Adolescent Health Clinical Research

Clinical researchers at Nationwide Children's and The Ohio State University are committed to identifying new approaches for the prevention, diagnosis and treatment of childhood diseases, taking research discoveries from the lab to the patient's bedside.

To see current Adolescent Health research studies being conducted at Nationwide Children's Hospital and The Ohio State University, search the options below.

Randomized Controlled Trial of Laser Hair Depilation in the Treatment of Pilonidal Disease

Purpose of the study:

A number of studies have found that laser hair removal greatly reduces the recurrence rate of pilonidal disease. Drs. Minneci and Deans, pediatric surgeons at Nationwide Children’s Hospital, are currently conducting a study that will help better understand how laser hair removal can help patients with pilonidal disease.

Eligibility criteria:

  • Ages 12-21 years old
  • Diagnosis of pilonidal disease

What will happen during the study:

Participants of the study will be assigned to receive laser hair removal or standard care. All participants will be followed through 1 year of treatment, with follow-up occurring, at 1, 2, 3, 4, 5, 6, 9, and 12 months after enrollment.

Who to contact:

Dr. Amy Lawrence or Dr. Devin Halleran

614-580-2828 or 614-722-0742

Amy.Lawrence@nationwidechildrens.org or Devin.Halleran@nationwidechildrens.org

Family Well-Being Study

What is the purpose of this study?

The Family Well-Being Study aims to increase healthcare provider understanding of how differences of sex development (DSD) affect the quality of life of children and their families. With this information, we hope that providers will learn how to best support patients with DSD and develop programs addressing their specific needs so that they can thrive.

Who can participate in this study?

  • Parents of children ages 0-19 with differences of sex development (DSD)
  • Participants must be able to read and understand English

What will happen during this study?

  • You will complete an online questionnaire that will be used to understand the thoughts and feelings of parents of children affected by congenital conditions.
  • This questionnaire will be completed once at your convenience and will require about 40 minutes of your time.
  • Participation in this research study is voluntary and may be discontinued at any point during the project.
  • Your participation or lack thereof will not impact your family's care at Nationwide Children's Hospital.
  • You will be compensated for your time.

Who can I contact for more information?

To learn more or participate in the Family Well-Being Study, please contact Hillary Kapa, Clinical Research Coordinator, at 614-722-2830 or ThriveStudies@NationwideChildrens.org

Family Well-Being Study for Parents of Healthy Youth

What is the purpose of this study?

The Family Well-Being Study seeks to understand how children’s congenital conditions impact the psychosocial well-being and quality of life of their parents and families.

Who can participate in this study?

  • Parents of physically and mentally health children ages 0-19 years old who will act as matched controls for patients affected by congenital conditions

  • Participants must be able to read and understand English

What will happen during this study?

  • You will complete an online questionnaire about how your feelings and experiences impact your well-being.

  • This questionnaire will be completed once at your convenience and will require about 40 minutes of your time.

  • Participation in this research study is voluntary and may be discontinued at any point during the project.

  • Your participation or lack thereof will not impact your family’s care at Nationwide Children's Hospital.

  • You will be compensated for your time.

Who can I contact for more information?

To learn more or participate in the Family Well-Being Study, please contact Hillary Kapa, Clinical Research Coordinator, at 614-722-2830 or ThriveStudies@NationwideChildrens.org

Youth and Young Adult Resilience Study

What is the purpose of this study?

The Youth and Young Adult Resiliency Study explores how differences of sex development (DSD) impact quality of life. This is a collaborative study between Nationwide Children's Hospital and Boston Children's Hospital. During this study, healthcare providers aim to learn what factors lead to the best outcomes for patients with DSD. With this information, providers hope to be proactive in supporting patients with DSD so that they can be their happiest and healthiest selves.

Who can participate in this study?

  • Youth and young adults ages 12-26 with differences of sex development (DSD)

  • Participants must be able to read and understand English

What will happen during this study?

  • You will complete an online questionnaire about how your feelings and experiences impact your well-being.

  • This questionnaire will be completed once at your convenience and will require about 40 minutes of your time.

  • A select number of participants will also complete a single face-to-face interview.

  • Participation in this research study is voluntary and may be discontinued at any point during the project.

  • Your participation or lack thereof will not impact your care at Nationwide Children's Hospital.

  • You will be compensated for your time.

Who can I contact for more information?

