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Search Results Within Category "Children's Health"

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38 Study Matches

A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104

This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.

Mark Schleiss
Up to 18 years old
This study is also accepting healthy volunteers
SITE00001871
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Inclusion Criteria:

• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
Exclusion Criteria:

• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
Children's Health, Infectious Diseases
CMV, cytomegalovirus, vaccine
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A Phase 1 Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants At Risk of Acquiring Neonatal Herpes Simplex Virus Disease

The purpose of this study is to determine the dose of medication (Valacyclovir) needed to prevent an infant from developing herpes simplex virus (HSV) if the infant was potentially exposed to HSV at the time of delivery as they passed through the birth canal.

Mark Schleiss
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001830
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Inclusion Criteria:

• Mother has a history of genital HSV infection
• Mother is receiving oral acyclovir, valacyclovir, or famciclovir suppressive therapy for 7 or more days before delivery
• Gestational age 38 or more weeks at birth
• Infant is no more than 2 days of age at study enrollment
• Weight at study enrollment at least 2,000 grams
Exclusion Criteria:

• Evidence of neonatal HSV infection
• Evidence of sepsis
• Kidney anomalies or dysfunction
• Maternal genital lesions suspicious for HSV at the time of delivery
• Infants known to be born to women who are HIV positive (HIV testing is not required )
• Infant currently receiving acyclovir, ganciclovir, famciclovir, or any investigational drugs
Infectious Diseases, Children's Health
herpes simplex virus, neonatal herpes, HSV
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Can spectral power and coherence reflect the integrity of the efferent cerebellar cortical pathway in cerebellar mutism syndrome?

This study will be measuring brain activity using EEG and assessing motor skills and speech in children following cancerous brain tumor resection. No direct cancer treatments or objectives are being targeted.

Sharyl Samagia-Grivette
Not specified
This study is also accepting healthy volunteers
STUDY00019602
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Inclusion Criteria:

• Cerebellar Mutism Syndrome (CMS) & Comparison (without CMS) Groups: ages 10 years 0 months to 25 years 11 months of age & fluent in English (parents/guardian do not need to be fluent in English)
• For those with Cerebellar Mutism Syndrome (CMS): history of resection of posterior fossa tumor at least 2 years before starting the study and at least 3 months post chemotherapy and radiation treatment
Exclusion Criteria:

• Comparison group without CMS: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder
• any genetic condition
• any neurologic condition including history of stroke, seizure disorder, or brain injury
• history of brain tumor or other cancer diagnosis
• CMS Group: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder prior to brain tumor diagnosis
• any genetic condition prior to brain tumor diagnosis
• any neurologic condition including history of stroke, seizure disorder, or brain injury disorder prior to brain tumor diagnosis
Brain & Nervous System, Cancer, Children's Health
brain tumor, cerebellar mutism syndrome (CMS)
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Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly versus Placebo in Adolescent Participants Who have Obesity, or are Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind Trial

This study is being done to see how safe an investigational drug is and how well it will work to help people with obesity, or overweight with weight-related conditions like hypertension, dyslipidemia, obstructive sleep apnea, non-alcoholic fatty liver disease, or diabetes. If you qualify to be in the study, you will be given frequent lifestyle and behavioral counseling for the first 12 weeks of the study. The counseling will consist of advice on physical activities and dietary advice on healthy eating. During the treatment period, you will receive either tirzepatide or placebo. Placebo is a solution that looks like the study drug but has no medicine. The chance that you will get the study drug is 2 in 3. This phase will last about 72 weeks.

Claudia Fox
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019351
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Inclusion Criteria:

• 12 to 17 years old
• have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart
• OR be overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity. These include: dyslipidemia, pre-hypertension, hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea, prediabetes, or Type 2 Diabetes
• those with Type 2 Diabetes have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0% Type 2 Diabetes
Exclusion Criteria:

• decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days
• have Type 1 Diabetes
• have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction
• have or plan have a weight reduction surgical procedure
• additional exclusion criteria apply (study staff will review)
Children's Health, Diabetes & Endocrine
BMI, Obesity, Overweight, T2D, Type 2 Diabetes
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Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP (PHARMATOP)

Topiramate is a commonly prescribed medication at weight management clinics. While doctors know that some people respond better to topiramate in terms of weight loss and changes in eating behaviors, the reasons WHY some respond better than others are not known. Knowing more about the relationships between topiramate doses, concentrations of topiramate in the blood stream, and an individual’s response to this medicine will help doctors determine those who may be more likely to benefit. Doctors also want to know if someone’s genes (their DNA) may help explain why some people respond better to topiramate than others. We expect that you will be in this research study for about 14 weeks (3.5 months).

