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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

431 Study Matches

Tissue biopsies for the study of FSHD

A single visit study with muscle and/or skin biopsy / blood draw, performed to determine whether a molecular or cellular defect can be attributed to cells of Fascioscapulohumeral Muscular Dystrophy (FSHD) muscle. This study is recruiting both individuals with genetically confirmed FSHD as well as unaffected healthy (control) individuals.

Principal Investigator: Michael Kyba
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00000409
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Inclusion Criteria:

• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
Exclusion Criteria:

• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
Conditions: Rare Diseases, Heart & Vascular
Keywords: Fascioscapulohumeral Muscular Dystrophy (FSHD), Clinics and Surgery Center (CSC)
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NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC043
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Inclusion Criteria:

• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
Exclusion Criteria:

• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Conditions: Brain & Nervous System, Cancer
Keywords: Brain Cancer, Brain Cancer, Glioblastoma
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Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting (DiRECT)

This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC058
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Inclusion Criteria:

• self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA), or Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• current diagnosis of invasive cancer at stage I-IV
• scheduled to receive anti-PD-1/-L1 ICI-containing therapy as standard of care treatment alone or in combination with co-treatments
Exclusion Criteria:

• identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• diagnosed with melanoma (because melanoma is very rare in AAs)
• received prior immunotherapy for cancer,
Conditions: Cancer
Keywords: Immune checkpoint inhibitor, Cancer, Disparities
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Treatment of Refractory Nausea

We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC057
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Inclusion Criteria:

• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
Exclusion Criteria:

• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Chemotherapy, Nausea
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Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.

Principal Investigator: Nicole Hartung
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC068
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Inclusion Criteria:

• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
Exclusion Criteria:

• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Conditions: Cancer
Keywords: Immunotherapy, Lung Cancer, Lung Cancer, Non Small cell lung cancer, NSCLC, Stage IV lung cancer
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Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

We are studying an internet-based pain coping skills program with pain education for cancer survivors who have persistent pain. Pain severity and interference will be compared to people who receive only pain education. The pain coping program has 8 sessions that are completed in the first 10 weeks of starting the study. The group that receives only pain education will receive access to the program after 6 months. Everyone is followed for 9 months

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC055
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Inclusion Criteria:

• diagnosis of invasive cancer that has been treated with either single therapy or any combination of surgery, radiation, chemotherapy/drug therapy
• may be either off all treatment OR actively receiving anticancer therapy in an adjuvant (after surgery) setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive
• less than/equal to 5 years since the completion of their anticancer therapy
• experiencing continued pain
Exclusion Criteria:

• cancer history of only superficial skin cancers or in situ malignancy
• only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia)
• known or suspected diagnosable substance use disorder or opioid overuse disorder
• enrolled in hospice care or end-of-life palliative care
Conditions: Cancer
Keywords: Cancer Pain, Cancer Survivorship
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A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

We are studying how well radiation therapy with or without olaparib works in treating people with inflammatory breast cancer. Olaparib may keep cancer cells from repairing themselves, making them die. We want to see if adding this drug to radiation therapy is more effective.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC051
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Inclusion Criteria:

• diagnosis of inflammatory breast cancer without distant metastases
• completed neoadjuvant chemotherapy prior to mastectomy
• radiation therapy has not been given to the affected breast
• able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication
Exclusion Criteria:

• active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
• history of uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or extensive interstitial bilateral lung disease
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Inflammatory Breast Cancer
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CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease (MRD)

We are enrolling people who have had complete surgical removal of a stage II or stage III colorectal cancer. We will draw blood samples for circulating tumor DNA (ctDNA) to find out if this blood test can be used to detect recurrence of the cancer. People will be followed for at least 3 years and up to 5 years.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC050
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Inclusion Criteria:

• diagnosis of cancer of the colon or rectum (CRC)
• complete surgical resection, with last surgery occurring within 180 days prior to enrollment
Exclusion Criteria:

• started adjuvant (after surgery) therapy for current CRC diagnosis
• women who are pregnant or breastfeeding
• history of any invasive cancer except non-melanoma skin cancer
Conditions: Cancer
Keywords: Colon Cancer, Colon Cancer, Colorectal Cancer
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A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

We are comparing treatment of early stage, hormone positive breast cancer with and without radiation therapy. One group will receive radiation therapy with endocrine therapy and the other group will receive endocrine therapy alone. We want to find out if there is any difference in how often breast cancer recurs in the same breast.

