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.
The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.
Colleen Correll
All
to 21 Years old
This study is NOT accepting healthy volunteers
1506M74443
1506M74443
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Inclusion Criteria:
Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.
Exclusion Criteria:
• Greater than 21 years of age at the time of enrollment.
In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota, Minneapolis VA, and Allina Health (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.
Anne Joseph
All
55 Years to 79 Years old
NA
This study is NOT accepting healthy volunteers
1506M74221
1506M74221
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Inclusion Criteria:
scheduled or has order for low dose CT screening for lung cancer, or is eligible for screening low-dose CT
current daily smoker (eligible smokers will have smoked during the past 30 days and on at least 5 out of the past 7 days; individuals who have made a recent quit attempt, for example, in anticipation of their low dose CT scan for lung cancer screening, will be eligible if during the last 30 days, when they were smoking regularly, they smoked on at least 5 out of 7 days of the week).
55 to 79 years old,
Interested in quitting and willing to choose a quit smoking date within the next 12 weeks,
voluntary written consent
Exclusion Criteria:
Unstable psychiatric disease, unless stable in treatment for 3 months (smokers on mental health medication with any changes in medication in past 3 months require study MD approval to participate) - Smokers with stable psychiatric disease will be eligible; this baseline characteristic and related symptoms will be considered in analyses,
No hospitalization for mental health reasons in past 3 months; No thoughts of self-harm in past 2 weeks,
No recent cognitive impairment (difficulties planning or organizing daily activities, such as managing finances, having trouble remembering appointments, or forgetting the correct month of the year); participants reporting recent cognitive impairment will be given the 6-item Callahan Cognitive Screener and must score at least a 5 out of 6 to participate,
Participating in a formal quit program (such as tobacco cessation counseling with or without use of NRT, bupropion, or varenicline; Smokers using NRT will be eligible as long as they are not using it as part of a formal quit program),
No phone
Non-English speaking
Current diagnosis of lung cancer
This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
Emily Greengard
All
to 25 Years old
This study is NOT accepting healthy volunteers
1603M85344
1603M85344
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Inclusion Criteria:
Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)
All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
The following other benign/borderline conditions:
Mesoblastic nephroma
Teratomas (mature and immature types)
Myeloproliferative diseases including transient myeloproliferative disease
Langerhans cell histiocytosis
Lymphoproliferative diseases
Desmoid tumors
Gonadal stromal cell tumors
Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
Cytology Specimen Collection Procedure, Medical Chart Review, Cytology Specimen Collection Procedure, Medical Chart Review
This study's primary aims are to define and characterize disease progression for the infantile and juvenile forms of the gangliosidoses, and the late-onset forms of gangliosidosis, including their heterogeneity; and to observe treatment outcomes for any treatments tried. The secondary aims of this study are to understand the neurological involvement in late-onset gangliosidosis; and to collect data on disease progression that can be used for creation of an objective disease stage and severity index.
Jeanine Jarnes
All
This study is NOT accepting healthy volunteers
1007M85712
1007M85712
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Inclusion Criteria:
Subjects must have a documented gangliosidosis disease.
Subjects must be able to complete appropriate neuropsychological and neurobehavioral assessments.
Late-onset gangliosidosis subjects must be able to tolerate a head MRI.
Exclusion Criteria:
• There are no exclusion criteria, beyond a desire not to participate.
Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.
Exclusion Criteria:
To be eligible a person must not:
Have diabetes already
Have a previous history of being treated with insulin or oral diabetes medications.
Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
Have any known serious diseases
Diabetes Mellitus, Type 1
"at risk" for developing type 1 diabetes, T1DM, T1D, juvenile diabetes, Type 1 Diabetes TrialNet, TrialNet
The primary objective of the study will be to further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments. This is meant to be a follow up study of the long term effects of participation in selected completed ITN new-onset T1D studies with immunomodulatory agents.
Antoinette Moran
All
8 Years to 35 Years old
This study is NOT accepting healthy volunteers
STUDY00001310
STUDY00001310
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Inclusion Criteria:
Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
Ability to sign informed consent/assent (as applicable for children).
Exclusion Criteria:
Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
Inability to comply with the study visit schedule and required assessments.
