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Northwestern Scleroderma Program Patient Registry
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the cours…
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
Lee, Yvonne ClaireLee, Yvonne Claire
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00002669
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NU 05H6: Acute Leukemias and Map Kinase

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

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

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

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

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

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

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

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

Yang, Guang-YuYang, Guang-Yu
  • Map it 201 E. Huron St.
    Chicago, IL
STU00007180
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HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor …
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic unresponsiveness, and to investigate the safety and efficacy of the treatment regimen including withdrawal of immunosuppression after one year post-transplant for those recipients having received DHSC infusions.
Leventhal, Joseph RLeventhal, Joseph R
NCT00619528 STU00008874
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Chicago Lupus Database
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number …
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00009193
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DERMATOLOGY TISSUE ACQUISITION AND REPOSITORY
Northwestern University’s Department of Dermatology is collecting skin, hair, nail, blood, saliva, skin and/or buccal swabs, and mucous membrane(part of your skin which lines body passages and cavities such as the inside of your mouth or nose), and ot…
Northwestern University’s Department of Dermatology is collecting skin, hair, nail, blood, saliva, skin and/or buccal swabs, and mucous membrane(part of your skin which lines body passages and cavities such as the inside of your mouth or nose), and other tissue samples for use in a biorepository. By operating this biorepository, the Department of Dermatology hopes to develop a better understanding of skin diseases (meaning the knowledge about how cells in the skin behave and react to medical treatments) among researchers at Northwestern University and other approved researchers. This basic knowledge is expected to help the development of more effective patient care and new treatment methods.
-Having specimens collected as part of a standard of care procedure;
-Have a skin disease which researchers want samples of in order to further understand
it; or
-Qualify as a healthy volunteer whose samples researchers can use as control samples
for research.
Rangel, Stephanie MarieRangel, Stephanie Marie
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00009443
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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 import…

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
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A Multicenter Group to Study Acute Liver Failure. Long-term Outcomes of Acute Liver Failure Study Group Patients
Data Registry study for acute liver failure.
18-70 yr old adults. Acute Liver Failure (ALF) - INR > 1.5 and hepatic encephalopathy. Acute Liver Injury (ALI) - INR > 2, ALT > 10 x ULN
Ganger, Daniel RGanger, Daniel R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00518440 STU00016475
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Mediators of Atherosclerosis in South Asians Living in America
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians r…
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
Kandula, Namratha RKandula, Namratha R
NCT01207167 STU00019837
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NU 00X3: Pathology Core Facility

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

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

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

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

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

Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Donnelly, Eric DonaldDonnelly, Eric Donald
  • Map it 201 E. Huron St.
    Chicago, IL
NCT00980954 STU00021457
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Language in Primary Progressive Aphasia

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

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

  • better understand progression in PPA and its link to brain changes,
  • increase awareness of PPA and better educate patients, families, and clinicians, and
  • identify biomarkers that will lead to earlier diagnosis and earlier intervention.
  • Participants are compensated for participation and travel expenses and meals are covered for those not local to Chicago.
    You must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet screening criteria which require the patient to be a right-handed, native English speaker and safe to undergo a 3T MRI.
    Mesulam, Marek-MarselMesulam, Marek-Marsel
    NCT00537004 STU00026372
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    NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
    RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods …
    RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
    Shulman, Lee PShulman, Lee P
    NCT00005095 STU00005421
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    Alzheimer's Disease Core 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, br…

    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
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    Neural Mechanisms in Sensory Reception and Processing in the Healthy Adult (VA RR&D Grant # B3302K)
    The measures of treatment effect in the project include reception and processing of sensory stimulation as measured by functional MRI in the severely injured brain. The neural responses to these senso…
    The measures of treatment effect in the project include reception and processing of sensory stimulation as measured by functional MRI in the severely injured brain. The neural responses to these sensory stimuli in the healthy brain have never been identified nor mapped. Therefore, the purpose of this new project is to determine the mechanisms of responses to the same sensory stimuli used in the 597-006 except in the healthy brain, which will allow for comparisons between the healthy and severely injured brains mechanistic responses to sensory input. The rationale is that in order to assert that the neural responses in the injured brain are measured reliably with fMRI over time and that they deviate from normal, a comparable fMRI protocol with healthy brains must be completed because this basic knowledge does not exist in the scientific literature. It is hypothesized that images acquired at rest and contrasted with images acquired during sensory stimulation will identify significant activation in the relevant association areas (i.e., auditory cortex-A1, somatosensory area-S1) as well as the brain stem and thalamus in accordance with receiving and processing sensory stimulation. It is also hypothesized that significant activation will be demonstrated in these areas for each of the 4 imaging sessions (i.e., reliably over time).
    Pape, Theresa L BenderPape, Theresa L Bender
    STU00024134
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    PACTG 1026s: PHARMACOKINETIC PROPERTIES OF ANTIRETROVIRAL AND RELATED DRUGS DURING PREGNANCY AND POSTPARTUM
    The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokineti…
    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
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    NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection Facility

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

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

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

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

    Genetic Cohort-Unaffected Subjects
    • 50 years or older with LRRK2/GBA mutation or first degree relative with LRRK2/GBA mutation
    • Willing to undergo genetic testing
    OR
    • 30 years or older with SNCA mutation or first degree relative with SNCA mutation
    • Willing to undergo genetic testing
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT01141023 STU00031752
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    Department of Psychiatry and Behavioral Sciences Research Registry
    Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potenti…
    Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potential research participants who view the Department’s website. This application is not in itself a research project, but only for the establishment of the registry for recruitment. Recruitment will be for studies that have been approved by the Northwestern University Institutional Review Board. Advertising for the research database will be posted on the Department’s website. Our aim is to recruit psychiatric patients, their family members, and healthy controls for research on mood disorders, schizophrenia, and Alzheimer's disease.
    Goldman, Morris BGoldman, Morris B
    STU00034881
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    Nulliparous Pregnancy Outcomes Study: Monitoring Mothers to be
    Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might ha…
    Forty percent of pregnant women in the United States are women who have never given birth. As a group, they sometimes have complications with their pregnancy, but there is no information from a previous pregnancy to identify who might have a problem. Very little research has been done with this group. The Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) is collecting data from a diverse population of about 10,000 women who are having their first baby and are carrying only one baby. The women are enrolled early in pregnancy and undergo research assessments four times during their pregnancies. Data are collected through interviews, self-completed data forms, clinical measurements, ultrasound, and collection and storage of blood samples, urine samples, and fluid from the vagina and cervix. Some information comes from medical records. A subset of women may be asked to participate in substudies collecting information on sleep breathing, sleep patterns and quality, or other areas possibly related to birth outcomes. The goal of the research is to find ways to identify women in this group who might develop a problem with their pregnancy and use this information to improve the health of pregnant women and their babies in the future. The study is focusing on pregnancy problems like high blood pressure, babies that are born much too early and very small babies.
    Recruitment closed.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT01322529 STU00030993
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    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 i…
    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
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    NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid Malignancy

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

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

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

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

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

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00074258
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    Communication Bridge: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to Care
    The purpose of this study is to evaluate the effectiveness of speech and language therapy on individuals diagnosed with Primary Progressive Aphasia (PPA) ability to communicate immediately after tr…
    The purpose of this study is to evaluate the effectiveness of speech and language therapy on individuals diagnosed with Primary Progressive Aphasia (PPA) ability to communicate immediately after treatment, 6-months after treatment. We additionally hope to identify the most effective speech and language therapy strategies for persons with these conditions. Lastly, we hope to determine the feasibility of Internet-based video-practice of speech and language therapy for persons with these conditions. The study will involve 11 to 14 session over the course of 6 months. These sessions will all take place over the Internet, using an online study portal.
    For individuals with who wish to participate: You must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet screening criteria which require the patient and care-partner to be comfortable using computers and videoconferencing software. Care-partners of patients must be available to participate for all speech-language therapy sessions and evaluations.
    Rogalski, EmilyRogalski, Emily
    NCT02439853 STU00073634
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    CENTER FOR BEHAVIORAL INTERVENTION TECHNOLOGIES (CBITs) RESEARCH SUBJECT RECRUITMENT REGISTRY
    WHAT IS THE REGISTRY ABOUT? Becoming a member of this registry allows researchers at Northwestern University to get in touch with you to see if you might be interested in and eligible to participate in diff…
    WHAT IS THE REGISTRY ABOUT? Becoming a member of this registry allows researchers at Northwestern University to get in touch with you to see if you might be interested in and eligible to participate in different research studies at CBITs. The research conducted at CBITs generally involves evaluating different aspects of technology-assisted health interventions. WHAT WILL I BE ASKED TO DO? You will be asked to provide some basic contact and background information, as well as continue on to complete a brief survey. There is no cost to join the registry. You can read more about the current studies and sign up for the registry on our website: http://cbitshealth.northwestern.edu
    If you're an adult (18 years or older), living in the United States, who speaks English, and has Internet access, you may be eligible to join.
    Mohr, David CMohr, David C
    STU00076804
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    Non-Invasive Marker of Ovarian Reserve in Women with Epilepsy
    The purpose of this study is to assess and compare AMH hormone levels in women with epilepsy vs. healthy controls, utilizing medical history questionnaires and a finger stick.
    Gerard, Elizabeth ErwayGerard, Elizabeth Erway
    STU00077630
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    Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
    This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms a…
    This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).
    Salem, RiadSalem, Riad
    NCT02026908 STU00081296
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    Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder

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

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

    Participation Involves:

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

    To qualify for this study you must be:

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

    Clark, Crystal TClark, Crystal T
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT01996293 STU00079810
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    Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa
    This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).
    Apkarian, ApkarApkarian, Apkar
    NCT01951105 STU00081444
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    RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (A7007)
    The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practic…
    The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and to evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
    Key Inclusion Criteria:
    -Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
    -Signed a valid, IRB/EC-approved informed consent form
    -18 years of age or older

    Key Exclusion Criteria:
    -Contraindicated for Boston Scientific neurostimulation system
    -Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
    Rosenow, Joshua MRosenow, Joshua M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01719055 STU00083506
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    Targeting Siglecs in Disease supported by NIH Grant R01 AI072265 Targeting Siglec-8/-F to treat eosinophil and mast cell related disorders and P01 HL107151 Glycobiology of Inflammatory Lung Diseases: Project 1 and U19 AI136443 Using Siglecs and Their Ligands to Treat Allergic Diseases: Project 1 and Core B.
    The study involves recruiting paid volunteers to donate blood. The goal of the studies is to isolate certain cells from the blood called eosinophils to examine certain proteins and their functions in the laboratory.
    Adults with or without allergies
    Bochner, Bruce ScottBochner, Bruce Scott
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00085003
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    NUDB 13C03: Northwestern Brain Tumor Institute Research Database

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

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

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

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

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00087359
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    Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial
    Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe ne…
    Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe neonatal morbidity and perinatal mortality.
    first time mom, singleton pregnancy in women 18 years of age or older
    Grobman, William AGrobman, William A
    NCT01990612 STU00087536
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    Parkinson’s Disease and Movement Disorders Center Biorepository
    This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the regi…
    This is a registry aimed to collect biologic and clinical information, such as blood and tissue samples, and family and medical histories from patients diagnosed with a movement disorder. The purpose of studying materials from the registry is to identify factors that either cause these neurologic conditions or increase one’s risk for developing them. Samples collected for this biorepository include a blood sample (or a saliva sample) and a skin biopsy. Participants may choose to donate one or both samples.
    • Diagnosis of a movement disorder
    • Male or female 5 years of age or older when diagnosed
    • Genetic mutation related to a movement disorder
    • Family members of patients with movement disorders
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00091585
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    A 36 month multi-center, open label, randomized, comparator study to evaluate the efficacy and safety of everolimus immunosuppression treatment in liver transplantation for hepatocellular carcinoma exceeding Milan criteria.
    This study is a prospective Phase IV study to determine if the …
    This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.
    Kulik, Laura MKulik, Laura M
    NCT02081755 STU00083409
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    RANDOMIZED CONVERSION OF EBV+ KIDNEY TRANSPLANT RECIPIENTS OF LIVING OR STANDARD CRITERIA DONORS AT THREE MONTHS POST TRANSPLANTATION TO BELATACEPT WITH MPA OR BELATACEPT WITH LOW-DOSE TACROLIMUS (50% OF DOSE) COMPARED TO PATIENTS REMAINING ON CENTER SPECIFIC STANDARD THERAPY OF TACROLIMUS AND MPA
    Th…
    This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.
    Gallon, LorenzoGallon, Lorenzo
    NCT02213068 STU00085274
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    HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network-A Longitudinal, Observational Study
    The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both …
    The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.
    Levitsky, JoshLevitsky, Josh
    STU00092110
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    The Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
    The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN a…
    The Scleroderma Patient-Centered Intervention Network (SPIN) is an organization that was established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are: 1. To learn more about important problems faced by people living with scleroderma (e.g., fatigue, emotional distress, physical limitations). 2. To develop and test internet-based interventions to support people in their efforts to cope with living with scleroderma. Participants will be asked to complete quality of life questionnaires via the internet every 3 months.
    Diagnosis of scleroderma. Fluent in English. Must have access to the Internet to complete questionnaires.
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00092924
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    B-WELL-Mom (Breathe-Wellbeing, Environment, Lifestyle, and Lung Function)
    This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience…
    This NIH funded research study is to better understand how the lungs function during pregnancy and how the immune system responds to pregnancy. This study will help us to better understand why some women with asthma experience worsening of their symptoms while others improve. Because pregnancy affects lung function and immune response of all women, we are looking for both women with and without asthma to participate. The study consists of 4 clinic visits (1st, 2nd, and 3rd trimesters of pregnancy and 4 months postpartum), and an at-home diary.
    -Pregnant women at least 18 years old.
    -Less than 15 weeks pregnant with a single baby.
    -Women with and without asthma are eligible to participate. -No diagnosis of Multiple Sclerosis, Lupus, Rheumatoid Arthritis, HIV, or Mixed Connective Tissue Disease.
    Grobman, William AGrobman, William A
    STU00093038
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    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderatel…
    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
    Hanauer, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT01848561 STU00094204
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    Healthy Control Esophageal Registry and Biorepository
    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biop…
    This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
    Must not be:
    - Obese (i.e. BMI ≥30)
    - Known medical illnesses that could affect esophageal function, gene expression or histology
    - Have a diagnosis of an eating disorder
    - Have a diagnosis of an autoimmune disease
    - A current or previous smoker (smoked >100 cigarettes in lifetime)
    - Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
    - Taking antacids and/or proton pump inhibitors for heartburn
    - Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
    - Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
    - Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
    Carlson, Dustin AllanCarlson, Dustin Allan
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00096856
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    Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease
    This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are …
    This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 7 years postpartum. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in the nuMOM2b Study.
    By invitation only. Women who previously participated in the nuMOM2b Study and who are 18+ years old are invited to participate in the nuMOM2b Heart Health Study. These women also consented to be contacted for future research studies and did not previously withdraw from the nuMoM2b cohort.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT02231398 STU00098233
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    Neural Systems for the Dynamic Use of Memory
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our re…
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our research studies. Depending on your eligibility, you could take part in studies involving cognitive testing or studies involving noninvasive recording of brain function (using EEG, TMS, and MRI). Please contact us if you are interested in participating and we can determine your eligibility and provide additional details. All studies take place in downtown Chicago on the Northwestern University campus. Individuals will receive monetary compensation for participating, ranging from $10-$40 per hour depending on the experiment. Please contact fill out our participant survey if you are interested at https://redcap.nubic.northwestern.edu/redcap/surveys/?s=w7RfNPbxwJ or contact us at lhn@northwestern.edu or 312-503-5613.
    Voss, Joel LVoss, Joel L
    STU00060723
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    Noninvasive Manipulation of Hippocampal-Cortical Brain Networks and Memory
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individual…
    The Laboratory for Human Neuroscience at the Northwestern University Feinberg School of Medicine is seeking participants for research studies on how the brain develops across the lifespan. We are currently enrolling individuals 18-34 years of age in our research studies. Depending on your eligibility, you could take part in studies involving cognitive testing or studies involving noninvasive recording of brain function (using EEG, TMS, and MRI). Please contact us if you are interested in participating and we can determine your eligibility and provide additional details. All studies take place in downtown Chicago on the Northwestern University campus. Individuals will receive monetary compensation for participating, ranging from $10-$40 per hour depending on the experiment. Please fill out our participant survey if you are interested at https://redcap.nubic.northwestern.edu/redcap/surveys/?s=w7RfNPbxwJ or contact us at lhn@northwestern.edu or 312-503-5613.
    Voss, Joel LVoss, Joel L
    STU00070522
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    Development of a Kidney Cancer Patient Outcomes Database
    Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who …
    Purpose This study is evaluating an on-line registry for kidney cancer patients called ‰ÛÏMyQOL,‰Û which stands for My Quality of Life. Overview A registry is a repository (database) of information about a group of people who share a common characteristic - in this case, kidney cancer. MYQOL registry participants enter information about their disease, treatment, symptoms, health status, and quality of life into an on-line, password-protected database on a regularly scheduled basis. Participants can use the registry to track many of their symptoms and their health status over time and to compare themselves (anonymously) with other groups of people (for example, how their level of fatigue compares with the average level of fatigue reported by other participants in the registry). Participants can also choose to share relevant information about themselves (from the registry) with their health care provider(s), by printing copies of their completed forms. Registry participants will be offered opportunities to join in other research studies when available. Description of Treatment Participants in this study will be asked to do the following for a 1-year trial period: 1) enroll in the on-line registry; 2) complete questionnaires about their health and treatment every 3 months ; and 3) be willing to have MYQOL researchers contact them confidentially about participating in other research studies. This does not mean that participants are obligated to participate in future research studies; only that they agree to be contacted.
    Some of the eligibility criteria include:

