VOLUME 10

Cincinnati Children’s Clinical Research Studies Update

Research Studies at Cincinnati Children’s A SAMPLING OF STUDIES

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Research Studies at Cincinnati Children’s About this Booklet This booklet includes a small sample of the hundreds of research studies at Cincinnati Children’s. Please take a look to see if there are studies that might be of interest to you and your family. If so, please call or email the study contact. Your participation in research may lead to knowledge that could benefit you and others. Without volunteers who participate in research, doctors cannot know how best to help treat children and adults.

Get Connected to Other Research Studies @ Visit Our Web Site

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Contact Us [email protected] or 513-636-0098

Sign Up to Receive Study Information • Visit our web site at cincinnatichildrens.org/clinical-studies and enroll in our database to receive research study e-newsletters and/or this booklet. or • Fill out the reply card opposite this page to receive research study e-newsletters and/or this booklet.

Thank you for your interest in research studies. Please feel free to share this information with your friends and family.

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Healthy Studies for Children and Teens Newborn Babies Up to 13 Weeks What

 e purpose of this research study is to look at what effects the routine rotavirus vaccines have on Th the bowel function of babies.

Who Mothers and their newborn babies who are up to 13 weeks old Pay

Families may receive up to $400 for time and effort.

Contact Study coordinator at [email protected] or 513-803-8800

Infants, Children and Teens up to 18 Years Old What  The purpose of this research study is to use an EEG test to examine how the brain responds to sensory stimuli such as sounds or pictures. An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”). Who  Healthy infants, children and teens up to 18 years old with no history of mental illness or head trauma may be eligible to participate. Pay

Participants will receive $20 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

Babies, Children and Teens Who Listened to a White Noise Generator/Sleep Machine in the Crib What The purpose of this research study is to use an EEG test to examine how the brain responds to sensory stimuli such as sounds or pictures. An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”). Who  Healthy infants, children and teens up to 18 years old who: • L  isten or listened to a white noise generator/sleep machine while in the crib

• Have no history of mental illness or head trauma

Pay

Participants will receive $20 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

Children 18 Months to 3 Years Old What  We are evaluating a lab test being developed to diagnose children with autism spectrum disorder (ASD) and differentiate them from children with developmental delays and/or who are developing normally. This study will look at 2 ways of diagnosing ASD: the lab test AND standard behavioral testing/ observation by a trained psychologist. Who  Healthy children, 18 months through 3 years old, may be eligible for participation. Pay

Participants will receive $100 for their time, effort and travel.

Contact [email protected] or 513-803-2860

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HEALTHY STUDIES FOR CHILDREN AND TEENS

Children 4 to 6 Years Old Who Were Preemies at Birth What  This is a research study to learn more about brain development and language in children born preterm (at less than 30 weeks).  The study involves brain imaging with MRI (magnetic resonance imaging) and MEG (magnetoencephalography). These are non-invasive procedures which are not associated with injections or harmful radiation. Who  Children 4 to 6 years old who:

• Were born at less than 30 weeks gestation



and



•D  o not have cerebral palsy or a significant developmental delay

Pay

Families may receive up to $100 for their time and effort.

Contact The study coordinator at [email protected] or 513-803-5180

Children 6 to 12 Years Old What  The purpose of this research study is to learn more about listening difficulties in children using MRI, EEG, listening and cognitive tests. We will compare brain structure and function of children with listening difficulties to that of typically developing children. Who  Healthy children, 6 to 12 years old, who have no history of listening difficulties, may be eligible to participate. Pay  Participants will receive up to $80 total for their time and travel. Contact Nicholette Smith at [email protected] or 513-803-4937

Children and Teens 7 to 17 Years Old What

We want to learn more about how the brain works.

We will use a non-invasive test called an MEG to measure activity in the brain. Who  Healthy children and teens, 7 to 17 years old, who are right-handed may be able to participate. Anyone with neurological or psychiatric disorders (like epilepsy, OCD or ADHD), or who has a non-removable implant or metal device (like a cochlear implant, pacemaker, permanent retainer or braces) will NOT be able to participate. Pay

Participants will receive up to $100 for their time and travel.

Contact Elana Harris at 513-636-2100 or [email protected]

Children and Teens 5 to 18 Years Old What  This is a research study to learn more about the role that genes and the environment play in determining why some children develop certain disorders or symptoms and others do not. Who  Healthy children and teens 5 to 18 years old may be eligible to participate. Pay  Families may receive up to $50 for their time and travel and may receive allergy test results at no charge. Contact Study coordinator at 513-803-0672

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HEALTHY STUDIES FOR CHILDREN AND TEENS

Children and Teens 5 to 17 Years Old What  We will compare the test results of people with Fragile X Syndrome (FXS) to people without FXS to learn more about the effectiveness of an investigational drug treatment for reducing symptoms associated with FXS. FXS is the most commonly inherited cause of intellectual disability and autism.