Eric Bomberg
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00013488
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Inclusion Criteria:

• ages 12 to less than 18 years old
• Body mass index (BMI) greater than or equal to 1.2 times the 95th percentile (age and sex-adjusted) and/or BMI greater than or equal to 35 kg/m2
• deemed appropriate candidates to receive topiramate (without contraindications) for weight loss by an obesity medicine specialist at the University of Minnesota
Exclusion Criteria:

• history of metabolic/bariatric surgery
• obesity associated with a diagnosed genetic disorder
• clinically diagnosed hyperthyroidism or uncontrolled hypothyroidism
• history of acute angle closure glaucoma
• see link to clinicaltrials.gov for additional exclusion criteria
Diabetes & Endocrine, Children's Health
Weight management
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Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribe meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00008743
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Inclusion Criteria:

• severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• 12 to less than 18 years of age at enrollment
• female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:

• diabetes (type 1 or 2)
• current or recent (< six months prior to enrollment) use of anti-obesity medication(s) (use of naltrexone or bupropion alone is not an exclusion)
• previous metabolic/bariatric surgery
• current use of a stimulant medication
• history of glaucoma
• current or recent (<14 days) use of monoamine oxidase inhibitor
• history of treatment with growth hormone
• history of bulimia nervosa
• major psychiatric disorder
• any history of active suicide attempt
• history of suicidal ideation or self-harm within the previous 30 days
• current pregnancy or plans to become pregnant during study participation
• current tobacco use
• history of cardiac, endocrine, kidney disease (study staff will review)
Children's Health, Diabetes & Endocrine
Clinics and Surgery Center (CSC), Obesity, overweight, weight loss
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COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients (365 Days to 31 Years) with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000644
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Inclusion Criteria:

• Age: patients must be > 365 days and < 10 years of age (B-ALL patients without DS) OR no more than 31 years of age (B-ALL patients with DS) OR no more than 31 years of age (B-LLy patients with or without DS)
• Diagnosis: Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a BM aspirate; OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000 circulating leukemic cells;
• OR Patient has newly diagnosed B-cell LLy Murphy Stages I or II, with or without Down syndrome
• White Blood Cell Count (WBC) Criteria: B-ALL patients without DS must have an initial white blood cell count < 50,000
• B-ALL patients with DS are eligible regardless of the presenting WBC
Exclusion Criteria:

• Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
• Patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731
• Patients requiring radiation at diagnosis
• Female patients who are pregnant or breastfeeding their infants
Cancer, Children's Health
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Down Syndrome
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An Observational Registry of Abatacept in Patients with Juvenile Idiopathic Arthritis (BMS Protocol IM101240)

The objective of this study is to create an international registry with long-term follow-up to characterize and evaluate the safety of abatacept in juvenile idiopathic arthritis (JIA). The primary objective of the JIA registry is to describe the long-term safety of abatacept treatment for JIA by quantifying the incidence rates of serious infections, autoimmune disorders, and malignancies.

Colleen Correll
Up to 18 years old
This study is NOT accepting healthy volunteers
1403M48721
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Inclusion Criteria:

• less than 18 years of age (unless currently or previously enrolled in an abatacept clinical trial and received abatacept)
• diagnosis of Juvenile Idiopathic Arthritis (JIA)
• currently receiving abatacept per treating physician's decision or received abatacept in a clinical trial
Exclusion Criteria:

• pregnant or breast feeding
• history of cancer unless cancer free for at least 5 years
• any serious acute or chronic medical condition other than JIA
• history of frequently missing clinic appointments
Arthritis & Rheumatic Diseases, Children's Health
Abatacept, Juvenile Idiopathic Arthritis
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A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK) (EPPIK)

Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK) trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.

Michelle Rheault
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001245
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Inclusion Criteria:

• Child 1 to 18 years old
• Diagnosed by biopsy with specific types of glomerular disease & protein in the urine
• Blood pressure is within normal range for age
• Maintained on a stable dose of immunosuppressive medications
Exclusion Criteria:

• Weight less than 7.3 kg 16 pounds) at screening.
• Disease due to to viral infections, drug toxicities, or cancer.
• Kidney function is below the minimum required
Children's Health, Kidney, Prostate & Urinary, Rare Diseases
Alport Syndrome, Glomerulosclerosis, IgA Vasculitis, Immunoglobulin A Nephropathy
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Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Sonya Wang
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00020174
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Inclusion Criteria:

• age 10-17 years at time of enrollment
• 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. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Brain & Nervous System, Children's Health, Mental Health & Addiction
cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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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.

