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72 Study Matches

BCC017: Precision mEdicine and Adoptive Cellular tHerapy for the treatment of recurrent neuroblastoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG)

This study is being done to learn if a vaccine made in the laboratory from your tumor and your immune cells is safe to give to you to treat your tumor. It is believed that the body’s immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use your tumor and immune cells from your blood to make a vaccine that we hope will stimulate your T-cells to kill tumor cells and leave your normal cells alone.

You will need routine (standard of care) testing for your tumor, as well as research tests and procedures including further analysis of your tumor sample, generation and review of a personalized genetic report, and procedures to collect certain cells for different infusions and creation of specialized cellular vaccines. You will then be offered and placed on a treatment plan. As a subject in this study you will remain in this study until you complete vaccine therapy as long as you have no disease progression or unless you need to come off study for another reason.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04837547
STUDY00023080
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Inclusion Criteria:
Neuroblastoma that has either returned or has not responded to standard therapies or a diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG).
For Neuroblastoma must be >12 months and ≤ 30 years of age
For DIPG must be ≥ 3 years and ≤ 30 years of age

Exclusion Criteria:
Absence of tumor on biopsy specimen or a diagnosis other than NBL or glioma on biopsy
Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection
Cancer
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Hershey, PA ,

BCC021: Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

The purpose of this study is to evaluate the investigational drug Silmitasertib (CX-4945) (a pill taken by mouth) in combination with chemotherapy drugs standardly used for your tumor type. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06541262
STUDY00025626
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Inclusion Criteria:
Less than 30 years old at initial diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

Parent-to-child anxiety transmission in early childhood: Capturing in-the-moment mechanisms through emotion modeling and biological synchrony

Anxiety can emerge as early as pre-school age (4-6) and is often linked to anxiety in the parent. This study will examine patterns of brain and behavioral synchrony in parent-child pairs as they complete puzzles together and other social activities.

This is a longitudinal study examining the role that parent-child synchrony and emotional modeling plays in the transmission of anxiety. Participants will complete yearly laboratory visits and 6-month follow-up visits. The yearly laboratory visits (V1,3,5) will include a battery of tasks and questionnaires, but the six-month follow-up visits(V2,4) will only include online questionnaires. Participants at both Penn State and Washington University, St. Louis will follow the same procedures.

Participating families will be given $100 at each of V1 and V3, $25 for each of the follow-ups at V2 and V4, $100 and a $50 completion bonus at V5, for a total amount of $400.

Yes
 

Koraly Perez-Edgar
Kimberly Labra-Franco - at kml7098@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00019415
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Inclusion Criteria:
Families with children between the ages of 4 and 6
Children without serious medical issues or complications
Parents or caregivers aged 18 or older

Exclusion Criteria:
Families that cannot communicate in either English, Spanish, or a language with an available translator
Children diagnosed with any neurological disorders and/or diseases
Children unable to communicate at a level similar to their peers
Children that have experienced a head injury with a loss of consciousness
Children 0 to 3 years of age; Children 7 and older
Children's Health, Mental & Behavioral Health
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State College, PA ,

POE23-01 - TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II

This study is being done to improve upon the previous TINI study treatment. It replaces one of the chemotherapy cycles with a type of immunotherapy called blinatumomab. The use of blinatumomab in this study is investigational. In addition, infants that have persistent disease will receive a new investigational drug called ziftomenib that specifically targets infant ALL cells.

You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, lumbar puncture, and chest x-ray.Treatment on this study from Day 1 of Remission Induction period through the end of Maintenance period will last almost 2 years. After study treatment is completed, you will have blood tests and other evaluations. You will be seen every 4 months for the first year, every 6 months for the second year, and then once a year for up to 10 years.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT05848687
STUDY00025408
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Inclusion Criteria:
less than or equal to 365 days of age
Newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia.
Limited prior therapy

Exclusion Criteria:
Patients with prior therapy, other than therapy specified in inclusion criteria
Patients with mature B-cell ALL that does not have a KMT2Ar or patients with acute myelogenous (AML) or T-cell ALL
Patients with Down syndrome
Cancer
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Hershey, PA ,

Characterizing resilience to food-cue induced overeating in children

This is a behavioral and neuroimaging study that will examine how food commercials affect the way a child eats and responds to food. Children enrolled in the study will complete 5 in-lab sessions that include eating meals and snacks, watching TV, and playing computer games. For one of these sessions, children will complete an fMRI scan. On the first and last visit to the lab, children will receive a DXA scan to assess their body composition.

We are looking for children to help us learn about how kids respond to different types of foods and food advertisements. The study consists of 5 visits to our facilities in Noll and Chandlee Labs, located on the University Park Campus. For 3 visits your child will eat test meals and snack buffets in our laboratory. On 1 visit we will use fMRI to take pictures of your child’s brain. We will use a DXA to scan for lean muscle and conduct an IQ test. These procedures are not harmful. You and your child will fill out questionnaires.Your child will also play computer games and watch commercials.

