Skip to main content

Search Trials

Trials

Clinical and Molecular Analysis Of Neoplasms

Pedram, GeramiPedram, Gerami
STU00001127
More Info
Copy

NU 05H6: Acute Leukemias and Map Kinase

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

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

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

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

Platanias, Leonidas CPlatanias, Leonidas C
  • Map it 201 E. Huron St.
    Chicago, IL
STU00004841
More Info
Copy

NCI 02X3: SPORE in Pancreatic Cancer Tissue Core

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

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

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

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
More Info
Copy

HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H

The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor 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
More Info
Copy

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 of research studies designed to help us …
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
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
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00009193
More Info
lupus
Copy

DERMATOLOGY TISSUE ACQUISITION AND REPOSITORY

This study is collecting skin, hair, nail, blood,saliva, skin and/or buccal swabs, and mucous membrane (part of your skin which lines bodypassages and cavities such as the inside of your mouth or nose), and other tissue samples for usein a biorepository. By operating this biorepository, the Department of …
This study is collecting skin, hair, nail, blood,saliva, skin and/or buccal swabs, and mucous membrane (part of your skin which lines bodypassages and cavities such as the inside of your mouth or nose), and other tissue samples for usein a biorepository. By operating this biorepository, the Department of Dermatology hopes todevelop a better understanding of skin diseases (meaning the knowledge about how cells in theskin behave and react to medical treatments) among researchers at Northwestern University andother approved researchers. This basic knowledge is expected to help the development of moreeffective patient care and new treatment methods.
  • Consent to have specimens collected as part of a standard of care procedure
  • Have a skin disease diagnosis which researchers want samples of in order to further understand the disease
  • Qualify as a healthy volunteer (a person with no skin disease)
Rangel, Stephanie MarieRangel, Stephanie Marie
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00009443
More Info
Copy

NUGene: Gene-Disease Associations and Treatment Outcomes

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to …

Share your health data and a little blood to help with studies on all kinds of diseases— cancer, diabetes, heart disease. A ready pool of samples and treatment histories speeds up research. It’s simple to help. And your info is so important to the search for new ways to prevent and treat illnesses.

Want to make an impact in just 20 minutes? Give some blood, answer some questions, and share your health records with your study team’s database. Researchers use it to find disease patterns and search for new ways to prevent and treat illnesses.

Must be a patient at Northwestern or one of its affiliates.
Chisholm, Rex LChisholm, Rex L
  • Map it 201 East Huron Street Suite 12-160​
    Chicago, IL
STU00010003
More Info
Copy

Genetics of Prostate Cancer

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early …

Recruiting Research Participants for a New Study on the “Genetics of Prostate Cancer”

At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early stages of embryonic development, the embryo is made up of cells that have the potential to develop into all types of cells, like skin, muscle, liver, brain, pancreas, breast, ovary, fallopian tube, or prostate cells. Because of this ability, these cells are called “pluripotent” embryonic stem cells (ESCs). However, about a week after fertilization, the embryonic cells lose their ability to develop into all of the different cells and tissues of the body and gradually “differentiate” into the various tissues and organs that have different specific functions. So, there is a relatively narrow window during which pluripotent ESCs exist in the embryo.

At the end of the in vitro fertilization (IVF) process for couples undergoing subfertility treatment, the doctors are usually left with one-week-old embryos. In 1998, using such embryos for research, scientists figured out how to grow pluripotent ESCs in the lab that can stay in their pluripotent state if the right growth conditions are present. Changing the growth conditions in certain ways, scientists learned how to stimulate the ESCs to go through a process called “differentiation,” in which the stem cells can develop into any of the different cell types present in the body. ESCs were used in the early animal cloning experiments that produced the cloned ewe named “Dolly;” however, cloning human cells is illegal. While ESCs offer promising and exciting opportunities, like the possibility of growing organs in the lab, because their production involves technical and ethical problems, efforts were directed to produce pluripotent stem cells from mature cells to avoid the use of embryos.

In 2007, Japanese researchers found an amazing way (for which they received a Nobel Prize) to transform mature cells, like regular skin or blood cells, directly into stem cells without using human eggs. They found a combination of proteins that, if injected into mature cells, gradually reprogrammed them into induced pluripotent stem cells, abbreviated iPSCs.

Research Project

Drs. Dan Theodorescu and Clive Svendsen, the Principal Investigators at the Cedars-Sinai Medical Center in Los Angeles, California in collaboration with Dr. William Catalona, the Principal Investigator at Northwestern University are engaged in research using iPSCs to develop a model of human prostate cancer using iPSCs from men who carry BRCA2 mutations that are related to a higher risk for developing aggressive prostate cancer (the Cedars-Sinai team has already accomplished this for ovarian cancer in women who carry BRCA1 mutations). As study controls, they will also enroll men with non-BRCA2-related prostate cancer and those without prostate cancer. They will not use embryos.

In the laboratory, the researchers will take the white blood cells from a blood sample back in time to when they were capable of making any cell type in the body and differentiate them forward into prostate cells carrying (or for non-BRCA2-mutation carriers, not carrying) the BRCA2 mutation in a petri dish. Using these transformed prostate cells, they will use current genetic engineering and molecular biology research methods to study the mechanisms of the transformation of normal prostate cells into aggressive prostate cancer cells. This model also can be used in cell-signaling studies and drug screening studies for designing future therapies. The bank of prostate iPSCs that they will create may be shared with research institutions around the world.

These researchers are now recruiting men and their male family members who carry a BRCA2 mutation and other prostate cancer patients and controls without prostate cancer to participate in this study. This research is being performed to discover the causes of prostate cancer and how it is passed down in families using the BRCA2 mutation as a model system and also can be applied to non-BRCA2-related cancers.

This study is called “The genetics of prostate cancer” and is approved by the Institutional Review Boards at Northwestern University (STU00018651) and Cedars Sinai, whose function is to protect the rights of research subjects and to oversee ethical issues. Participation in this study will involve having up to 50 ml of your blood drawn (10 teaspoons), and completing family history questionnaires (baseline and follow-ups) and clinical follow-up questionnaires, if applicable. The time involved includes the time required to read the 10-page consent form, and the time required to travel to Northwestern Memorial Hospital, Galter Pavilion, 675 North St. Clair Street, Chicago, IL 60611 for the research blood draw.If it is not convenient for you to come to our clinic you may be able to get blood drawn at a clinic of your choice and we will arrange to have it shipped to Cedars-Sinai in Los Angeles, California. It will take about 20 to 40 minutes to complete the questionnaire. In the case that your family history suggests familial prostate cancer, Dr. Catalona may want your family members to participate in the study as well. You may be asked to contact your relative(s) about the study. We will follow up with a family history follow-up questionnaire annually, which takes 15 to 30 minutes to finish, to update the file. If you develop prostate cancer, we will want you to fill out a clinical follow-up questionnaire about prostate cancer and follow you up with the questionnaire annually as well, which takes 10 minutes to finish.

In addition, we may request up one or more additional blood samples of 10 to 20 ml (2-4 teaspoons) from you at a later date, depending on the evolving needs of the study. You may refuse to provide these follow-up blood samples without affecting your participation in this study. The blood sample(s) will be saved for future analysis. Efforts will be made to limit the use and disclosure of your personal information, including research studies and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution.

Research results will not be available to you or your physician except under extraordinary circumstances. These are situations in which a life-threatening medical disorder is discovered for which medical treatment is available to prevent or alleviate long-term medical complications. If such a situation should occur, we will contact you via phone, email or mail.

Those interested in participating may contact Dr. Catalona at 312 695-4471 or william.catalona@nm.org.

Further background information on stem cells is available from the author who created the background information for this article: Meshorer E (2020) What Are Embryonic Stem Cells and How Can They Help Us?. Front. Young Minds. 8:32. doi: 10.3389/frym.2020.00032. Copyright © 2020 Meshorer

Male carriers of BRCA2 mutations with prostate cancer and men with metastases aged 18 years or older

Catalona, William JCatalona, William J
  • Map it 675 N. Saint Clair St. Twentieth Floor, Suite 150
    Chicago, IL
STU00018651
More Info
Copy

Mediators of Atherosclerosis in South Asians Living in America

South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
Kandula, Namratha RKandula, Namratha R
NCT01207167 STU00019837
More Info
Copy

NU 00X3: Pathology Core Facility

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

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

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

Horbinski, Craig MichaelHorbinski, Craig Michael
  • Map it 201 E. Huron St.
    Chicago, IL
STU00020989
More Info
Copy

RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy

RATIONALE: Drugs used in chemotherapy, such as cisplatin, 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, Eric DonaldDonnelly, Eric Donald
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
More Info
Copy

Asymmetric Neurodegeneration and Language in Primary Progressive Aphasia

The observational primary progressive aphasia (PPA) research program at Northwestern University seeks to study individuals living with PPA over time using neuropsychological testing and advanced imaging techniques. Participants are asked to come to Chicago in order to help:better understand progression in PPA and its link to brain changes,increase …

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

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

    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, urine, and expressed prostatic secretions. …
    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 with chronic pelvic pain syndrome (CPPS). 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
    More Info
    Copy

    NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study

    RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods 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
    More Info
    Copy

    Alzheimer's Disease Research Center

    The purpose of the Northwestern Alzheimer’s Disease Center (NADC) Clinical Core study is to support clinical and basic research on memory and aging by collecting, storing,and disseminating clinical data. These data and samples include memory and thinking tests, brain imaging scans, blood samples, and brain donations. We collect …

    The purpose of the Northwestern Alzheimer’s Disease Center (NADC) Clinical Core study is to support clinical and basic research on memory and aging by collecting, storing,and disseminating clinical data. These data and samples include memory and thinking tests, brain imaging scans, blood samples, and brain donations. We collect these data and samples from study participants who are experiencing healthy aging and those who suffer from dementia or Mild Cognitive Impairment. This study is a longitudinal, observational trial meaning that research participants will be observed over time, and data will be collected,but there is no attempt to alter the symptoms or course of disease (an intervention). Participants attend annual visits that typically last one to three hours. If participants can no longer attend in-person visits, we will continue to follow them through telephone visits with a designated study partner.

    This study is a multi-site study meaning Northwestern University is one of 32 sites in the United States. All data are de-identified and shared with a national database. There are currently over 15,000 participants in this study nationally with approximately 500 of them enrolled at Northwestern University. Once they enroll, most participants are referred to other research studies being led by investigators within the Mesulam Center or the greater Northwestern University scientific community.

    The Northwestern Alzheimer’s Disease Center (NADC) ClinicalCore study enrolls individuals with diagnoses of Mild CognitiveImpairment, Alzheimer's disease or other dementia (frontotemporal dementia,primary progressive aphasia, Lewy Body disease and others) as well as healthyindividuals with no cognitive impairment. See below for specific eligibilitycriteria.

    Patients Diagnosed with Dementia or Mild Cognitive Impairment(MCI)

    • 18 years or older
    • Must have had aclinical evaluation with the ability to provide medical records and doctor’snotes
    • Speaks fluent English
    • Ability to providereliable study partner (someone who knows you well to provide up to date informationabout how you are functioning)

    Healthy Volunteers

    • Over the age of 55, but some exceptions can be made, especially if there is a strong family history of dementia
    • Cognitively normal,based on an absence of significant impairment in cognitive functions oractivities of daily living
    • Living independentlyin the community
    • Visual and auditoryacuity adequate for neuropsychological testing
    • Good general healthwith no diseases expected to interfere with the study
    • Speaks fluent English
    • Ability to provide areliable study partner
    All participants are encouraged to participate in research brainimaging scans (MRI, PET, etc.), donate a sample of blood, and donate theirbrain at time of death. All in-person visits take place at NorthwesternUniversity’s downtown Chicago campus and participants can receive free parking ifthey park on Northwestern University’s campus. Additional compensation isdetermined by participation. Please contact the study coordinator forquestions.

    Vassar, Robert JVassar, Robert J
    STU00023196
    More Info
    Copy

    Neural Mechanisms in Sensory Reception and Processing in the Healthy Adult (VA RR&D Grant # B3302K)

    Pape, Theresa L BenderPape, Theresa L Bender
    STU00024134
    More Info
    Copy

    PACTG 1026s: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL AND RELATED DRUGS DURING PREGNANCY AND POSTPARTUM

    The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (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.
    This study is closed to accrual and is no longer recruiting subjects.
    Jao, JenniferJao, Jennifer
    NCT00042289 STU00030724
    More Info
    Copy

    NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility

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

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

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

    You may be eligible for this research study if you are a woman with breast cancer undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of your cancer. 
    Wei, Jian-JunWei, Jian-Jun
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT00898131 STU00023488
    More Info
    Copy

    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 factors, genetic factors, and brain structure. The second purpose of this study is …
    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, EmilyRogalski, Emily
    STU00027225
    More Info
    Copy

    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 potential research participants who view the Department’s website. This application is not in itself a research project, but only …
    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
    More Info
    Copy

    Peripheral Neuropathy Research Registry (PNRR)

    National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with …
    National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with PN. By using thisregistry, researchers will facilitate both basic and clinical research studies that will bring improvedunderstandings of the etiology (origination) and pathogenesis (development) of PN. They willspecifically ask why some patients with peripheral neuropathy develop neuropathic pain and othersdo not, and what the characteristics of patients with painful peripheral neuropathy are in terms oftheir symptoms, examination findings, and blood tests. Ultimately this research may result inimproved 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
    More Info
    Copy

    NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

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

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00039629
    More Info
    Copy

    Microbiomes of Pelvic Pain

    Klumpp, DavidKlumpp, David
    STU00055668
    More Info
    Copy

    Northwestern University The Department of Psychiatry and Behavioral Sciences, Clinical Research Program (NU CRP) Recruitment Pipeline

    The recruitment pipeline provides research staff with an organized system of identifying researchsubjects.NU CRP clinical research studies covers a wide spectrum of 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’…
    The recruitment pipeline provides research staff with an organized system of identifying researchsubjects.NU CRP clinical research studies covers a wide spectrum of Axis I Diagnoses such as schizophrenia, depression, anxiety, etc. NU CRP also conducts research studies for patients who are diagnosed with certain neurological diseases such as Alzheimer’s disease, Tourette’s Syndrome, etc. NU CRP conducts basic, translational and clinical research. Personal Health Information (PHI) will not be collected. All information collected in this recruitmentregistry is based on the patient self-report. You will be contacted to answer additional questions by someone in the study staff and to determine your eligibility for the current studies.
    Goldman, Morris BGoldman, Morris B
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    STU00059328
    More Info
    Copy

    A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS

    Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
    Borja-Cacho, DanielBorja-Cacho, Daniel
    NCT01897688 STU00059469
    More Info
    Copy

    A Randomized Trial to Prevent Congenital Cytomegalovirus Infection (CMV)

    Cytomegalovirus (CMV) is a common virus that usually presents withfew if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. …
    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.
    Yee, Lynn MYee, Lynn M
    NCT01376778 STU00059714
    More Info
    Copy

    A Registry of Interstitial Lung Disease Patients

    The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine …
    The purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine who might be eligible for and interested in participating in future studies related to ILD.

    Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis.

    • At least 18 years old
    • Diagnosis of interstitial lung disease (ILD)
    • Receives care at Northwestern's Pulmonary Clinic
    Dematte DDematte D'Amico, Jane E
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    STU00060593
    More Info
    Copy

    A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety

    The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well 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 …
    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
    More Info
    Copy

    NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid Leukemia

    In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop …

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00074258
    More Info
    Copy

    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 treatment, 6-months after treatment. We additionally hope to identify the most effective speech and language therapy strategies for persons with these …
    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, EmilyRogalski, Emily
    NCT02439853 STU00073634
    More Info
    Copy

    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 different research studies at CBITs. The research conducted at CBITs generally involves evaluating different aspects …
    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
    More Info
    Copy

    Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

    This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).
    Salem, RiadSalem, Riad
    NCT02026908 STU00081296
    More Info
    Copy

    Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa

    This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).
    Apkarian, ApkarApkarian, Apkar
    NCT01951105 STU00081444
    More Info
    Copy

    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 practice, when used according to the applicable Directions for Use and to evaluate the economic value and technical performance of Boston Scientific commercially approved …
    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
    More Info
    Copy

    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.…
    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, Bruce ScottBochner, Bruce Scott
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00085003
    More Info
    Copy

    NUDB 13C03: Northwestern Brain Tumor Institute Research Database

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

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

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

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

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
    More Info
    Copy

    Parkinson’s Disease and Movement Disorders Center Biorepository

    This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’…
    This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’s risk for developing them. Samples collected for this biorepository include a blood sample (or a saliva sample) and a skin biopsy. Participants may choose to donate one or both samples.

    • Diagnosis of a movement disorder • Male or female 18 years of age or older when diagnosed • Ability to provide informed consent

    Akhtar, Rizwan SmeerAkhtar, Rizwan Smeer
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00091585
    More Info
    Copy

    A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.

    This study is a prospective Phase IV study to determine if the 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
    More Info
    Copy

    RANDOMIZED CONVERSION OF EBV+ KIDNEY TRANSPLANT RECIPIENTS OF LIVING OR STANDARD CRITERIA DONORS AT THREE MONTHS POST TRANSPLANTATION TO BELATACEPT WITH MPA OR BELATACEPT WITH LOW-DOSE TACROLIMUS (50% OF DOSE) COMPARED TO PATIENTS REMAINING ON CENTER SPECIFIC STANDARD THERAPY OF TACROLIMUS AND MPA

    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 …
    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
    More Info
    Copy

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

    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)…
    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
    Hanauer, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01848561 STU00094204
    More Info
    Copy

    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 biopsies (small pieces of tissue) to be used for several studies.…
    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
    Must not be:
    - Obese (i.e. BMI ≥30)
    - Known medical illnesses that could affect esophageal function, gene expression or histology
    - Have a diagnosis of an eating disorder
    - Have a diagnosis of an autoimmune disease
    - A current or previous smoker (smoked >100 cigarettes in lifetime)
    - Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
    - Taking antacids and/or proton pump inhibitors for heartburn
    - Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
    - Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
    - Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
    Carlson, Dustin AllanCarlson, Dustin Allan
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00096856
    More Info
    Copy

    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 research studies. Depending on your eligibility, you could take part in …
    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, Joel LVoss, Joel L
    STU00060723
    More Info
    Copy

    Noninvasive Manipulation of Hippocampal-Cortical Brain Networks and Memory

    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our research studies. Depending on your eligibility, you could take part in …
    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, Joel LVoss, Joel L
    STU00070522
    More Info
    Copy

    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 share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter …
    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
    More Info
    Copy

    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 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 BenderPape, Theresa L Bender
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02366754 STU00103966
    More Info
    Copy

    Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic Efficacy

    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, …
    We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
    • Diagnosis of rheumatoid arthritis (RA).
    • Must have been 18 years of age or older at the time of diagnosis of RA.
    • At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
    Perlman, Harris RPerlman, Harris R
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00104822
    More Info
    Copy

    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 McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02462824 STU00100697
    More Info
    Copy

    NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

    There are two study questions the investigators are asking in this randomized phase II/III trial 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.
    Gharzai, LailaGharzai, Laila
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02135042 STU00200330
    More Info
    Copy

    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. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an …
    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
    More Info
    Copy

    NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

    Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to …

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

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200435
    More Info
    Copy

    Low InTensity Exercise intervention in PAD: The LITE Trial.

    This study is being done to determine whether an exercise intervention that avoids continuous supervision and exercise-related pain in the legs can improve walking ability in people with lower extremity peripheral artery disease (PAD).
    Peripheral artery disease
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02538900 STU00105855
    More Info
    Copy

    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 likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.
    Miller, Emily StinnettMiller, Emily Stinnett
    NCT02454322 STU00200388
    More Info
    Copy

    Demo/Test Study

    This is a screener for a demo study. Thank you for your interest!
    Wehbe, FirasWehbe, Firas
    STUXXXXXXXX
    More Info
    prostate
    Copy

    Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)

    This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), 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
    More Info
    Copy

    A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)

    This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
    Miller, Emily StinnettMiller, Emily Stinnett
    NCT02518594 STU00200799
    More Info
    Copy

    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 performance more than telmisartan alone and more than supervised treadmill exercise alone. …
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
    More Info
    Copy

    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)

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

    Chronic Kidney Disease Research Biorepository

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

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

    ITN056ST: Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults

    The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
    Levitsky, JoshLevitsky, Josh
    NCT02533180 STU00201197
    More Info
    Copy

    High Resolution and Functional MRI Assessment of Intracranial Atherosclerotic Plaque

    Intracranial atherosclerotic disease (ICAD) accounts for 7-10% of cute ischemic stroke with a substantial risk of recurrent stroke in a setting of severe intracranial stenosis, approaching 12-25% over 1-2 years despite medical management. However, a risk stratification scheme is not available to identify this susceptible population for …
    Intracranial atherosclerotic disease (ICAD) accounts for 7-10% of cute ischemic stroke with a substantial risk of recurrent stroke in a setting of severe intracranial stenosis, approaching 12-25% over 1-2 years despite medical management. However, a risk stratification scheme is not available to identify this susceptible population for targeted treatment trials when intervention with more aggressive medical management and/or endovascular angioplasty/stenting could limit complications of ischemic stroke. The unmet need that we plan to address is to develop and study MR imaging modalities that may characterize vulnerable inflammatory and/or hemodynamically significant intracranial plaques, stratifying the mechanisms and potential predictors of primary/recurrent ischemic stroke in ICAD. Recently, we have identified unique intracranial plaque characteristics as well as hemodynamic parameters using quantitative MR perfusion techniques to stage cerebrovascular reserve failure that are associated with symptomatic intracranial stenoses. We propose a prospective study to recruit asymptomatic and symptomatic patients with severe ICAD and longitudinally assess them with a comprehensive and novel MRI protocol: high resolution 3T MR imaging, ferumoxytol molecular imaging, dynamic contrast enhanced (DCE) MRI to quantify the transfer constant (Ktrans) of contrast plaque permeability, and dynamic susceptibility contrast (DSC) MR perfusion weighted imaging (MRPWI) using the quantitative SCALE-PWI sequence. Our study hypothesis is that high resolution T1 plaque enhancement, T1/T2 plaque hemorrhage, early ferumoxytol uptake as a marker of macrophage infiltration/inflammation, intraplaque Ktrans permeability, and/or altered qCBF/qCBV perfusion based parameters with vascular territory analysis will assist in stratifying patient risk for thromboembolic versus hypoperfusion related ischemic complications respectively. This project aims to identify specific qualitative and quantitative thresholds with advanced high resolution, molecular, and functional MRI techniques that can be correlated to clinical presentations (asymptomatic, symptomatic, recurrent symptomatic), DWI infarct distributions (perforator, thromboembolic, hypoperfusion related infarcts), inflammatory blood markers, and clinical/imaging outcomes to inform an understanding of differential stroke mechanisms and to improve the selection of high risk ICAD patients who may be susceptible to primary or recurrent ischemic stroke despite aggressive medical management.
    Inclusion:
    1- Severe ICAD>70% confirmed by SOC CTA/MRA/DSA using SAMMPRIS criteria2
    2- AGE 30-80 YEARS
    3- At least one segment of
    a) supraclinoid ICA,
    b) A1-A2 ACA,
    c) M1-M2 MCA,
    d) intracranial vertebral-basilar artery
    e) P1-P2 PCA
    4- Age 30-80 years
    5- Symptomatic patients defined as an association between the intracranial stenosis and hemodynamic impairment of the corresponding vascular territory, based on either neurological exam (TIAs/stroke) and/or acute/subacute infarcts documented on MR-DWI

    Exclusion:
    1- Contraindications to MRI-Fill safety questionnaire day before MRI/Call to ask
    2- GFR70% cervical carotid or vertebral artery proximal stenosis, or tandem intracranial stenoses,
    5- Impaired liver function
    Ansari, Sameer AhmadAnsari, Sameer Ahmad
    STU00201681
    More Info
    Copy

    Role Functioning Changes in New Onset Symptoms

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

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

    Adults unable to consent
    Individuals who have not reached the age of 18
    Pregnant women
    Prisoners.
    Cronenwett, Will JCronenwett, Will J
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    STU00201133
    More Info
    Copy

    LIFT: Lupus Intervention for Fatigue Trial

    This study is designed to evaluate the effectiveness of one-on-one counseling sessions on reducing symptoms of fatigue in persons with lupus by providing them with individualized coaching on increasing physical activity and improving diet.
    Have lupus and experience fatigue as a result.

