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Corticosteroid

Dexamethasone for Autoimmune Thyroid Disease

Phase 4

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 months

Awards & highlights

Study Summary

This trial will study if corticosteroids can reduce inflammation before thyroid surgery to make the operation easier. #medicine

Who is the study for?

This trial is for adults with Graves' disease or Hashimoto's thyroiditis planning to have their thyroid removed. They must have certain autoantibodies present and not be on immunosuppressants, diabetic medication, or have a history of neck surgeries, steroid therapy, adverse reactions to corticosteroids, or any drug interactions.Check my eligibility

What is being tested?

The study is testing if taking a short course of Dexamethasone (a corticosteroid) before surgery can reduce inflammation in the thyroid gland compared to a placebo. Patients are randomly assigned to either receive Dexamethasone or an inactive substance.See study design

What are the potential side effects?

Dexamethasone may cause increased blood sugar levels, mood swings, high blood pressure, weight gain, insomnia and increase the risk of infections. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Graves' or Hashimoto's disease and am having my thyroid removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Thyroid difficulty Scale score

Secondary outcome measures

Calcium

FT4

Number of participants with the following surgical complications

+11 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SteroidsExperimental Treatment1 Intervention

Will be given pre-operative corticosteroid regimen

Group II: placeboPlacebo Group1 Intervention

Will be given Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,686 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA endorse steroids for medical use?

"Due to the fact that Steroids are already approved, our team at Power have ascribed it a score of 3 in terms of its safety."

Answered by AI

Are researchers still enrolling participants for this trial?

"Affirmative, the records found on clinicaltrials.gov indicate that this medical trial is still open to applicants. The study was initially posted in July 14th 2023 and most recently updated on November 16th of the same year. 76 participants will be accepted from 3 different sites for this research project."

Answered by AI

What is the total number of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov's information shows that this medical investigation, which was first posted on July 14th 2023, is actively enrolling patients. Specifically, 76 people are being sought from 3 distinct facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative Corticosteroids in Autoimmune Thyroid Disease

Alexandria D. McDow 2023. "Preoperative Corticosteroids in Autoimmune Thyroid Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05435547.

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