$250.00-450.00

Yes
 

Kathleen Keller
Ben Baney - at bab349@psu.edu or 814-753-1005
Nutritional Sciences (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
NCT05073185
STUDY00015835
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Inclusion Criteria:
In order to be enrolled, children must be of good health based on parental self-report.
Be 7-9 years-old at enrollment.
Not be taking any medications known to influence body weight, taste, food intake, behavior, or blood flow.
Have no learning disabilities (e.g., ADHD).
The biological mother must have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 (high-risk group).

Exclusion Criteria:
They are not within the age requirements (< than 7 years old or > than 9 years-old at baseline).
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
If they have a pre-existing medical condition such as diabetes, rheumatoid arthritis, Cushing’s syndrome, Down’s syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, cerebral palsy, or can't engage in moderate exercise.
If they don’t speak English.
Biological mother must have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or greater than or equal to 30 kg/m2 for mothers (high-risk group), or they are excluded.
Children's Health, Food & Nutrition, Prevention
Not applicable
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State College, PA ,

NMTRC014: NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

A study of DFMO for patients with neuroblastoma in remission.

Participating in this study requires that you visit the Penn State health Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG).If you agree to take part, you will receive treatment on this study for about 2 years and will be followed for survival for 5 years after the last dose of study drug. You will be asked to return to the research site approximately 15 times.

Yes
 

Valerie Brown
Suzanne Treadway, MS, RN, CCRP - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT02679144
STUDY00004295
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be in complete remission (CR).
Tests and scans will be required to confirm remission.

Exclusion Criteria:
Patients below the defined minimum of height and weight.
Patients who are currently receiving another study drug may not participate.
Patients who are currently receiving other anticancer agents may not participate.
Children's Health, Cancer
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Hershey, PA ,

Exploring the effects of nighttime indoor light exposure on children with autism spectrum disorder

This study aims to identify potential differences in psychological and physiological responses to indoor light at night and to offer recommendations for optimizing the sleep patterns, circadian rhythms, and sensory regulation of children with ASD.

Parents and/or caregivers of children with ASD will fill out surveys and collect saliva samples.

20

No
 

Dorukalp Durmus
Merve Oner - at mjo5773@psu.edu
Architectural Engineering (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00025039
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Inclusion Criteria:
Children with ASD
Aged 9-15
Sleep difficulties

Exclusion Criteria:
Candidates who cannot guarantee that they will refrain from using non-steroidal anti-inflammatory and psychotropic medications
Disorders such as sleep apnea, restless legs syndrome, or periodic limb disorder during sleep
Children with fragile X syndrome, Down syndrome, neurofibromatosis, or tuberous sclerosis complex and children who had a non-febrile unprovoked epileptic seizure within the last two years
Sleep Management, Mental & Behavioral Health
Not applicable
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BCC020: A Dose Escalation Study Using Difluoromethylornithine(DFMO) and AMXT-1501 followed by a Randomized Controlled Trial of DFMO with or without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

The purpose of this study is to evaluate the investigational drug AMXT-1501 (a pill taken by mouth) in combination with the study drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food &amp; Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06465199
STUDY00025296
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Inclusion Criteria:
0-21 years of age at diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

The original Childhood Arthritis &amp; Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection onpatients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressingquestions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.

In addition to allowing the researchers to collect data on you from your medical record, we will ask you and your parents/caregivers to complete a short survey that takes about 15 minutes to completeThe research team will follow up every 6 months by reviewing your medical record and asking you and your parents/caregivers to complete a short survey that takes about 15 minutes to complete.If you agree to take part, you will be in the study for 10 or more years.

Yes
 

Timothy Hahn
Meredith Buckley - at mbuckley@pennstatehealth.psu.edu
Pediatrics: General Pediatrics (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00008987
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Inclusion Criteria:
Onset of rheumatic disease prior to age 16 years for Juvenile Idiopathic Arthritis
Onset prior to age 19 years for all other rheumatic diseases
Willing to participate in a registry you will be followed during your treatment and have information about you disease and treatment collected.

Exclusion Criteria:
More than 21 years of age.
Arthritis & Rheumatic Diseases
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Hershey, PA ,

Interoception and eating behaviors in children

The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

Child and parent will attend 2 visits at the Clinical Research Center, about 1-3 weeks apart.At visit 1 (~3 hours)- Your child's height and weight will be measured- Your child's percent body fat will be measured using an x-ray based technology- Your child will wear a heart rate monitor and will complete tasks where they are asked to notice or count their heartbeat- Your child will complete questionnaires via an interview with a researcher- Your child will be asked to drink several glasses of water to measure their stomach sensations- You will complete questionnairesAt visit 2 (~2.5 hours)- We will collect 4 saliva samples from your child- Your child will eat a meal and taste snacks- Your child will play brain games on an iPad- You will complete questionnaires