Principal Investigator: Jocelin Huang
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC044
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Inclusion Criteria:

• completed surgery to remove a breast tumor and there isn't any evidence of remaining tumor.
• Early stage (T1) tumor without lymph node involvement and a Oncotype DX Recurrence Score of less than or equal to 18
• ER and/or PgR positive and HER2 negative tumor
Exclusion Criteria:

• tumor size larger that T1
• surgical procedure was a mastectomy
• any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy given for the currently diagnosed breast cancer prior to study entry
• Women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Radiation, Stage 1 breast cancer. Hormone positive breast cancer
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CANADIAN-AUSTRALASIAN RANDOMISED TRIAL OF SCREENING KIDNEY TRANSPLANT CANDIDATES FOR CORONARY ARTERY DISEASE (CARSK)

The current study is designed to determine which strategy (regular screening or screening only in the presence of symptoms) is more effective in preventing heart attacks in kidney transplant candidates. Another goal of the study is to determine whether biomarker tests are able to predict the need for regular CAD screening tests.

Principal Investigator: Arthur Matas, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018456
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Inclusion Criteria:

• Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
• expected to require further screening for coronary artery disease (CAD) prior to transplant
• anticipated to undergo transplant more than 12 months from date of enrollment
Exclusion Criteria:

• patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease
• patients with other solid organ transplants
• multi-organ transplant candidates
• planned living donor transplant
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Cardiovascular Diseases, End Stage Renal Disease, ESRD, Kidney transplant
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Immune Modulation Associations With Urinary tract Infection In People With Neurogenic Bladder.

The goal of this study is to understand how urine and bladder tissue changes from infection, or a bladder that does not function normally, in people who use a catheter to empty their bladder. This may help future people because it can help determine who needs antibiotics to treat an infection in the bladder, and will help avoid the cost and side effects of using antibiotics in people who do not have a true infection. This study will take less than 1 hour – the time required to provide a urine sample in clinic. Or, if a participant is undergoing bladder Botox injection, the time necessary to participate in the study will add approximately 5 minutes to the total surgery time.

Principal Investigator: Sean Elliott
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019225
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Inclusion Criteria:

• at least 18 years old
• use clean intermittent catheterization (CIC) to empty the bladder
• without diagnosis of neurogenic bladder (NGB)
• OR NGB managed with bladder botulinum toxin injections with/without recurrent urinary tract infection (UTI) (may have an active UTI)
Exclusion Criteria:

• presence of an indwelling catheter (i.e., Foley)
• history of bladder augmentation
• history of urinary diversion
• women who are pregnant
• non-English speaker
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Neurogenic Bladder, Self Catheterization, Urinary Tract Infection, UTI
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison.

Principal Investigator: Melena Bellin
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001256
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Inclusion Criteria:

• diagnosis of acute pancreatitis no more than 90 days ago
Exclusion Criteria:

• definite diagnosis of chronic pancreatitis based on results of scans (study staff will review)
• pancreas tumors
• prior surgery on the pancreas
• pregnancy
• other significant health problems, study staff will review
Conditions: Diabetes & Endocrine, Digestive & Liver Health
Keywords: Diabetes, Pancreatitis, Pancreas
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CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL (CREST-2) PROTOCOL (CREST-2)

CREST-2 is a parallel trial to compare carotid endarterectomy + intensive medical management (IMM) vs IMM alone, and carotid artery stenting plus IMM vs IMM alone in patients with asymptomatic carotid stenosis >70%.

