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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.

103 Study Matches

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.

Status: Recruiting
Contact(s):

Gregory Beilman - beilman@umn.edu

Principal Investigator: Gregory Beilman
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 20365
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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.

Status: Recruiting
Contact(s):

Timothy Krepski - tkrepsk1@fairview.org

Principal Investigator: Margaret MacMillan, MD
Age: Not specified
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 15529
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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 objectives of this study are to assess the following: - Incidence of sustained donor engraftment at day 42 post transplant - Incidence of transplant related mortality (TRM) at day 100 - Overall survival at day 100 and 1 year - Acute GVHD after this second transplant at day 100 and 6 months - Chronic GVHD after this second transplant at day 12 and 24 months

Status: Recruiting
Contact(s):

Timothy Krepski - tkrepsk1@fairview.org

Principal Investigator: Troy Lund
Age: Not specified
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 15449
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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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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.

Status: Recruiting
Contact(s):

Teresa Bekkala - tkivist1@fairview.org

Principal Investigator: Troy Lund
Age: Not specified
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 14660
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Inclusion Criteria:

• up to 55 years old
• diagnosis of any disease for which a second or greater hematopoietic stem cell transplant (HSCT) is needed
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active, uncontrolled infection
• HIV positive
Conditions: Blood Disorders
Keywords: Hematologic Disorders, Hemoglobinopathies, HSCT, Immunodeficiencies, Stem Cell Transplant
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A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study (COMPLETE TAVR)

The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes.

Status: Recruiting
Contact(s):

Julie Longman - longm021@umn.edu

Principal Investigator: Greg Helmer
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 32001
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Inclusion Criteria:

• at least 18 years old
• diagnosis of severe symptomatic aortic valve stenosis and coronary artery disease
• successful transfemoral transcatheter aortic valve replacement (TAVR) defined as the implantation of a single transcatheter aortic valve within the past 96 hours
Exclusion Criteria:

• percutaneous coronary intervention (PCI) already completed less than 90 days before TAVR
• planned PCI or cardiac surgery
• additional significant heart or medical diagnosis (study team will review)
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), Aortic Stenosis, Coronary Artery Disease, TAVR, transfemoral transcatheter aortic valve replacement
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Ten Thousand Families Study

The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

Status: Recruiting
Contact(s):

Clemen Wilcox - clemenw@umn.edu

Principal Investigator: Jen Poynter
Age: Not specified
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 20212
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Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Conditions: Cancer, Microbiota, Prevention & Wellness
Keywords: 10KFS, environment, exposures, family, genetics, glyphosate, lifestyle, Minnesota, PFAS, radon, D2D
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A Phase 2, Open-Label, Basket Study of Atrasentan in
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.

Status: Recruiting
Contact(s):

Anael Kuperwajs Cohen - kuper029@umn.edu

Principal Investigator: Michelle Rheault
Age: Not specified
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 32403
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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: Alport Syndrome, FSGS, Glomerular Disease, IgAN, Proteinuric Glomerular Diseases
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Defining Clinical Endpoints in LGMD (GRASP-01-001)

Limb Girdle Muscular Dystrophy comprise a group of disorders made up of over 30 mutations which share a common phenotype of progressive weakness of the shoulder and hip girdle muscles. While the individual genetic mutations are rare, as a cohort, LGMDs are one of the four most common muscular dystrophies. The overall goal of project 1 is to define the key phenotypes as measured by standard clinical outcome assessments (COAs) for limb girdle muscular dystrophies (LGMD) to hasten therapeutic development.

Status: Recruiting
Contact(s):

Allison Johnston - joh21779@umn.edu

Principal Investigator: Peter Kang
Age: Not specified
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 39368
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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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National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)

This study is a prospective, non-randomized, observational multi-center study, utilizing a quality improvement methodology to facilitate systematic care coordination, interstage cardiovascular monitoring, and nutritional monitoring into every day practice. Utilizes a national registry to document the impact of these changes on various care processes and outcomes. The aim of this Phase II project intends to: 1) develop and support a robust national registry to gather clinical care process, outcome and developmental data on infants with HLHS between diagnosis and the first year of life, 2) engage pediatric cardiology and cardiac surgery programs in using the registry, and 3) use data from the registry to support and monitor the implementation of QI strategies to standardize and improve care for these infants.