$100

Yes
 

Emily Hohman
Francisca Dungula - at ieatstudy@psu.edu or 814-865-5246
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT00650465
STUDY00024712
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Inclusion Criteria:
Age 7-10 years old
Able to understand and answer questions in English

Exclusion Criteria:
Child BMI <5th percentile
Any medical conditions impacting growth, eating, or heart function
Developmental delay
Autism/autism spectrum disorder
Taking medications that impact appetite
Children's Health, Food & Nutrition
Not applicable
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State College, PA ,

Home Observation of Meals and Environment (HOME) Bytes

This study aims to measure child eating behavior at home. Parents will video record their child eat 3 meals at home using a smart phone device and then take pictures of food storage locations (e.g., fridge, pantry). Videos will be coded for child eating behaviors. Parents will complete baseline and follow-up questionnaires. Children will wear an activity watch (like a Fitbit) for 1 week. In addition to these study procedures, there is an optional urine sample collection for children in order to study urinary metabolites as a marker of diet.

You will be asked to video record your child eating 3 meals at home and to take photos of food storage locations in your home (e.g., fridge, pantry).

$75 and an optional $25 for completing the urine sample collection

No
 

Alaina Pearce
Alaina Pearce - at homebytes@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00023102
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Inclusion Criteria:
Child must be of good health
Child must have no neurodevelopmental disorder (e.g., ADHD) or learning disabilities (e.g., dyslexia)
Child must not be taking any medications known to influence body weight, taste, food intake, behavior, or blood flow.
Child must be 7-10 years-old at enrollment
The child must speak English

Exclusion Criteria:
Child is not within the age requirements (< than 7 years old or > than 10 years-old at baseline).
Child is taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow.
Child has a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
Child has a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing’s syndrome, Down’s syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
Child has a highly restrictive diet limiting their ability to consume typical meals due to disordered eating (anorexia, RFID) or severe allergies.
Children's Health, Food & Nutrition
Not applicable
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Testing a Biosocial Model of Borderline Personality Features in Youth

In this study, we hope to better understand the neural mechanisms underlying risk for Borderline Personality Disorder (BPD) in adolescent girls. BPD is a condition that is usually found in adults. However, it may be possible to identify risk for the disorder before adulthood. Understanding who is at risk for BPD early in development is important in order to develop preventative interventions.

There will be a total of three visits - one main visit and two follow-ups. Participants will be completing questionnaires, participating in a parent-child observation task, and children will be doing an EEG assessment during the first visit. Participants will be asked to complete questionnaires and participate in a parent-child observation task during the follow-up visits.

$100

Yes
 

Dara Babinski
Psychiatry and Behavioral Health (HERSHEY)
 

Female
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00018370
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Inclusion Criteria:
Children 10 to 13 year olds
Girls
With or without a current or past history of mental health disorder
Fluent in English

Exclusion Criteria:
Children who are younger than 10 years of age and children who are older than 13 years of age
Diagnosis of intellectual or developmental disabilities (e.g., Autism, Asperger's) , or any psychotic disorders (e.g., schizophrenia, bipolar disorder)
Males
Not fluent in English
Children's Health, Mental & Behavioral Health
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Hershey, PA ,

Insulitis, Inflammation, Dietary intake and Omega-3 Biostatus of Youth with Partial Remission of Type 1 Diabetes

Only 50% of patients with type 1 diabetes (T1D) recover insulin secretion function after 3 months of initial diagnosis, and this phase is called partial remission (PR) of T1D, also called "Honeymoon phase". During this PR phase of T1D, patients recover the ability to secrete more than 50% of their insulin secretion function. This phase of PR typically lasts no longer than 6 or up to12 months, and has been frequently defined as requiring exogenous insulin below 0.5 units per kilogram per day, and hemoglobin A1C is typically below 7.5%. Most recently the use of a coefficient called IDAA1C ≤ 9 has became more accepted as the methodology to determine the development of partial clinical remission of T1D (honeymoon phase). Prior data published by the SEARCH study (national epidemiological study) showed that youth with prolonged honeymoon phase had higher intake of omega -3 fatty acids, vitamin D intake and leucine intake than those youth without prolonged honeymoon phase of T1D. Currently, there are not approved medications to prolong this phase of partial remission of type 1 diabetes, however inducing PR in youth with T1D could potentially decrease the risk of multi-organ damage caused by chronic severe hyperglycemia associated to the chronic hyperglycemia related to T1D.We aim to perform a case- multiple control study between youth with prolonged partial remission phase of T1D after one year of diagnosis, and compare these youths with multiple controls matched by age, gender, race, and puberty stage to study the potential protective factors associated to the development of prolonged partial remission of T1D.

Participants will be approached at their routine Pediatric diabetes clinic appointment. If participants agrees to be in the research, informed consent/assent will be reviewed and signed by all parties. Participant's parent/guardian will be asked to complete a questionnaire. The participant's glucose machine/insulin pump will be downloaded for study purposes. Participant will undergo a fingerstick and a blood draw to collect specific lab values as outlined in the consent.

