Official Title A PHASE 3, DOUBLE-MASKED, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT INJECTION IN PATIENTS WITH MODERATELY SEVERE TO SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY

Purpose

The purpose of this 28-week study to investigate the effects and safety of a medication in participants with Center Involving Diabetic Macular Edema (CI-DME). .

Could this study be right for you?

• 18 years and older
• Macular edema associated with diabetic retinopathy (DR)
• Diagnosis of diabetes mellitus (DM)

Age Range

18 and up

Contact Information

William Bloom

William.Bloom@osumc.edu

614-293-5287

Official Title Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)

Purpose

The purpose of this study is to improve hemoglobin A1c levels in patients with type 2 diabetes experiencing food insecurity.

The study will examine the effects of a produce referral program alone and in combination with other interventions. Our research is designed to develop a deeper understanding of how to provide patients with type 2 diabetes that are experiencing food insecurity with the resources, skills, and education to manage their health and social needs.

Could this study be right for you?

Inclusion Criteria:

• Age 18 years and older
• Type 2 diabetes based on American Diabetes Association Criteria
• Hemoglobin A1c level > 7.5%
• Worried about running out of food before you have money to buy more

Exclusion Criteria:

• Pregnant

Contact Information

Luiza Reopell

luiza.reopell@osumc.edu

614-653-8213

Official Title DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping Phase II

Purpose

Deep Brain Stimulation (DBS) surgery is FDA approved for the treatment of Parkinson's Disease. The purpose of this study is to examine a technology (DBS-Expert system) that uses objective measurements to guide DBS programming. The DBS-Expert system analyzes motion data and provides recommendations to the physician or healthcare professional regarding DBS programming settings.

Could this study be right for you?

You may be eligible if you:

• Over the age of 18
• Able and willing to provide informed consent
• Clinical diagnosis of idiopathic Parkinson's Disease
• Implanted Boston Scientific DBS system

Exclusion Criteria

• You are currently participating in any study with an investigational medicinal product (IMP) or investigational device.

Age Range

18 and up

Contact Information

Erin Woodburn

Erin.Woodburn@osumc.edu

614-366-7822

Official Title SMALL Talk: Study of Milestones to Advance Language Learning

Purpose

The goal of this study is to identify early risk for developmental language disorder (DLD) among young, low-income children, and to determine how caregiver and child chronic stress and interaction quality interact to disrupt language growth among these children. The long-term objective is to identify pathways through which early family situations and the conditions of poverty disrupt early language paths among low-income children and contribute to heightened rates of DLD.

Could this study be right for you?

Inclusion criteria are:

• have a child that is 9 months or younger
• child resides in a low-income household, using some sort of government assistance or using the 200% threshold from the Department of Health and Human Services based on annual household income and number of persons in home

Exclusion criteria:

• Children who are multiple births, preterm (<35 weeks), and have profound or severe disabilities will be excluded, with the latter including congenital blindness, deafness, Down syndrome, and other frank neurological deficits.

Contact Information

Amanda Harvey

harvey.374@osu.edu

6143545938

Official Title Laying the Groundwork for Personalized Medicine in Aphasia Therapy: Genetic and Cognitive Predictors of Restorative Treatment Response

Purpose

This NIH-funded project will investigate patient-specific factors that may influence response to therapy for language impairment after stroke, or aphasia. Results from this work will assist with better estimation of prognosis for stroke survivors with aphasia, which could empower patients and families to make more informed health care decisions about how to pursue the most appropriate rehabilitation services based on their unique characteristics, such as genetics, cognitive skills, and brain structure after stroke.

Could this study be right for you?

Participants must meet the following criteria:

• Native English speaker
• Able to have an MRI

Age Range

18 and up

Contact Information

Stacy Harnish

harnish.18@osu.edu

Official Title A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

Purpose

The purpose of this study is to find out how well ABBV-951 works to control Parkinson's disease symptoms compared to oral Carbidopa (CD)/Levodopa (LD). The study is also seeking to test whether ABBV-951 is well tolerated in patients with Parkinson's disease.

Could this study be right for you?

