StudyFinder
Search Results
151 Study Matches
RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial
The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.
Eugenia Shmidt
Not specified
STUDY00013632
Inclusion Criteria:
• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:
• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's disease
PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
We are testing whether treating people who have FSGS with plasmapheresis and rituximab before or shortly after kidney transplant can prevent the recurrence of FSGS after kidney transplant. All participants will receive plasmapheresis. Each participant has a 50% chance of receiving rituximab and a 50% chance of receiving no additional treatment. Rituximab is given by infusion. If a participant is assigned to receive rituximab, it will be given one time immediately after plasmapheresis.
Michelle Rheault
Not specified
STUDY00004388
Inclusion Criteria:
• 1 to 65 years old
• biopsy proven diagnosis of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease
• history of nephrotic syndrome (proteinuria, edema, hypoalbuminemia)
• first kidney transplant or second or third transplant with a history of recurrent FSGS in the first or second kidney transplant
• males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab
Exclusion Criteria:
• known genetic cause of FSGS
• FSGS secondary to another condition (obesity, viral infection, medications, etc.)
• received rituximab within 1 year prior to transplant
• women who are pregnant, lactating, or refuse use of birth control
• additional medical or mental health diagnosis (study staff will review)
Kidney, Prostate & Urinary
Focal Segmental Glomerulosclerosis
MT2019-09: A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR alpha beta +/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC CSIDE Protocol (CSIDE)
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
0 years to 2 years old
SITE00000541
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.COG ACNS1831 - A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
Christopher Moertel, MD
2 years to 21 years old
SITE00000735
Inclusion Criteria:
Patients must be >= 2 years and =< 21 years at the time of enrollment
Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment
Patients must have neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing
Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
For patients with optic pathway gliomas (OPGs):
Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor
Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth
For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria:
Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR
Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR [20/80, 6/24, or 2.5/10] or more in one or both eyes)
For patients with LGG in other locations (i.e., not OPGs):
Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor
NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible
Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth
Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
Patients must have two-dimensional measurable tumor >= 1 cm^2
Patients with metastatic disease or multiple independent primary LGGs are allowed on study
Creatinine clearance or radioisotope glomerular filtration Rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender (within 7 days prior to enrollment) as follows:
Age; maximum serum creatinine (mg/dL)
2 to < 6 years; 0.8 (male) and 0.8 (female)
6 to < 10 years; 1 (male) and 1 (female)
10 to < 13 years; 1.2 (male) and 1.2 (female)
13 to < 16 years; 1.5 (male) and 1.4 (female)
>= 16 years; 1.7 (male) and 1.4 (female)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL)
Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) = 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
Albumin >= 2 g/dL (within 7 days prior to enrollment)
Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (within 4 weeks prior to enrollment)
Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (within 4 weeks prior to enrollment)
Absolute neutrophil count >= 1,000/uL (unsupported) (within 7 days prior to enrollment)
Platelets >= 100,000/uL (unsupported) (within 7 days prior to enrollment)
Hemoglobin >= 8 g/dL (may be supported) (within 7 days prior to enrollment)
Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and gender at the time of enrollment. Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications).
Note: Adequate blood pressure can be achieved using medication for the treatment of hypertension
All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment
For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment
For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative* MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed within 4 weeks prior to enrollment
The post-operative MRIs should be performed ideally within 48 hours after surgery if possible
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Patients must have the ability to swallow whole capsules
Patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments
All patients and/or their parents or legal guardians must sign a written informed consent.
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
Patients may not be receiving any other investigational agents
Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible
Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible
Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants are not eligible
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible
Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo
Cardiac conditions:
Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented
Symptomatic heart failure
New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy
Severe valvular heart disease
History of atrial fibrillation
Ophthalmologic conditions:
Current or past history of central serous retinopathy
Current or past history of retinal vein occlusion or retinal detachment
Patients with uncontrolled glaucoma
If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible
Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN), such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
Treatments and/or medications patient is receiving that would make her/him ineligible, such as:
Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
Surgery within 2 weeks prior to enrollment, with the exception of surgical placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt.
