Search Results within category "Children's Health"
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A Phase I/II, Multicenter, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of Cobimetinib in Pediatric And Young Adult Patients with Previously Treated Solid Tumors
A study of the safety and effectiveness of cobimetinib in patients with previously treated solid tumors.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
NCT02639546
Children's Health, Cancer
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia
A study of the safety and efficacy of ruxolitinib with routine chemotherapy for children with leukemia with specific genetic changes.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
NCT02723994
Children's Health, Cancer
The Role of Parental Emotion Regulation in Parent-Child Conflicts
This study seeks to examine parenting skills in responses to child misbehavior. Parents complete rating scales about their child's symptoms and behaviors and also participate in computer tasks to measure brain wave activity through EEG. There is an optional section where parent and child will be video recorded while completing activities together. Following the testing sessions are 8 weeks of counseling sessions for parents to help better manage their child's attention and behavior symptoms.
james waxmonsky at jwaxmonsky@pennstatehealth.psu.edu or 717-531-8646
All
Younger than 18 years old
N/A
Children's Health, Mental & Behavioral Health
Improving Autism Screening with Brain-Related miRNA
The central aim of this project is to characterize the expression of exosomal microRNA (miRNA) and nucleic acids in children with autism spectrum disorder (ASD). We propose to measure the expression of extracellular miRNA and nucleic acids in children with ASD. Expression levels of miRNA and nucleic acids from blood and saliva will be compared between children with autism and normally developing controls. The goal of this study will be to identify genetic regulatory mechanisms involved in ASD and provide potential biomarkers for diagnostic screening.
Alexandra Confair at aconfair1@pennstatehealth.psu.edu or 717-531-0003, ext=323206
All
Younger than 18 years old
NCT02712853
Children's Health, Mental & Behavioral Health
A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/ Refractory Solid Tumors or Hematologic Malignancies
Neratininb for childhood cancer that has returned or is not responding to previous therapy
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
NCT02932280
Children's Health, Cancer
Interoception, the 8th Sensory System, Is it measurable?
Sensory processing is often affected in children and adolescents with ASD (autism). The 8th sensory system, coined interoception, is under studied in how it affects children with autism. Our study will compare children with and without autism (ages 11-18 years) using a tool we are developing. Our study hopes to develop psychometric properties of a tool to measure this new sensory sense.
Cheryl Tierney at ctierney@pennstatehealth.psu.edu or 717-531-8414
All
All
N/A
Children's Health, Mental & Behavioral Health
Mobile phones in the bedroom: Impact on adolescent sleep
The purpose of this study is to explore the behaviors, sleep patterns, and sleep attitudes of adolescents who use mobile phones within the bedroom setting after lights out. Participants will complete a series of questionnaires at the beginning of the study. The participants will wear a wrist device for 7 days which measure sleep and wake patterns by activity, as well as complete short daily diary surveys in the morning and evening related to sleep patterns and behaviors, and their mobile phone use.