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Cella, DavidCella, David
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00070200
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    rTMS: A Treatment to Restore Function after Severe TBI
    The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiven…
    The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the relationship between neurobehavioral changes and net neural effects, and to identify and define the neural mechanisms related to neurobehavioral improvements by providing 30 active or placebo rTMS sessions.
    Inclusion Criteria:
    -Veteran of any combat era
    -Both Genders
    -20-65 years
    -History of Post Traumatic Amnesia < 1 day for mild TBI; 1 day> x < 7days for moderate TBI))
    -Ability to obtain a Motor Threshold (MT) will be determined during the screening process.
    -If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
    -Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
    -For female participants, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive; Norplant
    -Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.

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

    Inclusion Criteria:

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

    Exclusion Criteria:

    Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
    Prior VBAC.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT02646423 STU00104496
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    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
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    NRG HN001: Randomized Phase II And Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
    There are two study questions the investigators are asking in this randomized phase II/III trial b…
    There are two study questions the investigators are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
    Mittal, Bharat BMittal, Bharat B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02135042 STU00200330
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    Ex vivo interactions between high-density-like nanoparticles and human blood
    This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Pr…
    This research is significant because the high-density lipoprotein like nanoparticles (HDL-NPs) being investigated have been shown to have tremendous therapeutic properties when evaluated in in vitro and in vivo settings. Prior to initiating large-scale in vivo animal and human studies it is imperative that we obtain an in-depth knowledge of the interaction of the HDL-NPs with human blood cells using safe ex vivo experiments.
    Healthy, non-pregnant adult (age >18-75 years) volunteers.
    Thaxton, Colby SThaxton, Colby S
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200368
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    NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia Suppressor

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

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

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

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

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

    Eklund, Elizabeth AEklund, Elizabeth A
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00200435
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    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
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    Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) P
    Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical managem…
    Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
    Eskandari, MarkEskandari, Mark
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02089217 STU00200290
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    Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE (A5332)/ A5333s: Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE/A5361s: Pitavastatin to REduce Physical Function Impairment and Frailty in HIV (PREPARE)
    People infected wi…
    People infected with HIV are at risk for cardiovascular disease (CVD). REPRIEVE is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 months. The trial is testing the effect of statin therapy on preventing heart disease and death in HIV-infected persons on HIV medications who do not meet guidelines for starting statins. HIV causes inflammation (irritation) inside the body that may contribute to diseases such as heart disease. HIV medications can lower inflammation, however the levels of inflammation can remain higher compared to people who are not infected with HIV. Statins, such as pitavastatin, are medications that are used to lower the levels of cholesterol and triglycerides (fat in the blood) and have been shown to lower levels of inflammation and heart disease.
    • HIV infected men and women between the ages of 40 and 75
    • On anti-HIV medications for at least 6 months
    • CD4 cell count greater than 100
    • No history of cardiovascular disease, such as heart attack, stroke, etc.
    • No history of cancer in the last 3 years
    • Not currently using a statin drug
    Taiwo, Babafemi OTaiwo, Babafemi O
    NCT02344290 STU00200323
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    The effect of magnesium on maternal mood, cognitive function, and birth experience
    Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less …
    Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of pregnancy. The primary aim of this study is to determine if women who receive magnesium are less likely to experience postpartum depression. Other aims include examining the relationship between receiving magnesium and cognitive function and birth experience.
    Miller, Emily StinnettMiller, Emily Stinnett
    NCT02454322 STU00200388
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    Lithium Therapy: Understanding Mothers, Mood and Metabolism
    We are working to understand how physiological changes during pregnancy and postpartum affect lithium blood levels. Changes in metabolism have the potential to lead to high lithium levels that can lead to toxicity or less than therapeutic li…
    We are working to understand how physiological changes during pregnancy and postpartum affect lithium blood levels. Changes in metabolism have the potential to lead to high lithium levels that can lead to toxicity or less than therapeutic lithium levels which may cause an increase in mood symptoms. Participating in this study will help researchers better understand how to adjust lithium dose in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

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

    To qualify for this study you must be:

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

    Clark, Crystal TClark, Crystal T
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02490241 STU00200026
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    SPARC: Gene expression profiling in scleroderma to discover therapeutic targets and predict clinical course
    The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match tar…
    The purpose of this study is to identify and validate a molecular classification of scleroderma that will allow us to predict which patients will develop specific complications and to match targeted treatments to the appropriate patients. The study will also focus on identifying inflammatory and fibrotic molecular pathways that are important in the disease Participants will be asked to give: - Two punch skin biopsies from the forearm (size of a pencil eraser) - Two tubes of blood - Urine collection Participants will be paid $110 for the one-time study visit. We are recruiting both patients with scleroderma and healthy control subjects.
    Participants must be: Over age 18, No chronic skin conditions, No rheumatic autoimmune diagnosis (e.g., lupus, rheumatoid arthritis, scleroderma), Not currently pregnant.
    Varga, JohnVarga, John
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00200631
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    Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
    This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enr…
    This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
    Schaeffer, Anthony JSchaeffer, Anthony J
    NCT02514265 STU00200928
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    Testing the ability of JNJ-18038683, a selective serotonin (5-HT)7 antagonist, to improve cognition and reduce residual depressive symptoms in stable bipolar patients
    This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in …
    This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in people who have bipolar disorder and are taking other medications for their illness. Mental function is how your brain works and includes your mood, memory and how you think and concentrate. An investigational drug is one that is not approved for sale by the US Food and Drug Administration (FDA) or any other regulatory or health agency. This study compares an experimental drug to a placebo. A placebo is an inactive substance made to look/taste like an active medicine. We expect that you will be in this research study for up to 10 weeks, including the screening period.
    Adults 18 to 60 years old with diagnosis of of bipolar disorder
    Meltzer, Herbert YMeltzer, Herbert Y
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT02466685 STU00200919
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    A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)
    This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent earl…
    This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
    Miller, Emily StinnettMiller, Emily Stinnett
    NCT02518594 STU00200799
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    Telmisartan Plus Exercise to Improve Functioning in PAD
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performan…
    The purpose of this study is to establish whether the angiotensin receptor blocker (ARB) telmisartan improves walking performance in people with PAD. We will also determine whether telmisartan plus supervised exercise improves walking performance more than telmisartan alone and more than supervised treadmill exercise alone.
    We are asking you to take part in this research study because you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent blood from getting down to the legs and feet during exercise.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02593110 STU00200954
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    Optimizing Medication Management for Mothers with Depression (OPTI-MOM)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    pregnant women.

    Pregnant women ages 18-45 years old less than 18 weeks pregnant with a singleton pregnancy taking sertraline (Zoloft), fluoxetine (Prozac), escitalopram (Lexapro), or citalopram (Celexa) and plan to continue this medication throughout pregnancy and through the first 4 months postpartum. 
    Wisner, Katherine LeahWisner, Katherine Leah
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00201386
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    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
    A Phase III, Randomized, Double-Blind, Placebo…
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Etrolizumab As An Induction And Maintenance Treatment For Patients With Moderately To Severely Active Crohn’s Disease (Protocol GA29144)
    Hanauer, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02394028 STU00201257
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    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active …
    An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
    Hanauer, Stephen BHanauer, Stephen B
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02403323 STU00201259
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    NU 15B01: A Single Arm Phase II Study Evaluating the Efficacy and Safety of Durvalumab (MEDI4736) in Combination with Tremelimumab in Patients with Metastatic HER2 Negative Breast Cancer: TNBC Expansion Cohort

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

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

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

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

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

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02536794 STU00200984
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    Chronic Kidney Disease Research Biorepository
    The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00201546
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    Improving Outpatient Safety of Older Adults through Electronic Patient Portals
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers an…
    The objective of this study is to assess whether providing caregivers of older adults proxy access to an electronic patient portal (MyChart) improves the outpatient medication safety and communication between caregivers and health care providers.
    Adults age 65 and older, a patient in the General Internal Medicine and Geriatrics (NMFF GIM-GER) clinics, not currently enrolled in MyChart Electronic Patient Portal, English speaking, can identify a caregiver who assists with their care (can be informal e.g. adult child, spouse, caregiver agency). Additional eligibility criteria are focused on the caregiver identified: English speaking, assist the older adult with medications and communication with the health care team, and have internet access (either phone, tablet, or laptop/computer).
    Lindquist, Lee ALindquist, Lee A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    STU00201242
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    ITN056ST: Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Operational Tolerance Following Liver Transplantation in Adults
    The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or …
    The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
    Levitsky, JoshLevitsky, Josh
    NCT02533180 STU00201197
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    High Resolution and Functional MRI Assessment of Intracranial Atherosclerotic Plaque
    Intracranial atherosclerotic disease (ICAD) accounts for 7-10% of cute ischemic stroke with a substantial risk of recurrent stroke in a setting of severe intracranial stenosis, approaching 12-25% over 1-2 years despi…
    Intracranial atherosclerotic disease (ICAD) accounts for 7-10% of cute ischemic stroke with a substantial risk of recurrent stroke in a setting of severe intracranial stenosis, approaching 12-25% over 1-2 years despite medical management. However, a risk stratification scheme is not available to identify this susceptible population for targeted treatment trials when intervention with more aggressive medical management and/or endovascular angioplasty/stenting could limit complications of ischemic stroke. The unmet need that we plan to address is to develop and study MR imaging modalities that may characterize vulnerable inflammatory and/or hemodynamically significant intracranial plaques, stratifying the mechanisms and potential predictors of primary/recurrent ischemic stroke in ICAD. Recently, we have identified unique intracranial plaque characteristics as well as hemodynamic parameters using quantitative MR perfusion techniques to stage cerebrovascular reserve failure that are associated with symptomatic intracranial stenoses. We propose a prospective study to recruit asymptomatic and symptomatic patients with severe ICAD and longitudinally assess them with a comprehensive and novel MRI protocol: high resolution 3T MR imaging, ferumoxytol molecular imaging, dynamic contrast enhanced (DCE) MRI to quantify the transfer constant (Ktrans) of contrast plaque permeability, and dynamic susceptibility contrast (DSC) MR perfusion weighted imaging (MRPWI) using the quantitative SCALE-PWI sequence. Our study hypothesis is that high resolution T1 plaque enhancement, T1/T2 plaque hemorrhage, early ferumoxytol uptake as a marker of macrophage infiltration/inflammation, intraplaque Ktrans permeability, and/or altered qCBF/qCBV perfusion based parameters with vascular territory analysis will assist in stratifying patient risk for thromboembolic versus hypoperfusion related ischemic complications respectively. This project aims to identify specific qualitative and quantitative thresholds with advanced high resolution, molecular, and functional MRI techniques that can be correlated to clinical presentations (asymptomatic, symptomatic, recurrent symptomatic), DWI infarct distributions (perforator, thromboembolic, hypoperfusion related infarcts), inflammatory blood markers, and clinical/imaging outcomes to inform an understanding of differential stroke mechanisms and to improve the selection of high risk ICAD patients who may be susceptible to primary or recurrent ischemic stroke despite aggressive medical management.
    Inclusion:
    1- Severe ICAD>70% confirmed by SOC CTA/MRA/DSA using SAMMPRIS criteria2
    2- AGE 30-80 YEARS
    3- At least one segment of
    a) supraclinoid ICA,
    b) A1-A2 ACA,
    c) M1-M2 MCA,
    d) intracranial vertebral-basilar artery
    e) P1-P2 PCA
    4- Age 30-80 years
    5- Symptomatic patients defined as an association between the intracranial stenosis and hemodynamic impairment of the corresponding vascular territory, based on either neurological exam (TIAs/stroke) and/or acute/subacute infarcts documented on MR-DWI

