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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

134 Study Matches

MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

This study is testing a stem cell (bone marrow) transplant for people with certain blood disorders. The goal is to find a treatment approach that is effective while causing fewer side effects. Participants will receive treatment to prepare their body, followed by a transplant using stem cells from a donor. After the transplant, they will receive medications to help prevent complications.

Principal Investigator: Christopher Graham
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027522
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• recent stem cell transplant within the past 3 months
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Hematological Diseases, Stem Cell Transplant
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MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

Principal Investigator: Punita Grover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001087
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• no more than 60 years old
• may be unable to work; able to live at home and care for self
• 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 inclusion and exclusion criteria (differ by diagnosis)
Exclusion Criteria:

• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• active central nervous system cancer
• active HIV infection or known HIV positive serology
• active uncontrolled infection
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, ALL, AML, HSCT
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
Conditions: Cancer
Keywords: childhood cancer
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COG AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC # 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to < 31 Years Old with First Relapse

The overall goal of this study is to determine if treating first relapse B-cell acute lymphoblastic leukemia (B-ALL) with a combination of blinatumomab and nivolumab is more effective than blinatumomab alone.

Principal Investigator: Peter Gordon
Age Group: 1 year to 30 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001178
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Sex: Male or Female
Age Group: 1 year to 30 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 1 to 30 years old
• must have first relapse of CD19+ B-ALL (relapse blasts must express CD19)
• must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• see link to clinicaltrials.gov for completed Inclusion criteria
Exclusion Criteria:

• other types of blood disorders including: B-lymphoblastic lymphoma (B-LLy), Burkitt leukemia/lymphoma or mature B-cell leukemia, Philadelphia chromosome positive (Ph+) B-ALL, mixed phenotype acute leukemia (MPAL), known Charcot-Marie-Tooth disease, MYC translocation associated with mature (Burkitt) B-cell ALL
• active, uncontrolled infection
• significant central nervous system pathology including history of severe neurologic disorder or autoimmune disease with CNS involvement
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia
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PEPN1924 - A Phase 1/2 study of DS-8201a (NSC# 807708, IND# 153036) in children, adolescents, or young adults with recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor

This phase II trial studies the effects of trastuzumab deruxtecan in treating patients (> 12 years and ≤ 39 years of age) with HER2 positive osteosarcoma that is newly diagnosed or has come back (recurrent). Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001108
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• children, adolescents, and young adults with Wilms tumor or desmoplastic small round cell tumor (DSRCT)
• disease that has returned after treatment or has not responded to standard treatment
• measurable tumor that can be evaluated during the study
• recovered from previous cancer treatment and meet study health requirements
• see the ClinicalTrials.gov listing for complete inclusion criteria
Exclusion Criteria:

• currently receiving another investigational treatment or anti-cancer therapy
• previous treatment with certain HER2-targeted therapies
• previous solid organ transplant
• pregnant or breastfeeding
• see the ClinicalTrials.gov listing for complete exclusion criteria
Conditions: Cancer
Keywords: bone cancer, DSRCT, HER2+ Osteosarcoma, Wilms tumor
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D2D: Tyrannosaurus Flex: Finding the "Fair-ly Normal" Grip

How strong is your squeeze? We’re inviting kids aged 2-12 to test their grip and help us establish new standards for hand strength. Your contribution allows our team to create more inclusive, accurately calibrated technology that works for everybody. Stop by the Minnesota State Fair Research Building for a Tyrannosaurus Flex to help us find the Fair-ly Normal Grip and help us build the future of interactive play!

Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00028771
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 2-12 years old
Exclusion Criteria:

• musculoskeletal, neurological, or neuromuscular conditions affecting upper limb strength or function
• diagnosis of a systemic condition affecting the musculoskeletal or nervous system
• previous hand, wrist, or upper limb surgery
• history of hand, wrist, or upper limb trauma
• current pain in either hand or upper limb
Conditions: Arthritis & Rheumatic Diseases, Bone, Joint & Muscle, Brain & Nervous System
Keywords: Grip strength, hand function, MNFair
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MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.