Healthy controls will NOT receive any investigational drug.

Who  Healthy children and teens who:

• Are 5 to 17 years old



and



•D  o not have a history of psychiatric illness or intellectual disability

Pay

Participants will be reimbursed $20 for their time and travel.

Contact [email protected] or 513-636-0523

Children and Teens 6 to 17 Years Old What  A research study to evaluate and compare the changes in knee cartilage in healthy children, teens and adults with that of patients with juvenile idiopathic arthritis. This study includes an MRI (magnetic resonance imaging) to take photos of the participant’s knees. Who

Healthy children, teens and adults 6 to 17 years old

Pay

Participants may receive $50 for this 1-visit study.

Contact Study coordinator at [email protected] or 513-636-0160

Healthy Children and Teens 11 to 17 With a Healthy Sister or Brother 11 to 17 What  A study to look at the emotions and behaviors of adolescents who have healthy siblings, as compared to adolescents who have a brother or sister with an eating disorder Who  Children and teens (11 to 17 years old) who have a sibling (11 to 17 years old) who has not been diagnosed with a chronic medical or mental health condition Pay  Participants will receive $50 for completing a survey during 1 study visit. Contact Emily Copps-Smith at [email protected] or 513-636-2463

Teens 13 to 17 Who Have Normal or High Blood Pressure What  We want to learn more about how high blood pressure in teens affects the risk for cardiovascular injury later in life. We will compare study results of teens with normal, mid and high blood pressure. Who  Teens, 13 to 17 years old, who have normal (healthy) or high blood pressure, may be eligible for participation. Teens who are taking medicine to control his/her blood pressure; type 1 or type 2 Diabetes; or cholesterol may NOT be able to participate. Pay

Participants may receive up to $125 for their time and travel.

Contact Shalayna Woodly at 513-803-0366 or [email protected]

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HEALTHY STUDIES FOR CHILDREN AND TEENS

Teens 13 to 17 Years Old What  We want to learn more about what areas of the brain teens normally use for executive functions thinking skills like planning, organization and memory. These executive functions can affect areas of life can such as school performance, social skills and adherence to medication. We also want to see how these areas may be changed in teenagers that have epilepsy compared to teenagers without epilepsy. Who  Healthy teens, 13 to 17 years old, may be eligible for participation. Teens who have the following will NOT be able to participate:

•A  non-removable implant or metal device (like a cochlear implant, pacemaker or braces)



•A  diagnosis of any developmental (such as autism), neurologic or psychiatric disorder/disease (such as ADHD)

Pay  Participants will receive up to $60 for their time, effort and travel. Contact Study coordinator at [email protected] or 513-803-7935

African American Teens 16 and 17 Years Old What  We want to learn more about how microbes (helpful germs) affect disease. We will try to find out new ways to measure how the microbes interact with the genes that some people inherit and how that leads to the development of lupus. Who  Healthy African American teens 16 and 17 years old may be eligible for participation. What’s Involved Information about participants (sex, ethnicity, age and race) will be matched to that of a person with lupus. Participants will then be asked to answer a questionnaire and provide a blood and stool sample.

Pay

Participants will receive up to $40 for their time and travel.

Contact Diana Taft at 513-803-5313 or [email protected]

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HEALTHY ADULT STUDIES

Healthy Adult Studies Adults 18 to 22 Years Old What  We will compare the test results of people with Fragile X Syndrome (FXS) to people without FXS to learn more about the effectiveness of an investigational drug treatment for reducing symptoms associated with FXS. FXS is the most commonly inherited cause of intellectual disability and autism.

Healthy controls will NOT receive any investigational drug.

Who  Healthy adults who:

• Are 18 to 22 years old



and



• Do not have a history of psychiatric illness or intellectual disability

Pay

Participants will be reimbursed $20 for their time and travel.

Contact [email protected] or 513-636-0523

Adults 18 to 20 Years Old What  A research study to evaluate and compare the changes in knee cartilage in healthy children, teens and adults with that of patients with juvenile idiopathic arthritis. This study includes an MRI (magnetic resonance imaging) to take photos of the participant’s knees. Who  Healthy adults 18 to 20 years old Pay

Participants may receive $50 for this 1-visit study.

Contact Study coordinator at [email protected] or 513-636-0160

Adults 18 to 40 Years Old What  This research study will help us to learn more about blood stem cells from healthy adults. The study involves receiving a medicine that increases the total circulating blood cells, and then collecting the blood cells, just like a platelet donation. These circulating blood cells have a small proportion of blood stem cells that our researchers are studying to understand and find new cures for blood diseases and cancer. Who  Adults 18 to 40 years old in good health may be eligible to participate. Interested individuals will undergo a screening, and if found to be in good health, will be eligible for this study. Pay

Participants will receive up to $700 for their effort, time and travel.