To learn more or participate in the Youth and Young Adult Resiliency Study, please contact Hillary Kapa, Clinical Research Coordinator, at 614-722-2830 or ThriveStudies@NationwideChildrens.org.

Life After Pregnancy Study

What is the purpose of this study?

The Life After Pregnancy Study is a one-time survey study for mothers of babies.

It is a 40-minute survey about the joys and challenges of being a new mother. Participants are asked questions about the birth and feeding of one’s child, one’s physical health and emotional well-being, as well as services one may have received. The research team hopes to learn more about the experiences of new mothers to improve services offered both before and shortly after birth.

Who can participate in this study?

Women are eligible to participate in this study if they:

  1. Are 18 years of age or older
  2. Have a child between 2 and 6 months of age

How can I get more information or participate?

If you are interested in participating in our Life After Pregnancy Study, please click the link below to read about your rights as a research participant and take the survey.

If you have questions about the study, you can reach us at 614-355-3578 or LAPS@NationwideChildrens.org.

SPARK

What is the purpose of this study?

SPARK stands for Simons Foundation Powering Autism Research for Knowledge. The mission of SPARK - an online research partnership involving 50,000 individuals with autism and their families - is simple: to speed up research and advance understanding of autism.

For additional information on SPARK, please visit the SPARK website for Nationwide Children's Hospital.

Who can participate in this study?

SPARK is open to individuals of all ages with a professional diagnosis of autism spectrum disorder (ASD) living in the United States. ASD includes Asperger syndrome, autism/autistic disorder and pervasive development disorder-not otherwise specific (PDD-NOS). Participants are welcome to invite biological parents and full biological siblings (with and without ASD) to participate as well.

What will happen during this study?

Participants will be asked to share medical and genetic information with researchers and to agree to be contacted about future research studies. One of SPARK's key goals is to enable research that has not been possible before by linking individuals in the scientific community with autism research participants.

Who can I contact for more information?

For more information on this study, or if you are interested in participating, please contact Sara Eldred by phone at 614-722-4115 or by email at Sara.Eldred@NationwideChildrens.org.

Multi-Center Study for Adolescents with Melanoma, Rhabdomyosarcoma or Other Solid Tumors Undergoing Lymph Node Mapping

Study Overview

Nationwide Children's Hospital is the first site in the United States participating in this multi-center research study designed to determine the detection and correlation rates of Lymphoseek and of a vital blue dye in lymph nodes and to assess these lymph nodes for the presence of tumor metastases in patients with melanoma and extremity rhabdomyosarcoma.

Why are we doing this study?

Melanoma and rhabdomyosarcoma are rare tumors in children and adolescents, but when present they can spread to lymph nodes, increasing the stage of the disease if this occurs. If these tumors have spread to the lymph nodes, the treatment is escalated to cover the regional spread of disease.

Who can participate in this study?

Researchers are looking for patients with melanoma, rhabdomyosarcoma, or other solid tumors between the ages of 12 to 18 years.

What will happen during this study?

This study is an Open-Label, Multicenter Study Comparing Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping.

All patients will receive treatment, and all study visits will occur at Nationwide Children’s Hospital. In addition, families will be compensated for time and travel.

If you are interested in participating in this study or would like additional information, please contact Lauren Bird, RN, clinical research nurse at Lauren.Bird@NationwideChildrens.org or 614-722-2699, or contact the primary investigator, Jennifer Aldrink, MD, at 614-722-0440.

Heavy Menstrual Bleeding Study for Adolescent Girls

What is the purpose of the study?

Heavy menstrual bleeding is the most common symptom in females with bleeding disorders, and it can have a significant impact on a person's quality of life. The purpose of this study is to learn more about a drug called tranexamic acid (TA), otherwise known as Lysteda, and to determine whether or not this drug can decrease menstrual blood loss in young women to increase their quality of life.

TA is a hormone-free medicine that has been approved by the FDA for use in patients who are at least 18 years of age, but not for younger patients.

Who is eligible for the study?

Females ages 10-19 years old who experience heavy menstrual bleeding and are non-smokers are eligible for this study.

What will happen during this study?

Participation in this study will last for about six (6) months. There are two required study visits at which a physical exam will be completed and blood will be drawn, and there are four telephone calls.

All patients will take tranexamic acid (TA) during their menses for three (3) months. The study will also include surveys each month to record the heaviness of menstrual bleeding and how it affects everyday life (school, extracurrical activities, etc.)

