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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03607071 |
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Date of registration:
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20/07/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
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Scientific title:
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Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study |
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Date of first enrolment:
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May 15, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03607071 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Thailand
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Key inclusion & exclusion criteria
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Inclusion Criteria:
• The adult scleroderma patients who were defined as having myocardial inflammation by
cardiac MRI.
Exclusion Criteria:
- Current infection that needs systemic antibiotic therapy
- Active viral hepatitis B or C
- Uncontrolled diabetes mellitus
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myocardial Inflammation
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Intervention(s)
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Drug: Prednisolone and taper
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Primary Outcome(s)
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Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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