Official Title AN OBSERVATIONAL, LONG-TERM SAFETY STUDY OF TZIELD® (TEPLIZUMAB-MZWV) IN PATIENTS WITH STAGE 2 TYPE 1 DIABETES

Purpose

The objective of the study is to test the safety and efficacy of TZIELD over the course of 10 years in patients with Stage 2, Type 1 Diabetes, as well as the prevention of Stage 3, Type 1 Diabetes. 

Could this study be right for you?

Inclusion Criteria:

TZIELD-Exposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
− Day 1: 65 μg/m²
− Day 2: 125 μg/m²
− Day 3: 250 μg/m²
− Day 4: 500 μg/m²
− Days 5 through 14: 1,030 μg/m² per day
− Cumulative dose is approximately 11,240 μg/m²

2. Appropriate written informed consent/assent as applicable for the age of the patient

TZIELD-Unexposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
2. Appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria:
1. Patients who initiated TZIELD treatment more than 6 months prior to enrollment
2. Patients who had participated in a previous clinical trial for TZIELD
3. Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled.

Age Range

18 - 70 years

Contact Information

CarePoint East, CarePoint Dublin

Zack Lauderback

zackary.lauderback@osumc.edu

614-814-1055

Official Title A Phase 2/3 multicenter, double blinded, randomized, dose-conversion, active control study examining the efficacy and safety of Armour Thyroid compared to synthetic T4 for the treatment of adults with primary hypothyroidism

Purpose

The purpose of this study is to evaluate if Armour Thyroid is safe and effective in the treatment of hypothyroidism.

 

You will participate in this study for up to 90 weeks. The study will be conducted in 3 treatment periods plus a Screening and Follow-up period: • Screening period (up to 28 days)– the dose of Armour Thyroid will be adjusted as needed to ensure your Hypothyroidism is well controlled  • Follow-up period (approximately 35 days following the last dose of study drug)  

Could this study be right for you?

• Were diagnosed with hypothyroidism at least 12 months ago

• Have been on a stable dose of T4 (like levothyroxine or Synthroid) for at least 3 months

• Have a recent TSH level between 0.45–4.12 mIU/L

• Are between BMI 18 and 40

• Are not pregnant or breastfeeding and use birth control if needed

• Are not allergic to thyroid meds or pork products

• Have no recent drug/alcohol abuse or severe liver/kidney disease

• Are not in another clinical trial

• Take no more than 200 mcg of T4 daily

Age Range

18 - 75 years

Contact Information

Ohio State University Carepoint East

Lindsey Aldrich

lindsey.aldrich@osumc.edu

614-814-0772

Official Title Biomechanical Metrics of Movement Relative to Total Knee Arthroplasty

Purpose

This study aims to understand how a total knee replacement surgery (TKR) affects muscle function and movement in the lower body. It focuses on four key areas:

1. Examining how TKR changes the way muscles work in the lower body.

2. Exploring how these muscle changes relate to the forces people experience when walking and doing daily activities after surgery.

3. Connecting muscle function to how well patients feel and move after TKR.

4. Identifying different types of TKR patients based on their physical traits, movement patterns, and medical history to see how they compare.

Could this study be right for you?

• Must be scheduled to receive a total knee replacement within the next 2 months
• Have a body mass index (BMI) < 40
• Do not require the use of a cane or other assistive device when walking, climbing stairs, and getting up from a chair

Exclusion criteria varies; please contact Study Coordinator for more information

Age Range

18 years and up

Contact Information

Science Village (1381 Kinnear Rd Columbus, OH, 43212)

Kathryn Blessinger

blessinger.1@osu.edu

Official Title Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects with Diabetes

Purpose

This placebo-controlled study is being done to evaluate the effects of a ketone ester drink on exercise performance and heart health in a group of subjects diagnosed with type 2 diabetes.

Could this study be right for you?

There are additional exclusion criteria, study staff will screen fully before enrollment.

Age Range

18 - 80 years

Contact Information

Center for Imaging Excellence, 2050 Kenny Road

Debbie Scandling

debbie.scandling@osumc.edu

614-688-5623

Official Title Radiotracer Imaging of Lower Extremity Skeletal Muscle Perfusion in Patients with Peripheral Arterial Disease

Purpose

The purpose of this study is to look at a new method to evaluate blood flow to the calves and feet. 

Peripheral Artery Disease (PAD) patient outcomes will be evaluated for up to 12 months after their revascularization procedure to assess how early changes in SPECT-derived foot perfusion relate to rates of diabetic wound healing and limb salvage. Outcomes will be specifically evaluated at 3, 6, 9, and 12 months after revascularization at the time of their follow-up clinic visits to the OSU Comprehensive Wound Center at OSU Hospital East. Primary outcomes of interest will be 1) changes in wound size and healing, 2) minor or major amputations of the lower extremity, and 3) any subsequent interventional procedures, such as balloon angioplasty, stenting, or surgical bypass.

 

Could this study be right for you?

Heathly Volunteers with out previous cardiovascular disease

Or 

PAD

Age Range

18 years and up

Contact Information

The Ohio State University Wexner Medical Center and Nationwide Children's Hospital

Kyle Shin

Kyle.Shin@osumc.edu

Official Title Lifestyle solutions to postprandial hypotension in spinal cord injury

Purpose

To test if a low-glycemic diet and electrical stimulation of leg muscles can improve blood pressure control after eating.

Could this study be right for you?

