Official Title

STATBI: School Transitions after Traumatic Brain Injury

Purpose

The purpose of this study is to understand the best ways to help students return to school after brain injury of any severity. This is important to study because finding the best ways to help students go back to school right after brain injury, and over time, can help improve student success and recovery.

Your participation in the study would take place when you/your child begins the study and then at 3 months, 6 months, 12 months, 2 years (if applicable) and 3 years (if applicable) after the study starts.

Could this study be right for you?

• Students aged 5 to 18 years old
• In kindergarten through 12th grade
• Must Speak English
• Traumatic Brain Injury (TBI) of any severity
• Parent/caregiver is willing to share medical and academic information with the research team (all study activities are virtual/remote)

Age Range

5 and up

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

Official Title

Cognition and Brain Circuitry

Purpose

The purpose of the study is to look at how our brain networks interact for different mental functions and how individual differences in brain structure and function determines individual differences in behavior. During this study, we use magnetic resonance imaging methods: functional magnetic resonance imaging (fMRI) and diffusion weighted imaging (DWI). Functional MRI (fMRI) and DWI are typical imaging methods that use a strong magnetic field and radio waves to make pictures of your body. The total length of the study will be between 3 and 4 hours, including up to 2 hours outside the MRI scanner and 2 hours in the scanner.

Could this study be right for you?

- Healthy adults between 18-40 years of age - Have normal or corrected-to-normal vision

Age Range

18 and up

Official Title

FREEDOM 1, A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors

Purpose

The purpose of this study is to learn more about whether FCR001, an investigational cell therapy, can prevent the rejection of living donor kidney transplants without the need for lifelong anti-rejection drugs.

Could this study be right for you?

• Recipient age ≥ 18 years
• Donor age ≥ 18 and ≤ 60 years
• Recipient of a first kidney transplant from a living donor
• Not diagnosed with or treated for any type of cancer (donor or recipient)

Age Range

18 and up

Official Title

Mobile Health App as a Cardiotoxicity Symptom Logging Tool: Feasibility Pilot Study

Purpose

To evaluate the cardio-oncology patient population’s experience with using smart-phone technology as a part of self-management with their care through features such as symptom logging and education. Eligible patients will be asked to participate in a 30-minute virtual interview and/or a 60-minute virtual design or usability session to discuss their thoughts on a mobile app for cardio-oncology patients.

Could this study be right for you?

- English-speaking - Prior cancer diagnosis - Currently undergoing a cancer regimen that includes a targeted, biologic, radiation, and/or immune-based therapy (ex. TKIs and/or ICIs). - No pregnant females - No prisoners

Age Range

18 and up

Official Title

“Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)”

Purpose

The purpose of this study is to see whether people living with HIV who gained a significant amount of weight after starting an antiretroviral therapy (ART) could gain less weight, or might lose weight, after an ART regimen switch. The study will also look at whether a switch in antiretroviral therapy leads to differences in how the body stores and uses energy, heart and blood vessel health, and bone health. The study will last for 48 weeks (about 1 year). Following the first visit, you will need to come back to the clinic after about 4, 12, 24, 36, and 48 weeks. Each visit may take up to 3 hours.

Could this study be right for you?

• Living with HIV-1 • Be 18 years or older • Currently on an Integrase Inhibitor (INSTI) containing regimen (BIC, DTG or RAL), with > 48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry • Have experienced more than 10% weight gain in the 1-3 years after starting these medications • Have a body mass index (BMI) >27.5 kg/m2 • Have study related tests done • Agree to use contraception/birth control methods if capable of becoming pregnant

Age Range

18 and up

Official Title

A5383, Randomized, Controlled Trial to Evaluate the Antiinflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)

Purpose

The purpose of this study is to evaluate whether letermovir (Prevymis), taken as two 240 mg tablets (480 mg total) or one 480 mg tablet once daily for 48 weeks, reduces inflammation in adults with human immunodeficiency virus (HIV-1) who also have cytomegalovirus (CMV) without any symptoms and who have been on effective anti-HIV medication for at least one year. Reducing inflammation might in turn help prevent some longer-term consequences of HIV, like heart disease and diabetes. This study will also look at whether you experience any side effects to the study drug. The study will last for about 1 year and 2 months (about 11 months on either letermovir or no anti-CMV study reatment and then about another 3 months of follow-up).

Could this study be right for you?

