All Clinical Trials
Clinical and Molecular Analysis Of NeoplasmsThe objective of the Abbott Molecular Early Access Program (Program) is to allow the laboratory to assess the performance and usability of the Vysis® LSI® RREB1/LSI MYB/ CEP® 6 probes and Vysis® LSI® CCND1 SpectrumGreenTM probe in an actual clinical setting by comparing the performance of the assay to that of the pathological determination currently in use. The study will test the following types of samples: 1) samples with a clear diagnosis of either nevi or melanoma; and 2) samples that have an ambiguous diagnosis by current determination.
Principal Investigator, Study ID, Keywords STU00001127 Click to Copy URL to Clipboard |
Northwestern Scleroderma Program Patient RegistryThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00002669 Click to Copy URL to Clipboard For questions about this study, contact: |
NU 05H6: Acute Leukemias and Map KinaseNormally, 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00004841 Click to Copy URL to Clipboard For questions about this study, contact: |
NCI 02X3: SPORE in Pancreatic Cancer Tissue CoreThe 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00007180 Click to Copy URL to Clipboard For questions about this study, contact: |
HLA-Identical Sibling Renal Transplant Tolerance With Donor Hematopoietic Stem Cells and Campath-1H
The purpose of this study is to attempt to eliminate the necessity of immunosuppressive
therapy for HLA-identical sibling Kidney Transplants, examine cellular chimerism of donor
hematopoietic stem cell (DHSC) lineages for pairs to demonstrate immunologic
unresponsiveness, and to investigate the safety and efficacy of the treatment regimen
including withdrawal of immunosuppression after one year post-transplant for those
recipients having received DHSC infusions.
Principal Investigator, Study ID, Keywords |
Chicago Lupus DatabaseEstablishing 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.
Who Can Participate?Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.Principal Investigator, Study ID, Keywords STU00009193 Click to Copy URL to Clipboard For questions about this study, contact: |
DERMATOLOGY TISSUE ACQUISITION AND REPOSITORYThis study is collecting skin, hair, nail, blood,saliva, skin and/or buccal swabs, and mucous membrane (part of your skin which lines bodypassages and cavities such as the inside of your mouth or nose), and other tissue samples for usein a biorepository. By operating this biorepository, the Department of Dermatology hopes todevelop a better understanding of skin diseases (meaning the knowledge about how cells in theskin behave and react to medical treatments) among researchers at Northwestern University andother approved researchers. This basic knowledge is expected to help the development of moreeffective patient care and new treatment methods.
Who Can Participate?
Principal Investigator, Study ID, Keywords STU00009443 Click to Copy URL to Clipboard For questions about this study, contact: |
NUGene: Gene-Disease Associations and Treatment OutcomesShare 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. Who Can Participate?Must be a patient at Northwestern or one of its affiliates.Principal Investigator, Study ID, Keywords STU00010003 Click to Copy URL to Clipboard For questions about this study, contact: |
Genetics of Prostate CancerRecruiting Research Participants for a New Study on the “Genetics of Prostate Cancer” At the time of conception, fertilization of the egg by the sperm brings together the genetic material (DNA) from both parents, half from the mother and half from the father, producing the embryo. In the very early stages of embryonic development, the embryo is made up of cells that have the potential to develop into all types of cells, like skin, muscle, liver, brain, pancreas, breast, ovary, fallopian tube, or prostate cells. Because of this ability, these cells are called “pluripotent” embryonic stem cells (ESCs). However, about a week after fertilization, the embryonic cells lose their ability to develop into all of the different cells and tissues of the body and gradually “differentiate” into the various tissues and organs that have different specific functions. So, there is a relatively narrow window during which pluripotent ESCs exist in the embryo. At the end of the in vitro fertilization (IVF) process for couples undergoing subfertility treatment, the doctors are usually left with one-week-old embryos. In 1998, using such embryos for research, scientists figured out how to grow pluripotent ESCs in the lab that can stay in their pluripotent state if the right growth conditions are present. Changing the growth conditions in certain ways, scientists learned how to stimulate the ESCs to go through a process called “differentiation,” in which the stem cells can develop into any of the different cell types present in the body. ESCs were used in the early animal cloning experiments that produced the cloned ewe named “Dolly;” however, cloning human cells is illegal. While ESCs offer promising and exciting opportunities, like the possibility of growing organs in the lab, because their production involves technical and ethical problems, efforts were directed to produce pluripotent stem cells from mature cells to avoid the use of embryos. In 2007, Japanese researchers found an amazing way (for which they received a Nobel Prize) to transform mature cells, like regular skin or blood cells, directly into stem cells without using human eggs. They found a combination of proteins that, if injected into mature cells, gradually reprogrammed them into induced pluripotent stem cells, abbreviated iPSCs. Research Project Drs. Dan Theodorescu and Clive Svendsen, the Principal Investigators at the Cedars-Sinai Medical Center in Los Angeles, California in collaboration with Dr. William Catalona, the Principal Investigator at Northwestern University are engaged in research using iPSCs to develop a model of human prostate cancer using iPSCs from men who carry BRCA2 mutations that are related to a higher risk for developing aggressive prostate cancer (the Cedars-Sinai team has already accomplished this for ovarian cancer in women who carry BRCA1 mutations). As study controls, they will also enroll men with non-BRCA2-related prostate cancer and those without prostate cancer. They will not use embryos. In the laboratory, the researchers will take the white blood cells from a blood sample back in time to when they were capable of making any cell type in the body and differentiate them forward into prostate cells carrying (or for non-BRCA2-mutation carriers, not carrying) the BRCA2 mutation in a petri dish. Using these transformed prostate cells, they will use current genetic engineering and molecular biology research methods to study the mechanisms of the transformation of normal prostate cells into aggressive prostate cancer cells. This model also can be used in cell-signaling studies and drug screening studies for designing future therapies. The bank of prostate iPSCs that they will create may be shared with research institutions around the world. These researchers are now recruiting men and their male family members who carry a BRCA2 mutation and other prostate cancer patients and controls without prostate cancer to participate in this study. This research is being performed to discover the causes of prostate cancer and how it is passed down in families using the BRCA2 mutation as a model system and also can be applied to non-BRCA2-related cancers. This study is called “The genetics of prostate cancer” and is approved by the Institutional Review Boards at Northwestern University (STU00018651) and Cedars Sinai, whose function is to protect the rights of research subjects and to oversee ethical issues. Participation in this study will involve having up to 50 ml of your blood drawn (10 teaspoons), and completing family history questionnaires (baseline and follow-ups) and clinical follow-up questionnaires, if applicable. The time involved includes the time required to read the 10-page consent form, and the time required to travel to Northwestern Memorial Hospital, Galter Pavilion, 675 North St. Clair Street, Chicago, IL 60611 for the research blood draw.If it is not convenient for you to come to our clinic you may be able to get blood drawn at a clinic of your choice and we will arrange to have it shipped to Cedars-Sinai in Los Angeles, California. It will take about 20 to 40 minutes to complete the questionnaire. In the case that your family history suggests familial prostate cancer, Dr. Catalona may want your family members to participate in the study as well. You may be asked to contact your relative(s) about the study. We will follow up with a family history follow-up questionnaire annually, which takes 15 to 30 minutes to finish, to update the file. If you develop prostate cancer, we will want you to fill out a clinical follow-up questionnaire about prostate cancer and follow you up with the questionnaire annually as well, which takes 10 minutes to finish. In addition, we may request up one or more additional blood samples of 10 to 20 ml (2-4 teaspoons) from you at a later date, depending on the evolving needs of the study. You may refuse to provide these follow-up blood samples without affecting your participation in this study. The blood sample(s) will be saved for future analysis. Efforts will be made to limit the use and disclosure of your personal information, including research studies and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution. Research results will not be available to you or your physician except under extraordinary circumstances. These are situations in which a life-threatening medical disorder is discovered for which medical treatment is available to prevent or alleviate long-term medical complications. If such a situation should occur, we will contact you via phone, email or mail. Those interested in participating may contact Dr. Catalona at 312 695-4471 or william.catalona@nm.org. Further background information on stem cells is available from the author who created the background information for this article: Meshorer E (2020) What Are Embryonic Stem Cells and How Can They Help Us?. Front. Young Minds. 8:32. doi: 10.3389/frym.2020.00032. Copyright © 2020 Meshorer Who Can Participate?Male carriers of BRCA2 mutations with prostate cancer and men with metastases aged 18 years or older Principal Investigator, Study ID, Keywords STU00018651 Click to Copy URL to Clipboard |
Mediators of Atherosclerosis in South Asians Living in America
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high
rates of cardiovascular disease that is not explained by traditional cardiovascular risk
factors. Though South Asians represent over one-quarter of the world's population, there are
no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a
longitudinal study of South Asians at two United States centers to identify risk factors
linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of
this study is to understand the causes of heart disease and stroke in South Asians and
compare these causes to those in other United States ethnic groups.
Principal Investigator, Study ID, Keywords |
NU 00X3: Pathology Core FacilityThe 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. Principal Investigator, Study ID, Keywords STU00020989 Click to Copy URL to Clipboard For questions about this study, contact: |
RTOG 0724 - A Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterecotmy
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
It is not yet known whether chemotherapy and radiation therapy are more effective when given
with or without additional chemotherapy in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation
therapy to see how well they work when given with or without additional chemotherapy in
treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Who Can Participate?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. Principal Investigator, Study ID, Keywords cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer
For questions about this study, contact: |
Asymmetric Neurodegeneration and Language in Primary Progressive AphasiaThe 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: Who Can Participate?You must carry a diagnosis of Primary Progressive Aphasia, established at a thorough evaluation prior to enrollment. If you think you may have dementia, but have not yet been evaluated, you must first undergo a clinical evaluation. This clinical evaluation is not part of the research. Patients must also meet screening criteria which require the patient to be a right-handed, native English speaker and safe to undergo a 3T MRI.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Chemokine mechanisms in chronic pelvic painThe purpose of this study is to investigate the types of biomarkers, which are measurable indicators of a health condition, present in patients who suffer from chronic pelvic pain syndrome. Biomarker levels will be determined from patient samples of blood, urine, and expressed prostatic secretions.
Who Can Participate?Patients with chronic pelvic pain syndrome (CPPS). Pain must be present for 3 out of the past 6 months. Must be 18 years of age or older.Principal Investigator, Study ID, Keywords STU00030121 Click to Copy URL to Clipboard For questions about this study, contact: |
NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
RATIONALE: To improve strategies for detection and prevention of early-stage disease.
PURPOSE: This research study is collecting specimens and data to develop better methods for
early detection and prevention of ovarian cancer among the high risk population and those
who have the disease.
Principal Investigator, Study ID, Keywords |
Alzheimer's Disease Research CenterThe 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. Who Can Participate?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)
Healthy Volunteers
Principal Investigator, Study ID, Keywords STU00023196 Click to Copy URL to Clipboard For questions about this study, contact: |
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 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).
Principal Investigator, Study ID, Keywords STU00024134 Click to Copy URL to Clipboard For questions about this study, contact: |
NCI 01X1: Breast Cancer Program: Tissue and Specimen Collection FacilityThe 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). Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
MACS/WIHS Combined Cohort StudyThis is a long term study to look at the comprehensive health and well-being of men who have sex with men (MSM) Who Can Participate?Cisgender men between the ages of 30-70 who have sex with men. Willing to complete an in-person study visit at least twice a year. Principal Investigator, Study ID, Keywords STU00022906 Click to Copy URL to Clipboard |
Super Aging Study: Correlates of Active Engagement in Life in the ElderlyThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00027225 Click to Copy URL to Clipboard For questions about this study, contact: |
Peripheral Neuropathy Research Registry (PNRR)National Peripheral Neuropathy Research Registry (PNRR), a collection of different types ofinformation, such as patient medical, family, and social histories and blood samples. Theinformation is carefully maintained so that it can be studied repeatedly in the future. The registryaims to help researchers’ access large amounts of information about people with 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.
Who Can Participate?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 NeuropathyPrincipal Investigator, Study ID, Keywords STU00048864 Click to Copy URL to Clipboard For questions about this study, contact: |
NU 04H7: Molecular Mechanisms of Disease Progression in Myeloid MalignancyIn 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00039629 Click to Copy URL to Clipboard For questions about this study, contact: |
Microbiomes of Pelvic PainInterstitial 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.
Principal Investigator, Study ID, Keywords STU00055668 Click to Copy URL to Clipboard For questions about this study, contact: |
Northwestern University The Department of Psychiatry and Behavioral Sciences, Clinical Research Program (NU CRP) Recruitment PipelineThe 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.
Principal Investigator, Study ID, Keywords STU00059328 Click to Copy URL to Clipboard Schizophrenia Schizoaffective Depression Anxiety Bipolar Bipolar Type 1 Bipolar Type 2 Mania Hypomania Major Depressive Disorder Mood Cognition Research Study Adult Adolescent Children Alzheimer's disease Clinical Trial Non Clinical Trial Therapy Investigational Drug Post Traumatic Stress Disorder
For questions about this study, contact: |
A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta
cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to
determine the safety and effectiveness of islet transplantation, combined with
immunosuppressive medications, specifically using Campath as induction, for treating type 1
diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic
episodes.
Principal Investigator, Study ID, Keywords |
A Randomized Trial to Prevent Congenital Cytomegalovirus Infection (CMV)Cytomegalovirus (CMV) is a common virus that usually presents withfew if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. 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.