Principal Investigator: Andrew Grande
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000106
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Inclusion Criteria:

• patients at least 35 years old
• confirmed diagnosis of carotid stenosis
• no history of stroke or TIA on the side of the stenosis in the past six months
Exclusion Criteria:

• other significant medical diagnosis (study staff will review)
• taking anticoagulants
• specific exclusion criteria exist for stent and surgery (contact study staff for more information)
Conditions: Heart & Vascular
Keywords: Carotid Stenosis
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Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors&#13;&#10;for Stroke Prevention and Recovery (ASPIRE)

This study will compare the effects of apixaban to aspirin in patients who have atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.

Principal Investigator: Oladi Bentho
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000694
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Inclusion Criteria:

• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
Exclusion Criteria:

• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
• contact study staff for additional exclusion criteria
Conditions: Brain & Nervous System, Heart & Vascular
Keywords: Anticoagulation, Atrial Fibrillation (AF), CVA, ICH, Intracerebral Hemorrhage, Stroke
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Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)

This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.

Principal Investigator: Rene Pierpont
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00016246
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Inclusion Criteria:

• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
Exclusion Criteria:

• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Conditions: Brain & Nervous System, Children's Health, Rare Diseases
Keywords: Healthy control, children, pediatrics, adolescents
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A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)

One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.

Principal Investigator: Gregory Beilman
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00003956
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Inclusion Criteria:

• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
Exclusion Criteria:

• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin
• other medical or mental health diagnosis (study staff with review)
Conditions: Digestive & Liver Health
Keywords: Clinics and Surgery Center (CSC), Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
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MT2013-09C : Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases

This is a treatment protocol for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. There is no research element except the collection of routine clinical data.

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1305M34181
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Inclusion Criteria:

• up to 55 years old
• see link to clinicaltrials.gov for inclusion criteria specific to each type of leukemia
Exclusion Criteria:

• Radiation Oncology will evaluate all patients who have had previous radiation therapy
• pregnant or breastfeeding
• HIV positive
• study staff will review additional exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia
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MT2013-06C : Treatment of graft Failure after HSCT

The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients undergoing a second transplant using a haploidentical donor, an unrelated donor or umbilical cord blood. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.

Principal Investigator: Troy Lund
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1404M49341
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Inclusion Criteria:

• patients with primary or secondary HSCT graft failure
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• uncontrolled infection at the time of transplant
• patients with Fanconi Anemia or other DNA breakage syndromes
Keywords: Clinics and Surgery Center (CSC), Failure, Hematopoietic Stem Cell Transplantation, HSCT
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Use of Continuous Wave Doppler to assess Vascular Malformations in Pediatric Dermatology

The aim of our study is to look at blood flow in various tumors and irregularities located in blood vessels using a handheld continuous wave doppler. Correct and efficient diagnosis of vascular anomalies (outside of what is expected to happen in blood vessels) in pediatric patients will help determine a treatment plan. Blood flow in vascular anomalies has not been well described in the past.

Principal Investigator: Sheilagh Maguiness
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012200
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Inclusion Criteria:

• less than 21 years old
• have a vascular anomaly such as Arteriovenous malformations (AVM), Capillary malformations (CM), Venous malformations (VM), Lymphatic malformations (LM), Pyogenic granuloma (PG), Infantile hemangioma (IH), or Congenital hemangioma (CH)
• being treated at University of MN pediatric dermatology outpatient clinic or the multidisciplinary vascular anomalies clinic
Exclusion Criteria:

• history of any prior surgical, radiologic, medications for treatment (including oral or topical beta blocking agents)
Conditions: Dermatology (Skin, Hair & Nails)
Keywords: Vascular Anomalies
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EX-VIVO TARGETED TREATMENT OF CANCEROUS EXTIRPATED PROSTATE TISSUE

This study focuses on testing new treatments on prostate tissue that has been removed during surgery. All testing is done in a lab setting to help develop and improve potential treatment options.