What are the benefits of participating?

Possible benefits to the participant may be an improvement in quality of life and a decrease in menstrual blood loss. Additionally, for their time and inconvenience, participants will receive gift cards after completing several study milestones. 

Who can I contact if I want to learn more?

If you want to learn more or are interested in participating in this study, please contact either of the following two individuals:

Heidi Ziegler, RN
Phone: (614) 722-3883
Email: Heidi.Ziegler@NationwideChildrens.org

Sarah O'Brien, MD
Phone: (614) 722-6230
Email: Sarah.O'Brien@NationwideChildrens.org

Established Status Epilepticus Treatment Trial (ESETT)

Nationwide Children's Hospital is one of forty sites in the United States participating in this multi-center research study designed to find out which of three commonly used, FDA-approved drugs best stops established status epilepticus.

What is Status Epilepticus (SE)?

Status Epilepticus (SE) is a life-threatening condition in which the brain is in a state of persistent seizure. SE is defined as a seizure or recurrent seizures lasting longer than five minutes without stopping or regaining consciousness (waking up).

  • There are approximately 120,000-180,000 episodes of SE each year in the United States.

  • About one third of SE patients continue to have a seizure despite receiving adequate doses of medicine (benzodiazepines) to make it stop.

  • SE affects individuals of all ages, from the very young to the elderly.

What is ESETT?

ESETT is a multi-center emergency medicine study designed to try to save and improve the lives of people who experience a seizure that will not stop on its own or has not responded to a medicine like valium. Emergency Department care of these patients is not the same across the U.S. Because it is not known which drug best treats this type of seizure, different doctors use different medicines.

For this reason, this study (ESETT) plans to look at three commonly used medicines given in the emergency departments for a seizure not stopping: fosphenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT) to learn which treatment is best at stopping a seizure quickly. All three of these medications are FDA-approved for seizures, which means all patients in the study will be receiving treatment.

How is ESETT different from other studies?

Normally, researchers get permission before a person can be included in a study. A person having a seizure will NOT be able to give consent. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study.

Because of this, all patients will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the participant wakes up, they will be told about the study and asked to give their permission to continue in the study. For more information on Exception from Informed Consent, please read the last section on this page, entitled What is Exception from Informed Consent (EFIC)?

Why is ESETT important?

The best possible outcomes for seizing patients are likely to depend on a treatment that leads to a rapid stop of the seizure. The reason for doing this study is to find out which of three commonly used drugs is safer and faster at stopping seizures.

Who will be included in the study?

  1. Any patient who is two (2) years old or older with an

  2. Active recurrent or ongoing seizure lasting longer than five minutes, AND

  3. Has already received an adequate dose of benzodiazepine (like valium) in the past 5-30 minutes for a generalized tonic-clonic seizure could be enrolled. 

How will someone be entered into the study?

Every patient coming to the ED who is eligible for the study (if they meet ALL three of the inclusion criteria listed above) will get study treatment.

If you do not wish to be enrolled into the ESETT study, you can wear an "ESETT Declined" bracelet at all times during the study enrollment period (approximately five years, beginning August 2015). If you are wearing this bracelet when you arrive at any participating hospital, researchers will know not to enroll you in this study. If you would like to wear a bracelet to opt out of the ESETT study, please contact the study team or complete this form and submit it by mail.

What are the benefits of this study?

Because we do not know which of the FDA-approved drugs in this study is better, participants may benefit from receiving a better medicine, although this is not guaranteed. Some participants may not get any benefit from being in this research study, but all will be receiving an FDA-approved treatment for their seizures. Additionally, the information obtained from this study may help seizure patients in the future.

What is Exception from Informed Consent (EFIC)?

The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research involving medicine. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be done in certain emergency situations.

EFIC only applies when:

  1. The person's life is at risk, AND

  2. The best treatment is not known, AND

  3. The study might help the person, AND

  4. It is not possible to get permission:

    • From the person, because of his or her medical problem, OR

    • From the person's legally authorized representative because the medical problem must be treated very quickly

Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback. This is known as public disclosure and community consultation. The ESETT team at Nationwide Children's Hospital has notified the community about this trial and surveyed the public to ensure clarity and transparency.