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

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

    Adults unable to consent
    Individuals who have not reached the age of 18
    Pregnant women
    Prisoners.
    Cronenwett, Will JCronenwett, Will J
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    STU00201133
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    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
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    The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure me…
    The purpose of the ENRGISE Pilot Study is to look at the effect of anti-inflammatory drugs on physical functioning in older adults. This study will see if two study drugs (fish oil and losartan, a commonly used blood pressure medicine) have an effect on walking ability.
    Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02676466 STU00201974
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    Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot Study
    Preeclampsia is a serious medical condition affecting pregnancy. Certain chemicals in your blood may increase your risk of developing preeclampsia. A medicine called pravastatin, which you take by mouth, may decr…
    Preeclampsia is a serious medical condition affecting pregnancy. Certain chemicals in your blood may increase your risk of developing preeclampsia. A medicine called pravastatin, which you take by mouth, may decrease the levels of these chemicals. The purpose of this pilot study is to determine how the body handles Pravastatin during pregnancy and to determine its safety.
    • Are 18 years or older
    • Currently between 12-16 weeks pregnant
    • Have a documented history of prior severe PE, requiring delivery before 35 weeks gestation
    Wisner, Katherine LeahWisner, Katherine Leah
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT01717586 STU00202090
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    A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
    The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxife…
    The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
    Some of the eligibility criteria include:

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Kulkarni, SwatiKulkarni, Swati
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02694809 STU00202100
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    amaze Trial Continued Access Protocol (CAP): Left Atrial Appendage Ligation with the LARIAT+® Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation (PVI) for Persistent or Longstanding Persistent Atrial Fibrillation
    This study is a prospective, multicenter, randomized (2:1) contr…
    This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites - Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both stages will be included in the primary analysis.
    Lin, Albert Chao-tunLin, Albert Chao-tun
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04468334 STU00201623
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    NU 15N01: Head and Neck Tissue Bank

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

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

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

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

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

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202177
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    NU 15N02: Northwestern Head and Neck Cancer Registry

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

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

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

    Samant, SandeepSamant, Sandeep
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00202162
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    Motivational Interviewing and Physical Activity in Parkinson’s Disease
    We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coac…
    We are conducting a study to evaluate ways to increase physical activity in people with Parkinson’s Disease. Participants in this study will be placed into one of four groups: 1) motivational interviewing, a counseling/coaching style used to help people change their behavior; 2) a web-based application for participants to keep track of their physical activity; 3) a combination of the motivational interviewing and the web-based application; and 4) an educational program on various issues related to Parkinson’s disease.
    Live in the community
    At least 18 years of age
    A diagnosis of Idiopathic Parkinson’s Disease
    Be able to walk for a distance of 50 feet or 10 minutes at a time
    Do NOT currently complete 150 minutes or 2.5 hours of moderate to vigorous physical activity per week
    Currently has and uses a smartphone, tablet, or computer to access the internet
    Ehrlich-Jones, Linda SEhrlich-Jones, Linda S
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT03329833 STU00202265
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    A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS
    Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.
    Huang, WenyuHuang, Wenyu
    NCT02685709 STU00202258
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    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
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    North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) Study
    This is a non-interventional study (i.e. no study drug)

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

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

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

    The NARCRMS database is unique for the following reasons:

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

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

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

    Inclusion Criteria:

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

    Exclusion Criteria:

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

    Cohen, Bruce ArnoldCohen, Bruce Arnold
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    STU00201852
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    LiveWell: A Mobile Intervention for Bipolar Disorder
    This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent …
    This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If you are eligible for the study, your participation will last up to 12 months.
    Individuals 18-65 years old who have been diagnosed with bipolar disorder and are currently working with a psychiatrist
    Goulding, Evan HGoulding, Evan H
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03088462 STU00202860
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    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…

    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
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    Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
    Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y prom…
    Este estudio está diseñado para ayudar a los hombres a mejorar la calidad de vida y reducir los síntomas del cáncer de próstata. El estudio imparte habilidades de manejo de estrés y promueve la salud. Este programa de salud e intervención para hombres diagnosticados con cáncer de próstata, ofrece información sobre cómo reducir el estrés y aprender a relajarse. Este estudio dentro Northwestern University está financiado por el Instituto Nacional del Cáncer. El objetivo del estudio es examinar cómo los programas de salud pueden mejorar la calidad de vida de los hombres tratados por cáncer de próstata.
    (a) ≥ 18 years of age;
    (b) Hispanic/Latino self-identification;
    (c) Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention); (d) Willingness to be randomized and followed for approximately 12 months.
    (d) Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
    (e) Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within the past 48 months prior to participating in the study
    Miller, GregMiller, Greg
    • Map it 633 N. St. Clair St.
      Chicago , IL
    NCT03344757 STU00203197
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    Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD Study
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve card…
    The purpose of this study is to determine whether drinking daily cocoa-enriched beverages improves walking performance in people with PAD. Previous studies have shown that cocoa may improve blood flow, improve cardiovascular health, and improve muscle function and strength. Some evidence suggests that cocoa may also improve walking ability in people with PAD.
    We are asking you to take part in this research study because you are age 65 or older and you have or may have peripheral artery disease (PAD). PAD is a condition in which cholesterol blockages in the leg arteries prevent adequate blood flow to the legs and feet.
    McDermott, Mary McGraeMcDermott, Mary McGrae
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02876887 STU00202741
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    PFF Patient Registry Protocol version 1.0 date 21.Jan.2016
    The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollmen…
    The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research
    Diagnosed with IPF
    Tomic, RadeTomic, Rade
    • Map it 201 East Huron Street Suite 12-160​
      Chicago, IL
    NCT02758808 STU00202873
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    MAST CELLS IN MALE CHRONIC PELVIC PAIN AND LOWER URINARY TRACT DYSFUNCTION
    The purpose of this study is to figure out if drug treatments using cromolyn sodium and cetirizine hydrochloride lessen painful symptoms in patients suffering from chronic pelvic pain syndrome (CPPS).
    Men diagnosed with Category IIIB Chronic Pelvic Pain Syndrome reporting pain or discomfort in any of the 8 domains of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
    Thumbikat, PraveenThumbikat, Praveen
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03167216 STU00202831
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    Alliance A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas with SMO/AKT/NF2 Mutations

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

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

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

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

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

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

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Meeks, Joshua JMeeks, Joshua J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02808143 STU00202754
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    A Double Blind, Randomized, Vehicle Controlled, Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients with the Mycosis Fungoides (MF) or Sézary Syndrome (SS) Forms of Cutaneous T-Cell Lymphoma (CTCL)
    The main goal of …
    The main goal of this study is to test the efficacy and safety of topical Naloxone for itching in patients with MF.
    21 years of age or older with a diagnosis of mycosis fungoides (MF) with itching present on a daily basis for more than one month and willing to fill out a diary for 7 days to provide severity of itch before enrollment.
    Guitart, JoanGuitart, Joan
    • Map it 676 N. St. Clair St.
      Chicago, IL
    NCT02811783 STU00203078
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    Phase II Multicenter Study of Natalizumab Plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

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

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

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

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

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

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

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

    Adekola, KehindeAdekola, Kehinde
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02133924 STU00203346
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    Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase Disorder
    This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will i…
    This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity monitoring.
    Individuals with delayed sleep-wake phase disorder and healthy controls
    Abbott, Sabra MargaretAbbott, Sabra Margaret
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203647
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    DRUG AG-221-AML-005: A phase 1B/2 open-label, randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant targeted therapies plus azacitidine: oral AG-120 plus subcutaneous azacitidine and oral AG-221 plus SC azacitidine in subjects with newly diagnosed acute myeloid leukemia harboring an IDH1 or an IDH2 mutation, respectively, who are not candidates to receive intensive induction chemotherapy

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

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

    - Adults at least 18 years of age

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

    - Have an IDH1 or IDH2 gene mutation

    - Not candidates to receive intensive IC.

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

    At least 18 years of age

    - Had a stroke more than 6 months ago

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

    - Not currently participating in another research study on the arm

    Slutzky, Marc WSlutzky, Marc W
    • Map it 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
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    Alzheimer’s Disease Neuroimaging Initiative 3
    The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through …
    The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private collaboration between academia and industry to study biomarkers of AD. ADNI will continue to inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios. This is a non-randomized natural history non-treatment study. Participants will need to be 55 - 90 years, otherwise healthy with no neurologic disease such as Alzheimer's disease. Approximately 1070 - 2000 participants will be enrolled at approximately 59 sites in the United States and Canada. Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 - 1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts. Subjects will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.
    - No history of major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia.
    - Must be between the ages of 55-90 years (inclusive).
    - Must have a study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol.
    - Must have visual and auditory acuity adequate for neuropsychological testing.
    - Must be in good general health with no diseases expected to interfere with the study.
    - For females only: Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
    - Must be willing and able to participate in a longitudinal imaging study lasting up to 5 years.
    - Must have completed six grades of education or has a good work history (sufficient to exclude mental retardation).
    - Must speak English fluently.
    - Must be willing to undergo repeated MRIs (3Tesla) and at least two PET scans - must not have any MRI contraindications (i.e. pacemaker, claustrophobia)
    - Must agree to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking.
    - Must agree to collection of blood for biomarker testing.
    - Must agree to at least one lumbar puncture for the collection of CSF.
    - Must agree to share genomic data and biomarker samples.
    Rogalski, EmilyRogalski, Emily
    NCT02854033 STU00203359
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    Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)
    Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have hear…
    Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin every day. That way, we can learn which is better in terms of reducing the risk of heart attacks, strokes, bleeding, and death. We expect up to 15,000 subjects with heart disease from across the U.S. will take part in ADAPTABLE.
    Criteria


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

    Exclusion Criteria:
    • There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
    • Patients and sites interested in participating must be part of the listed health systems collaborators.
    Kho, Abel NKho, Abel N
    • Map it 675 N. St. Clair St.
      Chicago, IL
    NCT02697916 STU00203465
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    Stellate Ganglion Blockade for the Management of Vasomotor Symptoms
    This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot flashes in post menopausal women. You will be asked to come downtown for 5 visits over …
    This study is being done to determine whether a non-hormonal intervention utilizing a numbing injection can reduce the number and severity of hot flashes in post menopausal women. You will be asked to come downtown for 5 visits over the period of 7 months. During this time, you will keep a daily diary, wear a hot flash monitor for 24 hrs at three time points, a sleep and activity watch for 72hrs at 3 time points, and complete memory testing. You will be given a parking pass and compensation for your participation. If you're interested and would like to learn more, please click on the buttons to the right to call or email our study team.
    female, post-menopausal (no menstrual periods), 40-70 years old, moderate to severe hot flashes
    Walega, David RWalega, David R
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02907983 STU00203490
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    NUDB 16Z01: The OncoSET Program Database and Biobank - Combining Clinical Outcomes with Next Generation Sequencing and other Advanced Molecular Testing for Genetic Aberrations in Patients with Advanced Solid Malignancies

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

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

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

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

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

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

    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203944
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    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 a high risk for traditional open-heart surgery. Mitral…
    This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. Mitral regurgitation, MR, is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that is simpler than traditional open-heart procedure and may be safer for patients who are at a higher risk from open-heart surgery. The new device is called the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transseptal and Transapical Delivery Systems). The CardiAQ™ TMVI system is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transseptal) or through an incision in the chest between the ribs (transapical). The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 8 scheduled study visits after discharge from the hospital at 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
    Patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. General Criteria:
    1. Greater than or equal to 18 years of age.
    2. New York Heart Associate Classification ≥ II
    3. Left Ventricular Ejection Fraction ≥ 30%.
    4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe) where EROA ≥ 0.30 cm2 or VC width ˃ 0.7 cm.
    5. Patient is determined to be high surgical risk but operable as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). Inclusion of a heart failure specialist is strongly recommended.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02718001 STU00204104
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    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
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    Reducing Assessment Barriers for Patients with Low Literacy
    This study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
    You may be eligible for this study if you are the age of 18 or older, are fluent in English and/or Spanish, have no plans to move outside of the Chicagoland area in the next 6 months, and are willing to complete questionnaires on an electronic tablet or in paper & pencil format. You will be asked to complete 3 face-to-face interviews at Northwestern in downtown Chicago and will be compensated for your time and transportation.
    Griffith, James WGriffith, James W
    NCT03584490 STU00204308
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    OT-15-001: A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
    Purpose The purpose of this study i…
    Purpose The purpose of this study is to measure how well and how safe eflornithine is in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has come back after radiation and chemotherapy. Overview Elfornithine is an experimental drug. An experimental drug means that the United States Food and Drug Administration (FDA) has not approved it for use. This drug will be used with another drug called Lomustine that is approved by the FDA in the United States for patients with anaplastic astrocytoma. Description of Treatment This study has two study groups. Patients will be randomly placed in one of the 2 groups.
    Some of the eligibility criteria include:

    - Participants must be 18 years of age or older.

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

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.
    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02796261 STU00203957
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    Investigating Serum Concentrations of Mood Stabilizing Medications in Pregnancy and Postpartum
    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as lamotrigine (Lamictal), lithium (Lithium Carbonate), ris…
    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as lamotrigine (Lamictal), lithium (Lithium Carbonate), risperidone (Risperdal), aripiprazole (Abilify), lurasidone (Latuda), and olanzapine (Zyprexa). Changes in the metabolism of these medications can lead to less than therapeutic drug levels which may cause an increase in mood symptoms or recurrence of mood episodes. The study offers additional monitoring of mood symptoms and drug concentrations in the blood during pregnancy. Participating in this study may help researchers better understand how to adjust mood-stabilizing medications in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

    Participation involves:

    • monthly 30min checkups,
    • expert evaluation, mood assessments, and blood draws,
    • validation of on-site parking, and
    • to compensate for your time and effort, $25 for each completed checkup.

    Este estudio tiene el fin de entender como ciertos cambios fisiológicos durante el embarazo y postparto afectan el metabolismo de medicamentos como lamotrigine (Lamictal), lithium (Lithium Carbonate), risperidone (Risperdal), aripiprazole (Abilify), lurasidone (Latuda), y olanzapine (Zyprexa). Cambios en el nivel del medicamento en sangre tienen el potencial de inducir un nivel terapeutico del medicamento menor al estándar lo cual puede llevar a un incremento en cambios de ánimo o recurrencia de episodios anímicos.