$35.00

Yes
 

Lina Huerta-Saenz
Erica Miller - at emiller25@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Endocrinology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
STUDY00014114
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Inclusion Criteria:
Type 1 diabetes diagnosis for more than one year
Age 1-17 years old, any gender
Attendance to the Pediatric diabetes clinic at Penn State Health in Hershey, PA
Most recent hemoglobin A1C below 7.5%

Exclusion Criteria:
Age older than 17 years old
History of seafood allergies and/or milk/dairy related allergies
Medical conditions (such as severe cerebral palsy, etc.) that could make patients unable to communicate with the study team
Existence of other autoimmune diseases in addition to T1D requiring regular treatment with immunosuppressive or anti-inflammatory treatment
Diagnosis of type 2 diabetes, monogenic diabetes (MODY), secondary diabetes, pregnancy, compromised kidney function, or liver diseases
Children's Health, Food & Nutrition, Diabetes & Hormones
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Carlisle, PA ,
Harrisburg, PA ,
Hershey, PA ,

BCC016: DFMO for Medullo

This is a study of the drug DFMO (difluoromethylornithine) for medulloblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.

You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as MRI of your brain and spine. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04696029
SITE00000984
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Inclusion Criteria:
You have had medulloblastoma that was either high risk or had relapsed or had not responded to therapy
You are 21 years old or younger
You must have no evidence of disease at this time

Exclusion Criteria:
You are currently taking another study drug or an anticancer drug
Cancer
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Hershey, PA ,

Mechanisms of Cardiovascular Disease (MCD)

The primary objective of this protocol, Mechanisms of Cardiovascular Disease (MCD) is to collect biological specimens and data from patients with cardiovascular disease (CVD) to study the mechanisms that contribute to cardiovascular dysfunction and disease.

If you decide to participate in this study, you will be asked to provide a blood sample and possibly additional optional samples, either immediately or later. Additional samples may include saliva, cheek swab, urine, waste tissue or nasal swabs. You will decide whether you are willing to provide these other samples. Clinical data will be included in the dataset along with your sample.

Yes
 

Elisa Bradley
Heart and Vascular Institute (HERSHEY)
 

All
All
This study is also accepting healthy volunteers
STUDY00019928
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Inclusion Criteria:
adults 18 years or older with or without cardiovascular disease
children less than 18 years with or without cardiovascular disease

Exclusion Criteria:
Prisoners are excluded from participation
Adult participants who are unable to provide a biologic sample
Heart & Vascular
Not applicable
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Harrisburg, PA ,
Hershey, PA ,
Reading, PA ,
State College, PA ,
Wilkes-Barre/Scranton Area, PA ,
York, PA ,

Examining executive functioning deficits, affective deficits, and social functioning to better understand disruptive behaviors and callous-unemotional traits

This research seeks to better understand functioning in children who differ in symptoms of Attention-Deficit Hyperactivity Disorder (ADHD), conduct problems (CP), and callous-unemotional (CU) traits, ages 6 - 13. Specifically, this research is being done to find out how these different types of behaviors impact cognitive skills (like attention, impulsivity, working memory, emotion identification) and social functioning to help inform future treatment with these children.

Yes
 

Dan Waschbusch
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00005703
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Inclusion Criteria:
Children ages 6 to 13 years old
Estimated IQ of 80 or above
Willing and able to discontinue psychoactive medication treatment for the experiemental session, if relevant
Caregiver and child must be fluent in written and spoken English

Exclusion Criteria:
Current or past diagnosis of intellectual disability, any psychotic disorder or autism spectrum disorder, or schizophrenia or rleated disorders
Psychiatric symptoms requiring urgent treatment, such as mania or suicidal ideation/homicidal ideation
Unable to be tested off medication
Physical disabilities that are incompatible with completing laboratory tasks such as hearing or speech impairments, or visual impairments that cannot be corrected with visual aids
Mental & Behavioral Health
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Hershey, PA ,

Feasibility of an experimental protocol for studying the effects of changes in bedtime on eating behavior in children

The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, we are asking parents to follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. We will also ask participants questions about their experiences completing the protocol.

Participants will attend an enrollment visit at the Noll Laboratory at Penn State's campus where we will go over the study and give participants a sleep monitor. We will then ask parents to put their child to bed at different, specified times over the course of three weeks - normal bedtime in one week; 1 hour later than their usual bedtime in another week; and at a different assigned time each day that will be +/- 1 hour of their normal bedtime during the third week. During all three weeks, children will wear a sleep monitor on their wrist (similar to a Fitbit), and parents will answer a short survey each evening on their smartphone or other device. At the end of the study, participants will attend a final visit (either in-person or by Zoom depending on preference) to answer questions about their experience with the protocol.