Who Can Participate?Primary CMV infection in women with singleton pregnancy at less than 24 weeks.Principal Investigator, Study ID, Keywords Perinatology Cytomegalovirus immune globulin Cytogam CMVIG infusions primary CMV infection in pregnancy
For questions about this study, contact: |
A Registry of Interstitial Lung Disease PatientsThe purpose of this registry is to collect clinical information about people with interstitial lung disease (ILD) to help us better understand the causes of ILD and determine if particular types of treatment work better for some causes of ILD than others. The Registry will also be used to determine who might be eligible for and interested in participating in future studies related to ILD.
Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis. Who Can Participate?
Principal Investigator, Study ID, Keywords STU00060593 Click to Copy URL to Clipboard For questions about this study, contact: |
NCI 12H13: Molecular Mechanisms of Relapse After Therapy Discontinuation in Chronic Myeloid LeukemiaIn 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00074258 Click to Copy URL to Clipboard For questions about this study, contact: |
Communication Bridge: Using Internet-Based Speech Therapy to Improve Quality of Life and Access to CareThe 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.
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
CENTER FOR BEHAVIORAL INTERVENTION TECHNOLOGIES (CBITs) RESEARCH SUBJECT RECRUITMENT REGISTRYWHAT 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
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00076804 Click to Copy URL to Clipboard For questions about this study, contact: |
RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (A7007)The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and to evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
Who Can Participate?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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Targeting Siglecs in DiseaseThe 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.
Who Can Participate?Adults with or without allergiesPrincipal Investigator, Study ID, Keywords STU00085003 Click to Copy URL to Clipboard For questions about this study, contact: |
NUDB 13C03: Northwestern Brain Tumor Institute Research DatabaseThe 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00087359 Click to Copy URL to Clipboard For questions about this study, contact: |
Parkinson’s Disease and Movement Disorders Center BiorepositoryThis 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.
Who Can Participate?• Diagnosis of a movement disorder • Male or female 18 years of age or older when diagnosed • Ability to provide informed consent Principal Investigator, Study ID, Keywords STU00091585 Click to Copy URL to Clipboard For questions about this study, contact: |
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 MPAThis 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.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
Principal Investigator, Study ID, Keywords Registry Gastrointestinal Diseases Inflammatory Bowel Diseases Gastroenteritis Adalimumab Colitis Ulcerative Colitis Humira
For questions about this study, contact: |
Healthy Control Esophageal Registry and BiorepositoryThis 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.
Who Can Participate?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) Principal Investigator, Study ID, Keywords STU00096856 Click to Copy URL to Clipboard For questions about this study, contact: |
Neural Systems for the Dynamic Use of MemoryThe 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.
Principal Investigator, Study ID, Keywords STU00060723 Click to Copy URL to Clipboard For questions about this study, contact: |
Noninvasive Manipulation of Hippocampal-Cortical Brain Networks and MemoryThe 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.
Principal Investigator, Study ID, Keywords STU00070522 Click to Copy URL to Clipboard For questions about this study, contact: |
Development of a Kidney Cancer Patient Outcomes DatabasePurpose
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.
Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00070200 Click to Copy URL to Clipboard For questions about this study, contact: |
rTMS: A Treatment to Restore Function after Severe TBI The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the relationship between neurobehavioral changes and net neural effects, and to identify and define the neural mechanisms related to neurobehavioral improvements by providing 30 active or placebo rTMS sessions.
Who Can Participate?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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic EfficacyWe 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.
Who Can Participate?• 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. Principal Investigator, Study ID, Keywords STU00104822 Click to Copy URL to Clipboard For questions about this study, contact: |
HOme-based moNitORed exercise for PADThis study will determine the effects of a home based walking exercise intervention on walking ability in people with peripheral artery disease (PAD).
Who Can Participate?Peripheral artery diseasePrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Ex vivo interactions between high-density-like nanoparticles and human bloodThis 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.
Who Can Participate?Healthy, non-pregnant adult (age >18-75 years) volunteers.Principal Investigator, Study ID, Keywords STU00200368 Click to Copy URL to Clipboard For questions about this study, contact: |
NCI 15H01: Triad1 Regulates Myelopoiesis and Functions as a Leukemia SuppressorResearchers 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. Who Can Participate?You may be eligible for this research study if you have been diagnosed with acute myeloid leukemia (AML), a cancer of the blood. Principal Investigator, Study ID, Keywords STU00200435 Click to Copy URL to Clipboard For questions about this study, contact: |
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).
Who Can Participate?Peripheral artery diseasePrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
The effect of magnesium on maternal mood, cognitive function, and birth experience
Magnesium is sometimes used to prevent seizures in the setting of hypertensive disorders of
pregnancy. The primary aim of this study is to determine if women who receive magnesium are
less likely to experience postpartum depression. Other aims include examining the
relationship between receiving magnesium and cognitive function and birth experience.
Principal Investigator, Study ID, Keywords |
A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)
This protocol outlines a randomized trial of 600 women evaluating the use of micronized
vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in
women carrying twins and with a cervical length of less than 30 millimeters.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Telmisartan Plus Exercise to Improve Functioning in PADThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords peripheral artery disease atherosclerosis vascular disease cardiovascular disease telmisartan exercise
For questions about this study, contact: |
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn’s Disease Previously Enrolled In The Etrolizumab Phase III Protocol GA29144 (Protocol GA29145)
Principal Investigator, Study ID, Keywords Inflammatory Bowel Disease IBD Crohn's Disease Gastroenteritis Gastrointestinal Diseases Etrolizumab
For questions about this study, contact: |
Chronic Kidney Disease Research BiorepositoryThe 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
Principal Investigator, Study ID, Keywords STU00201546 Click to Copy URL to Clipboard For questions about this study, contact: |
Improving Outpatient Safety of Older Adults through Electronic Patient PortalsThe 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.
Who Can Participate?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).Principal Investigator, Study ID, Keywords STU00201242 Click to Copy URL to Clipboard For questions about this study, contact: |
High Resolution and Functional MRI Assessment of Intracranial Atherosclerotic PlaqueIntracranial 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.
Who Can Participate?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 Principal Investigator, Study ID, Keywords STU00201681 Click to Copy URL to Clipboard For questions about this study, contact: |
LIFT: Lupus Intervention for Fatigue TrialThis 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.
Who Can Participate?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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
The ENabling Reduction of low-Grade Inflammation in SEniors) Pilot StudyThe 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.
Who Can Participate?Age 70 or older, slow walking speed, and high levels of markers of inflammation in your blood.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot StudyPreeclampsia 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.
Who Can Participate?• 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 Principal Investigator, Study ID, Keywords preeclampsia pravastatin Pravachol® statin high-risk pregnancy safety fetal morbidity and mortality maternal morbidity and mortality neonatal mortality premature delivery preemie
For questions about this study, contact: |
A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.
The main purpose of this study is to determine if taking the study drug, conjugated
estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the
breast tissue of the study subjects. The study drug is approved by the US Food and Drug
Administration in healthy postmenopausal women to treat certain symptoms of menopause such
as hot flashes. Since it is not approved in women with DCIS, its use in this study is
experimental. This study will also look at whether taking the study drug causes any
significant or undesirable side effects in women with DCIS. The researchers hope that this
study will help them determine if taking the study drug is safe in women taking DCIS and if
it can possibly reduce the risk of developing breast cancer in women with DCIS.
Who Can Participate?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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
NU 15N01: Head and Neck Tissue BankResearchers 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. Who Can Participate?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). Principal Investigator, Study ID, Keywords STU00202177 Click to Copy URL to Clipboard For questions about this study, contact: |
NU 15N02: Northwestern Head and Neck Cancer RegistryThe 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00202162 Click to Copy URL to Clipboard For questions about this study, contact: |
Motivational Interviewing and Physical Activity in Parkinson’s DiseaseWe 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.
Who Can Participate?Live in the communityAt 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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
ECOG-ACRIN 6141: Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
This randomized phase II/III trial studies the side effects and best dose of nivolumab and
ipilimumab when given together with or without sargramostim and to see how well they work in
treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal
antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to
the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking
specific tumor cells and stop them from growing or kill them. Colony-stimulating factors,
such as sargramostim, may increase the production of white blood cells. It is not yet known
whether nivolumab and ipilimumab are more effective with or without sargramostim in treating
patients with melanoma.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Semen quality in males with inflammatory bowel disease: Influence of medication for IBDSemen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
Principal Investigator, Study ID, Keywords STU00201469 Click to Copy URL to Clipboard For questions about this study, contact: |
Epidermolysis Bullosa Clinical Characterization and Outcomes DatabaseThe aim this study is to collaboratively advance knowledge about epidermolysis bullosa (EB) by collecting clinical data from patients with EB from multiple EB centers in the United States and Canada. As EB is a rare disease, coordination and collaboration between multiple centers will help our understanding of disease manifestations, course, and complications, with the aim of improving future care, expanding clinical and translational research, and finding an eventual cure for individuals with EB. Who Can Participate?All candidates with a clinical diagnosis of epidermolysis bullosa are eligible for this study. The subjects can be from any age, male or female without restriction.Principal Investigator, Study ID, Keywords STU00202682 Click to Copy URL to Clipboard For questions about this study, contact: |
North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) StudyThis 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. Who Can Participate?Inclusion Criteria:
Exclusion Criteria:
Principal Investigator, Study ID, Keywords STU00201852 Click to Copy URL to Clipboard For questions about this study, contact: |
LiveWell: A Mobile Intervention for Bipolar DisorderThis 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.
Who Can Participate?Individuals 18-65 years old who have been diagnosed with bipolar disorder and are currently working with a psychiatristPrincipal Investigator, Study ID, Keywords Bipolar Type 1 Mania Depression Bipolar Mood disorders Mental health Lithium Depakote Abilify Latuda Zyprexa Seroquel Smartphone
For questions about this study, contact: |
Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men2GETHER 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. Who Can Participate?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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Cocoa to Improve Walking Performance in Peripheral Artery Disease: The COCOA-PAD StudyThe 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.
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
MAST CELLS IN MALE CHRONIC PELVIC PAIN AND LOWER URINARY TRACT DYSFUNCTIONThe 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).
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
NU 16B06: Investigation of Blood-Based Prognostic Biomarkers in Patients with Advanced Breast Cancer for Molecular Mechanisms Underlying Circulating Tumor Cell ClustersThis study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is. Who Can Participate?You may be eligible for this research study if you have advanced stage (III/IV)breast cancer. Principal Investigator, Study ID, Keywords STU00203283 Click to Copy URL to Clipboard For questions about this study, contact: |
Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase DisorderThis 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.
Who Can Participate?Individuals with delayed sleep-wake phase disorder and healthy controlsPrincipal Investigator, Study ID, Keywords STU00203647 Click to Copy URL to Clipboard For questions about this study, contact: |
A wearable myoelectric-computer interface to reduce muscle co-activation in acute and chronic strokeWe 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.
Who Can Participate?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 Principal Investigator, Study ID, Keywords STU00203644 Click to Copy URL to Clipboard For questions about this study, contact: |
Alzheimer’s Disease Neuroimaging Initiative 3The 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.
Who Can Participate?- 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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 MalignanciesThe 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00203944 Click to Copy URL to Clipboard For questions about this study, contact: |
Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance after Mitral Valve Replacement with Transcatheter DeviceThis study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. Mitral regurgitation (MR) is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to assess the safety and performance of a new bioprosthetic mitral valve device when implanted through groin (transfemoral) access. The new mitral valve replacement device is called the Edwards EVOQUE Eos System. The Edwards EVOQUE Eos System is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transfemoral/transseptal).The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure.
Who Can Participate?Patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. General Criteria:1. Greater than or equal to 18 years of age.2. New York Heart Associate Classification ≥ II3. Left Ventricular Ejection Fraction ≥ 30%.4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe).5. Patient is determined to be high surgical risk as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist).Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Improve PAD PERformance with METformin: The PERMET TrialThe purpose of this study is to establish whether metformin improves walking ability in people with PAD.
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Reducing Assessment Barriers for Patients with Low LiteracyThis study aims to learn whether routine health questionnaires are valid across groups of people who have different levels of understanding of basic health information.
Who Can Participate?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.Principal Investigator, Study ID, Keywords health research health literacy surveys health survey mental health assessment psychometrics biostatistics
For questions about this study, contact: |
Investigating Serum Concentrations of Mood Stabilizing Medications in Pregnancy and PostpartumWe 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:
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:
Who Can Participate?To qualify for this study you must:
Los requisitos parta participar en este estudio son:
Principal Investigator, Study ID, Keywords STU00203693 Click to Copy URL to Clipboard bipolar disorder major depressive disorder depression schizophrenia bipolar psychiatry pregnancy pregnant lamotrigine lithium risperidone aripiprazole lurasidone quetiapine olanzapine
For questions about this study, contact: |
NU 16U05: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients with Metastatic Castration-Resistant Prostate CancerPurpose
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.
Who Can Participate?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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Prevalence of aneuploidy in ectopic pregnanciesThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00203775 Click to Copy URL to Clipboard For questions about this study, contact: |
Enroll-HD: A Prospective Registry Study in a Global Huntington’s Disease CohortThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00203021 Click to Copy URL to Clipboard For questions about this study, contact: |
ELUCDITATING THE MOLECULAR MECHANISMS UNDERLYING CYP2D6 INDUCTION DURING PREGNANCYWe 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.
Who Can Participate?• 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 Principal Investigator, Study ID, Keywords STU00204600 Click to Copy URL to Clipboard For questions about this study, contact: |
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic AortaThis research study is recruiting patients who have one of the following conditions:1.A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2.A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture.3.Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture.4.A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture.5.A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening conditionThe study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits after mTBI plus PTSDThe purpose of this study is to alleviate persisting attention deficits related to mTBI and PTSD by treating the neurocognitive system of attention.
Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
INtervention Study In OverweiGHT Patients with COPD (INSIGHT COPD)We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find 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. Who Can Participate?40 years of age or older with COPD, wants to participate in a healthy lifestyle intervention, body mass index of 25 -44.9Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
The Role of Circadian Dysfunction in Hepatic Encephalopathy in Patients with CirrhosisIndividuals with advanced liver disease (cirrhosis) often report new or worsening sleep problems.
Who Can Participate?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)Principal Investigator, Study ID, Keywords STU00204423 Click to Copy URL to Clipboard Cirrhosis End-stage liver disease hepatic encephalopathy sleep circadian cognitive impairment dementia transplant insomnia
For questions about this study, contact: |
Bimanual balanced reaching with visual biofeedbackThe 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.
Who Can Participate?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 Principal Investigator, Study ID, Keywords STU00204661 Click to Copy URL to Clipboard For questions about this study, contact: |
Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) to Study Natural History and Genetic Modifiers in Spinocerebellar Ataxia (SCA)The purpose of this study is to collect natural history data among ataxia patients in a cohort of SCA 1, 2, 3, 6 patients using clinic-based neurological rating scales and performance measures. Another study goal is to identify new measures of ataxia, cognition, and neurobehavior in comparison to traditional clinician rating methods. The gene analysis is expected to establish a relationship, if any, between age at onset of disease and disease progression rates.
Who Can Participate?• 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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic ValveThis 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.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Long-Term Nicotine Treatment of Mild Cognitive ImpairmentThe 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.
Who Can Participate?Inclusion Criteria:
Exclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 pessary).
Who Can Participate?cervical length less than or equal to 20 mm when measured between 16 weeks -23 weeks of singleton pregnancyPrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Physical activity and DNA methylation among women with high breast densityThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00204639 Click to Copy URL to Clipboard For questions about this study, contact: |
Melanoma and Skin Cancer Tissue RepositoryThe 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. Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00204151 Click to Copy URL to Clipboard For questions about this study, contact: |
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 DiseaseCombined 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
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6-Year All-Participants-On-Treatment Extension (PASADENA)This is a multicenter, Phase II study to evaluate the effect of IV administration of RO7046015 in
participants with early stage Parkinson's Disease (PD). Participants will be eligible if they have PD with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without 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).
Who Can Participate?*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 SelegilinePrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
D-Cycloserine for the Treatment of Chronic, Refractory Low Back PainThe 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.
Who Can Participate?Must have a history of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathyMale 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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that 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.
Who Can Participate?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 Principal Investigator, Study ID, Keywords chronic kidney diease kidney disease diabetes renal biopsy kidney biopsy research study research study diabetes mellitus diabetic nephropathy
For questions about this study, contact: |
The Role of Positron Emission Tomography and Magnetic Resonance Imaging (without Fluorodeoxyglucose or Gadolinium) in Yttrium-90 Radioembolization Treatment Planning for Patients with Liver MalignanciesPatients 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.
Who Can Participate?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. Principal Investigator, Study ID, Keywords STU00205918 Click to Copy URL to Clipboard For questions about this study, contact: |
Cerebello-Thalamo-Cortical Circuit Activation and Verbal Working Memory tDCS/fMRI Paradigm in Early Course PsychosisIf you are ages 18 to 40 and have been diagnosed with a psychotic disorder such as schizophrenia in the last 5 years, you may be eligible for a study at the ADAPT Program. The study involves coming in for 2-3 visits for a total of 7 hours, and participants are compensated $30 per hour of their time for a total of $210. The purpose of the study is to examine verbal working memory in individuals with early psychosis. Participants are asked to complete clinical interviews, questionnaires, non-invasive brain stimulation, and an MRI scan. Who Can Participate?Eligible individuals should meet the following: · A diagnosis of psychotic disorder in the last 5 years · No history of brain injury or neurological conditions · No metal in body (such as metal implants, braces, pacemakers) · No changes in medication in the past 6 weeks Principal Investigator, Study ID, Keywords STU00205279 Click to Copy URL to Clipboard For questions about this study, contact: |
Genetic causes and pathogenic mechanisms of adult epilepsiesThe 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.
Principal Investigator, Study ID, Keywords STU00205877 Click to Copy URL to Clipboard For questions about this study, contact: |
Alterations of Sleep and Circadian Timing in AgingPurpose: 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.
Who Can Participate?Eligibility Criteria:Men and women age 55-75 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
NIH All of Us Research Program Precision Medicine Initiative® Precision Medicine Initiative Cohort Program Healthcare Provider Organization Enrollment Centers Research Program in Illinois. The mission of this ambitious National Institutes of Health (NIH) initiative is to speed up health research and medical breakthroughs. To do this, the All of Us Research Program is asking one million people to lead the way to provide the types of information that can help us create individualized prevention, treatment, and care for all of us. Visit nm.org/joinallofus to learn more and enroll.
WHATARE THE BENEFITS OF JOINING? · · · WHATWOULD I NEED TO DO? · · · Visit an All of Us Participant Center for physical measurements (bloodpressure, height, weight, waist/hip, & heart rate) and biosamples (blood& urine) Participants receive a $25 payment for completing all researchcomponents.You will also receive a voucher for free parking. Who Can Participate?- 18 years of age or older- Currently live in the United StatesPrincipal Investigator, Study ID, Keywords STU00204480 Click to Copy URL to Clipboard Precision Medicine genetics individualized medicine health care environment lifestyle biology biobank technology behavior
For questions about this study, contact: |
Clinical Database of Prostate Cancer at Northwestern UniversityThe 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.
Who Can Participate?Men ages 18-89 years daignosed with prostate cancer.Principal Investigator, Study ID, Keywords STU00206270 Click to Copy URL to Clipboard For questions about this study, contact: |
Bilateral Priming plus Task Specific Training for Severe Upper Limb HemiparesisThis 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.
Who Can Participate?Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasiaThe 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. Who Can Participate?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:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Strengthening Circadian Signals to Enhance Cardiometabolic FunctionsPurpose: 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.
Who Can Participate?Eligibility Criteria:Men and women age 40-54 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
APOLLO Trial Clinical Investigation Plan - Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitationThis study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC). The new investigational device is a mitral valve replacement called the Medtronic IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The IntrepidTM TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support or stopping the heart. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 in-person scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure.
Who Can Participate?Enrolling participants with mitral valve regurgitation who are at high risk of experiencing major complications while undergoing open-heart surgery due to their current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within the body). Additionally, physicians have determined that these participants may not be optimally treated with currently approved transcatheter repair therapies.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
cIRB: AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic StrokeARCADIA 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.
Who Can Participate?Inclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Life Enhancing Activities for Family Caregivers (LEAF) 2.0The 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.
Who Can Participate?-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 Principal Investigator, Study ID, Keywords Alzheimer's Disease Caregiving Caregivers Positive Emotion Anxiety Depression Positive Affect Coping Family caregivers
For questions about this study, contact: |
A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MACTEL StudySince 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. Who Can Participate?1. Must have a confirmed clinical diagnosis of MacTel Type 2. 2. Must be 18 years of age or older. Principal Investigator, Study ID, Keywords STU00206885 Click to Copy URL to Clipboard |
A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2Brief 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. Who Can Participate?Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)Sexes Eligible for Study: AllAccepts Healthy Volunteers: NoCriteria Key Inclusion Criteria:
Key Exclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(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 StatesThe 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. Who Can Participate?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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Clinical Trial Readiness for SCA1 and SCA3Subjects 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.
Who Can Participate?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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
CHRONIC VENOUS THROMBOSIS: RELIEF WITH ADJUNCTIVE CATHETER-DIRECTED THERAPYThe 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. Who Can Participate?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 Principal Investigator, Study ID, Keywords blood clot venous thrombosis varicose ulcer leg ulcer postthrombotic syndrome vascular disease iliac vein obstruction embolism and thrombosis peripheral vascular diseases varicose veins cardiovascular disease superficial venous reflux venous insufficiency phlebitis deep vein thrombosis
For questions about this study, contact: |
Mitochondrial Dysfunction and Disability in Peripheral Artery DiseaseThe 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00206722 Click to Copy URL to Clipboard For questions about this study, contact: |
Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA ProtocolThe study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating one tube of blood for the collection of genetic information (DNA) at one study visit.
Who Can Participate?- Giant Cell Arteritis- Takayasu’s Arteritis - Polyarteritis Nodosa - Granulomatosis with Polyangiitis (Wegener’s) - Microscopic Polyangiitis - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)Principal Investigator, Study ID, Keywords STU00206908 Click to Copy URL to Clipboard For questions about this study, contact: |
Evaluation of Renal Microvascular Perfusion by Contrast Enhanced UltrasoundContrast Enhanced Ultrasound Study:
Who Can Participate?INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Principal Investigator, Study ID, Keywords STU00206894 Click to Copy URL to Clipboard CKD Kidney Disease Healthy Volunteers Contrast Enhanced Ultrasound CKD Stage 1 CKD Stage 2 CKD Stage 3 CKD Stage 4 CKD Stage 5 Renal Microvascular Perfusion
For questions about this study, contact: |
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 MonthsThe 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.
Who Can Participate?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 treatmentPrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Longitudinal Early-onset Alzheimer’s Disease Study (LEADS)The Longitudinal Early-onsetAlzheimer's Disease Study (LEADS) is a non-randomized, natural history,non-treatment study designed to look at disease progression in individuals withearly onset Alzheimer's disease (EOAD). Clinical/cognitive, imaging, biomarker,and genetic characteristics will be assessed across two cohorts: (1)individuals with cognitive impairment and (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. Who Can Participate?Inclusion Criteria (Cognitively Impaired Cohort Only):
Inclusion Criteria (Cognitively Normal Cohort Only):
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 strokeIntervention study on hand and arm function in individuals with stroke
Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Randomized Controlled Trial of a Mindfulness-based Intervention in a Federally Qualified Center (FQHC)Northwestern University and Near North Health are currently recruiting participants for a research study to understand if mind and body approaches such as breathing techniques, mindfulness meditation, and gentle yoga work to improve stress. Up to $110 in compensation for full participation! Participants will either be assigned to receive an 8-week, 90 min per session group or to the wellness check-in group. For more info, please call 773-683-1275.
Who Can Participate?Inclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Pathogenic Wnt-beta catenin target genes in macrophages and fibrosisThe purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.
Patients who participate in this study will:
Who Can Participate?
Principal Investigator, Study ID, Keywords STU00207083 Click to Copy URL to Clipboard systemic sclerosis scleroderma interstitial lung disease ILD SSc-ILD fibrosis SSc endoscospy bronchoscopy
For questions about this study, contact: |
A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis(ACTIVE, NOT RECRUITING) This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).
Who Can Participate?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. Principal Investigator, Study ID, Keywords focal segmental glomerulosclerosis fsgs glomerulonephropathy glomerulosclerosis primary fsgs primary focal segmental glomerulosclerosis
For questions about this study, contact: |
A pragmatic trial of two strategies for implementing an effective eHealth HIV prevention program (Keep It Up! 3.0)We would like to reach about 250 – 500 people. Our eligibility criteria: (1) 18 – 29 years old, (2) HIV-negative, (3) male assigned at birth & currently identify as male, (4) live in one of 22 counties (please see counties below) in the USA.
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
Who Can Participate?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=25Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Gut Microbial remodeling with Resistant Maltodextrin for motor and non-motor symptoms in Parkinson's disease: safety and tolerability study.The objective of this study is to examine thesafety and tolerability of resistant maltodextrin (RM), a prebioticnon-digestible fiber, and its effect on the gut microbiome, as well as motor and non-motorsymptoms, in Parkinson's Disease.
We will conduct a randomized, parallel-groupdouble-blinded controlled trial assessing resistant maltodextrin 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. Who Can Participate?You may be eligible if you:Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Clinical Study of the Edwards Cardioband™ Tricuspid Valve Reconstruction SystemThis study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ).
The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation.
Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Project 1, Adaptations of the brain in chronic pain with opioid exposureIn 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.
Who Can Participate?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 monthsPrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Wearable sensors and video recording for children (birth to 24 months) to monitor motor developmentThe 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. Who Can Participate?Infant must meet the following criteria:
Principal Investigator, Study ID, Keywords STU00207900 Click to Copy URL to Clipboard infant cerebral palsy atypical motor development typical motor devleopment video recording wireless sensor
For questions about this study, contact: |
The Collaborative, National Quality and Efficacy Registry (CONQUER)The CONQUER Registry will enable researchers to:
Who Can Participate?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) Principal Investigator, Study ID, Keywords STU00207506 Click to Copy URL to Clipboard For questions about this study, contact: |
Testing Intervention Strategies for Addressing Obesity and Binge EatingAdult 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? To find out if you may be eligible, please take our online screener. https://redcap.link/foodsteps Who Can Participate?To be eligible for this study, you must be:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Brain pathophysiology of osteoarthritis painThis 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.
Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00207973 Click to Copy URL to Clipboard For questions about this study, contact: |
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablationTo improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF
Who Can Participate?Primary Inclusion Criteria:
Primary Exclusion Criteria:
Principal Investigator, Study ID, Keywords STU00207885 Click to Copy URL to Clipboard For questions about this study, contact: |
PK and Safety of Commonly Used Drugs in Lactating Women and Breastfed InfantsWe are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of that drug is consumed by breastfed infants.