    El estudio incluye:

    • consultas mensuales de 30min,
    • la evaluación de un experto, cuestionarios del estado de ánimo, y muestras de sangre,
    • pago por el parqueo en el hospital, y
    • para compensar su tiempo y esfuerzo, por cada visita completada usted recibirá $25.

    To qualify for this study you must:

    • speak English or Spanish,
    • be pregnancy planning or less than 27 weeks pregnant,
    • be between the ages of 18 and 45, and
    • be taking at least one of the following medications: lamotrigine (Lamictal), lithium (Lithium Carbonate), risperidone (Risperdal), aripiprazole (Abilify), lurasidone (Latuda), or olanzapine (Zyprexa), and planning to continue during pregnancy and postpartum

    Los requisitos parta participar en este estudio son:

    • hablar inglés o español,
    • estar planeando quedar embarazada o tener menos de 27 semanas de embarazo,
    • tener entre 18 y 45 años de edad, y
    • estar tomando alguno de los siguientes medicamentos: lamotrigine (Lamictal), lithium (Lithium Carbonate), risperidone (Risperdal), aripiprazole (Abilify), lurasidone (Latuda), o olanzapine (Zyprexa), y planear seguir tomándolo durante el embarazo y el tiempo postparto.

    Clark, Crystal TClark, Crystal T
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00203693
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    NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects
    Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in p…
    Purpose The purpose of this research is to study two US FDA approved drugs alone or in combination with each other in people who have metastatic castration-resistant prostate cancer and specific changes in their DNA, to see which one is best at keeping prostate cancer from growing. Metastatic castration-resistant prostate cancer means the cancer is spreading outside of the prostate and does not stop or go away with hormone therapy or surgery to reduce testosterone. One of the drugs, Olaparib, is not FDA approved for prostate cancer, which means it is experimental or investigational. Overview Once prostate cancer has progressed to metastatic castration-resistant prostate cancer, standard treatment focuses on extending life, delaying disease progression, and improving symptoms and quality of life. The purpose of this research is to study two US FDA approved drugs alone and in combination with each other in people who have metastatic castration-resistant prostate cancer and DNA repair defects. One of the drugs, Olaparib, is not FDA approved for prostate cancer. People who take part in this research study have been diagnosed with metastatic castration-resistant prostate cancer and either their body or the the cancer have a genetic defect (flaw) that causes problems with their body‰Ûªs ability to repair damage to their DNA. Description of Treatment Participants will be placed into one of four groups. The treatment that each group will receive is as follows. Group 1 will receive Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Group 2 and 4 will receive Olaparib (300 mg by mouth twice per day). Group 3 will receive Olaparib (300 mg by mouth twice per day), Abiraterone (1000 mg by mouth once per day) and prednisone (5 mg by mouth twice per day). Treatment may continue until disease progression, severe or unacceptable side effects, or until the participant or study doctor think the treatment should stop.
    Some of the eligibility criteria include:

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

    Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
    Hussain, MahaHussain, Maha
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03012321 STU00203960
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    Prevalence of aneuploidy in ectopic pregnancies
    The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectop…
    The purpose of this study is to evaluate genetic associations with ectopic pregnancies. It has commonly been thought that ectopic pregnancies are caused from fallopian tube damage or other maternal factors. However, a newer theory has emerged that ectopic pregnancies may implant outside of the uterus because they are chromosomally abnormal. The tissue from the ectopic pregnancy, called products of conception, that was removed at the time of your surgery will undergo genetic testing to identify if the pregnancy implanted in the wrong place due to a genetic abnormality with the fetus. Results of the genetic analysis of your ectopic pregnancy tissue will be made available to you. You and the biological father of the ectopic pregnancy will also be required to provide a cheek swab sample for analysis.
    Inclusion: 1) Women with previous ectopic pregnancy that required surgery while under care at Northwestern Memorial Hospital; 2) Biological father of ectopic pregnancy willing and able to participate; 3) English-speaking.
    Feinberg, Eve CFeinberg, Eve C
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00203775
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    Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease Cohort
    The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers wil…
    The purpose of this research study is to collect clinical information about patients and their health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). Researchers will use this information and samples to learn more about HD and to try to find new treatments for the disease. People from many countries contribute to Enroll-HD.
    Individuals 18 yrs or older affected by Huntington's Disease (HD) or from a HD family or are a "community control" (a person who does not carry the HD genetic mutation that causes Huntington's disease and is not part of an HD family, but would like to participate in the study). Research visits are conducted yearly and will consists of a collection of medical and family history and biological samples.
    Bega, DannyBega, Danny
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    STU00203021
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    ELUCDITATING THE MOLECULAR MECHANISMS UNDERLYING CYP2D6 INDUCTION DURING PREGNANCY
    We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimest…
    We know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women’s body, processes such as the rate of drug metabolism can change over the course of the three trimesters. Drug metabolism is controlled by certain genes in the body. This study will be examining the up-regulation of a certain enzyme in the liver called CYP2D6, which helps the body process many different drugs. We will measure compounds related to vitamin A, which we think might be involved in the process that speeds up the enzyme activity, from blood samples. The primary goal of our research is to understand how drug metabolism changes across pregnancy. The secondary goal is to define how the activity of enzymes in the liver are up-regulated (increased) during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.
    • Are 18-45 years of age
    • Are currently at or less than 13 weeks pregnant
    • Speak English
    • Singleton Gestation (not pregnant with twins)
    • Able to present for blood sampling between 8am-noon once per each month of pregnancy, and for two months postpartum
    Wisner, Katherine LeahWisner, Katherine Leah
    • Map it 676 N. St. Clair St.
      Chicago, IL
    STU00204600
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    Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
    This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening i…
    This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2. A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture. 3. Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture. 4. A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture. 5. A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening condition The study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
    Primary Inclusion Criteria:

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

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

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

    1 year, 2 visits.

    40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02634268 STU00204332
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    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
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    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…
    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
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    Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)
    The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurolo…
    The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
    • Age 18 and older
    • Presence of symptoms and signs of ataxia
    • Molecular diagnosis of SCA 1, 2, 3, 6 either in the participant or an affected family member
    • Willingness to participate in the study and ability to give informed consent.
    Opal, PuneetOpal, Puneet
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT01060371 STU00204294
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    The Molecular Markers of Bladder Cancer
    Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer i…
    Genetic research may discover genes, find out how genes function, or help researchers learn how to use what we know about genes to treat or prevent and treat disease. The purpose is to study whether the results of genetic testing can predict if bladder cancer is going to recur, progress (get worse), or respond to chemotherapy.
    Male or female patients ages 40-89 with high-grade T1 bladder cancer or patients with muscle invasive (>T2) bladder cancer undergoing neoadjuvant chemotherapy and radical cystectomy.
    Meeks, Joshua JMeeks, Joshua J
    STU00204352
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    Losartan Effects on Emphysema Progression (LEEP)
    This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms…
    This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD. Losartan is a medicine used for treatment of high blood pressure. Losartan has been shown to slow the damage to lungs caused by COPD in animals. We would like to find out if taking Losartan can slow the damage to lungs caused by COPD. We will use images of participants’ lungs taken with high resolution computed tomography (HRCT) to measure changes in the lung. We also want to find out if Losartan has effects on blood and breathing tests.
    40 years of age or older with COPD, controlled blood pressure, no flare of COPD in the last 6 weeks or the use of antibiotics or prednisone
    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02696564 STU00204797
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    A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with Acute, Complicated Type B Aortic Dissections
    This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissectio…
    This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissection. One way to repair an acute, complicated type B aortic dissection is with an endovascular stent-graft. A stent-graft is a polyester fabric tube (graft) sewn onto metal springs (stent). The stent-graft is compressed inside a narrow plastic tube called a delivery system, which is inserted into the blood vessels in the groin area (femoral/iliac artery) and then threaded through the blood vessels to be placed at the area of the dissection inside the aorta.This research study will assess and evaluate safety and performance of an endovascular stent graft called the RelayPro Thoracic Stent-Graft System (the “Study Device”). The Study Device is investigational, which means it is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.We expect that participants will be in this research study for approximately 5 years after their endovascular repair procedure. Participants will return to clinic at 1-month, 6-months, and 1-year, and then annually out to 5 years. These visits are considered part of standard care, and the results of test done at these visits will be recorded for the study.We expect up to 5 people here will be in this research study out of 80 people in the entire study nationally.
    Inclusion Criteria:

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

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

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

    *Main Exclusion Criteria*
    Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
    Severe regurgitation (>3+) or stenosis of any other valve.
    Failing valve is unstable, rocking, or not structurally intact.
    Malaisrie, S ChrisMalaisrie, S Chris
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03003299 STU00204739
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    Long-Term Nicotine Treatment of Mild Cognitive Impairment
    The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been …
    The purpose of the study is to see if daily transdermal nicotine is able to produce a significant cognitive, clinical and functional improvement in participants with Mild Cognitive Impairment (MCI). Neuronal nicotinic receptors have long been known to play a critical role in memory function in preclinical studies, with nicotine improving attention, learning, and memory function. The study will enroll participants for a 2 year period. Participants will be randomized (50:50) to either the transdermal nicotine, beginning at 7mg/day, and increasing to 21mg/day, or placebo skin patch.

    Inclusion Criteria:

    • 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 676 N. St. Clair St. Suite 945
      Chicago, IL
    NCT02720445 STU00204222
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    A Randomized Trial of Pessary in Singleton Pregnancies with a Short Cervix (TOPS)
    Eligible and consented women who are pregnant with one baby and have a short cervix when measured during an ultrasound performed between 16 week - 23 weeks are assigned to pessary placement or standard of care (no pes…
    Eligible and consented women who are pregnant with one baby and have a short cervix when measured during an ultrasound performed between 16 week - 23 weeks are assigned to pessary placement or standard of care (no pessary).
    cervical length less than or equal to 20 mm when measured between 16 weeks -23 weeks of singleton pregnancy
    Grobman, William AGrobman, William A
    • Map it 675 N. St. Clair St.
      Chicago, IL
    • Map it 633 N. St. Clair St
      Chicago, IL
    NCT02901626 STU00204650
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    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, F…
    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
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    Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
    The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
    The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
    Inclusion Criteria:
    Severe aortic stenosis
    Patient is asymptomatic
    The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

    Exclusion Criteria:
    Patient is symptomatic.
    Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
    Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
    Aortic valve is a unicuspid, bicuspid, or is non-calcified.
    Severe aortic regurgitation (>3+).
    Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
    Davidson, Charles JDavidson, Charles J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03042104 STU00204517
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    Physical activity and DNA methylation among women with high breast density
    The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy p…
    The purpose of this study is to learn more about how physical activity may influence your genes through a mechanism called DNA methylation. Our goal is to determine if being physically active may be associated with a healthy pattern of DNA methylation in your immune system cells. Exercising and being physically active are believed to be important for preventing cancer. It may be particularly important for women with high breast density, and may help reduce risk for breast cancer. However, we do not understand what physical activity changes within the body to alter risk of breast cancer. DNA methylation is a biological process that may help explain the relationship between physical activity and cancer risk.
    Generally healthy women with a history of heterogeneously or extremely dense breasts, aged 40-74 with no history of cancer (other than non-melanoma skin cancer), diabetes, and cardiovascular disease.
    Hibler, Elizabeth AHibler, Elizabeth A
    • Map it 680 N. Lake Shore Drive Suite 1410
      Chicago, IL
    STU00204639
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    Melanoma and Skin Cancer Tissue Repository

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

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

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

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204151
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    A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness
    This is a study ( http://enlightenstudy.com/ ) to evaluate the effect of the investigational drug compared to Ol…
    This is a study ( http://enlightenstudy.com/ ) to evaluate the effect of the investigational drug compared to Olanzapine on body Weight in young adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder who are Early in their Illness. Participation will last up to 20 weeks. Before starting the study, each participant will be evaluated to determine his or her eligibility to participate. Each participant who qualifies will receive study-related tests, investigational medication and study-related care at no cost. Qualifying participants may be compensated for time and travel. If eligible, they will start the 12 week program where they are randomly assigned (like flipping a coin) to take one of two treatments. No one will know which type of treatment they are taking. During the 12 weeks, qualified participants will return for clinic visits where they will meet with the study doctor or staff and complete the following procedures: Interviews about symptoms, medical and psychiatric history, and general quality of life.Answer questions about the treatments they receive and how they are doing Measure their weight, blood pressure,

    Ages Eligible for Study: 18 Years to 40 Years
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No
    Criteria
    Inclusion Criteria:
    Has less than 10 weeks previous treatment with antipsychotics (cumulative; lifetime)
    Has less than 4 years elapse since the initial onset of active-phase of symptoms
    Have a body mass index (BMI) of 18.0 to
    Rado, Jeffrey ThomasRado, Jeffrey Thomas
    • Map it 680 N. Lake Shore Dr.
      Chicago, IL
    NCT03187769 STU00205116
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    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies…
    Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease
    Hanauer, Stephen BHanauer, Stephen B
    NCT02914561 STU00205056
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    Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial
    The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethas…
    The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

    Inclusion criteria:

    Patient level inclusion criterion

  • 18 years of age or older;

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

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

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

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

    Patient level exclusion criteria

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

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

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

    The study is being done to see if the study drug gabapentin decreases postoperative pain, and if it improves the quality of recovery in su…

    The study is being done to see if the study drug gabapentin decreases postoperative pain, and if it improves the quality of recovery in subjects undergoing this scheduled procedure.

    You have a condition called nephrolithiasis (obstructive kidney stones) and you are planning to undergo a urologic surgical procedure (ureteroscopy or cystoscopy with stent placement).