$150

Yes
 

Emily Hohman
Emily Hohman - at eeh12@psu.edu or 814-865-5245
Center for Childhood Obesity Research (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT06501690
STUDY00025204
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Inclusion Criteria:
Child 6-10 years
Parent 18+ years
Child has a regular bedtime

Exclusion Criteria:
Child medical conditions affecting sleep or development
Child regular use of supplements or medications for sleep (e.g. melatonin, antihistamines)
Children's Health, Sleep Management
Not applicable
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State College, PA ,

NMTRC006B: An Intermediate Expanded Use Trial of DFMO(eflornithine HCl)

This research study is to provide expanded access to a new investigational drug DFMO (difluoromethylornithine) for patients with neuroblastoma, medulloblastoma, and certain rare tumors that have no other curative options. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.

If you are enrolled on this study, DFMO will be started in clinic on Day 1. After this first day you will be seen in clinic approximately once every 30 days for the first 6 months of study and once every 90 days for the last 18 months of study. These visits will last about 2 hours, and involve a physical exam, blood tests, and other testing.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT03581240
STUDY00023046
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Inclusion Criteria:
0-30 years of age at the time of initial diagnosis
Not eligible for DFMO studies NMTRC014, BCC015, or BCC016

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
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Hershey, PA ,

Neurodevelopmental Mechanisms Underlying the Onset of Depression among At-Risk Youth: The Role of Dysregulation in the Negative Valence System

The purpose of this voluntary research study is to examine how individual differences in emotion regulation patterns are implicated in risk for depression in children and adolescents.

In this study, you will complete some interviews and surveys about you and your child’s mental health history, moods and emotions. We will also have your child complete two brain assessments (EEG and fMRI) at the start of the study, and at 12 and 24 months. You will complete follow-up surveys and interview assessments at 6, 12, 18, and 24 months.

$455

Yes
 

Katie Burkhouse
Katie Burkhouse - at klb5023@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00026372
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Inclusion Criteria:
Mother-child biological dyads (children ages 9-14 years old, males and females)
High Risk Dyads: Biological mothers must meet criteria for current or past recurrent DSM-5 major depressive disorder (MDD) or persistent depressive disorder (PDD)
Low Risk Dyads: Biological mothers must have no lifetime diagnosis of a depressive disorder

Exclusion Criteria:
Maternal history of schizophrenia, psychosis disorder, or bipolar disorder
Clinically significant medical or neurologic condition or neurocognitive dysfunction that would interfere with the study protocol
Having symptoms or a past/current diagnosis of DSM-5 schizophrenia, bipolar disorders, or major depressive disorder (MDD) (child)
Presence of ferrous-containing metals within the body (child)
Unable to speak or read in English
Children's Health, Mental & Behavioral Health
Not applicable
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State College, PA ,

Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients(Ages 2-11) with Hereditary Angioedema Type I or II

The purpose of this research study is to test the safety of the study drug, sebetralstat and to see if it can treat Hereditary Angioedema (HAE) at the time of an HAE attack and to determine how children's bodies absorbs, breaks down, and remove sebetralstat.

You and your child will be expected to attend all study visits, complete the HAE attack diaries to the best of your ability, and tell the study staff about changes to your child’s health, medications, and other medical treatments. Your child is expected to take the study medication as instructed and will allow study staff to draw blood.

Yes
 

Timothy Craig
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT06467084
STUDY00025025
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Inclusion Criteria:
Aged 2 to 11 years
Diagnosis of Hereditary Angioedema (HAE) Type 1 or Type 2
At least 1 HAE attack in the last year
Caregiver must be able to appropriately store and administer the study medication
Caregiver must be able to complete a paper diary about attack information

Exclusion Criteria:
Child weighs less than 20.9 pounds
Child participated in a investigational clinical trial within 4 weeks prior to the screening visit
Infectious Diseases & Immune System
Experimental drug compared to an approved drug
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Hershey, PA ,

Charting Positive Valence Systems Trajectories in Offspring of Depressed Mothers to Predict Internalizing Symptoms in Early Childhood

The purpose of this voluntary research study is to understand the impact of maternal depression on child outcomes, such as how children respond to rewarding or positive information in their environment and their mental health outcomes, such as anxiety and depression.

In this study, you will complete some interviews and surveys about your and your child’s mental health history, parenting practices, and stress exposure. We will also have your child complete a few computer tasks while we measure their brain activity. You and your child will also complete a few discussion tasks. These procedures will be completed three times over the course of two years.