1. Male or female, age 30 or older
2. Has not received deep brain stimulation, Carbidopa (CD)/Levodopa (LD) enteral suspension, or any other Parkinson's Disease (PD) medication as continuous daily infusion
3. Subject does not have a history of significant skin conditions or disorders
4. Subject does not have a recent (within 6 months before screening) history of drug or alcohol abuse
5. Subject does not have a history or presence of psychotic episodes
6. Subject does not have other clinically significant unstable medical conditions
7. Subject must have a diagnosis of levodopa-responsive idiopathic PD

* other eligibility criteria to be discussed/reviewed with the study team

Age Range

30 and up

Contact Information

Erika Shultz

erika.shultz@osumc.edu

Official Title A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients (NOVA-II)

Purpose

Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) treatment in cancer patients. The main purpose of this study is to evaluate the safety and efficacy of OQL011 compared to vehicle ointment in treating patients with moderate to severe VEGFRi-associated HFSR. This study will also identify an optimal dosage for Phase III study and explore the pharmacokinetics profile of OQL011 in HFSR patients.

Could this study be right for you?

• Patient must be age 18 years of age or older.
• Patient must have a confirmed cancer diagnosis for which VEGFRi treatment is indicated, and must be currently under VEGFRi-based anti-cancer therapy with stable dosage for ≥ 1 week.
• Patient on pain medications is allowed provided they have been on stable dosage in the past 1 week and is going to continue at the same dosage.

Age Range

18 and up

Contact Information

Erin Frey

Erin.Frey@osumc.edu

Official Title A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP)

Purpose

The purpose of this study is to understand how Continuous Positive Airway Pressure (CPAP)
for mild to moderate sleep apnea may affect hypertensive disorders of pregnancy and other
complications of pregnancy such as gestational diabetes.

Could this study be right for you?

1. No prior delivery at or after 20 weeks 0 days of gestation
2. Pregnancy with only one fetus
3. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days
4. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30

Age Range

18 and up

Contact Information

Anna Bartholomew

Anna.Bartholomew@osumc.edu

614-685-3229

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

Contact Information

Marvin McCreary, MD

marvin.mccreary@osumc.edu

614-526-8432

Official Title Microdosed Atropine for the Reduction of Pediatric Myopia Progression (The CHAPERONE Study)

Purpose

The purpose of this study to test the safety and effectiveness of atropine 0.1% and atropine 0.01% eye solutions. These drugs are being tested to see if they slow the worsening of nearsightedness. Children who participate in this study will be asked to use their assigned study medication every night and willing to attend visits at The Ohio State University of Optometry 1 month after starting treatment. These visits will continue for 6 months until the duration of the study ends. This study will take place over a 4-year time period.

Could this study be right for you?

• Children aged 3 to < 13 years old.
• No previous use of medications related to myopia control.
• Glasses and/or contact lens prescription between -1.00 and -6.00 diopters.

Interested guardians who believe their child may be eligible should contact study coordinators to further determine eligibility.

Age Range

3 and up

Contact Information

Emma Grant

OPT-CHAPERONEStudy@osu.edu

614-292-8858

Official Title Breathing Reduces Enteric symptoms and Anxiety promoting Therapeutic Healing Experience (BREATHE) – A Randomized Clinical Trial in Patients with Symptoms of Gastroparesis

Purpose

The purpose of this research study is to see if practicing mindful breathing daily can reduce stress, improve sleep
and possibly improve symptoms in patients with Gastroparesis.

Gastroparesis is a condition characterized by symptoms such as nausea, vomiting, feeling excessively full after eating a little bit, bloating and abdominal pain. One or more of these symptoms can be present in a given patient.

Your participation throughout the study will last 6 weeks.

Could this study be right for you?

• At least 18 years of age
• Able to read and understand English
• Has symptoms of gastroparesis for at least 6 months (gastric emptying study is NOT required for inclusion)

Age Range

18 and up

Contact Information

SUBHANKAR CHAKRABORTY

SUBHANKAR.CHAKRABORTY@OSUMC.EDU

614-293-6255

Official Title A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Purpose

The purpose of this study is to determine the safety and effectiveness of a device called the RejuvenAir® System, developed for patients with chronic bronchitis. The primary objective of this trial is to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adult subjects with a diagnosis of CB defined as COPD with classic 3 months of cough and sputum production for a minimum of 2 years who demonstrate ongoing symptoms of cough and significant mucus production. You will be in the study for approximately 36 months, including the screening period.

Could this study be right for you?

Inclusion Criteria:

1. Males and females 40-80 years of age
2. Must demonstrate daily cough and significant mucus production
3. Have had a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years. (CB is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
4. Smoking history of at least 10 pack years
5. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

1. Have had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
2. Diagnosis of Asthma
3. You have had any type of transplant procedure
4. Use e-cigarettes, vaping or inhaled substances not prescribed by a physician RejuvenAir® System
5. You are pregnant, nursing, or planning to get pregnant during study

* This is not a complete list of either inclusion or exclusion criteria

Age Range

40 and up

Contact Information

Pulmonary Clinical Trials Office

LungResearch@osumc.edu