    At least 18 years old.

    Can participate in physical activity.

    Live in the Chicago area.

    Be able to speak and read English.

    Be able to consent to being in the study.

    Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT02653287 STU00201960
    More Info
    Copy

    The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study

    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.…
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
    Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
    More Info
    Copy

    Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot Study

    Preeclampsia is a serious medical condition affecting pregnancy. Certain chemicals in your blood may increase your risk of developing preeclampsia. A medicine called pravastatin, which you take by mouth, may decrease the levels of these chemicals. The purpose of this pilot study is to determine how the body handles Pravastatin …
    Preeclampsia is a serious medical condition affecting pregnancy. Certain chemicals in your blood may increase your risk of developing preeclampsia. A medicine called pravastatin, which you take by mouth, may decrease the levels of these chemicals. The purpose of this pilot study is to determine how the body handles Pravastatin during pregnancy and to determine its safety.
    • Are 18 years or older
    • Currently between 12-16 weeks pregnant
    • Have a documented history of prior severe PE, requiring delivery before 35 weeks gestation
    Wisner, Katherine LeahWisner, Katherine Leah
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT01717586 STU00202090
    More Info
    Copy

    A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.

    The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
    Some of the eligibility criteria include:

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Kulkarni, SwatiKulkarni, Swati
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02694809 STU00202100
    More Info
    Copy

    NU 15N01: Head and Neck Tissue Bank

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

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

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

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

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

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202177
    More Info
    Copy

    NU 15N02: Northwestern Head and Neck Cancer Registry

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

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

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

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202162
    More Info
    Copy

    Motivational Interviewing and Physical Activity in Parkinson’s Disease

    We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coaching style used to help people change their behavior; 2) a web-based application for …
    We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coaching style used to help people change their behavior; 2) a web-based application for participants to keep track of their physical activity; 3) a combination of the motivational interviewing and the web-based application; and 4) an educational program on various issues related to Parkinson’s disease.
    Live in the community
    At least 18 years of age
    A diagnosis of Idiopathic Parkinson’s Disease
    Be able to walk for a distance of 50 feet or 10 minutes at a time
    Do NOT currently complete 150 minutes or 2.5 hours of moderate to vigorous physical activity per week
    Currently has and uses a smartphone, tablet, or computer to access the internet
    Ehrlich-Jones, Linda SEhrlich-Jones, Linda S
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT03329833 STU00202265
    More Info
    Copy

    ECOG-ACRIN 6141: Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

    This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
    Chandra, SunandanaChandra, Sunandana
    NCT02339571 STU00202372
    More Info
    Copy

    Semen quality in males with inflammatory bowel disease: Influence of medication for IBD

    Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00201469
    More Info
    Copy

    Epidermolysis Bullosa Clinical Characterization and Outcomes Database

    The aim this study is to collaboratively advance knowledge about epidermolysis bullosa (EB) by collecting clinical data from patients with EB from multiple EB centers in the United States and Canada. As EB is a rare disease, coordination and collaboration between multiple centers will help our understanding of disease manifestations, …

    The aim this study is to collaboratively advance knowledge about epidermolysis bullosa (EB) by collecting clinical data from patients with EB from multiple EB centers in the United States and Canada. As EB is a rare disease, coordination and collaboration between multiple centers will help our understanding of disease manifestations, course, and complications, with the aim of improving future care, expanding clinical and translational research, and finding an eventual cure for individuals with EB.

    All candidates with a clinical diagnosis of epidermolysis bullosa are eligible for this study.  The subjects can be from any age, male or female without restriction.
    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00202682
    More Info
    Copy

    North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) Study

    This is a non-interventional study (i.e. no study drug)NARCRMS is a highly collaborative effort involving investigators, industry, and, mostimportantly, patients. The goal of this effort is to make information on all aspects of MS availableto all stakeholders in real-time. The feedback that patients will eventually receive …
    This is a non-interventional study (i.e. no study drug)

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

    The NARCRMS database is unique for the following reasons:

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

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

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

    Inclusion Criteria:

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

    Exclusion Criteria:

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

    Cohen, Bruce ArnoldCohen, Bruce Arnold
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00201852
    More Info
    Copy

    LiveWell: A Mobile Intervention for Bipolar Disorder

    This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If you are eligible for …
    This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If you are eligible for the study, your participation will last up to 12 months.
    Individuals 18-65 years old who have been diagnosed with bipolar disorder and are currently working with a psychiatrist
    Goulding, Evan HGoulding, Evan H
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03088462 STU00202860
    More Info
    Copy

    Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men

    2GETHER is a relationship education program and study designed to help male couples navigate the complexities of being in same-gender loving and gay relationships. 2GETHER provides participants with relationship tools to help them in the years to come.2GETHER participants will be asked to complete one of two different …

    2GETHER is a relationship education program and study designed to help male couples navigate the complexities of being in same-gender loving and gay relationships. 2GETHER provides participants with relationship tools to help them in the years to come.

    2GETHER participants will be asked to complete one of two different relationship programs, both of which focus on couples-specific skills and gay relationship coaching.

    Each relationship program involves:

    2 group sessions with other male couples.

    2 individual couples sessions with a trained 2GETHER facilitator

    Participant couples will then be tracked for the following year and will receive surveys at 3, 6, 9, and 12 months. As an incentive for participating in the clinical trial of the relationship program, each member of the couple has the potential to make up to $250.

    Inclusion:

    You’re assigned male at birth and currently identify as male.

    You’re 18 or older.

    You are in a relationship with another cisgender male.

    Newcomb, MichaelNewcomb, Michael
    NCT03186534 STU00202939
    More Info
    Copy

    Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer

    Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados …
    Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
    (a) ≥ 18 years of age;
    (b) Hispanic/Latino self-identification;
    (c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
    (d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
    (e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
    Miller, GregMiller, Greg
    • Map it 633 N. St. Clair St.
      Chicago , IL
    NCT03344757 STU00203197
    More Info
    Copy

    Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study

    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability …
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
    We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
    More Info
    Copy

    MAST CELLS IN MALE CHRONIC PELVIC PAIN AND LOWER URINARY TRACT DYSFUNCTION

    The purpose of this study is to figure out if drug treatments using cromolyn sodium and cetirizine hydrochloride lessen painful symptoms in patients suffering from chronic pelvic pain syndrome (CPPS).
    Men diagnosed with Category IIIB Chronic Pelvic Pain Syndrome reporting pain or discomfort in any of the 8 domains of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
    Thumbikat, PraveenThumbikat, Praveen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03167216 STU00202831
    More Info
    Copy

    NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell Clusters

    This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in …

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

    You may be eligible for this research study if you have advanced stage (III/IV)breast cancer.

    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203283
    More Info
    Copy

    Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase Disorder

    This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity …
    This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity monitoring.
    Individuals with delayed sleep-wake phase disorder and healthy controls
    Abbott, Sabra MargaretAbbott, Sabra Margaret
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203647
    More Info
    Copy

    A wearable myoelectric-computer interface to reduce muscle co-activation in acute and chronic stroke

    We are conducting a study investigating the use of small wearable devices, called myoelectric computer interfaces, to reduce abnormal arm muscle coordination in individuals with impaired arm movement from a stroke. Training will take place predominantly at home, with some sessions in the lab as well. This study could potentially …
    We are conducting a study investigating the use of small wearable devices, called myoelectric computer interfaces, to reduce abnormal arm muscle coordination in individuals with impaired arm movement from a stroke. Training will take place predominantly at home, with some sessions in the lab as well. This study could potentially lead to improved arm function for stroke survivors who have abnormal arm coordination.

    At least 18 years of age

    - Had a stroke more than 6 months ago

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

    - Not currently participating in another research study on the arm

    Slutzky, Marc WSlutzky, Marc W
    • Map it 355 E. Erie St.
      Chicago, IL
    • Map it 320 E. Superior Ave. Searle 11
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203644
    More Info
    Copy

    Alzheimer’s Disease Neuroimaging Initiative 3

    The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the …
    The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios. This is a non-randomized natural history non-treatment study. Participants will need to be 55 - 90 years, otherwise healthy with no neurologic disease such as Alzheimer's disease. Approximately 1070 - 2000 participants will be enrolled at approximately 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts. Subjects will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.
    - No history of major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia.
    - Must be between the ages of 55-90 years (inclusive).
    - Must have a study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol.
    - Must have visual and auditory acuity adequate for neuropsychological testing.
    - Must be in good general health with no diseases expected to interfere with the study.
    - For females only: Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
    - Must be willing and able to participate in a longitudinal imaging study lasting up to 5 years.
    - Must have completed six grades of education or has a good work history (sufficient to exclude mental retardation).
    - Must speak English fluently.
    - Must be willing to undergo repeated MRIs (3Tesla) and at least two PET scans - must not have any MRI contraindications (i.e. pacemaker, claustrophobia)
    - Must agree to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking.
    - Must agree to collection of blood for biomarker testing.
    - Must agree to at least one lumbar puncture for the collection of CSF.
    - Must agree to share genomic data and biomarker samples.
    Rogalski, EmilyRogalski, Emily
    NCT02854033 STU00203359
    More Info
    Copy

    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

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

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

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

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

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

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

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
    More Info
    Copy

    Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance after Mitral Valve Replacement with Transcatheter Device

    This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. Mitral regurgitation (MR) is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which …
    This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. Mitral regurgitation (MR) is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to assess the safety and performance of a new bioprosthetic mitral valve device when implanted through groin (transfemoral) access. The new mitral valve replacement device is called the Edwards EVOQUE Eos System. The Edwards EVOQUE Eos System is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transfemoral/transseptal).The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure.
    Patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. General Criteria:1. Greater than or equal to 18 years of age.2. New York Heart Associate Classification ≥ II3. Left Ventricular Ejection Fraction ≥ 30%.4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe).5. Patient is determined to be high surgical risk as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). 
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02718001 STU00204104
    More Info
    Copy

    Improve PAD PERformance with METformin: The PERMET Trial

    The purpose of this study is to establish whether metformin improves walking ability in people with PAD.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03054519 STU00203784
    More Info
    Copy

    Reducing Assessment Barriers for Patients with Low Literacy

    This study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
    You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation.
    Griffith, James WGriffith, James W
    NCT03584490 STU00204308
    More Info
    Copy

    NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer

    Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-…
    Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
    Some of the eligibility criteria include:

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03012321 STU00203960
    More Info
    Copy

    Prevalence of aneuploidy in ectopic pregnancies

    The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectopic pregnancies may implant outside of the uterus because they are chromosomally …
    The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectopic pregnancies may implant outside of the uterus because they are chromosomally abnormal. The tissue from the ectopic pregnancy, called products of conception, that was removed at the time of your surgery will undergo genetic testing to identify if the pregnancy implanted in the wrong place due to a genetic abnormality with the fetus. Results of the genetic analysis of your ectopic pregnancy tissue will be made available to you. You and the biological father of the ectopic pregnancy will also be required to provide a cheek swab sample for analysis.
    Inclusion: 1) Women with previous ectopic pregnancy that required surgery while under care at Northwestern Memorial Hospital; 2) Biological father of ectopic pregnancy willing and able to participate; 3) English-speaking.
    Feinberg, Eve CFeinberg, Eve C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203775
    More Info
    Copy

    Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort

    The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find …
    The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find new treatments for the disease. People from many countries contribute to Enroll-HD.
    Individuals 18 yrs or older affected by Huntington's Disease (HD) or from a HD family or are a "community control" (a person who does not carry the HD genetic mutation that causes Huntington's disease and is not part of an HD family, but would like to participate in the study). Research visits are conducted yearly and will consists of a collection of medical and family history and biological samples.
    Bega, DannyBega, Danny
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    STU00203021
    More Info
    Copy

    ELUCDITATING THE MOLECULAR MECHANISMS UNDERLYING CYP2D6 INDUCTION DURING PREGNANCY

    We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimesters. Drug metabolism is controlled by certain genes in the …
    We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimesters. Drug metabolism is controlled by certain genes in the body. This study will be examining the up-regulation of a certain enzyme in the liver called CYP2D6, which helps the body process many different drugs. We will measure compounds related to vitamin A, which we think might be involved in the process that speeds up the enzyme activity, from blood samples. The primary goal of our research is to understand how drug metabolism changes across pregnancy. The secondary goal is to define how the activity of enzymes in the liver are up-regulated (increased) during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.
    • Are 18-45 years of age
    • Are currently at or less than 13 weeks pregnant
    • Speak English
    • Singleton Gestation (not pregnant with twins)
    • Able to present for blood sampling between 8am-noon once per each month of pregnancy, and for two months postpartum
    Wisner, Katherine LeahWisner, Katherine Leah
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00204600
    More Info
    Copy

    Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

    This research study is recruiting patients who have one of the following conditions:1.A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2.A tear in your aortic wall (dissection). Blood flows …
    This research study is recruiting patients who have one of the following conditions:1.A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2.A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture.3.Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture.4.A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture.5.A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening conditionThe study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
    Hoel, Andrew WarfieldHoel, Andrew Warfield
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02777593 STU00203850
    More Info
    Copy

    Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits after mTBI plus PTSD

    The purpose of this study is to alleviate persisting attention deficits related to mTBI and PTSD by treating the neurocognitive system of attention.
    • Adults age 18-60
    • mild Traumatic Brain Injury (mTBI) event at least 3 months to 10 years ago
    • Have co-occurring mTBI and PTSD as defined by the Symptom Attribution and Classification Algorithm (SACA) and Clinically Administered PTSD Scale for DSMV (CAPS5)
    Pape, Theresa L BenderPape, Theresa L Bender
    • Map it 710 N. Fairbanks Ct. Olson Paivlion
      Chicago, IL
    NCT02397668 STU00203773
    More Info
    Copy

    INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)

    We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find …
    We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. We hope that the program will lead to weight loss and better exercise tolerance. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors.

    1 year, 2 visits.

    40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02634268 STU00204332
    More Info
    Copy

    The Role of Circadian Dysfunction in Hepatic Encephalopathy in Patients with Cirrhosis

    Individuals with advanced liver disease (cirrhosis) often report new or worsening sleep problems. 
    1) Diagnosis of end-stage liver disease or cirrhosis; 2) being evaluated for liver transplant; 3) Age >=18yo; 4) no severe kidney disease (for example, patients currently on dialysis are not eligible)
    Kim, MinjeeKim, Minjee
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204423
    More Info
    Copy

    Bimanual balanced reaching with visual biofeedback

    The purpose of this study is to increase understanding of error augmentation by applying it to visual feedback during motion tracking with a Leap Motion device - a recently developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality environment, as a feasible treatment method of upper extremity …
    The purpose of this study is to increase understanding of error augmentation by applying it to visual feedback during motion tracking with a Leap Motion device - a recently developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality environment, as a feasible treatment method of upper extremity chronic stroke impairment when combined with a balancing task.

    8 months post stroke

    Ability to actively flex and extend elbow when supported against gravity

    History of a single stroke event

    No Botox® injection in your arm within the past 4 months

    Ability to provide informed consent

    Patton, James LanphierPatton, James Lanphier
    • Map it 355 E. Erie St.
      Chicago, IL
    STU00204661
    More Info
    stroke
    Copy

    Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)

    The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional …
    The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
    • Age 18 and older
    • Presence of symptoms and signs of ataxia
    • Molecular diagnosis of SCA 1, 2, 3, 6 either in the participant or an affected family member
    • Willingness to participate in the study and ability to give informed consent.
    Opal, PuneetOpal, Puneet
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT01060371 STU00204294
    More Info
    Copy

    A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

    This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace …
    This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the chest. The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace the diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in the heart. Study participation will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally.
    Malaisrie, S ChrisMalaisrie, S Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03003299 STU00204739
    More Info
    Copy

    Long-Term Nicotine Treatment of Mild Cognitive Impairment

    The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine …
    The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function. The study will enroll participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.

    Inclusion Criteria:

    • Subject must have a subjective memory concern

    • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease dementia cannot be made by the site physician at the time of the screening visit

    • Age 55-90 (inclusive)

    • Stable permitted medications for 4 weeks or longer (memantine is allowable if stable for 12 weeks prior to screen)

    • Study partner is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), and can accompany the subject to most visits to answer questions about the subject

    • Adequate visual and auditory acuity to allow neuropsychological testing

    • Good general health with no additional diseases/disorders expected to interfere with the study

    • Completed six grades of education or has a good work history

    • Must speak English fluently

    Exclusion Criteria:

    • Regular use of tobacco produce within the past year, such as smoking (cigarettes, pipes, cigars, etc.) or use of other nicotine products (chewing tobacco, e-cigarettes, nicotine patches, gum, sprays, etc.)
    • Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities
    • Major depression, bipolar disorder within the past year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol
    • History of schizophrenia
    • History of alcohol or substance abuse or dependence within the past 2 years
    • Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study
    • Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
    • Residence in a skilled nursing facility
    Grant, Ian MichaelGrant, Ian Michael
    • Map it 320 E. Superior Ave. Searle 11
      Chicago, IL
    NCT02720445 STU00204222
    More Info
    Copy

    Wearable Activity Monitors in Aortic Stenosis Patients

    This trial is enrolling patients who have aortic stenosis and are undergoing a transcatheter aortic valve replacement or a surgical aortic valve replacement. This research is being performed to evaluate wearable activity monitors (specifically, FitBits will be used) in patients with aortic stenosis undergoing a procedure to fix their aortic …
    This trial is enrolling patients who have aortic stenosis and are undergoing a transcatheter aortic valve replacement or a surgical aortic valve replacement. This research is being performed to evaluate wearable activity monitors (specifically, FitBits will be used) in patients with aortic stenosis undergoing a procedure to fix their aortic stenosis. Many patients with aortic stenosis have low activity levels which improve after undergoing a procedure to fix their aortic stenosis, but the current methods used to assess activity levels are limited. This study will use a unique method (wearable activity monitors) to continuously track activity, both before and after the procedure. We are interested in comparing this method to the traditional methods used, which includes a 6 minute walk test and an assessment of the ability to engage in physical activity as determined by study coordinators and/or the physician through a conversation with patients. We are also

    interested in assessing quality of life through surveys to determine how that relates to activity data.

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204803
    More Info
    Copy

    Physical activity and DNA methylation among women with high breast density

    The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being …
    The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being physically active are believed to be important for preventing cancer. It may be particularly important for women with high breast density, and may help reduce risk for breast cancer. However, we do not understand what physical activity changes within the body to alter risk of breast cancer. DNA methylation is a biological process that may help explain the relationship between physical activity and cancer risk.
    Generally healthy women with a history of heterogeneously or extremely dense breasts, aged 40-74 with no history of cancer (other than non-melanoma skin cancer), diabetes, and cardiovascular disease.
    Hibler, Elizabeth AHibler, Elizabeth A
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00204639
    More Info
    Copy

    Melanoma and Skin Cancer Tissue Repository

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

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

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

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

    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease…
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Hanauer, Stephen BHanauer, Stephen B
    NCT02914561 STU00205056
    More Info
    Copy

    Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial

    The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:…
    The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

    Inclusion criteria:

    Patient level inclusion criterion

  • 18 years of age or older;

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

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

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

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

    Patient level exclusion criteria

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

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

  • History of infectious endophthalmitis;
  • History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
  • History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment);
  • Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface);
  • Torn or ruptured posterior lens capsule
  • Presence of silicone oil;
  • Ozurdex administered in past 12 weeks;
  • Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
  • Fluocinolone acetonide implant (Retisert) placed in past 3 years.
  • Koreishi, Anjum FarukKoreishi, Anjum Faruk
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT02623426 STU00205049
    More Info
    Copy

    (xIRB NCI CIRB) SWOG 1609 DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors

    The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also …
    The purpose of this study is to test any good and bad effects of the combination of study drugs called ipilimumab and nivolumab in treating rare cancers and cancers of unknown primary origin. The combination treatment of ipilimumab and nivolumab could shrink a participant's cancer but it could also cause side effects. Researchers hope to learn if the study drugs will shrink the cancer by at least one-quarter compared to its present size. Both ipilimumab and nivolumab have already been FDA-approved to treat other cancers. However, ipilimumab and nivolumab are investigational and not FDA-approved for use in combination in treating rare cancers or cancers of unknown primary origin.Description of TreatmentAll study participants will get the same study drugs: ipilimumab and nivolumab. Participants will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and they will receive nivolumab through a vein every 2 weeks. Participants will continue to receive study drugs until their disease gets worse or they experience bad side effects from the study drugs or their study doctor decides that they are not benefiting from the study drugs.
    Some of the eligibility criteria include:

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

    No other prior malignancy is allowed except for the following:

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

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

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02834013 STU00205572
    More Info
    Copy

    A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6-Year All-Participants-On-Treatment Extension (PASADENA)

    This is a multicenter, Phase II study to evaluate the effect of IV administration of RO7046015 in participants with early stage Parkinson's Disease (PD). Participants will be eligible if they have PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without …
    This is a multicenter, Phase II study to evaluate the effect of IV administration of RO7046015 in participants with early stage Parkinson's Disease (PD). Participants will be eligible if they have PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD and are either untreated or treated with Azilect or Selegiline. The study will consist of two parts: a 52-week, treatment period of the study medication vs placebo (Part 1) after which eligible participants will continue into an all-participants-on-treatment (RO7046015) blinded to dose extension for an additional 52 weeks (Part 2).
    *Men and women, aged 40 to 80 years inclusive, early PD , who were recently (< 2 years) diagnosed, and either untreated or treated with Azilect or Selegiline
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03100149 STU00205125
    More Info
    Copy

    D-Cycloserine for the Treatment of Chronic, Refractory Low Back Pain

    The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain. This study will last for 26 weeks and will require approximately 6 visits to the study clinic. There will be …
    The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain. This study will last for 26 weeks and will require approximately 6 visits to the study clinic. There will be two groups in this study. You will have an equal chance of being in either group. One group will receive D-cycloserine in capsule form and one group will receive placebo in capsule form. All participants have to take two capsules every day, one in the morning and one in the evening. There will be a 1 in 2 chance of receiving placebo.
    Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
    Male or female, age 18 years or older
    Must be in generally stable health
    Must have a smartphone that will allow downloading of the pain app
    Must be willing to abstain from drinking alcohol during the course of the study.
    If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue during the course of the study.
    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03535688 STU00205398
    More Info
    Copy

    Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)

    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that …
    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
    Inclusion Criteria
    • Type 1 and 2 Diabetes by ADA criteria (see appendix )
    • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
    • Able to provide informed consent
    • Adult participants (no age restriction)
    • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
    Exclusion Criteria
    • ESRD, defined as chronic dialysis or kidney transplant
    • History of receiving dialysis for more than 30 days
    • Institutionalized
    • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
    • Less than 3-year life expectancy
    • Known alcohol or substance abuse
    • Unable to provide informed consent
    • No evidence of active cancer other than non-melanoma skin cancer
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02986984 STU00204808
    More Info
    Copy

    The Role of Positron Emission Tomography and Magnetic Resonance Imaging (without Fluorodeoxyglucose or Gadolinium) in Yttrium-90 Radioembolization Treatment Planning for Patients with Liver Malignancies

    Patients who are already scheduled to receive Y90 radioembolization, will first be treated with Y90 radioembolization for liver cancer or metastasis in the liver.  They will then have a Positron Emission Tomography (PET/MR) scan done a few hours after the treatment. You will be placed inside a small …
    Patients who are already scheduled to receive Y90 radioembolization, will first be treated with Y90 radioembolization for liver cancer or metastasis in the liver.  They will then have a Positron Emission Tomography (PET/MR) scan done a few hours after the treatment. You will be placed inside a small tube for 2-3 hours for the PET/MR scan.  There is no contrast or radiation involved in the PET/MR scan.  The purpose of the PET/MR scan is to capture specific images of the liver to see where the Y90 radioactive particles are a few hours after treatment.  These images will be used to compare determine how much of the radioactive particles went to the tumor(s) compared to how much of them went to healthy liver tissue.  We hope to use this information to help develop care that is more specific to the patient.
    Inclusion Criteria (patients must meet these criteria):

    1. 18 years of age or older.