360 dollars

Yes
 

Katie Burkhouse
Katie Burkhouse - at klb5023@psu.edu
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00025082
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Inclusion Criteria:
Mother-biological child dyads (children ages 4-6 years old, males and females)
High Risk Dyads: Biological mothers must meet criteria for current or past DSM-5 major depressive disorder (MDD) or persistent depressive disorder (PDD) in the child’s lifetime
Low Risk: Biological mothers must have no lifetime diagnosis of a depressive disorder

Exclusion Criteria:
Maternal history of schizophrenia, psychosis disorder, or bipolar disorder
Children with intellectual or developmental disabilities and hearing and vision impairments that would interfere with completing measures.
Children currently taking psychiatric medications (in the past 4 weeks)
Unable to speak or read in English
Unable to access to a computer or a tablet with a video camera and internet that can be used for study appointments by Zoom
Children's Health, Mental & Behavioral Health
Not applicable
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State College, PA ,

PACE – Development of an Eating Behavior Risk Score

The prevention of obesity is a far more effective approach than treating obesity after it has developed. Researchers and medical providers need better tools to identify risk factors for developing obesity, so families and their physicians can work to reduce a child's risk. This proposed study tests whether a novel risk score (PACE) is good at predicting if children will develop obesity. The PACE Score combines the measures of sensitivity to portion size, behavior while hungry or craving, loss of control during eating, and eating speed. This study will follow children in middle childhood through four visits, followed by two visits one year later. We will identify the components of PACE as well as biological and environmental factors that may work with or against the PACE factors to predict how children's body composition changes over a year.

Four baseline visits followed by two follow-up visits one year laterChildren will be provided meals at each visitChildren and parents will complete questionnairesChildren will have a DXA scan and an MRI scanChildren will play learning games on the computerChildren will wear an activity monitor for one weekChildren will perform brief and moderate exercise while wearing a heart rate monitor

$300

Yes
 

Kathleen Keller
Ben Baney - at bab349@psu.edu or 814-883-8523
Nutritional Sciences (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT05073185
STUDY00023903
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Inclusion Criteria:
children must be between the ages of 7-9 years-old at enrollment
The biological mother must have a BMI between 18.5 – 25 or greater than 30. The parent primarily in charge of feeding must be able to accompany children to the visits.
children must speak English fluently
children should have no learning disabilities or developmental delays (e.g., ADHD, Autism, dyslexia)
children generally healthy with a BMI-for-age percentile less than 85 or greater than 95 to be enrolled.

Exclusion Criteria:
If they have a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions.
Child medical condition affecting digestion, cardio, etc.
Child not fluent in English
Child should not be taking a medication that affects blood flow, appetite, behavior, etc.
Child should not have any unremovable metal in their body (e.g. steel dental work) or be claustrophobic
Children's Health, Food & Nutrition, Prevention
Not applicable
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State College, PA ,

Personality Pathology in Youth

In this study, we hope to better understand the neural mechanisms underlying risk for personality disorders in adolescent youth. Understanding who is at risk for personality disorders early in development is important in order to develop preventative interventions.

Youth participants and their parent will be required to attend one in-person visit at our lab in Hershey, PA where youth participants will complete two computer tasks while EEG and cardiac data are collected. Youth participants will also complete questionnaires and a peer-interaction task with another peer their age. Parents will complete questionnaires and an interaction task with their child. Youth participants will complete remote surveys via a survey app for two weeks after the visit. This study includes 4 follow-up appointments (once every 6 months) which can be completed in-person or remotely via a Microsoft Teams meeting. These follow-up appointments will consist of a parent-child interaction task and surveys for parent and youth participants.

Up to $305

Yes
 

Dara Babinski
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00023682
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Inclusion Criteria:
Children ages 10-13 and their parent
Current or past history of a mental health disorder OR no history of mental health disorder
Fluent in English

Exclusion Criteria:
Children under 10 or over 13
Youth or parent not fluent in English
Youth with intellectual or development disabilities
Youth with schizophrenia, bipolar disorder, or other psychotic disorders
Mental & Behavioral Health
Not applicable
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Hershey, PA ,

Decision-Making in ADHD: An Evaluation of the Subjective Value of Rewards and Costs

Children with attention and behavior problems often need external rewards to motivate them to perform challenging tasks, but we don’t yet know much about how children weigh potential rewards and the effort required to obtain the rewards. This research is being done to find out how children with varying levels of ADHD symptoms value rewards and costs when making decisions about whether or not to perform a difficult task.

There will be one in-person visit. Children will complete two computerized cognitive tasks (thinking games), and will be able to earn prizes from the points they earn on these tasks. Parents will also be asked to complete a few questionnaires that should take about 25 minutes to finish. Children can earn up to $50 in compensation for completing the study.

$50

Yes
 

Dan Waschbusch
Thresia Casanova - at abc@pennstatehealth.psu.edu or 717-531-0003, ext=285966
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is also accepting healthy volunteers
STUDY00018076
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Inclusion Criteria:
Children ages 8 to 12 years old
Children with normal or corrected vision
Caregiver and child must be fluent in written and spoken English
Willing to stop stimulant medications, when appropriate, for research testing

Exclusion Criteria:
Children who are younger than 8 years of age and children who are older than 12 years of age.
Current or past diagnosis of autism spectrum disorder, schizophrenia or other psychotic disorders.
Current use of non-stimulant medication due to its extended washout period.
Physical disabilities that are incompatible with completing laboratory tasks such as hearing impairments, or visual impairments that cannot be corrected with visual aids (i.e., glasses, contacts).
Children's Health, Mental & Behavioral Health
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Harrisburg, PA ,
Hershey, PA ,

A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Repotrectinib for cancer that has returned or is not responding to treatment

If you agree to take part in this study, you will need to visit the study site regularly and follow the study procedures listed later in this document. You will be told what these procedures are and why they are needed. These procedures include interviews, exams, heart testing, tumor assessments, and blood and urine samples. You will be asked to take the study drug Repotrectinib. This is a capsule to be taken orally.