Note: Patients must have healed from any prior surgery prior to enrollment
Patients who have an uncontrolled infection are not eligibleA Phase II, Open Label, Two Arm Study of Therapeutic Iobenguane (131I) as Single Agent or in Combination with Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects (OPTIMUM Trial) Protocol Number: MIBG 2014-01 (OPTIMUM)
This will be a Phase II, two-arm, nonrandomized, non-comparative, open-label study in participants ≥ 1 year of age with iobenguane avid, recurrent or progressive high-risk neuroblastoma. Participants not eligible for vorinostat treatment may receive 131I-MIBG as monotherapy.
Emily Greengard
Not specified
STUDY00005792
Inclusion Criteria:
• at least 1 year old
• diagnosis of iobenguane avid, high-risk neuroblastoma, with recurrent or progressive disease at any time
• frontline therapy includes a minimum of 4 cycles of induction therapy at any time
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:
• less than 12 weeks after myeloablative therapy with autologous stem cell transplant
• receiving hemodialysis
• women who are pregnant or breastfeeding
• significant active infections including active hepatitis B, or hepatitis C infection, or known infection with human immunodeficiency virus (HIV)
Cancer
Neoplasms, Neuroblastoma, Neuroectodermal Tumors
Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)
This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.
Rene Pierpont
Up to 18 years old
STUDY00016246
Inclusion Criteria:
• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
Exclusion Criteria:
• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Brain & Nervous System, Children's Health, Rare Diseases
Healthy control, children, pediatrics, adolescents
Genetics of Developmental Disorders - Data and Specimen Repository
This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.
Williams Dobyns
Not specified
STUDY00011194
Inclusion Criteria:
• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Brain & Nervous System, Rare Diseases, Children's Health
Genetic disorders, developmental brain disorders, developmental disorders
Food Parenting Practices on Child Dietary Intake
This research is being done to help better understand the ways parents interact with their children at meal and snack times at different time points during the day and in different circumstances. We want to study how the feeding approaches affect the child’s dietary intake over time. Study participation will be two years with activities every six months.
Katie Loth
Up to 18 years old
00018340
Inclusion Criteria:
• Family attends Fairview Primary Care clinic
• Child between 3-5 years of age
• Caregiver has primary responsibility of feeding child outside of childcare
• Child must live at least 50% of the time or more with the primary guardian
• Caregiver must be able to speak and read English or Spanish
Exclusion Criteria:
• Caregiver is less than 18 years of age
• Child is in the foster system
Children's Health, Community Health
child, children, eat, eating, feeding, food, kid, nutrition, parent, preschool, psychology
Understanding modifiable barriers to treatment adherence in youth with type 2 diabetes to inform intervention development
This study will seek to learn about barriers to management of Type 2 diabetes for children ages 10-17. This study is recruiting children, and their parent/guardian, who are managing with oral medication or insulin.
Amy Noser
Up to 18 years old
STUDY00019484
Inclusion Criteria:
• 10 to 17 years old
• confirmed diagnosis of type 2 diabetes
• prescribed pharmacologic therapy for treatment of type 2 diabetes (oral medication or insulin)
• live with a parent/caregiver at least 50% of the time who is willing to participate in the study
• able to read and speak English
• the parent/caregiver must be the adult who spends the largest proportion of time caring for the child (or at least 50%) & able to speak and read English
Exclusion Criteria:
• diagnosis of type 1 or monogenic diabetes
• evidence of significant cognitive deficits or a severe, persistent psychiatric disorder
Children's Health, Diabetes & Endocrine
Type 2 Diabetes
MT2014-10C : Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
Ashish Gupta
Up to 55 years old
1407M52125
Inclusion Criteria:
Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
Acceptable stem cell source identified
Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children
Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%
Exclusion Criteria:
active, uncontrolled infection
pregnant or breastfeeding
HIV positive Clinics and Surgery Center (CSC)
MT2013-34C: Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia: Standard of Care Considerations
The purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and Bone Marrow Transplant (BMT) databases for patients undergoing a transplant for the treatment of Dyskeratosis Congenita (DC) or Severe Aplastic Anemia (SAA). The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
Christen Ebens
Not specified
1404M50183
Inclusion Criteria:
-0 to 70 years old
• acceptable hematopoeitic stem cell donor identified
• Dyskeratosis Congenita (DC) with evidence of bone marrow failure
• Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• women who are pregnant or breast feeding
• uncontrolled infection
Blood Disorders
Clinics and Surgery Center (CSC), Aplastic Anemia, DC, Dyskeratosis Congenita, SAA
MT2013-09C : Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases
This is a treatment protocol for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. There is no research element except the collection of routine clinical data.