    Tureanu, Luminita MTureanu, Luminita M
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03151746 STU00205047
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    Pharmacokinetics of Risperidone and Similarly Metabolized Second Generation Antipsychotics Across Pregnancy
    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as aripiprazole, lurasidone, quetiapine, and r…
    We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as aripiprazole, lurasidone, quetiapine, and risperidone. Changes in the metabolism of these medications have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust mood-stabilizing medications in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

    Participation Involves:

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

    To qualify for this study you must be:

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

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

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

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

    You may be eligible for this research study if you have advanced breast cancerthat is triple negative and you have been found to have more than 5 circulating cancer cellsdetected by the FDA-approved test, CellSearch™, in one tube of blood.
    Cristofanilli, MassimoCristofanilli, Massimo
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03213041 STU00205013
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    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 eva…
    This is a multicenter, Phase II study to evaluate the effect of IV administration of RO7046015 in participants with early stage Parkinson's Disease (PD). Participants will be eligible if they have PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD and are either untreated or treated with Azilect or Selegiline. The study will consist of two parts: a 52-week, treatment period of the study medication vs placebo (Part 1) after which eligible participants will continue into an all-participants-on-treatment (RO7046015) blinded to dose extension for an additional 52 weeks (Part 2).
    *Men and women, aged 40 to 80 years inclusive, early PD , who were recently (< 2 years) diagnosed, and either untreated or treated with Azilect or Selegiline
    Simuni, TatyanaSimuni, Tatyana
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03100149 STU00205125
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    D-Cycloserine for the Treatment of Chronic, Refractory Low Back Pain
    The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain. This study will last for 26 weeks and will require approx…
    The purpose of this study is to evaluate the efficacy and safety of D-cycloserine versus placebo in relieving the signs and symptoms of patients with chronic lower back pain. This study will last for 26 weeks and will require approximately 6 visits to the study clinic. There will be two groups in this study. You will have an equal chance of being in either group. One group will receive D-cycloserine in capsule form and one group will receive placebo in capsule form. All participants have to take two capsules every day, one in the morning and one in the evening. There will be a 1 in 2 chance of receiving placebo.
    Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
    Male or female, age 18 years or older
    Must be in generally stable health
    Must have a smartphone that will allow downloading of the pain app
    Must be willing to abstain from drinking alcohol during the course of the study.
    If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue during the course of the study.
    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03535688 STU00205398
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    Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
    This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
    Inclusion Criteria
    • Type 1 and 2 Diabetes by ADA criteria (see appendix )
    • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
    • Able to provide informed consent
    • Adult participants (no age restriction)
    • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
    Exclusion Criteria
    • ESRD, defined as chronic dialysis or kidney transplant
    • History of receiving dialysis for more than 30 days
    • Institutionalized
    • Solid organ or bone marrow transplant recipient at time of first kidney biopsy
    • Less than 3-year life expectancy
    • Known alcohol or substance abuse
    • Unable to provide informed consent
    • No evidence of active cancer other than non-melanoma skin cancer
    Isakova, TamaraIsakova, Tamara
    • Map it 633 N. St. Clair St.
      Chicago , IL
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02986984 STU00204808
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    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 Y9…
    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
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    Genetic causes and pathogenic mechanisms of adult epilepsies
    The purpose of this study is to look at genetic markers of epilepsy in patients and their families using blood, saliva, skin, and brain tissue analysis.
    Gerard, Elizabeth ErwayGerard, Elizabeth Erway
    STU00205877
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    DRUG CA209-914: A Phase 3 Randomized Double Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

    The purpose of this stu…

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

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

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

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

    Sosman, Jeffrey AlanSosman, Jeffrey Alan
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03138512 STU00205491
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    Alterations of Sleep and Circadian Timing in Aging
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have…
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.
    Eligibility Criteria:Men and women age 55-75 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
    Zee, Phyllis CZee, Phyllis C
    NCT03490825 STU00206014
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    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
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    NIH All of Us Research Program Precision Medicine Initiative® Precision Medicine Initiative Cohort Program Healthcare Provider Organization Enrollment Centers
    Research Program in Illinois. The mission of this ambitious National Institutes of Health (NIH) initiative is to speed up health research an…
    Research Program in Illinois. The mission of this ambitious National Institutes of Health (NIH) initiative is to speed up health research and medical breakthroughs. To do this, the All of Us Research Program is asking one million people to lead the way to provide the types of information that can help us create individualized prevention, treatment, and care for all of us. Visit nm.org/joinallofus to learn more and enroll.

    WHATARE THE BENEFITS OF JOINING?

    · · ·

    WHATWOULD I NEED TO DO?

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

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

    - 18 years of age or older- Currently live in the United States
    Greenland, PhilipGreenland, Philip
    • Map it 201 E. Huron St.
      Chicago, IL
    STU00204480
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    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
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    (xIRB) A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non infectious Uveitis
    The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfecti…
    The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.

    Criteria

    Key Inclusion Criteria:

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

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

    Key Exclusion Criteria:

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

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

    Koreishi, Anjum FarukKoreishi, Anjum Faruk
    • Map it Lavin Pavillion 259 E. Erie St., Suite 15-20
      Chicago, IL
    NCT03207815 STU00205424
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    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 f…
    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
    STU00205857
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    Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasia

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

    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
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    Strengthening Circadian Signals to Enhance Cardiometabolic Functions
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circ…
    Purpose: The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.
    Eligibility Criteria:Men and women age 40-54 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
    Zee, Phyllis CZee, Phyllis C
    • Map it 675 N. St. Clair St. Suite 20-100
      Chicago, IL
    NCT03490864 STU00206038
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    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 moderate-to-severe symptomatic mitral regurgitation to test a new investigational…
    This study is enrolling subjects with moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart.
    Enrolling participants with mitral valve regurgitation that 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 determined condition 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
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    Microburst VNS Therapy Feasibility Study in Subjects with Refractory Epilepsy
    The purpose of this study is for patients with first-time implants of a Vagus Nerve Stimulator (VNS) to have the new Microburst stimulation settings optimized using fMRI scans.
    Macken, Micheal PMacken, Micheal P
    NCT01281293 STU00206259
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    A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
    (ACTIVE, NOT RECRUITING) C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in th…
    (ACTIVE, NOT RECRUITING) C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
    Inclusion Criteria:
    1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, within 12 weeks prior to screening or during screening:
    2. Male or female subjects, aged at least 18 years
    3. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion;
    4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
    5. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments.
    Exclusion Criteria:
    1. Pregnant or nursing;
    2. Secondary C3 disease
    3. History or presence of any form of cancer within the 5 years prior to screening,
    4. Currently on dialysis or will require dialysis wtihin 7 days of screening
    5. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
    6. Evidence of tuberculosis
    7. Evidence of liver disease
    Ghossein, CybeleGhossein, Cybele
    NCT03301467 STU00206182
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    cIRB: AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic Stroke
    ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of u…
    ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
    Inclusion Criteria:

    • 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
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    (xIRB) DRUG 201973: A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer
    The purpose of this study is to evaluate the safety of the investiga…
    The purpose of this study is to evaluate the safety of the investigational drug, GSK525762, and how well it works when taken with fulvestrant, a drug that is a standard treatment for estrogen receptor positive breast cancer. Researchers will test 2 dose levels of GSK525762 and fulvestrant. There will be 2 groups of subjects at each dose level. If dose level 1 is shown to be tolerated without serious side effects, a small number of consenting participants will be enrolled and start a second, higher dose level (dose level 2) of GSK252762. If DL1 is not safe, a lower dose will be given. If the small number of subjects completes DL2 and it is shown to be safe, additional subjects will be randomly assigned to receive either DL1 or DL2.
    • Diagnosis of advanced or metastatic estrogen receptor-positive breast cancer (ER+BC) that hasn’t responded to previous endocrine treatment.
    • Age of at least 18 years
    Gradishar, William JGradishar, William J
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT02964507 STU00206335
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    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 trai…
    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
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    Environmental Influences on Child Health Outcomes (ECHO) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies
    Understanding the effects of environmental exposures on child health and development is a priority for the National Institutes of Healt…
    Understanding the effects of environmental exposures on child health and development is a priority for the National Institutes of Health. To advance knowledge in this area, NIH has launched a new seven-year initiative called the Environmental influences on Child Health Outcomes (ECHO) program. ECHO will support multiple, synergistic, longitudinal studies using existing study populations, called cohorts, to investigate environmental exposures — including physical, chemical, biological, social, behavioral, natural and built environments — on child health and development. The studies will focus on four key pediatric outcomes that have a high public health impact: Upper and Lower Airway, Obesity, Pre-, peri-, and Postnatal Outcomes, Neurodevelopment. (Source: https://www.nih.gov/echo)
    By invitation only. Women who previously participated in the NICHD Fetal Growth Study are being invited to participate.
    Grobman, William AGrobman, William A
    • Map it 633 N. St. Clair St
      Chicago, IL
    STU00206857
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    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 pre…

    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
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    Synthetic Lipoprotein Nanoparticles as Biosensors for Rapid Ex Vivo Assessment of Lecithin: Cholesterol Acyltransferase Activity
    The purpose of this study is to utilize a new technology developed in the Thaxton Laboratory to measure molecular changes that occur in a person’s blood as a result of ex…
    The purpose of this study is to utilize a new technology developed in the Thaxton Laboratory to measure molecular changes that occur in a person’s blood as a result of exercise. Research shows that high-density lipoproteins (HDL), particles made up of multiple proteins that transport fat molecules around the body, are broken down during exercise. Comparing the levels of HDLs before and after exercise may provide a way for individuals to monitor their individual response to exercise. Furthermore, the levels may change based upon the time exercised, the intensity of exercise and the type of exercise. We will utilize blood samples taken from individuals before and after exercise in order to test a device that examines differences between HDL levels before and after exercise.
    Healthy, non-pregnant adults ages 18-75 years.
    Thaxton, Colby SThaxton, Colby S
    STU00206658
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    A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2

    Brief Summary:

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

    Brief Summary:

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

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

    Criteria

    Key Inclusion Criteria:

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

    Key Exclusion Criteria:

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

    Fawzi, Amani AFawzi, Amani A
    • Map it 259 E. Erie St. Suite 1520
      Chicago, IL
    NCT03319849 STU00206919
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    (xIRB) The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States

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

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

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

    18 years of age or older

    Diagnosis of asthma for at least 12 months

    Frequent, current symptoms of asthma

    Taking a daily asthma medication

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

    Kalhan, RaviKalhan, Ravi
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03373045 STU00206953
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    Clinical Trial Readiness for SCA1 and SCA3
    Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain…
    Subjects must be 18-65 years of age with symptoms of ataxia or a diagnosis of SCA1 or SCA3 or have an affected family member. Subjects with a previous diagnosis of early stage SCA1 or SCA 3 may also be eligible. Subject must be able to undergo a MRI (brain scan) and not weigh over 300 lbs.
    Subjects aged 18 to 65 with presence of symptomatic ataxic disease or asymptomatic mutation carrier or subjects with definite molecular diagnosis of SCA1 or SCA3 or another affected family member or Subjects of age >18 with previous diagnosis of early stage SCA1 and SCA3. Subjects must not make changes in physical/occupational therapy status within two months prior to enrollment. Subjects must not weigh over 300 lbs.
    5) 6) No changes in sical/occupational therapy status within two months prior to enrolment
    Opal, PuneetOpal, Puneet
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03487367 STU00206988
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    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 compre…
    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
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    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 …
    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
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    Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol
    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover…
    The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating two tubes of blood for the collection of genetic information (DNA) at one study visit.
    - Giant Cell Arteritis
    - Takayasu’s Arteritis
    - Polyarteritis Nodosa
    - Granulomatosis with Polyangiitis (Wegener’s)
    - Microscopic Polyangiitis
    - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 633 N. St. Clair St.
      Chicago , IL
    STU00206908
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    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)

    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
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    xIRB A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men with Osteoporosis
    A 12 month study to see if abaloparatide (an investigational medication) is safe and effective in treating osteoporosis in …
    A 12 month study to see if abaloparatide (an investigational medication) is safe and effective in treating osteoporosis in men.
    Men 40-85 years old

    Schnitzer, Thomas JSchnitzer, Thomas J
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    NCT03512262 STU00207208
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    The Gut and Skin Microbiome in Vitiligo Disease Progression

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

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

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

    Why is this study being done?

    Many people hear a ringing or buzzing in their ears, called tinnitus. This study uses brain scans (MRI) to understand how painless electrical currents applied to the head, a method c…

    Why is this study being done?

    Many people hear a ringing or buzzing in their ears, called tinnitus. This study uses brain scans (MRI) to understand how painless electrical currents applied to the head, a method called "transcranial electrical stimulation," might change the way the brain works to relieve tinnitus.​​What's involved in this study?

    This study involves one 5-hour visit to Northwestern's Chicago Streeterville campus. You may also have 5 more visits, which will take one hour (or less). Whether you have 1 or 6 visits will depend on your availability, staff availability, and other factors like our funding.

    During the first visit, you'll answer questionnaires about your health history, take a brief hearing test, and have an MRI. During the MRI, you will have active and inactive tES.

    If you have 5 more visits, you'll have tES applied to your head for 20 minutes during the first visit and on the next 4 consecutive days. You may have active tES during all 5 visits, or inactive "sham" tES during all 5 visits. At the last visit, you'll have a short MRI. Two weeks later, we'll tell you whether you had active or inactive tES. If you had inactive tES, you can come back in for five sessions of active tES, if you'd like.

    In past studies, about half of people noticed that tinnitus was less intrusive right after tES, but these effects did not seem to last long term. Your tinnitus symptoms may or may not decrease during this study. *Note that we are unable to compensate volunteers for travel expenses, and we are not encouraging volunteers outside the Chicago area to participate in this study.​

    Who can participate in this study?

    If you have had tinnitus for 1 year or longer, and have spoken with a physician or audiologist about your symptoms, you may be eligible to volunteer for our study. Other criteria include:

    • 18-75 years old
    • Able to have an MRI scan
    • No history of other major health issues (cancer, substance abuse, head injury, neurological, neuropsychiatric, or severe mood disorder)
    • Available to attend 1 study visit at the Northwestern University Chicago Campus

    What does tES feel like?

    People describe tES as a light tingling or itching on their skin that is not painful. For most people, this feeling decreases or goes away after ~30 seconds, and some don’t feel tES at all. Remember that we can stop tES right away if you decide to stop for any reason. tES uses sponges covered in gel to prevent irritation, which can be removed with water.

    I'd like to volunteer for this study. What's next?

    If you're interested in volunteering for this study, please contact the study team via email or phone to schedule prescreening. During prescreening, we will review questions about your health history over phone or secure website to determine whether you’re eligible for this study. We will also talk more about the study, and answer your questions.