Principal Investigator, Study ID, Keywords STU00208328 Click to Copy URL to Clipboard For questions about this study, contact: |
The effect of inflammatory bowel disease flares on serum prostate specific antigenThis 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.
Who Can Participate?Men with a confirmed diagnosis of inflammatory bowel disease (IBD) between the ages of 40-69 years old.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(xIRB) Characterization of Lipoprotein Composition and Function in Pediatric Psoriasis Before and After TreatmentThe purpose of this study is to investigate if systemic psoriasis medication changes the makeup of lipoproteins (substances made up of fat and protein), cholesterol, and other proteins in the blood. Who Can Participate?
Principal Investigator, Study ID, Keywords STU00208518 Click to Copy URL to Clipboard For questions about this study, contact: |
Mobile – PrOmoting Wellness after cancER Study: M-POWER Feasibility StudyM-POWER is an 8-week weight loss study in the Department of Preventive Medicine at Northwestern University. The participant will be given a smartphone application and have weekly telephone calls with health coaches. Participants will be asked to track their weight, diet, and activity through the smartphone application and will be asked to recruit a "Buddy" to support them throughout their time in the study. Participants will be compensated for their time in the study. If you are interested in participating, please complete our eligibility here: https://tinyurl.com/2p86cm5a Who Can Participate?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.Principal Investigator, Study ID, Keywords STU00207968 Click to Copy URL to Clipboard For questions about this study, contact: |
The AZITRAMBA trial: Azithromycin treatment for the airway microbiome in asthmaAsthma 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. Who Can Participate?Age 18-55 Currently receiving care from a specialist physician (pulmonologist/allergist) Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Wool Clothing for Atopic DermatitisThis 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.
Who Can Participate?Ages 3 months to 5 years with moderate to severe eczema as determined atinitial visit. Principal Investigator, Study ID, Keywords STU00208730 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB NCI CIRB) CCTG MA.39: TAILOR RT: A Randomized Trial Of Regional Radiotherapy In Biomarker Low Risk Node Positive Breast CancerIn 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.
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
CalorieHarmony for ObesityThe purpose of this study is to learn about the factors that most influence participants in their ability to perform specific daily activities with varying intensity, while also measuring calorie expenditure. Using self-report questionnaires, we will collect a participant's medical history and determine their perceived ability to perform certain activities. We will also use data collected from wearable sensors to build a more accurate energy expenditure estimator. Participants are asked to put on two wearable devices as well as a mask to measure breathing and perform 12 specific physical activities in the lab. The in-lab session lasts 3 hours. Lastly, participants will be asked their opinion about the wearability of the devices. Who Can Participate?This study is looking for men and women who:
Principal Investigator, Study ID, Keywords STU00208545 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB NCI CIRB) NRG GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer.This is a study to look at a different approach to treating endometrial cancer. It is being done to answer the following question: Can we lower the chance of your endometrial cancer growing or spreading by giving a combination of two experimental drugs or one experimental drug rather than the usual approach? The purpose of this study is to compare any good and bad effects of using experimental study drugs cediranib alone, olaparib alone, or a combination of cediranib and olaparib. These drugs could shrink your cancer but they could also cause side effects. This study will allow the researchers to know whether one of these approaches is better, the same, or worse than the usual approach. The usual approach is defined as care most people get for endometrial cancer. Who Can Participate?You may be eligible for this research study if you have endometrial cancer which has grown or has returned after earlier treatment. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Randomized trial of Retropubic versus Single-incision Mid-Urethral Sling (Altis™) for Concomitant Management of Stress urinary incontinence during Native Tissue Vaginal RepairThis 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.
Who Can Participate?You may be eligible for this study if:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Impaired sensorimotor integration for prosodic speech production in Ataxic DysarthriaThis 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.
Who Can Participate?For all participants:For participants with ataxia: For control participants: Principal Investigator, Study ID, Keywords STU00208945 Click to Copy URL to Clipboard For questions about this study, contact: |
BP40283 -Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder and Negative SymptomsThe 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). Who Can Participate?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)
Principal Investigator, Study ID, Keywords schizophrenia schizoaffective psychosis abilify haldol olanzapine risperidone latuda geodon seroquel fluphenazine lithium lamictal voices
For questions about this study, contact: |
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 regurgitationThe 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.
Who Can Participate?Primary Inclusion Criteria: Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
XIRB-A pragmatic trial of home versus office based narrow band ultraviolet B phototherapy for the treatment of psoriasisThe purpose of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband UVB phototherapy for the treatment of psoriasis. Phototherapy delivered at home or the office are both common treatments for psoriasis but it is not known how well they compare to one another. Who Can Participate?12 years or older with plaque or guttate psoriasis predominantly on trunk and/or extremities. Patient needs to be willing to comply with in-office or in-home phototherapy.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced AlopeciaThis study will test if low-dose oral minoxidil has an effect on permanent chemotherapy-induced alopecia (defined as hair loss after the completion of a chemotherapy regimen that persists for over six months). In this study, you will receive the study drug; there is no placebo option. The effectiveness and safety of the treatment will be determined by a range of assessments, including biopsies, images, and subjective evaluation of perceived hair growth. Who Can Participate?Age 18 and above with a diagnosis of permanent chemotherapy-induced alopecia and agree to use contraception for the duration of the study. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
NU 18B05: A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated BreastThe 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.
Who Can Participate?Patients who had radiation for breast cancer in one breast and their other breast has not undergone radiationPrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea.The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).
Who Can Participate?Inclusion Criteria:
Exclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Characterization of the microbiome in cutaneous T cell lymphomaThe purpose of this study is to investigate the organisms that reside on the skin, in the gut, and nasal cavity and study their relationship with Cutaneous T-Cell Lymphoma (CTCL).
Who Can Participate?
Principal Investigator, Study ID, Keywords STU00209226 Click to Copy URL to Clipboard For questions about this study, contact: |
Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). 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.
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 placementALTA 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.
Who Can Participate?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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(xIRB NCI) SWOG 1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast CancerThe 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. Who Can Participate?inflammatory breast cancer who have already had chemotherapy and surgery to remove the cancerPrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects ((≥6 To <18 Years of Age)The purpose of this research study is to see if guselkumab is safe and effective for treating patients with chronic plaque psoriasis, and to find out how long guselkumab stays in and acts on the body and how the body reacts to it. This is shown by laboratory blood tests. Another purpose is to find out if guselkumab can cause side effects (unexpected or unwanted reactions from taking a drug). Who Can Participate?You could be in this study if:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin ConditionsThe purpose of this research is to observe patients with skin conditions in a ‘real world’ setting and to create an patient registry of skin conditions, to better understand these diseases and how they are treated. A patient registry is a collection of information about a group of patients who share a condition or experience. Additionally, researchers are interested in:
Who Can Participate?
Principal Investigator, Study ID, Keywords STU00209616 Click to Copy URL to Clipboard Immune-mediated Inflammatory Skin Condition Atopic Dermatitis Psoriasis Alopecia Vitiligo Hidradenitis Suppurativa
For questions about this study, contact: |
(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 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. Who Can Participate?-Participants must be 18 years of age or older-Participants must be diagnosed with a brain tumor Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)The purpose of this study is to test your tumor tissue for certain biomarker (which may be the cause of your cancers, such as specific mutations in certain proteins). This will help determine your eligibility to participate in either matched sub-studies involving investigational agents that targets the specific mutated protein or alternatively to un-matched sub-studies. Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Modulating stimuli intensity to improve clinical outcomes in aphasia treatmentA 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) Who Can Participate?Diagnosis of aphasia from a single stroke More than 6 months since stroke onset At least 18 years old English-speaking before the stroke Principal Investigator, Study ID, Keywords STU00209618 Click to Copy URL to Clipboard For questions about this study, contact: |
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac SurgeryThis 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.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage (MIND)This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the 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. Who Can Participate?Patients with bleeding in the brain causing a type of stroke (intracerebral hemorrhage or ICH) may be eligible for this study. Principal Investigator, Study ID, Keywords ICH Intracerebral hemorrhage Minimally invasive surgery Stroke MIS Neuroendoscopy Clinical trial Brain hemorrhage Brain bleed
For questions about this study, contact: |
(xIRB NCI CIRB) ETCTN 10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial CarcinomaThe 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. Who Can Participate?Diagnosis ofadvanced urothelial carcinoma · Age of at least 18 years Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
NU MTBC 18M02: International Melanoma Tissue Bank Consortium Site at Northwestern UniversityThe purpose of this research study is to create a MTBC biorepository (the “MTBC Biobank”) of human biospecimens (the “Biospecimens”) and medical and health history information, for example, test and treatment results, age, gender, history of sun exposure (the “Annotating Data”). This part of the project is called the “Biobanking Study”. The second purpose is for MTBC to provide the Biospecimens and/or Annotating Data from the MTBC Biobank to researchers around the world for them to use in specific studies in order to study melanoma (“Future Use Study). Melanoma is a lethal form of skin cancer and more research is necessary to help scientists to understand what causes it, how to diagnose it, how it can be prevented, and how it can be treated. To do this research, scientists need biospecimens (like biopsied tissue and blood samples) from people who have been diagnosed with melanoma and other skin disorders. This study will help scientists learn about melanoma and the projects being conducted on behalf of the Melanoma Tissue Bank Consortium(“MTBC”).
Who Can Participate?We are asking you to take part in this research study because you have melanoma or another skin disorder.Your participation is completely voluntary. You may choose not to take part.Your decision to sign this informed consent and authorization form in order to participate in the Biobanking Study and to allow the use of your Biospecimens and Annotating Data in a Future Use Study will not change the treatment you receive for your skin disorder. Principal Investigator, Study ID, Keywords STU00209847 Click to Copy URL to Clipboard For questions about this study, contact: |
Radicava® (Edaravone) Biomarker Study in Participants with Amyotrophic Lateral SclerosisThis 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. Who Can Participate?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 criteria2. 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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 NaïveWe 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. Who Can Participate?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).Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 DecompensationNon-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).
Who Can Participate?You may qualify for this study if you have been diagnosed with NASH or are suspected ofhaving NASH (fatty liver disease).
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A041702: A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)This study is being done to answer the following questions:1. Is adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plusobinutuzumab) better, the same as, or worse than the usual treatment alone for untreatedolder patients with CLL?2. Can patients who have no detectable CLL after a year of receiving the usual treatmentplus the new anti-cancer drug discontinue therapy?
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Yttrium-90 Radiation Lobectomy: Dose Optimization and Prediction of FLR Hypertrophy to Enable Resection of Hepatic MalignanciesIn 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. Who Can Participate?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 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder CancerThepurpose of this study is to compare the effects, good and/or bad, ofchemotherapy and radiation therapy with or without the use of atezolizumab,which is used to treat bladder cancer. The combination of chemotherapy,radiation therapy and the immunotherapy atezolizumab is consideredexperimental.
Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Natural history study of ALS and other motor neuron disordersThis 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. Who Can Participate?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 Principal Investigator, Study ID, Keywords STU00209860 Click to Copy URL to Clipboard For questions about this study, contact: |
A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE – Protocol 402-C-1808FALCON 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.
Who Can Participate?18 to 70 years of ageDiagnosed with ADPKD Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
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 donorsResearch 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.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Parkinson’s Foundation Genetic Research InitiativeThe 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). Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(XIRB) DRUG IMSA101-101: Phase I/IIA Safety and Efficacy Study of IMSA101 in Patients with Advanced Treatment-Refractory MalignanciesThe 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. Who Can Participate?All adult subjects ages 18 and above with advanced cancer that is no longer responding to standard of care treatment are eligible to participate.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval StudyThis 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).
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
BTCRC HN17-111: Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinomaThis study is being done to study two investigational drugs called pembrolizumab and goserelin to see if they shrink your cancer or stop it from growing.
Who Can Participate?You may be eligible for this research study if you have salivary gland carcinoma that has grown or has come back after treatment.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated REnal Cell CancEr [PDIGREE]This study is being done to answer the following question: Can we prolong life for patients with advanced kidney cancer, by adding a drug called cabozantinib to another treatment after receiving the standard treatment? We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer. Who Can Participate?-Participants must be 18 years of age or older-Participants must be diagnosed with advanced kidney cancer Principal Investigator, Study ID, Keywords kidney cancer Renal Cell Carcinoma Metastatic Cabozantinib Nivolumab Ipilimumab Immunotherapy Chemotherapy
For questions about this study, contact: |
A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSORMASKED, ACTIVE COMPARATOR STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA (PAGODA)The purpose of this study is to compare the effects, good or bad, of ranibizumab when it is delivered by an ocular (eye) implant (also known as the Port Delivery System with ranibizumab, or PDS) versus ranibizumab delivered by injections into the eye as treatment for your DME. The ocular 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. Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Parkinson's Disease: Intervening Early Concerning Employment (PIECE) Aims 2 and 3Partner 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.
Who Can Participate?You are eligible to participate if you meet all of these main criteria:
Principal Investigator, Study ID, Keywords STU00210681 Click to Copy URL to Clipboard For questions about this study, contact: |
(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 PeritoneumThe 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. Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Project 1, Adaptations of the Brain in Chronic Pain with Opioid ExposureIn 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.
Who Can Participate?Must have a history of chronic 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 access to a pain diary website. Must be on regular opioid therapy for at least 3 months. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain MetastasesThe 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. Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
AtRial Cardiopathy and Antithrombotic Drugs In prevention After Crypotgenic Stroke- Cognition and Silent InfarctsARCADIA-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.
Who Can Participate?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.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) (Protocol #: B01-04)A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem®, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.