Margaret MacMillan, MD
Not specified
1305M34181
Inclusion Criteria:
• up to 55 years old
• see link to clinicaltrials.gov for inclusion criteria specific to each type of leukemia
Exclusion Criteria:
• Radiation Oncology will evaluate all patients who have had previous radiation therapy
• pregnant or breastfeeding
• HIV positive
• study staff will review additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia
MT2013-06C : Treatment of graft Failure after HSCT
Troy Lund
1404M49341
Inclusion Criteria:
Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant.
Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery.
Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
Recipients should have acceptable organ function defined as:
Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
Cardiac: left ventricular ejection fraction > 40%
Exclusion Criteria:
Uncontrolled infection at the time of transplant.
Patients with Fanconi Anemia or other DNA breakage syndromes. Clinics and Surgery Center (CSC)
MT2012-11C: Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HSCT. While it will primarily be applied for the treatment of non-malignant diseases (NMD), on occasion it may be used to treat patients with malignant disorders as well.
Troy Lund
Up to 55 years old
1207M17641
Inclusion Criteria:
Diagnosis of any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of "insufficiency of donor chimerism" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations.
Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority.
Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institutional recommendations.
Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease.
At the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available.
Age, Performance Status, Consent
Age: 0 to 55 years
Consent: voluntary written consent (adult or parental/guardian)
Exclusion Criteria:
Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI
Pregnant or breastfeeding
Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
HIV positive
While it would be advantageous to begin therapy on this second transplant regimen > 6 months following a prior myeloablative regimen or >2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.MT2012-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
The primary purpose of this study is to record outcomes and patient characteristics in the Cancer Center’s and BMT databases for patients who are undergoing an allogeneic (donor) hematopoietic stem cell transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
Christen Ebens
Not specified
1207M17321
Inclusion Criteria:
• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• pregnant or breastfeeding
• active, uncontrolled infection and/or HIV positive
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
Immune Diseases, Rare Diseases
Clinics and Surgery Center (CSC), Allogeneic Hematopoietic Stem Cell Transplant, Primary Immune Deficiencies
Use of Continuous Wave Doppler to assess Vascular Malformations in Pediatric Dermatology
The aim of our study is to look at blood flow in various tumors and irregularities located in blood vessels using a handheld continuous wave doppler. Correct and efficient diagnosis of vascular anomalies (outside of what is expected to happen in blood vessels) in pediatric patients will help determine a treatment plan. Blood flow in vascular anomalies has not been well described in the past.
Sheilagh Maguiness
Not specified
STUDY00012200
Inclusion Criteria:
• less than 21 years old
• have a vascular anomaly such as Arteriovenous malformations (AVM), Capillary malformations (CM), Venous malformations (VM), Lymphatic malformations (LM), Pyogenic granuloma (PG), Infantile hemangioma (IH), or Congenital hemangioma (CH)
• being treated at University of MN pediatric dermatology outpatient clinic or the multidisciplinary vascular anomalies clinic
Exclusion Criteria:
• history of any prior surgical, radiologic, medications for treatment (including oral or topical beta blocking agents)
Dermatology (Skin, Hair & Nails)
Vascular Anomalies
EFC17574: A Phase 3, single-arm, multicenter, multinational, open label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged >= 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX (ATLAS-NEO)
A study to test a medicine (fitusiran) injected under the skin for preventing bleeding episodes in male adolescent or adult participants with severe Hemophilia.