Cynthia Snyder at ckg2@psu.edu or 717-572-5771
All
Younger than 18 years old
N/A
Children's Health
Molecular-guided therapy for the treatment of patients with relapsed and refractory childhood cancers
Molecular-guided therapy for childhood cancer that has returned or is not responding to previous therapy.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 771-531-3097
All
All
N/A
Children's Health, Cancer
A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma and Medulloblastoma
A study if the safety and effectiveness of nifurtimox in children with neuroblastoma or medulloblastoma, that has returned or is not responding to treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
NCT00601003
Children's Health, Cancer
NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)
A study of DFMO for patients with neuroblastoma in remission.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
NCT02679144
Children's Health, Cancer
Phase I Study of Carfilzomib in combination with Cyclophosphamide and Etoposide for Children with Relapsed or Refractory Solid Tumors and Leukemias
A study of the safety of carfilzomib for children with solid tumors and leukemias that returned or did not respond to previous treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
NCT02512926
Children's Health, Cancer
A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B cell) Treated with Pegylated Asparaginase
A study to confirm and expand information on safety and effectiveness of apixaban to prevent blood clots as compared to no prevention treatment in children with newly diagnosed leukemia and lymphoma. This is a randomized study so patients will be selected by chance to be in either the group that receives apixaban or the group that does not receive apixaban.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
NCT02369653
Children's Health, Cancer
A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant
A study to confirm and expand information on safety and effectiveness of defibrotide compared to best standard care to prevent veno-occlusive disease of the liver in adult and pediatric transplant patients. This is a randomized study so patients will be selected by chance to be in either the group that receives defibrotide or the group that does not receive defibrotide.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
NCT02851407
Blood Disorders, Children's Health, Cancer
Emerging relations between attention and negative affect in the first two years of life
The CAT Lab focuses on the ways in which emotion and attention interact to shape how children navigate through their social world. We do this through questionnaires and observations of behavior in our laboratory. This particular study will examine how children respond to emotional and social events.
We ask infants and their parents to visit our lab 5 times, each visit being 4-6 months apart and usually lasting a little over an hour. During each visit to our lab, we ask infants to look at pictures of people and animals on a computer monitor while we record where their eyes are looking on the screen. Children also participate in several different games and play with different toys (just like those found in a common household such as balls, puppets, plastic animals, etc.). Some of these activities involve parents and some do not, but we do ask parents to stay in the room with their child for the full visit.
During visits 2-5, we would also like to collect electroencephalogram (EEG) and respiratory sinus arrhythmia (RSA) data from your child. EEG measures the electrical activity in the brain using small metal sensors placed on the head with gel. RSA measures heart rate and breathing by placing small sensors on the torso. These procedures do not hurt, are low-risk, and provide real-time measurement of your child’s autonomic nervous system signals, much like an arm cuff measures blood pressure. When the sensors are removed, some children may feel like a bandage is being pulled off.
Norbert Promagan at nup21@psu.edu or 814-867-2322
All
Younger than 18 years old
N/A
Children's Health, Mental & Behavioral Health
Predicting Concussion Outcomes with Salivary miRNA
The purpose of this study is to identify changes in salivary micro ribosomal nucleic acid (miRNA) expression that are predictive of symptom duration and severity following mild traumatic brain injury (mTBI) in children.
The primary endpoints of this study are as follows:
1) Characterization of brain-related miRNA in the saliva of 250 children with mTBI and 200 age- and gender-matched controls between the ages of five and twenty-three years.
2) Identification of a set of salivary miRNAs that is predictive of duration and severity of mTBI symptoms.
Jennifer Stokes at jstokes1@pennstatehealth.psu.edu
All
All
NCT02901821
Children's Health, Neurology, Sports Medicine
Monetary Reward Processing and Emotion Regulation in Adolescence: An fMRI pilot Study
This research is being done to identify patterns of brain activation underlying monetary reward processing and emotion regulation in adolescence, as well as correspondence between parent and adolescent neural activation.
Children and their parents will complete questionnaires. Children will complete computer tasks during EEG and in an MRI scanner. Parents can also complete the MRI scan if interested.
Vanessa Cao at ABC@pennstatehealth.psu.edu or 717-531-0003, ext=285966
All
Younger than 18 years old
N/A
Children's Health, Neurology, Mental & Behavioral Health
Bioactive RNA in Infant Nutrition: A Novel Regulator of Developmental Origins and Allergic Response
Characterize longitudinal changes in immune-related ribonucleic acids (RNAs) during the first four months after birth (a critical period when protective breastfeeding benefits are conferred) and compare breast milk RNA exposure between atopic and non-atopic infants.
Atopy, the genetic tendency to develop allergic diseases such as asthma and atopic dermatitis (AD), is present in nearly one-third of children. Atopy results from activation of the immune response to environmental exposures. The developmental origins that influence this response are not completely understood.