Claudia Fox
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019097
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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)
Children's Health, Diabetes & Endocrine
healthy weight, Obesity
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Electronic Platform for Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long&#8208;Acting Growth Hormone Therapy (LAuGH TRACK UMN) (LAuGH TRACK)

The purpose of the study is to compare quality of life (QOL), adherence, insulin resistance, body composition and efficacy of LAGH to DGH in children with GHD.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00011784
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Inclusion Criteria:

• girls ages 2-11 years
• boys ages 2-13 years
• established diagnosis of pediatric growth hormone deficiency (GHD).
• For this study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of <10 ng/mL Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance.
Exclusion Criteria:

• any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment
• current treatment with long-acting growth hormone
• currently pregnant or breastfeeding
Children's Health, Diabetes & Endocrine
Growth Hormone Deficiency
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A Retrospective Follow-Up Study of the Durability of Antiviral Therapy on Long-Term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers

The purpose of this study is to find out if treatment of congenital cytomegalovirus (cCMV) with an antiviral medicine has any impact on hearing, development of cancers, overall development and sexual maturity development. No treatment for cCMV will be provided in this study.

Mark Schleiss
Not specified
This study is NOT accepting healthy volunteers
SITE00002065
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Inclusion Criteria:

• at least 2 years old
• received intravenous ganciclovir or oral valganciclovir to treat congenital cytomegalovirus (CMV) infection
• may have participated in the CASG study of the treatment of congenital CMV
Exclusion Criteria:

• unable to comply with study-related procedures
Children's Health, Infectious Diseases
CMV, Cytomegalovirus
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SPR001-205 A Phase 2 Study to Evaluate the Safety, Pharmacokinetics,;and Exploratory Pharmacodynamics of SPR001 (Tildacerfont) in Children: Aged 6 to 17 Years with Congenital Adrenal Hyperplasia

The goal of this study is to test the safety and effectiveness of tildacerfont in children with congenital adrenal hyperplasia (CAH). When a child is enrolled in the study, in addition to taking the study drug (tildacerfont), he or she will continue to take his or her standard glucocorticoid doses. A part of the study will be to test different doses of the study drug and to measure adrenal hormones at each visit. Children will be in the study for 18 weeks and will have to visit the study clinic 5 times.

Kyriakie Sarafoglou
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001409
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Inclusion Criteria:

• age 2 to 17 years
• childhood diagnosis of classic congenital adrenal hyperplasia (CAH) a genetic mutation in CYP21A2
• currently taking steroids to treat CAH and on a stable dose for 1 month or more
Exclusion Criteria:

• clinically significant unstable medical or mental health condition (study staff will review)
• females who are pregnant or nursing
• unable to swallow medications
Rare Diseases, Children's Health
CAH, Congenital Adrenal Hyperplasia
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COG ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00001858
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Inclusion Criteria:

• 21 or younger at time of enrollment
• newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma
• must be enrolled in APEC14B1 (NCT02402244) prior to enrollment and treatment on ARST2032 (this trial)
• contact study team for more detailed criteria
Exclusion Criteria:

• received prior chemotherapy and/or radiation therapy for cancer prior to enrollment
• unable to undergo radiation therapy
• Females who are pregnant
Cancer, Cancer, Children's Health
Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
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The MyGender Dolls: Development of a Therapeutic Intervention for Transgender and Gender Diverse Children and their Caregivers

The goals of the current proposal are to systematically approach the development and iterative testing of a novel, culturally-responsive, evidence-informed psychotherapeutic activities (MyGender Dolls) for transgender and gender diverse (TGD) children (ages 5-10) and their caregivers. There are two primary objectives: 1) to develop and refine the MyGender Dolls psychotherapeutic activities based on feedback from community stakeholders, and 2) to assess the initial feasibility, acceptability, and usability of the MyGender Dolls with TGD children and their caregivers.

G. Nic Rider
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00019477
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Inclusion Criteria:

• child aged 5 to 10 years old who identifies as transgender or gender diverse
• parent of a child aged 5 to 10 years old who identifies as transgender or gender diverse
Exclusion Criteria:

• child younger than 5 years old and older than 10 years old
• child who does not identify as transgender or gender diverse
Children's Health, Mental Health & Addiction, Prevention & Wellness
Transgender, Non-Binary, Gender Diverse, Children
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An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety,and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients with Central (Gonadotropin-Dependent) Precocious Puberty

The study drug FP-001 (Leuprolide mesylate) is being developed for children that are suffering from central (gonadotropin-dependent) precocious puberty (CPP). Leuprolide has been approved in the United States (US) and the European Union (EU) as treatment for prostate cancer already, and other forms of Leuprolide from other companies have been approved for the treatment of CPP. In this clinical study, Leuprolide will be used in the form of a 6-month depot injection.