Jacob Cogan
Not specified
STUDY00017896
Inclusion Criteria:
• 12 years or older
• diagnosis of severe congenital hemophilia A or B
• participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months
Exclusion Criteria:
• co-existing bleeding disorders other than congenital hemophilia A or B
• current participation in immune tolerance induction therapy (ITI)
• prior treatment with gene therapy
• acute hepatitis, ie, hepatitis A, hepatitis E, acute or chronic hepatitis B infection
• additional exclusion criteria apply (study staff will review)
Blood Disorders
Hemophilia
Accelerating Therapies for Refractory SJIA Patients
This research study aims to learn more about the causes of Systemic Juvenile Idiopathic Arthritis (sJIA) including its complications such as Macrophage Activation Syndrome (MAS) and sJIA associated lung disease and identify new therapeutic targets. The study is asking for biological samples from those diagnosed with sJIA as well as their family members.
Mona Riskalla
Up to 18 years old
SITE00001576
Inclusion Criteria:
• at least 6 months old
• new onset SJIA or established SJIA with or without lung and/or liver complications
• parent or sibling of the enrolled child will also be asked to participate
Exclusion Criteria:
• illness sufficient to prohibit study participation
• inability to cooperate with the study
Arthritis & Rheumatic Diseases, Rare Diseases
SJIA, Systemic Juvenile Idiopathic Arthritis
AAML18P1: Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.
Peter Gordon
Not specified
SITE00001982
Inclusion Criteria:
• < 25 years old
• diagnosis of CML-CP before age 18
• patient must be in molecular remission (MR) for ? 2 consecutive years at the time of enrollment
• patient must have received any TKI for a minimum of 3 consecutive years and agree to stop using TKI therapy
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:
• known T3151 mutation
• history of accelerated phase or blast crisis CML
• women who are pregnant
• if breast feeding, must agree to stop
Cancer
BCR-ABL1 Positive, Chronic Phase Chronic Myeloid Leukemia, CML-CP, Leukemia
Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Kristin Gravel
Up to 18 years old
STUDY00010956
Inclusion Criteria:
• Parents and child fluent in English
• Parents desire functional hearing in both ears for their child
• Severe to profound sensorineural hearing loss in one ear and normal hearing in the other ear
• If older than 5 years, documentation of progressive hearing loss (i.e. passed newborn hearing screening, or significant change in hearing)
Exclusion Criteria:
• Medical condition that contraindicates a cochlear implant, including abnormal hearing nerve
• Already using a cochlear implant
• Inability to complete study procedures
• Unrealistic expectations related to the benefits and limitations of cochlear implantation
• Unwillingness or inability to comply with all investigational requirement
Ear, Nose & Throat
Pediatric audiology, Audiology, Cochlear Implant, Single-Sided Deafness
A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (ribitol) in Patients with Limb Girdle Muscular Dystrophy 21 (LGMD21) (Fortify)
This study will use BBP-418 study drug in patients with LGMD to assess the clinical biomarkers, efficacy and safety of BBP-418 during the 36 months treatment phase.
Peter Kang
Not specified
STUDY00018570
Inclusion Criteria:
• 12 to 60 years of age
• genetically confirmed diagnosis of limb girdle muscular dystrophy
• have clinical symptoms of weakness
• weight at least 30 kg (66 lbs.)