Infants who breastfeed beyond three months have lower atopy risk. What factors in maternal breast milk (MBM) confer these health benefits and why is breastfeeding beyond three months so critical? The answer may be a bioactive factor in MBM called microRNA (miRNA). MiRNAs are small non-coding molecules that regulate gene expression across multiple tissues. There are nearly 1,000 types of miRNAs in MBM. The majority are found in the lipid or cellular milk fractions, and evidence suggests that they regulate metabolic and immune pathways. Studies by our lab and others demonstrate that MBM miRNA composition is influenced by both maternal factors (delivery method and weight) and infant factors (prematurity). Animal studies suggest nutritional miRNA influences the immune system through immune-modulation. Thus, breast milk miRNA exposure may mitigate infant atopy risk.
jessica Beiler at jbeiler@pennstatehealth.psu.edu or 717-531-5656
Female
18 year(s) or older
N/A
Children's Health
Caregiver's Perceptions of High-quality Early Education and Care
This is an exploratory study which looks at how caregivers define high-quality early education and care. Participants will fill out a questionnaire containing open-ended and closed-ended questions. It will take participants no longer than 20 minutes to complete.
Hannah Mudrick at hxm99@psu.edu
All
18 year(s) or older
N/A
Children's Health, Education, Mental & Behavioral Health
Pennsylvania Adoptees Longitudinal Study (PALS)
This study will examine various factors within the home of children adopted from the child welfare system between the ages of 4 and 10 that may impact their development. At the current time, there are two planned home visits, each 1-year apart. The children and parents will not be required to travel for sessions as all visits will occur in the home. This research will help understand the factors that impact the development of children adopted from the child welfare system and how we may better serve these children and their families.
Ashley Bucher at abucher2@pennstatehealth.psu.edu or 717-531-0003, ext=281513
All
All
N/A
Children's Health, Mental & Behavioral Health
Integrating AAT into TF-CBT for Maltreated Youth: A Randomized Feasibility Trial
This is a randomized clinical trial designed to test the feasibility of integrating Animal-Assisted Therapy (AAT) into standard Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for the treatment of posttraumatic stress and associated symptoms of maltreated youth.
Brian Allen at ballen1@pennstatehealth.psu.edu or 717-531-4100
All
Younger than 18 years old
NCT03135119
Children's Health, Mental & Behavioral Health
The Child Health Study
We want to understand how a child's environment affects biology in ways that impact child health
Megann Koegler at childhealthstudy@psu.edu or 888-924-4535
All
Younger than 18 years old
N/A
Children's Health, Food & Nutrition, Education
Development of Adolescent and Young Adult Social Health (DASH)
Adolescence is a unique developmental period that prepares individuals for adulthood. We are studying the behavioral and brain basis of this important time, particularly in terms of how adolescents understand and think about other people. To study this important developmental transition, we are inviting typically developing children (6-8 yrs), adolescents (10-14 yrs), and young adults (18-22 yrs) to help us with this study. Participants answer questionnaires, play games of face recognition, and have pictures of their brains taken in a neuroimaging session. Child and adolescent participants also have physical exams. Volunteers are compensated for time (between $185-630) in the lab and for the neuroimaging session.
If you are a parent and want to begin the screening process for you child, please go here
https://pennstate.qualtrics.com/jfe/form/SV_51lN8sODiukYOON
If you are an adult, and want to begin the screening process please go here:
https://pennstate.qualtrics.com/jfe/form/SV_5cXMng6ybKe0WwJ
Dr. Suzy Scherf at suzyscherf@psu.edu or 814-954-0112
All
All
N/A
Children's Health, Education, Mental & Behavioral Health
Neurophysiological Markers of Pediatric Irritability and its Response to Intervention
This study uses specific computer tasks to predict irritability in children with Attention Deficit/Hyperactivity Disorder (ADHD), as well as the effect of ADHD medication (stimulants) on irritability symptoms in children with ADHD. Children ages between the ages of 5 and 12 years are eligible and must have an established diagnosis of ADHD or suspected symptoms of ADHD.