This is prospective, non-interventional, observational study. The main purpose of this study is to develop an algorithm for the early detection of RV dysfunction/failure. The algorithm will be based on the RV pressure waveform gradients (the difference between early right ventricular diastolic pressure and end right ventricular diastolic pressure), RV end-diastolic pressure, and RV contractility (dpdt) and validated through associated clinical measures including perioperative mean arterial blood pressure, advanced hemodynamic measures like cardiac output, stroke volume and systemic vascular resistance, perioperative cerebral oximetry (a measure of cerebral perfusion), intraoperative transesophageal echocardiography and clinical outcomes. These associations will be used to train multiple mathematical models to discriminate between patients with and without RV dysfunction/failure as a primary endpoint. Examining the association between the slope of the diastolic right ventricular waveform (RV end-diastolic pressure, and RV contractility) and perioperative hemodynamics, TEE, cerebral saturation and clinical outcomes will allow us to estimate the specificity and sensitivity of our model.
Tjorvi Perry
Male or Female
18 Years and over
This study is NOT accepting healthy volunteers
STUDY00010185
STUDY00010185
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Inclusion Criteria:
All patients 18 years or older presenting to the University of Minnesota Medical Center for any cardiac surgery with cardiopulmonary bypass (CPB), single or double lung transplantation or liver transplantation.
Exclusion Criteria:
The following patients will be excluded;
? Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
? Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
? Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
? Patients unable to consent to participating in the study
? Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery.
? Patients under the age of 18 years old.
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
Kathryn Dusenbery
All
18 Years to old
This study is NOT accepting healthy volunteers
STUDY00002191
STUDY00002191
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Inclusion Criteria:
Diagnoses of Dupuytren's disease
English-speaking
Exclusion Criteria:
• Patients with Dupuytren's disease who are not currently seeking treatment
Evaluation of Dupuytren's Disease Treatment, Evaluation of Dupuytren's Disease Treatment
Dupuytren's Disease, Dupuytren Contracture, Dupuytren Disease of Palm and Finger, Dupuytren Disease of Finger, Dupuytrens Contracture of Both Hands, Dupuytren's Disease of Palm of Right Hand, Dupuytren's Disease of Palm of Left Hand, Dupuytren Contracture of Right Palm, Dupuytren Contracture of Left Palm, Dupuytren's Contracture Left, Dupuytren's Contracture Right
The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.
Jerica Berge
All
5 Years to 10 Years old
NA
This study is also accepting healthy volunteers
STUDY00000706
STUDY00000706
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STUDY INCLUSION CRITERIA
The inclusionary criteria used to select participants for the proposed study includes:
Boys and girls (n=525) ages 5-10 years old who attend a University of Minnesota Physicians (n=4) or Fairview (n=8) primary care clinic and their primary caregiver (e.g., mother, father, grandparent) and at least one sibling. A second primary caregiver and other family members can also participate.
Must eat ≤3 family dinner meals per week. Research shows that youth who have more than three family meals per week are less likely to be obese ten years later. Thus, families who report three or fewer family meals per week will be recruited to optimize the potential for change in family meal frequency. Families will focus on the family dinner in the intervention to improve their family meal quality and quantity. This decision is based on: (1) Family Systems Theory, which indicates that change in one setting (e.g., family dinner) will generalize to other settings (e.g., breakfast, lunch, snacks).
Child with age and sex adjusted BMI ≥75th percentile (no upper limit).
One of the following race/ethnicities: African American, Hispanic/Latino, Native American, Asian American, or White. In order to examine racial/ethnic differences in study hypotheses, equal numbers of children per racial/ethnic group (total=525) will be recruited.
Parent and family members who speak English or Spanish.
Not expected to move within the next two years.
STUDY EXCLUSION CRITERIA
The exclusionary criteria used to exclude participants from the proposed study includes:
Children with medically necessary dietary restrictions (reviewed by MD from primary care clinics).
Non-custodial parents, who the child does not live with more than 50% of the time.
In-home Visits and Food Preparation Activities, Ecological Momentary Intervention, Feedback on Video-recorded Family Meals, Maintenance, In-home Visits and Food Preparation Activities, Ecological Momentary Intervention, Feedback on Video-recorded Family Meals, Maintenance
Childhood Obesity
Childhood Obesity, Ecological Momentary Intervention, Video Feedback
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
All
18 Years to 68 Years old
N/A
This study is NOT accepting healthy volunteers
STUDY00003956
STUDY00003956
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Inclusion Criteria:
Age 18-68
Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approved for pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committee including surgeons, gastroenterologists specializing in pancreatic disease, a pain specialist psychologist, and endocrinologist to confirm the diagnosis of chronic pancreatitis and candidate suitability for surgery.
Able to provide informed consent
Exclusion Criteria:
Pre-Existing diabetes mellitus fasting blood glucose>115mg/dl, or hemoglobin A1c level >6.0% because these are all evidence of inadequate beta-cello mass.
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.