    2. Diagnosed with primary liver cancer or metastasis in the liver.

    3. Planning to have Y90 radioembolization treatment at Northwestern Medicine.

    4. Be able to have an MRI- not claustrophobic or have any other contraindications to MRI.

    Riaz, AhsunRiaz, Ahsun
    STU00205918
    More Info
    Copy

    Genetic causes and pathogenic mechanisms of adult epilepsies

    The purpose of this study is to look at genetic markers of epilepsy in patients and their families using blood, saliva, skin, and brain tissue analysis.
    Gerard, Elizabeth ErwayGerard, Elizabeth Erway
    STU00205877
    More Info
    Copy

    Alterations of Sleep and Circadian Timing in Aging

    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study …
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.
    Eligibility Criteria:Men and women age 55-75 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
    Zee, Phyllis CZee, Phyllis C
    NCT03490825 STU00206014
    More Info
    Copy

    cIRB: Topiramate as a disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy (CSPN)

    This is a 96-week placebo-controlled trial of topiramate at a target dose of 100 mg daily (50 mg twice daily) as a potentially disease altering therapy for Cryptogenic Sensory Peripheral Neuropathy
    INCLUSION: 1. Age 18-75; 2. Diagnosis of confirmed cryptogenic symptomatic distal symmetric peripheral polyneuropathy; 3. Prediabetes based on American Diabetes Association; 4. No history of prior therapy with topiramate; 5. Waist circumference >102 cm for men, >88 cm for women
    Menichella, Daniela MMenichella, Daniela M
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT02878798 STU00206049
    More Info
    Copy

    NIH All of Us Research Program Precision Medicine Initiative® Precision Medicine Initiative Cohort Program Healthcare Provider Organization Enrollment Centers

    Research Program in Illinois. The mission of this ambitious National Institutes of Health (NIH) initiative is to speed up health research and medical breakthroughs. To do this, the All of Us Research Program is asking one million people to lead the way to provide the types of information that can help us create individualized prevention, treatment, and care for all of us. Visit nm.org/joinallofus to learn more and enroll.

    WHATARE THE BENEFITS OF JOINING?

    · · ·

    WHATWOULD I NEED TO DO?

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

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

    - 18 years of age or older- Currently live in the United States
    Greenland, PhilipGreenland, Philip
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204480
    More Info
    Copy

    Clinical Database of Prostate Cancer at Northwestern University

    The goal of this study is to create a database of prostate cancer patients at Northwestern Memorial Group to better understand, learn about, prevent, treat or cure prostate cancer.
    Men ages 18-89 years daignosed with prostate cancer.
    Schaeffer, Edward MatthewSchaeffer, Edward Matthew
    STU00206270
    More Info
    Copy

    Bilateral Priming plus Task Specific Training for Severe Upper Limb Hemiparesis

    This is a 16-week study testing a new rehabilitation approach that combines bilateral priming with high-repetition, task-specific training. Training will focus on the hand and arm. Training consists of 3 visits per week for 5 weeks. Evaluation sessions (including transcranial magnetic stimulation - TMS) will occur throughout the …
    This is a 16-week study testing a new rehabilitation approach that combines bilateral priming with high-repetition, task-specific training. Training will focus on the hand and arm. Training consists of 3 visits per week for 5 weeks. Evaluation sessions (including transcranial magnetic stimulation - TMS) will occur throughout the study.
  • 18 years or older
  • Stroke at least 6 months ago
  • Impairment in your arm and hand
  • No Botox® injection in your arm within the past 6 months
  • No history of epilepsy or seizure disorder
  • No previous head injury
  • Corcos, Daniel MontieCorcos, Daniel Montie
    • Map it 355 E. Erie St.
      Chicago, IL
    NCT03517657 STU00205857
    More Info
    Copy

    Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasia

    The Communication Bridge study is an internet-based, speech therapy intervention for individuals with Primary Progressive Aphasia and their Communication Partner. A Communication Partner can be a spouse, relative, or close friend that will participate in the study along with the individual with PPA. The goal of the study is …

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

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

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

    Rogalski, EmilyRogalski, Emily
    NCT03371706 STU00206086
    More Info
    Copy

    Strengthening Circadian Signals to Enhance Cardiometabolic Functions

    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study …
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.
    Eligibility Criteria:Men and women age 40-54 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
    Zee, Phyllis CZee, Phyllis C
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT03490864 STU00206038
    More Info
    Copy

    APOLLO Trial Clinical Investigation Plan - Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation

    This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (…
    This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC). The new investigational device is a mitral valve replacement called the Medtronic IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The IntrepidTM TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 in-person scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure.
    Enrolling participants with mitral valve regurgitation who are at high risk of experiencing major complications while undergoing open-heart surgery due to their current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within the body). Additionally, physicians have determined that these participants may not be optimally treated with currently approved transcatheter repair therapies.
    Malaisrie, S ChrisMalaisrie, S Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03242642 STU00206197
    More Info
    Copy

    cIRB: AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic Stroke

    ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS …
    ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
    Inclusion Criteria:

    • Age ≥ 45 years.
    • Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
    • Modified Rankin Scale (MRS) score ≤ 4.
    • Ability to be randomized within 3 to 120 days after stroke onset.
    • ESUS (embolic stroke of underdetermined source).
    Exclusion Criteria:

    • History of atrial fibrillation
    • Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
    • Need for antiplatelet agent other than aspirin, such as clopidogrel after implantation of a coronary artery stent.
    • History of spontaneous intracranial hemorrhage.
    • Chronic kidney disease with serum creatinine ≥2.5 mg/dL.

    Caprio, Fan ZhangCaprio, Fan Zhang
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03192215 STU00206251
    More Info
    Copy

    Life Enhancing Activities for Family Caregivers (LEAF) 2.0

    The LEAF Study is an online program designed for family caregivers of individuals diagnosed with Alzheimer's Disease. The LEAF program consists of 8 skills delivered online, either through video-conferencing (“video sessions”) with a trained staff member or through a self-guided course (“online lessons”), to help manage your …
    The LEAF Study is an online program designed for family caregivers of individuals diagnosed with Alzheimer's Disease. The LEAF program consists of 8 skills delivered online, either through video-conferencing (“video sessions”) with a trained staff member or through a self-guided course (“online lessons”), to help manage your mood and cope with the stressors of caregiving. The LEAF course consists of 6 sessions delivered over 6-8 weeks. From start to finish, your involvement with LEAF involves up to 30 hours of your time over 14 months.

    -Age 18 and over

    -Identifies as the primary family caregiver of a person with Alzheimer’s Disease (AD)

    -Speaks and reads English

    -Has access to high speed internet connection at home or in a location where they can speak privately with a LEAF staff member

    Moskowitz, Judith TedlieMoskowitz, Judith Tedlie
    • Map it 633 N. St. Clair St.
      Chicago , IL
    NCT03610698 STU00206756
    More Info
    Copy

    A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MACTEL Study

    Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help prevent the condition from developing and to find potential treatment(s) but more work is needed. Special …

    Since 2005, a group of scientists and clinicians from around the world have identified and are studying hundreds of persons with MacTel Type 2. Progress has been made to find ways to help prevent the condition from developing and to find potential treatment(s) but more work is needed. Special scientists (geneticists) are working to understand if this disorder is inherited (passed down from your parents) and basic scientists are working to understand what happens to the eye tissue inside a MacTel eye.

    The purpose of this study is to identify persons with MacTel Type 2, and their affected family members to create a Registry of persons with MacTel Type 2. This Registry will be used to study participants with MacTel Type 2 now and may be used in the future to identify persons to be in a study that may help find a way to prevent or treat this eye condition. We also wish to keep in contact with persons who have told by their MacTel doctor that they have MacTel Type 2.

    In this document, the word “affected” means that it has been confirmed that you have MacTel Type 2. These persons may also be referred to as “Probands” when they are the first person in the family to be diagnosed with the disorder.

    “Unaffected” means that at this time, there is no evidence of MacTel Type 2.

    1. Must have a confirmed clinical diagnosis of MacTel Type 2.

    2. Must be 18 years of age or older.

    Fawzi, Amani AFawzi, Amani A
    • Map it 259 E. Erie St. Suite 1520
      Chicago, IL
    STU00206885
    More Info
    Copy

    A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2

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

    Brief Summary:

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

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

    Criteria

    Key Inclusion Criteria:

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

    Key Exclusion Criteria:

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

    Fawzi, Amani AFawzi, Amani A
    • Map it 259 E. Erie St. Suite 1520
      Chicago, IL
    NCT03319849 STU00206919
    More Info
    Copy

    (xIRB) The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States

    The purpose of this study is to collect information to help us understand how doctors treat and manage people with severe asthma and how the health of people with severe asthma changes with those treatments.At least 75 doctors in the United States will provide information on their patients for …

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

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

    18 years of age or older

    Diagnosis of asthma for at least 12 months

    Frequent, current symptoms of asthma

    Taking a daily asthma medication

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

    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03373045 STU00206953
    More Info
    Copy

    Clinical Trial Readiness for SCA1 and SCA3

    Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain …
    Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain scan) and not weigh over 300 lbs.
    Subjects aged 18 to 65 with presence of symptomatic ataxic disease or asymptomatic mutation carrier or subjects with definite molecular diagnosis of SCA1 or SCA3 or another affected family member or Subjects of age >18 with previous diagnosis of early stage SCA1 and SCA3. Subjects must not make changes in physical/occupational therapy status within two months prior to enrollment. Subjects must not weigh over 300 lbs.
    5) 6) No changes in sical/occupational therapy status within two months prior to enrolment
    Opal, PuneetOpal, Puneet
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03487367 STU00206988
    More Info
    Copy

    CHRONIC VENOUS THROMBOSIS: RELIEF WITH ADJUNCTIVE CATHETER-DIRECTED THERAPY

    The purpose of this study is to help improve your quality of life due to your chronic blood clots. You will be randomly assigned (like a flip of a coin) to either the high quality medial care (including receiving free compression stockings and reviewing your medications) treatment group or a …
    The purpose of this study is to help improve your quality of life due to your chronic blood clots. You will be randomly assigned (like a flip of a coin) to either the high quality medial care (including receiving free compression stockings and reviewing your medications) treatment group or a low risk out-patient procedure to place a stent (a metal mesh tube) to open your veins to hopefully help reduce the severity of your blood clot symptoms. This group will also receive the high quality medical care treatment.

    If you decide to participate in the study, the study team will:

    1. Ask you to sign a consent form that you are agreeing to participate in the study

    2. Review your health history and collect a small amount of blood to check your general health

    3. Perform a physical exam and measure your leg

    4. Perform imaging to assess your blood flow in your leg

    5. Ask you to complete questionnaires

    6. Ask you to come in for follow-up visits at 2 months, 4 months, 6 months, 12 months, 18 months and 24 months.

    Treatment assignment:

    1. If you are randomly assigned to the low-risk stent procedure, you will return about 1 week after you consent to participate in the study to have the procedure

    If you participate in the study, you will receive $100.00 after completion of each follow-up visit. Enrolled participants will also receive compression stockings at enrollment and every six months during their participation.

    You are eligible to participate in the study if:

    1. You are 18 years of age or older

    2. You have been diagnosed with a blood clot in your leg in the past (more than 3 months ago)

    3. You now have leg heaviness, fatigue, swelling, aching, or pain

    Desai, Kush RDesai, Kush R
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03250247 STU00206999
    More Info
    Copy

    Mitochondrial Dysfunction and Disability in Peripheral Artery Disease

    The reasons for walking impairment and functional decline in patients with PAD are not well understood, and few treatments are available to improve walking performance. This study will look at the association of walking difficulty with calf muscle abnormalities. In addition, the study will compare the changes in calf muscle …
    The reasons for walking impairment and functional decline in patients with PAD are not well understood, and few treatments are available to improve walking performance. This study will look at the association of walking difficulty with calf muscle abnormalities. In addition, the study will compare the changes in calf muscle tissue between participants with PAD and those without PAD. Knowledge gained from the study may lead to the development of new treatments for patients with PAD. You will be asked to undergo baseline testing including walking tests and a calf muscle biopsy and asked to return one year later and two years later to repeat the tests performed at baseline.
    The MDD study is recruiting indivdiuals of any age with peripheral artery disease, as well as individuals without PAD who do not have diabetes and are age 60 and older. Peripheral artery disease can cause leg pain on walking. You may be at risk of PAD if you have a history of smoking, diabetes, high cholesterol, and/or high blood pressure.
    Greenland, PhilipGreenland, Philip
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00206722
    More Info
    Copy

    Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol

    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms …
    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating one tube of blood for the collection of genetic information (DNA) at one study visit.
    - Giant Cell Arteritis- Takayasu’s Arteritis - Polyarteritis Nodosa - Granulomatosis with Polyangiitis (Wegener’s) - Microscopic Polyangiitis - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00206908
    More Info
    Copy

    Evaluation of Renal Microvascular Perfusion by Contrast Enhanced Ultrasound

    Contrast Enhanced Ultrasound Study:The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants …

    Contrast Enhanced Ultrasound Study:

    • The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)
    • Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants only complete the first 2 study visits)
    • Study procedures consist of measuring height, weight, and vital signs, answering questions about demographics and medical history, a blood draw and urine collection at every visit, and undergoing the contrast-enhanced ultrasound (only at visit 2)
    INCLUSION CRITERIA:
    • ≥ 18 years of age
    • Patient is able to provide written informed consent
    • Meet criteria for one of following patient populations:
    • CKD
    • eGFR ≥30 and <90 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation17 (with or without history of hypertension)
    AND
    • Urine albumin to creatinine ratio (UACR) ≥ 30mg/g creatinine
    OR
    • eGFR <30 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation (with or without history of hypertension AND with no UACR requirement)
    • ESRD
    • Currently receiving dialysis (hemodialysis or peritoneal dialysis)
    • No eGFR or UACR requirement
    • Healthy volunteer
    • No prior history of kidney disease (as defined by eGFR >60 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation and UACR <30 mg/g creatinine, based on Screening Visit lab results or average between local lab results (collected within 3 months from the date of the Screening Visit) and lab results from Screening Visit.
    • No self-reported history of hypertension, diabetes mellitus, liver disease, or cardiovascular disease

    • CKD-Biopsy
    • eGFR <90 ml/min/1.73m2 by CKD EPI equation
    OR
    • Urine albumin to creatinine ratio (UACR) ≥30 mg/g creatinine
    AND
    • Undergoing a clinically indicated renal biopsy
    • Transplant Kidney Biopsy
    • Kidney transplant recipient undergoing a protocol surveillance transplant kidney biopsy

    EXCLUSION CRITERIA:

    • Known hypersensitivity to sulfur hexafluoride lipid or to any component of Lumason®
    • Known severe pulmonary hypertension (pulmonary artery pressure > 75mmHg)
    • Active cardiac disease including any of the following:
    • Unstable angina
    • Myocardial infarction within 48 hours prior to date of proposed Lumason® administration
    • Severe arrhythmia (ventricular tachycardia, uncontrolled atrial fibrillation with rapid ventricular response, torsades de pointes)
    • Escalating vasopressor requirements in prior 24 hours
    • Recent neurological compromise (i.e. cerebrovascular accident including transient ischemic attacks within 3 months of Lumason® administration)
    • Emergency cardiac surgery
    • BMI ≥ 35 kg/m2
    • Clinical signs of acute rejection as the indication for transplant kidney biopsy
    • Inability for patient or patient’s surrogate to provide informed consent
    • Pregnancy
    • Incarcerated individuals

    Srivastava, AnandSrivastava, Anand
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00206894
    More Info
    Copy

    A Phase 3, Randomized, Rater-Blinded, Multi-Center Study to Evaluate the Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Patients with Wilson Disease Aged 12 Years and Older with an Extension Period of Up to 60 Months

    The primary objective of this study is to evaluate the efficacy of the drug WTX101 administered for 48 weeks, compared to standard of care (SoC), on copper (Cu) control in subjects with Wilson's disease aged 18 and older.…
    The primary objective of this study is to evaluate the efficacy of the drug WTX101 administered for 48 weeks, compared to standard of care (SoC), on copper (Cu) control in subjects with Wilson's disease aged 18 and older.
    Diagnosis of Wilson's Disease, Treatment for >28 days with chelation therapy, Zn therapy or a combination of chelator and Zn; willing to avoid the use of vitamins and/or minerals containing CU, Zn or Mo throughout the study, willing to undergo > 48-hour washout from current WD treatment
    Bega, DannyBega, Danny
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03403205 STU00206921
    More Info
    Copy

    Longitudinal Early-onset Alzheimer’s Disease Study (LEADS)

    The Longitudinal Early-onsetAlzheimer's Disease Study (LEADS) is a non-randomized, natural history,non-treatment study designed to look at disease progression in individuals withearly onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker,and genetic characteristics will be assessed across two cohorts: (1)individuals with cognitive impairment and (…

    The Longitudinal Early-onsetAlzheimer's Disease Study (LEADS) is a non-randomized, natural history,non-treatment study designed to look at disease progression in individuals withearly onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker,and genetic characteristics will be assessed across two cohorts: (1)individuals with cognitive impairment and (2) cognitively normal controlparticipants. The primary objectives of the LEADS study are to: collectlongitudinal assessments and biomarker data; to compare baseline andlongitudinal cognitive and functional characteristics between cognitivelyimpaired and cognitively normal individuals, and EOAD and Late OnsetAlzheimer's Disease (LOAD) individuals from the Alzheimer's DiseaseNeuroimaging Initiative (ADNI); and to study the associations of longitudinalclinical and cognitive assessments with multimodal imaging and biofluid markersthat capture different elements of the AD pathophysiological cascade.

    Inclusion Criteria (Cognitively Impaired Cohort Only):

    • Meets NIA-AA criteria for MCI due to AD or probable AD dementia
    • Have capacity to provide informed consent (IC) or has a legally authorized representative or guardian who provides IC
    • Age between 40-64 years (inclusive) at the time of consent
    • Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participant's cognitive and functional performance
    • Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile or have a negative pregnancy test prior to each PET scan
    • Fluent in English

    Inclusion Criteria (Cognitively Normal Cohort Only):

    • Meets criteria for cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living
    • Have capacity to provide informed consent
    • Age between 40-64 years (inclusive) at the time of consent
    • Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, caregiver) who is generally aware of the participant's cognitive and functional performance
    • Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
    • Fluent in English
    Rogalski, EmilyRogalski, Emily
    NCT03507257 STU00207242
    More Info
    Copy

    Effects of device-assisted practice of activities of daily living in a close-to-normal pattern on upper extremity motor recovery in individuals with moderate to severe stroke

    Intervention study on hand and arm function in individuals with stroke
    • Between 21-80 years old
    • At least one year since a stroke that affects one of the upper limbs
    • Able to give informed consent
    • Some shoulder and elbow control, but limited function in the paretic limb
    Yao, JunYao, Jun
    • Map it 645 N. Michigan Ave. Suite 1100
      Chicago, IL
    NCT04077073 STU00206913
    More Info
    Copy

    Randomized Controlled Trial of a Mindfulness-based Intervention in a Federally Qualified Center (FQHC)

    Northwestern University and Near North Health are currently recruiting participants for a research study to understand if mind and body approaches such as breathing techniques, mindfulness meditation, and gentle yoga work to improve stress. Up to $110 in compensation for full participation! Participants will either be assigned to receive an …
    Northwestern University and Near North Health are currently recruiting participants for a research study to understand if mind and body approaches such as breathing techniques, mindfulness meditation, and gentle yoga work to improve stress. Up to $110 in compensation for full participation! Participants will either be assigned to receive an 8-week, 90 min per session group or to the wellness check-in group. For more info, please call 773-683-1275.

    Inclusion Criteria:

    • 18-65 years old
    • at least mild depressive symptoms
    • English speaking
    Burnett-Zeigler, Inger EBurnett-Zeigler, Inger E
    NCT03620721 STU00207126
    More Info
    Zhou, Elayne
    Copy

    Pathogenic Wnt-beta catenin target genes in macrophages and fibrosis

    The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, …
    The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.

    Patients who participate in this study will:

    • donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
    • give a blood sample
    • give esophageal biopsies (taken during their scheduled endoscopy)
    • as an option, give skin biopsies

    • At least 18 years old
    • Meet criteria for systemic sclerosis
    • Receive care at Northwestern Medicine in Rheumatology, Pulmonary & Critical Care, and/or Gastroenterology scleroderma clinics
    • Plan to undergo a standard of care bronchoscopy or endoscopy at Northwestern or a research bronchoscopy through a separate Northwestern study
    Perlman, Harris RPerlman, Harris R
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00207083
    More Info
    Copy

    A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis

    (ACTIVE, NOT RECRUITING) This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan). 
    Inclusion Criteria:
    1. Primary FSGS
    2. Male or Female aged 18-75 years
    3. Urine protein/creatinine ratio ≥ 1.5 g/g
    4. Estimated glomerular filtration rate (eGFR) ≥ 30
    5. Blood pressure criteria: ≥100/60 mmHg and ≤160/100 mmHg
    6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
    Exclusion Criteria:
    1. Secondary FSGS
    2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
    3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
    4. Body Mass Index (BMI) > 40
    3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
    Ghossein, CybeleGhossein, Cybele
    NCT03493685 STU00206193
    More Info
    Copy

    A pragmatic trial of two strategies for implementing an effective eHealth HIV prevention program (Keep It Up! 3.0)

    We would like to reach about 250 – 500 people. Our eligibility criteria: (1) 18 – 29 years old, (2) HIV-negative, (3) male assigned at birth & currently identify as male, (4) live in one of 22 counties (please see counties below) in the USA. statecountyAZMaricopa CountyTXDallas CountyTXBexar CountyTXTravis CountyMIWayne CountyPAAllegheny …

    We would like to reach about 250 – 500 people. Our eligibility criteria: (1) 18 – 29 years old, (2) HIV-negative, (3) male assigned at birth & currently identify as male, (4) live in one of 22 counties (please see counties below) in the USA.

    state

    county

    AZ

    Maricopa County

    TX

    Dallas County

    TX

    Bexar County

    TX

    Travis County

    MI

    Wayne County

    PA

    Allegheny County

    MA

    Suffolk County

    CA

    San Bernardino County

    NJ

    Essex County

    NY

    Nassau County

    AL

    Jefferson County

    VA

    Arlington County

    WA

    Snohomish County

    CA

    Fresno County

    TN

    Shelby County

    CT

    Hartford County

    MO

    Jackson County

    OH

    Hamilton County

    WA

    Pierce County

    MO

    St. Louis city

    DE

    New Castle County

    FL

    Lee County

    Keep It Up! (KIU!) is an online, interactive program for gay, bisexual, and queer men that has been proven by the CDC to be effective at reducing the risk for HIV and sexually transmitted infections (STI). KIU! uses a variety of content (e.g., web-series, animation, activities) to encourage healthy relationships and increase sexual health knowledge through information on topics such as pre-exposure prophylaxis (PrEP), Undetectable = Untransmittable (U = U), and sexual agreements with partners. The content is divided into five episodes that each take approximately 20 minutes to complete.By joining KIU!, you will receive FREE at-home HIV & STI kits, a $10-$25 gift card for completing the first three episodes, entry to $200 raffle prizes, and other awesome goodies! Your participation will help inform the development of future programs and services for young men.You may be eligible to participate if:• You are between the ages of 18–29• You are a man who has sex with men• You are HIV-negativeIf you are interested in finding out if you are eligible for KIU!, please click the link below to complete the registration form.https://ikeepitup.isgmh.northwestern.edu/register/new?link=25
    Mustanski, BrianMustanski, Brian
    NCT03896776 STU00207476
    More Info
    Copy

    Gut Microbial remodeling with Resistant Maltodextrin for motor and non-motor symptoms in Parkinson's disease: safety and tolerability study.

    The objective of this study is to examine thesafety and tolerability of resistant maltodextrin (RM), a prebioticnon-digestible fiber, and its effect on the gut microbiome, as well as motor and non-motorsymptoms, in Parkinson's Disease.We will conduct a randomized, parallel-groupdouble-blinded controlled trial assessing resistant maltodextrin …
    The objective of this study is to examine thesafety and tolerability of resistant maltodextrin (RM), a prebioticnon-digestible fiber, and its effect on the gut microbiome, as well as motor and non-motorsymptoms, in Parkinson's Disease.