Contact Information for the ESETT Study Team at Nationwide Children's:

Daniel M. Cohen, M.D.
Daniel.Cohen@NationwideChildrens.org
614-722-4385

Amy Nowakowski
Amy.Nowakowski@NationwideChildrens.org
614-355-7682

Jennifer Kline
Jennifer.Kline@NationwideChildrens.org
614-722-4406

For more general information on ESETT, including Fast Facts and a toolbox with additional resources, please visit the http://esett.org/.

Egg Nutrition Study Seeking Overweight Men Ages 18-50

What is purpose of this study?

The purpose of this study is to understand how eggs can help regulate blood glucose responses and improve cardiovascular health in men.

Who can participate in this study?

  • Men, aged 18-50 years old

  • At least 20 pounds overweight (BMI > 25)

  • Non-smoker

  • Do not have allergies or aversions to eggs

  • Do not take any medications to manage high cholesterol, inflammation or metabolism

  • Do not have a history of cardiovascular disease or gastrointestinal disorders

  • Do not consume more than 3 alcoholic drinks per day

  • Do not exercise aerobically more than 7 hours per week

What will happen during the study?

If you are eligible for this study and choose to participate, you will visit our study center for four visits, each separated by at least a week. During these visits you will be fed a meal, and then we will draw blood and assess arterial function every thirty minutes, for three hours.

This study will have 4 study visits over 4-6 weeks and will take place at Campbell Hall at The Ohio State University. There is no cost for taking part in this study, and participants will be compensated up to $300 for completing the study. Cost of parking will also be provided.

Who can I contact for more information?

If you have questions or would like to take part in this study, please email OSUeggs@gmail.com or call 614-292-1698 from 8AM to 5PM, Monday through Friday.

Natural Herbal Supplement Study Participants Needed

What is the purpose of the study?

To study whether the all-natural, over-the-counter herbal supplement, Capros, decreases blood glucose levels.

Who can participate in the study?

This study is for Type 1 diabetics who are at least 10-40 years of age and have been using a CGM (continuous glucose monitoring) system for at least the last three (3) months.

What will happen during the study?

Study participants will take the herbal supplement twice daily for 12 weeks and complete a daily diary.

  • There will be four (4) study visits over 12 weeks.

  • Participants will receive $200 for completion of the study.

Who can I contact for more information?

If you are interested or have any questions, please call Amy Hoover, LPN at 614-293-0390.

CITT-ART: Convergence Insufficiency Attention and Reading Trial

What is convergence insufficiency?

Convergence insufficiency (CI) affects about 5 out of every 100 people. CI is an eye-teaming problem in which the eyes have a strong tendency to drift outward when reading or doing work up close. If the eyes drift out, the person may see double. To avoid seeing double, a person with CI must use extra effort to make the eyes turn back in. This extra effort can lead to annoying symptoms that can interfere with the ability to read and work comfortably up close.

Symptoms often associated with CI:

  • Eye strain and headaches

  • Inability to concentrate

  • Short attention span

  • Frequent loss of place

  • Blur

  • Trouble remembering what was read

  • The need to re-read the same line of words

What is the purpose of the CITT?

The CITT-ART was designed to find out whether therapy for CI improves reading and attention. Children with CI have many more symptoms when reading and show worse attention than children without CI. We know that CI therapy improves these symptoms and we have some early evidence that treatment also results in improvements in reading and attention.

However, to know for sure, we need to study this question in a larger group of children, and some children need to receive a harmless control therapy that is not designed to treat convergence insufficiency.

What will happen during the study?

If you agree to have your child take part in the study, a computer program will determine whether your child will receive active or control therapy. This is similar to flipping a coin. Two of every three children will receive the active therapy. Children who receive the control therapy and don’t get better will be given the active treatment.

The study involves standard tests and treatments which have the same risks as receiving treatment outside the study. No long-term problems are expected. The only known risk is that your child may continue to have eyestrain/headaches.

To allow your child to take part in the study, you must be willing to bring your child to The Ohio State University’s College of Optometry for the following tests and sessions:

  1. Initial testing to see if your child is eligible.

  2. Initial tests of reading and attention.

  3. Weekly therapy sessions for 16 weeks in a row.

  4. Follow-up visits to check your child’s vision, attention and reading about one week and one year after completing the therapy.

You will also need to ensure that your child performs the prescribed home therapy.

Who can I contact for more information?

If you have questions or would like your child to take part in this study, please contact Dr. Marjean Kulp at Kulp.6@osu.edu or 614-688-3336. For more information online, you can visit www.citt-art.com.

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