Brad Miller, MD, PhD
Up to 18 years old
This study is NOT accepting healthy volunteers
SITE00001817
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Inclusion Criteria:

• females aged 2 to 8 years or males aged 2 to 9 years old
• diagnosis of Central Precocious Puberty (CPP) within 12 months
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• major medical or psychiatric illness that could interfere with study visits
• history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
• specific prior treatments (study staff will review)
Children's Health, Diabetes & Endocrine
Central Precocious Puberty, CPP, Early Puberty, Precocious Puberty, Puberty
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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.

Sandra Montezuma
Not specified
SITE00001950
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Children's Health, Vision & Eyes
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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).

Deanna Teoh
Not specified
This study is NOT accepting healthy volunteers
SITE00001561
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Inclusion Criteria:

• 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)
Exclusion Criteria:

• 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)
Cancer, Children's Health
Clinics and Surgery Center (CSC), cancer survivors, HPV, vaccination
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Lifestyle Counseling and Medication for Adolescent Weight Management (QUEST)

This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI and body fat and greater improvement in cardiometabolic factors and quality of life compared to intensive behavioral counseling at 56 weeks.

Aaron Kelly
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00012932
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Inclusion Criteria:

• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
Exclusion Criteria:

• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Diabetes & Endocrine, Children's Health
Obesity, Overweight, weight loss
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Validation of the Autism Diagnostic Interview: 3rd Edition

The goal of this study is to support the validation of a revision to the Autism Diagnostic Interview – Revised (ADI-R). The ADI-R is a highly validated diagnostic tool used in clinical assessments for autism spectrum disorder and widely used in research for participant characterization and inclusion. Aims: 1. To explore the validity of the ADI-3 (concurrent validity with ADI-R and other autism instruments; predictive validity with best estimate clinical diagnosis). 2. To explore the reliability of the ADI-3 (interrater, test-retest, internal consistency) 3. To derive diagnostic algorithms that better match DSM-5 criteria and maximize sensitivity and specificity 4. To ensure that changes (e.g., reduced length, new format to codes) yield sufficient information to inform diagnoses.

Amy Esler
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00018321
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Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Children's Health, Mental Health & Addiction
Autism
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Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)

This study is about a genetic condition called Adrenoleukodystrophy (ALD). The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in medical care and monitoring. This is important to identify the optimal ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future. We will also have healthy comparisons to help to learn more about the condition (ALD) being studied, by comparing the information collected to a child without the condition.

Rene Pierpont
Up to 18 years old
This study is also accepting healthy volunteers
STUDY00016246
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Inclusion Criteria:

• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
Exclusion Criteria:

• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
Brain & Nervous System, Children's Health, Rare Diseases
Healthy control, children, pediatrics, adolescents
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Genetics of Developmental Disorders - Data and Specimen Repository

This project is a data and specimen repository for developmental disorders. Participants provide biological samples and permission to store their health-related data. The purpose is collect and manage these materials for use in biomedical research related to developmental disorders.

Williams Dobyns
Not specified
This study is NOT accepting healthy volunteers
STUDY00011194
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Inclusion Criteria:

• All ages
• Individuals with a developmental disorder (mostly but not exclusively developmental brain disorders)
• Parents and other selected relatives of individuals with developmental disorders
Brain & Nervous System, Rare Diseases, Children's Health
Genetic disorders, developmental brain disorders, developmental disorders
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Food Parenting Practices on Child Dietary Intake

This research is being done to help better understand the ways parents interact with their children at meal and snack times at different time points during the day and in different circumstances. We want to study how the feeding approaches affect the child’s dietary intake over time. Study participation will be two years with activities every six months.

Katie Loth
Up to 18 years old
This study is also accepting healthy volunteers
00018340
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Inclusion Criteria:

• Family attends Fairview Primary Care clinic
• Child between 3-5 years of age
• Caregiver has primary responsibility of feeding child outside of childcare
• Child must live at least 50% of the time or more with the primary guardian
• Caregiver must be able to speak and read English or Spanish
Exclusion Criteria:

• Caregiver is less than 18 years of age
• Child is in the foster system
Children's Health, Community Health
child, children, eat, eating, feeding, food, kid, nutrition, parent, preschool, psychology
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Understanding modifiable barriers to treatment adherence in youth with type 2 diabetes to inform intervention development

This study will seek to learn about barriers to management of Type 2 diabetes for children ages 10-17. This study is recruiting children, and their parent/guardian, who are managing with oral medication or insulin.