Principal Investigator: Christopher Warlick, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00010808
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Inclusion Criteria:

• age 18 or older
• scheduled to undergo a radical prostatectomy
• able to understand and provide informed consent
Conditions: Cancer, Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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Intermittent Pneumatic Compression with and without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL (INTERCEDE)

The purpose of this study is to establish whether the device, intermittent pneumatic compression (IPC), both with and without walking exercise, can improve the ability to walk and prevent decline in the ability to walk for people with PAD. Intermittent pneumatic compression consists of blood pressure cuffs that are wrapped around the lower legs (below the knees) that inflate three times per minute. These cuffs may improve blood flow to the lower legs and feet.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013094
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Inclusion Criteria:

• diagnosis of Peripheral Artery Disease (PAD) based on specific criteria that study staff will review
Exclusion Criteria:

• above or below-knee amputation
• wheelchair-bound
• currently have a foot ulcer on bottom of foot or ongoing infection of the toes, foot, or lower extremity
• walking is limited by a symptom other than PAD
• major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months
• already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months)
• non English speaking
• BMI greater than 45kg/M2
• major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness (study staff will review)
Conditions: Heart & Vascular
Keywords: peripheral arterial disease, cocoa, intercede, pad, peripheral artery disease, prove
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A Phase 2, Open-Label, Basket Study of Atrasentan in&#13;&#10;Patients with Proteinuric Glomerular Diseases (AFFINITY)

The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome.

Principal Investigator: Michelle Rheault
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00012146
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Inclusion Criteria:

• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• age 18-70 years for patients in the DKD cohort
• receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks
• there are different requirements for each diagnosis category & study staff will review these
Exclusion Criteria:

• current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy
• history of kidney transplantation or other organ transplantation
• except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months
• blood pressure above 150 mmHg systolic or 95 mmHg diastolic
• history of heart failure or a previous hospital admission for fluid overload.
• history of liver disease
• hemoglobin below 9 g/dL or blood transfusion for anemia within the past 3 months.
• cancer in the past 5 years (except nonmelanoma skin cancer and curatively treated cervical carcinoma in situ)
• women who are pregnant, breastfeeding, or intend become pregnant during the study
• recently received an investigational agent -clinically significant unstable or uncontrolled medical condition (study staff will review)
Conditions: Kidney, Prostate & Urinary
Keywords: Glomerular Disease, Alport Syndrome, IgAN, FSGS, Proteinuric Glomerular Diseases
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Defining Clinical Endpoints in LGMD (GRASP-01-001)

The purpose of this study to learn more about Limb Girdle Muscular Dystrophy by measuring how muscles change over a twelve-month period. Our clinical evaluator will test muscle strength and participants will be asked to complete a series of questionnaires to find out how Limb Girdle impacts daily activities. This information will help plan future studies and drug development for people with LGMD.

Principal Investigator: Peter Kang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001632
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Inclusion Criteria:

• 4 to 65 years of age
• diagnosis of Muscular Dystrophy with weakness in either a limb-girdle pattern, or in a arm or leg
• confirmed mutation in ANO5, CAPN3, DYSF, DNAJB6 or SGCA-G.
Exclusion Criteria:

• bleeding disorder, platelet count less than 50,000, or currently taking an anticoagulant.
• women who are pregnant
• other illness that would interfere clinical trial (study staff will review)
Conditions: Rare Diseases
Keywords: Limb Girdle Muscular Dystrophy, Limb-Girdle Muscular Dystrophy (LGMD), Muscular Dystrophy
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Neuroplasticity in REM Sleep Behavior Disorder

REM sleep behavior disorder may predict the eventual symptom development of Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy. This occurs over years to decades and the sleep disorder may hide other typical symptoms and result in a delay in diagnosis. We are studying the changes in the brain over two years. We will do high field MRI’s (7T) and other tests of neurological function of people who have REM sleep disorder and people who don’t have this disorder (matched for age and sex).

Principal Investigator: Colum MacKinnon
IRB Number: STUDY00016232
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Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord

The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.