Principal Investigator: Margaret MacMillan, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016450
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• hematological cancer needing stem cell transplant
• 60 years old or younger
Exclusion Criteria:

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Conditions: Cancer
Keywords: Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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MT2023-29: Long-term Follow-up of Subjects With Sickle Cell Disease Treated With ExVivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector

The purpose of this study is to evaluate the long-term safety and ability of a transplant with gene modified stem cells (autologous stem cell transplant) to treat sickle cell disease. Participants must have received investigational gene therapy with bb1111 in a clinical study sponsored by bluebird bio. There is no additional treatment associated with this study as this is a long-term follow-up study.

Principal Investigator: Ashish Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020842
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to 53 years old
• treated with a clinical product to Sickle Cell Disease (SCD) in clinical study sponsored by bluebird bio-
Exclusion Criteria:

• there are no exclusion criteria for this study
Conditions: Rare Diseases, Blood Disorders
Keywords: SCD, Sickle Cell, Clinics and Surgery Center (CSC)
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D2D: studying planning by playing Tetris

Play Tetris while researchers at the Minnesota State Fair Research Building measure your brain activity to better understand how the brain works during gameplay.

Principal Investigator: Jean-Paul Noel
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00028192
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 14-80 years
Exclusion Criteria:

• have had a seizure
• family history of epilepsy
Conditions: Brain & Nervous System
Keywords: Brain Science, EEG, MNFair, Neuroscience, Planning
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Determining Normative Hand Measurements to Optimize Hand Reconstruction Aesthetic Outcomes

Help researchers at the Minnesota State Fair Research Building learn how people naturally hold a pen while writing. This information may improve therapies that support handwriting skills.

Principal Investigator: Ann Van Heest
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00019161
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• ages 5 years and older
Conditions: Arthritis & Rheumatic Diseases, Bone, Joint & Muscle
Keywords: grip strength, Hand therapy, pencil grip, tripod grip, MNFair
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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.

Principal Investigator: Erin Marcotte
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00018811
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 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
Conditions: Cancer
Keywords: blood specimen, cancer, tumor
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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.

Principal Investigator: Samuel Goldfarb
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023347
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 24
• physician thinks patient might benefit from early and more frequent pulmonary function monitoring
• at risk for developing lung disease
Exclusion Criteria:

• unlikely to complete required study components
Conditions: Cancer, Respiratory System
Keywords: child cancer, lungs, oxygen level, asthma, BPD, Cystic Fibrosis, interstitial lung disease
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: THE RESTORATIVE303 STUDY (RESTORATiVE303)

The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022419
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 12 years old
• laboratory-confirmed Clostridium Difficile Infection (CDI) and at least one prior occurrence of CDI within the last 6 months
• OR 75 years or older with laboratory confirmed CDI
• OR CDI with additional risk factors
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Exclusion Criteria:

• history of chronic diarrhea unrelated to CDI
• history of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months) of intestinal ischemia or ischemic colitis
Conditions: Rare Diseases, Infectious Diseases
Keywords: C. Diff Infection, CDI, Clostridium Difficile, Clostridium Difficile Infections, Diarrhea
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AALL2131; An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025612
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients must be >365 days and < 22 at the time of enrollment
• Diagnosis: Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
Exclusion Criteria:

• Known history of chronic myeloid leukemia (CML)
• ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome (trisomy 21)
• Pregnancy and breast feeding
Conditions: Blood Disorders, Cancer, Children's Health
Keywords: Acute Lymphoblastic Leukemia, ALL
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Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

This study is looking at whether rezpegaldesleukin can help preserve insulin-producing cells in people who were recently diagnosed with type 1 diabetes. Participants will receive treatment every 2 weeks for 26 weeks, followed by a 6-month follow-up period.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027051
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 8 to 45 years
• recently diagnosed with type 1 diabetes (T1D) within the past 100 days
• have at least one blood test showing an immune response associated with T1D and some remaining insulin production
• see link to ClinicalTrials.gov for complete Inclusion criteria
Exclusion Criteria:

• current or recent serious infection, including tuberculosis, HIV, or hepatitis B or C
• currently taking medications that suppress the immune system or have recently received certain immune-modulating treatments
• history of certain serious heart conditions, cancer, or organ transplant
• currently pregnant or breastfeeding, or planning to become pregnant during the study
• see link to ClinicalTrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: T1D, type 1 diabetes
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Pathogen Genomics Center of Excellence: Prospective Surveillance of Respiratory Pathogens and Antimicrobial Resistance in Diverse Regional Populations (MINNE-LOVE-2)

