
Search Results
Causal inference and impact of prior beliefs on perception
The study is being conducted in order to further understand how we perceive the world, and if and how this may be different in individuals on the autism spectrum. We hope to further understand sensory processing differences in autism.
• 14to 36 years old
• right-handed
• normal (or corrected) vision - normal hearing
• able to sit quietly and make judgments of sensory stimuli
• diagnosis of Autism
• history of epilepsy
MT2021-29: Evaluation of intravenous laronidase pharmacokinetics before and after hematopoietic cell transplantation in patients with mucopolysaccharidosis type IH
In this study, the researchers are collecting blood samples to learn more about laronidase treatment in children that receive a hematopoietic cell transplantation. The laronidase dose regimens used after a hematopoietic cell transplantation may differ from those administered before. This study will establish the basis for determining if there is a need to adjust laronidase dosing regimens after receiving a hematopoietic cell transplantation.
• between 0 to 3 years of age
• meet protocol specific eligibility criteria for allogeneic HCT for MPS IH
• planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course
• patient's parent/ legal guardians are unable to provide informed consent.
MT2019-38: Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)
The purpose of this study is to develop a questionnaire specifically designed for children and adolescents, which will help health care providers to better measure how bothersome symptoms of cGVHD are for children and adolescents living with cGVHD. Another purpose of this study is to design a caregiver companion questionnaire, to allow caregivers to measure how bothersome the symptoms of cGVHD are for their child/adolescent.
• children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
• clinical diagnosis of Graft vs Host Disease (cGVHD)
• currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 12 months -eligible caregiver proxy who is willing to participate in the study
• see link to clinicaltrials.gov for complete inclusion criteria
• participant's cognitive ability would compromise their ability to participate in study related procedures
• see link to clinicaltrials.gov for complete exclusion criteria
HM2024-28: A Pilot Study to Investigate the Clinical Utility of Tremoflo Airway Oscillometry in the Pediatric and Adolescent Population with Pulmonary Pathology or at Risk of Lung Injury
The purpose of this study is to help investigators learn more about what are the best methods for diagnosing and monitoring lung problems.
• age 0 to 24
• physician thinks patient might benefit from early and more frequent pulmonary function monitoring
• at risk for developing lung disease
• unlikely to complete required study components
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.
• 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
• 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
MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study
The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).
• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
• pregnancy
• women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
Gender Identity Measurement In Early School Aged Children
The goal of this study is to learn more about how children (ages 5-8 years) describe their gender identities. We are also interested in learning more about the ways children think and develop. We will be giving children several tasks designed as games to assess flexibility in thinking, creativity, and the ability to take another person’s perspective.
• Ages 5 to 8
• English speaking
• unable to speak English
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.
• 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
• diagnosis of type 1 or monogenic diabetes
• evidence of significant cognitive deficits or a severe, persistent psychiatric disorder
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy (BLOSSOM)
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various organs of the body, especially the skin, joints, blood, kidneys and central nervous system. "Chronic" means that it can last for a long time. "Autoimmune" means that there is a disorder of the immune system, which, instead of protecting the body from bacteria and viruses, attacks the one’s own tissues. We are doing this study to see if the investigational medication called anifrolumab may have an effect in treating pediatric SLE, to see how well it is tolerated or how safe it is, to measure levels of anifrolumab in the blood and learn more about the disease and associated health problems.
• 5 years to less than 18 years old
• weight at lest 15 kg (33 pounds)
• diagnosis of Systemic Lupus Erythematosus (SLE)
• being treated with prednisone, or antimalarial drugs
• no active or chronic TB or contact with someone who has TB
• females and males must be willing to use birth control during the study
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months
• history of multiple infections requiring hospitalization and IV antibiotics over the past year
• history of cancer
• history of severe COVID-19 infection
• prior treatment with anifrolumab
Global Patient Registry of Inherited Retinal Diseases
The purpose of this research study is to collect timely and relevant data that will support the evolving research needs of the Inherited Retinal Disease community (IRD), in order to provide insights that can be used to improve patient management, and to inform development of future treatments. No visits, assessments, or procedures are mandated, and follow-up will be captured as part of your standard of care. The planned length of registry is of 8 years with a potential to extend the duration as needs evolve.