    Contact us

    inmri at northwestern dot edu

    (312) 694 2966

    • 18-75 years old
    • Able to have an MRI scan
    • No history of other major health issues (cancer, substance abuse, head injury, neurological, neuropsychiatric, or severe mood disorder)
    • Available to attend 1 study visit at the Northwestern University Chicago Campus
    Leaver, Amber MichelleLeaver, Amber Michelle
    • Map it 710 N. Fairbanks Ct. Olson Paivlion
      Chicago, IL
    NCT03544359 STU00207056
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    A Phase 3, Randomized, Rater-Blinded, Multi-Center Study to Evaluate the Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Patients with Wilson Disease Aged 12 Years and Older with an Extension Period of Up to 60 Months
    The primary objective of this study is to eval…
    The primary objective of this study is to evaluate the efficacy of the drug WTX101 administered for 48 weeks, compared to standard of care (SoC), on copper (Cu) control in subjects with Wilson's disease aged 18 and older.
    Diagnosis of Wilson's Disease, Treatment for >28 days with chelation therapy, Zn therapy or a combination of chelator and Zn; willing to avoid the use of vitamins and/or minerals containing CU, Zn or Mo throughout the study, willing to undergo > 48-hour washout from current WD treatment
    Bega, DannyBega, Danny
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT03403205 STU00206921
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    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,…

    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
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    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
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    The Impact of Pediatric Skin Disorders: The “Big” Study

    The purpose of this study is to understand the possible burden of skin disorders in school-age children, such as its impact on the development of anxiety, depression and relationships with friends. The study will look at the relationship …

    The purpose of this study is to understand the possible burden of skin disorders in school-age children, such as its impact on the development of anxiety, depression and relationships with friends. The study will look at the relationship between the burden and how severe or visible the skin problem is.​ Surveys can be done remotely.

    Paller, AmyPaller, Amy
    • Map it 225 E. Chicago Ave.
      Chicago, IL
    STU00207281
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    Palbociclib after CDK and Endocrine Therapy (PACE): A Randomized Phase II study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

    This research study is studying three combinations of drugs as treatments for this type of cancer:

    • Ar…

    This research study is studying three combinations of drugs as treatments for this type of cancer:

    • Arm A: fulvestrant
    • Arm B: fulvestrant with palbociclib
    • Arm C: fulvestrant with palbociclib and avelumab

    This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied and the researchers are trying to find out more about it— for example, the side effects it may cause, and the activity of a drug, or combination of drugs, against a cancer.

    In this research study, we are evaluating the activity of fulvestrant alone, fulvestrant and palbociclib, or fulvestrant, palbociclib, and avelumab in participants with metastatic hormone receptor positive breast cancer that has previously stopped responding to prior palbociclib therapy, or another medication in the class of therapy called CDK 4/6 inhibitors.

    You may be eligible for this research study if you have breast cancer that has spread to other parts of your body (metastatic cancer) and your cancer is hormone receptor positive. This study is designed for patients who have previously had exposure to the medication palbociclib, or another medication in the class of therapy called CDK 4/6 inhibitors.

    Shah, Ami NShah, Ami N
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03147287 STU00207256
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    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, multicen…
    (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
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    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…

    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
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    Functional MRI Study of Transcranial Electrical Stimulation in Healthy Adults

    Why is this study being done?This study uses brain scans (MRI) to understand how painless electrical currents applied to the head using a method called "transcranial electrical stimulation" (tES) might change the way the…

    Why is this study being done?This study uses brain scans (MRI) to understand how painless electrical currents applied to the head using a method called "transcranial electrical stimulation" (tES) might change the way the brain works. We hope to use this information to improve tES so that it can be used to treat symptoms of brain conditions like depression, chronic pain, stroke, and others.​

    What's involved in this study?This study involves one 3-hour visit to Northwestern's Chicago campus. During this visit, you'll receive tES for ~10 minutes while changes in brain function are measured with functional MRI. You'll also fill out questionnaires about your health history. You may also choose to have an optional hearing test, which will last approximately 1 hour, for a total time commitment of four hours.

    Who can volunteer for this study?Eligible volunteers will be 18-65 years old, able to have an MRI scan, and have no history of developmental, neurological, or psychiatric disorders.

    What does tES feel like?People describe tES as a light tingling or itching on their skin that is not painful. For most people, this tingling feeling decreases or goes away after ~30 seconds, and some don't feel tES at all. Remember that we can stop tES right away if you decide to stop for any reason.

    I'd like to volunteer for this study. What's next?If you're interested in volunteering for this study, please contact the study team via email or phone for more information and to schedule prescreening. During prescreening, we will review questions about your health history over phone or secure website to determine whether you’re eligible for this study. We will also talk more about the study, and answer your questions.

    Contact us

    inmri at northwestern dot edu

    (312) 694 2966

    Eligible volunteers will be 18-65 years old, able to have an MRI scan, and have no history of developmental, neurological, or psychiatric disorders.
    Leaver, Amber MichelleLeaver, Amber Michelle
    • Map it 710 N. Fairbanks Ct. Olson Paivlion
      Chicago, IL
    STU00206920
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    Isolation of peripheral blood mononuclear cells to develop novel therapeutics for cancer and autoimmune diseases
    The purpose of this study is to collect blood samples to help find new ways to treat diseases. Our lab develops small particles that have the potential to be useful for the delivery of t…
    The purpose of this study is to collect blood samples to help find new ways to treat diseases. Our lab develops small particles that have the potential to be useful for the delivery of therapeutic agents like anticancer drugs to cells or to remove biotoxins from the human body. We would like to test in the laboratory if these particles have any harmful effects on human blood cells. You will not come in contact with these particles, and all experiments will be performed on the blood sample only. You will be asked to provide a blood sample. About 10mls or approximately 2 tablespoons will be drawn.
    Healthy, non-pregnant, adult (age 18-75 years) participants

    Thaxton, Colby SThaxton, Colby S
    STU00207342
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    A Phase Ib/ II Study of Sorafenib and Pembrolizumab in Advanced Hepatocellular Cancer (HCC)

    The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause n…

    The standard therapy for advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery is sorafenib (Nexavar®). Sorafenib works by interfering with signaling pathways in the body that cause normal and cancerous cells to grow and multiply. While sorafenib is an effective drug for treating HCC, there is evidence suggesting that combining sorafenib therapy with pembrolizumab may be more effective than sorafenib by itself.

    Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat HCC. Pembrolizumab works by helping the immune system to fight cancer. However, pembrolizumab can also cause the immune system to attack normal organs and tissues in the body and can affect the way they work, which can result in side effects that may become serious or life-threatening, and in some cases, may lead to death.

    The purpose of this study is to test the safety of giving pembrolizumab in combination with sorafenib, and to look at the effect that this combination has on HCC and how it responds to this treatment.

    You may be eligible for this research study if you have hepatocellular carcinoma (HCC), which is the most common type of liver cancer and usually occurs with chronic liver disease.

    Mahalingam, DevalingamMahalingam, Devalingam
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT03211416 STU00207399
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    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 …
    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
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    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 t…
    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
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    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 continuin…

    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
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    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 re…
  • 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)

    Fantus, SarahFantus, Sarah
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00207506
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    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 w…

    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
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    DARPeggio: An observational study to explore the vibrations and sounds of the body

    The application is for a pilot study to observe how various non-invasive, wearable sensor data

    behave in healthy subjects. As one’s body is in motion, vibrations and sounds are generated by

    the joints.…

    The application is for a pilot study to observe how various non-invasive, wearable sensor data

    behave in healthy subjects. As one’s body is in motion, vibrations and sounds are generated by

    the joints. As the heart beats inside the body, a number of physical phenomena can be "picked

    up" at the surface of the body, including the sounds of the heart, the vibrations of the chest wall

    as the heart moves, the motion of the body's center of mass as the heart displaces blood, and

    the electrical potential generated by the heart (the latter is known as the ECG/EKG or

    electrocardiogram). While many of these data have been recorded and studied in detail and

    separately, the goal of this study is to record from multiple sensors and combine the data in a

    meaningful way. This is a completely observational study—the number and types of noninvasive

    sensors used may change throughout as data are collected and analyzed. Subjects

    will be observed while wearing a number of sensors and/or commercial "gold standard"

    equipment such as ECGs. The data from these sensors/devices will be recorded and analyzed

    for correlations to known physiologic phenomena.

    We are looking for healthy volunteers, any adult age 18 years or older with no significant medical

    history and no history of osteoarthritis or knee pain.

    Etemadi, MozziyarEtemadi, Mozziyar
    • Map it 710 N. Lake Shore Dr. Abbott Hall
      Chicago, IL
    STU00207549
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    Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination with R-CHOP in a Cohort of Patients with DLBCL/tFL/ high grade B-NHL

    The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffu…

    The purpose of this research study is to evaluate a new drug, nivolumab, given in combination with standard chemotherapy, for the treatment of diffuse large B-cell lymphoma (DLBCL).

    The standard chemotherapy regimen for DLBCL and many other aggressive B-cell non-Hodgkin lymphomas is called “R-CHOP” and includes the drugs: Rituximab (R), Cyclophosphamide (C), Doxorubicin (H), Vincristine (O) and Prednisone (P). The new drug, nivolumab, works by targeting the immune system and increasing the effect of immune cells against the cancer cells.

    The purpose of the study is to determine if the combination of nivolumab with R-CHOP is safe and will not cause significant or dangerous side effects. We also want to see how well the combination works in controlling the cancer growth, and whether or not it improves symptoms and quality of life in those who participate in the study.

    Nivolumab is investigational, which means that it has not been approved by the FDA for the treatment of this kind of cancer. However, it has been studied and approved by the FDA for other types of cancer.

      You may be eligible for this research study if you have been diagnosed with aggressive diffuse large B-cell lymphoma (DLBCL) or another form of aggressive B-cell non-Hodgkin lymphoma, and you have not been treated for this type of cancer.

      Karmali, ReemKarmali, Reem
      • Map it 201 East Huron Street Suite 12-160​
        Chicago, IL
      NCT03704714 STU00207793
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      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 …
      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
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      (xIRB NCI CIRB) ALLIANCE A041501: A PHASE III TRIAL TO EVALUATE THE EFFICACY OF THE ADDITION OF INOTUZUMAB OZOGAMICIN (A CONJUGATED ANTI-CD22 MONOCLONAL ANTIBODY) TO FRONTLINE THERAPY IN YOUNG ADULTS (AGES 18-39 YEARS) WITH NEWLY DIAGNOSED PRECURSOR B-CELL ALL
      The first purpose of this study is to te…
      The first purpose of this study is to test the safety of adding a new drug called inotuzumab to the usual chemotherapy drugs. The second purpose of this study is to compare any good and bad effects of using inotuzumab along with the usual chemotherapy treatment to using the usual treatment alone. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Inotuzumab is investigational and is not FDA-approved.
      You may be able to take part in this study if you have acute lymphoblastic leukemia (ALL) and are 18 to 39 years old.
      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03150693 STU00208162
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      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
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      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). S…
      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
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      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 ser…
      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
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      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. Partic…

      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.

      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
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      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. Fo…
      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
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      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 an…
      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
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      (xIRB) DRUG 017004: An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
      JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that …
      JCAR017 is an investigational treatment. Investigational means that it is an experimental therapy that has not yet been approved for sale or use to the public by the United States Food and Drug Administration (FDA). This study is designed to test the safety and effectiveness of a new approach to treating Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. This study has many parts and you will be asked to participate in one portion of the study. The Phase 1 portion of the study will evaluate whether the treatment works in treating your cancer. In the Phase 1 portion, you may be required to be on another cancer treatment called ibrutinib (IMBRUVICA®). Your study doctor will tell you which group you are eligible to be treated on. The Phase 2 is designed to assess JCAR017 as treatment versus standard of care. The approach involves modifying the patient's own immune cells, called T cells, to enable them to kill their cancer cells. T cells fight infections and can also kill cancer cells in some cases. In most cases, a patient's T cells are not able to kill their own cancer cells. In this study, some of the patient's T cells are removed from their blood, modified in a laboratory, and then given back to them by intravenous (IV) injection. While in the laboratory, researchers will put a new gene into the T cells that allows the patient's T cells to then recognize and kill the lymphoma cells. The method of putting the gene into the T cells uses a weakened virus that cannot multiply or spread. T cells that have genes added in the laboratory are called “genetically modified T cells” or “chimeric antigen receptor T cells (CAR T cells)”. When the genetically modified T cells recognize and attach to cancer cells, they have the ability to become activated and kill them. The modified T cells do not appear to recognize other normal cells in the body, with the exception of normal B cells. However, studies have shown that normal B cells will return after being treated with the modified T cells.
      • Participants must have any of the following types of lymphoma: Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
      • You must have received 2 or 3 prior treatments for your CLL or SLL
      • Participants must have cancer that has returned or has not responded to other treatment.
      • Participants must be 18 or older
      Ma, ShuoMa, Shuo
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT03331198 STU00208648
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      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 stan…
      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
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      A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy At Risk Of Progressing to End-Stage Renal Disease (NefIgArd)

      The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate …

      The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate the efficacy, safety, and tolerabilityof Nefecon 16 mg per day in the treatment of patients with primaryImmunoglobulin A nephropathy at risk of progressing to end-stage renal diseasedespite maximum tolerated treatment with renin-angiotensin system blockadeusing angiotensin converting enzyme inhibitors or angiotensin II type Ireceptor blockers. The study will consist of 2 parts. Part A will includea 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B willconsist of an observational Long-term Follow up Period in which the patientswill be followed until 100 clinical events, measured as reduction in eGFRcompared to baseline.

      Inclusion Criteria:

    • Female or male patients ≥18 years
    • Biopsy-verified IgA nephropathy
    • Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
    • Urine protein creatinine ratio ≥1 g/24hr
    • eGFR ≥45 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
    • Willing and able to give informed consent
    • Exclusion Criteria:

    • Systemic diseases that may cause mesangial IgA deposition.
    • Patients who have undergone a kidney transplant.
    • Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
    • Patients with liver cirrhosis, as assessed by the Investigator.
    • Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
    • Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
    • Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
    • Patients with diagnosed malignancy within the past 5 years.
    • Wadhwani, ShikhaWadhwani, Shikha
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03643965 STU00207093
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      xIRB A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis

      This study is being done to learn more about the safety ofan experimental drug called ATYR1923 to see if taking this medication willallow people who have…

      This study is being done to learn more about the safety ofan experimental drug called ATYR1923 to see if taking this medication willallow people who have pulmonary sarcoidosis to reduce their steroid dose, andto find out more about the effects of different doses of this drug on the lungsof people who have pulmonary sarcoidosis. This study will also look at how thebody responds to the drug. These things will be measured by taking samples ofblood, performing medical examinations, conducting lung function tests andreviewing images of the lungs.

      In this study, people with pulmonary sarcoidosis willreceive monthly doses of ATYR1923 or Placebo for a total of 6 doses.Participation will last up to 28 weeks. The screening period to see if youqualify for the study may last up to 4 weeks and may require up to 3 visits atthe study site clinic. Participants who enter the study will receive study drugonce a month for 20 weeks. The study drug will be administered by infusion andeach visit will take approximately 6 hours. There are a total of 7 study clinicvisits and 8 telephone contacts during the treatment period. Finally, there will be a follow-up studyvisit 4 weeks after receiving the last dose of study drug.

