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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.

411 Study Matches

Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial (APOLLO)

The purpose of this study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions. This system allows a bioprosthetic mitral valve (investigational valve) to be implanted through a long, thin, flexible tube that is inserted through an incision in the side of the chest or through an incision made in the groin area and through a vein in the leg. Participation in the study is expected to last approximately 5 years from the day the valve is implanted.

Greg Helmer
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017497
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Inclusion Criteria:

• diagnosis of moderate or severe mitral value regurgitation with symptoms
• multidisciplinary heart team thinks patient is not able to have treatment an approved transcatheter repair or conventional mitral valve procedure
Exclusion Criteria:

• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
Heart & Vascular
Clinics and Surgery Center (CSC), Intrepid, Mitral valve, Mitral Valve Replacement, TAVR

TMS x DPX

We will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while we are measuring the change in brain function with EEG. Please fill out the linked screening questionnaire to determine if you are eligible.

Alik Widge
18 years and over
This study is also accepting healthy volunteers
STUDY00019156
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Inclusion Criteria:

• age 18 to 65
Exclusion Criteria:

• diagnosed with a psychiatric disorder
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of, or recent withdrawal from, medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or have an implanted medical device
Mental Health & Addiction
cognition, EEG, rTMS
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COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00000295
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Inclusion Criteria:

• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
Exclusion Criteria:

• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Cancer
Germ Cell Tumor, Malignant Germ Cell Tumor
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See this study on ClinicalTrials.gov

Robotic Gait Training to Improve Functional Outcomes after SCI

We are researching the benefits of physical therapy guided exoskeleton gait training in people with a spinal cord injury. We want to describe the benefits to overall function and how the brain changes after gait training.

Leslie Morse
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018674
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Inclusion Criteria:

• spinal cord injury level C7-T12
• medically stable, no acute issues that would prevent gaiting
• motor complete (AIS A or B) spinal cord injury OR motor incomplete (AIS C or D) spinal cord injury who use a wheelchair for more than 50% of personal mobility
• height between 155-191cm (5'1" to 6'2")
• weight less than 113kg (248 pounds)
• sufficient upper body strength to complete sit-to-sit transfers
• women of childbearing age must agree to use contraception during study participation
Exclusion Criteria:

• women who are pregnant
• symptomatic orthostatic hypotension
• active Grade 2 or greater pressure ulcer that can be potentially worsened by use of an exoskeleton
• lower extremity contractures that interfere with wearing an exoskeleton
• unhealed lower extremity fracture
• history of neurologic diseases (e.g. stroke, peripheral neuropathy, myopathy)
• active treatment for epilepsy or thyroid disorders
• women with osteoporosis at baseline by DXA scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Spinal Cord Injury (SCI)
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Ankle Position Sense Acuity in People with Parkinson's Disease Experiencing Freezing of Gait and Its Relationship to Gait

This study aims to investigate whether there is difference in ankle position sense acuity between people with Parkinson's with freezing of gait and without freezing of gait. It also examines the relationship between position sense acuity and severity of freezing of gait, and gait measurements.

Juergen Konczak
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019098
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Inclusion Criteria:

• 50 to 80 years old
• diagnosis of idiopathic Parkinsons Disease (PD) as determined by a movement disorder neurologist
• PD severity is mild to moderate
Exclusion Criteria:

• significant central or peripheral nervous system disease
• previous exposure to chemotherapy
• history of lower limb surgery or lower limb fractures within the last 6 months
• amputation or joint replacement of any part of the leg
• implanted deep brain stimulation or other neurosurgery to treat PD
• additional medical factors (study team will review)
Bone, Joint & Muscle, Brain & Nervous System
Parkinson's, Parkinson's Disease
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Profiling of Adipose Tissue Depots and Immune Correlates

This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009134
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Digestive & Liver Health, Diabetes & Endocrine, Prevention & Wellness
abdominal surgery, fat collection
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Study in Parkinson Disease of Exercise Phase 3 Clinical Trial: SPARX3 (SPARX3)

The purpose of this study is to compare the effects of 2 different levels of exercise intensity and to learn more about effects of aerobic exercise for people with Parkinson’s disease (PD). This study will help us better understand what exercise guidelines should be used in the future.