Time  Participants will be in the study for approximately 13 hours during 4 study visits (approximately 2 hrs for visit 1, 1 hr for visit 2, 5 hrs for visit 3, and 5 hrs for visit 4). Contact Carrie Stevens at [email protected]

Healthy Studies for Children and Teens



Adults 18 to 45 Years Old What  The purpose of this research study is to test how safe an investigational vaccine (dmLT) is, in preventing ETEC – E. coli infection. ETEC is a common cause of diarrhea in areas of the world where there are unclean conditions including poor sanitation and dirty drinking water. Who  Healthy adults 18 to 45 years old who are willing to receive 3 vaccines against traveler’s diarrhea and come in for 12 study visits in our outpatient clinic may be eligible to participate. Pay

Participants may receive up to $900 for their time and effort to complete the entire study.

Contact Gamble Program for Clinical Studies at Cincinnati Children’s: [email protected] | Study Line: 513-636-7699

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HEALTHY ADULT STUDIES

Adults 18 to 65 Years Old What The purpose of this research study is to improve EEG techniques and examine how the brain responds to sensory stimuli such as sounds or pictures.

An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”).

Who  Healthy adults 18 to 65 years old with no history of mental illness or head trauma may be eligible to participate. Pay

Participants will receive $20 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

African American Adults 18 and Older What  We want to learn more about how microbes (helpful germs) affect disease. We will try to find out new ways to measure how the microbes interact with the genes that some people inherit and how that leads to the development of lupus. Who  Healthy African American adults 18 years old and older may be eligible for participation. What’s Information about participants (sex, ethnicity, age and race) will be matched to that of a person Involved  with lupus. Participants will then be asked to answer a questionnaire and provide a blood and

stool sample.

Pay

Participants will receive up to $40 for their time and travel.

Contact Diana Taft at 513-803-5313 or [email protected]

Adults 20 to 45 Years Old Who Have a Parent, Child or Brother/Sister With Type 1 Diabetes What  This research study is being conducted to learn more about how type 1 diabetes develops and to look at ways to delay it or prevent the condition from occurring. Who  Adults 20 to 45 years old without diabetes who have a parent, child, brother or sister with type 1 diabetes Pay  There is no cost to you or your insurance company, but compensation is not provided for this phase of the study. (Should you test positive for a risk to develop type 1 diabetes, you could take part in and be compensated for other study phases or prevention studies.) Contact Tammy Weis at [email protected] or 513-636-4212

Breastfeeding Mothers Who Are Having Difficulty Making Enough Milk What

This research study will help us learn about the causes of low milk supply.

Participating mothers will be loaned a baby scale and breast pump during the study. Mothers will also be given a summary of how much milk they are making. Who  Breastfeeding mothers whose babies are between 1 week and 2 months old and who are supplementing with formula Pay

Participants may receive up to $220 for time and effort.

Contact Erin Wagner at [email protected] or 513-636-4659

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HEALTHY ADULT STUDIES

Women Who Have Had a Premature Baby or Who Are at Risk to Do So What  This is a research study to determine if there is a pattern in some families of mothers giving birth prematurely, and if so, to explore a possible genetic link. Who  Women who have given birth to a premature baby (more than one month before their due date) or are at risk for giving birth prematurely may be eligible to participate. Pay

Participants will receive between $50 and $100 for their time.

Contact Dr. Louis Muglia at [email protected] or 513-803-7902

Or



To take a survey to see if you are eligible for this study, go to cincinnatichildrens.org/fetalstudy.

Veterans Who Have Combat-Related PTSD What  We want see if couple’s-based therapy reduces Post-Traumatic Stress Disorder (PTSD) symptoms and improves relationships with partners and children. Who  Veterans who have been diagnosed with or are suspected of having PTSD and:

• Report significant distress with their partner or family members



• Have at least one child, ages 4 to 12 years old, living with them



All parties must be willing to participate in the research study.

Pay

Families will receive up to $200 for their time.

Contact Rich Gilman at 513-558-5872

Adults Who Have a Partner With Combat-Related PTSD What  We want see if couple’s-based therapy reduces Post-Traumatic Stress Disorder (PTSD) symptoms and improves relationships with partners and children. Who  Adults, 18 and over, with a partner who:

• Has been diagnosed with or is suspected of having combat-related PTSD



• Reports a high level of relationship dissatisfaction



• Has at least one child, ages 4 to 12 years old, living with them



All parties must be willing to participate in the research study.

Pay

Families will receive up to $200 for their time and travel.

Contact Rich Gilman at 513-558-5872

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HEALTHY ADULT STUDIES

ADD/ADHD



Children 8 to 12 Years Old With ADHD and/or Attention Problems What  This is a research study to learn more about how children with ADHD differ from children without ADHD, in their cognitive and sleep functioning. Who  Children 8 to 12 years old with ADHD and/or who have problems with attention Pay

Families may receive up to $100 for time and effort.