• at least 3 years old
• documented genetic diagnosis of X-linked retinitis pigmentosa (XLRP) or Achromatopsia (ACHM) with any signs or symptoms of disease
• Caregiver participants must be at least 18 years old and identified by the participant as the primary care giver
• received a treatment in an Inherited Retinal Disease (IRD) related interventional trial, or is being screened for an IIRD-related interventional trial
• Caregiver participant has an IRD and has visual impairment
Bladder Management Patient Reported Outcomes for Young Adults with Spina Bifida
The purpose of this study is to determine how different bladder management methods affect the quality of life for young people with spina bifida. We hope to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with spina bifida.
• at least 14 years old
• diagnosis of spina bifida
• able to effectively communicate in English
• reconstructive surgery or urinary diversion in the last 3 months
• admitted to the hospital admission in the last month
MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
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.
• 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
• 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
MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)
The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.
• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
This study will enroll children aged 6 to 12 years who have difficulty in maintaining a healthy weight and see if the medication Vyvanse may help them to reduce their weight.
• children 6 to 12 years old
• severe obesity defined as BMI greater than or equal to 1.2 times the 95th percentile
• failed attempt of lifestyle therapy
• significant congenital or structural heart disease or arrhythmia
• hypertension
• history of chemical dependency
• Diabetes mellitus (type 1 or 2)
• current or recent ( less than 3 months ago) use of anti-obesity medication(s)
• additional medical or mental health conditions (study staff will review)
COG AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
This phase II trial studies how well combination chemotherapy works in treating patients (≤ 30 years old) with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).This trial may help doctors find out what effects, good and/or bad, regimen UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT)and regimen ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
• patients must be =< 30 years old at study enrollment
• patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor and have received an initial risk assignment showing DAWT or patients with relapsed favorable histology Wilms tumor
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• patients with a history of bilateral Wilms tumor
• patients with any uncontrolled, intercurrent illness
• female patients who are pregnant or breastfeeding
Computational Modeling of Tic Change Trajectories in Tourette Syndrome
We are looking for participants who have tics. We would like to measure your tics before, during and after a course of Comprehensive Behavioral Intervention for Tics (CBIT) .
• age 12-17
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months
• at least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only)
• full scale IQ greater than 80
• previous diagnosis of psychosis or cognitive disability
• substance abuse or dependence within the past year
• neuroleptic/antipsychotic medications
Creativity Camp Study
This study explores how engaging in creative activities may be helpful for mental health and wellbeing in adolescents. Study participants will attend eight sessions (over two weeks) of Creativity Camp which involves a range of different kinds of arts activities. Participants will also complete a series of questionnaires, interviews, and other assessments to assess the potential benefits of the camp. We have previously shown that Creativity Camp is effective for reducing depression symptoms and improving well-being in adolescents with depression.
• ages 12-17
• neurodevelopmental disorder (e.g. intellectual disability, severe autism)
• major medical and/or neurological illness
MT2023-38 Monitoring of Immune Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
The purpose of this research is to collect and store specimens and information about the recovery of the immune system following a stem cell transplant (HCT) or immunotherapy to treat a cancer or blood disease. Samples from many people are being collected and stored so they can be used for research now and in the future.
• planning to have a Hematopoietic Cell Transplant (HCT), gene therapy or other cell therapy or immunotherapy
• allogeneic related donors
A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1) (PRIOH-1)
The purpose of this research study is to look at the safety and effectiveness of pritelivir given orally (by mouth for a maximum of 42 days) for people with an impaired immune system who have recurrent lesions caused by the form of HSV that does respond to treatment with acyclovir.
• at least 16 years old
• immunocompromised or body is unable to fight off infection
• have lesions that can been seen in order to determine if they are healing
• willing to use highly effective birth control
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• history or current evidence of gastrointestinal malabsorption
• on hemodialysis for any reason and end stage renal disease (ESRD)
• women who are pregnant or breastfeeding
• unable to communicate with study staff
BEGIN-OB-19: A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN) (BEGIN)
This is a study of highly effective CFTR modulators and their impact in children with CF on endocrine growth factors, the gut microbiome, respiratory microbiome, liver and pancreatic function, lung function, sweat chloride, and inflammatory markers.