ALT or AST>2.5 times the upper limit of normal (ULN). Bilirubin>ULN, unless due to benign diagnosis such as Gilbert's.
Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL), thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L).
Current use or expected use of oral or injected corticosteroids, or any mediation likely to affect glucose tolerance. However, use of hydrocortisone for physiologic replacement, or use of any topical, inhaled or intranasal glucocorticoid is permitted.
Current or expected use of any other immunosuppressive agent.
Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin, enoxaparin), or any history of pulmonary embolism.
For females, plans to become pregnant or unwillingness to use birth control for the study duration.
Inability to comply with the study protocol.
Untreated psychiatric illness that may interfere with ability to give informed consent, or other developmental delay or neurocognitive disorder that impairs with a patient's ability to consent on their own behalf.
Any other medical condition that , in the opinion of the investigator, may interfere wit the patient's ability to successfully and safely complete the trial.
Intrahepatic islets and islets in the omental pouch, Intrahepatic islets alone, Normal Volunteers, Intrahepatic islets and islets in the omental pouch, Intrahepatic islets alone, Normal Volunteers
Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect
information regarding the natural history, health care interactions, participant reported questionnaire data to assess
quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic
pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and
banked for future research projects.
Hyun Kim
All
30 Years to old
This study is NOT accepting healthy volunteers
1408M52921
1408M52921
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Inclusion Criteria:
Willing and able to provide informed consent
Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
Age 30 years or older, or
Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype
Exclusion Criteria:
Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
Currently listed for lung transplantation at the time of enrollment
Currently enrolled in a clinical trial at the time of enrollment in this registry
Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
Subjects willing to provide written informed consent to participate.
KOAR
Exclusion Criteria:
___________________________________________________________
Exclusions for AlloSure® Intended Use
Specimens from patients for whom any of the following are true will not be tested:
Recipients of transplanted organs other than kidney
Recipients of a transplant from a monozygotic (identical)
Recipients of a bone marrow transplant
Recipients who are pregnant
Recipients who are under the age of 18
Recipient who are less than 14 days post-transplant
Donor-derived cell-free DNA (AlloSure®), Standard care, Peripheral blood gene expression profiling (AlloMap Kidney), Analytic platform (IBox), Donor-derived cell-free DNA (AlloSure®), Standard care, Peripheral blood gene expression profiling (AlloMap Kidney), Analytic platform (IBox)
The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.
Irina Stepanov
Male or Female
18 Years and over
Phase 1
This study is also accepting healthy volunteers
STUDY00002033
STUDY00002033
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Inclusion Criteria:
Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
Biochemically confirmed regular smoking status by a NicAlert test level of 6;
Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
Subjects are in good physical health (no unstable medical condition);
Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
Women who are not pregnant or nursing or planning to become pregnant;
Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:
Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
Currently using nicotine replacement or other tobacco cessation products;
Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
Pregnant or breastfeeding;
Failure to agree to take adequate protection to avoid becoming pregnant during the study;
Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
Systolic BP greater than or equal to 160 mm/hg
Diastolic BP greater than or equal to 100 mm/hg
Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
Heart rate greater than or equal to 105 bpm
Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
Expired air carbon monoxide (CO) level greater than 80 ppm;
Self-reported allergies to propylene glycol or vegetable glycerin;
Adverse reactions when previously using electronic cigarettes;
Household member enrolled in the study concurrently;
Unable to read for comprehension or completion of study documents;
Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Standardized Research E-cigarette (SREC), Nicotine Mini-Lozenge, Standardized Research E-cigarette (SREC), Nicotine Mini-Lozenge
This is a prospective, observational study designed to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients.
Timothy Pruett
All
18 Years to old
This study is NOT accepting healthy volunteers
1608M93841
1608M93841
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RECIPIENT ELIGIBILITY CRITERIA HIV-Positive Recipient Inclusion Criteria (liver, kidney)
Participant is able to understand and provide informed consent.
Participant meets standard listing criteria for transplant.
Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA).
Participant is ≥ 18 years old.
No evidence of active opportunistic complications of HIV infection.
Participant CD4+ T-cell count is >/= 200/µL within 16 weeks prior to transplant for kidney transplant recipients. For liver transplant recipient, CD4+ T-cell counts need to be >/= 100/ul (or >/= 200/µL if history of opportunistic infection) within 16 weeks prior to transplant.
Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in CLIA-approved laboratory), in the 26 weeks prior to transplant. Participants unable to tolerate ART due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.
Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant.
No history of primary CNS lymphoma or progressive PML.
On a stable antiretroviral regimen. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.