Contact The study coordinator at [email protected] or 513-803-0771

Children 7 to 11 Years Old Who Have or May Have ADHD What  This research study will look at how children with attention deficit hyperactivity disorder (ADHD) respond to medication.

Children will have a full diagnostic evaluation for ADHD, as part of this study.

Who  Children 7 to 11 years old who:

• Have been diagnosed with ADHD and have not previously taken medication for ADHD



OR



•H  ave ADHD symptoms including: short attention span for age, difficulty listening to others, easily distracted, excessive fidgeting and/or talking, or often interrupting others

Pay

Families may receive up to $310 for time and effort.

Contact Study staff at [email protected] or 513-803-1344

Teen Drivers with ADD/ADHD What  A research study to test training programs to see if they might help teens with ADD or ADHD become safer drivers Who  Teenagers 16 to 19 years who have a history of ADD or ADHD and a valid driver’s license may be eligible to participate. A parent will also be asked to participate. Pay

Families may receive up to $280 for their time and effort.

Contact The study coordinator at [email protected]

Children Who Are Sluggish, Spacey or Easily Confused What  This is a research study to learn more about how children with specific attentional difficulties differ from other children, in their cognitive, academic and daily life functioning. Who  Children 8 to 12 years old who do and do not have attentional problems may be eligible to participate. Pay

Families may receive up to $100 for time and effort.

Contact The study coordinator at [email protected] or 513-803-0771

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ALLERGY | ASTHMA

Allergy



Children and Teens 5 to 18 Years Old Who Have Allergies What  This is a research study to learn more about the role that genes and the environment play in determining why some children develop certain disorders or symptoms and others do not. Who  Children and teens 5 to 18 years old who have allergies (sneezing; runny, stuffy nose; itchy, watery eyes) but do NOT have asthma may be eligible to participate. Pay

Families may receive up to $50 for their time and travel and may receive allergy test results at no charge.

Contact The study coordinator at 513-803-0672

Asthma Children and Teens 6 to 17 Years Old With Asthma What  This research study will help us learn more about how a viral cold impacts asthma in children who are taking a large amount of asthma medication. Who  Children and teens 6 to 17 years old who:

•H  ave a history of asthma and have had 2 and or more asthma attacks in the last year

Pay

Families will be reimbursed for time and effort.

• Take a large amount of medication to control their asthma

Contact Steve Austin at [email protected] or 513-356-6102

Preteens and Teens 12 to 17 Years Old With Asthma What  The purpose of this research study is to find out if the study drug helps preteens and teens with asthma that is not controlled with the use of inhalers and a second controller medication. Who  Preteens and teens 12 to 17 years old diagnosed with asthma who have had:

• Asthma for at least 1 year

and



Pay

• Symptoms such as wheezing, chest tightness, cough or shortness of breath within the last month

Participants will receive pay for each completed study visit, as compensation for time and effort.

Contact Kyle Connolly at [email protected] or 513-803-9243

Children 10 to 14 Years Old With Asthma Who Live Near a Highway or Interstate What  A study to look at whether an air purifier can reduce air pollution in the home and how it might help children with asthma Who  Children and teens 10 to 14 years old who:

• Have been diagnosed with asthma

and

• Live near a highway or interstate

Pay  Families may receive up to $115 for time and effort. All study visits will be conducted at the participant’s home. Contact Chris Wolfe at 513-803-1661 or [email protected]

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AUTISM

Autism Children 18 Months to 3 Years Old Who Show Signs of an Autism Spectrum Disorder (ASD) What  We are evaluating a blood test being developed to identify children diagnosed with autism spectrum disorder (ASD). Researchers want to know if this type of blood test will differentiate children with ASD from children with developmental delays and/or children who are developing normally. Who  Children, 18 months through 3 years old, who show signs of an ASD may be eligible for participation. Children who have a genetic disorder (ex. Fragile X, Rett syndrome, Down syndrome, tuberous sclerosis) will NOT be able to participate. Pay

Participants will receive $100 for their time, effort and travel.

Contact [email protected] or 513-803-2860

Girls 9 to 14 Years Old With ASD What  This is a research study to learn more about how school-aged girls with ASD develop and use their social communication skills across different settings. Who  Girls 9 to 14 years old who:

•H  ave a diagnosis of autism, Asperger’s disorder/syndrome, pervasive developmental disorder-not otherwise specified (PDD-NOS), or autism spectrum disorder



• Speak in sentences



• Can ask and answer questions

Pay  Families may receive $60 for time and effort and an additional $30 for travel (if traveling more than 50 miles one way). They will also receive a copy of a speech-language assessment report. Contact Jenny Burton at [email protected] or 513-803-3586

Preteens and Teens 12 to 17 Years Old With ASD What  We want to learn more about an investigational drug, ketamine, and see if it may be helpful for the treatment of autism spectrum disorders (ASD). We also hope to learn more about the safety of the drug and if it works on symptoms of ASD. Ketamine is considered investigational because the United States Food and Drug Administration (FDA) has not yet approved it for the treatment of autism. Who  Preteens and teens, 12 to 17 years old, who have an ASD may be eligible for participation.