Status: Recruiting
Contact(s):

Brittany Faanes - grego318@umn.edu

Principal Investigator: Kavisha Shah
Age: Up to 18 years old
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 23651
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Inclusion Criteria:

• up to 15 months old
• newborns diagnosed with HLHS or other univentricular condition
• intended to undergo Norwood procedure
Conditions: Children's Health, Heart & Vascular
Keywords: Hypoplastic Left Heart Syndrome (HLHS)
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Plasticity of motor systems in early stage Parkinson's disease

The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.

Status: Recruiting
Contact(s):

Madison Aasen - aasen056@umn.edu

Principal Investigator: Colum MacKinnon
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 28055
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Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years
• Able to walk independently Inclusion Criteria For Control Subject Group: Age and sex matched to participants with PD and able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
• Other significant neurological disorders that may affect participation or performance in the study
• Implanted DBS or other neurosurgeries to treat PD
• Pregnant women
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group: same as exclusion criteria of PD group
Conditions: Brain & Nervous System
Keywords: Parkinson
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Measurement of Glucose Homeostasis in Human Brain by NMR: Effect of Recurrent Hypoglycemia on Type 1 Diabetes (Aim 2)

To measure glucose transport in the frontal cortex and hypothalamus in subjects with T1D before and after induction of impaired awareness of hypoglycemia (IAH). Kinetic parameters for glucose transport and metabolism will be measured using hyperglycemic clamps at 3T at baseline and after recurrent HG.

Status: Recruiting
Contact(s):

Diabetes Study - studydiabetes@umn.edu

Principal Investigator: Elizabeth Seaquist
Age: 18 years and over
Phase: NA
System ID: 27975
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Inclusion Criteria:

• 18 to 65 years old
• diagnosis of Type 1 diabetes
• diabetes duration 2 - 30 years
• Hemoglobin A1C less than 8.5%
Exclusion Criteria:

• unaware of hypoglycemia when it is occurring
• pregnant or plan to become pregnant during the study
• uncontrolled hypertension (blood pressure greater than 145/95 mmHg)
• inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 pounds
• other medical or mental health issues (study staff will review)
Conditions: Diabetes & Endocrine
Keywords: Diabetes Mellitus, Type 1
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MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)

This study is evaluating the efficacy of MultiStem (drug) on functional outcome in participants with ischemic stroke.

Status: Recruiting
Contact(s):

Justin Eklund - eklun063@umn.edu

Principal Investigator: Muhammad Affan
Age: 18 years and over
Phase: PHASE3
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 27154
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Inclusion Criteria:

• clinical diagnosis of ischemic stroke involving cerebral cortex
• moderate to moderately severe stroke with a persistent neurologic deficit
Exclusion Criteria:

• stroke involving other areas of the brain
• stroke or head injury within the past 6 months
Conditions: Brain & Nervous System
Keywords: Ischemic Stroke, Stroke
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Post-contracture release radiation for Dupuytren's disease

The purpose of this study is to critically assess the current treatment that patients are undergoing by reviewing routine data collected and adding one additional outcome questionnaire solely for research purposes

Status: Recruiting
Contact(s):

Lydia Golden - golde406@umn.edu

Principal Investigator: Kathryn Dusenbery
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 21650
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Inclusion Criteria:

• at least 18 years old
• diagnoses of Dupuytren's disease
• English-speaking
Exclusion Criteria:

• people who have Dupuytren's disease and are not currently seeking treatment
Keywords: Dupuytren Contracture, Dupuytren's Disease
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Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)

This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.

Status: Recruiting
Contact(s):

Maria Bunch - mbunch@umn.edu

Principal Investigator: Marie Hickey
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 38904
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Inclusion Criteria:

• pregnant women in their second or third trimester with a diagnosis of gestational diabetes
• screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) with screening done between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive a oral glucose tolerance test (OGTT)
• BMI 18.5-45 kg/m2 at first prenatal visit
• age 21-45 at time of delivery
• pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior)
• single pregnancy
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy or lactation
• inability to speak and understand English
• known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• history of type I Diabetes
• mothers currently taking over the counter probiotic preparation
Conditions: Women's Health
Keywords: women's health, pregnancy, pregnant women, gestational diabetes
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RARE-OB-16: Rare CFTR Mutation Cell Collection Protocol (RARE) (RARE)