Who Can Participate?Primary Inclusion Criteria:
Primary Exclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson’s Disease (Protocol# 254PD101)The purpose of study is to determine whether BIIB094 may improve PD symptoms in subjects with or without changes in the LRRK2 gene. The study medication will be given as an injection into your back near the spinal cord. This iscalled an “intrathecal” injection.
Who Can Participate?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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Pathogenesis of Heart Failure with Preserved Ejection Fraction in Chronic Kidney DiseaseHeart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes. Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early changes in cardiac function and poor knowledge of CKD-specific mechanisms for both HF and heart failure with preserved ejection fraction (HFpEF). Who Can Participate?Inclusion Criteria:Inclusion criteria for all: >18 years of age Inclusion criteria for CKD: eGFR 20-60 ml/min/1.73m2 on stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker, unless contraindicated. Inclusion criteria for the non-CKD group: eGFR >60 ml/min/1.73m2 and UACR <30 mg/g. Exclusion Criteria: Exclusion criteria for all: presence or history of diabetes, coronary revascularization within the last 6 months, hemodynamically significant valvular disease, significant lung disease requiring home oxygen, angina, non-revascularized myocardial ischemia, systolic BP <100 or >180 mmHg, pregnancy, clinical HF symptoms, history of systemic disease processes that can cause HFpEF, such as amyloidosis or sarcoidosis, any musculoskeletal or chronic condition that will interfere with completion of cardiac testing, or active cancer, immunosuppressive therapy. Participants will also be excluded from continuing in the study if the pre-exercise echocardiogram demonstrates a reduced ejection fraction ≤50% or hemodynamically significant valvular disease at the baseline study visit. Exclusion criteria for the non-CKD group: eGFR <60 ml/min/1.73m2 and UACR >30 mg/ Exclusion criteria for CKD: currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy, SGLT2i hypersensitivity, liver disease, ALT/AST> 3x normal, history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months. Principal Investigator, Study ID, Keywords STU00210997 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB) Social Processing in Remitted Adolescent DepressionParticipate 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. Who Can Participate?Eligibility Criteria:
Principal Investigator, Study ID, Keywords STU00211494 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB) NCI CIRB ECOG-ACRIN 2182: A Randomized Phase II Study of De-Intensified ChemoRadiation for EarlyStage Anal Squamous Cell Carcinoma (DECREASE)This study will helpthe study doctors find out if this different approach is the same as the usualapproach. To decide if it is aseffective, the study doctors will be looking to see if the study approach showsat least the same results as the normal approach. This study has 2 studygroups. · 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. Who Can Participate?Participants who are 18 years of age or older with anal cancer will beinvited to participant in this study.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Right Ventricular Ischemia and Fibrosis in Chronic Thromboembolic Pulmonary Hypertension (CTEPH)This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH.
For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart). Principal Investigator, Study ID, Keywords STU00210998 Click to Copy URL to Clipboard For questions about this study, contact: |
NU 19H08: Signal Transduction of Type I Interferons in Malignant CellsThis is a lab study of a group of diseases called myeloproliferative neoplasms (MPN). MPN is abnormal blood coagulation (abnormal or irregular blood clotting) and includes polycythemia vera (PV) and essential thrombocytosis (ET). The purpose of this research is to learn more about how a drug called interferon stops the growth of MPN blood cells in the laboratory. Alpha-interferon is a natural protein present in the body in small amounts. Treatment with interferon is known to have significant activity in MPN, but the way that this drug works is not fully known.
Who Can Participate?
Principal Investigator, Study ID, Keywords STU00211647 Click to Copy URL to Clipboard For questions about this study, contact: |
Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complicationsProstate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate. However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually. Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor. Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge. Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers. Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer. This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice. Who Can Participate?This study will include allmen who are recommended to undergo prostate biopsy as part of routine clinicalcare.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
DRUG CKAZ954A12101: A Phase I/IB, Open-label, Multi-Center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients with Advanced Solid TumorsThe purpose of the study is to identify the best dose and treatment schedule of KAZ954 alone,and with Spartalizumab (PDR001), NIR178 or NZV930 that can be given safely to patients with cancer.
Who Can Participate?All patients age 18 and above who have advanced cancers are eligible to participate.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
xIRB ALLFTD: ARTFL-LEFFTDS LONGITUDINAL FRONTOTEMPORAL LOBAR DEGENERATIONALLFTD is a comprehensive study targeting most varieties of frontotemporal lobar degeneration (FTLD). FTLD is a neurological disease that causes Frontotemporal Dementia (FTD) syndromes including Primary Progressive Aphasia (PPA) and Behavioral Variant Frontotemporal Dementia (bvFTD), among others. This study is an international multi-site study and Northwestern University is one of 19 sites. The overall goal of ALLFTD is to prepare for treatment trials in FTLD by focusing on several major activities: 1. Characterizing FTLD patients (including familial FTLD [f-FTLD] and sporadic FTLD [s-FTLD]) followed at expert centers who can potentially be available for treatment trials 2. Collecting comprehensive cognitive and behavioral assessment data, in addition to imaging, blood, and cerebrospinal fluid (CSF), with the following goals: o Identifying the best clinical measurements and biomarkers for following patients with FTLD in treatment trials o Identifying clinical measurements and biomarkers that indicate when a person with a high risk of developing FTLD due to a mutation will begin to have symptoms. 3. Sharing clinical data, images and biological samples from participants affected by FTLD with the scientific community to address additional scientific questions about FTLD Who Can Participate?ALLFTD includes symptomatic and “at-risk” participants. FTLD may be sporadic, with no known cause. It may also be familial, due to genetic mutations. We are still learning about mutations that cause FTLD, so a strong family history of FTLD is sufficient to enroll as: Familial FTLD (f-FTLD). You are eligible to enroll in the familial FTLD cohort if 1) you have a mutation in one of the three most common genes associated with FTD –microtubule associated protein tau (MAPT), progranulin (GRN), or chromosome 9 open reading frame 72 (C9orf72), regardless of whether you have symptoms or not, 2) you have a blood relative with a mutation in one of those genes, or 3) you have a strong family history of FTLD but no genetic mutation has been identified. Sporadic FTLD (s-FTLD). You are eligible to enroll in the sporadic cohort of the study if you have one of the following FTLD spectrum diagnoses: frontotemporal dementia, primary progressive aphasia, progressive supranuclear palsy, corticobasal degeneration syndrome, or frontotemporal dementia with amyotrophic lateral sclerosis Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Large Vessel Vasculitis Tissue Registry and Repository (LVVRR)The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become inflamed, commonly causing headaches, joint pain, facial pain, fever, and difficulties with vision.
We will study the gene expression (i.e., the genes that are being "read" to make proteins) in these immune cells, with a special focus on macrophages (one type of cell in the immune system). We will compare the gene expression in patients with vasculitis to the gene expression in people without vasculitis to determine what goes wrong in patients with this condition. If we can identify the molecular pathways that are affected in vasculitis, we can begin to develop treatments that will target these pathways. This may help us predict which patients will respond to treatment in the future. Patients who participate in this research will:
Participants will be given a stipend after the samples (blood and biopsy) have been collected. Who Can Participate?For Vasculitis Patients:
For Controls:
Principal Investigator, Study ID, Keywords STU00210635 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB) Study in Parkinson Disease of Exercise Phase 3 Clinical TrialThis study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months. Subjects will be randomly assigned to 2 endurance exercise groups: 1) moderate intensity exercise: 60-65% HRmax or 2) high intensity exercise: 80-85% HRmax. The endurance exercise will be 4 days per week for approximately 30 minutes per session for 18 months. Who Can Participate?-Diagnosis of Parkinson's disease for less than 3 years -Cannot be treated with any PD medication Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
XIRB A master protocol for randomized, placebo-controlled, Phase 2 clinical trials of multiple interventions for the treatment of chronic painThis study is a master protocol to accelerate the development of treatments for chronic pain. The chronic pain conditions being studied are osteoarthritis, chronic low back pain and diabetic nerve pain. The study is being done to see how safe different investigational drugs are and how well they may work to help people with these conditions.
Who Can Participate?Subjects must:-have osteoarthritis pain, or chronic low back pain, or diabetic nerve pain -have a BMI less than 40kg/m2 -be willing to discontinue any other pain medications Subjects must not: -have any ongoing medical condition that would limit subject participation -have any surgeries planned during the study -have had cancer within 2 years of the first visit, other than basal cell or squamous cell skin cancer -have substance use disorder -have a positive HIV test result at screening -have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to first visit -have participated within 30 days in a clinical study involving an investigational intervention -have current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding the pain condition, or any closed claim Principal Investigator, Study ID, Keywords pain chronic pain osteoarthritis knee pain joint pain arthritis chronic low back pain back pain low back pain diabetic nerve pain neuropathy peripheral neuropathy diabetic pain
For questions about this study, contact: |
(xIRB) DRUG JCAR017-FOL-001: A Phase 2, Open-Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of jcar017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL) (Transcend FL)The purpose of this research study is to determineif the experimental therapy called JCAR017 is effective and safe to treatFollicular Lymphoma or Marginal Zone Lymphoma. This study will have 4 cohorts or patientgroups. Assignment to one of these patient groups depends on if you haveFollicular Lymphoma or Marginal Zone Lymphoma and the number and type oftreatments that you have received in the past, as well as how long it took foryour lymphoma to return after your last treatment. Everyone in all 4 patientgroups will receive the same dose of JCAR017 T cells. JCAR017 is a type oftherapy known as chimeric antigen receptor (CAR) T cell therapy which isco-developed with Juno Therapeutics. The visit schedule will also be the samefor all 4 patient groups. At the time you decide to take part in the study andgo through the screening procedures, it will be determined which patient groupyou will be assigned to. In this study, your immunecells will be collected from your blood in a procedure called leukapheresis.The T cells will be separated from the collected immune cells and will bemodified in a laboratory. In the laboratory, a new gene will be put into your Tcells using genetic modification techniques. After they have been modified, thecells will be grown in the laboratory to reach the expected dose for thetreatment. Adding in the new gene may enable your T cells (now called JCAR017 Tcells) to bind to the CD19 protein, which your type of cancer cells carry ontheir surface. Binding to these cells activates the JCAR017 T cells, and theyattack the cancer cells. The JCAR017 T cells will persist in your body afterattacking the cancer cells, you will be monitored during the study to evaluatehow long these JCAR017 T cells persist. The JCAR017 T cells will be given backto you via infusion (IV).
Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in the trial. Who Can Participate?Age of at least 18 years Diagnosis of Follicular Lymphoma or Marginal Zone Lymphoma, which has either returned or is not responding toyour current treatment. Follicular Lymphoma and Marginal Zone Lymphoma are twotypes of non-Hodgkin lymphoma (NHL). Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic AneurysmsThis study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research study will look at treating thoracoabdominal or pararenal aneurysm disease with a new device design known as the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (the ‘Study Device’).The Study Device that will be used to treat the aneurysm is called a “stent-graft”. The Study Device combines a surgical graft material with an outer metal mesh-like form (stent). The nonmetal graft component of the Study Device is made of a soft, polymer material (ePTFE). This material is routinely and safely used for surgical procedures throughout the world today. The graft is surrounded on the outside with a metal frame made from an elastic metal (nitinol wire or stainless steel) bent into a wave pattern and shaped to fit the graft. The materials used in the Study Device are not investigational and have a long, safe history of performance in similar applications.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve.
Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward. The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm. Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Comparison of disease knowledge in dyads of parents and their adolescents with chronic skin disordersThe main goal of this study is to understand how much parents and teenagers know about the teenagers’ chronic skin condition. Who Can Participate?This study will enroll children ages 12 to 17 years of age with a diagnosis of psoriasis, atopic dermatitis (eczema), or ichthyosis. Both the child and participating parent must speak English. Principal Investigator, Study ID, Keywords STU00212092 Click to Copy URL to Clipboard For questions about this study, contact: |
TeleHD: Feasibility, validity, and value of telemedicine for motor and non-motor assessments in patients with Huntington’s Disease (HD)The purpose of this study is to determine if it possible to conduct clinic visits through telemedicine for patient's with Huntington's disease. Patients will not have to come into clinic to be a part of this study. All study assessments will be conducted via telemedicine.
Who Can Participate?To be included in this study, Individuals must have a diagnosis of Huntington's Disease, be between the ages of 18 and 70, speak fluent English and have a personal computer, laptop, tablet, or smartphone equipped with highspeed internet, camera, and microphone in order to facilitate the telemedicine visits. Principal Investigator, Study ID, Keywords STU00211872 Click to Copy URL to Clipboard For questions about this study, contact: |
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized AdultsACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir in adult patients hospitalized with COVID-19 and requiring supplemental oxygen administered by low flow, high flow, or non-invasive mechanical ventilation.
Who Can Participate?Hospitalized adults (>18 years) with symptoms suggestive of COVID-19 Illness of any duration and laboratory-confirmed SARS-CoV-2 infection within 14 days Requires low or high flow oxygen devices or non-invasive mechanical ventilation Has not received 5 or more doses of remdesivir as treatment for COVID-19 Has not receive 6mg or more of dexamethasone in one day, on more than one day in the past 7 days Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF OQL011 ON VEGFR INHIBITOR-ASSOCIATED HAND-FOOT SKIN REACTION IN CANCER PATIENTSThis study is trying to determine whether an ointment is safe and effective for the treatment of hand-foot skin reaction induced by VEGRF inhibitors.
