Official Title A PHASE 1, SINGLE DOSE PK AND SAFETY STUDY WITH NI-03 FOLLOWED BY A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NI-03 COMPARED TO PLACEBO IN SUBJECTS WITH CHRONIC PANCREATITIS

Purpose

The purpose of this study is to learn if a study drug called NI-03 (also known as Camostat) can help people with chronic pancreatitis. We want to find out what effects, good or bad, the study drug has on the disease. It has been approved in Japan and has been available by prescription for the treatment of the acute pain associated with chronic pancreatitis. The study drug will not be approved for sale in the United States until tests from studies like this one show that it is safe and effective.

Could this study be right for you?

• You are between the ages of 18-80
• You have a diagnosis of chronic pancreatitis
• For males: documented surgical sterilization, sexual abstinence, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required
• For females: documented surgical sterilization, sexual abstinence, postmenopausal status for at least 1 year, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required

Age Range

18 and up

Contact Information

Brianna Conley

Brianna.conley@osumc.edu

614-366-4495

Official Title Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies PROCEED Study)

Purpose

This study is done for researchers to understand pancreatitis and learn how the disease progresses naturally over time.

From the results of this study, researchers hope to develop some lab tests to support early diagnosis of chronic pancreatitis and to also discover any genetic factors that may affect your chances of developing chronic pancreatitis. The results of this study may also provide information that will open opportunities for new drug discovery.

Could this study be right for you?

• You have a history of acute or chronic pancreatitis OR
• You have experienced pain in your abdomen that a doctor has suggested could be due to pancreatitis
• You are between the ages of 18 and 75

Age Range

18 and up

Contact Information

Uchechi Okafor

PROCEEDSTUDY@osumc.edu

614-293-4876

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

Nicolette Coovert

nicolette.coovert@osumc.edu

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 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 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

Official Title Evaluation of the efficacy of radiofrequency-based debridement vs. mechanical debridement for the treatment of articular cartilage lesions.

Purpose

The purpose of this study is to evaluate 2 different treatments, Mechanical Debridement (i.e., a mechanical shaver that removes areas of damaged tissue) and Radiofrequency Debridement (i.e., electrical energy that removes areas of damaged tissue), used to treat the chondral lesion in your knee.

Could this study be right for you?

You may be eligible for this study if you:

• Are 18 - 50 years of age
• Suspected chondral damage in the following locations where debridement is indicated:
  • Medial femoral condyle
  • Lateral femoral condyle
  • Trochlea
  • Patella
• 1 or more chondral lesion(s) as noted on MRI

Exclusion:

• Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable)
• Pregnant and/or intending to become pregnant during this study period

Age Range

18 and up

Contact Information

Angela Pedroza

angela.pedroza@osumc.edu

614-293-7952

Official Title A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Purpose

The purpose of this research study is to evaluate the safety and efficacy of the Nuvaira System, which is made by Nuvaira, Inc., for Targeted Lung Denervation (TLD) Therapy.

The primary purpose of conducting this study is to see if TLD Therapy in addition to optimal medical care (daily breathing medications you have been prescribed by your doctor) is better at reducing a moderate or severe worsening of symptoms (known as an COPD flare-ups or exacerbations) and related hospitalizations than optimal medical care (daily breathing medications you have been prescribed by your doctor) alone.

Could this study be right for you?

Inclusion Criteria:

• Between 40 and 75 years of age
• Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the study
• Diagnosis of COPD with 30% ≤ FEV1 <60% of predicted and FEV1/FVC <70% (post-bronchodilator)
• SpO2 of at least 89% on room air at the time of screening
• Has a documented history of having minimally been taking a regular respiratory maintenance medication for at least 12 months at the time of consent; medications will be reviewed by study team
• If you have participated in a formal pulmonary rehabilitation program recently, program completion should have occurred more than 3 months prior to consent; if in a maintenance program, you will agree to continue your current program through your 12-month follow-up visit;
• Additional criteria will be reviewed by the study team

Involvement in this study will last approximately 62 months.

Age Range

40 and up

Contact Information

Pulmonary Clinical Trials Office

LungResearch@osumc.edu

Official Title ABT-CIP-10300: Abbott DBS Registry of Outcomes for Indications over Time (ADROIT)

Purpose

The purpose of this study is to collect information and evaluate outcomes for Abbott Deep Brain Stimulation (DBS) systems that are approved and sold in your country.

In order to evaluate how the DBS system performs, data will be collected before, during and after DBS implant when you visit the study doctor. The data collected will include information on your movements, feelings, daily activities, and DBS program settings.

The information gathered in this study will add to the understanding of treatment options for future patients receiving DBS.

Could this study be right for you?

Inclusion Criteria:

• You are scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 3 months

Exclusion Criteria:

• You are currently enrolled or plan to enroll in another study that may alter the results of this clinical investigation
• You have another disease, conditions, or other medical, social, or psychological conditions that could limit your ability to participate in the clinical investigation or to satisfy follow-up requirements

Contact Information

Paige Aquino

aquino.40@osu.edu

6146854484