Colum MacKinnon
18 years and over
This study is NOT accepting healthy volunteers
SITE00001163
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Inclusion Criteria:

• 40 to 80 years old
• diagnosis of idiopathic Parkinson Disease (PD)
• less than 3 years since disease diagnosis
Exclusion Criteria:

• currently being treated with PD medications such as levodopa or dopamine receptor agonists, monoamine oxidase-B (MAO-B) inhibitors, amantadine, or anticholinergics
• expected to start medication within six months of starting the study
• previous use of medications for PD for more than 60 days
• exercising at greater than moderate intensity for 120 minutes or more per week consistently over the last 6 months
• known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program
• uncontrolled hypertension (resting blood pressure greater than 150/90 mmHg)
• any medical, mental health, drug or alcohol abuse, assessment or laboratory abnormality that indicates a problem that could limit ability to participate in the exercise program (study staff will evaluate)
• women who are breast-feeding, pregnant, or plan to become pregnant in the next 12 months
• unable to have a brain scan
Brain & Nervous System
Clinics and Surgery Center (CSC), Parkinson Disease, Parkinson's Disease
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See this study on ClinicalTrials.gov

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. Diabetes is a known complication of acute pancreatitis. Diabetes can last a few weeks after acute pancreatitis and get better. Diabetes may not improve after acute pancreatitis. It can also appear a year or more after acute pancreatitis. Little data is available on diabetes after acute pancreatitis. This study will help us better understand diabetes after acute pancreatitis and who is at increased risk of developing it, as well as the different types of diabetes. We are asking participants to take part in this research study who have recently had an acute pancreatitis attack. Participants may be on this study for up to 5 years. There is a screening/enrollment visit, a metabolic visit and 5 year follow-up period. If you had diabetes before your acute pancreatitis attack, your study participation will end after the enrollment visit. If you did not have diabetes before your acute pancreatitis attack, you will return to the clinic for up to 6 more visits. An additional two visits can be done either at the clinic or by phone. If you are diagnosed with diabetes during the follow-up period, you will be asked to come in for an additional visit.

Melena Bellin
18 years and over
This study is NOT accepting healthy volunteers
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
Diabetes & Endocrine, Digestive & Liver Health
Diabetes, Pancreatitis
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See this study on ClinicalTrials.gov

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%.

Andrew Grande
18 years and over
This study is NOT accepting healthy volunteers
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)
Heart & Vascular
Carotid Stenosis
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See this study on ClinicalTrials.gov

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.

Oladi Bentho
18 years and over
This study is NOT accepting healthy volunteers
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
Brain & Nervous System, Heart & Vascular
Anticoagulation, Atrial Fibrillation (AF), CVA, ICH, Intracerebral Hemorrhage, Stroke
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COG ACNS1831 - A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Christopher Moertel, MD
2 years to 21 years old
SITE00000735
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Inclusion Criteria:
Patients must be >= 2 years and =< 21 years at the time of enrollment Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment Patients must have neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery For patients with optic pathway gliomas (OPGs): Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria: Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR [20/80, 6/24, or 2.5/10] or more in one or both eyes) For patients with LGG in other locations (i.e., not OPGs): Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma Patients must have two-dimensional measurable tumor >= 1 cm^2 Patients with metastatic disease or multiple independent primary LGGs are allowed on study Creatinine clearance or radioisotope glomerular filtration Rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender (within 7 days prior to enrollment) as follows: Age; maximum serum creatinine (mg/dL) 2 to < 6 years; 0.8 (male) and 0.8 (female) 6 to < 10 years; 1 (male) and 1 (female) 10 to < 13 years; 1.2 (male) and 1.2 (female) 13 to < 16 years; 1.5 (male) and 1.4 (female) >= 16 years; 1.7 (male) and 1.4 (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL) Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) = 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L Albumin >= 2 g/dL (within 7 days prior to enrollment) Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (within 4 weeks prior to enrollment) Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (within 4 weeks prior to enrollment) Absolute neutrophil count >= 1,000/uL (unsupported) (within 7 days prior to enrollment) Platelets >= 100,000/uL (unsupported) (within 7 days prior to enrollment) Hemoglobin >= 8 g/dL (may be supported) (within 7 days prior to enrollment) Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and gender at the time of enrollment. Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications). Note: Adequate blood pressure can be achieved using medication for the treatment of hypertension All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative* MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed within 4 weeks prior to enrollment The post-operative MRIs should be performed ideally within 48 hours after surgery if possible Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have the ability to swallow whole capsules Patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments All patients and/or their parents or legal guardians must sign a written informed consent. All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible Patients may not be receiving any other investigational agents Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants are not eligible Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo Cardiac conditions: Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented Symptomatic heart failure New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy Severe valvular heart disease History of atrial fibrillation Ophthalmologic conditions: Current or past history of central serous retinopathy Current or past history of retinal vein occlusion or retinal detachment Patients with uncontrolled glaucoma If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN), such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study Treatments and/or medications patient is receiving that would make her/him ineligible, such as: Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E Surgery within 2 weeks prior to enrollment, with the exception of surgical placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt. Note: Patients must have healed from any prior surgery prior to enrollment Patients who have an uncontrolled infection are not eligible
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A Phase II, Open Label, Two Arm Study of Therapeutic Iobenguane (131I) as Single Agent or in Combination with Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects (OPTIMUM Trial) Protocol Number: MIBG 2014-01 (OPTIMUM)