• willing to use a highly effective method of birth control until 12 weeks after last dose of study medication
Exclusion Criteria:
• any significant medical or mental health diagnosis including abnormal lab values (study staff will review)
• surgery for scoliosis or other indication planned during the time of the study
• use of ribose or other sugar alcohol-containing supplement within 90 days of staring the study
• use of a systemic corticosteroid for the treatment of muscular dystrophy within 90 days of starting the study
Rare Diseases
Clinics and Surgery Center (CSC), Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I), Muscular Dystrophy
Genetic Modifiers and Glycemic Variability in Turner Syndrome
This study is looking at glucose (blood sugar) patterns in participants with Turner Syndrome between the ages of 3-80 years old. This will be done by obtaining 2 hours frequent blood sampling by completing an Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test. Participants will also wear a continuous glucose monitor for 2 weeks. Along with the OGTT and MMTT, participants are asked to provide a blood sample for DNA and RNA testing. Participant’s parents are asked to provide a saliva sample for DNA testing
Kyriakie Sarafoglou
Not specified
STUDY00013812
Inclusion Criteria:
• Participants with a diagnosis of Turner syndrome by karyotype
• Ages 3 to 80
Exclusion Criteria:
• Additional genetic diagnosis detected on karyotype, CMA, or FISH
• Prior diabetes diagnosis
• Current or recent (last 72 hours) use of systemic glucocorticoids
• Current use of hypoglycemic agents
• History of solid organ or bone marrow transplant
• Currently pregnant
• Non English-speaking
Diabetes & Endocrine, Rare Diseases
Turner Syndrome
PEPN2113: A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy
A Phase 1 and pharmacokinetic study of Uproleselan (GMI-1271, IND #139758, NSC #801708) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane and is in second or greater relapse or that is refractory to relapse therapy
Emily Greengard
Up to 18 years old
SITE00001697
Inclusion Criteria:
• patient must be enrolled on APAL2020SC (NCT04726241)
• patients must be between 1 and 17 years of age at the time of study enrollment
• patients, with or without Down syndrome (DS), and with de novo acute myeloid leukemia, therapy-related acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that expresses E-selectin ligand on the cell membrane
• second or greater relapse or refractory AML OR refractory myelodysplastic syndrome (MDS) OR mixed phenotype acute leukemia (MPAL)
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:
• patients who are currently receiving another investigational drug are not eligible
• patients who are currently receiving other anti-cancer agents are not eligible except patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy
• study staff will review additional exclusion criteria
Cancer, Cancer
AML, Myelodysplastic Syndrome Post Cytotoxic Therapy, Recurrent Acute Myeloid Leukemia
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.
Jen Poynter
Not specified
STUDY00000877
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
Cancer, Microbiota, Prevention & Wellness
Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS
MT2005-25 Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia
To determine the incidence of engraftment (defined as achieving donor derived neutrophil count >500/uL by day 42) in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.
Christen Ebens
Up to 3 years old
0511M77206
Inclusion Criteria:
Matched sibling donor (HLA 8/8), if available, or a unrelated partially HLA matched single unit based on the following priority:
1st priority: 4/6 matched unit, cell dose >5 x 10-7 nucleated cells/kg
2nd priority: 5/6 matched unit, cell dose > 4 x 10-7 nucleated cells/kg
3rd priority: 6/6 matched unit, cell dose > 3 x 10-7 nucleated cells/kg
Patients aged ≤ 3 years at diagnosis (not age of transplant) with hematological malignancy as detailed below:
Acute myeloid leukemia: high risk CR1 as evidenced by:
High risk cytogenetics t(4;11) or other MLL rearrangements; chromosome 5, 7, or 19 abnormalities; complex karyotype (>5 distinct changes); ≥ 2 cycles to obtain complete response (CR); CR2 or higher; Preceding myelodysplastic syndrome (MDS); All patients must be in CR or early relapse (i.e., <15% blasts in BM).
Acute lymphocytic leukemia: high risk CR1 as evidenced by: High-risk cytogenetic: t(4;11) or other MLL rearrangements; hypodiploid; t(9;22); >1 cycle to obtain CR; CR2 or higher; All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology.
Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: Patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy. MRD will be defined by either flow cytometry (>0.1% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (PCR or FISH) or conventional cytogenetics (g-banding).
New Leukemia Subtypes: A major effort in the field of pediatric hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.
Recipients must have a Lansky score ≥ 50% and have acceptable organ function defined as:
Renal: glomerial filtration rate > 60ml/min/1.73m^2
Hepatic: bilirubin, AST/ALT, ALP < 5 x upper limit of normal,
Pulmonary function: oxygen saturation >92%
Cardiac: left ventricular ejection fraction > 45%.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Exclusion Criteria:
Active infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days).
History of HIV infection or known positive serology
Myeloablative transplant within the last 6 months.