HIV-Positive Recipient Exclusion Criteria (liver, kidney)
• Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.
DONOR ELIGIBILITY CRITERIA HIV-Positive Deceased Donor (liver, kidney)
Must meet all clinical criteria for HIV-uninfected organ donors.
No evidence of invasive opportunistic complications of HIV infection.
Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study.
Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory.
If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.
HIV-Positive Living Donor (liver)
Donor meets all clinical criteria to be a living liver donor other than being HIV positive.
Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory.
No evidence of invasive opportunistic complications of HIV infection
Donor CD4+ T-cell count is >/= 500/µL in the 26 weeks prior to donation.
The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation.
On a stable antiretroviral regimen.
Must be evaluated by the HIV/Transplant Infectious Diseases team to verify resistance history and current ART regimens. The potential for transmission of resistant strain of HIV will be assessed.
Pre-implant donor liver biopsy to be stored for the duration of the study showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient.
Must be evaluated by an independent HIV study living donor advocate separate from the transplant service in addition to the living donor advocate seen by all living donors.
This is an observational cohort study in which patients with cystic fibrosis and healthy controls will undergo one research MRI to test cognitive function and map brain structures.
Amir Moheet
All
18 Years to old
This study is NOT accepting healthy volunteers
STUDY00002606
STUDY00002606
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Inclusion Criteria:
patients with Cystic fibrosis
Exclusion Criteria:
History of stroke
History of epilepsy
History of neurosurgical procedures
Past or current history of severe psychiatric illness
Pass or current history of alcohol or substance abuse
Presence of metallic substances in body or inability to remove before imaging procedure
History of claustrophobia or known inability to tolerate MRI
Current pregnancy
Inability to consent
There are 3 objectives in this study:
• Reliability of AFAS
• Impact of relaxation breathing and patient perception on spasticity and movement of the upper limb
• Validity of AFAS
Ann Van de Winckel
All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
STUDY00000821
STUDY00000821
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Inclusion Criteria:
Females and males ages 18-99 years of age
People with stroke who are medically stable with one or more ischemic or
hemorrhagic stroke(s)
left or right hemiplegia
willing and able to attend a one-time behavioral testing session
willing and able to sign consent to participate
able to hear, read and comprehend instructions given during the study
English speaking (or willing to work with a (student) translator)
Exclusion Criteria:
cognitive impairment (Mini-mental State Exam-brief version, <13/16)
contractures in the tested arm that would hinder testing arm movements
adults lacking capacity to consent
severe neglect, aphasia, apraxia
other medical conditions that preclude participation
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.
Logan Spector
Male or Female
Not specified
This study is also accepting healthy volunteers
STUDY00000877
STUDY00000877
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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
Combat and sports injuries as well as automobile accidents can result in complex knee injuries involving tears of two or more major ligaments. These are referred to as multiple ligament knee injuries (or knee dislocations). Other structures like nerves, blood vessels, tendons and bones may also be injured at the same time. Due to their severity, knee dislocations are difficult to treat and problems after surgery, such as poor healing, stiffness or looseness of the knee, persistent pain, and early arthritis, can be quite common. Experts agree that surgery is necessary after a knee dislocation, but they do not agree on when to perform surgery or when rehabilitation after surgery should be started. Early surgery for knee dislocations may result in better outcomes, but may also be associated with increased joint stiffness. However, delayed surgery may be associated with the knee being too loose. The best evidence for when to start rehabilitation is based on treatment of anterior cruciate ligament (ACL) injuries in sports, where early post-op rehabilitation is the standard. However, unlike ACL surgery which typically replaces the ACL with a tendon graft, surgeons frequently sew torn ligaments back together after a knee dislocation. Therefore, rehabilitation typically involves protection of the knee by keeping weight off the leg and only allowing the knee to move a little for 6 weeks, which delays return to activity. This study is being conducted to determine when the best time to do surgery is and when to start rehabilitation after surgery for the treatment of a multiple ligament knee injury.
Jeffrey Macalena
Male or Female
Not specified
Phase III
This study is NOT accepting healthy volunteers
STUDY00002789
STUDY00002789
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For the clinical trials for both aims, male and female military personnel and civilians between the ages of 16 and 55 with a MLKI (defined as a complete grade III injury of two or more ligaments) will be eligible to participate. Individuals with a nerve injury or biceps or popliteus tendon rupture or avulsion will not be excluded from participation in either trial.