    We will conduct a randomized, parallel-groupdouble-blinded controlled trial assessing resistant maltodextrin to placebo. You will be randomized (like a coin flip) toreceive either resistant maltodextrin or maltodextrin to take once a day in themorning for 4 weeks.

    Participation in this research study lasts 6-7 weeks and includes 3 in-person visits and 4 phone assessments.

    You may be eligible if you:

  • are ≥ 60 years
  • have been diagnosed with Parkinson's Disease
  • have NOT been diagnosed with diabetes
  • are not currently taking any probiotics or laxatives
  • Malkani, Roneil GopalMalkani, Roneil Gopal
    NCT03667404 STU00207142
    More Info
    Copy

    Clinical Study of the Edwards Cardioband™ Tricuspid Valve Reconstruction System

    This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and …
    This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ). The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation. Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03382457 STU00207338
    More Info
    Copy

    Project 1, Adaptations of the brain in chronic pain with opioid exposure

    In this project, we will study brain reorganization and behavioral responses in chronic pain with opioid exposure. Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the opioid epidemic. …
    In this project, we will study brain reorganization and behavioral responses in chronic pain with opioid exposure. Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the opioid epidemic. Although millions of people with CBP regularly use opioids, little is known about the impact of long-term opioid use on the chronic pain brain. Through pain tracking, MRI scans, and various other methods, this study will look at understanding the effect of long-term opioid use on the chronic pain brain.
    Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy Male or female, age 18 years or older Must be in generally stable health Must have a smartphone that will allow downloading of the pain app Must be on regular opioid or NSAID therapy for at least 3 months
    Apkarian, ApkarApkarian, Apkar
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT00301080 STU00207384
    More Info
    Copy

    Wearable sensors and video recording for children (birth to 24 months) to monitor motor development

    The purpose of this study is to test flexible body-worn sensors and video technology to provide high-resolution measures of motor development in infants, starting from a very young age and continuing up to 2 years of age. This study will enroll up to 200 infants: 100 infants expected …

    The purpose of this study is to test flexible body-worn sensors and video technology to provide high-resolution measures of motor development in infants, starting from a very young age and continuing up to 2 years of age.

    This study will enroll up to 200 infants: 100 infants expected to have typical motor development and 100 infants at risk of atypical motor development (based on clinician diagnosis or risk factors such as prematurity, neonatal hypoxic ischemic encephalopathy, neonatal stroke, etc.).

    During each study visit, sensors will be placed on the legs, arms, chest, and head using soft bandage wraps or a gentle adhesive. The sensors will record the child’s movements in various postures and tasks. Their movements will also be recorded on video.

    These measurements will be completed at the approximate ages of 1-2 weeks, 1 months, 3 months, 6 months, 9 months, 1 year, and 2 years old. Each study visit will take about 1-2 hours.

    Compensation will be provided.

    If ever it’s too difficult to travel to one of these locations, another option is that we can come to you, and do a study visit at your home.

    Infant must meet the following criteria:

    • Legal guardian able and willing to give written consent and comply with study procedures
    • Age less than 24 months
    • Does NOT have open wounds or skin breakdown on the limbs or upper torso
    • Does NOT have missing or incomplete limbs

    Jayaraman, ArunJayaraman, Arun
    • Map it 355 E. Erie St.
      Chicago, IL
    STU00207900
    More Info
    Copy

    The Collaborative, National Quality and Efficacy Registry (CONQUER)

    The CONQUER Registry will enable researchers to:Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waitingEvaluate the response in the real world (…

    The CONQUER Registry will enable researchers to:

  • Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).
    • Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waiting
  • Evaluate the response in the real world (as opposed to the controlled and constrained setting of a clinical trial) to therapeutic agents and to combinations of therapeutic agents.
    • Drive more personalized and effective therapy for patients
    • Develop insights into drug toxicities that are unique to scleroderma patients (e.g. underlying heart disease due to pulmonary vascular disease)
    • Understanding patient satisfaction/issues with the current Standard of Care
  • Collect biosamples for future analyses (e.g. genetic factors contributing to disease)
  • Establish and support a collaborative network for U.S. scleroderma investigators
  • Support the critical infrastructure for future scleroderma studies, including trials for novel therapeutics
  • Patients must:

    1. Be 18 years of age and older

    2. Have a confirmed diagnosis of systemic sclerosis (meeting the 2013 SSc ACR/EULAR criteria)

    3. Have had symptoms of SSc for less than 5 years (other than Raynauds - it is okay if this has been going on for greater than 5 years)

    Richardson, CarrieRichardson, Carrie
    • Map it 633 N. St. Clair St.
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00207506
    More Info
    Copy

    Testing Intervention Strategies for Addressing Obesity and Binge Eating

    Adult volunteers are invited to participate in a Northwestern research study! The study is recruiting people who struggle with their weight and binge eating to participate in testing a mobile app called FoodSteps.What will you do? Complete an online screening surveyComplete an initial assessmentReceive access to the app with …
    Adult volunteers are invited to participate in a Northwestern research study! The study is recruiting people who struggle with their weight and binge eating to participate in testing a mobile app called FoodSteps.

    What will you do?

  • Complete an online screening survey
  • Complete an initial assessment
  • Receive access to the app with coaching for 16 weeks
  • Complete assessments during and after the intervention
  • Receive up to $100
  • To find out if you may be eligible, please take our online screener.

    https://redcap.link/foodsteps

    To be eligible for this study, you must be:

    • 18 years or older
    • have obesity and experience binge eating
    • Interested in losing weight and reducing binge eating
    • willing to use a mobile app
    • have a smartphone with Internet access and capacity for calls and text messaging
    • have a valid email address
    • have access to a scale
    • not pregnant
    • English speaking
    • not currently receiving clinical services for weight management or binge eating

    Graham, Andrea K.Graham, Andrea K.
    • Map it 633 N. St. Clair St.
      Chicago , IL
    NCT04771455 STU00208056
    More Info
    Copy

    Brain pathophysiology of osteoarthritis pain

    This research study is being done to better understand the causes of knee pain in people with osteoarthritis, and to identify factors that lead to persistent pain after total knee replacement or recovery of knee pain following a total knee replacement. We are also trying to better understand the changes …
    This research study is being done to better understand the causes of knee pain in people with osteoarthritis, and to identify factors that lead to persistent pain after total knee replacement or recovery of knee pain following a total knee replacement. We are also trying to better understand the changes in brain function, senses, personality and performance abilities after a total knee replacement surgery. Participants will be enrolled in the study for about 13 months and will undergo up to 3 MRI scans of their brain.
    Must have a history of osteoarthritis in a knee and have elected to undergo total knee replacement surgery (TKR) in the knee. Or may have a history of osteoarthritis in a knee and have not elected to undergo a TKR. Must be 40 years or older and be in generally stable health. Must have a smartphone that will allow downloading of a pain app. If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue during the course of the study.
    Apkarian, ApkarApkarian, Apkar
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    STU00207973
    More Info
    Copy

    AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation

    To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
    Primary Inclusion Criteria:
    • Patients ≥ 18 years old
    • Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI)
    • Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation

    Primary Exclusion Criteria:

    • Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause
    • Previous catheter or surgical ablation for AF
    • Contraindication to MRI
    • Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL)
    • History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities
    Passman, Rod SPassman, Rod S
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00207885
    More Info
    Copy

    PEA-Valve Study: Phono- and Electrocardiogram Assisted Detection of Valvular Disease

    The purpose of this study is to test whether data obtained from the Eko DUO and Eko CORE ElectronicStethoscope Systems and analysis of your heart sounds can identify valvular abnormalities usually foundby echocardiography. We want to know whether listening to your heart with this device could be used inplace of …

    The purpose of this study is to test whether data obtained from the Eko DUO and Eko CORE Electronic

    Stethoscope Systems and analysis of your heart sounds can identify valvular abnormalities usually found

    by echocardiography. We want to know whether listening to your heart with this device could be used in

    place of an echocardiogram for screening certain heart conditions. Echocardiograms require highly

    trained sonographers to capture images of your heart, as well as a cardiologist to interpret those images.

    These devices can be easily used by any healthcare provider with minimal training, and a computer runs

    the analysis so these devices may be able to provide a much simpler way of diagnosing certain types of

    heart disease.

    Thomas, James DavidThomas, James David
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00208027
    More Info
    echo eko
    Copy

    PK and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

    We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of that drug is consumed by breastfed infants.…
    We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of that drug is consumed by breastfed infants.
    Wisner, Katherine LeahWisner, Katherine Leah
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00208328
    More Info
    Copy

    The effect of inflammatory bowel disease flares on serum prostate specific antigen

    This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate …
    This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
    Men with a confirmed diagnosis of inflammatory bowel disease (IBD) between the ages of 40-69 years old.
    Kundu, Shilajit DKundu, Shilajit D
    NCT03558048 STU00207583
    More Info
    Copy

    A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

    This study is being conducted as part of a series of studies for the clinical development of APL-2 for advanced Age-related Macular Degeneration (AMD) (neovascular AMD and geographic atrophy [GA]). The subject population will be comprised of adult male and female subjects with GA secondary to AMD.Age-…
    This study is being conducted as part of a series of studies for the clinical development of APL-2 for advanced Age-related Macular Degeneration (AMD) (neovascular AMD and geographic atrophy [GA]). The subject population will be comprised of adult male and female subjects with GA secondary to AMD.Age-related macular degeneration is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. In the United States, about 1.75 million people have the advanced forms of AMD. The early signs of AMD (drusen and pigmentary changes) are common in individuals over age 65 and precede the late stage forms, which are visually devastating. The late stage forms of AMD are classified into either macular neovascularization (neovascular, wet, or exudative AMD) or GA.Geographic Atrophy is a disease characterized by thinning and loss of the retinal pigment epithelium (RPE) and concurrent atrophy of photoreceptors and choriocapillaris. Clinically, GA is characterized by gradually expanding atrophy leaving islands of dead retinal cells in the back of the eye. Although GA can result in significant visual function deficits in reading, night vision, anddark adaptation, and produce dense, irreversible scotomas in the visual field, the initial decline in visual acuity may be relatively limited if the fovea is spared. When the fovea is involved, GA quickly causes blindness.Genetic susceptibility has become increasingly recognized as a risk factor and important contributor to AMD. More than 19 genetic polymorphisms have been demonstrated to influence AMD risk, with as many as 5 of these encoded by genes that modulate the complement system. Inflammatory processes, especially those mediated by complement are thought to play a key role in AMD. It is thought that these may contribute to loss of choriocapillaris, photoreceptors and RPE cells.GA is responsible for approximately 20% of all cases of legal blindness in North America (i.e. BCVA 20/200 or worse) with increasing incidence and prevalence owing to a higher life expectancy. While there is treatment for exudative AMD with anti-VEGF therapies, no approved therapy exists for GA which is usually bilateral and relentlessly progressive. It represents asignificant unmet need as it leads to significant visual impairment and affects more than 5 million people worldwide.Primary Objective:To evaluate the efficacy of APL-2 compared to sham injection in patient with GA secondary to AMD assessed by change in the total area of GA lesions from baseline as measured by FAF.

    The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.

    Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.

    • Age ≥ 60 years.
    • Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).
    • Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
    • The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:

      • Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
      • If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 4a.
      • The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
      • Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
    • Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
    • Female subjects must be:

      • Women of non-child-bearing potential (WONCBP), or
      • Women of child-bearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
    • Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
    • Willing and able to give informed consent and to comply with the study procedures and assessments.
    • Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
      • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
      • Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
      • Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
      • Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).
      • Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
      • History of laser therapy in the macular region.
      • Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
      • Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
      • Any contraindication to IVT injection including current ocular or periocular infection.
      • History of prior intravitreal injection.
      • Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
      • Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
      • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
      • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
      • Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
      • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.
    Lyon, ALyon, A
    • Map it 259 E. Erie St. Suite 1520
      Chicago, IL
    NCT03525600 STU00208380
    More Info
    Copy

    (xIRB) Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After Treatment

    The purpose of this study is to investigate if systemic psoriasis medication changes the makeup of lipoproteins (substances made up of fat and protein), cholesterol, and other proteins in the blood. …

    The purpose of this study is to investigate if systemic psoriasis medication changes the makeup of lipoproteins (substances made up of fat and protein), cholesterol, and other proteins in the blood.

    • Be 6 to 17 years
    • Have psoriasis or be a healthy volunteer (someone who does not have a skin condition)
    • Participants with psoriasis must have a 6 month or more history of treatment with a topical medication or have a 3 month or less history of treatment with a systemic medication (medication that works throughout the whole body)
    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00208518
    More Info
    Copy

    Mobile – PrOmoting Wellness after cancER Study: M-POWER Feasibility Study

    M-POWER is an 8-week weight loss study in the Department of Preventive Medicine at Northwestern University. The participant will be given a smartphone application and have weekly telephone calls with health coaches. Participants will be asked to track their weight, diet, and activity through the smartphone application and …

    M-POWER is an 8-week weight loss study in the Department of Preventive Medicine at Northwestern University. The participant will be given a smartphone application and have weekly telephone calls with health coaches. Participants will be asked to track their weight, diet, and activity through the smartphone application and will be asked to recruit a "Buddy" to support them throughout their time in the study. Participants will be compensated for their time in the study. If you are interested in participating, please complete our eligibility here: https://tinyurl.com/2p86cm5a

    You are a cancer survivor (breast, melanoma, prostate or colorectal) between the ages of 18 and 84 years old. You own a smartphone; you are living with obesity and willing to participate in a weight-loss research study that focuses on health behavior changes.
    Spring, BonnieSpring, Bonnie
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00207968
    More Info
    Copy

    NU 18I01: A Phase 2 study of pembrolizumab in combination with pelareorep in patients with advanced pancreatic adenocarcinoma

    This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any …
    This study involves the use of an investigational drug called pelareorep (Reolysin®).“Investigational” means that the drug pelareorep has not been approved by the U.S. Food &Drug Administration (FDA) for treating pancreatic adenocarcinoma.The primary goal is to see if a treatment using both pelareorepand pembrolizumab has any effect on pancreatic cancer and also to evaluate the safety ofthis combination of these two drugs. Pelareorep is an investigational product that uses a type ofvirus called reovirus. This virus is commonly found in natural environments throughout the world(such as ponds) and is associated with minor breathing difficulties and stomach upsets inhumans. Infection of cancer cells by this virus is expected to be able to slow cancer lesiongrowth and kill cancer cells.  Pembrolizumab is a drug thatworks on stimulating the immune system to fight the cancer cells and it is currently approvedfor the treatment of other tumors (melanoma and lung). It is not presently known if it will help inthe treatment of pancreatic cancer. The combination of pembrolizumab and pelareorep isexpected to be able to determine if pelareorep will or will not stimulate the immune systemand make it more responsive to therapy with pembrolizumab.
    Participants with advancedpancreatic adenocarcinoma.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03723915 STU00207577
    More Info
    Copy

    The AZITRAMBA trial: Azithromycin treatment for the airway microbiome in asthma

    Asthma researchers at Northwestern University and the University of Chicago are conducting a study to determine whether the bacteria inside the lungs of people with asthma can be changed if they are given an antibiotic and if this change is associated with an improvement in their asthma.The antibiotic that …
    Asthma researchers at Northwestern University and the University of Chicago are conducting a study to determine whether the bacteria inside the lungs of people with asthma can be changed if they are given an antibiotic and if this change is associated with an improvement in their asthma.The antibiotic that will be given during the study is called azithromycin.

    Individuals without asthma arealso needed so we have information and samples to use as a comparison to peoplewith asthma.

    14 weeks, 4 in clinic visits and 3 phone calls.

    Age 18-55

    Currently receiving care from a specialist physician (pulmonologist/allergist)

    Rosenberg, Sharon ReiflerRosenberg, Sharon Reifler
    NCT03736629 STU00208077
    More Info
    Copy

    Wool Clothing for Atopic Dermatitis

    This is a clinical research study that aims to determine if there is an improvement in eczema in children when they wear superfine merino wool clothing. Participants will be randomly assigned to two groups and begin with wool garments for 6 weeks and switch to standard garments for 6 weeks …
    This is a clinical research study that aims to determine if there is an improvement in eczema in children when they wear superfine merino wool clothing. Participants will be randomly assigned to two groups and begin with wool garments for 6 weeks and switch to standard garments for 6 weeks or begin with standard garments for 6 weeks and switch to wool garments for a further 6 weeks. Participants will attend follow-up appointments at 3, 6, 9 and 12 weeks where severity of eczema,quality of life, and any side effects will be assessed. Wool clothing and laundry detergent will be provided for the duration of the entire study.

    Ages 3 months to 5 years with moderate to severe eczema as determined atinitial visit.

    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00208730
    More Info
    Copy

    (xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast Cancer

    In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, …
    In addition to endocrine therapy and possibly chemotherapy, many women with node positive breast cancer will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). Because no one really knows whether patients with low risk breast cancer need to receive regional radiotherapy, it is possible that some women who get it may not actually need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to learn if not giving regional radiotherapy is just as good as using regional radiotherapy by comparing any good and bad effects of both approaches. The study has two randomly assigned study groups; Group 1 will receive regional radiotherapy and Group 2 will not. 
    Patients who are of 40 years of age or older may be able to take part in this study if they have newly diagnosed breast cancer that has been treated with breast-conserving surgery or mastectomy and has not spread to other parts of the body.
    Donnelly, Eric DonaldDonnelly, Eric Donald
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03488693 STU00208897
    More Info
    Copy

    CalorieHarmony for Obesity

    The purpose of this study is to learn about the factors that most influence participants in their ability to perform specific daily activities with varying intensity, while also measuring calorie expenditure. Using self-report questionnaires, we will collect a participant's medical history and determine their perceived ability to perform …

    The purpose of this study is to learn about the factors that most influence participants in their ability to perform specific daily activities with varying intensity, while also measuring calorie expenditure. Using self-report questionnaires, we will collect a participant's medical history and determine their perceived ability to perform certain activities. We will also use data collected from wearable sensors to build a more accurate energy expenditure estimator. Participants are asked to put on two wearable devices as well as a mask to measure breathing and perform 12 specific physical activities in the lab. The in-lab session lasts 3 hours. Lastly, participants will be asked their opinion about the wearability of the devices.

    This study is looking for men and women who:

    • Are between ages 18 and 64
    • Have a BMI of 30 or greater
    • Live in the Chicago area
    • Can speak, read and write in English

    Alshurafa, NabilAlshurafa, Nabil
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00208545
    More Info
    Copy

    ECOG-ACRIN 6174: STAMP: Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial

    We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, andtreat diseases like cancer.This study is being done to answer the following question: Can we lower the chance of your cancer growing back by …

    We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, andtreat diseases like cancer.This study is being done to answer the following question: Can we lower the chance of your cancer growing back by adding a study drug after your surgery?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your Merkel Cell Carcinoma. The usual approach is defined as care most people get after surgery to remove the cancer.

    We are asking you to take part in this research study because you have stage I-IIIB Merkel Cell Carcinoma (MCC) that has been removed by surgery.

    Chandra, SunandanaChandra, Sunandana
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03712605 STU00208944
    More Info
    Copy

    Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence

    We are conducting this research study because we are seeking a better treatment regimen for patients that have pelvic organ prolapse (POP). Surgical correction of POP can result in development of stress urinary incontinence (SUI) - leakage of urine associated with cough, laugh or sneeze even in patients who have never …
    We are conducting this research study because we are seeking a better treatment regimen for patients that have pelvic organ prolapse (POP). Surgical correction of POP can result in development of stress urinary incontinence (SUI) - leakage of urine associated with cough, laugh or sneeze even in patients who have never had these symptoms before. We therefore want to investigate if addition of minimally invasive Burch colposuspension at the time of sacrocolpopexy will help prevent SUI after surgery in women who do not have pre-existing symptoms of SUI. If our hypothesis that minimally invasive Burch colposuspension at the time of minimally invasive sacrocolpopexy will lower rates of SUI after surgery is correct, this could greatly improve upon our current surgical treatment of women with POP. 

    You may be eligible for this study if you are a woman over the age of 18 who is planning to have a laparoscopic or robotic sacrocolpopexy, with or without hysterectomy. Participants may be English or Spanish speaking and reading. This study is for women who are stress continent, who do not leak urine with coughing, sneezing, or laughing. To participate in this study you must have completed childbearing.

    Exclusion Criteria:

    • Pregnant women or patients desiring future pregnancy
    • Patients undergoing uterine sparing surgery
    • Individuals under age 18
    • Prior procedure for stress urinary incontinence
    • Prior retropubic surgery

    Collins, Sarah AbbieCollins, Sarah Abbie
    • Map it 676 N St. Clair Arkes Pavillion Suite 950
      Chicago, IL
    NCT03841513 STU00208016
    More Info
    Copy

    (xIRB NCI CIRB) NRG GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer.

    This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the …

    This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the usual approach?

    The purpose of this study is to compare any good and bad effects of using experimental study drugs cediranib alone, olaparib alone, or a combination of cediranib and olaparib. These drugs could shrink your cancer but they could also cause side effects. This study will allow the researchers to know whether one of these approaches is better, the same, or worse than the usual approach. The usual approach is defined as care most people get for endometrial cancer.

    You may be eligible for this research study if you have endometrial cancer which has grown or has returned after earlier treatment.

    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03660826 STU00208995
    More Info
    Copy

    Randomized trial of Retropubic versus Single-incision Mid-Urethral Sling (Altis™) for Concomitant Management of Stress urinary incontinence during Native Tissue Vaginal Repair

    This study is for women who have stress urinary incontinence when their vaginal bulge is returned to its normal position and who have opted for surgical management with a sling that will help support the urethra or the tube that carries urine from the bladder to the outside of the …
    This study is for women who have stress urinary incontinence when their vaginal bulge is returned to its normal position and who have opted for surgical management with a sling that will help support the urethra or the tube that carries urine from the bladder to the outside of the body. The purpose of this study is to compare two different types of FDA approved slings used for surgery. Participants will be asked to complete study questionnaires and attend 6 regular care visits. 
    You may be eligible for this study if:

    • You are at least 21 years of age
    • You are a woman being considered for a native vaginal repair in any vaginal compartment or colpocleisis
    • You have pelvic organ prolapse stage 2-4 and have vaginal bulge symptoms

    Kenton, Kimberly SueKenton, Kimberly Sue
    • Map it 676 N St. Clair Arkes Pavillion Suite 950
      Chicago, IL
    NCT03520114 STU00208116
    More Info
    Copy

    Impaired sensorimotor integration for prosodic speech production in Ataxic Dysarthria

    This study is investigating speech production in individuals with cerebellar damage to better understand the cerebellum's role in speech naturalness and prosody. If you have ataxia due to cerebellar disease or damage or if you are person who can serve as a control, please contact about participating. The study …
    This study is investigating speech production in individuals with cerebellar damage to better understand the cerebellum's role in speech naturalness and prosody. If you have ataxia due to cerebellar disease or damage or if you are person who can serve as a control, please contact about participating. The study session will only take 2-3 hours and you will be compensated for you time $10/hour. We are running the study both at our lab in Evanston, IL and at the Ataxia Clinic at the Northwestern Memorial Hospital in Chicago, IL. Participants will receive complimentary parking.
    For all participants:

  • Native-English proficiency
  • Ability to read and write
  • 18-90 years of age
  • For participants with ataxia:

  • History of damage to the cerebellum either due to disease and illness or to stroke or injury
  • Difficulty speaking
  • For control participants:

  • No history of neurological, speech, or language disorders
  • Larson, ChuckLarson, Chuck
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00208945
    More Info
    Copy

    BP40283 -Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder and Negative Symptoms

    The purpose of this study is to find out what effects, good or bad, the study medication RO6889450, has on you and symptoms of your schizophrenia or schizoaffective disorder. You were selected as a possible participant in this study because you have been diagnosed with schizophrenia or schizoaffective disorder and …

    The purpose of this study is to find out what effects, good or bad, the study medication RO6889450, has on you and symptoms of your schizophrenia or schizoaffective disorder.

    You were selected as a possible participant in this study because you have been diagnosed with schizophrenia or schizoaffective disorder and negative symptoms (thoughts, feelings, or behaviors normally present that are absent or diminished in people with schizophrenia or schizoaffective disorder)

    This study is intended to contribute to the further development of the study medication. The study medication is still being tested and has not been approved by any national health authority, including the US Food and Drug Administration (FDA).