Yes
 

Valerie Brown
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04094610
STUDY00014715
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Inclusion Criteria:
You have cancer that has returned or is not respondin g to treatment
You are positive for certain changes in your genes which we will test you for as needed

Exclusion Criteria:
1. You have gastrointestinal disease, such as Crohn’s disease,
Cancer
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Hershey, PA ,

One Talk at a Time - Anti-Racism

This is a psychological study to examine the effect of a new intervention that provides parents with tools to speak with their kids about race, racism, and privilege.Participants will complete a 2-3 hour long program and answer questionnaires over the course of 6-8 weeks. The total time required for this study is approximately 4.5 hours for parents and 2 hours for children. Parents can earn up to $165 and children can earn up to $50.

Parents and children will both be asked to participate, and all participation will be remote.Over the course of 6-8 weeks, parents will answer 3 sets of questionnaires in addition to completing 2-3 hour long interactive program. Parents will also be asked to participate in a recorded discussion task with their child, and will be invited back for a short interview as the final task.Children will answer 2 sets of questionnaires at the beginning and end of the study, and will also participate in the recorded discussion task with their parents.

215

No
 

Chardee Galan
Chardee Galan - at dreamlab@psu.edu or 626-205-5563
Psychology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00023214
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Inclusion Criteria:
Non-Hispanic, White parent and child
Child between the ages of 10-14 years old
Child in 5th through 8th grade
Parent and youth are fluent in English
Parent and youth have access to devices with WiFi

Exclusion Criteria:
Parent or youth identify as any race/ethnicity other than non-Hispanic White, including multiracial individuals that identify as White
Family does not have reliable internet access or access to a device that can appropriately display the virtual program.
Parent or children does not speak or read sufficient English
Youth or parent/caregiver has an intellectual disability, autism spectrum disorder, or other disorder that may limit ability to complete study (surveys and interviews require sustained attention, mental processing, and comprehension)
Children's Health, Education, Mental & Behavioral Health
Not applicable
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A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema

This study will investigate the effects of NTLA-2002 on people with Hereditary Angioedema (HAE). NTLA-2002, which consists of a CRISPR/Cas9 gene editing system, is designed to limit production of plasma kallikrein in the liver cells by acting on the KLKB1 gene. This means NTLA-2002 would permanently change the DNA in the liver cells so less plasma kallikrein would be produced. Lower levels of plasma kallikrein may result in fewer HAE attacks.

During part 1 of the study, participants will either be given NTLA-2002 or placebo (no active ingredients) as an intravenous infusion. Participants will have the option to receive the opposite infusion about 28 weeks later. This study involves getting pre-medications to reduce the chance of an HAE attack and a reaction to the infusion. Study assessments will be preformed to monitor safety. Daily electronic diaries will be completed to monitor for HAE attacks. Also quality of life questionnaires will be completed. If part 1 and part 2 are completed, there are 22 visits. Some of those visits can occur over the phone.

Yes
 

Timothy Craig
Kara Grim - at kgrim@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT06634420
STUDY00025612
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Inclusion Criteria:
Males or females 16 years of age or older and Ability to understand and the willingness to sign a written informed consent document
Diagnosis of Hereditary Angioedema Type 1 or Type 2
Access to rescue treatment for Hereditary Angioedema

Exclusion Criteria:
Liver cirrhosis
history of drug or alcohol abuse in the past 3 years
history of active cancer in the past 3 years
Infectious Diseases & Immune System, Allergies
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Children's appetite regulation study

The purpose of this study is to determine whether girls and boys regulate their appetites differently. Children will attend 1, 3 hour session in the laboratory, complete some surveys and health measures, donate saliva, and eat pizza.

Children will come to the lab for a 3.5 hour session where they will wear a heart rate monitor, conduct some surveys, have their veggie intake measured, provide some saliva, and eat some pizza. Parents will attend the lab visit with the child and complete questionnaires about feeding and the home environment.

$50 plus travel costs for &gt; 20 miles from lab

Yes
 

Kathleen Keller
Rhea Sarma - at rvs6115@psu.edu
Nutritional Sciences (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
NCT00000000
STUDY00025564
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Inclusion Criteria:
Age 4-6 years
Healthy without food allergies
Parent in charge of feeding able to attend with child

Exclusion Criteria:
Younger than age 4 or older than age 6 years
Children with medical problems or taking a prescription medication that may affect appetite
Children who are not willing to eat pizza in the laboratory
The parent in charge of feeding decisions cannot attend with the child
Children's Health, Food & Nutrition
Not applicable
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State College, PA ,

Central Pennsylvania Rural Birth Cohort

This study is being conducted to understand what strategies are most successful: 1) in building and retaining a cohort of families from rural communities in Central Pennsylvania with recruitment beginning in pregnancy, infant/toddler age, and preschool age using a cohort sequential design; 2) for collecting clinical and semi-invasive, remote-based biobehavioral measurements to better characterize synergistic factors associated with obesity and substance use in this high risk population; and 3) for identifying points for future intervention, treatment, prevention, and policy efforts to reduce health disparities in maternal-child morbidity and promote positive family processes.

