Search Results
ANHL2121: Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.
• 180 days to < 22 years (at time of study enrollment)
• patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry
• participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
• see link to clinicaltrials.gov for complete inclusion criteria
• LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
• history of solid organ or hematopoietic bone marrow transplantation
• female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
• lactating females who plan to breastfeed their infants are ineligible
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1/2A, (Part B, participant-, investigator-, and sponsor-blind) study; to investigate the safety, pharmacokinetics, and efficacy (Part B only) of UCB1381 in study participants with moderate to severe atopic dermatitis;(Part B)
This is an early study of a new drug called UCB1381. In the first part of the study, we are looking at increasing doses of the drug when compared to an inactive drug (placebo) when given to healthy participants. In the second part, we will look at the safety and effectiveness of one dose of UCB1381 compared to an inactive drug (placebo) when given to people who have moderate to severe Atopic Dermatitis.
• 18-65 years of age
• moderate to severe itch
• diabetes not well controlled with diet
• history of Crohns disease or Colitis
Validation of the Autism Diagnostic Interview: 3rd Edition
The purpose of this research is to find out whether the Autism Diagnostic Interview, 3rd edition (ADI-3) is useful for gathering information to help with the diagnosis of autism spectrum disorder (autism). Parents/caregivers will be asked to complete questionnaires and participate in two separate interviews about your child (the focus participant). We estimate that one interview will take 2-3 hours and the other will take 3-4 hours. Children will be asked to complete questionnaires (if they are able) and an in-person assessment that will take approximately 3-4 hours.
• ages 1 to 17 who have an adult (parent or caregiver) who is also willing to participate
• able to read and communicate in English
• Autism group: children with a previous diagnosis or concern about autism
• Non-autism group: children with or without a previous diagnosis or concern about another developmental or psychiatric condition
• significant visual or auditory impairments that would make it difficult to complete standard testing
• severe mental illness or medical condition that is not currently managed and would interfere with the completion of the testing
CANADIAN-AUSTRALASIAN RANDOMISED TRIAL OF SCREENING KIDNEY TRANSPLANT CANDIDATES FOR CORONARY ARTERY DISEASE (CARSK)
The current study is designed to determine which strategy (regular screening or screening only in the presence of symptoms) is more effective in preventing heart attacks in kidney transplant candidates. Another goal of the study is to determine whether biomarker tests are able to predict the need for regular CAD screening tests.
• Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
• expected to require further screening for coronary artery disease (CAD) prior to transplant
• anticipated to undergo transplant more than 12 months from date of enrollment
• patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease
• patients with other solid organ transplants
• multi-organ transplant candidates
• planned living donor transplant
A Phase 1b, Randomized, Vehicle-Controlled, Double-Blind, Pharmacokinetics, Pharmacodynamics, and Safety Study of ARQ-255 Topical Suspension in Healthy Volunteers and Subjects with Alopecia Areata
This study is being done to evaluate the safety and tolerability of twice daily application of the study drug, ARQ-255 topical suspension 3% people with alopecia areata. There are 2 study drugs in this study: ARQ-255 topical suspension 3% and vehicle (placebo). Participants will be randomized (like drawing straws) to either ARQ-255 topical suspension 3% or vehicle to be applied twice daily for 12 weeks. A vehicle is a study treatment that looks like the test drug and is made from the same base products used to make ARQ-255 topical suspension 3%, but it does not contain any active study ingredients.
• 18 to 70 years of age
• have alopecia areata
• able to apply topical study medication
• alopecia totalis
• alopecia universalis
Immune Modulation Associations With Urinary tract Infection In People With Neurogenic Bladder.
The goal of this study is to understand how urine and bladder tissue changes from infection, or a bladder that does not function normally, in people who use a catheter to empty their bladder. This may help future people because it can help determine who needs antibiotics to treat an infection in the bladder, and will help avoid the cost and side effects of using antibiotics in people who do not have a true infection. This study will take less than 1 hour – the time required to provide a urine sample in clinic. Or, if a participant is undergoing bladder Botox injection, the time necessary to participate in the study will add approximately 5 minutes to the total surgery time.
• at least 18 years old
• use clean intermittent catheterization (CIC) to empty the bladder
• without diagnosis of neurogenic bladder (NGB)
• OR NGB managed with bladder botulinum toxin injections with/without recurrent urinary tract infection (UTI) (may have an active UTI)
• presence of an indwelling catheter (i.e., Foley)
• history of bladder augmentation
• history of urinary diversion
• women who are pregnant
• non-English speaker
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.
• 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
• 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.)
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.
• 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
• 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)
Ankle Position Sense Acuity in People with Parkinson's Disease Experiencing Freezing of Gait and Its Relationship to Gait
This study aims to investigate whether there is difference in ankle position sense acuity between people with Parkinson's with freezing of gait and without freezing of gait. It also examines the relationship between position sense acuity and severity of freezing of gait, and gait measurements.
• 50 to 80 years old
• diagnosis of idiopathic Parkinsons Disease (PD) as determined by a movement disorder neurologist
• PD severity is mild to moderate
• significant central or peripheral nervous system disease
• previous exposure to chemotherapy
• history of lower limb surgery or lower limb fractures within the last 6 months
• amputation or joint replacement of any part of the leg
• implanted deep brain stimulation or other neurosurgery to treat PD
• additional medical factors (study team will review)
Profiling of Adipose Tissue Depots and Immune Correlates
This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.
• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (DREAM)
The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison.
• diagnosis of acute pancreatitis no more than 90 days ago
• definite diagnosis of chronic pancreatitis based on results of scans (study staff will review)
• pancreas tumors
• prior surgery on the pancreas
• pregnancy
• other significant health problems, study staff will review
CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL (CREST-2) PROTOCOL (CREST-2)
CREST-2 is a parallel trial to compare carotid endarterectomy + intensive medical management (IMM) vs IMM alone, and carotid artery stenting plus IMM vs IMM alone in patients with asymptomatic carotid stenosis >70%.
• patients at least 35 years old
• confirmed diagnosis of carotid stenosis
• no history of stroke or TIA on the side of the stenosis in the past six months
• other significant medical diagnosis (study staff will review)
• taking anticoagulants
• specific exclusion criteria exist for stent and surgery (contact study staff for more information)
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery (ASPIRE)
This study will compare the effects of apixaban to aspirin in patients who have atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.
• diagnosis of Intracerebral hemorrhage (ICH) confirmed by brain CT or MRI
• documented atrial fibrillation or atrial flutter
• can enter study 14 to 180 days after ICH
• women willing to use highly effective birth control
• prior ICH within last 12 months
• women who are pregnant or breast feeding
• allergy to aspirin or apixaban
• persistent, uncontrolled systolic blood pressure (?180 mm Hg)
• contact study staff for additional exclusion criteria
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)
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves).
• 2 to 21 years old
• neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing
• newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
• 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
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant
• women who are pregnant or breast feeding
• patients who have an uncontrolled infection
A Phase II, Open Label, Two Arm Study of Therapeutic Iobenguane (131I) as Single Agent or in Combination with Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects (OPTIMUM Trial) Protocol Number: MIBG 2014-01 (OPTIMUM)
This will be a Phase II, two-arm, nonrandomized, non-comparative, open-label study in participants ≥ 1 year of age with iobenguane avid, recurrent or progressive high-risk neuroblastoma. Participants not eligible for vorinostat treatment may receive 131I-MIBG as monotherapy.
• 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
• 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)
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.
• 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
• 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
Stratifying Patient Immune Endotypes in Sepsis (SPIES Study)
The purpose of this research is to learn more about the immune function of patients who are critically ill and may or may not have sepsis through assessment of blood samples at the time of their illness. We will use the blood to determine whether the immune system is suppressed (slowed or stunted) and measure the amount of suppression. Our research team will compare blood from healthy participants to people who are critically ill to better understand immune system suppression.
• Adults age 45 and older
• Ability to obtain Informed Consent prior to blood collection.
• Current, chronic steroid use
• Pregnancy
• Current or recent (within 7 days) use of antibiotics.
Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement
The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the longterm outcomes and complications over a 5-year period. There are no expected direct benefits to participation in this study however knowledge gained from this research may beneficial to future patients undergoing this procedure. This study does not involve any investigational drugs.
• at least 18 years old
• scheduled to undergo a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure
• women who are pregnant
• undergoing TIPS placement as part of an investigational study
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.
• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
20-0001: A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa
We are looking at a new intravenous drug, Bacteriophage, to treat Pseudomonas Aeruginosa in people at least 18 years of age who have cystic fibrosis. The drug is given one time and different doses will be evaluated to see if they work and to look at side effects.
• Cystic Fibrosis (CF) diagnosis based on clinical symptoms and confirmed by either an abnormal sweat chloride test or CFTR gene variations
• P. aeruginosa isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months.
• body weight less than 30 kg
• Forced Expiratory Volume 1 second less than 20% of predicted value
• women who are pregnant, planning to become pregnant during the study, or breastfeeding
• anticipate change chronic antibiotic regimens during the study
A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)
One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.
• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin
• other medical or mental health diagnosis (study staff with review)
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.
• 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
• acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• women who are pregnant or breast feeding
• uncontrolled infection
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.
• up to 55 years old
• see link to clinicaltrials.gov for inclusion criteria specific to each type of leukemia
• Radiation Oncology will evaluate all patients who have had previous radiation therapy
• pregnant or breastfeeding
• HIV positive
• study staff will review additional exclusion criteria
MT2013-06C : Treatment of graft Failure after HSCT
The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center and BMT databases for patients undergoing a second transplant using a haploidentical donor, an unrelated donor or umbilical cord blood. The data will be analyzed for transplant “milestones” such as time to blood count recovery (engraftment) and how patients are doing at 3 months and 6 months after the transplant. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• patients with primary or secondary HSCT graft failure
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• uncontrolled infection at the time of transplant
• patients with Fanconi Anemia or other DNA breakage syndromes
MT2012-11C: Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
The primary purpose of this study is to record outcomes and patient characteristics in the Masonic Cancer Center 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.
• up to 55 years old
• diagnosis of any disease for which a second or greater hematopoietic stem cell transplant (HSCT) is needed
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• women who are pregnant or breastfeeding
• active, uncontrolled infection
• HIV positive
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.
• up to 50 years old
• diagnosis of immunodeficiency or histiocytic disorder
• see link to clinicaltrials.gov for complete inclusion 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
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.
• 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
• history of any prior surgical, radiologic, medications for treatment (including oral or topical beta blocking agents)
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.
• 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
• 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)
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.
• 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
• illness sufficient to prohibit study participation
• inability to cooperate with the study
Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
• 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)
• 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