This will be a Phase II, two-arm, nonrandomized, non-comparative, open-label study in participants ≥ 1 year of age with iobenguane avid, recurrent or progressive high-risk neuroblastoma. Participants not eligible for vorinostat treatment may receive 131I-MIBG as monotherapy.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
STUDY00005792
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Inclusion Criteria:

• at least 1 year old
• diagnosis of iobenguane avid, high-risk neuroblastoma, with recurrent or progressive disease at any time
• frontline therapy includes a minimum of 4 cycles of induction therapy at any time
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• less than 12 weeks after myeloablative therapy with autologous stem cell transplant
• receiving hemodialysis
• women who are pregnant or breastfeeding
• significant active infections including active hepatitis B, or hepatitis C infection, or known infection with human immunodeficiency virus (HIV)
Cancer
Neoplasms, Neuroblastoma, Neuroectodermal Tumors
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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.

Rene Pierpont
Up to 18 years old
This study is also accepting healthy volunteers
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
Brain & Nervous System, Children's Health, Rare Diseases
Healthy control, children, pediatrics, adolescents
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Stratifying Patient Immune Endotypes in Sepsis (SPIES Study)

The purpose of this research is to learn more about the immune function of patients who are critically ill and may or may not have sepsis through assessment of blood samples at the time of their illness. We will use the blood to determine whether the immune system is suppressed (slowed or stunted) and measure the amount of suppression. Our research team will compare blood from healthy participants to people who are critically ill to better understand immune system suppression.

Thomas Griffith
18 years and over
This study is also accepting healthy volunteers
SITE00001746
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Inclusion Criteria:

• Adults age 45 and older
• Ability to obtain Informed Consent prior to blood collection.
Exclusion Criteria:

• Current, chronic steroid use
• Pregnancy
• Current or recent (within 7 days) use of antibiotics.
Immune Diseases
Sepsis
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Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement

The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the longterm outcomes and complications over a 5-year period. There are no expected direct benefits to participation in this study however knowledge gained from this research may beneficial to future patients undergoing this procedure. This study does not involve any investigational drugs.

Nicholas Lim
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014403
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Inclusion Criteria:

• at least 18 years old
• scheduled to undergo a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure
Exclusion Criteria:

• women who are pregnant
• undergoing TIPS placement as part of an investigational study
Digestive & Liver Health
Clinics and Surgery Center (CSC), Cirrhosis, Liver Cirrhosis, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
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Genetics of Developmental Disorders - Data and Specimen Repository

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Williams Dobyns
Not specified
This study is NOT accepting healthy volunteers
STUDY00011194
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Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Brain & Nervous System, Rare Diseases, Children's Health
Genetic disorders, developmental brain disorders, developmental disorders
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Food Parenting Practices on Child Dietary Intake

This research is being done to help better understand the ways parents interact with their children at meal and snack times at different time points during the day and in different circumstances. We want to study how the feeding approaches affect the child’s dietary intake over time. Study participation will be two years with activities every six months.