We are doing the RARE study to learn more about Cystic Fibrosis (CF). CF is caused by mutations in a gene that produces a protein called the cystic fibrosis transmembrane conductance regulator (CFTR). In people with CF, the CFTR does not function correctly. Medications are being developed to help the CFTR function better, but those medications mostly benefit people with common CFTR mutations. There are more than 1,900 mutations of the CF gene. Some of these mutations are rare and found only in a few people. The goal of this research study is to collect specimens (blood, nasal cells, rectal cells) from people with rare CFTR mutations. Another purpose of this study is to create induced pluripotent stem cells or iPS cells. “Pluripotent” stem cells are cells that can be changed into almost any cell type of the body (such as lung or intestine). They can be kept alive and stored indefinitely. There are different kinds of pluripotent stem cells. Inducted pluripotent stem cells can be created from many different kinds of specimens (such as blood, nasal cells, rectal cells). This is different from embryonic stem cells, which can only be derived from embryos. The specimens collected during this study and iPS cells created from them will be stored for use in future research to learn more about CF and study the effect of new medications. This could identify new medications that may help people with rare CFTR mutations.

Status: Recruiting
Contact(s):

Dena Johnson - joh20459@umn.edu

Principal Investigator: Joanne Billings
Age: Not specified
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 19698
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Inclusion Criteria:

• at least 12 years old
• documented diagnosis of Cystic Fibrosis (CF)
• willing to travel (if needed) to a regional study site for cell collection
Exclusion Criteria:

• presence of a medical condition, abnormality, or laboratory value that would place the participant at risk (study staff will review)
Conditions: Rare Diseases, Respiratory System
Keywords: Clinics and Surgery Center (CSC), CF, Cystic Fibrosis
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Pediatric COVID-19: Does infection with the SARS-CoV-2 virus alter brain structure and function?

The goal of the proposed project is to investigate whether brain abnormalities are present in children to young adults after the recovery from coronavirus disease 2019 (COVID-19).

Status: Recruiting
Contact(s):

Monica Bondy - bondy023@umn.edu

Principal Investigator: Igor Nestrasil
Age: Not specified
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 38224
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Inclusion Criteria:

• diagnosis of COVID-19 in the past
• experiencing long covid symptoms for at least 2 months
• 3 to 25 years old at the time of entry into the study
Exclusion Criteria:

• active positive COVID-19 diagnosis (as confirmed by a medical provider &/or certified testing site) for at least 4 weeks prior to projected enrollment date
• surgically implanted pacemaker
• indwelling electronic device, including programmable shunts
• orthodontic braces, unless non-metallic
• implanted metal in the body other than titanium
• inability or unwillingness to complete an MRI
• pregnancy
• anyone not meeting standard MRI requirements according to CMMR protocol (ie presence of metal in body or implanted pacemaker) will be excluded from that portion of the study
Conditions: COVID-19
Keywords: COVID-19, long covid, MRI, Pediatric
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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Status: Recruiting
Contact(s):

Henry Madden - madde123@umn.edu

Principal Investigator: Stephen Huddleston
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 24414
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Inclusion Criteria:

• people who received OCS preserved double lung transplants
• OR people who receive a single lung transplant from OCS preserved lung pairs from either standard criteria donors
• AND all donor lungs that were perfused on OCS Lung System
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), Lung Transplant
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Natural History Study for DNA Repair Disorders

A single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with DNA repair disorders, including Cockayne syndrome (CS), xeroderma pigmentosum (XP), and trichothiodystrophy (TTD).

Status: Recruiting
Contact(s):

Erin Aguero - aguer008@umn.edu

Principal Investigator: Peter Kang
Age: Not specified
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 38563
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Inclusion Criteria:

• at least 6 months old
• diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics
• have one or more of the neurodevelopmental or neurological complications such as gross motor delay, language delay, altered muscle tone (study staff will review)
• family member of an individual with the above condition
Exclusion Criteria:

• prior history of systemic gene or cell-based therapy
• participation in a clinical trial for treatment
Conditions: Rare Diseases
Keywords: Cockayne Syndrome, DNA Repair Disorder, Trichothiodystrophy, Xeroderma Pigmentosum
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Asymmetries in motor control and their impact on functional independence

We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.

Status: Recruiting
Contact(s):

Shanie Jayasinghe - jayas045@umn.edu

Principal Investigator: Shanie Jayasinghe
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 37968
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Inclusion Criteria:

• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
Exclusion Criteria:

• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Conditions: Brain & Nervous System, Community Health, Heart & Vascular
Keywords: stroke, chronic, independence, movement, hemiparesis, deficits, rehabilitation, neuroscience
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Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications

The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1. We will also examine if there is a change in these blood and brain chemicals after participants begin taking oral N-acetylcysteine (NAC), which is available both as a prescription medication and a natural product that has antioxidant and anti-inflammatory effects.