Those who have schizophrenia, schizoaffective disorder, bipolar disorder or psychosis will NOT be able to participate in this study.

Pay

Participants will receive $260 for their time, effort and travel for this 7-visit study.

Contact [email protected] or 513-636-0526

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AUTISM

Adults 18 to 30 Years Old With ASD What  We want to learn more about an investigational drug, ketamine, and see if it may be helpful for the treatment of autism spectrum disorders (ASD). We also hope to learn more about the safety of the drug and if it works on symptoms of ASD.

Ketamine is considered investigational because the United States Food and Drug Administration (FDA) has not yet approved it for the treatment of autism.

Who  Adults, 18 to 30 years old, who have an ASD may be eligible for participation. Those who have schizophrenia, schizoaffective disorder, bipolar disorder or psychosis will NOT be able to participate in this study. Pay

Participants will receive $260 for their time, effort and travel for this 7-visit study.

Contact [email protected] or 513-636-0526

Children, Teens and Adults With Fragile X Syndrome What  The purpose of this research study is to learn more about the safety, tolerability and effectiveness of an investigational drug treatment called acamprosate and see if it reduces the symptoms (inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS). Investigational means that this drug has not currently been approved by the United States Food and Drug Administration (FDA) for the treatment of FXS. Who  Children, teens and adults, 5 to 22 years old, who have been diagnosed with FXS may be eligible for participation. Pay

Participants will be reimbursed $20 per visit for their time and travel.

Contact [email protected] or 513-636-0523

Children, Teens and Adults With Fragile X Syndrome AND/OR Their Family Members What  We want to learn about brain and behavioral problems associated with Fragile X Syndrome (FXS) and how they are connected with genetic factors related to FXS. Who  Those who can participate are children, teens and adults 5 to 80 years old who:

• Have a diagnosis of FXS



• Are known or suspected to carry a variation of the FXS gene

Those who have a significant medical, psychiatric, central nervous system or neurological disease that is unrelated to FXS will NOT be able to participate. Pay

Participants will receive up to $70 for their time, effort and travel.

Contact Janna Guilfoyle at [email protected] or 513-517-1087

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CEREBRAL PALSY | CONCUSSION/HEAD INJURY

Cerebral Palsy Children, Teens and Adults 6 to 21 Years Old With Hemiplegic Cerebral Palsy AND an Elbow That Won’t Straighten What  We are studying arm muscles in children with cerebral palsy who also have an elbow that does not straighten all the way (called elbow flexion contractures). Why  We want to learn why joints in children with cerebral palsy get stiff. We also want to know if not being able to straighten the elbow is from weakness and shortening of the biceps and brachialis arm muscles. Who  Children, teens and adults, 6 to 21 years old, who have a diagnosis of hemiplegic cerebral palsy AND:

• Have elbow flexion contracture between 10 and 90 degrees



• Are scheduled for a previously planned surgery under general anesthesia



• Have not had previous elbow surgery

Anyone who has had Botox to the affected elbow flexors within 6 months of the scheduled surgery, previous elbow surgery, phenol injections to the elbow OR are unable to perform Motion Analysis, will not be able to participate in this research study. Pay

Participants will not be paid for this research study.

Contact Emily Louden at [email protected] or 513-636-6972

Concussion/Head Injury Children and Teens 8 to 17 Years Old Who Have Had a Recent Concussion What  This research study will compare the EEG (electro-encephalography - a noninvasive test which records the electrical activity along the scalp) pattern in the brain of children who have had a concussion with that of children who have not had a concussion. Who  Children and teens 8 to 17 years old who have had a concussion within the last 10 days may be eligible to participate. Pay  Participants will receive $25 per visit up to 4 visits. Contact Kim Barber Foss at [email protected] or 513-636-5971

Teens Who Have Had a Concussion Within the Last 5 Days What  We want to improve our understanding of the evaluation and treatment of concussions. Teens and 1 of their parents will complete 2 study visits and daily surveys for 1 month. Teens will also wear an activity tracker. Who  Teens 13 to 18 years old who have had a concussion within the last 5 days and a parent Pay  Participants may receive an activity tracker and up to $100, and a parent may receive up to $100. Contact The study coordinator at [email protected] or 513-636-1246

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CONCUSSION/HEAD INJURY

Children and Teens Who Had a Sports-Related Concussion Around 3 Months Ago, and Have Migraines That Require Medication What  We want to look at what is happening in the brain when someone starts having regular migraines after an injury and then begins taking medication for those migraines. We will use a machine called an “MEG”, which measures the magnetic activity in the brain. Who

