Official Title A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Purpose

The purpose of this study is to examine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization. The duration of the study will consist over a 5 year period. You will visit the study site approximately 23 times after your implant surgery.

Could this study be right for you?

• Aged 18 years or older
• Must be in a major depressive episode (MDD or bipolar disorder) for ≥ two years or have at least had four episodes of depression including the current episode
• Patients depressive illness meets a minimum criteria of four prior failed treatments of adequate dose and duration

Age Range

18 and up

Contact Information

Gilles Fontgalland

gilles.fontgalland@osumc.edu

614-293-7109

Official Title AN OBSERVATIONAL, LONGITUDINAL, PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH HYPOPHOSPHATASIA

Purpose

The purpose of this registry is to collect information about Hypophosphatasia (HPP), a rare bone disorder characterized by the abnormal development of bones and teeth. This long-term registry will collect and store patient medical information, and other related information to use in medical research. The registry may help researchers better understand the condition and learn more about patients who have HPP. In the future, this data may help other people with HPP.

Could this study be right for you?

• 18 years of age or older
• Been diagnosed with Hypophosphatasia (HPP) - a rare genetic disorder characterized by the abnormal development of bones and teeth.
• Not participating in another Alexion-sponsored clinical trial

Age Range

18 and up

Contact Information

Zack Lauderback

zackary.lauderback@osumc.edu

614-814-1055

Official Title M16-046: A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis

Purpose

The purpose of this study is to compare the effectiveness and safety of upadacitinib (ABT-494) versus dupilumab for the treatment of adult subjects (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Could this study be right for you?

• Subject must have chronic Atopic Dermatitis (AD) with onset at least 3 years prior to study participation
• Subject must have > or = 10% body surface area involvement of atopic dermatitis
• Subject must have had inadequate response to topical corticosteroids or topical calcineurin inhibitors within the past 6 months
• OR documented systemic treatment for AD within the past 6 months
• OR for whom topical treatments are otherwise medically inadvisable
• No prior exposure to any JAK inhibitor (e.g., ruxolitinib, tofacitinib, baricitinib, upadacitinib, PF-04965842, and filgotinib)
• No prior exposure to dupilumab

Age Range

18 and up

Contact Information

Shelby Snodgrass

shelby.snodgrass@osumc.edu

6142939306

Official Title Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)

Purpose

This research study aims to determine the effects of a noninvasive form of brain stimulation on alertness for night shift workers.

Could this study be right for you?

• You are age 18 to 65
• You are currently working the night shift at least 3x/week
• You are suffering from sleepiness at work
• You do not have significant heart and lung problems
• You work within the Columbus, OH area

Age Range

18 and up

Contact Information

Pulmonary Clinical Trials Office

lung.research@osumc.edu

614-366-2361

Official Title SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Purpose

To determine whether placement of iFuse-3D across the ssacroiliac joint (SIJ) in the Bedrock configuration provides
clinical and/or radiographic benefits in patients undergoing multilevel spine fusion (MLF) surgery with fixation to the pelvis

Could this study be right for you?

You may be eligible for this study if you are:

1. Age 21-75 at time of screening
2. Scheduled for multilevel (4 or more levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria

1. The reason for your multilevel spine fusion surgery is any of the following:
   • Congenital neuromuscular disease
   • Prior pelvic fixation (already have S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
   • Grade IV spondylolisthesis
2. Prior sacroiliac joint fusion/fixation on either side
3. Presence of spinal cord stimulator
4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
5. Surgeon plans to use iliac screw for pelvic fixation
6. Severe osteoporosis
7. Known allergy to titanium or titanium alloys
8. Current local or systemic infection that raises the risk of surgery
9. Currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SIJ or low back pain.
10. Currently pregnant or planning pregnancy in the next 2 years
11. Known or suspected drug or alcohol abuse
12. Fibromyalgia

Age Range

21 and up

Contact Information

Elizabeth Sheridan

elizabeth.sheridan@osumc.edu

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