Katie Loth
Up to 18 years old
This study is also accepting healthy volunteers
00018340
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Inclusion Criteria:

• Family attends Fairview Primary Care clinic
• Child between 3-5 years of age
• Caregiver has primary responsibility of feeding child outside of childcare
• Child must live at least 50% of the time or more with the primary guardian
• Caregiver must be able to speak and read English or Spanish
Exclusion Criteria:

• Caregiver is less than 18 years of age
• Child is in the foster system
Children's Health, Community Health
child, children, eat, eating, feeding, food, kid, nutrition, parent, preschool, psychology
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duoABLE: Feasibility of a Behavioral Activation-Based Intervention to Reduce Sedentary Behavior Among People with Stroke and their Caregivers

We are exploring ways to help people with stroke and their caregivers be more physically active in their daily lives. The purpose of this study is to determine whether delivering the web-based Activating Behavior for Lasting Engagement (ABLE) program to duos is a feasible and acceptable approach.

Emily Kringle
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018984
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Inclusion Criteria:

• at least 18 years old
• diagnosed with stroke more than 6 months ago
• report 6 or more hours of sedentary behavior on a typical day
• live in a community-based setting (i.e., personal residence, assisted living facility)
• mobile within the home, with or without an assistive device and without physical assistance
• able to identify an eligible caregiver who will participate in the study who also: reports 6 or more hours of sedentary behavior on a typical day, lives in a community setting and mobile within their home, (with or without an assistive device and without physical assistance)
Exclusion Criteria:

• Stroke and caregiver participants will be excluded if:
• currently receiving chemotherapy or radiation treatments for cancer
• have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinsons disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma)
• received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months
• have a history of skin sensitivity related to adhesives
• pregnant or expecting to become pregnant in the next 2 months
• live in an institutional setting
• currently incarcerated
• stroke participants will also be excluded if they have severe aphasia
Brain & Nervous System
CVA, Stroke, caregiver, physical therapy, rehabilitation, remote, virtual
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20-0001: A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa

We are looking at a new intravenous drug, Bacteriophage, to treat Pseudomonas Aeruginosa in people at least 18 years of age who have cystic fibrosis. The drug is given one time and different doses will be evaluated to see if they work and to look at side effects.

Joanne Billings
18 years and over
This study is NOT accepting healthy volunteers
SITE00001310
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Inclusion Criteria:

• Cystic Fibrosis (CF) diagnosis based on clinical symptoms and confirmed by either an abnormal sweat chloride test or CFTR gene variations
• P. aeruginosa isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months.
Exclusion Criteria:

• body weight less than 30 kg
• Forced Expiratory Volume 1 second less than 20% of predicted value
• women who are pregnant, planning to become pregnant during the study, or breastfeeding
• anticipate change chronic antibiotic regimens during the study
Respiratory System, Rare Diseases
CF, Cystic Fibrosis, P. aeruginosa, Pseudomonas Aeruginosa
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Understanding modifiable barriers to treatment adherence in youth with type 2 diabetes to inform intervention development

This study will seek to learn about barriers to management of Type 2 diabetes for children ages 10-17. This study is recruiting children, and their parent/guardian, who are managing with oral medication or insulin.

Amy Noser
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019484
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Inclusion Criteria:

• 10 to 17 years old
• confirmed diagnosis of type 2 diabetes
• prescribed pharmacologic therapy for treatment of type 2 diabetes (oral medication or insulin)
• live with a parent/caregiver at least 50% of the time who is willing to participate in the study
• able to read and speak English
• the parent/caregiver must be the adult who spends the largest proportion of time caring for the child (or at least 50%) & able to speak and read English
Exclusion Criteria:

• diagnosis of type 1 or monogenic diabetes
• evidence of significant cognitive deficits or a severe, persistent psychiatric disorder
Children's Health, Diabetes & Endocrine
Type 2 Diabetes
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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.