Children and teens, 6 to 17 years old, who:



• Have experienced a sports-related concussion around 3 months ago



• Started having migraines 15 or more days a month



• Are taking migraine medication

Anyone with a non-removable implant or metal device (like a cochlear implant, pacemaker or braces) or other diagnosed neurological issues will NOT be able to participate. Pay  Participants will receive $25 for their time and travel along with an MRI reviewed by a radiologist. Contact Kimberly Leiken at [email protected] or 513-803-7228

Children and Teens Who Had a Sports-Related Concussion Within the Last Month, and Have Occasional Migraines What  We want to look at what is happening in the brain when someone suffers from migraines after a concussion. We will use a machine called an “MEG”, which measures the magnetic activity in the brain. Who  Children and teens, 6 to 17 years old, who:

• Have experienced a sports-related concussion within the last month



• Started having occasional migraines (and never had them before)



• Are not taking preventative migraine medication

Anyone with a non-removable implant or metal device (like a cochlear implant, pacemaker or braces) or other diagnosed neurological issues will NOT be able to participate. Pay  Participants will receive $25 for their time and travel along with an MRI reviewed by a radiologist. Contact Kimberly Leiken at [email protected] or 513-803-7228

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DEVELOPMENTAL DELAYS | DIABETES

Developmental Delays Children 18 Months to 3 Years Old Who Show Signs of a Developmental Delay/Disorder What  We are evaluating a blood test being developed to identify children diagnosed with autism spectrum disorder (ASD). Researchers want to know if this type of blood test will differentiate children with ASD from children with developmental delays and/or children who are developing normally. Who  Children, 18 months through 3 years old, who show signs of a developmental delay or disorder may be eligible for participation. Children who have a genetic disorder (ex. Fragile X, Rett syndrome, Down syndrome, tuberous sclerosis) will NOT be able to participate. Pay

Participants will receive $100 for their time, effort and travel.

Contact [email protected] or 513-803-2860

Pay

Participants will receive $100 for their time, effort and travel.

Contact [email protected] or 513-803-2860

Diabetes Study for Teenagers Being Seen at Cincinnati Children’s for Type 1 Diabetes What  This is a research study to learn more about how we can help teens with type 1 diabetes improve their blood sugar, reduce their risk of complications from the condition, and improve their quality of life. Who  Teenagers 13 to 16 years old:

• Who have had type 1 diabetes for at least 1 year



and



• Whose most recent A1c (average blood sugar level) is between 8 and 13%



A parent will also be asked to participate.

Pay

Families may receive up to $995 for time and effort to complete this 18-month study.

Contact Emily Smith at [email protected] or 513-803-9200

Children, Teens and Young Adults Who Have a Relative With Type 1 Diabetes What  This research study is being conducted to learn more about how type 1 diabetes develops and to look at ways to delay it or prevent the condition from occurring. Who  Children, teens and young adults 1 to 20 years old without diabetes who have a parent, brother, sister, aunt, uncle, grandparent, first cousin, niece, nephew, half brother or sister with type 1 diabetes Pay  There is no cost to you or your insurance company, but compensation is not provided for this phase of the study. (Should you or your child test positive for a risk to develop type 1 diabetes, you could take part in and be compensated for other study phases or prevention studies.) Contact Tammy Weis at [email protected] or 513-636-4212

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DIABETES | DOWN SYNDROME

Adults 20 to 45 Years Old Who Have a Parent, Child or Brother/ Sister With Type 1 Diabetes What  This research study is being conducted to learn more about how type 1 diabetes develops and to look at ways to delay it or prevent the condition from occurring. Who  Adults 20 to 45 years old without diabetes who have a parent, child, brother or sister with type 1 diabetes Pay  There is no cost to you or your insurance company, but compensation is not provided for this phase of the study. (Should you test positive for a risk to develop type 1 diabetes, you could take part in and be compensated for other study phases or prevention studies.) Contact Tammy Weis at [email protected] or 513-636-4212

Down Syndrome Children and Teens 6 to 17 Years Old With Down Syndrome What  An intervention study for parents of children with Down syndrome and sleep problems to improve child behavior, child and parental sleep, and parental stress Who

Children 6 to 17 years old with Down syndrome and a parent or legal guardian

Pay  Families may receive up to $200 for time and effort, and a copy of the testing report(s) at the end of the study. Contact Emily Hoffman at [email protected] or 513-803-3641 Study Lead  Anna Esbensen, PhD at the Thomas Center for Down Syndrome

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EOSINOPHILIC GASTROINTESTINAL DISORDER | EPILEPSY

Eosinophilic Gastrointestinal Disorder Children and Teens With an Eosinophilic Gastrointestinal Disorder What  We want to find the best way to define how well a person with an eosinophilic disorder is doing. We also want to see if the way questionnaires are answered can give us an idea of how well the person is doing. Who  Children and teens, 3 to 17 years old, with an eosinophilic gastrointestinal disorder may be eligible for participation. Eosinophilic gastrointestinal disorders include: eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), or eosinophilic colitis (EC). Pay

Participants will not receive pay for their time, effort or travel.

