Hepatitis C Virus Immunity in Women and Children

Official Title
Hepatitis C Virus Immunity in Women and Children
Purpose

This is a study to find out how pregnancy affects a mother’s immune system. (The “immune system” is the part of the body that fights germs.) This study is also to find out why some babies who are exposed to infections during pregnancy get infected and others do not.

To do this project we need to study some women and babies who are infected with the hepatitis C virus and others who are not. This will allow us to compare their immune systems.

Could this study be right for you?

You may be eligible to participate if you are:

PREGNANCY COHORT eligibility criteria:
1) Pregnant (enrollment preferably during 1st or 2nd trimester, but may occur as late as the delivery hospitalization)
2) HCV-RNA positive (#150) or HCV-RNA negative (#50)
3) Willing and able to attend all study visits

Exclusion criteria for mothers:
1) Inability to provide informed consent
2) Incarceration

Inclusion criteria for infants:
1) Child born to study mother

Exclusion criteria for infants:
1) In custody of county children’s services (Enrolled infants who are temporarily in custody of children’s services will not have further study blood draws, but lab results from blood tests ordered by their pediatrician may be followed to monitor the outcome of their HCV exposure. Infants who are later placed back in the custody of their mother or relative may be re-enrolled.)

NON-PREGNANCY COHORT eligibility criteria:
1) Willing and able to attend all study visits

Exclusion criteria:
1) Currently pregnant
2) Inability to provide informed consent
3) Incarceration

COVID-19 Determinants of Disease Severity, Perinatal Transmission, and Immune Response to COVID-19 Vaccine

Official Title
COVID-19 Determinants of Disease Severity, Perinatal Transmission, and Immune Response to COVID-19 Vaccine
Purpose

To identify the factors that determine disease severity, immune development, and perinatal transmission in COVID-19 infections.

Could this study be right for you?

Inclusion criteria

Cohorts 1: Suspected/Infected Individuals (inpatient or outpatient)
1) All ages
2) Suspected or confirmed COVID-19 infection
3) Parents, guardians or patients over the age of 18 years of age must sign the informed consent; and children older than 9 years of age should sign assent, as required.

Cohort 2: Pregnant Women and/or their Infants*
1) Suspected or confirmed COVID-19 infection AND
2) Pregnant women in any stage of gestation, or within 14 days of a 20+ week gestation delivery; we may enroll mothers alone in situations where they choose for their newborn to not participate OR
3) Infants born to eligible mothers; in situations where the mother does not participate in the study, we may enroll infants born to infected women individually into this cohort

*Pregnant women without suspected or confirmed COVID-19 infection will also be enrolled as a healthy control group and will follow the same visit schedule.

Cohort 3 Vaccinated Children, Adults, Pregnant/Lactating Women and/or their Infants
• Pregnant/lactating women with intent to receive a COVID-19 vaccine; we may enroll mothers alone in situation where they choose for their newborn to not participate OR
• Infants born to eligible mothers; in situations where the mother chooses not to participate in the study, we may enroll their infant separately. OR
• Children/Adults of any age with intent to receive a COVID-19 vaccine

Cohort 4 Healthy Controls
• Anyone without an acute illness at the time of enrollment who agrees to participate in the study.

Exclusion criteria
a) Individuals who refuse participation in the study.

A Study to Evaluate the Safety and Effectiveness of a Dietary Supplement Used in Treating COVID-19

Official Title
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of a Plant Polyphenol for COVID-19
Purpose

The purpose of this trial is to determine whether a commercially available dietary supplement may decrease the severity of patients with early COVID-19

Could this study be right for you?

Inclusion Criteria:

- Outpatients who test positive for infection with SARS-CoV-2
- Age 45 years and older
- Experiencing COVID 19 symptoms for 7 days or less,
OR 72 hours of new respiratory symptoms
- Patient must have access to the internet or a smartphone to complete surveys
- English-speaking patients

Age Range
45 and up

Adults Helping Adults With Immune Diseases

Official Title
Creation of a pediatric healthy control repository for clinical diagnostic immunology test development and validation
Purpose

A test for healthy adults from 19 - 75 years old to develop normal values for interpretation of immunological tests in adults with disorders of the immune system.