Individuals will be excluded from both trials if they:
Prior knee ligament surgery of the involved knee;
Torn or avulsed patellar or quadriceps tendon;
Periarticular or long bone fracture that is anticipated to preclude weight-bearing after surgery;
Require use of an external fixator for greater than 10 days;
Planned staged surgical treatment;
Unable to weight bear on the contralateral uninjured leg;
Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
Surgical procedures that precludes early weight-bearing or range of motion.
Any condition that would preclude the ability to comply with post-operative guidelines.
Additional Eligibility Criteria for Participation in Aim 1 - Randomization to Both Timing of Surgery and Post-Operative Rehabilitation
To be eligible to participate in the study for Aim 1 individuals with a MLKI must present to orthopaedic surgery in time to undergo definitive surgery within 6 weeks of injury if randomized to the early surgery group.
Individuals will also be ineligible to participate in the study for Aim 1 if they have:
Vascular injury that dictates timing of surgery;
Poly trauma that precludes surgery within 6 weeks of injury;
Skin or soft tissue injury that precludes early surgery and rehabilitation.
Additional Eligibility Criteria for Participation in Aim 2 - Randomization to Only timing of Post-operative Rehabilitation
Subjects with a MLKI that present to orthopaedic surgery at a time that precludes randomization to early surgery or have an injury that precludes randomizing the timing of surgery (such as a vascular injury) as well as those that refuse randomization to the timing of surgery will be eligible to participate in the study for Aim 2 which randomizes subjects to only early vs. delayed rehabilitation.
Individuals will also be excluded from the trial that randomizes only the timing post-operative rehabilitation if they have:
Vascular surgery that precludes early rehabilitation;
Polytrauma that limits ability to participate in post-operative care;
Skin or soft tissue injury that precludes early rehabilitation
Early Surgery, Delayed Surgery, Early Rehab, Delayed Rehab, Early Surgery, Delayed Surgery, Early Rehab, Delayed Rehab
The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.
Michael Mauer
All
1 Year to 75 Years old
This study is NOT accepting healthy volunteers
1205M14901
1205M14901
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Inclusion Criteria:
Patients diagnosed with Fabry disease who have/have not received enzyme replacement therapy where a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies or where patients have previously completed clinical trials which included measures of renal function and renal biopsies.
Exclusion Criteria:
Patients with serum creatinine more than 2.5 mg/dL or known to have a renal disease other than Fabry.
Patients will receive 20 minutes of continuous stimulation of either active or sham transcranial direct current stimulation every day for five consecutive days. This will allow investigation to whether the pairing of dorsolateral prefrontal corex stimulation and cognitive flexibility training can enhance functional connectivity between dorsolateral prefrontal corex and nucleaus accumbens, assisting with treatment for opioid use disorder.
Jazmin Camchong
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
STUDY00005047
STUDY00005047
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Inclusion Criteria:
20 abstinent individuals (18-60 years old; 1-2 weeks of abstinence) who meet DSM-V criteria for opioid use disorder (OUD) will be recruited from the Lodging Plus Program, part of University of Minnesota Medical Center
This 28-day program provides a supervised environment to treat individuals with OUD in which patients receive random drug screenings. Lodging Plus has 50 beds and admits an average of 20 patients per week and about 50% of patients admitted have a diagnosis of opioid use disorder.
Ability to provide written consent and comply with study procedures, meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for OUD. Subjects may have current comorbid drug use, but their primary substance use disorder diagnosis needs to be based on opioid use. Subjects must have the intention to remain in the Lodging Plus program (4 weeks) until the end of the intervention portion of the study. Vulnerable populations will not be included.
Exclusion Criteria:
Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
DSM-V criteria for psychiatric disorder, may have a lifetime diagnosis of depression
Presence of a condition that would render study measures difficult or impossible to administer or interpret
Age outside the range of 18 to 60
Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
Clinical evidence for Wernicke-Korsakoff syndrome
Nicotine use will be recorded.
Transcranial Direct Current Stimulation (tDCS), Transcranial Direct Current Stimulation (tDCS)
Cystic fibrosis (CF) is caused by gene mutations leading to absence or dysfunction of the cystic fibrosis transmembrane conductance regulator (CFTR) protein which functions as a chloride channel in epithelial cells lining the respiratory tract, gastrointestinal system and sweat glands.
Over the past several years, CFTR modulators (small molecule therapies that improve activity of the CFTR protein) have been shown in large clinical trials to improve clinical outcomes in people with CF resulting in the FDA approval of the modulators ivacaftor and lumacaftor/ivacaftor. In clinical trials, SC measurements emerged as an important marker of CFTR activity.