    You have been diagnosed with schizophrenia or schizoaffective disorder and negative symptoms(thoughts, feelings, or behaviors normally present that are absent or diminished in people with schizophrenia or schizoaffective disorder)

    Rado, Jeffrey ThomasRado, Jeffrey Thomas
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03669640 STU00209192
    More Info
    Copy

    Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation

    The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for …
    The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

    Primary Inclusion Criteria:

  • Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team
  • Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab
  • Left ventricular ejection fraction (LVEF) ≥ 20%
  • Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03706833 STU00208635
    More Info
    Copy

    XIRB-A pragmatic trial of home versus office based narrow band ultraviolet B phototherapy for the treatment of psoriasis

    The purpose of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband UVB phototherapy for the treatment of psoriasis. Phototherapy delivered at home or the office are both common treatments for psoriasis but it is not …

    The purpose of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband UVB phototherapy for the treatment of psoriasis. Phototherapy delivered at home or the office are both common treatments for psoriasis but it is not known how well they compare to one another.

    12 years or older with plaque or guttate psoriasis predominantly on trunk and/or extremities. Patient needs to be willing to comply with in-office or in-home phototherapy.  
    Amin, Ahmad ZAmin, Ahmad Z
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03726489 STU00209270
    More Info
    Copy

    An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia

    This study will test if low-dose oral minoxidil has an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy regimen that persists for over six months). In this study, you will receive the study drug; there is no placebo option. The effectiveness …

    This study will test if low-dose oral minoxidil has an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy regimen that persists for over six months). In this study, you will receive the study drug; there is no placebo option. The effectiveness and safety of the treatment will be determined by a range of assessments, including biopsies, images, and subjective evaluation of perceived hair growth.

    Age 18 and above with a diagnosis of permanent chemotherapy-induced alopecia and agree to use contraception for the duration of the study.

    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT03831334 STU00206882
    More Info
    Copy

    The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea.

    The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).…
    The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).

    Inclusion Criteria:

    • Aged ≥ 21 years at the date of consent.
    • History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 45% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
    • Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas) and a central AHI ≥ 10/h or obstructive apnea index (OAI) < 20%
    • New York Heart Association (NYHA) Class III or IV, or NYHA Class II with ≥ 1 hospitalization for HF in the last 24 months.
    • Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization.
    • In the investigator's opinion, willing and able to comply with all study requirements
    • Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent

    Exclusion Criteria:

    • Current positive airway pressure use of diagnosis of Obstructive Sleep Apnea (OSA).
    • Oxygen saturation < 90% at rest during the day.
    • Oxygen saturation < 88% for > 5 continuous minutes during sleep unaccompanied by respiratory events.
    • Chronic daytime or nighttime use of supplemental oxygen.
    • Current smoker or bed partner that smokes in the bedroom.
    • Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
    • Body mass index (BMI) > 35 kg/m2.
    • Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
    • Transient ischemic attack or stroke within the previous 3 months.
    • Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
    • Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial
    • Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
    • End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
    • Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
    • Life expectancy < 1 year for diseases unrelated to chronic HF.
    • Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
    Zee, Phyllis CZee, Phyllis C
    • Map it 676 N. Saint Clair St. Seventh Floor, Suite 701
      Chicago, IL
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03745898 STU00209337
    More Info
    Copy

    Characterization of the microbiome in cutaneous T cell lymphoma

    The purpose of this study is to investigate the organisms that reside on the skin, in the gut, and nasal cavity and study their relationship with Cutaneous T-Cell Lymphoma (CTCL).
    • Be between the ages of 18-89
    • Be able and willing to provide informed consent
    • You must not have cutaneous t-cell lymphoma (CTCL)
    • You must not be currently pregnant
    • You must not be on or exposed to systemic antibiotics with 4 weeks of beginning study participation
    Zhou, AlanZhou, Alan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00209226
    More Info
    Copy

    Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). …

    The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational.
    This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02661451 STU00208415
    More Info
    Copy

    Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension – A 5-year longitudinal observation study of patients with cirrhosis undergoing TIPS placement

    ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their …
    ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

    Undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement

    Subjects over the age of 18 able to provide consent or have a legally authorized representative to provide consent in the event the subject is unable to consent due to a transient clinical condition

    Boike, Justin RichardBoike, Justin Richard
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03973372 STU00208288
    More Info
    TIPS
    Copy

    (xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

    The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) …

    The purpose of this study is to determine if including thedrug olaparib taken along with radiation treatment decreases the recurrence of cancerin patients who have inflammatory breast cancer and have already hadchemotherapy and surgery to remove the cancer. The drug olaparib is already approved by the Food and DrugAdministration (FDA) for use in ovarian, fallopian tube, peritoneal cancer, andgBRCA mutated her2-negative metastatic breast cancer, however olaparib is notapproved for inflammatory breast cancer.

    inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancer
    Donnelly, Eric DonaldDonnelly, Eric Donald
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03598257 STU00209490
    More Info
    Copy

    A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects ((≥6 To <18 Years of Age)

    The purpose of this research study is to see if guselkumab is safe and effective for treating patients with chronic plaque psoriasis, and to find out how long guselkumab stays in and acts on the body and how the body reacts to it. This is shown by laboratory blood tests. …

    The purpose of this research study is to see if guselkumab is safe and effective for treating patients with chronic plaque psoriasis, and to find out how long guselkumab stays in and acts on the body and how the body reacts to it. This is shown by laboratory blood tests. Another purpose is to find out if guselkumab can cause side effects (unexpected or unwanted reactions from taking a drug).

    You could be in this study if:

    • You are 6 to 17 years old
    • A doctor has said you have chronic plaque psoriasis
    • You have had chronic plaque psoriasis for at least 6 months
    • You have taken medication for your psoriasis, but it hasn’t worked

    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    NCT03451851 STU00209613
    More Info
    Copy

    A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

    The purpose of this research is to observe patients with skin conditions in a ‘real world’ setting and to create an patient registry of skin conditions, to better understand these diseases and how they are treated. A patient registry is a collection of information about a group of patients who …

    The purpose of this research is to observe patients with skin conditions in a ‘real world’ setting and to create an patient registry of skin conditions, to better understand these diseases and how they are treated. A patient registry is a collection of information about a group of patients who share a condition or experience.

    Additionally, researchers are interested in:

    • Observing how skin condition treatments work and understand side effects caused by these medicines and how these are managed
    • Identifying other types of conditions associated with skin disorders
    • Collecting patient reported outcomes to better understand the patient perspective and feelings patients have about having a skin condition
    • Assessing the impact of Patient Support Programs for individuals with skin conditions and how these programs affect skin condition outcomes
    • Creating a “Biorepository Specimen Bank” with blood and saliva samples

    • Have a skin condition such as Atopic Dermatitis, Psoriasis, Alopecia, Vitiligo, Hidradenitis Suppurativa and others.
    • You will not be asked to take any medications as part of this study.
    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00209616
    More Info
    Copy

    (xIRB) NRG-BN005 A Phase II Randomized Trial of Proton vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas.

    The purpose of this study is to compare any good and bad effects of using proton therapy to using photontherapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam ofproton particles to send radiation inside the body to the tumor. This study will allow …

    The purpose of this study is to compare any good and bad effects of using proton therapy to using photon

    therapy. Photon therapy is the usual treatment approach for brain cancer. Proton therapy uses a beam of

    proton particles to send radiation inside the body to the tumor. This study will allow the researchers to know

    whether proton therapy is better, the same, or worse than the usual approach. Proton therapy may have less

    negative effects on brain function than photons because less brain is exposed to radiation when proton therapy

    is used. However, proton therapy might also be associated with more frequent tumor recurrences.

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with a brain tumor

    Stupp, RogerStupp, Roger
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03180502 STU00209631
    More Info
    Copy

    A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

    The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies.

    • Participants must be18 years or older
    • Participants must bediagnosed with non-small cell lung cancer
    Chae, Young KwangChae, Young Kwang
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03851445 STU00209659
    More Info
    Copy

    Modulating stimuli intensity to improve clinical outcomes in aphasia treatment

    A study is available for persons with aphasiaThe Shirley Ryan AbilityLab is conducting a research study that will help us understand how to better schedule speech and language therapy. If you should qualify, you will receive 10 hours of speech and language therapy. Therapy will be scheduled for either:a)…

    A study is available for persons with aphasia

    The Shirley Ryan AbilityLab is conducting a research study that will help us understand how to better schedule speech and language therapy.

    If you should qualify, you will receive 10 hours of speech and language therapy.

    Therapy will be scheduled for either:

    a)two weeks (1 hour a day, 5 days a week)

    or

    b)five weeks (1 hour a day, 2 days a week)

    Diagnosis of aphasia from a single stroke

    More than 6 months since stroke onset

    At least 18 years old

    English-speaking before the stroke

    Cherney, Leora RCherney, Leora R
    • Map it 355 E. Erie St.
      Chicago, IL
    STU00209618
    More Info
    Copy

    T Cell-Mediated Autoimmune Responses in Parkinson’s Disease

    This study aims to examine a type of T-cell, an immune cell in the blood. This type of T cell has been found in about half of people with PD and only rarely in control volunteers who do not have PD and may be a biomarker of PD. A biomarker is a substance or characteristic in our bodies that is associated with the presence of disease or that changes over time in a way that can be linked to the progression of disease. These biological measures may help develop treatments for PD, particularly therapies that could potentially slow or stop progression.

    Participants in this study will:

    - Have a one time study visit at the Shirley Ryan AbilityLab

    - Complete assessments of motor and cognitive symptoms

    - Provide medical history, history of PD in blood relatives, current list of medications, and fill out other surveys

    - Donate 250 cc (about ½ pint or 17 tablespoons) of blood for study of T cells

    - Be compensated $35 for their participation

    You may be eligible to participate as someone with Parkinson’s Disease (PD) if you:

    - Have been diagnosed with PD

    - Are 45 years or older

    - Weigh 110 lbs or more

    - Have no history of cancer (except skin cancer) or autoimmune disease

    You may be eligible to participate as a healthy control if you:

    - Are 45 years or older

    - Weigh 110 lbs or more

    - Have no history of cancer (except skin cancer) or autoimmune disease

    - Have no history of PD in blood relatives, such as a parent or sibling

    Goldman, Jennifer G.Goldman, Jennifer G.
    • Map it 355 E. Erie St.
      Chicago, IL
    STU00209668
    More Info
    Copy

    AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac Surgery

    This study is enrolling patients who have been diagnosed with a non-paroxysmal form of atrial fibrillation (persistent or longstanding persistent) and whose doctor determined that they need surgery to correct their AF, along with another heart problem (i.e., heart valve or blocked artery). Atrial fibrillation (AF) is an …
    This study is enrolling patients who have been diagnosed with a non-paroxysmal form of atrial fibrillation (persistent or longstanding persistent) and whose doctor determined that they need surgery to correct their AF, along with another heart problem (i.e., heart valve or blocked artery). Atrial fibrillation (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. People may participate in this clinical research trial if their study doctor has determined that they have a certain type of AF and require surgery to correct another heart problem other than AF. The purpose of this study is to evaluate safety and effectiveness of the cryoICE Cryoablation System, in conjunction with LAA exclusion using the AtriClip device, in patients with persistent or longstanding persistent atrial fibrillation who are having heart surgery for another reason. AtriCure’s cryoICE Cryoablation System has been cleared by the FDA to ablate cardiac tissue for the treatment of non-specific cardiac arrhythmias in patients who are undergoing open heart surgery. However, the cryoICE Cryoablation System is not approved by the FDA specifically for the treatment of atrial fibrillation and therefore its use is considered investigational in this study.
    McCarthy, Patrick MMcCarthy, Patrick M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03732794 STU00209056
    More Info
    Copy

    A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage (MIND)

    This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the …
    This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the size of the blood clot that forms in the head from the bleeding. The purpose of this study is to better understand how well and how safely the Artemis Neuro Evacuation Device (Artemis Device) impacts patients that have bleeding in their brain and compare that with patients who are not treated with the Artemis Device. The Artemis Device, used with the Penumbra Aspiration Pump, is designed to help remove blood and blood clots from the brain. This study will help to determine if more patients survive and have a better recovery after removing an ICH than if it wasn’t done.

    The Artemis Device is a medical device that has been cleared by the United States Food and Drug Administration (FDA) for controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in combination with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration System. The device is commercially available in the United States.

    Patients with bleeding in the brain causing a type of stroke (intracerebral hemorrhage or ICH) may be eligible for this study.

    Jahromi, Babak SJahromi, Babak S
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    • Map it 251 E. Huron St. Fifth Floor, Suite 704
      Chicago, IL
    • Map it 25 N. Winfield Road Suites 424 and 431
      Winfield, IL
    • Map it 25 N. Winfield Road
      Winfield, IL
    NCT03342664 STU00209486
    More Info
    Copy

    (xIRB NCI CIRB) ETCTN 10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma

    The purpose of this study is to see how peoplewith advanced urothelial carcinoma respond to an approved treatment for thistype of cancer (MK-3475) in combination with the study drug tazemetostat(MK-3475 with tazemetostat). Tazemetostat is an investigational drug, whichmeans it is not approved by the FDA. Laboratory research …

    The purpose of this study is to see how peoplewith advanced urothelial carcinoma respond to an approved treatment for thistype of cancer (MK-3475) in combination with the study drug tazemetostat(MK-3475 with tazemetostat). Tazemetostat is an investigational drug, whichmeans it is not approved by the FDA. Laboratory research indicates thatcombining the two drugs has the potential to have a better response thanMK-3475 alone.

    This study will help the study doctors findout the safest and most effective dose for tazemetostat when combined withMK-3475. It will also help doctors determine if the combination treatment has abetter anticancer effect than treatment with MK-3475 alone. To decide if it isbetter, the study doctors will be looking to see if adding tazemetostatimproves the response rates of patients compared to the usual approach.

    Diagnosis ofadvanced urothelial carcinoma

    · Age of at least 18 years

    Hussain, MahaHussain, Maha
    NCT03854474 STU00209918
    More Info
    Copy

    NU MTBC 18M02: Melanoma Tissue Bank Consortium Protocol

    The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun exposure (the “Annotating Data”). This part of the project is called the “Biobanking …

    The purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun exposure (the “Annotating Data”). This part of the project is called the “Biobanking Study”. The second purpose is for MTBC to provide the Biospecimens and/or Annotating Data from the MTBC Biobank to researchers around the world for them to use in specific studies in order to study melanoma (“Future Use Study).

    Melanoma is a lethal form of skin cancer and more research is necessary to help scientists to understand what causes it, how to diagnose it, how it can be prevented, and how it can be treated. To do this research, scientists need biospecimens (like biopsied tissue and blood samples) from people who have been diagnosed with melanoma and other skin disorders. This study will help scientists learn about melanoma and the projects being conducted on behalf of the Melanoma Tissue Bank Consortium(“MTBC”).

    We are asking you to take part in this research study because you have melanoma or another skin disorder.Your participation is completely voluntary. You may choose not to take part.Your decision to sign this informed consent and authorization form in order to participate in the Biobanking Study and to allow the use of your Biospecimens and Annotating Data in a Future Use Study will not change the treatment you receive for your skin disorder.

    Wayne, Jeffrey DWayne, Jeffrey D
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00209847
    More Info
    Copy

    Radicava® (Edaravone) Biomarker Study in Participants with Amyotrophic Lateral Sclerosis

    This is a non-interventional (no study drug), observational study of patients with ALS who elect to begin treatment with Edaravone (radicava).This study is designed to investigate a selected panel of biomarkers in patients with ALS, treated with Edaravone. Biomarkers of oxidative stress, inflammation and neurodegeneration will be explored. …

    This is a non-interventional (no study drug), observational study of patients with ALS who elect to begin treatment with Edaravone (radicava).

    This study is designed to investigate a selected panel of biomarkers in patients with ALS, treated with Edaravone. Biomarkers of oxidative stress, inflammation and neurodegeneration will be explored. Epigenetic and protein biomarkers will also be investigated.

    Edaravone will NOT be provided by the study sponsor.

    1. Sporadic or familial ALS diagnosed as possible, probable, probable-laboratory supported or definite as defined by the World Federation of Neurology revised El Escorial criteria

    2. Decision made to prescribe Edaravone prior to screening

    3. Participant will likely be able to obtain commercial Edaravone and likely to complete 6 cycles of treatment, per site investigator estimation

    4. Participant either naïve to Edaravone or who did not receive any Edaravone dose within 28 days prior to screening

    5. Participant with a contraindication to Edaravone may not participate

    6. Participant is participating in an interventional clinical trial may not participate

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04259255 STU00210057
    More Info
    Copy

    DRUG KRT-232-103: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

    We are asking you to take part in this research study because you have been diagnosed with Merkel cell carcinoma (MCC) and your prior treatment with a specific immunotherapy (a type of therapy called anti-PD-1 or anti-PD-L1) was not or is no longer effective for your …

    We are asking you to take part in this research study because you have been diagnosed with Merkel cell carcinoma (MCC) and your prior treatment with a specific immunotherapy (a type of therapy called anti-PD-1 or anti-PD-L1) was not or is no longer effective for your disease. The purpose of this study is to evaluate how well tolerated KRT-232 is when given to participants with Merkel cell carcinoma, and whether KRT-232 can improve your MCC.

    In order to participate in this study, your Merkel cell carcinoma cells must be a certain type of cell, called “p53 wild type” cells (p53wt).
    Chandra, SunandanaChandra, Sunandana
    NCT03787602 STU00209401
    More Info
    Copy

    A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

    Non-Alcoholic Steatohepatitis (NASH) is a liver disease that isassociated with an increased amount of fat and inflammation in the liver. Having NASH increases the chances of gettingheart disease. In time, liver cells may be so badly damaged that scar tissueforms (fibrosis) within the liver where healthy cells used to …

    Non-Alcoholic Steatohepatitis (NASH) is a liver disease that isassociated with an increased amount of fat and inflammation in the liver. Having NASH increases the chances of gettingheart disease. In time, liver cells may be so badly damaged that scar tissueforms (fibrosis) within the liver where healthy cells used to be. When this happens, your doctor might diagnoseyou with “NASH fibrosis”. When enoughscarring happens and the liver gets even more diseased, the liver becomescirrhotic and stops working which causes serious complications in your body. NASHfibrosis can only be accurately diagnosed by taking a sample of tissue called a“biopsy” directly from the liver. There are currently no approved medicines forNASH.

    MadrigalPharmaceuticals, Inc. (the Sponsor of the study) is running this medical researchstudy to see if a test medicine named MGL-3196 (resmetirom), will help in thetreatment of NASH fibrosis and also to find out how safe it is to use in peoplewith NASH. MGL-3196 is an ‘investigational’ drug, i.e., it is not approved foruse by the U.S. Food and Drug Administration (FDA) MGL-3196 was previouslytested in a 9-month study in patients with NASH and was found to be safe andwell-tolerated, caused a decrease in the amount of fat in the liver, and causeda decrease in NASH compared with placebo patients (placebo patients arepatients that did not receive MGL-3196 (“active drug”) in the 9-month study).

    You may qualify for this study if you have been diagnosed with NASH or are suspected ofhaving NASH (fatty liver disease).

    Boike, Justin RichardBoike, Justin Richard
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03900429 STU00210193
    More Info
    Copy

    A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after …
    This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after a year of receiving the usual treatmentplus the new anti-cancer drug discontinue therapy? 
    Some of the eligibility criteria include: - Participants must have intermediate or high-risk chronic lymphocyticleukemia that has not been treated before - 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.
    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03737981 STU00210225
    More Info
    Copy

    Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of Hepatic Malignancies

    In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass …

    In the study, there will be many patients, like you, with hepatocellular carcinoma (HCC) who are eligible to receive a treatment called Y90 radioembolization and who may also be liver resection candidates.

    Y90 radioembolization is a non-invasive, out-patient treatment that uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the Y90 radiation inside the tumor(s).

    Liver resection is used to remove the part of the liver that has the liver tumor(s). It has been shown that Y90 radioembolization can increase the untreated liver’s size and volume. Patients with HCC may be liver resection candidates if they have a large enough liver.

    The purpose of this research is to determine if there is an ideal Y90 dose to increase liver volume. This research may help determine the best Y90 dose for future patients who need a larger liver to have a liver resection.

    If you participate in this study, you will have standard-of-care Y90 radioembolization as well as study-specific imaging and two optional liver biopsies. You will participate in the study for up to 3 months. Your health status will continue to be followed for up to 5 years.

    Patients enrolled in the study will receive up to $195.00 for their participation.

    You are eligible to participate in this study if:

    1. You are an adult 18 years of age or older

    2. You have been diagnosed with hepatocellular cancer and may be a liver resection candidate to remove your disease

    Lewandowski, Robert JLewandowski, Robert J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04390724 STU00209629
    More Info
    Copy

    Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer

    Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.…
    Thepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.
    • Participants must be 18 years orolder
    • Participants must be diagnosed with bladder cancer thathas not spread beyond the bladder.
    Sachdev, SeanSachdev, Sean
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03775265 STU00210415
    More Info
    Copy

    Natural history study of ALS and other motor neuron disorders

    This is one of the largest non-interventional observational study of patients with ALS and other motor neuron disorders. It is both prospective and retrospective. It does not require blood sampling.

    1. A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS.

    2. Other motor neuron disorders, including but not limited to spinobulbar muscular atrophy (SBMA, Kennedy’s disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP).

    3. Excluded are any disease that does not meet criteria for any motor neuron disorder

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00209860
    More Info
    Copy

    A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE – Protocol 402-C-1808

    FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Approximately 300 patients, at 75 study centers, will be enrolled in FALCON around the world.…
    FALCON is a Phase 3 clinical study evaluating the effectiveness and safety of bardoxolone methyl (an oral investigational drug) in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Approximately 300 patients, at 75 study centers, will be enrolled in FALCON around the world.
    18 to 70 years of age

    Diagnosed with ADPKD

    Tuazon, Jennifer ATuazon, Jennifer A
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03918447 STU00209870
    More Info
    Copy

    A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors

    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 …
    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
    NCT03995901 STU00209928
    More Info
    Copy

    Parkinson’s Foundation Genetic Research Initiative

    The main objective of this study is to assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of their clinical care for People with Parkinson’s disease (PWP).…

    The main objective of this study is to assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of their clinical care for People with Parkinson’s disease (PWP).

    • Must have an official diagnosis of Parkinson's disease
    • Willingness to undergo genetic testing, and choose to be informed of genetic testing results for GBA, LRRK2 and 5 additional PD related
    genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
    • Must have necessary technology (computer with camera, or tablet) including internet access to complete telemedicine visit (if
    selected).

    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03924414 STU00210600
    More Info
    Copy

    (xIRB NCI CIRB) ECOG-ACRIN 9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine or Vincristine Sulfate in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

    This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine sulfate in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may …

    This phase Ib/II clinical trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine sulfate in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with vincristine sulfate may work better in treating patients with acute lymphoblastic leukemia.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    - Participants must have a diagnosis of acute lymphoblastic leukemia, which has grown after their first treatment regimen or has recurred.

    - Participants must be 18 or older.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Dinner, Shira NaomiDinner, Shira Naomi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03504644 STU00210605
    More Info
    Copy

    (XIRB) DRUG IMSA101-101: Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients with Advanced Treatment-Refractory Malignancies

    The purpose of this research is to find a safe and tolerable dose of the study drug, IMSA101, for the treatment of your type of cancer and other types of cancer. …

    The purpose of this research is to find a safe and tolerable dose of the study drug, IMSA101, for the treatment of your type of cancer and other types of cancer.