Principal Investigator: Dinesh Deelchand
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00009397
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Inclusion Criteria:
We are looking for healthy children volunteers who are: Do not have a history of neurological disorder (stroke, brain, or C-spine injury, etc., and are 6 years of age or older at time of screening.
Exclusion Criteria:

• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
Conditions: Brain & Nervous System
Keywords: MRI, MRS
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teleABLE: Adapting a Behavioral Activation-Based Intervention to Reduce Post-Stroke Sedentary Behavior Using Telehealth (Formative Phase) (teleABLE)

We are exploring ways to increase physical activity after stroke using a web-based rehabilitation program. The purpose of this study is to adapt the Activating Behavior for Lasting Engagement (ABLE) program using video visits so people with stroke can participate from home.

Principal Investigator: Emily Kringle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018044
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Inclusion Criteria:

• experienced a stroke in the last 12 months
• currently spend at least 6 hours per day sitting
• access to a device for virtual video visits
Conditions: Brain & Nervous System, Heart & Vascular, Prevention & Wellness
Keywords: dwell, exercise, occupational therapy, physical therapy, remote, stroke rehab, teleable, virtual
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RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE HER-2 NEGATIVE BREAST CANCER

This study is looking at how well serum tumor markers work to monitor people who have hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. We want to see if using the markers (from a blood sample) is as good as using scans to monitor disease.

Principal Investigator: Nicole Hartung
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC021
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Inclusion Criteria:

• diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative, metastatic (M1) breast cancer
• receiving or plan to receive first-line systemic treatment for metastatic disease
• no other prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years
Exclusion Criteria:

• known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia
• known brain leptomeningeal metastases
• must not be pregnant
Conditions: Cancer
Keywords: Breast Cancer, Breast Cancer, Tumor Markers, Metastatic Breast Cancer
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EA5163/S1709 INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature driven Analysis

We are studying the use of pembrolizumab to treat people who have stage IV non-squamous, non-small cell lung cancer. Pembrolizumab may help the body’s own immune system attack cancer so tumor cells cannot grow and spread. We are looking at when it is most effective to give the pembrolizumab and when to combine it with other anticancer drugs, pemetrexed and carboplatin.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC012
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Inclusion Criteria:

• confirmed stage IV non-squamous non-small cell lung cancer (NSCLC)
• PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells -
Exclusion Criteria:

• Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC
• EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations
• significant gastrointestinal disorders with diarrhea as a major symptom
• history of auto-immune condition (including Guillain-Barre Syndrome or Multiple Sclerosis) requiring ongoing or intermittent systemic treatment in the past 2 years
• pregnant or breast-feeding
Conditions: Cancer
Keywords: Lung Cancer, Lung Cancer, Immunotherapy, Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
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MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)

CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.

Principal Investigator: Christen Ebens
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001764
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Inclusion Criteria:

• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), CGD, Chronic Granulomatous Disease, Gene Therapy, GT, HCT, Hematopoietic Cell Transplant
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Investigating the Effects of VNS on Central Autonomic Network and Interoception

This study is being done to find out if vagus nerve stimulation (VNS) affects how different parts of the brain interact with each other and process information. Participants must be in the REVEAL study and have a new VNS device implanted for treatment of depression. The study will last for about 19 weeks after the VNS is implanted.

Principal Investigator: Ziad Nahas
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021940
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Inclusion Criteria:

• enrolled in a health insurance plan that will cover the costs associated with standard health care services and injuries
• diagnosis of chronic (at least 2 years) or 4 or more recurrent depressive episodes
• VNS therapy recommended for treatment
• has not had an adequate response to four or more adequate antidepressant treatments
• enrolled in the REVEAL CSP or REVEAL AP3 research studies
Exclusion Criteria:

• had a prior implantable stimulation device
• currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• acutely suicidal or made a suicide attempt within the previous 6 months
• additional mental health diagnosis other than depression (study staff will review)
• not able or willing to use their dominant arm, or upper arm circumference is greater than 50 cm
• do not speak English
• women who are pregnant
Conditions: Mental Health & Addiction
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