The CHEC-SC study is looking at SC levels in people with CF who are currently being treated with CFTR modulator therapies. This study is being done to answer the following questions:
• Why do different CF patients have larger or smaller reductions in sweat chloride after treatment with CFTR modulator therapy?
• Does the sweat chloride value achieved after treatment with CFTR modulator therapy impact long-term health outcomes in people with CF?
Joanne Billings
All
4 Months to old
This study is NOT accepting healthy volunteers
STUDY00001595
STUDY00001595
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Inclusion Criteria:
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
Enrolled in the CFFPR
Male or female ≥ 4 months of age on day of study visit
Diagnosis of CF.
Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment
Able to perform the testing and procedures required for this study, as judged by the investigator
Additional Inclusion Criteria for CHEC-PKPD Sub-Study:
Male or female ≥ 6 years of age on day of study visit.
Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment.
Last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last dose of ivacaftor taken at least 12 hours prior to trough blood draw on day of visit.
Exclusion Criteria:
Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Currently enrolled in an investigational trial (including open-label follow-on studies and Early Access Programs (EAP) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)
The primary aim of this feasibility study is to determine whether breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC) can accurately predict complete pathologic response (pCR) in women with biopsy-proven triple negative or HER2 breast cancer.
Todd Tuttle, MD
Female
18 Years to old
This study is NOT accepting healthy volunteers
STUDY00006873
STUDY00006873
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Inclusion Criteria:
Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
A biopsy clip placed at the time of diagnostic biopsy
18 years of age or older
Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
Able to provide written consent prior to any research related activities
Exclusion Criteria:
Stage IV breast cancer
T4 breast cancer
Previous ipsilateral breast cancer
Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
Standard Trimodality Breast Imaging, Standard Trimodality Breast Imaging
TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, ERany/PRany/HER2+ Breast Cancer
In this protocol, we will enroll pediatric, adolescent and adult patients diagnosed with adrenoleukodystrophy (ALD). These patients will include probands diagnosed by newborn screening and their relatives subsequently diagnosed, as well other patients who are diagnosed with ALD due to other presenting signs and symptoms and subsequently were confirmed to have ALD. We will ask consenting subjects to provide a medical history (with verification via medical records), to participate in a semi-annual health survey and provide consent to collect biospecimens. The overarching goal of this work is to engage with families affected by ALD and to assemble a resource of clinical, medical, and biological data that will allow of to better understand the natural history of ALD, and how this is affected by newborn screening. The initial focus will be on patients within Minnesota, but participation will be open to any family interested in the study, as this will be web-based.
This registry and biobank, together with other research conducted in tandem, will possibly provide information describing the natural history of ALD and outcomes with interventions. It is anticipated that the data collected will further our understanding of the natural history of the disease, basic biology of adrenoleukodystrophy, diagnosis and outcomes. Ultimately, this research may lead to new avenues for early diagnosis and development of safer and more effective therapies for ALD.
Ashish Gupta
All
This study is NOT accepting healthy volunteers
STUDY00003605
STUDY00003605
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Inclusion Criteria
Age 0 - 100
ALD patients or family member meeting any of the following criteria:
Any patient diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation).
Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
Participants living in the United States and territories
Exclusion Criteria
Patients diagnosed with ALD who lack the capacity to consent/assent AND do not have a designated legally authorized representative or guardian.
Patients who have undergone BMT or other cellular therapy .
Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.
Patients who are illiterate
Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)
Medical Record Abstraction, Biospecimen Sample Collection, Medical Record Abstraction, Biospecimen Sample Collection
To determine the incidence of humoral immune reconstitution by 2 years post-transplant in 2 SCID cohorts (IL2RG/JAK3, RAG1/RAG2) undergoing alternative donor HCT by randomized assignment to a busulfan preparative regimen targeted at cumulative area-under-the-curve (cAUC) exposure of 25-35 mg*h/L vs 55-65 mg*h/ L.
Christen Ebens
All
0 Years to 2 Years old
This study is NOT accepting healthy volunteers
STUDY00006513
STUDY00006513
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Inclusion Criteria:
• Infants with SCID, either typical or leaky or Omenn syndrome.
Typical SCID is defined as either of the following
Absence or very low number of T cells (CD3+ T cells <300/microliter AND no or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin OR
Presence of maternally derived T cells
Leaky SCID is defined as the following
• Absence of maternally derived T cells
• AND either one or both of the following (i, ii): i) <50% of lower limit of normal T cell function as measured by response to PHA OR <30% of lower limit of normal T cell function as measured by response to CD3 ii) Absent or <10% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens (must document post vaccination or exposure for this criterion to apply)
• AND at least two of the following (i through iii): i) CD3 T cells < 1500/microliter ii) >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (at < 4 years of age) AND/OR are oligoclonal T iii) Low TRECs and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower level of normal.