    All adult subjects ages 18 and above with advanced cancer that is no longer responding to standard of care treatment are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04020185 STU00210768
    More Info
    Copy

    GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

    This study is enrolling patients who have a patent foramen ovale (PFO), have had a stroke of unknown origin (cryptogenic stroke), and whose doctor has decided they are a candidate for a transcatheter procedure (a procedure performed through a flexible tube inserted through a narrow opening into a small incision …
    This study is enrolling patients who have a patent foramen ovale (PFO), have had a stroke of unknown origin (cryptogenic stroke), and whose doctor has decided they are a candidate for a transcatheter procedure (a procedure performed through a flexible tube inserted through a narrow opening into a small incision in the skin) to close their PFO. A PFO is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of your heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart. This post-market study will look at closing the PFO to reduce the risk for another stroke using a market-approved medical device called a septal occluder. This device is called the ‘GSO device’ in this description. The GSO device is a minimally invasive device intended for the closure of a PFO using cardiac catheterization. It is a permanent implant consisting of a near circular wire frame covered with thin material. The soft, conformable material, invented and manufactured by Gore, has been used in open-heart surgery for more than 40 years and has been shown to be safe in implanted medical devices. The wire frame is made of a nickel-titanium metal alloy called nitinol with a platinum core (so that it may be seen on X-ray images).
    Benzuly, Keith HBenzuly, Keith H
    • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
      Chicago, IL
    NCT03821129 STU00209945
    More Info
    PFO PFO Closure
    Copy

    BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma

    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. …
    This study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing. 
    You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.
    Boumber, YanisBoumber, Yanis
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03942653 STU00210435
    More Info
    Copy

    (xIRB) A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

    This study is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by adding anew immunotherapy drug called Pembrolizumab to the usual combination of chemotherapy drugs? We want to find out if this approach of using a new immunotherapy drug …

    This study is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by adding anew immunotherapy drug called Pembrolizumab to the usual combination of chemotherapy drugs? We want to find out if this approach of using a new immunotherapy drug called Pembrolizumab is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which includes treatment with surgery, radiation, or drugs including: carboplatin, paclitaxel, gemcitabine, pegylated liposomal doxorubicin, and topotecan (all U.S. Food and Drug Administration [FDA] approved agents). Sometimes, combinations of these treatments are used.

    Everyone in the study will get paclitaxel and carboplatin with pembrolizumab or paclitaxel and carboplatin with a placebo forfour and a half months, followed by pembrolizumab or a placebo for up to two years. Placebo looks like the study drug but contains no medication.

    • Stage III, IVA, IVB, or recurrent endometrial cancer.
    • No chemotherapy within 12 months and no radiation therapy within 4 weeks.
    Matei, Daniela ElenaMatei, Daniela Elena
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT03914612 STU00210842
    More Info
    Copy

    PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated REnal Cell CancEr [PDIGREE]

    This study is being done to answer the following question: Can we prolong life for patients withadvanced kidney cancer, by adding a drug called cabozantinib to another treatment afterreceiving the standard treatment?We are doing this study because we want to find out if this approach isbetter or worse than …

    This study is being done to answer the following question: Can we prolong life for patients with

    advanced kidney cancer, by adding a drug called cabozantinib to another treatment after

    receiving the standard treatment?

    We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer.

    -Participants must be 18 years of age or older

    -Participants must be diagnosed with advanced kidney cancer

    VanderWeele, David JamesVanderWeele, David James
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03793166 STU00210884
    More Info
    Copy

    The “RADIANCE II” Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension

    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may …
    This study is enrolling patients who have high blood pressure ("hypertension") and are taking two medications or fewer for it. It is believed that in some patients with high blood pressure, the nerves surrounding the blood vessels leading to the kidneys (renal arteries) are too active and that this may be causing high blood pressure. Renal denervation is a procedure where a catheter is placed inside these blood vessels and creates heat to disable the nerves and potentially lower blood pressure. The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension.
    Benzuly, Keith HBenzuly, Keith H
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03614260 STU00209790
    More Info
    Hypertension HTN
    Copy

    A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSORMASKED, ACTIVE COMPARATOR STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA (PAGODA)

    The purpose of this study is to compare the effects, good or bad, of ranibizumab when it is delivered by an ocular (eye) implant (also known as the Port Delivery System with ranibizumab, or PDS) versus ranibizumab delivered by injections into the eye as treatment for your DME. The ocular …

    The purpose of this study is to compare the effects, good or bad, of ranibizumab when it is delivered by an ocular (eye) implant (also known as the Port Delivery System with ranibizumab, or PDS) versus ranibizumab delivered by injections into the eye as treatment for your DME. The ocular implant releases ranibizumab continuously (without stopping) over a long period of time into the back of your eye, and it can be refilled with fresh ranibizumab by your study doctor. Because the implant continuously releases ranibizumab over time, you may not need additional eye injections to treat your DME. This study will help determine whether ranibizumab delivered continuously through an ocular implant is similar in effectiveness to ranibizumab injections into the eye for treating patients with DME.

    DME, a long-lasting condition, is the most common cause of vision loss among people with diabetes and causes problems in vision such as blurred or wavy vision and colors that appear to be washed out. It is caused by damage to blood vessels in the retina (the light-sensitive layer at the back of the eye) that causes the vessels to leak blood or fluid into the macula (the most sensitive and central part of the retina that gives you sharp vision). DME causes the macula to swell, leading to blurred or wavy vision. A protein called vascular endothelial growth factor (VEGF) is involved in the development and leakiness of damaged blood vessels, which leak blood or fluid in the macula in patients with DME.

    Ranibizumab is a medicine that blocks VEGF, which in turn slows the growth of and leakage from the damaged blood vessels in your eye. In this study, you will either get ranibizumab delivered by the ocular implant with refills every 6 months, which will release ranibizumab continuously over time into the back of your eye, or you will receive monthly injections of ranibizumab into your eye at a dose of 0.5 mg.

    Ranibizumab, given by regular injections into your eye at a dose of 0.3 mg in the U.S. and 0.5 mg in Europe, is approved for the treatment of DME. The Food and Drug Administration (FDA) has not approved a 0.5 mg monthly dose for DME in the U.S. The two doses have been shown in clinical studies to have similar safety and effectiveness results.

    For subjects receiving the ocular implant, the ranibizumab given as a dose of 2 mg in the implant and refilled every 6 months is considered an experimental study drug that will only be given to subjects in this research study. However, the active ingredient, ranibizumab, is the same as that in the approved product.

    The ocular implant is an experimental device, which means the FDA has not approved it to be implanted in the eye for the treatment of DME. The implant is slightly bigger than a grain of rice (see Figure 1 and Figure 2). The ocular implant is covered by the conjunctiva – the thin, clear skin covering the eye and is usually not visible to others because it is hidden by the upper eyelid.

    • 18 years or older
    • Diabetes mellitus (Type 1 or Type 2)
    • HbA1c level of < 10% within 2 months
    • Vision of 20/320 or better
    Gill, Manjot KGill, Manjot K
    • Map it 259 E. Erie St. Suite 1520
      Chicago, IL
    NCT04108156 STU00210925
    More Info
    Copy

    Parkinson's Disease: Intervening Early Concerning Employment (PIECE) Aims 2 and 3

    Partner with our study team to check in about your Parkinson's and work twice a year for three years. Every six months, you'll have a phone call and fill out an online survey where you'll answer questions about your Parkinson's, symptoms, and work status. Altogether, it'…
    Partner with our study team to check in about your Parkinson's and work twice a year for three years. Every six months, you'll have a phone call and fill out an online survey where you'll answer questions about your Parkinson's, symptoms, and work status. Altogether, it'll take about 45 minutes each time, and you'll receive $25 for each six-month check-in.
    You are eligible to participate if you meet all of these main criteria:

    • You've been diagnosed with Parkinson's disease for five years or less
    • You're currently employed or looking for work.
    • You plan to be employed for at least three years.
    • You are fluent in English.

    Rafferty, Miriam RoseRafferty, Miriam Rose
    • Map it 355 E. Erie St.
      Chicago, IL
    STU00210681
    More Info
    Copy

    (xIRB Sterling) DRUG 68284528MMY2003: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2)

    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and …
    The purpose of this study is to see if JNJ-68284528 is safe and useful for treating patients with relapsed or refractory multiple myeloma. In this type of treatment, your white blood cells (which are a part of the immune system) will be genetically modified to become JNJ-68284528 and used to treat your multiple myeloma.

    Some of the eligibility criteria include:

    • Participants must have a diagnosis of multiple myeloma
    • Participants must be 18 or older.
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Singhal, SeemaSinghal, Seema
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04133636 STU00210994
    More Info
    Copy

    (xIRB) NCI CIRB NRG GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

    The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of …

    The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. The use of the hormonal therapy drug letrozole without chemotherapy may shrink or stabilize cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen.

    This study will investigate if this approach is better, the same, or worse than the usual approach. In order to determine if the use of letrozole alone helps to improve treatment for patients with low-grade serous ovarian or peritoneal cancer compared to combined chemotherapy and letrozole, half of patients in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone. The study doctors will be looking to see if the letrozole alone prolongs the time cancer is in remission, or the duration of time participants are alive after treatment.

    Letrozole is approved by the FDA for breast cancer, but is not FDA approved for ovarian cancer and is therefore considered experimental in this setting.

    Participants will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone. Patients who are assigned to letrozole monotherapy will continue taking the letrozole for as long as they are tolerating the drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of their disease.

    After participants finish their study treatment, their doctor and study team will continue to follow their condition and watch for side effects during clinic visits or by phone. Participants will be checked every 3 months for the first 3 years after treatment. After that, this will happen every 6 months for two years.

    • New diagnosis of stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum.
    • At least 18 years old.
    • Must start within 8 weeks of primary surgery
    Barber, Emma LongleyBarber, Emma Longley
    • Map it 250 E. Superior St.
      Chicago, IL
    NCT04095364 STU00211055
    More Info
    Copy

    (xIRB) NCI CIRB NRG HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

    The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks with cisplatin chemotherapy to a reduced-dose radiationgiven over either 6 weeks with cisplatin or 5 weeks with the immunotherapydrug, nivolumab. A lower dose of radiation as compared to the …

    The purpose of PhaseII this study is to compare the usual treatment of a standard-dose radiationgiven over 6 weeks with cisplatin chemotherapy to a reduced-dose radiationgiven over either 6 weeks with cisplatin or 5 weeks with the immunotherapydrug, nivolumab. A lower dose of radiation as compared to the usual radiationtreatment dose could be as effective in lengthening the time without the cancergetting worse.

    This study will helpresearchers find out if this different approach is the same or worse than theusual approach. To decide if it is the same, the study doctors will be lookingto see if the study approach maintains the length of time without cancergetting worse compared to the usual approach. If the study approach is the sameas the usual approach, the study will advance to the second part, the phaseIII, and participants may be asked to participate in the second part of thestudy.

    The purpose of thesecond part of this study is to compare the usual treatment of a standard-doseradiation given over 6 weeks with cisplatin chemotherapy to a reduced-doseradiation given over either 6 weeks with cisplatin or 5 weeks with theimmunotherapy drug, nivolumab. A lower dose of radiation as compared to theusual radiation treatment dose may or may not be as effective in lengtheningthe time without the cancer getting worse. Another purpose of the second partof this study is to see if a lower dose of radiation as compared to the usualradiation treatment dose could also have a better effect on a participant'swell-being.

    We are asking you to take part in this research study because you have low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. 
    Gharzai, LailaGharzai, Laila
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03952585 STU00211079
    More Info
    Copy

    Project 1, Adaptations of the Brain in Chronic Pain with Opioid Exposure

    In this project, we will study brain reorganization and behavioral responses in chronic pain with opioid exposure. Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the opioid epidemic. …
    In this project, we will study brain reorganization and behavioral responses in chronic pain with opioid exposure. Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the opioid epidemic. Although millions of people with CBP regularly use opioids, little is known about the impact of long-term opioid use on the chronic pain brain. Through pain tracking, MRI scans, and various other methods, this study will look at understanding the effect of long-term opioid use on the chronic pain brain.
    Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy Male or female, age 18 years or older Must be in generally stable health Must have a smartphone that will allow downloading of the pain app Must be on regular opioid or NSAID therapy for at least 3 months
    Apkarian, ApkarApkarian, Apkar
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03535688 STU00209670
    More Info
    Copy

    (xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

    The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

    We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

    • Participantsmust be 18 years or older

    • Participants must have a confirmed diagnosis of cancermetastasized to the brain
    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03994796 STU00211229
    More Info
    Copy

    AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic Stroke- Cognition and Silent Infarcts

    ARCADIA-CSI an ancillary study to the ARCADIA trial in which we will assess cognitive function and silent infarcts in a subset of the ARCADIA population. The purpose of ARCADIA-CSI is to determine the effect of apixaban vs aspirin on these two additional outcomes in patients with stroke …
    ARCADIA-CSI an ancillary study to the ARCADIA trial in which we will assess cognitive function and silent infarcts in a subset of the ARCADIA population. The purpose of ARCADIA-CSI is to determine the effect of apixaban vs aspirin on these two additional outcomes in patients with stroke of unknown cause and atrial cardiopathy.
    Patients randomized in the ARCADIA trial and on study drug will be eligible for ARCADIA-CSI if they can undergo cognitive testing (english speaking) and have no MRI contraindications.
    Caprio, Fan ZhangCaprio, Fan Zhang
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03192215 STU00211262
    More Info
    Copy

    NU COH21S03: A Phase II Study of Cabozantinib and Temozolomide in Patients with Unresectable or Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

    The purpose of this study is to determine if cabozantinib, given together with temozolomide is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than temozolomide alone. Both drugs are considered investigational. Preclinical and clinical evidence shows that adding antiangiogenic agents (…
    The purpose of this study is to determine if cabozantinib, given together with temozolomide is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than temozolomide alone. Both drugs are considered investigational. Preclinical and clinical evidence shows that adding antiangiogenic agents (substances, drugs, or compounds which get rid of parts of the blood vessels needed by tumors to grow and spread) to chemotherapy, enhances anti-tumor and antiangiogenic effects.  
    We are asking you to take part in this research study because you have been diagnosed with leiomyosarcoma (cancer of the smooth muscles) or non leiomyosarcoma (another kind of soft tissue cancer), and your type of cancer cannot be removed through surgery or has spread to a different part of your body. 
    Pollack, Seth MichaelsPollack, Seth Michaels
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04200443 STU00210699
    More Info
    Copy

    MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) (Protocol #: B01-04)

    A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem®, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.…
    A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem®, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.

    Primary Inclusion Criteria:

    • Male or female subjects ≥18 years of age
    • Clinical diagnosis of ischemic stroke involving cerebral cortex
    • Onset of stroke symptoms must have occurred 18 to 36 hours prior to the planned start of administration of the investigational product
    • Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
    • A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke

    Primary Exclusion Criteria:

    • Presence of a lacunar or a brainstem infarct
    • Comatose state
    • Brain hemorrhage
    • Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study

    Batra, AyushBatra, Ayush
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03545607 STU00209969
    More Info
    Copy

    A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson’s Disease (Protocol# 254PD101)

    The purpose of study is to determine whether BIIB094 may improve PD symptoms in subjects with or without changes in the LRRK2 gene. The study medication will be given as an injection into your back near the spinal cord. This iscalled an “intrathecal” injection.…
    The purpose of study is to determine whether BIIB094 may improve PD symptoms in subjects with or without changes in the LRRK2 gene. The study medication will be given as an injection into your back near the spinal cord. This iscalled an “intrathecal” injection.

    2. Diagnosis of PD w/in 7yrs without motor fluctuationsor dyskinesia.

    3. Not on any medication for PD or on stable therapy for 8weeks prior to screening.

    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03976349 STU00210196
    More Info
    Copy

    (xIRB) NCI CIRB Alliance A021703: Randomized Double-blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different …

    Participants with colorectal cancer will beinvited to participant in this study. The purpose of this study is to comparethe usual treatment (usual chemotherapy plus bevacizumab) plus high-dosevitamin D3 to using the usual treatment plus regular-dose vitamin D3. Thisstudy will help the study doctors find out if this different approach isbetter, the same, or worse than the usual approach. To decide if it is better,the study doctors will be looking to see if the addition of high-dose vitaminD3 to usual approach can shrink or stabilize tumors for a longer period of timethan regular-dose vitamin D3 and usual approach.

    This study has two groups:

    Group 1: Participants in this group will getthe usual drug regimen used to treat this type of cancer, either FOLFOX plusbevacizumab or FOLFIRI plus bevacizumab, plus a study drug called high-dosevitamin D3.

    Group 2: Participants in this group you willget the usual drug regimen used to treat this type of cancer, either FOLFOXplus bevacizumab or FOLFIRI plus bevacizumab, plus a study drug calledregular-dose vitamin D3.

    Participants who are at least 18 years of age or older who have advanced colorectal cancer. 
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04094688 STU00211478
    More Info
    Copy

    (xIRB) Social Processing in Remitted Adolescent Depression

    Participate in a paid research study at Northwestern University Feinberg School of Medicine! We are actively recruiting for study on mood and phone use. Teens age 13-18 who use iPhones or Androids may be eligible. Teens may earn up to $519. Parents will also be compensated $25 for their …

    Participate in a paid research study at Northwestern University Feinberg School of Medicine! We are actively recruiting for study on mood and phone use. Teens age 13-18 who use iPhones or Androids may be eligible. Teens may earn up to $519. Parents will also be compensated $25 for their time.

    The study will consist of four total sessions – three virtual and one in person. The initial video call and in-person visit will take about 4 hours each. The remaining two video calls will take place approximately 6 and 12 months after the start of the study and will take about 2 hours each. Participation will also involve the use of a study-specific smartphone app throughout the 12-month study period.

    Interested teens/parents can email us directly at NUCU@northwestern.edu or complete the contact form at https://sites.northwestern.edu/nearlab/participate/.

    IRB Study Code: STU00211494 /Principal Investigator: Stewart Shankman, Ph.D.

    Eligibility Criteria:

    • Age 13-18
    • Use an iPhone or Android
    • Right-handed
    • Fluent in English

    Shankman, Stewart AShankman, Stewart A
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    STU00211494
    More Info
    Copy

    The effect of Epitomee Capsule on body weight in patients with overweight and obesity with and without pre-diabetes

    Weight loss study using a non-medication capsule along with lifestyle modification program.
    Non-diabetic or pre-diabetic, BMI between 27-40
    Kushner, Robert FKushner, Robert F
    NCT04222322 STU00211501
    More Info
    Copy

    (xIRB) NCI CIRB ECOG-ACRIN 2182: A Randomized Phase II Study of De-Intensified ChemoRadiation for EarlyStage Anal Squamous Cell Carcinoma (DECREASE)

    This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach. This study has 2 studygroups. · …

    This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach.

    This study has 2 studygroups.

    · Participants in groupA will get the standard dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 28 radiation treatment sessions in this group.

    · Group 2 (Arm B)

    Participants in group2 you will get the lower dose of chemoradiation therapy: this includesMitomycin-C and 5-Fluorouracil or Capecitabine, as well as radiation. Therewill be 20 or 23 radiation treatment sessions in this group, depending on thesize of the tumor.

    Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.
    Kircher, Sheetal MehtaKircher, Sheetal Mehta
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04166318 STU00211554
    More Info
    Copy

    Right Ventricular Ischemia and Fibrosis in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time …
    This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.

    For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

    Freed, Benjamin HowardFreed, Benjamin Howard
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    STU00210998
    More Info
    Copy

    NU 19H08: Signal Transduction of Type I Interferons in Malignant Cells

    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the …
    This is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.
    • Patients must have a diagnosis of either polycythemia vera (PV) or essential thrombocytosis (ET)
    • Patients must be age 18 years or older.
    Platanias, Leonidas CPlatanias, Leonidas C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211647
    More Info
    Copy

    Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complications

    Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with …

    Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

    However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

    Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

    Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

    Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

    Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

    This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

    This study will include allmen who are recommended to undergo prostate biopsy as part of routine clinicalcare.
    Schaeffer, Edward MatthewSchaeffer, Edward Matthew
    NCT04843566 STU00211699
    More Info
    Copy

    DRUG CKAZ954A12101: A Phase I/IB, Open-label, Multi-Center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients with Advanced Solid Tumors

    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.…
    The purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.
    All patients age 18 and above who have advanced cancers are eligible to participate.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT04237649 STU00211372
    More Info
    Copy

    xIRB ALLFTD: ARTFL-LEFFTDS LONGITUDINAL FRONTOTEMPORAL LOBAR DEGENERATION

    ALLFTD is a comprehensive study targeting most varieties of frontotemporal lobar degeneration (FTLD). FTLD is a neurological disease that causes Frontotemporal Dementia (FTD) syndromes including Primary Progressive Aphasia (PPA) and Behavioral Variant Frontotemporal Dementia (bvFTD), among others. This study is an international multi-site study and Northwestern University is one …

    ALLFTD is a comprehensive study targeting most varieties of frontotemporal lobar degeneration (FTLD). FTLD is a neurological disease that causes Frontotemporal Dementia (FTD) syndromes including Primary Progressive Aphasia (PPA) and Behavioral Variant Frontotemporal Dementia (bvFTD), among others. This study is an international multi-site study and Northwestern University is one of 19 sites. The overall goal of ALLFTD is to prepare for treatment trials in FTLD by focusing on several major activities:

    1. Characterizing FTLD patients (including familial FTLD [f-FTLD] and sporadic FTLD [s-FTLD]) followed at expert centers who can potentially be available for treatment trials

    2. Collecting comprehensive cognitive and behavioral assessment data, in addition to imaging, blood, and cerebrospinal fluid (CSF), with the following goals:

    o Identifying the best clinical measurements and biomarkers for following patients with FTLD in treatment trials

    o Identifying clinical measurements and biomarkers that indicate when a person with a high risk of developing FTLD due to a mutation will begin to have symptoms.

    3. Sharing clinical data, images and biological samples from participants affected by FTLD with the scientific community to address additional scientific questions about FTLD

    ALLFTD includes symptomatic and “at-risk” participants. FTLD may be sporadic, with no known cause. It may also be familial, due to genetic mutations. We are still learning about mutations that cause FTLD, so a strong family history of FTLD is sufficient to enroll as:

    Familial FTLD (f-FTLD). You are eligible to enroll in the familial FTLD cohort if 1) you have a mutation in one of the three most common genes associated with FTD –microtubule associated protein tau (MAPT), progranulin (GRN), or chromosome 9 open reading frame 72 (C9orf72), regardless of whether you have symptoms or not, 2) you have a blood relative with a mutation in one of those genes, or 3) you have a strong family history of FTLD but no genetic mutation has been identified.

    Sporadic FTLD (s-FTLD). You are eligible to enroll in the sporadic cohort of the study if you have one of the following FTLD spectrum diagnoses: frontotemporal dementia, primary progressive aphasia, progressive supranuclear palsy, corticobasal degeneration syndrome, or frontotemporal dementia with amyotrophic lateral sclerosis

    Grant, Ian MichaelGrant, Ian Michael
    NCT04363684 STU00211804
    More Info
    Copy

    Large Vessel Vasculitis Tissue Registry and Repository (LVVRR)

    The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become …
    The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become inflamed, commonly causing headaches, joint pain, facial pain, fever, and difficulties with vision.

    We will study the gene expression (i.e., the genes that are being "read" to make proteins) in these immune cells, with a special focus on macrophages (one type of cell in the immune system). We will compare the gene expression in patients with vasculitis to the gene expression in people without vasculitis to determine what goes wrong in patients with this condition. If we can identify the molecular pathways that are affected in vasculitis, we can begin to develop treatments that will target these pathways. This may help us predict which patients will respond to treatment in the future.

    Patients who participate in this research will:

    • Complete a screening and demographic form
    • Complete questionnaires
    • Give 2 tubes of blood
    • Donate a portion of the left-over biopsy tissue taken during your standard of care temporal artery biopsy procedure

    Participants will be given a stipend after the samples (blood and biopsy) have been collected.

    For Vasculitis Patients:

    • Suspected large vessel vasculitis - meet two of the giant cell arteritis (GCA) criteria, one of which is onset at age 50 or older
    • Planning to undergo a temporal artery biopsy

    For Controls:

    • Undergoing intracranial surgery from temporal approach for reasons unrelated to inflammatory autoimmune disease

    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00210635
    More Info
    Copy

    SWOG 1827: A Randomized Phase III Trial of MRI Surveillance with or Without Prophylactic Cranial Irradiation (PCI) in Small-Cell Lung Cancer

    This study is being done to answer the following question: Does the use of brain scans alone instead of brain scans plus preventive brain radiation affect the lifespan of patients with small cell lung cancer? We are doing this study because we want to find out if this approach is …

    This study is being done to answer the following question:

    Does the use of brain scans alone instead of brain scans plus preventive brain radiation affect the lifespan of patients with small cell lung cancer?