Voluntary participation involves blood draw at Nationwide Children's hospital. Qualified participants would be eligible to provide a sample every 2 months (not more than 6 times per year).

Could this study be right for you?

If you are:

- An adult 19 years of age or older
- Healthy with no significant medical diagnoses
- Have no chronic conditions that can affect results of immunological studies
- Not any medication known to alter immune status or function
- Have not undergone recent surgery, chemotherapy, radiation or transplantation
- Non-smoker
- Body mass index (BMI) in healthy range
- No infections within last 2 months

Age Range
19 and up

Children Helping Children With Immune Diseases

Official Title
Creation of a pediatric healthy control repository for clinical diagnostic immunology test development and validation
Purpose

This study uses healthy children from newborns to 18 years old to help understand immune disorders. This study will compare healthy children and teens to children and teens with disorders of the immune system.

Volunteers will visit Nationwide Children's Hospital (NCH) for a blood draw either one time or not more than once every three months.

Could this study be right for you?

If your child is:

- Newborn to 18 years of age
- Healthy with no significant medical diagnoses
- Has no chronic medical conditions that can affect results of immunological studies
- Is not on any medication known to alter immune status or function
- Has not undergone recent surgery, chemotherapy, radiation or transplantation
- Has had no infections within the last 2 months

A Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals

Official Title
A5359; A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals
Purpose

This study is investigating if Long-Acting (LA) Injectable HIV-medications will be more successful for people who are non-adherent to their HIV medications than oral standard of care regimens. To be eligible to receive LA ART, participants will need to attain virologic suppression through adherence to an oral regimen first.

Could this study be right for you?

• Be between 18 - 75 years of age
• Previously prescribed ART for at least 6 months
• Screening HIV RNA is greater than 200 copies
• Women must not be pregnant, planning to become pregnant, or breastfeeding. Women who can become pregnant must agree to use 1 form of effective birth control
• Evidence of non-adherence to previous HIV medications

Age Range
18 and up

Rheumatology Biorepository-- For Healthy Volunteers AND those with Autoimmune and Rheumatic Disorders

Official Title
The Ohio State University Rheumatology and Immunology Biorepository
Purpose

This study is being done to provide resources for future studies involving autoimmune and rheumatic disorders, such as systemic lupus erythematosus, rheumatoid arthritis, osteoarthritis, Sjogren’s syndrome, vasculitis, and undifferentiated connective tissue diseases. The samples and data collected will be stored and used in the future to learn more about rheumatic and autoimmune disorders. Healthy volunteers are also being recruited.

Could this study be right for you?

- 18 years of age or older

If you decide to participate in this study, you will be asked to provide some samples*.
The samples you can provide for this study could be any or all of the following:
• Blood (up to approximately 10 tablespoons)
• Urine
• Stool
• Saliva (approximately 2 teaspoons)
• Skin biopsy
• Oral mucosa biopsy
• Medical waste (such as skin or synovial fluid)

*You can choose which types of samples you would like to provide.

Age Range
18 and up

Babies Helping Babies--A Study for Healthy Babies Under the Age of 2

Official Title
Host Immune Responses to Microbial Pathogens
Purpose

This study is seeking babies who do NOT have infections. The purpose of this research study is to look at how the body responds to infection (immune response) caused by different types of microbes (bacteria and virus). To understand how the immune response to infection works, blood samples from people who have infections will be compared to blood samples from people who do not. You and your baby will have a one time/one hour visit at the Nationwide Children's Hospital.

Could this study be right for you?

- Age birth to 2 years
- Have been healthy for the past 3-4 weeks
- Do not have a chronic health condition
- Not born prematurely

Medication Study for the Symptoms of Systemic Lupus Erythematosus (SLE)

Official Title
A PILOT, PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, STUDY TO EVALUATE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PHARMACOGENETICS OF CC-220 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Purpose

The purpose of this study is to test the effects of a new drug called CC-22. Researchers want to find out if it does or does not improve the symptoms of those diagnosed with Systemic Lupus Erythematosus (SLE).

Could this study be right for you?

You may be eligible for this study if:
You have been diagnosed with SLE
You have had SLE longer than (or equal to) six (6) months
You have three (3) or more tender joints at the baseline visit
You have skin manifestations of Lupus

Age Range
18 and up