Who Can Participate?Participants must be over the age of 18 and have hand-foot skin reaction after taking anti-cancer medications calls VEGRF inhibitors.Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Oxidative Markers and Efficacy in ALS/MND Phenotypes Treated with Edaravone (Loma Linda)We are only recruiting patients who have not started their edaravone treatment. Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611. Who Can Participate?Inclusion: Either possible, probable, or definite ALS,predominantly lower motor neuron disease Predominantly upper motor neuron disease, orbulbar With or without cognitive involvement Willing to participate On no experimental treatment Ages 18 - 85 No prior exposure to Radicava On a stable dose of riluzole for 30 days or offriluzole Male or female Females of childbearing age must usecontraception Exclusion: Unstable medical illness Abnormal liver function (>2x ULN) Unlikely to survive for at least 26 weeks Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain TransitionFinding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors that lead to the development of pain centralization, so that in future studies we can learn more about how to prevent the development of this kind of chronic pain in RA. Participants will complete a total of 3 study visits (baseline, 3 months and 12 months). At each study visit, participants will have a physical exam, have blood drawn, answer questionnaires, and undergo quantitative sensory testing to assess responses to pressure and coldness. A subset of patients who are interested and eligible will undergo a brain MRI at baseline and the 12-month study visit. Participants will receive $50 for the completion of each study visit and an additional $100 for completing each MRI. Who Can Participate?Study participants must be 18 years or older with active Rheumatoid Arthritis and symptoms starting no more than one year prior to study participation. Participants taking pain medications must be on a stable dose for at least 3 months. Patients with Raynauds requiring treatment are not eligible to participate. Participants must refrain from taking prednisone (greater than 10 mg) or opioids within 24 hours of their study visit.Principal Investigator, Study ID, Keywords STU00211593 Click to Copy URL to Clipboard For questions about this study, contact: |
Sensory-specific peripheral stimulation for tremor managementHealthy Participants: The Shirley Ryan AbilityLab is seeking healthy adults to study the effect and ability of muscle stimulation to reduce tremor. We are seeking Healthy adults to participate as a comparison group. During the study, participants will be stimulated with non-invasive muscle electrostimulation and/or transcranial magnetic stimulation (TMS) while seated in a comfortable chair. To measure muscle activity, electrodes will be attached to the forearm. In one visit, magnetic resonance imaging (MRI) will be used to observe your brain. Clinical Participants: The Shirley Ryan AbilityLab is seeking patients with Parkinson’s disease or Essential Tremor, to study the effect and ability of muscle stimulation to reduce tremor. Exclusion criteria include epilepsy/seizures and incompatibility with MRI or transcranial magnetic stimulation (TMS). During the study, participants will be stimulated with non-invasive muscle electrostimulation and TMS while seated in a comfortable chair. To measure tremors, sensors will be placed over the wrist, elbow and shoulder and in some visits to the head. In two visits, magnetic resonance imaging (MRI) will be used to observe the brain. Who Can Participate?Healthy Participants: (recruitment closed)
Clinical Participants:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Positive Affect Regulation sKills (PARK)The Positive Affect Regulation sKills (PARK) Course is an online program that teaches positive emotion skills for individuals experiencing stress as a result of the COVID-19 outbreak, recommended/mandatory social distancing, and other related stressors (e.g., loss of income, shortages of daily essentials, etc.). The program consists of 8 skills aimed at increasing the daily experience of positive emotion to help individuals cope with whatever stress they might be experiencing. The skills are presented over the course of 5 weeks and after learning each skill by reading through content on our platform, there is the opportunity to practice the skill on the platform as well. Who Can Participate?•At least 18 years of age •Speaks and reads English •Able to access the online platform through their phone, a public device (i.e., at the library) or at home •Lives in US Principal Investigator, Study ID, Keywords STU00212262 Click to Copy URL to Clipboard For questions about this study, contact: |
Cure GlomerulonephropathyCure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention. Who Can Participate?
Biopsy-proven Membranous, Minimal Change, FSGS, or IgAN within 5 years of study enrollment Principal Investigator, Study ID, Keywords STU00212470 Click to Copy URL to Clipboard FSGS IgA Nephropathy IgAN Membranous Nephropathy Minimal change disease glomerulopathy glomerular disease
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A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients with Parkinson’s Disease with at Least One GBA1 Mutation (PROPEL, Protocol #: J3Z-MC-OJAA previously called PRV-PD101)PR001A is an investigational gene therapy product that is being developed for the treatment of PD in patients with GBA1 mutations. The purpose of this study is to find out what effects PR001A has on Parkinson’s disease patients. Participants will be assigned to receive one dose of PR001A by injection into the cisterna magna (a large space at the base of the brain).
Who Can Participate?1. 40-75 years of age. 2. Diagnosis of PD with H&Y 3-4. 3. On stable PD therapy for 8 weeks prior to baseline. 4. At least 1 GBA gene mutation. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
The role of the cortex and brainstem in motor preparation for proximal and distal upper extremity movementsThis study will take place over 3, each lasting about 4 hours. First we will do a hearing screening and right handedness screening to make sure you are a good fit for out study. For this study, you will be required to place your arm in a robot that tracks your movement, and then perform arm lifting and hand opening movements. We will measure your muscle placing electrode stickers on your arm, and measure your brain activity by asking your to wear a close fitting mesh cap. During one of the visits, we will also ask you to get an MRI to take a picture of your brain. The MRI scan will take between 5 and 10 minutes. Additionally, you will receive free parking for each visit as well as monetary compensation for your time. Please contact us to learn more information about the study, or if you are interested in participating.
Who Can Participate?In order to be in this study you must be a right-handed individual between the ages of 18-80 years old. We also ask that you have normal hearing and arm function.Principal Investigator, Study ID, Keywords STU00212195 Click to Copy URL to Clipboard For questions about this study, contact: |
NU COVID-19 MSK20H04: Examining COVID19 Course and Outcomes in Patients Previously Diagnosed with Chronic Lymphocytic Leukemia (CLL)This multicenter, retrospective cohort study will include patientstreated at national and international medical centers. Patients will be included if they have a prior diagnosis of CLL, havebeen diagnosed with COVID19, and received care at a participating medicalcenter.
Primary Aim: To determine the 28-daymortality rate from the time of COVID 19 diagnosis for CLL patients infectedwith SARS-CoV2 at MSKCC and other institutions. Secondary Aims: To describe baseline characteristics, prior and current CLL directed therapies, COVID19 clinical course and outcomes for CLL patients infected with SARS-CoV2. To examine relationships between CLL directed therapy and COVID19 disease course and outcomes. To examine current practices regarding management of CLL directed therapy in CLL patients infected with SARS-CoV2. Who Can Participate?Chronic lymphocytic leukemia (CLL) patients diagnosed with COVID19.Principal Investigator, Study ID, Keywords STU00212455 Click to Copy URL to Clipboard For questions about this study, contact: |
NU FC19L02: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smokedThe purpose of this research study is to determine if the combination therapy of carboplatin, pemetrexed, bevacizumab (Avastin) and atezolizumab (Tecentriq) is better at controlling disease progression in patients with sensitizing EGFR mutation induced NSCLC or patients with NSCLC who are never-smokers as compared to the combination without Tecentriq.
All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. A computer will by chance assign patients to one of the two arms in the study. This is called randomization. •Arm A: Carboplatin + Pemetrexed + Avastin + Tecentriq •Arm B: Carboplatin + Pemetrexed + Avastin Arm A: Participants will receive carboplatin, pemetrexed, Avastin and Tecentriq for 4 cycles in the treatment phase, followed by pemetrexed, Avastin and Tecentriq for the rest of the cycles, called the maintenance phase. Arm B: Participant will receive carboplatin, pemetrexed and Avastin for 4 cycles in treatment phase, followed by pemetrexed and Avastin during the following cycles of the maintenance phase. Participants will be asked to take the study drugs as long as they are benefitting from the treatment or their disease does not get worse. Participants will be removed from the study if the study doctor thinks that they have unacceptable toxicities due to the study drug/s and it is in their best interest to stop participating in the study. All the drugs will be administered intravenously on Day 1 of each cycle. Each cycle is made of 21 days. The number of cycles will depend on how participants respond to treatment. During the study, participants will have a CT scan every 6 weeks (every 9 weeks during the maintenance phase). Participants will also undergo a physical exam, blood tests, performance status, and vital signs. Blood will be collected during the study. A biopsy for tissue will be collected if the participant agrees. Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate?Some of the eligibility criteria include: •Stage IV advanced non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation or without a history of smoking •Age of at least 18 years Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Phase II Carboplatin Pemetrexed Bevacizumab Atezolizumab Non-Small Cell Lung Cancer NSCLC EGFR mutation
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Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen. The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting. Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo. The following regimens are active in the trial: Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8 Regimen D - Pridopidine Regimen E - Trehalose New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available. Who Can Participate?The basic eligibility criteria include: 1. Onset of ALS WEAKNESS within the last 3 years.2. FVC (breathing test) > 50% 3. If on riluzole, must be on a stable dose for 30 days. Must not start riluzole during the study. 4. If on radicava, must be on a stable dose for 30 days. Must not start riluzole during the study. 5. Must be able to swallow for the next 6 months 6. No history stem cell treatment 7. No history of cancer within the last 5 years Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Microglia-Specific Transcriptional Signatures in Patients with Neuropsychiatric Manifestations of Systemic Lupus ErythematosusThis study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what goes wrong in systemic lupus. Then, we hope to develop treatments that will target these factors. Who Can Participate?Inclusion Criteria:
Exclusion Criteria:
Principal Investigator, Study ID, Keywords STU00211615 Click to Copy URL to Clipboard For questions about this study, contact: |
The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical - Establishing a Deeply Phenotyped PD CohortThe purpose of this study is to obtaininformation from people with and without Parkinson disease (PD) so thatresearchers may better understand how Parkinson disease progresses, in order toinform better treatments. Participants will have a neurological examination, a brain scan, provide blood samples and complete some questionnaires.
Principal Investigator, Study ID, Keywords STU00212785 Click to Copy URL to Clipboard For questions about this study, contact: |
Screening for Coronavirus Antibodies in Neighborhoods (SCAN)Inthe SCAN study, we are measuring how many people in the Chicagoland area haveantibodies to SARS-CoV-2 (the virus that causes COVID-19), how widespread theinfection has been in Chicago, and whether some neighborhoods had moreinfection than others. By taking part, you will help us find out how many peoplein specific areas have been exposed to SARS-CoV-2, and if these antibodiesprotect people against re-infection.
Who Can Participate?Adults age 18 years and older living in the Chicagoland area or Illinois. Principal Investigator, Study ID, Keywords STU00212472 Click to Copy URL to Clipboard For questions about this study, contact: |
Immune checkpoint inhibitor-associated acute kidney injurySince 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer. These medications have been demonstrated to have great promise for treating a variety of cancers. However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal. Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide. We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors of toxicity and best practices for management.
Principal Investigator, Study ID, Keywords STU00212602 Click to Copy URL to Clipboard |
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) TrialThis study is investigating if participation ina 10-week high-intensity walkingintervention can improve walking balance of individuals who have had an incomplete spinal cord injury.
Who Can Participate?• Age 18 to 75 years • Have an incomplete spinal cord injury • Able to walk 10 meters without physicalassistance. • Able to tolerate 30 minutes of standing. • Must not have severe cardiovascular andpulmonary disease, a history of recurrentfractures, or concomitant neurological injury. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with TocilizumabThis study is enrolling patients who are about to have a heart transplant. After transplantation, or any other major surgery, there will be inflammation in the body. This inflammation can contribute to rejection of the transplanted heart. In addition, the immune system (your body’s defenses to protect against disease) will be activated by the presence of the new heart. Investigators believe that a drug called tocilizumab (ACTEMRA®) might reduce or prevent inflammation and reduce the immune system’s response to the new heart, and that this would improve the long-term health of your new heart. The purpose of this research study is to see if a study drug called Actemra® (tocilizumab) will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Tocilizumab is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and other inflammatory diseases. Tocilizumab has not been used before to treat people who receive a heart transplant. We don’t know if it will be good for people who have a heart transplant. Tocilizumab is not approved by the FDA to treat heart transplant patients, and therefore using it in this study is considered investigational. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
xIRB AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)This study will test an investigational drug called BAN2401 for the treatment of individuals with preclinical Alzheimer's Disease. Participation may last up to 4 years.