Omenn syndrome • Generalized skin rash
Maternal lymphocytes tested for and not detected.
>80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (<2 years of age)
Absent or low (up to 30% lower limit of normal (LLN)) T cell proliferation to antigens (Candida, tetanus) to which the patient has been exposed IF: Proliferation to antigen was not performed, but at least 4 of the following 8 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the patient is eligible as Omenn Syndrome.
Hepatomegaly
Splenomegaly
Lymphadenopathy
Elevated IgE
Elevated absolute eosinophil count
*Oligoclonal T cells measured by CDR3 length or flow cytometry (upload report)
*Proliferation to PHA is reduced to < 50% of lower limit of normal (LLN) or SI < 30
*Low TRECs and/or percentage of CD4+/RA+ CD31+ or CD4+/RA+ CD62L+ cells below the lower level of normal
• Documented mutation in one of the following SCID-related genes
a. Cytokine receptor defects (IL2RG, JAK3) b. T cell receptor rearrangement defects (RAG1, RAG2) 3. No available genotypically matched related donor (sibling) 4. Availability of a suitable donor and graft source
Haploidentical related mobilized peripheral blood cells
9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells 5. Age 0 to 2 years at enrollment
Note: to ensure appropriate hepatic metabolism, age at time of busulfan start:
For IL2RG/JAK3: 8 weeks For RAG1/RAG2: 12 weeks
• Adequate organ function defined as:
Cardiac:
Left ventricular ejection fraction (LVEF) at rest ≥ 40% or, shortening fraction (SF) ≥ 26% by echocardiogram.
Hepatic:
Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert's Disease are allowed to exceed this limit) and AST and ALT < 5.0 x ULN for age.
Renal:
GFR estimated by the updated Schwartz formula ≥ 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m2.
Pulmonary No need for supplemental oxygen and O2 saturation > 92% on room air at sea level (with lower levels allowed at higher elevations per established center standard of care).
Exclusion Criteria:
Presence of any serious life-threatening or opportunistic infection at time of enrollment and prior to the initiation of the preparative regimen. Serious infections as defined below that occur after enrollment must be reported immediately to the Study Coordinating Center, and enrollment will be put on hold until the infection resolves. Ideally enrolled subjects will not have had any infection. If patients have experienced infections, these must have resolved by the following definitions:
a. Bacterial i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site must be negative and patient has completed appropriate course of antibacterial therapy (typically at least 10 days).
ii. Tissue-based clinical infection (e.g. cellulitis): Complete resolution of clinical signs (e.g. erythema, tenderness, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days).
iii. Pneumonia, organism not identified by bronchoalveolar lavage: Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). If possible, radiographic resolution should also be demonstrated.
b. Fungal i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site is negative and patient has completed appropriate course of antifungal therapy (typically at least 14 days). The patient may be continued on antifungal prophylaxis following completion of the treatment course.
c. Pneumocystis i. Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of therapy (typically at least 21 days). If possible, radiographic resolution should also be demonstrated. The patient may be continued on prophylaxis following completion of the treatment course.
d. Viral i. Viral PCRs from previously documented sites (blood, nasopharynx, CSF) must be re-tested and are negative.
ii. If re-sampling a site is not clinically feasible (i.e. BAL fluid): Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.). If possible, radiographic resolution should also be demonstrated.
Patients with HIV or HTLV I/II infection will be excluded.
Busulfan, Cell processing for TCRαβ+/CD19+ depletion, Busulfan, Cell processing for TCRαβ+/CD19+ depletion
This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.
Byron Vaughn
All
18 Years to old
This study is NOT accepting healthy volunteers
STUDY00007736
STUDY00007736
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ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the Corrona IBD Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.
Inclusion Criteria:
At least 18 years of age or older.
Willing and able to provide written consent for participation in the IBD Registry.
Willing and able to provide Personally Identifiable Information (PII) which includes the following types of personal information at a minimum: full name, date of birth, sex, and home address zip code.
Diagnosis of one of the following by a gastroenterologist:
Crohn's disease
Ulcerative colitis
Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.