Contact Jonathan Kuhl at [email protected] or 513-803-3078

Adults 18 to 65 Years Old With An Eosinophilic Gastrointesinal Disorder What  We want to find the best way to define how well a person with an eosinophilic disorder is doing. We also want to see if the way questionnaires are answered can give us an idea of how well the person is doing. Who  Adults, 18 to 65 years old, with an eosinophilic gastrointestinal disorder may be eligible for participation. Eosinophilic gastrointestinal disorders include: eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), or eosinophilic colitis (EC). Pay

Participants will not receive pay for their time, effort or travel.

Contact Jonathan Kuhl at [email protected] or 513-803-3078

Epilepsy Teens 13 to 17 Years Old With Epilepsy What  We want to learn more about the areas of the brain normally used for executive functions (thinking skills like planning, organization and memory) and how they may be different in teens that have epilepsy. These executive functions can affect areas of life such as school performance, social skills and adherence to medication. Who  Teens 13 to 17 years old who been diagnosed with epilepsy and have had a seizure within the past year, may be eligible for participation.

Teens who have the following will NOT be able to participate:



• A non-removable implant or metal device (like a cochlear implant, pacemaker or braces)



• A diagnosis of any developmental delays (such as autism) or psychiatric problems (such as bipolar)

Pay

Participants will receive up to $60 for their time, effort and travel.

Contact Alex Arnett at [email protected] or 513-803-1465

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HEARING LOSS

Hearing Loss Infants and Children up to 6 Years Old Who Are Having an ABR (Auditory Brainstem Response) Test What  Infants who do not pass their newborn hearing screening need to have a more complete test to determine how well they can hear, or the type and degree of hearing loss that may be present. We want to find the best and fastest way to test hearing in infants and children by comparing a new type of hearing test to the current, standard testing. Who  Infants and children up to 6 years old who are having a hearing test at Cincinnati Children’s, which includes an ABR (Auditory Brainstem Response), may be eligible for participation. Pay  Participants will not be paid for their time. However, complete test results will be provided to you and your child’s doctors. Contact Research Coordinator at [email protected] or 513-636-2216

Infants and Toddlers With Hearing Loss in Both Ears What  This research study will look at how young children’s language and functional skills might be affected by their hearing loss. Who  Infants and toddlers 3 months to 3 years old who have hearing loss in both ears may be eligible to participate. Children with and without a disability may participate. Disabilities include cognitive delays, cerebral palsy, developmental delays, and speech delays. What Is Three study visits (lasting up to 2 hours each) which include language and cognitive evaluations Required Pay

Families may receive up to $150 for their time and effort.

Contact Laura Smith at [email protected] or 513-803-1901

Infants, Children and Teens Who Have Auditory Processing Disorder What  The purpose of this research study is to learn the best way to use EEG techniques with children who have auditory processing disorder (APD), listening difficulties or are being considered for the diagnosis of APD.

An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”).

Who  Infants, children and teens 0 to 17 years old who have APD and are not on medication for a neurologic condition may be eligible to participate. Pay

Participants will receive $50 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

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HEARING LOSS

Adults Who Have Auditory Processing Disorder What  The purpose of this research study is to learn the best way to use EEG techniques with people who have auditory processing disorder (APD), listening difficulties or are being considered for the diagnosis of APD.

An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”).

Who  Adults 18 to 70 years old who have APD and are not on medication for a neurologic condition may be eligible to participate. Pay

Participants will receive $50 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

Infants, Children and Teens Who Have Single Sided Deafness What  The purpose of this research study is to learn the best way to use EEG techniques with children who have single sided deafness (SSD).

An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”).

Who  Infants, children and teens 1 month to 17 years old who have SSD and are not on medication for a neurologic condition may be eligible to participate. Pay

Participants will receive $50 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

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HEARING LOSS | LISTENING DIFFICULTIES

Adults Who Have Single Sided Deafness What  The purpose of this research study is to learn the best way to use EEG techniques with children who have single sided deafness (SSD).

An EEG is a test that measures and records the electrical activity of the brain (or “brainwaves”).

Who  Adults 18 to 70 years old who have SSD and are not on medication for a neurologic condition may be eligible to participate. Pay

Participants will receive $50 for their time and travel.