Who Can Participate?This study is composed of two research trials aimed at preventing Alzheimer's Disease (AD) dementia. One is called AHEAD-3 and the other is called AHEAD-45. You may qualify to join one of the AHEAD Study prevention trials because you're aged 55-80 years and have normal memory and thinking abilities. General Inclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Prospective evaluation of an applied ATTR-CM Machine Learning model to a health system electronic health record (EHR)This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac amyloidosis”) based on other diagnoses in the medical record. Transthyretin cardiac amyloidosis is a rare disease that results from a protein in the body that becomes misfolded and starts depositing into the heart, a process known as amyloidosis. Because of these proteins getting into the heart muscle, the heart can get stiff and weak, thereby leading to congestive heart failure. Typically this form of heart disease (cardiac amyloidosis) is diagnosed late in its course and it associated with poor survival. However, there are now treatments for this disease, so earlier diagnosis is better. A machine learning (artificial intelligence)-based method to find potential patients with cardiac amyloidosis has been developed. This computer program automates finding patients who may have cardiac amyloidosis based on their other diagnoses in the electronic health record. This study seeks to validate the computer algorithm prospectively to see if it can be useful in patients to determine whether or not cardiac amyloidosis is the cause of heart failure. Principal Investigator, Study ID, Keywords STU00211906 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB) DRUG AVM-003-HC: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant.The purpose of this study is to determine if the study drug, ALVR-105, is safe and works well in the treatment for HC. The study will compare ALVR-105 to placebo in reducing your bladder pain, reducing the amount of blood in your urine, and seeing if specific viruses are lowered in your blood and urine. This is a randomized double-blind study. “Randomized” means that you will be randomly assigned (like the flip of a coin) to receive either ALVR-105, or placebo (inactive substance). You will have a 60% chance of receiving ALVR-105 and a 40% chance of receiving placebo. Your participation in this study will last approximately 6 months and include about 10 study visits to the study site. Some of these study visits will occur when you are already in the hospital in which case the study team will visit you to complete the study visit. In healthy people, T-cells defend the body against viruses. Because of the early stage / premature engraftment and /or immune suppressing therapy given for the HCT, T-cell numbers are low, and it is more difficult for the body to control viruses that are already in your body, but are not active. If you have low T-cell numbers and your body cannot control viruses, some of these viruses can cause HC. Viralym-M (ALVR-105) is a research study medicine that contains T-cells made from healthy human donors to potentially help defend your body against specific viruses. The research study medicine is “investigational.” It has not been approved by the United States Food and Drug Administration (FDA), the health authority that approves new medicine being prescribed for use in the United States. This means that it is not approved to treat patients with hemorrhagic cystitis or any other disease. All prospective patients will undergo screening tests to determine if they are eligible to take part in the study. If you qualify, the research study medicine (ALVR-105 or placebo) will be given to you by an infusion into a vein (IV injection). You will receive a second dose of research study medicine about two weeks after your first dose. Note: This is only a partial description of treatment. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate?Some of the eligibility criteria include: •Age of at least 18 years •Diagnosis of hemorrhagic cystitis (HC) caused by a viral infection after your allogeneic hematopoietic cell transplant (HCT) Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Phase 3 Double Blind Placebo Viralym-M (ALVR-105) Virus-Associated Hemorrhagic Cystitis Allogeneic Hematopoietic Cell Transplant
For questions about this study, contact: |
(xIRB) NCI CIRB ECOG-ACRIN 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance ProgramsThe purpose of this study is tocompare the two approaches for monitoring pancreatic cysts. The doctors want tosee if less frequent monitoring is better or worse than more frequentmonitoring for patients with pancreatic cysts. This study has 2 study groups: Group 1 Participants in this group willget less frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study and repeat the scan 1 year after joining thestudy. If the scans show normal results, scans will be repeated every 2 years.If the scans show abnormal results, participants will receive an endoscopicultrasound. Group 2 Participants in this group willget more frequent monitoring. Participants will receive an MRI or CT imagingscan at the beginning of the study. . The frequency of repeat imaging couldrange from every 6 months to every 2 years, based on the size of theparticipant's pancreatic cyst. Participants will be enrolled forup to five years. Who Can Participate?
Participants between the ages of 50and 75 who have pancreatic cysts will be enrolled into this study. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP)This research is being done to compare treatmentsfor knee osteoarthritis pain.
Knee osteoarthritis (KOA) occurs when the cartilagethat cushions your knee joint wears down over time or from trauma. Symptoms of KOA include pain, swelling,tenderness, stiffness, and loss of flexibility in the knee. People with KOA pain are often treated withopioids, which can lead to opioid addiction. In this study, we are comparing non-opioid treatments in an effort tolessen your pain and improve knee function. If you qualify for this study your participation will last between 18 and 48 months
Who Can Participate?Knee pain Diagnosis of knee osteoarthritisNot Pregnant or breastfeeding Meets American College of Rheumatology Classification criteria for knee osteoarthritis English speaking Internet connectivity Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD)You are invited to participate in a research study at Northwestern University that provides skills and training to fathers who have a partner with prenatal depression. The research study aims to give guidance on how fathers can optimize their support of their partner during this difficult time. ALL SESSIONS WILL BE VIRTUAL.
Who Can Participate?-Pregnant African-American mother and male partner -Available to begin study in 2nd trimester -Mother in treatment for depression with current symptoms -Parents are 18 y/o or older Principal Investigator, Study ID, Keywords STU00212595 Click to Copy URL to Clipboard For questions about this study, contact: |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin GeneThis study will test an investigational drug called AL001 for the treatment of individuals who have a progranulin gene mutation that causes frontotemporal dementia (FTD). Participation may last up to 2 years.
Who Can Participate?You may be eligible to participate if you have a progranulin gene mutation and have been diagnosed with FTD (we call this group of people symptomatic participants). You may also be eligible to participate if you have a progranulin gene mutation but are not diagnosed with FTD and have an increased level of a biomarker called neurofilament light chain (NfL) [we call this group of people pre-symptomatic participants]. General Inclusion Criteria:
Exclusion Criteria:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
COVID Prevention Trials RegistryAfteryou provide consent, you will be asked to complete a survey to collect some informationabout your health and risk of exposure to COVID. The study team may contact you to assess yourpotential eligibility for COVID prevention trials when they open. You may open the consent and registry survey in your web browser by clickingthe link below: COVID PreventionTrials Registry Consent . If thelink above does not work, try copying the link below into your web browser: https://is.gd/NUVaccineStudy
Who Can Participate?The NorthwesternCOVID Prevention Trials Registry is open to all adults who are interested inbeing contacted about upcoming COVID vaccine and other prevention studies.TheCOVID vaccine trials will enrollpersonswhoareatrisk of infection and COVID-19 disease. This· · · - - - Racial/ethnic groups such as African Americans, Latinx, and NativeAmericanpopulations. Principal Investigator, Study ID, Keywords STU00213110 Click to Copy URL to Clipboard For questions about this study, contact: |
Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastomaEligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients. Who Can Participate?Inclusion Criteria: Measurable or evaluable disease For patients with a childbearing potential Exclusion Criteria: Have multifocal disease that cannot be encompassed in the ultrasound fields: Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Human-like Robot Controllers for Enhanced Motor LearningThe Shirley Ryan AbilityLab is seeking healthy adults to study how humans interact with robots to program human-like behavior. This study involves an ankle robot and a lower limb robotic suit that track movements; participants may test only one robot or both. If testing the ankle robot, participants will wear the robot on their dominant foot and move their ankle while sitting. If testing the robotic suit, the participants will wear the robotic suit on both legs and the hips, and perform various movements like standing, squatting, or walking. Who Can Participate?Healthy Participants:
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
NRG HN006: Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity CancerThis study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the usual surgery in extending the time you have without cancer returning? The usual approach is defined as care most people get for this cancer. This study has 2 parts. In the first part,doctors will try to learn the answer to question #1 above. If the answer shows that neck and shoulder function and discomfort is better in patients who have the SLN biopsy, then the study will go on to the second part, and doctors will try to answer question #2. Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(xIRB) NCI CIRB ECOG-ACRIN 2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)The purpose of this study is to determine whether Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan are more effective treatments for vulnerable patients over the age of 70 with newly diagnosed metastatic pancreatic cancer (mPCA). These drugs are already approved by the FDA for use in pancreatic cancer. But, it is unknown which combination is the most effective for vulnerable mPCA patients over the age of 70. This study will help the study doctors find out which approach is better at prolonging the life of patients over 70 with mPCA. To determine this, the study doctors will be looking to see which of the two approaches shows better results. Participants who participate will be randomized to either get Gemcitabine and Nab-paclitaxel every other week or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan every other week. This study has 2 study groups. Group 1 (Arm A) Participants in this group will get the combination treatment of Gemcitabine and Nab-paclitaxel. Group 2 (Arm B) Participants in this group will get the combination treatment of 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan. Your doctor will continue to follow your condition for up to 2 years after you start the study, and watch you for side effects and monitor your cancer. Who Can Participate?Vulnerable patients over the age of 70 with newly diagnosed metastaticpancreatic cancer (mPCA).Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
COVID-19 TestUS an initiative of RADx AcceleRATeD study (Rapid Assessment of Technology for SARS-CoV-2 Detection)We are studying the accuracy and usability of NEW point-of-care COVID-19 diagnostic tests compared to standard laboratory testing. You will be asked to come to our clinic for ONE visit to collect nasal swabs (less than one inch into each nostril) for new and standard tests. You will also complete surveys through a web browser, App on mobile device, or telephone interview with research staff. These surveys take approximately 30 minutes and they collect information on prior COVID-19 testing, COVID-19 exposures, demographics, and brief medical history. Who Can Participate?Adults and children (over 10 years of age) with or without symptoms who are interested in getting tested for COVID-19 and willing to complete on-line or verbal surveys. Principal Investigator, Study ID, Keywords STU00213330 Click to Copy URL to Clipboard For questions about this study, contact: |
Prospective Molecular Profiling To Guide Therapeutic Decision-making in Patients with Advanced Hepatocellular Cancer (HCC): An Insight to Next Generation Sequencing-Matched Systemic Therapy in Liver Cancer (PROTOLIGHT STUDY)Hepatocellular carcinoma (HCC) is the most common form of liver cancer, making up approximately 90% of all liver cancers. It is the fourth largest contributor to cancer-related deaths worldwide. HCC is considered to be a complex tumor. Despite recent drug approvals for HCC, it has become clear that only some populations of patients benefit from certain drugs. This leads researchers to suspect that treatment for HCC would be more effective if we could match specific characteristics of a patient’s tumor with a drug that targets them best. Genomic analysis using an FDA-approved method called Next Generation Sequencing (NGS) could be used to potentially help physicians make such treatment decisions. The purpose of this study is to see how long patients will benefit if genomic analysis of their tumors is used to recommend more targeted treatments for HCC from a number of FDA-approved drugs. Who Can Participate?Eligible participants are at least 18 years of age and have advanced hepatocellular cancer (HCC) or recurrent HCC for which they have not yet received systemic therapy for, and are are not candidates for resection, transplant or liver-directed therapies.Principal Investigator, Study ID, Keywords STU00212975 Click to Copy URL to Clipboard NGS Next Generation Sequencing HCC Hepatocellular Cancer Hepatocellular Carcinoma Genomic analysis Targeted treatment
For questions about this study, contact: |
Impact of immunotherapy-related skin diseases on quality of lifeThe purpose of this study is to characterize the effects of cutaneous side effects from immunotherapies on quality of life. Participants will complete a one time survey.
Who Can Participate?Participants need to be 18 years and older, receiving immunotherapy, and may be experiencing a dermatologic side effect.Principal Investigator, Study ID, Keywords STU00212205 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB NCI CIRB) ECOG-ACRIN 1181: Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response Part 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer) (CompassHER2-pCR)This study isbeing done to answer the following question: Can participantswith HER2-positive breast cancer who have no cancer remaining at surgery(either in the breast or underarm lymph nodes) after 12 weeks of chemotherapyand two HER-targeted therapies eliminate further chemotherapy after surgery? This would be adecrease in the total number of chemotherapy drugs and the amount ofchemotherapy typically received to treat this type of cancer. We are doing thisstudy because we want to find out if this approach can enable you to take fewerchemotherapy drugs than the usual approach for your type of breast cancerwithout compromising your outcome. The usual approach is defined as care mostpeople get for HER2-positive breast cancer. Usual treatment includes additional chemotherapy drugs that might not benecessary, since the HER2-targeted drugs are so effective. The names of thestudy drugs involved in this study are:
All chemotherapy drugs will be givenintravenously through vein for 4 cycles. A cycle consists of 3 weeks. Before surgery, paclitaxel will be givenweekly for 12 weeks; pertuzumab will be given once every cycle; and trastuzumabonce every cycle or once weekly for 12 weeks. Alternatives to paclitaxel include docetaxel that will be given once percycle or nab-paclitaxel that would be given weekly for 12 weeks. Who Can Participate?
Note: This is only apartial list of eligibility criteria. Please contact the Robert H. LurieComprehensive Cancer Center of Northwestern University for complete screeninginformation if you are interested in this clinical trial. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
R1: Telehealth Pain Self-Management for Employed Adults (E-TIPS)The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a wait-list) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a wait-list control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.
Who Can Participate?Inclusion Criteria:
Principal Investigator, Study ID, Keywords Chronic Pain Traumatic Brain Injury Multiple Sclerosis Amputation Spinal Cord Injuries Cognitive Behavioral Therapy
For questions about this study, contact: |
DRUG CCTL019B2003I: Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to provide access for patients with out of specification leukapheresis product and/or out of specification manufactured tisagenlecleucel (CTL019; Kymriah®).The purpose of this Managed Access Program(MAP), which is an intermediate size patient population Expanded Access, is to allowtreatment with tisagenlecleucel (CTL019) for eligible patients diagnosed with B-cell acutelymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of thefollowing criteria: are 1) consistent with the approved prescribing information,2) unable to receive commercially manufactured product due to failure of the incomingapheresis material to meet acceptance specifications or final outgoing productto meet the commercial release specifications or other specification within theprescribing information, and 3) where no overwhelming safety concerns has beenidentified for manufacture and release of the out of specification product. Participation inthis treatment plan involves an experimental approach called gene transfer forALL or large B-cell lymphoma that involves cells in your blood called B cells(your tumor cells and also normal antibody-producing cells). During thistreatment, some of your own white blood cells (T cells) will be taken andchanged to turn against your tumor cells. T cells from your body will bechanged in a way that may allow them to identify and kill your tumor cells.This change may allow your T cells to go to the tumor cells, turn"on" and potentially kill the tumor cells. The modification is doneby gene transfer and results in a genetic change to your T cells. This mayallow the changed T cells to recognize your tumor cells but also normalantibody-producing cells called B cells. These changed cells are calledtisagenlecleucel cells. If you are eligible andchoose to participate in this MAP, you will be asked to come to the doctor’soffice/clinic/study site at least 3 times in order to make sure you areeligible to receive the tisagenlecleucel cells, and to prepare you for theexperimental treatments. Once you receive the tisagenlecleucel cells, acaregiver, relative, or friend should be in your presence at all times for thefirst 10 days to monitor your well-being and contact your study physician incase of fever or changes in your condition. If you become ill, immediatelycontact your study physician. Additionally, you may be required to spend about4 weeks after you have received tisagenlecleucel cells in close proximity tothe trial treatment center while the doctor and study team see how thetreatment is working and monitor your safety.