Exclusion Criteria:
• Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆
Eligible Medications Grouped by Drug Class
ANTI-TNF AGENTS AND BIOSIMILARS - Adalimumab (HUMIRA), Adalimumab-atto (AMJEVITA), Certolizumab pegol (CIMZIA), Golimumab (SIMPONI), Infliximab (REMICADE), Infliximab-dyyb (INFLECTRA)
INTEGRIN RECEPTOR ANTAGONISTS - Natalizumab (TYSABRI), Vedolizumab (ENTYVIO)
INTERLEUKIN ANTAGONIST (IL-12 AND IL-23), Ustekinumab (STELARA),
JAK INHIBITOR - Tofacitinib (XELJANZ)
SPHINGSOSINE-1-PHOSPHATE RECEPTOR (S1PR) - Ozanimod (ZEPOSIA)
∆ Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements.
∗ These criteria are subject to change with the needs of the registry at the sole discretion of the Sponsor (Corrona).
Define natural history, validate patient reported outcome and share knowledge on congenital disorders of glycosylation. We will recruit and enroll patients with CDG in this study evaluating clinical variation and natural history when a patient is being seen as part of routine clinical care.
Kyriakie Sarafoglou
All
This study is NOT accepting healthy volunteers
STUDY00009013
STUDY00009013
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Inclusion Criteria:
Patients diagnosed with congenital disorders of glycosylation based on genetic confirmatory testing
Exclusion Criteria:
Patients without congenital disorders of glycosylation
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.
Elizabeth Seaquist
All
18 Years to 65 Years old
N/A
This study is NOT accepting healthy volunteers
STUDY00008108
STUDY00008108
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Inclusion Criteria:
Type 1 diabetes diagnosed on clinical or laboratory grounds
Diabetes duration 2 - 30 years
Hemoglobin A1C <8.5%
Exclusion Criteria:
Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
Pregnant or plan to become pregnant during the study period
Uncontrolled hypertension (blood pressure > 145/95 mmHg at screening)
Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
Proliferative retinopathy
Impaired kidney function (GFR < 45)
History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
Current substance abuse
Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
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 lbs
Unable to complete all study visits or procedures, as determined by the investigator
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.
Colum MacKinnon
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00008043
STUDY00008043
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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.
• 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
To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion parent-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
Margaret MacMillan, MD
Male or Female
5 Years to old
This study is NOT accepting healthy volunteers
STUDY00008469
STUDY00008469
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INCLUSION CRITERIA:
Pediatric Subject
Inclusion Criteria:
Children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
Clinical diagnosis of cGVHD
Currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 12 months
No evidence of malignant disease relapse including molecular relapse and minimal residual disease. Patients with mixed chimerism are eligible to participate
Subject must have an eligible caregiver proxy who is willing to participate in the study.
Parent or guardian ability and willingness to sign a written informed consent document
Subjects must be able to comprehend and speak the English language
Subjects may participate in both Project 1 and Project 2 of the study. Participation in Project 1 is not required in order to be eligible to participate in Project 2.
Caregiver Proxy Inclusion Criteria
Adult, >18 years of age, caregiver of participating subject
Must be willing and able to provide informed consent.
Must be able to comprehend and speak the English language
EXCLUSOIN CRITERIA:
Patients may be excluded from this study if in the judgment of the Principal or Associate Investigator, the subject is too ill, or subject s cognitive ability would compromise their ability to participate in study related procedures.
Graft vs Host Disease
Hematopoietic Stem Cell Transplantation (HSCT), Allogeneic Stem Cell Transplant, Phototherapies, Graft Vs Host Disease, Natural History
A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression. Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected. Clinically measured tacrolimus trough concentrations will also be evaluated. Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied.
Pamala Jacobson
All
18 Years to old
This study is NOT accepting healthy volunteers
STUDY00007227
STUDY00007227
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Inclusion Criteria:
1) Participants undergoing kidney transplant 2) Male or female at least 18 years of age at time of enrollment 3) Will or have received a living or deceased donor kidney transplant 4) Planned post-transplant immunosuppression regimen of mycophenolate mofetil dosed every 12 hours (Cellcept or generic) and immediate release tacrolimus dosed twice daily with trough concentration monitoring (generic or brand formulation).
5) Able and willing to complete study-related procedures and visits 6) Signs written informed consent
Exclusion Criteria:
1) Recipient of a previous non-kidney transplant 2) Subject is a multi-organ transplant recipient 3) Presence of active gastroparesis and documented in medical record 4) Liver dysfunction (total bilirubin >2x upper limit of normal) within 2 months of enrollment 5) Patients that take medications that significantly inhibit UGT enzymes. 6) Patients that take medications that significantly inhibit or induce the biliary transporters 7) Patient is known to be HIV positive 8) Pregnant or nursing (lactating) women 9) Non-English speaking 10) Patients who have undergone bariatric surgery
collection of body microbioma, collection of body microbioma