• Spinal cord injury sustained at least 1-year ago
• Level of injury between C4 and T10
• Use of wheelchair for majority of daily activities

Age Range

18 years and up

Contact Information

Columbus, OH

Dr Matthew Farrow

Matthew.Farrow@osumc.edu

Official Title Digital Transformation of CRC Screening: Revolutionizing Access and Saving Lives

Purpose

The purpose of this study is to conduct usability testing to evaluate ease of use and overall user experience of a website designed to promote colorectal (CRC) awareness and screening uptake among adults 45-64.

Could this study be right for you?

Inclusion Criteria: Eligible participants will 1) be between the ages of 45-64, 2) at average risk for CRC and 3) from diverse racial/ethnic and socioeconomic backgrounds 

 

Those who are ineligible fall under the following categories:  

1. Age: Individuals outside the age range of 45-64 will be excluded

2. Pregnancy Status: Pregnant individuals will be excluded from the study. since CRC screening is not recommended for pregnant individuals

Age Range

45 - 64 years

Contact Information

Remote

Gaurav Kulkarni

Kulkarni.385@buckeyemail.osu.edu

614-688-0748

Official Title LOWFLC Study: Addiction potential of low nicotine filtered little cigars

Purpose

Researchers from The Ohio State University are recruiting adult users of little cigars and cigarillos to help improve understanding of the products’ health impact.

Could this study be right for you?

• Current smoker
• No significant health problems

Age Range

21 - 75 years

Contact Information

3650 Olentangy River Road, Suite 420, Columbus OH 43214

Ashley Takanashi

CTRLungLab@osumc.edu

Official Title Brief Digitally Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use during Medication for OUD (Phase Two)

Purpose

This study is being done to further examine and improve how a brief clinical treatment intervention may reduce alcohol use among patients engaged in medication for opioid use disorder (MOUD) treatment.

The length of the study is approximately 10 weeks and will include two on-campus lab visits at Ohio State's Medical Campus, daily surveys via a smartphone app (surveys 3 times a day for ~21 days), three treatment sessions (completed online or in-person), and follow-up questionnaires (completed online). The total time commitment of the study is 11 hours and 6 minutes.

Could this study be right for you?

Inclusion Criteria:

• engaged in MOUD treatment (for at least one month)
• alcohol consumption (within the past 12 months)
• age 18 or older
• access to a smart phone

(partial list of inclusion criteria)

Exclusion Criteria:

• diagnosis of psychosis or bipolar I
• currently pregnant (positive pregnancy test)

(partial list of exclusion criteria)

Age Range

18 years and up

Contact Information

The Ohio State University Wexner Medical Center

Sara Tallmadge

sara.tallmadge@osumc.edu

Official Title A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the
Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of
Patients with Major Depressive Disorder

Purpose

Depression is one of the most common mental health issues worldwide. Many people with major depressive disorder (MDD) take antidepressant medications that do not provide enough of a response to ease their depressive symptoms.

The primary objective of this study is to evaluate the benefit of Lumateperone 42 mg administered once daily compared with placebo as adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) who have an inadequate response to ongoing ADT.

Could this study be right for you?

You may be able to take part if you:

• are 18–65 years of age

• have a confirmed diagnosis of Major Depressive Disorder (MDD)

• feel that your current antidepressant medication is not working well

• Has tried 2 or more antidepressant medication in the current episode of depression

 

Other criteria will need to be met to confirm your eligibility for this study.

Age Range

18 - 65 years

Contact Information

Harding Hospital

Valeria Esis

valeria.esis@osumc.edu

6142931297

Official Title The KOBRA Study: The Effects of Knee Osteoarthritis on Brain Activation

Purpose

The purpose of this study is to assess changes in brain activation and processing in those with right knee osteoarthritis compared to healthy controls. 

Could this study be right for you?

• Either two healthy knees OR those with right knee pain from a diagnosis of right knee osteoarthritis with a healthy left knee
• No metal implants that prevent you from having an MRI
• No foot/ankle/leg/hip surgeries in the past year
• No neurologic conditions
• No conditions that prevent athletic participation or maximal effort exercise
• Able to provide informed consent
• Speak and read English

Age Range

45 - 70 years

Contact Information

Jameson Crane Sports Medicine Institute (2835 Fred Taylor Dr, Columbus, Ohio) and Center for Cognitive and Behavioral Brain Imaging (86 Psychology Building 1835 Neil Avenue, Columbus, Ohio)

Kat Rethman

Katherine.rethman@osumc.edu

Official Title The Development of Semantic Organization

Purpose

We are currently in the process of conducting a 5-year National Institutes of Health-funded longitudinal study on semantic and language development, specifically focusing on how children learn new words and understand their meanings. Our goal is to not only examine language learning but also how these processes evolve as children grow.

In this study, we will follow two hundred 4-year-old junior scientists as they participate in fun, interactive word-learning and language activities. Over the course of the study, participants will visit our lab twice a year, each lasting around 60-90 minutes (including breaks), to engage in a series of playful games with a research assistant designed to explore how children comprehend and retain new vocabulary. Additionally, your child will have the opportunity to wear a LENA recorder—a small, wearable device that tracks the number of words your child hears throughout the day, similar to a Fitbit but for words!

 

Could this study be right for you?

• Child must be monolingual
• Not born premature
• No developmental delays
• Can give a verbal response
• Normal to corrected vision

Age Range

4 - 4 years

Contact Information

1835 Neil Ave, PS 268, Columbus, Ohio

Madison Meares

meares.7@osu.edu

614-292-3427