    We are doing this study because we want to find out if this approach is better or worse than the usual approach. The usual approach is defined as care that most people get for small cell lung cancer.

    • Participantsmust be 18 years or older
    • Participants must have a confirmed diagnosis Small-CellLung cancer
    Abazeed, MohamedAbazeed, Mohamed
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211982
    More Info
    Copy

    XIRB A master protocol for randomized, placebo-controlled, Phase 2 clinical trials of multiple interventions for the treatment of chronic pain

    This study is a master protocol to accelerate the development of treatments for chronic pain. The chronic pain conditions being studied are osteoarthritis, chronic low back pain and diabetic nerve pain. The study is being done to see how safe different investigational drugs are and how well they may work …
    This study is a master protocol to accelerate the development of treatments for chronic pain. The chronic pain conditions being studied are osteoarthritis, chronic low back pain and diabetic nerve pain. The study is being done to see how safe different investigational drugs are and how well they may work to help people with these conditions. 
    Subjects must:

    -have osteoarthritis pain, or chronic low back pain, or diabetic nerve pain

    -have a BMI less than 40kg/m2

    -be willing to discontinue any other pain medications

    Subjects must not:

    -have any ongoing medical condition that would limit subject participation

    -have any surgeries planned during the study

    -have had cancer within 2 years of the first visit, other than basal cell or squamous cell skin cancer

    -have substance use disorder

    -have a positive HIV test result at screening

    -have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to first visit

    -have participated within 30 days in a clinical study involving an investigational intervention

    -have current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding the pain condition, or any closed claim

    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT04456686 STU00211998
    More Info
    Copy

    (xIRB) DRUG IMGN632-0802: A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

    The purposes of this research study are:•To combine IMGN632 (study drug), an experimental drug, with standard therapies (azacitidine and/or venetoclax). •To find out what effects, both good and/or bad, the combination of study drug (IMGN632) and standard therapy (azacitidine and/or venetoclax) may have on you and …

    The purposes of this research study are:

    •To combine IMGN632 (study drug), an experimental drug, with standard therapies (azacitidine and/or venetoclax).

    •To find out what effects, both good and/or bad, the combination of study drug (IMGN632) and standard therapy (azacitidine and/or venetoclax) may have on you and your type of cancer.

    •To find a safe dose of IMGN632 to use in combination with azacitidine and/or venetoclax.

    •To find out how well IMGN632 works with combination therapies (azacitidine and/or venetoclax) to treat your type of cancer.

    •Alternatively, if you are in complete remission but have a very small amount of leukemia detectable (called minimal residual disease positive, MRD+) after the previous treatment, this study will see if IMGN632 can make your disease no longer detectable.

    If you meet all the eligibility criteria for being in this study, you will be assigned to one of four different groups:

    •Combination A: IMGN632 + azacitidine

    •Combination B: IMGN632 + venetoclax

    •Combination C: IMGN632 + azacitidine + venetoclax

    •Combination D: IMGN632

    All prospective participants will undergo screening tests to determine if they are eligible to take part in the study. You will be assigned to one of the four study treatment groups in the study.

    •Combination A (IMGN632 + azacitidine): Azacitidine is given daily for 7 days, IMGN632 is given on day 7 after the last azacitidine dose. After day 7, no study drug is given for the rest of the cycle. Each cycle in Regimen A is 28 days.

    •Combination B (IMGN632 + venetoclax): Venetoclax is taken daily for 21 days. IMGN632 is given on day 7 after the seventh venetoclax dose. Each cycle in Regimen B is 21 days.

    •Combination C (IMGN632 + azacitidine + venetoclax): Venetoclax is taken daily for 28 days. Azacitidine is given daily for 7 days. IMGN632 is given on day 7 after the seventh azacitidine and venetoclax doses. Each cycle in Regimen C is 28 days.

    •Combination D (IMGN632): IMGN632 is given every 21 days. Each cycle in Regimen D is 21 days.

    Note: This is only a partial description of study treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete study treatment information if you are interested in this clinical trial.

    Some of the eligibility criteria include:

    •Diagnosis of Acute Myeloid Leukemia (AML) that has not responded fully to treatment or has come back after treatment or you have untreated AML but a clinical trial may be appropriate

    •Age of at least 18 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Altman, Jessica KAltman, Jessica K
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04086264 STU00212068
    More Info
    Copy

    (xIRB) DRUG JCAR017-FOL-001: A Phase 2, Open-Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of jcar017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL) (Transcend FL)

    The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma …

    The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma.

    This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma and the number and type oftreatments that you have received in the past, as well as how long it took foryour lymphoma to return after your last treatment. Everyone in all 4 patientgroups will receive the same dose of JCAR017 T cells. JCAR017 is a type oftherapy known as chimeric antigen receptor (CAR) T cell therapy which isco-developed with Juno Therapeutics. The visit schedule will also be the samefor all 4 patient groups. At the time you decide to take part in the study andgo through the screening procedures, it will be determined which patient groupyou will be assigned to.

    In this study, your immunecells will be collected from your blood in a procedure called leukapheresis.The T cells will be separated from the collected immune cells and will bemodified in a laboratory. In the laboratory, a new gene will be put into your Tcells using genetic modification techniques. After they have been modified, thecells will be grown in the laboratory to reach the expected dose for thetreatment. Adding in the new gene may enable your T cells (now called JCAR017 Tcells) to bind to the CD19 protein, which your type of cancer cells carry ontheir surface. Binding to these cells activates the JCAR017 T cells, and theyattack the cancer cells. The JCAR017 T cells will persist in your body afterattacking the cancer cells, you will be monitored during the study to evaluatehow long these JCAR017 T cells persist. The JCAR017 T cells will be given backto you via infusion (IV).

    Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in the trial.

    Age of at least 18 years

    Diagnosis of Follicular Lymphoma or Marginal Zone Lymphoma, which has either returned or is not responding toyour current treatment. Follicular Lymphoma and Marginal Zone Lymphoma are twotypes of non-Hodgkin lymphoma (NHL).

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04245839 STU00212069
    More Info
    Copy

    Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

    This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research …
    This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research study will look at treating thoracoabdominal or pararenal aneurysm disease with a new device design known as the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (the ‘Study Device’).The Study Device that will be used to treat the aneurysm is called a “stent-graft”. The Study Device combines a surgical graft material with an outer metal mesh-like form (stent). The nonmetal graft component of the Study Device is made of a soft, polymer material (ePTFE). This material is routinely and safely used for surgical procedures throughout the world today. The graft is surrounded on the outside with a metal frame made from an elastic metal (nitinol wire or stainless steel) bent into a wave pattern and shaped to fit the graft. The materials used in the Study Device are not investigational and have a long, safe history of performance in similar applications.
    Hoel, Andrew WarfieldHoel, Andrew Warfield
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03728985 STU00211408
    More Info
    Copy

    Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)

    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less …
    The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.

    Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

    The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severitygrades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed bythe ECL.
    • Subject is at least 75 years of age

    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04198870 STU00211557
    More Info
    Copy

    Comparison of disease knowledge in dyads of parents and their adolescents with chronic skin disorders

    The main goal of this study is to understand how much parents and teenagers know about the teenagers’ chronic skin condition.

    This study will enroll children ages 12 to 17 years of age with a diagnosis of psoriasis, atopic dermatitis (eczema), or ichthyosis. Both the child and participating parent must speak English.

    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00212092
    More Info
    Copy

    Improving the Pelvic Health of Women and Girls Through the Use of a Digital Coaching Platform

    CeCe is a personal virtual period coach designed to improve women's knowledge about menstrual and pelvic health. CeCe was designed to help mothers support their daughters (& other important women in their life) throughout their period journey. This study does not require any in-person visits and can be …
    CeCe is a personal virtual period coach designed to improve women's knowledge about menstrual and pelvic health. CeCe was designed to help mothers support their daughters (& other important women in their life) throughout their period journey. This study does not require any in-person visits and can be completed all remotely. 
    • Ages 25-60 years old
    • Have a daughter who is between ages 9-14 years old
    • Have a smartphone
    Kenton, Kimberly SueKenton, Kimberly Sue
    • Map it 676 N St. Clair Arkes Pavillion Suite 950
      Chicago, IL
    STU00211216
    More Info
    Copy

    Bullying in Pediatric Ichthyosis Patients and its Psychosocial Effects

    Pediatric volunteers with ichthyosis and their parents are needed for a study to better understand the frequency and severity of bullying experienced by children with ichthyosis, and the psychosocial effects of this bullying.…

    Pediatric volunteers with ichthyosis and their parents are needed for a study to better understand the frequency and severity of bullying experienced by children with ichthyosis, and the psychosocial effects of this bullying.

    • Be 8-17 years old and have ichthyosis
    • Be the parent/guardian of someone 8-17 years old who has ichthyosis
    • Be able to complete a questionnaire about your/your child’s experience with bullying, mental health, and social experiences

    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00212124
    More Info
    Copy

    TeleHD: Feasibility, validity, and value of telemedicine for motor and non-motor assessments in patients with Huntington’s Disease (HD)

    The purpose of this study is to determine if it possible to conduct clinic visits through telemedicine for patient's with Huntington's disease.  Patients will not have to come into clinic to be a part of this study.  All study assessments will be conducted via telemedicine.…
    The purpose of this study is to determine if it possible to conduct clinic visits through telemedicine for patient's with Huntington's disease.  Patients will not have to come into clinic to be a part of this study.  All study assessments will be conducted via telemedicine.

    To be included in this study, Individuals must have a diagnosis of Huntington's Disease, be between the ages of 18 and 70, speak fluent English and have a personal computer, laptop, tablet, or smartphone equipped with highspeed internet, camera, and microphone in order to facilitate the telemedicine visits.

    Bega, DannyBega, Danny
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00211872
    More Info
    Copy

    A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation.  …
    ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation. 

    Hospitalized adults (>18 years) with symptoms suggestive of COVID-19

    Illness of any duration and laboratory-confirmed SARS-CoV-2 infection within 14 days

    Requires low or high flow oxygen devices or non-invasive mechanical ventilation

    Has not received 5 or more doses of remdesivir as treatment for COVID-19

    Has not receive 6mg or more of dexamethasone in one day, on more than one day in the past 7 days

    Taiwo, Babafemi OTaiwo, Babafemi O
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04280705 STU00212207
    More Info
    Copy

    A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTS

    This study is trying to determine whether an ointment is safe and effective for the treatment of hand-foot skin reaction induced by VEGRF inhibitors. 
    Participants must be over the age of 18 and have hand-foot skin reaction after taking anti-cancer medications calls VEGRF inhibitors. 
    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT04088318 STU00211322
    More Info
    Copy

    Oxidative Markers and Efficacy in ALS/MND Phenotypes Treated with Edaravone

    We are only recruiting patients who have not started their edaravone treatment.

    Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

    Inclusion:

    Either possible, probable, or definite ALS,predominantly lower motor neuron disease Predominantly upper motor neuron disease, orbulbar

    With or without cognitive involvement

    Willing to participate

    On no experimental treatment

    Ages 18 - 85

    No prior exposure to Radicava

    On a stable dose of riluzole for 30 days or offriluzole

    Male or female

    Females of childbearing age must usecontraception

    Exclusion:

    Unstable medical illness

    Abnormal liver function (>2x ULN)

    Unlikely to survive for at least 26 weeks

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04097158 STU00211350
    More Info
    Copy

    CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will …

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors that lead to the development of pain centralization, so that in future studies we can learn more about how to prevent the development of this kind of chronic pain in RA.

    Participants will complete a total of 3 study visits (baseline, 3 months and 12 months). At each study visit, participants will have a physical exam, have blood drawn, answer questionnaires, and undergo quantitative sensory testing to assess responses to pressure and coldness. A subset of patients who are interested and eligible will undergo a brain MRI at baseline and the 12-month study visit. Participants will receive $50 for the completion of each study visit and an additional $100 for completing each MRI.

    Study participants must be 18 years or older with active Rheumatoid Arthritis and symptoms starting no more than one year prior to study participation.  Participants taking pain medications must be on a stable dose for at least 3 months.  Patients with Raynauds requiring treatment are not eligible to participate.  Participants must refrain from taking prednisone (greater than 10 mg) or opioids within 24 hours of their study visit.  
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 710 N. Fairbanks Ct. Olson Paivlion
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211593
    More Info
    Copy

    Sensory-specific peripheral stimulation for tremor management

    Healthy Participants:The Shirley Ryan AbilityLab is seeking healthy adults to study the effect and ability of muscle stimulation to reduce tremor. We are seeking Healthy adults to participate as a comparison group.During the study, participants will be stimulated with non-invasive muscle electrostimulation and/or transcranial magnetic stimulation (…

    Healthy Participants:

    The Shirley Ryan AbilityLab is seeking healthy adults to study the effect and ability of muscle stimulation to reduce tremor. We are seeking Healthy adults to participate as a comparison group.

    During the study, participants will be stimulated with non-invasive muscle electrostimulation and/or transcranial magnetic stimulation (TMS) while seated in a comfortable chair. To measure muscle activity, electrodes will be attached to the forearm.

    In one visit, magnetic resonance imaging (MRI) will be used to observe your brain.

    Clinical Participants:

    The Shirley Ryan AbilityLab is seeking patients with Parkinson’s disease or Essential Tremor, to study the effect and ability of muscle stimulation to reduce tremor. Exclusion criteria include epilepsy/seizures and incompatibility with MRI or transcranial magnetic stimulation (TMS).

    During the study, participants will be stimulated with non-invasive muscle electrostimulation and TMS while seated in a comfortable chair. To measure tremors, sensors will be placed over the wrist, elbow and shoulder and in some visits to the head.

    In two visits, magnetic resonance imaging (MRI) will be used to observe the brain.

    Healthy Participants: (recruitment closed)

    • English speaking adults
    • Ages 18-80
    • No history of neurological disease or injury
    • Available to come to the AbilityLab for five 1-4 hour visits

    Clinical Participants:

    • English speaking adults
    • Ages 18-80
    • Patients diagnosed with Parkinson’s disease, or essential tremor.
    • Available to come to the AbilityLab for thirteen 1-4 hour visits

    Pons, Jose LPons, Jose L
    • Map it 355 E. Erie St.
      Chicago, IL
    NCT04501133 STU00211930
    More Info
    Copy

    Positive Affect Regulation sKills (PARK)

    The Positive Affect Regulation sKills (PARK) Course is an online program that teaches positive emotion skills for individuals experiencing stress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g., loss of income, shortages of daily essentials, etc.). The program consists of …

    The Positive Affect Regulation sKills (PARK) Course is an online program that teaches positive emotion skills for individuals experiencing stress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g., loss of income, shortages of daily essentials, etc.). The program consists of 8 skills aimed at increasing the daily experience of positive emotion to help individuals cope with whatever stress they might be experiencing. The skills are presented over the course of 5 weeks and after learning each skill by reading through content on our platform, there is the opportunity to practice the skill on the platform as well.

    •At least 18 years of age

    •Speaks and reads English

    •Able to access the online platform through their phone, a public device (i.e., at the library) or at home

    •Lives in US

    Moskowitz, Judith TedlieMoskowitz, Judith Tedlie
    STU00212262
    More Info
    Copy

    Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal)

    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately …
    The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately 700 subjects at up to 80 sites in Europe, United States and Canada. Up to 50 participants will be enrolled at Northwestern. The Study is made up of three different groups: Randomized (up to 450), Roll-In (up to 150, and Single-Arm Registry (up to 100).
    • Age ≥18 years at time of consent.
    • Subject has been diagnosed with moderate or greater tricuspid regurgitation determined to have symptoms due to heart failure despite being treated with currently available therapies
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03904147 STU00210487
    More Info
    Copy

    Cure Glomerulonephropathy

    Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.…

    Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.

    Biopsy-proven Membranous, Minimal Change, FSGS, or IgAN within 5 years of study enrollment

    Wadhwani, ShikhaWadhwani, Shikha
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212470
    More Info
    Copy

    A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients with Parkinson’s Disease with at Least One GBA1 Mutation (PROPEL, Protocol #: J3Z-MC-OJAA previously called PRV-PD101)

    PR001A is an investigational gene therapy product that is being developed for the treatment of PD in patients with GBA1 mutations. The purpose of this study is to find out what effects PR001A has on Parkinson’s disease patients. Participants will be assigned to receive one dose of PR001A by …
    PR001A is an investigational gene therapy product that is being developed for the treatment of PD in patients with GBA1 mutations. The purpose of this study is to find out what effects PR001A has on Parkinson’s disease patients. Participants will be assigned to receive one dose of PR001A by injection into the cisterna magna (a large space at the base of the brain).

    1. 40-75 years of age.

    2. Diagnosis of PD with H&Y 3-4.

    3. On stable PD therapy for 8 weeks prior to baseline.

    4. At least 1 GBA gene mutation.

    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04127578 STU00209947
    More Info
    Copy

    A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK­3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy

    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work …
    This study is enrolling patients who have obstructive hypertrophic cardiomyopathy (oHCM). Obstructive HCM is a condition in which the heart muscle in the left ventricle (LV) becomes abnormally thickened, which can block blood flow out of the heart to the body. This obstruction causes the LV heart muscle to work harder to pump blood to the body and can cause symptoms of chest pain, dizziness, shortness of breath and fainting. This is the first time the investigational drug called CK-3773274 is being studied in participants who have oHCM, but it has already been studied in healthy volunteers. The purpose of this study is to learn how well CK-3773274 is tolerated at different, increasing dose levels in patients with oHCM and if it causes any side effects. The study will also measure the amount of CK-3773274 in your blood at various times, and the effect the study drug may have on your oHCM. CK-3773274 is an investigational (experimental) study drug. This means that CK-3773274 has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
    Choudhury, LubnaChoudhury, Lubna
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04219826 STU00211491
    More Info
    Copy

    The role of the cortex and brainstem in motor preparation for proximal and distal upper extremity movements

    This study will take place over 3, each lasting about 4 hours. First we will do a hearing screening and right handedness screening to make sure you are a good fit for out study. For this study, you will be required to place your arm in a robot that tracks …
    This study will take place over 3, each lasting about 4 hours. First we will do a hearing screening and right handedness screening to make sure you are a good fit for out study. For this study, you will be required to place your arm in a robot that tracks your movement, and then perform arm lifting and hand opening movements. We will measure your muscle placing electrode stickers on your arm, and measure your brain activity by asking your to wear a close fitting mesh cap. During one of the visits, we will also ask you to get an MRI to take a picture of your brain. The MRI scan will take between 5 and 10 minutes. Additionally, you will receive free parking for each visit as well as monetary compensation for your time. Please contact us to learn more information about the study, or if you are interested in participating. 
    In order to be in this study you must be a right-handed individual between the ages of 18-80 years old. We also ask that you have normal hearing and arm function. 
    Yao, JunYao, Jun
    • Map it 645 N. Michigan Ave. Suite 1100
      Chicago, IL
    STU00212195
    More Info
    Copy

    NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)

    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter. Primary Aim: To determine the 28-daymortality rate from the time of COVID …
    This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.

    Primary Aim:

    To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions.

    Secondary Aims:

    To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2.

    To examine relationships between CLL directed therapy and COVID19 disease course and outcomes.

    To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2.

    Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.
    Ma, ShuoMa, Shuo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212455
    More Info
    Copy

    Wearable sensor to monitor and track COVID-19-like signs and symptoms to develop better care strategies for COVID-19 pandemic

    Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for …
    Specific Aims:1. Develop a wearable sensor package to gather data on COVID-19-like signs andsymptoms such as elevated body temperature, respiratory parameters, heart rate ,coughand gait.2. Create algorithms to monitor and track changes to COVID19-like signs and symptomsfor developing a better care and isolation strategies for COVID-19 pandemic

    Ages between 18-95 years old

    Currently experiencing any COVID-like signs and symptoms such as fever, cough,shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusionor inability to arouse, bluish lips or face
    Jayaraman, ArunJayaraman, Arun
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212522
    More Info
    Copy

    NU FC19L02: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked

    The purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq. …
    The purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization.

    •Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq

    •Arm B: Carboplatin + Pemetrexed + Avastin

    Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase.

    Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase.

    Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study.

    All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Stage IV advanced non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation or without a history of smoking

    •Age of at least 18 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Patel, Jyoti DPatel, Jyoti D
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03786692 STU00211923
    More Info
    Copy

    Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

    In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.The additional details that …

    In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.

    The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting.

    Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo.

    The following regimens are active in the trial:

    Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8 Regimen D - Pridopidine Regimen E - Trehalose

    New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available.

    The basic eligibility criteria include:

    1. Onset of ALS WEAKNESS within the last 3 years.

    2. FVC (breathing test) > 50%

    3. If on riluzole, must be on a stable dose for 30 days. Must not start riluzole during the study.

    4. If on radicava, must be on a stable dose for 30 days. Must not start riluzole during the study.

    5. Must be able to swallow for the next 6 months

    6. No history stem cell treatment

    7. No history of cancer within the last 5 years

    Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04297683 STU00212680
    More Info
    ALS Platform
    Copy

    A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which …
    This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04136171 STU00211443
    More Info
    Copy

    A pilot study of use of oscillation and lung expansion (OLE) therapy in patients admitted for COVID-19 (Protocol # CR-RR-2020-002)

    This study is being done to evaluate the use of the MetaNeb System as an airway clearance and lung expansion therapy for patients with COVID-19 who require high-flow oxygen therapy. The MetaNeb System can be used for therapy when patients are on high-flow oxygen and may make …
    This study is being done to evaluate the use of the MetaNeb System as an airway clearance and lung expansion therapy for patients with COVID-19 who require high-flow oxygen therapy. The MetaNeb System can be used for therapy when patients are on high-flow oxygen and may make it easier to clear sputum out of the lungs. This study will evaluate the effect of the therapy on how quickly patients recover and can leave the hospital.

    Participants in this study will be:

    • Randomized to receive either the MetaNeb therapy in addition to their standard of care or standard of care treatment without the MetaNeb therapy
    • If randomized to MetaNeb, patients will receive treatment with the MetaNeb therapy for a maximum of 7 days (28 treatments) while receiving high-flow oxygen therapy.

    • At least 18 years old
    • Tested positive or person under investigation for COVID-19 infection
    • Treated with high-flow oxygen therapy
    • High-flow oxygen therapy initiated within the past 72 hours
    • Other exclusion criteria apply
    Wolfe, Lisa FWolfe, Lisa F
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04582214 STU00212652
    More Info
    Copy

    The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD Cohort

    The purpose of this study is to obtaininformation from people with and without Parkinson disease (PD) so thatresearchers may better understand how Parkinson disease progresses, in order toinform better treatments. Participants will have a neurological examination, a brain scan, provide blood samples and complete some questionnaires.…
    The purpose of this study is to obtaininformation from people with and without Parkinson disease (PD) so thatresearchers may better understand how Parkinson disease progresses, in order toinform better treatments. Participants will have a neurological examination, a brain scan, provide blood samples and complete some questionnaires.
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00212785
    More Info
    Copy

    Screening for Coronavirus Antibodies in Neighborhoods (SCAN)

    Inthe SCAN study, we are measuring how many people in the Chicagoland area haveantibodies to SARS-CoV-2 (the virus that causes COVID-19), how widespread theinfection has been in Chicago, and whether some neighborhoods had moreinfection than others. By taking part, you will help us find out how many …
    Inthe SCAN study, we are measuring how many people in the Chicagoland area haveantibodies to SARS-CoV-2 (the virus that causes COVID-19), how widespread theinfection has been in Chicago, and whether some neighborhoods had moreinfection than others. By taking part, you will help us find out how many peoplein specific areas have been exposed to SARS-CoV-2, and if these antibodiesprotect people against re-infection.

    Adults age 18 years and older living in the Chicagoland area or Illinois.

    McDade, ThomasMcDade, Thomas
    STU00212472
    More Info
    Copy

    Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment with NLY01 in Early-stage Parkinson’s Disease

    The purpose of study is to determine if NLY01 helps lessen symptoms and signs of early Parkinson’s disease and whether it slows the progression of Parkinson’s disease.…
    The purpose of study is to determine if NLY01 helps lessen symptoms and signs of early Parkinson’s disease and whether it slows the progression of Parkinson’s disease.