Gregory Beilman
18 years and over
This study is NOT accepting healthy volunteers
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)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
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MT2014-10C : Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

Ashish Gupta
Up to 55 years old
1407M52125
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Inclusion Criteria:
Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated Acceptable stem cell source identified Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score) Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%
Exclusion Criteria:
active, uncontrolled infection pregnant or breastfeeding HIV positive
Clinics and Surgery Center (CSC)
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MT2013-34C: Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia: Standard of Care Considerations

The purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and Bone Marrow Transplant (BMT) databases for patients undergoing a transplant for the treatment of Dyskeratosis Congenita (DC) or Severe Aplastic Anemia (SAA). 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.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
1404M50183
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Inclusion Criteria:
-0 to 70 years old
• acceptable hematopoeitic stem cell donor identified
• Dyskeratosis Congenita (DC) with evidence of bone marrow failure
• Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• women who are pregnant or breast feeding
• uncontrolled infection
Blood Disorders
Clinics and Surgery Center (CSC), Aplastic Anemia, DC, Dyskeratosis Congenita, SAA
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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.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
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
Cancer
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

Troy Lund
1404M49341
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Inclusion Criteria:
Patients with primary or secondary graft failure, as defined below, may receive a second transplant: Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant. Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery. Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood. Recipients should have acceptable organ function defined as: Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments. Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal Cardiac: left ventricular ejection fraction > 40%
Exclusion Criteria:
Uncontrolled infection at the time of transplant. Patients with Fanconi Anemia or other DNA breakage syndromes.
Clinics and Surgery Center (CSC)
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MT2012-11C: Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HSCT. While it will primarily be applied for the treatment of non-malignant diseases (NMD), on occasion it may be used to treat patients with malignant disorders as well.

Troy Lund
Up to 55 years old
1207M17641
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Inclusion Criteria:
Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of "insufficiency of donor chimerism" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations. Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority. Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institutional recommendations. Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease. At the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available. Age, Performance Status, Consent Age: 0 to 55 years Consent: voluntary written consent (adult or parental/guardian)
Exclusion Criteria:
Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI Pregnant or breastfeeding Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted HIV positive While it would be advantageous to begin therapy on this second transplant regimen > 6 months following a prior myeloablative regimen or >2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.
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MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

The primary purpose of this study is to record outcomes and patient characteristics in the Cancer Center’s and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. 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.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
1207M17321
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Inclusion Criteria:

• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Immune Diseases, Rare Diseases
Clinics and Surgery Center (CSC), Allogeneic Hematopoietic Stem Cell Transplant, Primary Immune Deficiencies
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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.

Sheilagh Maguiness
Not specified
This study is NOT accepting healthy volunteers
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)
Dermatology (Skin, Hair & Nails)
Vascular Anomalies
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EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX (ATLAS-NEO)

A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.

Jacob Cogan
Not specified
This study is NOT accepting healthy volunteers
STUDY00017896
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Inclusion Criteria:

• 12 years or older
• diagnosis of severe congenital hemophilia A or B
• participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months
Exclusion Criteria:

• co-existing bleeding disorders other than congenital hemophilia A or B
• current participation in immune tolerance induction therapy (ITI)
• prior treatment with gene therapy
• acute hepatitis, ie, hepatitis A, hepatitis E, acute or chronic hepatitis B infection
• additional exclusion criteria apply (study staff will review)
Blood Disorders
Hemophilia
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Accelerating Therapies for Refractory SJIA Patients

This research study aims to learn more about the causes of Systemic Juvenile Idiopathic Arthritis (sJIA) including its complications such as Macrophage Activation Syndrome (MAS) and sJIA associated lung disease and identify new therapeutic targets. The study is asking for biological samples from those diagnosed with sJIA as well as their family members.

Mona Riskalla
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001576
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Inclusion Criteria:

• at least 6 months old
• new onset SJIA or established SJIA with or without lung and/or liver complications
• parent or sibling of the enrolled child will also be asked to participate
Exclusion Criteria:

• illness sufficient to prohibit study participation
• inability to cooperate with the study
Arthritis & Rheumatic Diseases, Rare Diseases
SJIA, Systemic Juvenile Idiopathic Arthritis
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