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Steroids for Thyroid Disease
Phase 4
Waitlist Available
Led By Dawn K Elfenbein
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
Awards & highlights
Study Summary
This trial will see if a short course of prednisone can help reduce inflammation in people with autoimmune, inflammatory thyroid disease before surgery. Up to 30 people will be enrolled for 7 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Antibody-mediated Cytokine Levels
Change in Short Form Health Survey (SF-12) Mental Component Score (MCS)
Change in Short Form Health Survey (SF-12) Physical Component Score (PCS)
+3 moreSecondary outcome measures
Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury
Surgical Complications: Parathyroid Hormone (PTH) Level
Ultrasound Doppler Quantification of Blood Flow
Trial Design
2Treatment groups
Active Control
Group I: SteroidsActive Control1 Intervention
Participants randomized to the steroid arm will be given a prescription for prednisone 20mg daily for 7 days prior to surgery, otherwise, pre-operative standard of care
Group II: No SteroidsActive Control1 Intervention
Pre-operative Standard of Care
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,186 Previous Clinical Trials
3,169,417 Total Patients Enrolled
Dawn K ElfenbeinPrincipal InvestigatorUniversity of Wisconsin, Madison
Frequently Asked Questions
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