    1. Subjects aged 30-80 yrs of age

    2. Lessthan 5 yrs of PD symptom onset

    3. Must not be taking any medication for PD treatment

    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04154072 STU00211693
    More Info
    Copy

    A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban (PROACT Xa)

    This study is enrolling patients who had an On-X mechanical valve implanted in the aortic position at least 3 months (90 days) ago, are currently receiving warfarin anticoagulation, and are able to receive warfarin with a target INR (measurement of how long it takes for blood to form a …
    This study is enrolling patients who had an On-X mechanical valve implanted in the aortic position at least 3 months (90 days) ago, are currently receiving warfarin anticoagulation, and are able to receive warfarin with a target INR (measurement of how long it takes for blood to form a clot) of 2.0 to 3.0.  Studies have shown that patients who get tissue valves instead of mechanical valves (On-X Prosthetic Heart Valve / On-X valve) usually have to be operated on again. However, patients who get mechanical valves need to take warfarin for anticoagulation (helps to avoid blood clotting on or near the valve) and maintaining appropriate levels of warfarin can be hard to manage. Some patients may be too responsive to warfarin or not responsive enough. Some patients are allergic to warfarin. A larger number of patients have a hard time keeping warfarin control because of how warfarin interacts with other drugs or certain foods. Another reason people don’t want to take warfarin is because of the need for frequent blood testing. Thus, some patients choose tissue valves over mechanical valves even though studies show the outcomes are worse because the patients do not want to have to take warfarin because it can be hard to manage.
    • Male or female at least 18 years of age at the time of giving informed consent.
    • Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
    Malaisrie, S ChrisMalaisrie, S Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04142658 STU00211882
    More Info
    Copy

    Immune checkpoint inhibitor-associated acute kidney injury

    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, …
    Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
    Aggarwal, VikramAggarwal, Vikram
    STU00212602
    More Info
    Copy

    Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) Trial

    This study is investigating if participation ina 10-week high-intensity walkingintervention can improve walking balance of individuals who have had an incomplete spinal cord injury.

    • Age 18 to 75 years

    • Have an incomplete spinal cord injury

    • Able to walk 10 meters without physicalassistance.

    • Able to tolerate 30 minutes of standing.

    • Must not have severe cardiovascular andpulmonary disease, a history of recurrentfractures, or concomitant neurological injury.

    Gordon, Keith EdwardGordon, Keith Edward
    NCT04340063 STU00212115
    More Info
    Copy

    Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with Tocilizumab

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) …

    This study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational.

    Ghafourian, KambizGhafourian, Kambiz
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03644667 STU00212222
    More Info
    Copy

    xIRB AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)

    This study will test an investigational drug called BAN2401 for the treatment of individuals with preclinical Alzheimer's Disease. Participation may last up to 4 years.…
    This study will test an investigational drug called BAN2401 for the treatment of individuals with preclinical Alzheimer's Disease. Participation may last up to 4 years.

    This study is composed of two research trials aimed at preventing Alzheimer's Disease (AD) dementia. One is called AHEAD-3 and the other is called AHEAD-45. You may qualify to join one of the AHEAD Study prevention trials because you're aged 55-80 years and have normal memory and thinking abilities.

    General Inclusion Criteria:

    • Only individuals who have intermediate or elevated levels of amyloid in their brain will be able to participate in these studies. The screening process for the AHEAD Study will use a Positron Emission Tomography (PET) scan to measure the level of amyloid in your brain.
    • Must have a study partner that is willing to participate as a source of information and who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, or caregiver).
    Grant, Ian MichaelGrant, Ian Michael
    NCT04468659 STU00212910
    More Info
    Copy

    Circulating Endothelial Cells as Biomarkers of Cardiovascular Events in Patients with COVID-19

    This study is recruiting patients who have been admitted to the hospital with a diagnosis of COVID-19. The purpose of this research study is to look at a new marker of inflammation that may predict worsening clinical parameters or severe disease in patients with COVID-19…
    This study is recruiting patients who have been admitted to the hospital with a diagnosis of COVID-19. The purpose of this research study is to look at a new marker of inflammation that may predict worsening clinical parameters or severe disease in patients with COVID-19
    Akhter, NausheenAkhter, Nausheen
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212691
    More Info
    Copy

    Prospective evaluation of an applied ATTR-CM Machine Learning model to a health system electronic health record (EHR)

    This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac amyloidosis”) based on other diagnoses in the medical record. …

    This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac amyloidosis”) based on other diagnoses in the medical record. Transthyretin cardiac amyloidosis is a rare disease that results from a protein in the body that becomes misfolded and starts depositing into the heart, a process known as amyloidosis. Because of these proteins getting into the heart muscle, the heart can get stiff and weak, thereby leading to congestive heart failure. Typically this form of heart disease (cardiac amyloidosis) is diagnosed late in its course and it associated with poor survival. However, there are now treatments for this disease, so earlier diagnosis is better. A machine learning (artificial intelligence)-based method to find potential patients with cardiac amyloidosis has been developed. This computer program automates finding patients who may have cardiac amyloidosis based on their other diagnoses in the electronic health record. This study seeks to validate the computer algorithm prospectively to see if it can be useful in patients to determine whether or not cardiac amyloidosis is the cause of heart failure.

    Shah, Sanjiv JShah, Sanjiv J
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00211906
    More Info
    Copy

    (xIRB) DRUG AVM-003-HC: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant.

    The purpose of this study is to determine if the study drug, ALVR-105, is safe and works well in the treatment for HC. The study will compare ALVR-105 to placebo in reducing your bladder pain, reducing the amount of blood in your urine, and seeing if specific viruses …

    The purpose of this study is to determine if the study drug, ALVR-105, is safe and works well in the treatment for HC. The study will compare ALVR-105 to placebo in reducing your bladder pain, reducing the amount of blood in your urine, and seeing if specific viruses are lowered in your blood and urine.

    This is a randomized double-blind study. “Randomized” means that you will be randomly assigned (like the flip of a coin) to receive either ALVR-105, or placebo (inactive substance). You will have a 60% chance of receiving ALVR-105 and a 40% chance of receiving placebo.

    Your participation in this study will last approximately 6 months and include about 10 study visits to the study site. Some of these study visits will occur when you are already in the hospital in which case the study team will visit you to complete the study visit.

    In healthy people, T-cells defend the body against viruses. Because of the early stage / premature engraftment and /or immune suppressing therapy given for the HCT, T-cell numbers are low, and it is more difficult for the body to control viruses that are already in your body, but are not active. If you have low T-cell numbers and your body cannot control viruses, some of these viruses can cause HC.

    Viralym-M (ALVR-105) is a research study medicine that contains T-cells made from healthy human donors to potentially help defend your body against specific viruses. The research study medicine is “investigational.” It has not been approved by the United States Food and Drug Administration (FDA), the health authority that approves new medicine being prescribed for use in the United States. This means that it is not approved to treat patients with hemorrhagic cystitis or any other disease.

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    If you qualify, the research study medicine (ALVR-105 or placebo) will be given to you by an infusion into a vein (IV injection). You will receive a second dose of research study medicine about two weeks after your first dose.

    Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    •Age of at least 18 years

    •Diagnosis of hemorrhagic cystitis (HC) caused by a viral infection after your allogeneic hematopoietic cell transplant (HCT)

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Moreira, JonathanMoreira, Jonathan
    NCT04390113 STU00213027
    More Info
    Copy

    Sleep Fragmentation, Autonomic Dysfunction, and Centralized Pain in Rheumatoid Arthritis

    This study is looking at the relationship between sleep and pain in patients with RA. The goal of the study is to learn how toprevent the development of chronic pain in RA in the future. The study involves one study visit at thedowntown campus at Northwestern, completing questionnaires, undergoing quantitative …
    This study is looking at the relationship between sleep and pain in patients with RA. The goal of the study is to learn how toprevent the development of chronic pain in RA in the future. The study involves one study visit at thedowntown campus at Northwestern, completing questionnaires, undergoing quantitative sensory testing, wearing a wristmonitor (similar in size and appearance to a digital watch) to collectinformation about participant's sleep patterns, and wearing a patch to measureheart rate for about two weeks. Participantsare paid $50 for their time and effort.
    Participants must be 18 years or older and English-speaking with a confirmed diagnosis of Rheumatoid Arthritis. Participants cannot be taking beta blockers, certain pain medications, sedatives, or more than 10 mg of prednisone daily. Participants cannot have a history of heart conditions or work night shifts.
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211633
    More Info
    Copy

    (xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

    The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1Participants in this group willget less frequent monitoring. Participants …

    The purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts.

    This study has 2 study groups:

    Group 1

    Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound.

    Group 2

    Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst.

    Participants will be enrolled forup to five years.

    Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study.

    Chawla, AkhilChawla, Akhil
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04239573 STU00213102
    More Info
    Copy

    A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP)

    This research is being done to compare treatmentsfor knee osteoarthritis pain. Knee osteoarthritis (KOA) occurs when the cartilagethat cushions your knee joint wears down over time or from trauma. Symptoms of KOA include pain, swelling,tenderness, stiffness, and loss of flexibility in the knee. People with KOA pain are often …

    This research is being done to compare treatmentsfor knee osteoarthritis pain.

    Knee osteoarthritis (KOA) occurs when the cartilagethat cushions your knee joint wears down over time or from trauma. Symptoms of KOA include pain, swelling,tenderness, stiffness, and loss of flexibility in the knee. People with KOA pain are often treated withopioids, which can lead to opioid addiction. In this study, we are comparing non-opioid treatments in an effort tolessen your pain and improve knee function.

    If you qualify for this study your participation will last between 18 and 48 months

    Knee pain

    Diagnosis of knee osteoarthritis

    Not Pregnant or breastfeeding

    Meets American College of Rheumatology Classification criteria for knee osteoarthritis

    English speaking

    Internet connectivity

    Walega, David RWalega, David R
    • Map it 259 E. Erie St. Suite 1400
      Chicago, IL
    NCT04504812 STU00213108
    More Info
    Copy

    African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)

    You are invited to participate in a research study at Northwestern University that provides skills and training to fathers who have a partner with prenatal depression. The research study aims to give guidance on how fathers can optimize their support of their partner during this difficult time. ALL SESSIONS WILL …
    You are invited to participate in a research study at Northwestern University that provides skills and training to fathers who have a partner with prenatal depression. The research study aims to give guidance on how fathers can optimize their support of their partner during this difficult time. ALL SESSIONS WILL BE VIRTUAL. 

    -Pregnant African-American mother and male partner

    -Available to begin study in 2nd trimester

    -Mother in treatment for depression with current symptoms

    -Parents are 18 y/o or older

    Fisher, Sheehan DavidFisher, Sheehan David
    STU00212595
    More Info
    Copy

    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

    This study will test an investigational drug called AL001 for the treatment of individuals who have a progranulin gene mutation that causes frontotemporal dementia (FTD). Participation may last up to 2 years.…
    This study will test an investigational drug called AL001 for the treatment of individuals who have a progranulin gene mutation that causes frontotemporal dementia (FTD). Participation may last up to 2 years.

    You may be eligible to participate if you have a progranulin gene mutation and have been diagnosed with FTD (we call this group of people symptomatic participants). You may also be eligible to participate if you have a progranulin gene mutation but are not diagnosed with FTD and have an increased level of a biomarker called neurofilament light chain (NfL) [we call this group of people pre-symptomatic participants].

    General Inclusion Criteria:

    • 18 to 85 years of age, inclusive, at screening
    • At screening, female participants must be nonpregnant and nonlactating
    • Has availability of a person (study partner) who has frequent and sufficient contact with the participant (at least 5 hours per week of in-person contact), can provide accurate information regarding the participant's behavior, cognitive, and functional abilities as well as their health throughout the study

    Exclusion Criteria:

    • Has dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
    Grant, Ian MichaelGrant, Ian Michael
    NCT04374136 STU00212739
    More Info
    Copy

    COVID Prevention Trials Registry

    Afteryou provide consent, you will be asked to complete a survey to collect some informationabout your health and risk of exposure to COVID. The study team may contact you to assess yourpotential eligibility for COVID prevention trials when they open. You may open the consent and registry survey in your …
    Afteryou provide consent, you will be asked to complete a survey to collect some informationabout your health and risk of exposure to COVID. The study team may contact you to assess yourpotential eligibility for COVID prevention trials when they open. You may open the consent and registry survey in your web browser by clickingthe link below: COVID PreventionTrials Registry Consent . If thelink above does not work, try copying the link below into your web browser: https://is.gd/NUVaccineStudy
    The NorthwesternCOVID Prevention Trials Registry is open to all adults who are interested inbeing contacted about upcoming COVID vaccine and other prevention studies.

    TheCOVID vaccine trials will enrollpersonswhoareatrisk of infection and COVID-19 disease. This· · · - - - Racial/ethnic groups such as African Americans, Latinx, and NativeAmericanpopulations.

    Krueger, Karen MKrueger, Karen M
    STU00213110
    More Info
    COVID
    Copy

    Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma

    Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be …

    Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

    Inclusion Criteria:

  • Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4
  • Ability to undergo contrast-enhanced MRI
  • Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy
  • Measurable or evaluable disease

  • Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI
  • Non-measurable/evaluable: contrast-enhancement diameters < 1 cm
  • Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI
  • Candidate for at least partial surgical resection
  • Greater 12 weeks from completion of radiation therapy
  • Age ≥ 18 years
  • If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at < 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of < 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  • WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
  • Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration
  • For patients with a childbearing potential

  • Negative pregnancy test within 14 days prior to registration
  • Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively.
  • Have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • Be willing and able to comply with the protocol for the duration of the study
  • Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained
  • Exclusion Criteria:

  • Have multifocal disease that cannot be encompassed in the ultrasound fields:

  • e.g. > 70-mm apart
  • tumor located in the posterior fossa
  • Patients at risk of cranial wound dehiscence
  • Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
  • Have clinical evidence of peripheral neuropathy on examination
  • Have received any other investigational agents within 4 weeks of registration
  • Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
  • Medical contraindications to Abraxane® or carboplatin
  • Have an uncontrolled intercurrent illness
  • Are pregnant or nursing
  • Have a history of active malignancy within 3 years prior to registration.
  • Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study)
  • Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs.
  • Patients with medical need to continue antiplatelet therapy.
  • Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction).
  • Patients with impaired thermo-regulation or temperature sensation (due to device)
  • Sonabend Worthalter, Adam MendelSonabend Worthalter, Adam Mendel
    • Map it 675 N. Saint Clair St. Twentieth Floor
      Chicago, IL
    NCT04528680 STU00212298
    More Info
    Copy

    Human-like Robot Controllers for Enhanced Motor Learning

    The Shirley Ryan AbilityLab is seeking healthy adults to study how humans interact with robots to program human-like behavior.This study involves an ankle robot and a lower limb robotic suit that track movements; participants may test only one robot or both.If testing the ankle robot, participants will …

    The Shirley Ryan AbilityLab is seeking healthy adults to study how humans interact with robots to program human-like behavior.

    This study involves an ankle robot and a lower limb robotic suit that track movements; participants may test only one robot or both.

    If testing the ankle robot, participants will wear the robot on their dominant foot and move their ankle while sitting.

    If testing the robotic suit, the participants will wear the robotic suit on both legs and the hips, and perform various movements like standing, squatting, or walking.

    Healthy Participants:

    • English speaking adults
    • Ages 18-80
    • No history of neurological disease or injury
    • Available to come to the AbilityLab for up to five 4-hour visits

    Pons, Jose LPons, Jose L
    • Map it 355 E. Erie St.
      Chicago, IL
    NCT04578665 STU00212684
    More Info
    Copy

    NRG HN006: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

    This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the …

    This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the usual surgery in extending the time you have without cancer returning? The usual approach is defined as care most people get for this cancer.

    This study has 2 parts. In the first part,doctors will try to learn the answer to question #1 above. If the answer shows that neck and shoulder function and discomfort is better in patients who have the SLN biopsy, then the study will go on to the second part, and doctors will try to answer question #2.
    • Participants must be 18 years or older
    • Participants must have a confirmed diagnosis of early-stage oral cavity cancer
    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04333537 STU00213298
    More Info
    Copy

    COVID-19 TestUS an initiative of RADx AcceleRATeD study (Rapid Assessment of Technology for SARS-CoV-2 Detection)

    We are studying the accuracy and usability of NEW point-of-care COVID-19 diagnostic tests compared to standard laboratory testing. You will be asked to come to our clinic for ONE visit to collect nasal swabs (less than one inch into each nostril) for new and standard tests. You …

    We are studying the accuracy and usability of NEW point-of-care COVID-19 diagnostic tests compared to standard laboratory testing. You will be asked to come to our clinic for ONE visit to collect nasal swabs (less than one inch into each nostril) for new and standard tests. You will also complete surveys through a web browser, App on mobile device, or telephone interview with research staff. These surveys take approximately 30 minutes and they collect information on prior COVID-19 testing, COVID-19 exposures, demographics, and brief medical history.

    Adults and children (over 10 years of age) with or without symptoms who are interested in getting tested for COVID-19 and willing to complete on-line or verbal surveys.

    Murphy, Robert LeoMurphy, Robert Leo
    • Map it Arkes Pavilion, 676 N. Saint Clair St. Suite 940
      Chicago, IL
    STU00213330
    More Info
    Copy

    Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only …

    Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs.

    Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.
    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00212975
    More Info
    Copy

    Impact of immunotherapy-related skin diseases on quality of life

    The purpose of this study is to characterize the effects of cutaneous side effects from immunotherapies on quality of life. Participants will complete a one time survey. 
    Participants need to be 18 years and older, receiving immunotherapy, and may be experiencing a dermatologic side effect. 
    Choi, Jennifer NamChoi, Jennifer Nam
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00212205
    More Info
    Copy

    (xIRB NCI CIRB) ECOG-ACRIN 1181: Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer) (CompassHER2-pCR)

    This study isbeing done to answer the following question: Can participantswith HER2-positive breast cancer who have no cancer remaining at surgery(either in the breast or underarm lymph nodes) after 12 weeks of chemotherapyand two HER-targeted therapies eliminate further chemotherapy after surgery? This would be adecrease in the …

    This study isbeing done to answer the following question:

    Can participantswith HER2-positive breast cancer who have no cancer remaining at surgery(either in the breast or underarm lymph nodes) after 12 weeks of chemotherapyand two HER-targeted therapies eliminate further chemotherapy after surgery?

    This would be adecrease in the total number of chemotherapy drugs and the amount ofchemotherapy typically received to treat this type of cancer. We are doing thisstudy because we want to find out if this approach can enable you to take fewerchemotherapy drugs than the usual approach for your type of breast cancerwithout compromising your outcome. The usual approach is defined as care mostpeople get for HER2-positive breast cancer. Usual treatment includes additional chemotherapy drugs that might not benecessary, since the HER2-targeted drugs are so effective.

    The names of thestudy drugs involved in this study are:

    • Paclitaxel (also called Taxol). Thisis chemotherapy. [Alternativechemotherapy drugs allowed in the trial include docetaxel (also called Taxotere)or nab-paclitaxel (also called Abraxane)].
    • Trastuzumab (alsocalled Herceptin). This is HER2-therapy.
    • Pertuzumab (also called Perjeta).This is HER2-therapy.

    All chemotherapy drugs will be givenintravenously through vein for 4 cycles. A cycle consists of 3 weeks. Before surgery, paclitaxel will be givenweekly for 12 weeks; pertuzumab will be given once every cycle; and trastuzumabonce every cycle or once weekly for 12 weeks. Alternatives to paclitaxel include docetaxel that will be given once percycle or nab-paclitaxel that would be given weekly for 12 weeks.

    • Participantsmust have a confirmed diagnosis of HER2-positive primary invasive breastcarcinoma

    Note: This is only apartial list of eligibility criteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial.

    Stein, Regina MStein, Regina M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04266249 STU00213352
    More Info
    Copy

    R1: Telehealth Pain Self-Management for Employed Adults (E-TIPS)

    The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a wait-list) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-…
    The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a wait-list) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a wait-list control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.

    Inclusion Criteria:

    • 18 years of age or older
    • Self-reported physical disability
    • Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale
    • Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater)
    • Reads, speaks, and understands English
    • Has access to and is able to communicate over the telephone with our without assistive devices
    • Is employed, working 20 hours per week or more, on average, and earning in excess of substantial gainful activity (approximately $1200/month)
    Heinemann, Allen WalterHeinemann, Allen Walter
    • Map it 355 E. Erie St.
      Chicago, IL
    NCT04248725 STU00213141
    More Info
    Copy

    A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin's Lymphoma (NHL)

    atientsof Chronic Lymphocytic Leukemia/Small lymphocytic Lymphoma (CLL/SLL) orNon-Hodgkin's Lymphoma (NHL) who did not respond to standard treatment. Bruton’sTyrosine Kinase (BTK) is a molecular enzyme that plays a key role in thesurvival of B cell malignancies like CLL, SLL, and NHL. The drug LOXO -305 isknown …

    atientsof Chronic Lymphocytic Leukemia/Small lymphocytic Lymphoma (CLL/SLL) orNon-Hodgkin's Lymphoma (NHL) who did not respond to standard treatment.

    Bruton’sTyrosine Kinase (BTK) is a molecular enzyme that plays a key role in thesurvival of B cell malignancies like CLL, SLL, and NHL. The drug LOXO -305 isknown to inhibit /block the BTK pathway thus has the potential to treat thesecancers. There are previously approvedBTK inhibitor drugs, which are already in use in treating these cancers; however,they have limitations, due the development of toxicity or drug resistance.

    LOXO -305 is currently not approved by the FDA

    · Participants must be 18 years orolder

    Participants must have a confirmed diagnosis B-cell malignancy(e.g., CLL/SLL, WM, NHL), failed or intolerant to either ≥ 2 prior standard ofcare regimens
    Ma, ShuoMa, Shuo
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT03740529 STU00211921
    More Info
    Lymphoma
    Copy

    DRUG CCTL019B2003I: Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

    The purpose of this Managed Access Program(MAP), which is an intermediate size patientpopulation Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligiblepatients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,…

    The purpose of this Managed Access Program(MAP), which is an intermediate size patient

    population Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligible

    patients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,2) unable to receive commercially manufactured product due to failure of the incomingapheresis material to meet acceptance specifications or final outgoing productto meet the commercial release specifications or other specification within theprescribing information, and 3) where no overwhelming safety concerns has beenidentified for manufacture and release of the out of specification product.

    Participation inthis treatment plan involves an experimental approach called gene transfer forALL or large B-cell lymphoma that involves cells in your blood called B cells(your tumor cells and also normal antibody-producing cells). During thistreatment, some of your own white blood cells (T cells) will be taken andchanged to turn against your tumor cells. T cells from your body will bechanged in a way that may allow them to identify and kill your tumor cells.This change may allow your T cells to go to the tumor cells, turn"on" and potentially kill the tumor cells. The modification is doneby gene transfer and results in a genetic change to your T cells. This mayallow the changed T cells to recognize your tumor cells but also normalantibody-producing cells called B cells. These changed cells are calledtisagenlecleucel cells.

    If you are eligible andchoose to participate in this MAP, you will be asked to come to the doctor’soffice/clinic/study site at least 3 times in order to make sure you areeligible to receive the tisagenlecleucel cells, and to prepare you for theexperimental treatments. Once you receive the tisagenlecleucel cells, acaregiver, relative, or friend should be in your presence at all times for thefirst 10 days to monitor your well-being and contact your study physician incase of fever or changes in your condition. If you become ill, immediatelycontact your study physician. Additionally, you may be required to spend about4 weeks after you have received tisagenlecleucel cells in close proximity tothe trial treatment center while the doctor and study team see how thetreatment is working and monitor your safety.

    Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in this Managed Access Plan (MAP).

    Some of the eligibility criteria include:

    · Age of at least 18 years

    Diagnosis of acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse or have been diagnosed with relapsed or refractory large B-cell lymphoma after two or more lines of therapies including diffuse large B cell lymphoma not otherwise specified, high grade B cell lymphoma and Diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this Managed Access Plan (MAP).

    Karmali, ReemKarmali, Reem
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03601442 STU00213101
    More Info
    Copy

    Evaluating the EVO treatment optimized for resource constraints: Elements Vital to treat Obesity

    EVO is a 12-month healthy lifestyle and weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. Researchers are looking to determine the best strategy for weight loss and healthy living. Participants enroll in the 12-month study and receive a free 6-month …