      To qualify for the study you must be:

      1. Diagnosed with pulmonary sarcoidosis for at least 1year

      2. Taking 10 to 25 mg/day of oral prednisone (or oralequivalent), at the same dose for at least 4 weeks before receivingstudy drug.

      You will not qualify for the study if you have:

      1. Cardiac, neurological, gastrointestinal, and/or renalmanifestations of sarcoidosis

      2. Received treatment with biological medications (such asinfliximab (REMICADE) or adalimumab (HUMIRA) in the last 6 months

      3. Smoked or inhaled (including e-cigarettes ore-vaporizers) any nicotine containing product within 6 months prior toScreening visit.

      4. History of or positive results of hepatitis B, hepatitisC, or HIV

      5. Jo-1 Antibody levels >7 U/mL, or past history of Jo-1antibody positivity.

      Sporn, Peter HSporn, Peter H
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03824392 STU00208847
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      (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 an…
      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
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      Augmentation versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders with Treatment Resistant Depression (ASCERTAIN-TRD)
      We are asking you to take part in this research study because you have major depressive disorder and you have tried an antidepressa…
      We are asking you to take part in this research study because you have major depressive disorder and you have tried an antidepressant in the past that has not helped your depression. Also, you have not had a satisfactory response from your current antidepressant medication.

      We expect that you will be in this research study for up to 12 weeks and we will ask you to make 7 study visits to Northwestern University.

      1. women and men ages 18-80,with major depressive disorder

      2. You have tried an antidepressant but less than 50% of the symptoms have resolved

      Dokucu, Mehmet EDokucu, Mehmet E
      • Map it 680 N. Lake Shore Dr.
        Chicago, IL
      NCT02977299 STU00207732
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      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 do…

      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
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      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…
      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
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      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 an…
      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
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      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 damag…
      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
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      xIRB A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
      Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The length of …
      Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The length of study participation is about one year.
      Subjects must meet criteria for dermatomyositis and have active disease based on physician assessment.  Subjects can be on immunosuppressant medications for DM while in the study, but must be on a stable dose for 8 weeks at the screening visit.  If subject is on corticosteroids (≤ 20 mg), they must be on a stable dose at least 4 weeks at the time of study enrollment.  Subjects cannot have unstable dermatomyositis or end stage organ involvement.
      Hsieh, ChristineHsieh, Christine
      • Map it 633 N. St. Clair St.
        Chicago, IL
      NCT03813160 STU00209094
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      NU 18I03: Pilot study of nivolumab in combination with Therasphere (yttrium-90) for treatment of hepatocellular carcinoma (HCC) with intent for resection
      The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your…
      The purpose of this study is to evaluate the feasibility of using nivolumab in combination with Y90(Therasphere) to decrease the occurrence of your HCC from coming back. Also another purposeis to evaluate the efficacy (the effect on the tumor) of nivolumab, when given with standard ofcare Y-90 (Therasphere) in patients. Another purpose of the study is to see what tumor characteristics are different among patientswho undergo resection versus those who do not undergo resection. 
      Participants who have advancedhepatocellular carcinoma (HCC). 
      Kulik, Laura MKulik, Laura M
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03812562 STU00208542
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      Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors:Fit2ThriveMB

      The Fit2ThriveMB study is designed to study the effectiveness of a 3 month technology-supported physical activity intervention in metastatic breast cancer patients. This program primarily focuse…

      The Fit2ThriveMB study is designed to study the effectiveness of a 3 month technology-supported physical activity intervention in metastatic breast cancer patients. This program primarily focuses on increasing steps and is designed with progressions so that individuals of varying abilities will be able to engage in physical activity safely. All participants in the study will have access to a Fitbit and smartphone app specifically designed for this study, with half of participants obtaining immediate access and half obtaining access at a later time.

      Females 18 years of age or older

      Diagnosis of metastatic breast cancer

      Fluent in spoken and written Englsh

      Own a smartphone and have access to the internet

      Engage in less than 150 minutes of moderate to vigorous physical activity

      Phillips, Siobhan MPhillips, Siobhan M
      STU00208930
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      Hood, Susan
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      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 a…

      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
      NCT03108846 STU00209192
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      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 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
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      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 aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy re…

      This study will test if low-dose oral minoxidil has aneffect on permanent chemotherapy-induced alopecia (defined as hair loss afterthe completion of a chemotherapy regimen that persists for over six months). Inthis study, you will receive the study drug; there is no placebo option. Theeffectiveness 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 permanentchemotherapy-induced alopecia and agree to use contraception for the durationof the study.

      Choi, Jennifer NamChoi, Jennifer Nam
      • Map it 676 N. St. Clair St.
        Chicago, IL
      NCT03831334 STU00206882
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      NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast
      The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. …
      The benefits of anti-estrogen medications taken by mouth as pills (such as tamoxifen) are well-proven to reduce the risk of breast cancer in studies with more than 10 years of follow up. However, because tamoxifen is taken by mouth, it circulates through the whole body and may cause harmful effects to other organs. When tamoxifen is taken by mouth, it is broken down by the liver into two main active forms, one of which is 4-hydroxytamoxifen, also called 4-OHT. Tamoxifen is approved by the Food and Drug Administration (FDA) while 4-OHT is not and is, therefore, considered investigational. However, 4-OHT has anti-cancer activity, and has been developed as a quick drying medicated gel that can be applied to the breast skin. Early results from two previous studies show that 4-OHT gel, when applied to the skin, gets into the breast and blocks breast cancer cell growth as effectively as oral tamoxifen. Unlike oral tamoxifen, the gel is concentrated in the breasts and therefore very little tamoxifen reaches the blood or other parts of the body. Also, some women lack the proteins that are responsible for the break-down of tamoxifen. It is possible that the use of 4-OHT gel will be more effective than oral tamoxifen in these women.
      Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiation
      Khan, Seema AhsanKhan, Seema Ahsan
      • Map it 250 E. Superior St.
        Chicago, IL
      NCT04009044 STU00208708
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      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 f…
      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
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      A Phase II Randomized Study of Adjuvant Versus Neoadjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High Risk Melanoma

      This study is being done to answer the following question: How does treating melanoma with the study drug pembrolizumab, before versus after surgery affect t…

      This study is being done to answer the following question: How does treating melanoma with the study drug pembrolizumab, before versus after surgery affect the disease?

      We are doing this study because we want to find out which approach is better for treating high-risk melanoma. If you decide to take part in this study, you will eitherget treatment with pembrolizumab after your surgery, or you will be treated withpembrolizumab for a few weeks before surgery, then undergo surgery, and getmore pembrolizumab after your surgery.After you finish your study treatment, your doctor willcontinue to follow your condition for up to 10 years after you register to thestudy. Your doctor will watch you forside effects and to see how your cancer affects you. You will have clinic visits periodically fromthe time you stop taking treatment until 10 years after you register to the study.

      We are asking you to take part in this research study because you have melanoma which is ready for removal by surgery.

      Chandra, SunandanaChandra, Sunandana
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03698019 STU00209408
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      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 m…

      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
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      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 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

      VanWagner, Lisa BethVanWagner, Lisa Beth
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03973372 STU00208288
      More Info
      TIPS
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      (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…

      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
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      DRUG U31402-A-J101: Phase 1/2, Multicenter, Open-label, Multiple Dose First-In-Human Study of U3-1402, in Subjects with HER3 Positive Metastatic Breast Cancer
      In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous trea…
      In this study we are looking to see whether U3-1402 has any effect on slowing tumor growth inbreast cancer that progressed after previous treatments. The purpose of the study is tounderstand U3-1402 for its safety, how well it works, and how well it is tolerated.U3-1402 is an investigational drug being developed to be given in breast cancer. Aninvestigational drug is a medication that has not been approved by the United States (US) Foodand Drug Administration (FDA). The FDA allows U3-1402 to be used only in research.U3-1402 is a monoclonal antibody that has chemotherapy attached to it. A monoclonal antibody isa molecule that is made to target a specific cancer cells and may affect normal cells.Chemotherapy is a type of cancer treatment that kills cells that grow and divide quickly. This caninclude cancer cells or normal cells. U3-1402 is designed to bring chemotherapy inside HER3-positive cancer cells and kill them. HER3 is one of a number of proteins that are thought to beelevated in breast cancer. A protein is a large molecule that is important for many of the processesthat happen in and around cells in the body. 
      You may be eligible for this research study if you have breast cancer and your cancer has grown after prior treatments. Along with that your tumor tissue tested should have showed your cancer to be HER3 positive.
      Gradishar, William JGradishar, William J
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT02980341 STU00208625
      More Info
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      (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 photon

      therapy. Photon…

      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
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      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 mut…

      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 251 E. Huron St.
        Chicago, IL
      NCT03851445 STU00209659
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      Modulating stimuli intensity to improve clinical outcomes in aphasia treatment

      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 qualif…

      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
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      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. …

      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
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      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 persiste…
      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
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      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 resulti…
      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
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      (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 d…

      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
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      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 biom…

      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
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      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:

    • Is adding a new anti-cancer …
    • This study is being done to answer the following questions:

    • Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) better, the same as, or worse than the usual treatment alone for untreated older patients with CLL?
    • Can patients who have no detectable CLL after a year of receiving the usual treatment plus the new anti-cancer drug discontinue therapy?
    • We are doing this study because we want to find out if thisapproach is better or worse than the usual approach for your chroniclymphocytic leukemia. The usual approachis defined as care most people get for chronic lymphocytic leukemia.

      • Participants must be 70 years orolder
      • Participants must be diagnosed with Chronic LymphocyticLeukemia (CLL), a type of blood cancer.
      Ma, ShuoMa, Shuo
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT03737981 STU00210099
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      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 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
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      Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial

      This study is being done to determine whether phenol, a liquid chemical, is as effective as a steroid medication when injected on the genicular (knee) ner…

      This study is being done to determine whether phenol, a liquid chemical, is as effective as a steroid medication when injected on the genicular (knee) nerves in patients with chronic knee pain following a total knee replacement (TKR) surgery.

      Patients with chronic knee pain following a total knee replacement (TKR) surgery.

      INCLUSION CRITERIA

      - Ages 40-95 years

      - Patients with knee pain, on average > 4 (NRS) persisting more than 6 months after TKA

      - Willingness to undergo image guided diagnostic nerve block and the study intervention

      EXCLUSION CRITERIA

      - Pain score (NRS) < 4 at time of study enrollment

      - conditions that preclude the diagnostic block or the study intervention (e.g., irreversible coagulopathy or bleeding disorder, allergic reaction/contraindication to local anesthetic, contrast

      dye, steroids, and/or phenol, pregnancy, severe or uncontrolled medical illness).

      - Evidence of indolent infection of the knee prosthesis (elevated C-reactive protein assessed when clinically indicated)

      - Inability to write, speak, or read in English

      - Pregnancy

      Walega, David RWalega, David R
      • Map it 259 E. Erie St.
        Chicago, IL
      NCT03973177 STU00209591
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      DRUG CD07_TNBC: A Phase Ib/II Study of Leronlimab (PRO 140) Combined with Carboplatin in Patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC)
      The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carbopl…
      The purpose of this study to find out if the study drug, leronlimab (PRO 140), when given incombination with another chemotherapy drug, carboplatin, is safe and effective for the treatmentof patients with metastatic Triple Negative Breast Cancer (mTNBC).

      You may be eligible to take part in this research study if you have Triple Negative Breast Cancer that has come back, i.e. spread to other areas of your body (metastatic), after you have previously received chemotherapies at the time when your cancer was first detected.

      Cristofanilli, MassimoCristofanilli, Massimo
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03838367 STU00209594
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      Alliance A041703: A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-negative CD22-positive B-lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease

      Thepurpose of this study is to test the good and bad effects of th…

      Thepurpose of this study is to test the good and bad effects of the combination ofdrugs called inotuzumab ozogamicin and blinatumomab. The study doctors hope tolearn if the combination of study drugs will cause cancer to go away andprevent leukemia from coming back.

      Inotuzumabozogamicin and blinatumomab have already been approved by the FDA to treatrelapsed or refractory ALL as well as other cancers. The combination ofinotuzumab ozogamicin and blinatumomab is considered investigational for thisstudy.

      Participantswith ‘untreated ALL’ or ‘relapsed or refractory ALL’, will get a combination ofdrugs called inotuzumab ozogamicin and blinatumomab. This combination of drugsis known to be effective in patients with relapsed or refractory leukemia, butit is not the usual chemotherapy for patients with ‘untreated ALL.’Participants will also get a drug called methotrexate to prevent cancer cellsfrom entering the central nervous system.

      Diagnosed with Acute Lymphoblastic Leukemia (ALL) that is untreated or has come back. Participants with untreated ALL must be 60 years of age or older. Participants with ALL that has relapsed or come back must be at least 18 years of age or older. 
      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03739814 STU00210163
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      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 …

      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).

      Rinella, Mary EugeniaRinella, Mary Eugenia
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03900429 STU00210193
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      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…
      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
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      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 …

      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
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      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
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      SUPERIOR VENA CAVAL OCCLUSION IN SUBJECTS WITH ACUTE DECOMPENSATED HEART FAILURE- AN EARLY FEASIBILITY STUDY
      This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part o…
      This study is enrolling patients who have Acute Decompensated Heart Failure (ADHF) and are having or recently had a cardiac catheterization procedure as part of their clinical care (not part of the research).The reason we are doing this research study is to look at the preCARDIA device (the “study device”) to see if it can help treat Advanced Heart Failure. This type of research study is called an “early feasibility study”. Early feasibility studies typically evaluate innovative devices or innovative uses of approved devices. These studies enroll a small number of participants and provide initial information on the basic safety and performance of the study device when used to treat a specific patient type. The study device is investigational and not approved by the US Food and Drug Administration (FDA) for your medical condition. In patients with advanced heart failure, specifically severely congested patients with Acute Decompensated Heart Failure (ADHF), poor heart function leads to an excess of fluid in the right side of the heart (“fluid overload”) and symptoms such as shortness of breath. Drugs such as diuretics are designed to improve these symptoms and heart function by reducing fluid overload. However, diuretics take time to work and may be ineffective in patients with advanced heart failure, a phenomenon known as diuretic resistance. For this reason, a device-based approach designed to limit fluid overload is being studied to see if it could possibly improve symptoms and heart function in congested patients with advanced heart failure. The study device will temporarily block (“occlude”) one of the veins that return blood to the heart in order to potentially reduce fluid buildup and potentially improve the heart’s pumping function temporarily.
      Benzuly, Keith HBenzuly, Keith H
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03836079 STU00210029
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      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 Autos…
      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
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      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 Enriche…
      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
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      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…

      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
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      (xIRB NCI CIRB) ECOG-ACRIN 9152: A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or Bcell Acute Lymphoblastic Leukemia
      This study is being done to determine what effects (good and bad) the therapy venetoclax has on y…
      This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia.
      You may be eligible for this research study if you have acute lymphoblastic leukemia, which has grown after your first treatment regimen or has recurred.
      Dinner, Shira NaomiDinner, Shira Naomi
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03504644 STU00210605
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      A Phase 2 Study of pembrolizumab in patients with histiocyte/dendritic cell neoplasms and biologically selected subtypes of relapsed/refractory aggressive lymphomas. (Protocol #17-448)

      This is a clinical research study to test the safety and effectiveness of the study drug, pembrolizumab, in treat…

      This is a clinical research study to test the safety and effectiveness of the study drug, pembrolizumab, in treating patients with an aggressive lymphoma or a histiocyte or dendritic cell neoplasm (tumor) that hasnot responded to or has come back after other treatments. The effectiveness and safety of the treatment will be determined by a range of assessments including biopsies, scans (or imaging tests), as well as general health and performance status.