Respiratory illnesses, including ear and sinus infections, colds, and pneumonias, are among the most common infectious diseases affecting Minnesotans across their lifespan. These diseases can be caused by many different types of microbes—bacteria, viruses and fungi—and different types of microbes may require different kinds of treatment. This research is being done to learn more about the specific types of microbes that cause respiratory infections in children and adults across the state of Minnesota over time. Antimicrobial resistance happens when microbes develop the ability to defeat the drugs designed to kill them. Through this study, we will learn which types of genes are carried by microbes living in the respiratory tract by collecting and analyzing nasal and oral specimen.

Principal Investigator: Beth Thielen
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00019522
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• age at least 18 years and able to provide informed consent AND willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness Or
• age less than 18 years within the same household of at least 1 adult participant in study AND parent/guardian available to provide informed consent AND self or parent/guardian willing and able to collect nasal swabs and complete symptom questionnaires with symptomatic respiratory illness
Exclusion Criteria:

• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., parent not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe)
• routine mucosal specimen collection is not medically advised (such as severe immunocompromising condition, bleeding disorder)
Conditions: Community Health, Infectious Diseases, Respiratory System
Keywords: germs, infection, respiratory illness, RSV, virus, cough
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Amblyopia Treatment Study (ATS23): A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)

Amblyopia (sometimes called 'lazy eye') is reduced vision in one eye caused by abnormal visual development early in life. The weaker (or 'lazy') eye often wanders inward and outward. Amblyopia is the leading cause of reduced vision in children and can lead to blindness if not treated. Treatments for amblyopia are glasses, and if needed, further treatment with part-time patching or penalization with atropine eye drops. Patching or atropine are administered to the stronger eye to force the child to use the weaker (amblyopic) eye. In recent years, an alternative type of therapy has emerged. It is called dichoptic treatment and involves stimulating both eyes simultaneously but with different stimuli. When it was first introduced, it was done in an office-based setting. Home-based technologies utilizing games and movies have been developed and studied to a limited extent in younger children with amblyopia. In this study, we will use a system called Luminopia. It uses a virtual reality headset to view web-based videos in which the contrast of the image seen by the stronger eye is reduced by 15% from that of the weaker eye. Luminopia has been available for use in the U.S. since 2022 and has been approved by the FDA for the treatment of amblyopia in this age group. In a previous large randomized trial, home-based dichoptic movies were shown to be superior to glasses alone but treatment effectiveness compared to patching (the gold standard for treating amblyopia) has not yet been established. If dichoptic therapy using the Luminopia system is confirmed to be at least as effective as patching, it would be an appealing alternative for treating amblyopia in young children, as it shows promise of better adherence and an easier treatment experience for the parent and the child. Children in this study would be randomized 1:1 to either the Patching Group or the Luminopia Group and followed for at least 6 months. Children in the Patching Group will have the option to do the Luminopia treatment after 6 months of patching. They will be followed for an additional 6 months. Thus, their participation will last for a total of 1 year.

Principal Investigator: Raymond Areaux
Age Group: Up to 18 years old
IRB Number: STUDY00022243
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Sex: Male or Female
Age Group: Up to 18 years old
Inclusion Criteria:

• children 4 to 7 years old
• amblyopia (lazy eye) associated with strabismus, anisometropia, or both (previously treated or untreated)
• parent has phone (or access to phone) and is willing to be contacted
Exclusion Criteria:

• prism lenses or need of a prism prescription
• currently wearing bifocals
• known skin reactions to patch or bandage adhesives
• history of light-induced seizures
Conditions: Children's Health, Vision & Eyes
Keywords: Amblyopia, Lazy Eye
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MT2023-35: A Pilot Study to Identify Risk Factors for Long-Term Functional and Pulmonary Outcomes Following Allogeneic Hematopoietic Cell Transplantation for Oncologic Diagnoses.

The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what are the best methods for diagnosing lung problems and follow-up care. The lung problems that may develop after transplant varies from patient to patient, and we don’t exactly know what risk factors influence who develops them or how patients respond to pulmonary (breathing system) therapies. Also, we wish to improve how we monitor lung function and quality of life after transplant, especially in children and young adults.