• HIV and CMV antibody positive •greater than or equal to 40 years of age • Not currently using any of the following ART medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice daily OK) • Not pregnant or breastfeeding or planning to become pregnant during the study • No use of anti-CMV drugs within 90 days prior to study participation • No active HCV or HBV in past 24 weeks No presence or history of atrial or ventricular tachycardias • All gender identities are eligible, but there are enrollment targets for cis-women or transgender women on gender-affirming hormones

Age Range

40 and up

Official Title

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in people with Depression

Purpose

The purpose of this study is to see if a new drug (BI 1358894), taken in addition to a current antidepressant, is useful and safe for treating patients with Major Depressive Disorder.

You will be in this study approximately 13 weeks and have about 8 visits to the study center. You will also have about 2 visits that will be done by phone.

Could this study be right for you?

Inclusion criteria:
- Between the ages of 18 and 65
- Currently taking an antidepressant
- Currently experiencing symptoms of depression

Age Range

18 and up

Official Title

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV InfectionA Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, for HIV Pre-Exposure to Those Having Sex with Transgender Men, and Gender Non-binary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection

Purpose

The purpose of this study is to see if Lenacapavir is safe and effective to use as a pre-exposure prevention in Cisgender Men (CGM), Transgender Women (TGW), Transgender Men (TGM) and Gender Non-binary people (GNB), with a high risk of HIV infection.

Could this study be right for you?

• CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection. • HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months • Sexually active with ≥ 1 partner assigned male at birth in the last 12 months and 1 of the following: o Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks o History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks o Use of stimulants with sex in the last 12 weeks

Age Range

18 and up

Official Title

KNEE CREATIONS SCP® OBSERVATIONAL COHORT FOLLOW-UP STUDY

Purpose

A study for those who will (have undergone) the Subchondroplasty (SCP) procedure for their knee. SCP is a procedure performed on subjects who have bone marrow lesions(BMLs). BMLs are subchondral defects in the bone, also called Insufficiency Fractures. This follow-up study will collect information on the short- and long-term safety and effectiveness of the SCP procedure.

Could this study be right for you?

- 18 years of age or older
- Considered to be a candidate for SCP procedure by your surgeon
- Have agreed to undergo the SCP procedure or has already undergone the procedure
- Willing and able to sign a written consent form
- Has the ability and the willingness to contribute follow-up outcome data

Age Range

18 and up

Official Title

Immune Response in Adolescents

Purpose

Our goal in this study is to learn more about the immune system in adolescence and early adulthood. We are looking to enroll healthy children ages 12-18 years old.

Enrollment in the study will require 1 visit to Nationwide Children’s Hospital involving a blood draw and 2 nasal swabs.
The visit will take approximately 1- 1 ½ hour(s). We ask that the family brings a copy of the child’s immunization record to the visit.

Could this study be right for you?

Children will need to meet the following criteria to be in the study:

Inclusion Criteria:
· Parents/Legal guardian able and willing to sign informed consent and the child is willing to sign assent form for participation. All forms are in English.
· Healthy children, age 12-18 years old

Exclusion Criteria:
· Any chronic or congenital conditions that may potentially affect immune responses
· Cough, congestion, fever, rhinorrhea, rash and any other symptoms indicative of infection within the 2 weeks prior to enrollment sampling
· HIV, AIDS or other immunodeficiencies or any other condition that may affect their immune system
· Use of systemic steroids within 2 weeks prior to enrollment
· Immunization(s) within the last 30 days

Age Range

12 and up

Official Title

ImproviNg The BrEast CaNcer Care DelivEry MoDel for Sex and Gender Minority Survivors (INTENDED for SGM)

Purpose

The long-term goal of this study is to improve decision quality and health-related outcomes for sexual gender minority (SGM) breast/chest cancer survivors. The goal is to evaluate important ways the current care model needs adjusted for SGM people, and how best to combine a socially important care model into clinical practice.

Survivors: Eligible participants will participate in a 90-minute focus group and online survey regarding your opinions about improving LGBTQ+ breast/chest cancer care.

Clinicians: Eligible participants will participate in a 30-minute interview and brief survey regarding your opinions about improving LGBTQ+ breast/chest cancer care.

Participation in this study will take no more than 1 hour and 30 minutes.

Could this study be right for you?

Survivors:

1. Self-identify as a member of the SGM community

2. Age ≥18 years at the time of signing the informed consent form

3. Breast/chest cancer survivor in active treatment or completed active treatment in the last 10 years (not including hormone therapy)

4. Be able to read and speak English

5. Have received care in the U.S.

6. Be able to participate in virtual meetings

 

Clinicians:

1. Physicians, advance practice providers, nurses, psychologists, social workers, therapists, technologists, and other trained clinical professionals

2. Provide care to individuals diagnosed with breast cancer in the U.S.

3. Be able to read and speak English

4. Be able to participate in virtual meetings

Age Range

18 and up