Vanessa Cao at vcao@pennstatehealth.psu.edu or 717-531-0003, ext=285966
All
Younger than 18 years old
NCT03279952
Children's Health, Mental & Behavioral Health
Personality and Neurocognitive Development in Adolescence and Adulthood
This study seeks to learn how brain changes in teenagers and young adults may be related to the development of interpersonal and emotional functioning, as well as risky behavior. In particular, we hope to explore differences in the ways that adolescents and adults regulate their emotions and behavior and how this is reflected in computer-based tasks.
Begonia Herbert-Ramirez at bbh5255@psu.edu or 814-863-7624
All
All
N/A
Children's Health, Mental & Behavioral Health
Attention and Emotional Development in Children
Children with attention problems often feel anxious or worried, and likewise, children who are anxious or worried often have problems with attention. We are looking for children aged 8-12 who may or may not have problems with attention or anxiety to help us understand what happens in the brain that could explain why. You will receive up to $100 gift card for your participation, and informal clinical feedback on your child.
Tyler Warner at taw87@psu.edu or 814-867-5684
All
Younger than 18 years old
N/A
Children's Health
Preadolescent Stress and Health Study
This study will examine the effects of stress on physical and mental health during early adolescence. We are recruiting 11- and 12-year old boys and girls to participate in three yearly visits at the PennStateHealth Pediatric Clinical Research Center. At the visits, a youth and one of their parents or guardians will participate in interviews related to stress, coping, and everyday life. They will also complete some puzzles and cooperative activities both together and separately.Youths will also provide blood, urine, and saliva samples to measure stress hormones and other health indicators such as cholesterol and glucose levels. Participating families will receive compensation for completing surveys at the three timepoints.
Martha Wadsworth at mew27@psu.edu or 814-865-2878
All
Younger than 18 years old
NCT03436706
Children's Health, Mental & Behavioral Health
Examining Maternal Reward Responsiveness and the Intergenerational Risk for Depression
Children of depressed mothers are at high risk for developing depression, particularly as youth age into adolescence, yet relatively little is known about the mechanism underlying risk for depression in youth with depressed mothers. The present study examines maternal reward responsiveness, measured across neurophysiological, behavioral, and self-report measures as a marker of depression in mothers of adolescents. Associations between maternal reward responsiveness and parenting difficulties often associated with maternal depression, as well as adolescent functioning will be examined, to explore the clinical impact of maternal reward responsiveness on the intergenerational transmission of depression.
Sarah Shahriar at sshahriar1@pennstatehealth.psu.edu or 717-531-0003, ext=285189
All
All
N/A
Children's Health, Mental & Behavioral Health, Women's Health
Site For Protect Them-Spanish groups
Site For Protect Them-Spanish groups
William Calo at wcalo@phs.psu.edu or 717-531-3535
All
All
N/A
Children's Health, Prevention
PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
NCT02559778
Children's Health, Cancer
The Penn State Personalized Research for Innovation, Discovery, and Education (PRIDE) Program.
The Penn State Personalized Research for Innovation, Discovery, and Education (PRIDE) Program.
The aims of the PRIDE Program are to:
1. Create a centralized Biorepository using extra blood obtained from a clinically-ordered blood draw, leftover biospecimens that are removed during medically indicated procedures or a saliva sample from consented participants that do not have clinically ordered blood draws or a medical procedure.
2. Construct a dynamic database of health and related data (via both manual and electronic abstraction) from consented participants.
3. Establish a mechanism for approving use of the banked biospecimens for future research.
Syndi Reed at creed@pennstatehealth.psu.edu or 855-369-3540
All
All
N/A
Men's Health, Children's Health, Women's Health