Note:This is only a partial description of treatment. Please contact the Robert H.Lurie Comprehensive Cancer Center of Northwestern University if you areinterested in this Managed Access Plan (MAP). Who Can Participate?Some of the eligibility criteria include: · Age of at least 18 years Diagnosis of acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse or have been diagnosed with relapsed or refractory large B-cell lymphoma after two or more lines of therapies including diffuse large B cell lymphoma not otherwise specified, high grade B cell lymphoma and Diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma.
Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this Managed Access Plan (MAP). Principal Investigator, Study ID, Keywords Managed Access Program CTL019 CAR-T acute lymphoblastic leukemia ALL large B-cell lymphoma out of specification leukapheresis tisagenlecleucel
For questions about this study, contact: |
Evaluating the EVO treatment optimized for resource constraints: Elements Vital to treat ObesityEVO is a 12-month healthy lifestyle and weight loss research study taking place in the Department of Preventive Medicine at Northwestern University. Researchers are looking to determine the best strategy for weight loss and healthy living. Participants enroll in the 12-month study and receive a free 6-month health program.
Who Can Participate?You are between the ages of 18 - 70 years old. You are NOT currently pregnant, trying to become pregnant, or breastfeeding.You do NOT have an unstable medical condition.You own an Android or iPhone smartphone.You are willing to track your lifestyle behaviors for 6 months, and attend remote sessions with study staff over the course of 12 months.Principal Investigator, Study ID, Keywords STU00212742 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB) DRUG 209626: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants with Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Renal Function (DREAMM 12)The purpose of this study is to find out the relationship between kidney function and safety and pharmacokinetics of the study drug. Pharmacokinetics means study of the movement of drug through the body, and this study will be looking to see if kidney disease affects that movement. Patients with well-functioning kidneys will be invited into the study as well as patients with kidneys that do not work well (or not at all).
This is a study in people with relapsed (returning)and/or refractory (not responding to treatment) multiple myeloma (RRMM) with normal or reduced kidney function to test how the study drug belantamab mafodotin impacts kidney function. There are 2-parts to the study. Participants with RRMM from 4 groups based on how well your kidneys work will be enrolled. The study will include three phases. A Screening phase, a Study Treatment phase, and a Follow-up phase.
The screening assessment will be performed within 21 days before the first dose. After your screening period, if you are eligible, you will need to visit the study site repeatedly (at least every 3 weeks) to receive the study treatment and take part in additional exams, tests, or procedures. Study drug will be infused through a vein over approximately 30 minutes. Study visits will take as little as 3 hours or as much as 12 hours of your time.
Who Can Participate?Participants who are at least 18 years of age or older who have been diagnosed with relapsed or refractory multiple myeloma and who have impaired renal function will be enrolled into this study. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(xIRB) NCI CIRB ETCTN 10300: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy as Frontline Therapy in Patients with Acute Myeloid LeukemiaThe purpose of this study is to compare theusual treatment alone to adding immune system activating therapy, Pembrolizumab(MK-3475), to the usual treatment. This study will help the study doctors findout if this different approach is better than the usual approach. To decide if it is better, the study doctorswill be looking to see if the addition of pembrolizumab results in fewerdetectable leukemia using new methods. Pembrolizumab (MK-3475), is already approvedby the FDA for use in several cancers, including advanced or metastaticsmall-cell and non-small cell lung cancer, melanoma, head and neck cancer,urothelial cancer, hepatocellular carcinoma, gastric cancer, among others. However, Pembrolizumab (MK-3475) is notapproved by the FDA or known to be safe for use in AML either alone or incombination with standard chemotherapy. This study has 2 study groups. You will be putinto a group by chance. You will have anequal chance of being in Group 1 or Group 2 Group 1 Participants in group 1 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive a second roundof the first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine. If you remain in complete remission aftersecond part of therapy, you will be monitored without further therapy for up to3 years. If you proceed with atransplant, you will forgo any remaining protocol-defined therapy. Group 2 Participants in group 2 will get the usualstudy drugs, cytarabine on Days 1-7 and either daunorubicin or idarubicin onDays 1-3. If you have evidence ofresidual leukemia in the bone marrow at Day 14, you will receive second dose ofthe first part of therapy (5+2 chemotherapy), which means cytarabine on Days1-5 and either daunorubicin or idarubicin on Days 1-2. Regardless of your bone marrow findings onDay 14, you will receive Pembrolizumab (MK-3475) IV on Day 8. If you have a complete remission after thefirst part of therapy, you will continue with the second part of therapy thatconsists of up to four cycles of high dose cytarabine with Pembrolizumab(MK-3475). If you remain in completeremission after the second part of therapy, you will be monitored withoutPembrolizumab (MK-3475) therapy on Day 1 of each 21-day cycle for up to 2years. If you proceed with a transplant,you will forgo any remaining protocol-defined therapy. Who Can Participate?Participants between the ages of 18 and 75 who have newly diagnosed AML willbe enrolled into this study. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
xIRB Consortium of Early Arthritis Cohorts USA (CATCH-US) -- A prospective cohort study of adults with new onset inflammatory arthritis symptoms to understand predictors of optimal outcomesThis is an observational research study to provide data to better understand what characteristics and treatment approaches predict an optimal outcome (i.e., remission and no joint damage) in real world patients with new onset RA. We want to learn more about the factors that predict how patients’ disease might progress over time and what their response to treatment might be. Participation involves approximately 10 study visits: every 3 months for the first year, every 6 months until the end of year 2, and at year 3, year 4 and year 5. These visits will be at the time of routinely scheduled visits with the participant's Northwestern rheumatologist. Research procedures include collection of questionnaires and clinical information collected from the patient's rheumatologist at each visit. If participating in the optional biological specimen and genetic testing study component, participants may be asked to give research blood (during standard of care blood draws) and leftover joint fluid collected at the time of standard of care joint aspirations. Who Can Participate?• Age > 18 years at time of referral, AND • Joint symptoms for ≤12 months, AND • At least one of the following (summarized in checklist below): o two (2) or more swollen joints OR o one (1) swollen metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint and any one (or more) of the following:
Principal Investigator, Study ID, Keywords STU00213564 Click to Copy URL to Clipboard For questions about this study, contact: |
NU MSK19H03 : Combination Therapy with Entinostat and Pembrolizumab in Relapsed and Refractory LymphomasAlmost allpatients with relapsed and refractory Hodgkin lymphoma require additionaltreatment. Typical treatments for relapsed or refractory Hodgkin lymphoma inthe United States can include additional chemotherapy regimens such asbrentuximab vedotin, or nivolumab. Webelieve that the addition of entinostat to pembrolizumab may provide benefit tothese patients and without having the need to undergo a stemcell transplant ( SCT) Pembrolizumab has already been approved by theUS Food and Drug Administration (FDA) to treat relapsed or refractory classicalHodgkin lymphoma and other cancers. The combination of Entinostat andPembrolizumab has been tested in patients with lung cancer and has been foundto be safe. Who Can Participate?· Participantsmust be 18 years or older The target populationfor this study is patients relapsed and refractory Hodgkin lymphomaPrincipal Investigator, Study ID, KeywordsFor questions about this study, contact: |
(xIRB) NCI CIRB SWOG 1823: A Prospective Observational Cohort Study to Assess mRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell TumorsThe purpose of this study is for the study doctors to learn if miRNA 371 is useful for predicting relapse in patients with germ cell cancer. A germ cell tumor is a type of cancer that occurs in the ovaries (for females) or the testes (for males). This tumor may also be found in the pelvis along the tailbone, the chest, the abdomen and in other structures of the body, generally along the midline of the body. A sample of your blood will be collected during regular clinic visits to look for the presence of a tumor marker called miRNA 371. The study doctors do not know if the test is as good as the usual care (tumor scans and bloodwork) in predicting when cancer will return (relapse) in patients with germ cell cancer. If better, this blood test could change the way patients are monitored for relapse in the future. If you decide to take part in this study, an extra tube of blood will be collected during your regular clinic visits for miRNA 371 analysis for up to 3 years from enrollment into the study. Who Can Participate?Participants 18 years of age or older who have germ cell cancer will be enrolled. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Tape Strip Analysis in Dermatologic DiseasesThe main purpose of this study is to better understand the characteristics of various dermatologic diseases compared to healthy controls. The research team will do this by acquiring tape strips from subjects, a quick, painless, and non-invasive way to obtain skin cells. This study will collect tape strip samples from a broad range of dermatologic diseases, which may include psoriasis, epidermolysis bullosa, atopic dermatitis, ichthyosis, and other rare conditions, in addition to healthy controls.
Who Can Participate?
Principal Investigator, Study ID, Keywords STU00213591 Click to Copy URL to Clipboard For questions about this study, contact: |
Alliance A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic CancerThis study is being done to answer the following question:
Can we increase the chance of your pancreatic cancer staying away by giving you chemotherapy before and after 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 pancreatic cancer. The usual approach is defined as care most people get for removable pancreatic cancer. Who Can Participate?
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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Feasibility and Acceptability of Virtual Reality for Management of Pain of IBS patients in an Outpatient SettingDo you have abdominal pain from Irritable bowel syndrome? We are recruiting volunteers to participate in an investigational research study to see if virtual reality treatment can help with IBS pain. To qualify patients must: 1) Have a diagnosis of IBS 2) Male or female between 18-75 years old 3) Attend 5 weekly 30 minute virtual reality session at the digestive health center. Who Can Participate?Principal Investigator, Study ID, Keywords STU00212119 Click to Copy URL to Clipboard For questions about this study, contact: |
(xIRB NCI CIRB) ECOG-ACRIN Q172: Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 PneumonitisThis study is being done to answer the following question: Can treatment with either infliximab or Intravenous Immunoglobulin (IVIG) result in improvement in pneumonitis in patients whose pneumonitis has not improved with corticosteroids?We are doing this study because we want to find out if this approach is better or worse than the usual approach for the management of pneumonitis. We also want to find out if either infliximab or IVIG will help patients with pneumonitis that is not improving with corticosteroids.
Who Can Participate?
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. Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Optimization of a mHealth Physical Activity Promotion Intervention with Mindful Awareness for Adolescent and Young Adult Cancer SurvivorsAbout the Study Opt2Move is a 6-month smartphone-based study to help adolescent and young adult cancer survivors become more active. What’s involved? Assessments Complete before starting study and at 3 and 6 months:
Physical Activity Program All Participants
How can I learn more? For questions: Phone: 312-503-3465; Email: O2M@nm.org To complete online screening: https://redcap.link/opt2move Who Can Participate?Who can participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Use of Glenohumeral Injections for Management of Shoulder Pain in Individuals with ALSThe purpose of this study is to develop a practice for measuring the efficacy of ultrasound-guided shoulder joint injections in patients with ALS who have exhibited shoulder pain and/or adhesive capsulitis. Patients will receive corticosteroid injections as part of their normal or standard care for shoulder pain in ALS (not provided by the study). They will then be asked to complete questionnaires at Baseline and over the phone over approximately 3 months.
Who Can Participate?1. Diagnosed with ALS2. Being referred for evaluation for glenohumeral shoulder injections for management of shoulder pain 3. Able to utilize written, typed or verbal communication, independently or with the assistance of a caregiver 4. Able to understand study procedures, answer questionnaires, and provide informed consent Principal Investigator, Study ID, Keywords STU00213465 Click to Copy URL to Clipboard For questions about this study, contact: |
A Prospective and Retrospective Clinical, Histological and Molecular Analysis of the Spectrum of Cutaneous Presentations in Adult Patients Admitted to the HospitalThe purpose of this study is to better characterize and understand the spectrum of skin disease evaluated in the inpatient hospital setting. Who Can Participate?
Principal Investigator, Study ID, Keywords STU00212714 Click to Copy URL to Clipboard For questions about this study, contact: |
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel DeviceThis study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation.
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
ECOG-ACRIN 6192: A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)This study is being done to answer the following question:Can we safely shorten the use of standard of care anti-PD1 therapy for advanced melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy?
Who Can Participate?
Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington DiseaseThe purpose of this study is to evaluate the safety and effectiveness of the study drug, pridopidine,on everyday functioning and daily activities, as well as movement and behaviorin participants with early stage Huntington Disease (HD)
Who Can Participate?1. >25yrs of age. 2. Diagnosis of HD with CAG repeat > 36 Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
xIRB: Comparison of High vs. Standard Dose Influenza Vaccines in Adult Solid Organ Transplant RecipientsThe influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population. Who Can Participate?Criteria Inclusion criteria Exclusion criteria Principal Investigator, Study ID, KeywordsFor questions about this study, contact: |
Serial Monitoring of Circulating Tumor Cells During Radiotherapy for Women with Non-Metastatic Breast Cancer: A Prospective Observational Cohort StudyThe purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient. Who Can Participate?Eligible participants are post-menopausal women that have been diagnosed with non-metastatic, ER-positive and Her2-nonamplifed breast cancer and are planning on receiving radiation and hormone therapy. Principal Investigator, Study ID, Keywords STU00212971 Click to Copy URL to Clipboard |