…
This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants will be randomly assigned to one of the 3 treatment arms of the study: pembrolizumab as monotherapy, or pembrolizumab + cisplatin + 5-fluorouracil (5-FU) or capecitabine, or placebo + cisplatin + 5-FU or capecitabine. The primary hypothesis is that pembrolizumab provides a clinically meaningful progression free and/or overall survival.
Benson III, Al BBenson III, Al B
NCT02494583 STU00201509
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1-855-NU-STUDY
Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients
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-tolera…
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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Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in women receiving adjuvant anthracycline-based chemotherapy…
The purpose of this research study is to see if Atorvastatin(Lipitor) 40 mg by mouth daily decreases the chance of developing heart problems in women receiving adjuvant anthracycline-based chemotherapy for breast cancer.
Lee, Daniel CLee, Daniel C
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01988571 STU00201665
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Study Coordinator 312 695 1102
Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double bl…
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double blind study. This study will enroll subjects with portal hypertension (HVPG greater than or equal to 6 mm Hg) who also have a liver biopsy with cirrhosis (Ishak stage 5 or 6), presumably due to NASH, excluding subjects with medium and large varices and those with decompensated cirrhosis. Subjects with portal hypertension and cirrhosis will be randomly assigned (1:1:1 ratio) to receive 1 of 3 treatment assignments including placebo, GR MD 02 in a dose of 2 mg/kg lean body mass, or GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 intravenous infusions. The primary endpoint analysis is the baseline adjusted change in HVPG at 1 year (53 55 weeks) in subjects treated with placebo as compared to subjects treated with GR MD 02 (2 mg/kg/week or 8 mg/kg/week). An esophagogastroduodenoscopy (EGD) with evaluation for varices, HVPG, and liver biopsy will be performed before the first infusion and after the final 26th dose of IMP. Additionally, subjects will undergo a FibroScan (if available) prior to the first infusion, at Infusion Visit 13, and 14 to 28 days following final 26th infusion, an MBT (if available) will be performed at screening, at Infusion Visit 13, and 14 to 28 days after the final infusion, and blood will be collected for assessment of biomarkers. All subjects are to attend 2 postdose visits: the first will occur 14 to 28 days after the final dose administration and a second will occur 14 days following the first postdose visit. Subjects will be offered enrollment into a subsequent separate study, an open label extension study, if there is adequate tolerability and no safety issues or signs of clinical progression that would recommend discontinuation. Subjects who do not enroll in the open label extension study will be contacted via telephone every 6 months for 2 years and annually thereafter for a total of 4 years.
Rinella, Mary EugeniaRinella, Mary Eugenia
NCT02462967 STU00201120
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1-855-NU-STUDY
Efficacy and Safety of BI 655066 in Patients With Severe Persistent Asthma.
Many people with severe asthma do not have their symptoms controlled even after taking current therapies that are available, and experience frequent asthma attacks. The purpose of the study is to test the safety and ef…
Many people with severe asthma do not have their symptoms controlled even after taking current therapies that are available, and experience frequent asthma attacks. The purpose of the study is to test the safety and effectiveness of the study drug called risankizumab administered by injections beneath the skin in adults with severe asthma. This study will test whether the study drug will reduce attack frequency, reduce episodes of asthma worsening, improve asthma symptoms, improve lung function, and resolve inflammation in the airways.
18 years of age or older with severe asthma
Rosenberg, Sharon ReiflerRosenberg, Sharon Reifler
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02443298 STU00201582
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Hixon, Jenny Lorraine 312 926 0975
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
A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis Who Have an F508del-CFTR Mutation
This is a Phase 3, multicenter, open-label, rollover study in subjects with CF who are homozygous or hetero…
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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Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas [Transsphenoidal Extent of Resection Study – TRANSSPHER Study]
Endonasal transsphenoidal removal of…
Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the surgical techniques. The purpose of this research is to compare surgical techniques in patients with nonfunctioning pituitary adenomas (tumors that do not change hormone levels in patients). This is an observational, data collection study, which means there will be no experimental procedures or experimental medicines. Your participation in this study has no effect on the type of surgery you will have.
Adult patients with suspected nonfunctional pituitary macroadenomas who have planned transsphenoidal surgery.
Inclusion Criteria
-Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery
-Adults (age 18-80 years)
-Medically stable for surgery
-Reasonable expectation that patient will complete study and be available for follow-up assessments
*Patients who have had prior surgery are eligible for the study.
Exclusion Criteria
-Pregnant women
-Patients with suspected functioning pituitary adenoma
-Unable to obtain MRI of the pituitary
-Pituitary apoplexy
Chandler, James PChandler, James P
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02357498 STU00200458
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Amidei, Christina 312 695 9124
Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares …
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
Strauss, Jonathan BStrauss, Jonathan B
NCT02364557 STU00201769
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1-855-NU-STUDY
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
This randomized phase III trial studies how well initial treatment with ipilimumab and nivolum…
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
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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Study Coordinator 312 695 0700
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients Using Levodopa
Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part …
Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (Part A) with an open-label phase (Part B).
Zadikoff, CindyZadikoff, Cindy
NCT02453386 STU00201468
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1-855-NU-STUDY
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation
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 opera…
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
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
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 …
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