Cohort 1 (Pregnancy Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 16-weeks gestation. You will complete online surveys. The surveys should take 1 hour or less.. Visit 2 will occur around 32-weeks gestation. You will complete online surveys, and a semi-structured health behaviors interview via Zoom. You may also be asked to collect hair and/or nail samples. The visit should take 2 hours or less. Visit 3 will occur around 6 months post-delivery. You will complete online surveys. The surveys should take 1 hour or less. Visit 4 will occur around 12 months post-delivery. You will complete online surveys and a parent-child interaction observation (one session). This visit should take 1 hour or less.Cohort 2 (12 month old child Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 12 months post-delivery. You will complete online surveys, and a parent-child interaction observation (one session). You may also be asked to provide hair and/or nail samples. This visit should take 2 hours or less. Visit 2 will occur around 24 months post-delivery. You will complete online surveys. This visit should take 1 hour or less.Cohort 3 (24 month old child Cohort) will follow the assessment schedule as described below:Visit 1 will occur around 24 months post-delivery. You will complete online surveys. You may also be asked to provide hair and/or nail samples. This visit should take 1 hour or less.Visit 2 will occur around 36 months post-delivery. You will complete online surveys. This visit should take 1 hour or less.All electronic health record data will be extracted at the end of study participation.

$100-200

No
 

Danielle Downs
Birth Cohort Team at birthcohort@psu.edu
Kinesiology (UNIVERSITY PARK)
 

All
All
This study is also accepting healthy volunteers
STUDY00020841
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Inclusion Criteria:
Pregnant person over age of 18 with a singleton pregnancy
Over the age of 18
Families with toddlers that are either 12 or 36 months of age
Live in rural Pennsylvania
Have smartphone/wifi access

Exclusion Criteria:
Not pregnant or multiple pregnancy
Pregnant person or parents under age of 18
Families without toddlers that are either 12 or 36 months of age or a multiple (twin, triple, etc.)
Live outside of rural Pennsylvania
Do not have smartphone/wifi access
Children's Health, Pregnancy & Infertility, Women's Health
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Identification of Neural Markers of Aggression and Irritability and Their Capacity to Predict Treatment Response to CNS Stimulants in Youth with ADHD

This is a drug study for children between 7-12 years old with ADHD that will examine how central nervous system (CNS) stimulants improve anger and irritability in children. It uses only meds that are already FDA approved for ADHD. After intake, families will meet with study doctors to determine an ideal stimulant dose (no placebos in this phase) over 6 visits spaced 1-2 weeks apart. All youth showing improved ADHD and stable or reduced levels of irritability/aggression will advance to a 2 week blinded crossover trial. Participants will complete computer tasks while hooked up to EEG to measure how CNS stimulants impact processing of reward and loss. Participants will complete two EEG visits one week apart - one visit will occur while the child is on the optimal active dose of CNS stimulant from the prior phase, and the other will occur while the child is on a placebo pill. Parents will complete 3 cell phone surveys per day of their child's behavior over these 14 days. This study is expected to take an average of 10 visits over 3 months.

Parent and child will first complete an intake up two hours (30 minutes for child) to verify that child has ADHD and issues with temper problems at home. Then over 6 visits spaced 1-2 weeks apart study doctors will find the best dose of ADHD medication for the child that also helps their anger, with parents filling out weekly ratings of child behavior. All medicines used in the study are already approved to treat ADHD in children and commercially available. At least half of these visits need to occur at the study site at 22 NE Drive in Hershey, PA. For the last two weeks, there will be one in office visit per week at the Hershey office. Children will complete 3 computer games while undergoing EEG testing to measure their brain wave activity. For each of these 14 days, parents will fill out 3 cell phone surveys per day about their child’s behavior. During one of these two weeks, children will take the dose of ADHD medication that worked the best for them. For the other week, it will be replaced with placebo (fake pill). Neither parent or child will know which week is real and which week is fake medication. The total study takes between 10 to 12 visits over an average of 3 months.

child is $100 parent is $105

Yes
 

James Waxmonsky
Psychiatry and Behavioral Health (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT06871488
STUDY00026311
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Inclusion Criteria:
ADHD (suspected or diagnosed)
ages 7 to 12
problems with anger or irritability at home

Exclusion Criteria:
Autism Spectrum Disorder
Current Major Depression
Not interested in using medicine for ADHD
Mental & Behavioral Health
Approved drug(s)
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Hershey, PA ,