Status: Recruiting
Contact(s):

Reena Kartha - rvkartha@umn.edu

Principal Investigator: James Cloyd
Age: 18 years and over
Phase: PHASE2
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 19782
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Inclusion Criteria:

• 18 years or older
• diagnosis of Type 1 Gaucher's Disease (GD1) who are medically stable
• on a stable medication therapy for 2 years, or if dosage or drug has been changed it has been at least 6 months and condition is stable
Exclusion Criteria:

• women who are pregnant or breast feeding
• asthma that is currently being treated
• unable to have a MRI scan
Conditions: Rare Diseases
Keywords: Gaucher disease
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Wearable monitor for FOG detection

Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.

Status: Recruiting
Contact(s):

Madison Aasen - aasen056@umn.edu

Principal Investigator: Colum MacKinnon
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 31557
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Inclusion Criteria:

• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
Exclusion Criteria:

• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson’s disease, or a family member with a diagnosis of Parkinson’s disease.
Conditions: Brain & Nervous System
Keywords: Parkinson's
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Quality of life in patients who have undergone different treatments for upper airway stenosis

The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.

Status: Recruiting
Contact(s):

Ali Stockness - nicho656@umn.edu

Principal Investigator: Raluca Gray
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 38428
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Inclusion Criteria:

• diagnosis of upper airway stenosis treated with tracheotomy or t-tube.
• seen at the Lions Voice Clinic
• at least 18 years old
• able to complete questionnaires in English without help
Exclusion Criteria:

• require mechanical ventilation
• neurological conditions such as stroke, cerebral palsy, neurodegenerative disease.
• new diagnosis (less than 1 year) of head and neck cancer as the indication for tracheotomy
Conditions: Breathing, Lung & Sleep Health, Ear, Nose & Throat
Keywords: airway stenosis, Clinics and Surgery Center (CSC), Montgomery t-tube, stenosis, t-tube, trach, tracheotomy
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Cortical Inhibitory Biomarkers of Acute Suicidal States in Adolescents

Prospective study investigating brain activity associated with markers of suicidal behavior (SB) in adolescents.

Status: Recruiting
Contact(s):

Ab Flab Study - abflab@umn.edu

Principal Investigator: Charles Lewis
Age: Up to 18 years old
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 31797
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Inclusion Criteria:

• ages 13-21
• current diagnosis of depression
• prior history of either thoughts about suicide, or suicidal behaviors (a suicide attempt or a planned attempt that was stopped before it began)
• must be able to communicate verbally and in writing in English
• parental permission is needed for participants aged 17 or younger
• must have reliable internet connection
Healthy volunteers
also needed
Exclusion Criteria:

• Active substance use in the past month
• Neurological disorders such as seizures, head injury
Conditions: Children's Health, Mental Health & Addiction
Keywords: Adolescent, Depression, Suicide
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Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial

To determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

Status: Recruiting
Contact(s):

Candace Nelson - nelso377@umn.edu

Principal Investigator: James Flaherty
Age: 18 years and over
Phase: PHASE4
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 29879
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Inclusion Criteria:

• undergoing one of the following elective or urgent (but not emergency) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
Exclusion Criteria:

• history of atrial fibrillation or flutter
• Infective endocarditis
• Left ventricular ejection fraction (LVEF) < 30%
• redo surgery
• unable to have a block because of local anesthetic allergy, bleeding problem
• Body mass index > 35kg/m2
• woman who is pregnant
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), AF, Atrial Fibrillation, CABG, Cardiac Disease, Coronary Artery By-Pass Surgery
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Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

Status: Recruiting
Contact(s):

Sandy Bowers - kraus012@umn.edu

Principal Investigator: Melanie Nicol
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 19440
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Inclusion Criteria:

• at least 18 years old
• female, or transgender female with a cervix
• HIV- positive
• on a stable antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks before starting the study
Exclusion Criteria:

• currently pregnant, or previous pregnancy in the past 3 months, or breast feeding
• vaginal infection within 2 weeks before starting the study
• abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior starting the study
• use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to starting the study
Conditions: Women's Health
Keywords: HIV/AIDS, Inflammation Vagina, Menopause
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Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa

The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).