Contact Hearing Lab at [email protected] or 513-803-3252

Listening Difficulties Children 6 to 12 Years Old Who Have a History of Listening Difficulties What  The purpose of this research study is to learn more about listening difficulties in children using MRI, EEG, listening and cognitive tests. We will compare brain structure and function of children with listening difficulties to that of typically developing children. Who  Children, 6 to 12 years old, who have a history of listening difficulties, may be eligible to participate. Pay  Participants will receive up to $80 total for their time and travel. Contact Nicholette Smith at [email protected] or 513-803-4937

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MENTAL HEALTH | MIGRAINE HEADACHES

Mental Health Children and Teens 7 to 17 Years Old With Obsessive Compulsive Disorder (OCD) What  We want to learn more about how the brain works in children who have Obsessive Compulsive Disorder (OCD).

We will use a non-invasive test called an MEG to measure activity in the brain.

Who

Children and teens, 7 to 17 years old, who have OCD and:



• Have a contamination obsession



• Are right-handed



•H  ave never been on any medication for their OCD but are interested in considering treatment, such as sertraline (Zoloft®)

Anyone with other neurological or psychiatric disorders (like epilepsy or ADHD), or who has a non-removable implant or metal device (like a cochlear implant, pacemaker, permanent retainer or braces) will NOT be able to participate. Pay  Participants will receive up to $100 for their time and travel. Contact Elana Harris at 513-636-2100 or [email protected]

Children and Teens 11 to 17 Who Have a Sibling With an Eating Disorder What  This research study will look at how teens are affected, when they have a brother or sister with an eating disorder. Who  Children and teens (11 to 17 years old) who have a sibling (11 to 17 years old) who has been diagnosed with an eating disorder Pay  Participants will receive $50 for completing a survey during 1 study visit. Contact Emily Copps-Smith at [email protected] or 513-636-2463

Migraine Headaches Children and Teens 6 to 18 Years Old With Chronic Migraine What  We want to look at what is happening in the brain before and after someone has started treatment for a migraine, using a machine called an MEG. We will compare those results to someone who does not have migraines.

An MEG measures the magnetic activity in the brain.

Who

Children and teens, 6 to 18 years old, who are:



• Diagnosed with chronic migraine



• Not currently taking any prescribed drugs for their migraines

Anyone with a non-removable implant or metal device (like a cochlear implant, pacemaker or braces) will NOT be able to participate. Pay  Participants will receive up to $50 for their time and travel ($25 for each of 2 MEG scans). Contact Kim Leiken at 513-803-7228 or [email protected]

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RARE CONDITIONS | SAMPLES NEEDED

Rare Conditions – Fetal Center Toddlers 22 to 26 Months Old Who Were Prenatally Diagnosed With a Rare Condition What

The purpose of this research study is to evaluate the neurologic (nervous system), behavioral and developmental progress of children who are 22 to 26 months old and were prenatally diagnosed with a rare condition.

Who  Children 22 to 26 months old who were prenatally diagnosed with a rare condition, including amniotic band syndrome, bladder outlet obstruction, congenital lung lesion, fetal tumor, surgical fetal intervention, spina bifida or twin-to-twin transfusion, among others Pay

Families will receive between $25 and $100 for this 1 study visit, depending upon travel time.

Contact Trish Burns at [email protected] or 513-803-5270

Samples Needed Donate Your Child’s Leftover Samples Better Outcomes for Children Project What  This project will ensure researchers at Cincinnati Children’s have access to samples (such as blood and tissue) they need to find new ways to identify, treat and prevent childhood diseases and conditions. How  To participate, patients can choose to donate “leftovers” samples collected during a scheduled appointment or procedure.

• No additional samples will be taken for this project.



• Donors’ identities will not be revealed to the researchers using the samples.

Who  Cincinnati Children’s patients who have had samples collected during an appointment or procedure are eligible to participate. Contact 513-636-8695 or [email protected]

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Cincinnati Children’s Hospital Medical Center Clinical Research Studies Update

VOLUME 10

polio worldwide.

Sabin oral polio vaccine, which has made it possible to conquer

possible the first open-heart surgery, and development of the

development of the bubble oxygenator, which made

Achievements by Cincinnati Children’s researchers include

of pediatric medicine since the foundation opened in 1931.

researchers have made major contributions to the advancement

Institutes of Health. Historically, the Research Foundation

ranked children’s hospital in funding received from the National

to leading-edge treatments. Cincinnati Children’s is the third

of childhood and adult diseases and offers patients access

Children’s Research Foundation investigates a wide variety

1883. Owned and operated by Cincinnati Children’s, Cincinnati

leader in improving child healthcare dating back to its start in

Cincinnati Children’s Hospital Medical Center is an international

A SAMPLING OF STUDIES

Research Studies at Cincinnati Children’s RETURN SERVICE REQUESTED

Office for Clinical and Translational Research Cincinnati Children’s Hospital Medical Center MLC 7004 3333 Burnet Ave. Cincinnati, OH 45229-9980