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

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

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

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

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

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

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

Official Title Depressive Episodes Associated with Bipolar I or II Disorder: A Double-Blind,
Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of
ABBV-932

Purpose

The purpose of this study is to see if the investigational study drug is safe and useful for treating patients with bipolar depression.

Eligible participants will be randomized to receive the drug or placebo. A placebo looks just like the investigational study drug but has no active drug in it.

The maximum duration of the study treatment period is 6 weeks. Participants receive psychiatric evaluation at each visit, and physical exam, urine test and blood draws at some of the visits. All study medication and procedures are provided at no cost, and participants may be compensated for their time and travel for each visit attended.

Could this study be right for you?

A diagnosis of bipolar disorder (type I or II) and be currently depressed.

Age Range

18 - 65 years

Official Title A Phase III, multicentre, randomised, double-blind,
controlled study to investigate the efficacy, safety,
and tolerability of two initial administrations of
COMP360 in participants with treatment-resistant
depression

Purpose

The study investigates a new approach for treatment-resistant depression using an investigational medicine related to psilocybin alongside psychological support.

Could this study be right for you?

You may be able to join the study if you:

—         Are 18 years of age or older

—         Have been diagnosed with major depression and have not responded to 2+ antidepressants

Other criteria will need to be met to confirm your eligibility for this study, which will last up to 62 weeks.

Age Range

18 years and up

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

Official Title Evaluation of Wear Experience with PRECISION7® For Astigmatism Contact Lenses in Neophyte Lens Wearers

Purpose

The purpose of this study is to explore the wear experience with PRECISION7® For Astigmatism lenses in adults who have not previously worn contact lenses.

Could this study be right for you?

1. Adults who have never worn contact lenses.
2. Adults who have astigmatism
3. Ability to attend 3 visits over the course of 3 weeks.
4. Satisfy all other study eligibility and exclusion criteria.

Age Range

18 - 40 years

Official Title A Multi-center, Phase 1/2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered via Magnetic Resonance Imaging (MRI)-guided Convection-enhanced Delivery (CED)

Purpose

You are being invited to participate in a study about mesial temporal lobe epilepsy (MTLE) on only 1 side (unilateral) of the brain that has not responded to medication (refractory).

The study will test AMT-260, which is a new gene therapy under investigation for use in treating people like you with MTLE. It is not yet approved as a drug for treating MTLE. It can only be used in a study like this one. This is the first time this gene therapy will be used in humans. It has previously been studied in animals.

AMT-260 is a gene therapy designed to reduce the electrical signals between nerve cells (neurons) in the parts of your brain where nerve cells are abnormally connected. This reduces the extra electrical signals that happen at the same time and is intended to reduce your seizure activity.

The overall goals of this study are:

• To observe whether participants have any side effects from AMT-260 or from the procedure to deliver AMT-260 into the brain and how well participants tolerate any side effects that may occur.
• To measure if participants have changes in:
  • frequency of their seizures
  • how their seizures affect their life
  • how the human body takes up and removes AMT-260
• To find the best dose of AMT-260 for future participants to ensure clinical benefit with minimal or no side effects.

Could this study be right for you?

Adult, 18-65 years of age, inclusive, capable of giving informed consent.
Written informed consent is given freely after the nature of the study has been explained to the participant and the completion of data disclosure.
Willingness to undergo necessary surgical procedures.
Diagnosis of unilateral refractory MTLE for ≥360 days, confirmed by an Epilepsy Monitoring Unit.

Additional Eligibility Criteria to be assessed by neurosurgery team, and as described in the study protocol.

Age Range

18 - 65 years