• For Part A: less than 5 years of age at the first study visit
• For Part B: participated in Part A OR less than 6 years of age at the first study visit, CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy and physician intends to prescribe ivacaftor or elexacaftor/tezacaftor/ ivacaftor
• Documented diagnosis of Cystic Fibrosis (CF)
• use of ivacaftor or elexacaftor/tezacaftor/ ivacaftor within the 180 days
• use of an investigational drug within 28 days prior to first study visit
• use of chronic oral corticosteroids within the 28 days prior to first study visit
MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.
Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.
• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
Increasing HPV vaccination coverage among pediatric, adolescent, and young adult (PAYA) cancer survivors: A multilevel intervention
The purpose of this research is to test the efficacy of different interventions to increase vaccination against human papillomavirus (HPV). Survivors of childhood, adolescent and young adult cancers are at increased risk of developing HPV-associated secondary cancers, but have lower HPV vaccination coverage compared to the general population. Interventions which are found to be successful in this study will be incorporated into future survivorship care to improve adherence to recommend preventive healthcare practices. All research procedures will be conducted remotely (e.g. online).
• current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic
• seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder
• survivor of childhood cancer (diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age
• at least 6 months post-treatment (current treatment for graft-versus-host disease allowed)
• no previous HPV vaccination or incomplete HPV vaccination
• people who are unsure of their HPV vaccination status and are unable to find vaccination records (study staff will review)
• previously completed HPV vaccination series
• unable to read and write in English
• pregnant or plans to become pregnant in the next year
• currently receiving treatment for cancer or hematologic disorder or plan for treatment in next 12 months
• immediate hypersensitivity reaction to any vaccine component (study staff will review)
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
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). (APPARENT)
To evaluate the efficacy and safety of iptacopan compared to placebo in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN)
• 12 to 60 years old
• diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to starting the study for adults and within 3 years for adolescents
• must have a vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• have had cell or a solid organ transplantation, including kidney transplantation
• Body mass index (BMI) >38 kg/m2
• Body weight <35 kg (77 pounds)
• additional criteria that study staff will review
AHOD2131, A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.
• 5 to 60 years old
• newly diagnosed untreated confirmed Hodgkin lymphoma
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• patients with nodular lymphocyte predominant Hodgkin lymphoma
• patients with a history of active interstitial pneumonitis or interstitial lung disease
• administration of prior chemotherapy, radiation, or antibody-based treatment for classic Hodgkin Lymphoma (cHL)
• prior solid organ transplant
• prior allogeneic stem cell transplantation
• women who are pregnant or breast feeding
Registry Study of Childhood Cancer in Minnesota
The aim of this study is to obtain newborn blood spots (NBS) and tumor specimens for children and adolescents diagnosed with malignant neoplasms.
• 0 to 21 years of age
• child diagnosed with any type of tumor or cancer
• born in a state that banks newborn blood spots
• able to understand English or Spanish
• parents or siblings may also contribute specimens
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery. We expect that people will be in this research study for 3-6 months depending on the timing of surgery and postoperative visits. The number of preoperative and postoperative visits, physician exams, scans, X-rays, and laboratory tests for preparation for surgery or after the surgery does not change because of this study.
• at least 18 years old
• having bowel diversion urologic surgery
• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
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)
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects (NEXPEDE-1) (NEXPEDE-1)
The clear layer at the front of the eye that covers the pupil and iris (colored part of the eye) is called the “cornea”. When the cornea is damaged, it normally heals within a few days but it may take up to 2 weeks depending on the size and depth of the defect (wound). Some corneal defects heal much slower than expected. A defect in the cornea that fails to heal within the normal time of 2 weeks despite using the best available medicines and procedures, is known as Persistent Corneal Epithelial Defect (or PCED for short). The purpose of this research study is to evaluate the safety, tolerability, and effectiveness (risks and benefits) of of NEXAGON ophthalmic gel for the treatment of PCEDs.
• at least 2 years old
• diagnosis of Persistent Corneal Epithelial Defect (PCED) for at least 2 weeks that hasn't responded to one or more conventional non-surgical treatments
• active eye infection that requires treatment
• additional eye conditions that exclude study participation (study staff will review)