Status: Recruiting
Contact(s):

Emma Rasmussen - rasmu960@umn.edu

Principal Investigator: Carol Peterson
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 29819
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Inclusion Criteria:

• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
Exclusion Criteria:

• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
Conditions: Mental Health & Addiction
Keywords: Bulimia Nervosa
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Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients

This is a prospective study aimed at quantifying walking and balance in patients with parkinsonism in the clinical setting in addition to a living environment setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Demonstrate that parkinsonism patient-specific kinematics can be used to detect postural instability in the clinic using wearable IMUs. 2. Demonstrate that individualized, home-based postural response curves can detect postural instability and prospectively predict fall risk in patients with parkinsonism.

Status: Recruiting
Contact(s):

Thomas Lisko - tlisko@umn.edu

Principal Investigator: Robert McGovern, MD
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 27494
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Inclusion Criteria:

• Anyone who has been diagnosed with parkinsonism including Parkinsons disease, Normal Pressure Hydrocephalus, or atypical parkinsonism
• Healthy adults of similar age as study participants
Exclusion Criteria:

• people who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Conditions: Brain & Nervous System
Keywords: Deep Brain Stimulation (DBS), Falls, Parkinson's Disease
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Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)

This study will be a multi-site, single-blinded, randomized controlled trial (RCT) that will screen older adults with mild cognitive impairment (MCI) using 4 steps (over the phone, in-person interview including informed consent, medical verification, exercise stress test/magnetic resonance imaging [MRI]). We will enroll 128 participants (target 96 completers, assuming 25% attrition rate at 6 months). After baseline assessment, participants will be enrolled and randomized within age (65-74 years of age or ≥75 years of age) and study site (Minnesota or Rochester) strata centrally at the University of Minnesota (UMN) to one of four groups: ACT, cycling only, SOP only, or control with equal allocation and using a randomization scheme generated by our UMN biostatistician (CI: Vock). Group allocations will be concealed to all investigators and data collectors. The interventions will last for 6 months with 12-month follow-up. Outcomes include: 1) cognition: composite measures of executive function and episodic memory, 2) AD signature cortical thickness: composite using structural magnetic resonance imaging (MRI), 3) functional connectivity in DMN: resting-state using functional MRI (fMRI), 4) aerobic fitness, and 5) clinical and pathological AD conversion. Cognition and aerobic fitness will be assessed at baseline, 3, 6, 12, and 18 months; AD conversion at 6, 12, and 18 months; and AD signature cortical thickness and DMN at baseline, 6, 12, and 18 months. PIs Yu and Lin have developed and tested strategies in their preliminary studies to successfully ensure the protection of human participants.

Status: Recruiting
Contact(s):

Russell Spafford - spaff010@umn.edu

Principal Investigator: Dereck Salisbury
Age: 18 years and over
Phase: NA
System ID: 32543
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Inclusion Criteria:
-65 years and older
• diagnosis of Mild Cognitive Impairment
• live in the community
• English speaking
• adequate vision
• physician confirms that exercise is safe
• stable on drugs affecting cognitive and psychological status
• able to have a MRI
Exclusion Criteria:

• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
Conditions: Brain & Nervous System, Community Health
Keywords: cognitive decline, memory complaint, mild cognitive impairment
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A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury

Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.

Status: Recruiting
Contact(s):

Ann Van de Winckel - avandewi@umn.edu

Principal Investigator: Ann Van de Winckel
Age: 18 years and over
Phase: NA
Healthy Volunteers:
This study is NOT accepting healthy volunteers
System ID: 36922
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Inclusion Criteria:

• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
Exclusion Criteria:

• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Conditions: Brain & Nervous System
Keywords: movement, sensation, spinal cord injury, SCI
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Autonomic regulation of blood pressure in premature and early menopausal women

The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.

Status: Recruiting
Contact(s):

Emma Lee - leex4357@umn.edu

Principal Investigator: Manda Keller-Ross
Age: 18 years and over
Healthy Volunteers:
This study is also accepting healthy volunteers
System ID: 23571
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Inclusion Criteria:

• 35 to 70 years old
• experienced premature (less than 40 years old) or early (45 or younger) menopause OR
• premenopausal 35-49 years of age OR
• typical-age menopause who are between 50-70 years old
• menopause will be confirmed by report of amenorrhea for 12 months
Exclusion Criteria:

• nicotine or tobacco use within the past six months
• have diabetes or asthma
• diagnosed significant carotid stenosis
• additional medical diagnosis (study staff will review)
• women who are pregnant or breastfeeding
Conditions: Heart & Vascular, Women's Health
Keywords: Blood Pressure, Early Menopause, Hypertension, Menopause
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