      Age 18 and above with a diagnosis of a histiocyte/dendritic cell neoplasm or relapsed/refractory aggressive lymphoma. Must be willing to provide tissue from a newly obtained biopsy, have normal organ and marrow function and not a candidate for potentially curative therapy at the time of enrollment.

      Choi, JaehyukChoi, Jaehyuk
      • Map it 676 N. St. Clair St.
        Chicago, IL
      NCT03316573 STU00209675
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      lymphoma
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      Utility of Esophageal Temperature Management for the Prevention of Thermal Injury During Cryoballoon Ablation for Atrial Fibrillation
      This study is enrolling patient who have an irregular heart rhythm called atrial fibrillation (AF) and are scheduled for a first-time AF ablation procedure to treat th…
      This study is enrolling patient who have an irregular heart rhythm called atrial fibrillation (AF) and are scheduled for a first-time AF ablation procedure to treat their AF. Current techniques used during AF ablation procedures to try and reduce potential damage to the esophagus during ablation are limited. The purpose of this study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (ensoETM) limits the injury to the esophagus during atrial fibrillation ablation procedures. The ensoETM is an FDA approved device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.
      Verma, NishantVerma, Nishant
      • Map it 201 East Huron Street Suite 12-160​
        Chicago, IL
      NCT04079634 STU00209610
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      (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
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      DRUG AL3818-US-004: A Phase III Study of AL3818 (Catequentinib, Anlotinib) Hydrochloride Monotherapy in Subjects with Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

      If you have ASPS, the main purpose of the study is to learn if you respond to treatment with …

      If you have ASPS, the main purpose of the study is to learn if you respond to treatment with a drug called AL3818. If you have either LMS or SS, the main purpose is to learn if AL3818 delays the time until your cancer worsens when compared to another drug called dacarbazine.

      You may be eligible for this research study if you have a soft tissue sarcoma (STS) - specifically alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), or synovial sarcoma (SS) - and you either need new treatment or your prior treatments have not been effective.
      Pollack, Seth MichaelsPollack, Seth Michaels
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03016819 STU00210420
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      RTK inhibitor
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      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 …
      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
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      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 n…
      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
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      (XIRB) DRUG CPI-006-001: A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent or In Combination With Ciforadenant, with Pembrolizumab, And With Ciforadenant Plus Pembrolizumab In Adult Subjects With Advanced Cancers
      The purpose of this research is to…
      The purpose of this research is to evaluate the safety of the study drug called CPI-006 when administered alone, or in combination with another drug called Ciforadenant, or in combination with another drug called Pembrolizumab, or when given with Ciforadenant plus Pembrolizumab.
      All adults subjects 18 years of age or over with advanced or metastatic cancer that has grown, spread, and/or has not responded to previous treatments are eligible to participate.
      Sosman, Jeffrey AlanSosman, Jeffrey Alan
      • Map it 201 East Huron Street Suite 12-160​
        Chicago, IL
      NCT03454451 STU00210900
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      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 r…

      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
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      A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

      The purpose of this study is to compare nivolumab plus the three chemotherapy drugs: doxorubic…

      The purpose of this study is to compare nivolumab plus the three chemotherapy drugs: doxorubicin, dacarbazine, and vinblastine sulfate (AVD) to brentuximab vedotin plus the three chemotherapy drugs: doxorubicin, dacarbazine, and vinblastine sulfate (AVD), followed by targeted radiation therapy in some patients with lymphoma that does not completely respond to therapy. The addition of either nivolumab or brentuximab vedotin to the usual treatment could shrink the cancer or extend your time without your disease symptoms coming back.

      Nivolumab is an immunotherapy drug (a type of drug that works by boosting your immune system) that attaches to a target protein called PD-1 (found within white blood cells) and helps to increase the immune system’s activity against the cancer. Brentuximab vedotin is an antibody drug conjugate, which means that the drug contains an antibody that attaches to a protein (CD30) that is found on the surface of classical Hodgkin Lymphoma cells and then releases a drug inside those cells that kills the cancer cells.

      This study will help the study doctors find out if one of the drug combinations (nivolumab plus the usual chemotherapy or brentuximab vedotin plus the usual chemotherapy) is better, the same, or worse than the other drug combination, followed by radiation therapy in some patients. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 2 years or more after the completion of the study treatment and which drug combination extends the overall survival of patients at 10 years after completion of the study treatment.

      • Participantsmust be 18 years or older
      • Participants must have a confirmed diagnosis newlydiagnosed and previously untreated stage III or IV classical Hodgkin lymphoma
      Winter, Jane NormaWinter, Jane Norma
      • Map it 251 E. Huron St.
        Chicago, IL
      NCT03907488 STU00210926
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      (xIRB) NCI CIRB: ECOG-ACRIN Z171: Prospective validation trial of taxane therapy (docetaxel or weekly paclitaxel) and risk of chemotherapy-induced peripheral neuropathy in African American women

      This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will re…

      This study isbeing done to determine which routine course of treatment (docetaxel orpaclitaxel) will result in less nerve damage (known as peripheral neuropathy)in African-American women.

      You may beeligible to participate in this study if you are an adult with breast cancerand if you self-identify as black, African American, or of African descent.

      Shah, Ami NShah, Ami N
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04001829 STU00210984
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      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 Par…
      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
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      (xIRB) DRUG 18-0402: A Phase 1/2 Dose-Finding Study Followed by Expansion Cohorts of NGM120, A GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, In Subjects With Advanced Solid Tumors And Pancreatic Cancer Using Combination Therapy
      find out what effects, both good and/or bad, ofthe study…
      find out what effects, both good and/or bad, ofthe study drug “NGM120”, as well as the combination of NGM120 and standardtherapy (gemcitabine and Abraxane) may have on you and your type of cancer andyour cancer associated loss of appetite, weight loss and loss of muscle.

      • Participants must be 18 years or older

      •Participants must have a confirmed diagnosis of advanced solid cancers

      Mahalingam, DevalingamMahalingam, Devalingam
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04068896 STU00211037
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      (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 carbopl…

      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
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      (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…

      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. 
      Mittal, Bharat BMittal, Bharat B
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03952585 STU00211079
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      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 t…
      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
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      (xIRB) NCI CIRB NRG LU005: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

      Thepurpose of this study is to compare the usual treatment to atezolizumab plusthe usual treatment. This study will help the study do…

      Thepurpose of this study is to compare the usual treatment to atezolizumab plusthe usual treatment. This study will help the study doctors find out if thisdifferent approach is better, the same or worse than the usual approach. To decide if it is better, the study doctorswill be looking to see if the study drug increases the average lifespan ofpatients by 6 months or more compared to the usual approach.

      Thisimmunotherapy drug, atezolizumab, is approved by the FDA for use in metastaticnon-small cell lung cancer for patients whose cancer progresses. But, it is notapproved for use in small cell lung cancer.

      Thisstudy has 2 study groups. Allparticipants will have received one cycle of chemotherapy before entering thestudy. On the study all participants will receive 3 cycles of chemotherapy (fora total of 4 cycles including the one cycle of chemotherapy received beforeentering the entry), plus radiation.

      • Group 1

      Participants in group 1will get the usual chemotherapy used to treat this type of cancer (etoposideand either cisplatin or carboplatin) 3 weeks for 3 cycles; each cycle equals 21days. In addition, you will receive the usual radiation to your tumor.Radiation will be given either twice a day for approximately 3 weeks or once aday for approximately 6-7 weeks.

      • Group 2

      Participants in group 2will get the same chemotherapy and radiation as noted above, plus the studydrug called atezolizumab. The atezolizumab will be given on days 1 or 2 of eachchemotherapy cycle and will continue every 3 weeks for up to one year or until thedisease gets worse or the side effects become too severe.

      Participants ages 18 years or older who have been diagnosed with limited state small cell lung cancer. 
      Mohindra, Nisha AnjaliMohindra, Nisha Anjali
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT03811002 STU00211222
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      (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 a…

      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 251 E. Huron St.
        Chicago, IL
      NCT03994796 STU00211229
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      (xIRB) NCI CIRB: ETCTN 10089: A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination with Nivolumab in Patients with Relapsed or Refractory Aggressive B-cell Lymphomas

      The purpose of this study is to compare any good and bad effects of using CDX-1127 (varlilumab) along with anot…

      The purpose of this study is to compare any good and bad effects of using CDX-1127 (varlilumab) along with another immunotherapy drug, nivolumab. CDX-1127 (varlilumab) is an antibody that can stimulate the immune system to attack cancer tumor cells. Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system.

      The addition of CDX-1127 (varlilumab) to nivolumab could shrink your cancer but it could also cause side effects. This study will allow researchers to know whether the study approach is better, the same, or worse than nivolumab alone. To be better, the study drug combination should increase the proportion of the patients who have at least partial shrinkage of the tumors by 20 percent compared to the nivolumab only approach.

      • Participantsmust be 18 years or older
      • Participants must have a confirmed diagnosis of B-celllymphomas that have come back after standard treatment or did not respond tothe standard treatment
      Karmali, ReemKarmali, Reem
      • Map it 251 E. Huron St. Seventh Floor
        Chicago, IL
      NCT03038672 STU00211260
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      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 i…
      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
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      (xIRB) NCI CIRB Alliance A071801: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

      The purpose ofthis study is to compare the usual treatment of single fraction radiosurgery tousing fraction…

      The purpose ofthis study is to compare the usual treatment of single fraction radiosurgery tousing fractionated radiosurgery.This study will help the study doctors find outif this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if fractionated radiosurgery decreases the chances ofcancer coming back in the area where you had your brain surgery by 17.4% at oneyear compared to the usual approach of single fraction radiosurgery.

      This study has two groups. All study participants in each group will get radiosurgery.

      Group 1:Participants in this group will get the usual approach to treat the surgicalcavity with single fraction radiosurgery delivered in a single treatment.

      Group 2: Participants in this group will get fractionatedradiosurgery to the surgical cavity in three or five daily treatments, withsmaller cavities treated with 3 daily fractions and larger cavities treatedwith 5 daily treatments.

      After participants finish radiosurgery, they will befollowed for side effects for 2 years after treatment.

      Participants 18 years or older who have resected metastatic brain disease. 
      Sachdev, SeanSachdev, Sean
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04114981 STU00211282
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      A clinical evaluation protocol of the OMRON digital blood pressure monitors BP7450 and BP5450, together with 3 Private Brand models: Walmart Equate 8000, Walgreens 15+ Premium Arm, and CVS 800 Upper Arm; blood pressure measurement accuracy based on auscultation
      We want to test the accuracy of up to 5…
      We want to test the accuracy of up to 5 at-home blood pressure monitors: OMRON BP7450, OMRON BP5450, Walmart Equate 8000, Walgreens 15+ Premium Arm, and CVS 800 Upper Arm. We are looking for people who have high blood pressure or hypertension (BP above 140/85 or higher). This is just one in-person study visit lasting up to 2 hours. Participants receive $20 for each at-home monitor they test for us at their visit, and we pay for your parking if you choose to drive. If you are interested in learning more, please reach out!
      • You are 18 years are older
      • You have high blood pressure or hypertension (BP above 140/85 or higher, especially 160/85)
      • Your arm circumference is smaller than 43 cm
      • You are not be pregnant
      • You are not on dialysis
      • You do not have arrhythmia or a pacemaker
      Persell, Stephen DPersell, Stephen D
      • Map it 420 E. Superior St.
        Chicago, IL
      STU00210788
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      DRUG PRELUDEDX : A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
      This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who ar…
      This is a registry study that is keeping track of people who are undergoing therapy for ductal carcinomain situ (DCIS) and who are having genomic testing. This type of genomic testing looks athow certain genes are used by your tumor cells.
      The use of the DCISionRT DCIS test results in recommending treatment for your DCIS
      Strauss, Jonathan BStrauss, Jonathan B
      • Map it 250 E. Superior St.
        Chicago, IL
      NCT03448926 STU00210952
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      DCIS DCISionRT
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      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 pre…
      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
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      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…
      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
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      (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 comp…

      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
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      (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 …

      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
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      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
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      Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
      This study is enrolling patients with severe Tricuspid Regurgitation (TR), a condition in the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate or cure tricuspid regurgitation.  The goal of this trial is to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System) with optimal medical therapy (OMT) compared to OMT alone in the treatment of participants with symptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve). Optimal Medical Therapy (OMT) refers to standard of care treatment using recommended medications
      Davidson, Charles JDavidson, Charles J
      • Map it 201 E. Huron St.
        Chicago, IL
      NCT04097145 STU00211052
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      (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 stud…

      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
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      A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated with Huntington Disease
      The purpose of this research study is to evaluate the effectiveness of valbenazine to reduce chorea associated w…
      The purpose of this research study is to evaluate the effectiveness of valbenazine to reduce chorea associated with Huntington disease (HD) and the safety and tolerability of valbenazine.

      • Age 18 to 75 years of age.

      • Diagnosis of motor manifest HD

      • Genetic diagnosis of HD with CAG repeat ≥ 37

      Bega, DannyBega, Danny
      • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
        Chicago, IL
      NCT04102579 STU00210771
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      DRUG KO-MEN-001: A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
      The main purpose of this study is to determine the tolerability and the potential safety of a new drug called