Amy Noser
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00019484
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Inclusion Criteria:

• 10 to 17 years old
• confirmed diagnosis of type 2 diabetes
• prescribed pharmacologic therapy for treatment of type 2 diabetes (oral medication or insulin)
• live with a parent/caregiver at least 50% of the time who is willing to participate in the study
• able to read and speak English
• the parent/caregiver must be the adult who spends the largest proportion of time caring for the child (or at least 50%) & able to speak and read English
Exclusion Criteria:

• diagnosis of type 1 or monogenic diabetes
• evidence of significant cognitive deficits or a severe, persistent psychiatric disorder
Children's Health, Diabetes & Endocrine
Type 2 Diabetes
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JAK Inhibitors to Preserve C-Peptide Production in New Onset T1D: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

This is a new type 1 diabetes onset study for ages 12-35 years old. We are looking at JAK inhibitor drugs to see if they can preserve beta cell function.

Antoinette Moran
Not specified
This study is NOT accepting healthy volunteers
SITE00001949
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Inclusion Criteria:

• age 12-35 years (inclusive)
• diagnosis of T1D within 100 days of first study visit
• positive for at least one islet cell autoantibody
• HbA1c no more than 10 %
• body weight at least 35kg (77 pounds)
• willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM)
• up to date on recommended immunizations (including flu and COVID-19)
• willing to use highly effective contraception for 3 months after the last dose of study medication
Exclusion Criteria:

• current use of a medication that affects glucose control
• treatment with other immunosuppressive agents (including biologics or steroids), other than inhaled or topical glucocorticoids
• current history of infection (HIV, Hepatitis B, TB, herpes etc.)
• current or past use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day
• current or past medical or mental health conditions (study staff will review)
• women who are pregnant, breast feeding, or planning to become pregnant
Children's Health, Diabetes & Endocrine
T1D, new onset, type 1 diabetes,
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See this study on ClinicalTrials.gov

Neural and Behavioral Markers of the Temporal Dynamics of Language Planning and Phonological Working Memory Processes in Persons Who Stutter

This is a study of persons who do and do not stutter between ages 7 and 65 years. This study is trying to figure out how attention skills influence memory, language, and speech fluency skills.

Jayanthi Sasisekaran
Not specified
This study is also accepting healthy volunteers
STUDY00013042
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Inclusion Criteria:

• age 7 through 65 years
• remaining eligibility will be determined based on response to an intake survey
Children's Health, Community Health
adults, attention, fluency, language, memory, speech production, Stuttering, children
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Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

Emily Nagel
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00016926
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Inclusion Criteria:

• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
Exclusion Criteria:

• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Children's Health, Women's Health
Breast Milk, Maternal Stress, Neurodevelopmental and Feeding, Preterm baby, Preterm feeding
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See this study on ClinicalTrials.gov

National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)

Kavisha Shah
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00004329
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Inclusion Criteria:

• up to 15 months old
• newborns diagnosed with HLHS or other univentricular condition
• intended to undergo Norwood procedure
Children's Health, Heart & Vascular
Hypoplastic Left Heart Syndrome (HLHS)
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See this study on ClinicalTrials.gov

A Pilot Study of a Parenting Intervention for Parents of Adolescents with Non-Suicidal Self-Injury

University of Minnesota researchers are conducting a research study to learn more about how an individually-delivered parenting program may help teens with self-harm. Eligible parents will be assigned by chance (like flipping a coin) to one of two conditions: (1) Healthy Emotions and Relationships with Teens – A Guide for Parents (HEART-P): a 12-session individually-delivered parenting program that teaches parents skills and strategies to help them respond to their adolescents’ emotions, or (2) wait list: parents will be offered the opportunity to receive HEART-P following their completion of the assessments during the study phase.

Meredith Gunlicks-Stoessel
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00017096
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Inclusion Criteria:

• Age 12-17 years
• at least 3 episodes of non suicidal self injury with at least one episode occurring in the past 12 weeks
• receiving mental health treatment that doesn't include individually delivered treatment for the parent. This can be at any mental health clinic
• at least one parent or caregiver who is willing to participate -for parents/caregivers: able to speak and write English
Exclusion Criteria:

• history of a primary psychotic disorder
• neurodevelopmental disorder such as intellectual disability or autism
Children's Health, Mental Health & Addiction
anxiety, cutting, depression, non suicidal self injury, self-harm
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