Principal Investigator: Alex Hoover
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021591
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Sex: Male or Female
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 0 to 25 years at the time of Hematopoietic Cell Transplantation (HCT)
• received stem cell transplant for cancer
• receive ongoing care at the University of Minnesota Childhood Cancer/BMT Survivor Program
Exclusion Criteria:

• people who don't speak or read English
Conditions: Cancer
Keywords: HCT, Hematopoietic Cell Transplantation
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PEPN2413; A Phase 1 study of oral cedazuridine and decitabine combination (ASTX727, IND# 175393, NSC# 820631) and filgrastim as maintenance therapy post-hematopoietic stem cell transplant in children with high-risk acute myeloid leukemia

This study is evaluating a new treatment after stem cell transplant for children with high-risk acute myeloid leukemia (AML). Researchers hope to identify a safe dose, better understand possible side effects, and learn how the treatment works in the body.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027685
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 21 years old
• newly diagnosed, relapsed, or treatment-resistant Acute Myeloid Leukemia (AML) that is in remission before a planned donor stem cell (bone marrow) transplant
• planning to receive your first donor stem cell (bone marrow), peripheral blood stem cell, or cord blood transplant
• see the ClinicalTrials.gov listing for complete inclusion criteria
Exclusion Criteria:

• currently receiving another investigational treatment or certain anti-cancer medications
• previous solid organ transplant
• pregnant or breastfeeding
• see the ClinicalTrials.gov listing for complete exclusion criteria
Conditions: Cancer
Keywords: Acute Myeloid Leukemia, AML, blood cancer
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A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients with Severe Alopecia Areata with an Open-Label Extension Period

The purpose of this study is to determine if deuruxolitinib is a safe and effective treatment for adolescents ages 12 to 17 with severe alopecia areata and at least 50% scalp hair loss.

Principal Investigator: Maria Hordinsky
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025881
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• ages 12-17
• moderate to severe alopecia areata with at least 50% scalp hair loss
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• have a scalp condition, such as psoriasis or seborrheic dermatitis, that requires treatment
• taking medications or other treatments that could affect hair growth or your immune system
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Dermatology (Skin, Hair & Nails), Children's Health
Keywords: Alopecia Areata, AA, hair loss
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A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (WAVE T1D)

This study is looking at if we give ATG followed by either adalimumab or verapamil if those combinations will help in preserving insulin secretion 2 years after newly diagnosed type 1 diabetes.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025666
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 9 to <21 years
• recently diagnosed with T1D and can start the treatment phase within 6 months of diagnosis
• body weight more than 66 pounds
• fully vaccinated for age and willing to avoid certain live vaccines during the study
• able to read and understand English or Spanish
• use only insulin to control blood sugar (no other glucose-lowering medicines)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of serious bacterial, viral, fungal, or other infections or current active infection
• history of underlying heart disease
• history of cancer other than of skin
• severe allergy to milk or adhesives
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Diabetes & Endocrine
Keywords: T1D, Type 1 Diabetes
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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.

Principal Investigator: Alex Hoover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1601M82901
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Conditions: Cancer
Keywords: Neuroblastoma
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COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000723
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ≥25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• female patients who are pregnant, 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 women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Leukemia, Testicular Leukemia
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Efficacy, safety, and pharmacokinetics of cargrilinitide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity

This study will evaluate the efficacy, safety and pharmacokinetics of a combination drug called CagriSema, which is a combination of cagrilintide s.c. 2.4 mg and semaglutide s.c. 2.4 mg for the management of weight in children and adolescents with overweight or obesity. Participants in the study may receive study medication for up to 250 weeks.

Principal Investigator: Eric Bomberg
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026377
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• children who are 8 to <18 years old
• history of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counselling) for at least 3 months
• BMI requirements vary by age
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• treatment with any medication prescribed for obesity or weight management within 90 days before starting this study -Type 1 diabetes or monogenic diabetes
• HbA1c greater than or equal to 6.5% if diagnosis of Type 2 diabetes has not been made
• recurrent severe hypoglycaemic episodes within 1 year before starting the study
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Children's Health
Keywords: Clinics and Surgery Center (CSC), obesity, overweight
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A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Letermovir in Pediatric Kidney Transplant (KT) Recipients Less Than 18 Years of Age and Weighing Less Than 40 Kilograms

Letermovir (MK-8228) is a medication that is used to prevent cytomegalovirus (CMV) infection and disease. This trial is testing letermovir in children and adolescents who weigh less than 40 kilograms and have had a kidney transplant. Letermovir is experimental in this trial. Everyone in this trial will get letermovir. The dose a child gets will depend on their weight at the start of the trial. The child, the trial doctor and the trial staff will know your child is getting letermovir and what dose they are getting.