Evidence of active extramedullary disease (including central nervous system leukemia).A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis
The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. We will also check if the study drug works to improve your kidney function, if has an impact on your daily life and the amount of the study drug in your blood over a period of time (called pharmacokinetics)
Michelle Rheault
Not specified
STUDY00015869
Inclusion Criteria:
• at least 12 years of age
• for people with Alport Syndrome: confirmed diagnosis by genetic testing and /or kidney biopsy
• for primary Focal Segmental Glomerulosclerosis (FSGS), (without any identifiable cause, and where the FSGS is confirmed by renal biopsy) or FSGS where there is documentation of a genetic mutation in a podocyte protein
• female patients, as well as, female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study (90 days after the last dose of study medication)
• males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug
• contact study staff for additional criteria
Exclusion Criteria:
• uncontrolled diabetes mellitus as evidenced by an HbA1c greater or equal to 11%
• uncontrolled high blood pressure
• moderate or severe liver impairment
• BMI greater than 40
• women who are pregnant or breast feeding
• additional exclusion criteria apply (study staff will review)
Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Alport Syndrome, Focal Segmental Glomerulosclerosis
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.
Michelle Rheault
Not specified
STUDY00012146
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)
Kidney, Prostate & Urinary
Glomerular Disease, Alport Syndrome, IgAN, FSGS, Proteinuric Glomerular Diseases
Defining Clinical Endpoints in LGMD (GRASP-01-001)
The purpose of this study to learn more about Limb Girdle Muscular Dystrophy by measuring how muscles change over a twelve-month period. Our clinical evaluator will test muscle strength and participants will be asked to complete a series of questionnaires to find out how Limb Girdle impacts daily activities. This information will help plan future studies and drug development for people with LGMD.
Peter Kang
Not specified
SITE00001632
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)
Rare Diseases
Limb Girdle Muscular Dystrophy, Limb-Girdle Muscular Dystrophy (LGMD), Muscular Dystrophy
MT2019-01: Adrenoleukodystrophy National Registry Study (ALD) and Biobank
The purpose of this research to enhance our understanding of adrenoleukodystrophy ALD and study biospecimens such assaliva, blood, urine and stool to identify potential biomarkers for early identification of dise. We invite people who have or are at risk to have ALD, including females who are known or at risk carriers of the mutation for ALD, to help us learn more.
Ashish Gupta
Not specified
STUDY00003605
Inclusion Criteria:
• age 0 to 100
• patient or family member diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation
• patient or family member with known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• living in the United States and territories
Exclusion Criteria:
• have undergone BMT or other cellular therapy
• not fluent in English who are unable to consent in-person
• people who are unable to read or write
Rare Diseases
Adrenoleukodystrophy, ALD, Cerebral Adrenoleukodystrophy
Fully Automated Motion-corrected MR Spectroscopy in Human Brain and Spinal Cord
The goal of this proposal is to develop fully automated, high performance, motion-corrected MRS sequences for the brain and spinal cord, that are also easy to share (no additional external hardware needed) with other institutions and easy to use.
Dinesh Deelchand
Up to 18 years old
STUDY00009397
Inclusion Criteria:
We are looking for healthy children volunteers who are: Do not have a history of neurological disorder (stroke, brain, or C-spine injury, etc., and are 6 years of age or older at time of screening.
Exclusion Criteria:
• Participants who cannot have an MRI, as determined by the CMRR safety screening form (e.g. metal implant)
• Pregnancy
• Claustrophobia
• Inability or unwillingness to complete an MRI because of low cognitive function or behavioral dysregulation
• Diabetes that has been diagnosed within the past 3 months (diabetes is OK if it is stably controlled (per participant report of either HbA1c <7.0 or stable control for at least 3 months))
• Hearing loss sufficient to prevent communication via telephone
• Weight > 250 and BMI > 35.
• Uncontrolled high blood pressure (>170/100) or working with doctor to stabilize blood pressure
• Severe lung, liver, kidney or heart disease of other major organ failure.
• Head size > 23.25 inches
Brain & Nervous System
MRI, MRS