Principal Investigator: Shannon Andrews
Age Group: Up to 17 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026525
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Sex: Male or Female
Age Group: Up to 17 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 17 years old
• recipient of a primary or secondary allograft kidney
• at least 4 weeks posttransplant and not more than 52 weeks posttransplant
• has stable kidney function since the transplant
• able to take letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube
• weighs ≥2.5 and <40 kg at enrollment (5.5 to 88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• has CMV disease
• on dialysis or plasmapheresis
• multi-organ transplant recipient (e.g., kidney-pancreas)
• any uncontrolled infection
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Children's Health, Infectious Diseases, Kidney, Prostate & Urinary
Keywords: CMV, cytomegalovirus, kidney transplant
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Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants with Fragile X Syndrome

Researchers are studying an investigational medication called MRM-3379 for males with Fragile X syndrome (FXS), a genetic condition that can affect learning, memory, communication, and behavior. The goal of this study is to evaluate the safety and tolerability of MRM-3379 and explore whether it may help improve cognitive function by supporting brain cell communication. The study will also examine how the body processes the medication.

Principal Investigator: Amy Esler
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027846
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Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• male, ages 13-45
• diagnosed with Fragile X syndrome (FXS) confirmed through genetic testing
• able to complete study activities that assess language and thinking abilities
• have a consistent caregiver who is willing and able to provide regular support during the study
• able to swallow tablets or capsules
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Rare Diseases, Brain & Nervous System
Keywords: Fragile X Syndrome, FXS
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Project GRaNoLA (Gender Role and Norm: Learning and Accepting)

This study is exploring how children understand and form opinions about differences in how adults express their gender through appearance, speech, and behavior. Researchers are interested in learning how children think about gender expression and whether their perceptions vary based on different aspects of how gender is represented.

Principal Investigator: Melissa Koenig
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00024846
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• children between 5 and 10 years old
• able to understand and speak English
Exclusion Criteria:

• history of developmental disorders, language delays/disorders, or vision or hearing impairments
Conditions: Children's Health
Keywords: Children, Cognitive Development, Learning, MNFair
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Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients with Soft Tissue and Bone Sarcoma (TARGET-RT) (TARGET-RT)

This study aims to improve treatment and outcomes for children, adolescents, and young adults with metastatic sarcoma and help guide future care for this disease.

Principal Investigator: Leslie Chang
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026346
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• younger than 39 years old or were first diagnosed with a soft tissue or bone sarcoma before age 39
• have a newly diagnosed, recurrent, or progressive (continued to grow) soft tissue or bone sarcoma
• have sarcoma that has spread (metastasized) to another part of the body and can be measured on imaging scans
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have cancer that has spread to the brain or spinal fluid
• have metastatic disease that cannot be measured on imaging scans
• pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Rare Diseases
Keywords: Oligometastatic, radiotherapy
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ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001628
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
Conditions: Cancer, Cancer
Keywords: Acute Myeloid Leukemia, AML
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Emotion Regulation Knowledge Study

The purpose of this study is to develop and evaluate a storybook-based tool that measures how children ages 4 and older understand and manage their emotions. Researchers will examine how children choose different emotion regulation strategies in a variety of situations, such as interactions with family, friends, or when alone, and how these skills relate to children's social and emotional development.

Principal Investigator: Ka Ip
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
IRB Number: STUDY00026826
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Sex: Male or Female
Age Group: Up to 18 years old
This study is also accepting healthy volunteers
Inclusion Criteria:

• children ages 4–12 years
• parent or legal guardian able to provide informed consent
• child and parent willing to participate in a single research visit involving an iPad-based storybook activity and a brief parent survey
Conditions: Children's Health, Mental Health & Addiction
Keywords: Child development, Emotion regulation, Social-emotional development, MNFair, iPad-based activities
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