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| Name | Class |
|---|---|
| Graz University of Technology | OTHER |
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The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semi-automated computer-aided treatment | Experimental | Treatment based on the dosing suggestions by a mathematical algorithm and cross-checked by the treating physician |
|
| Usual care | Active Comparator | Treatment based on the dosing suggestions by the treating physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-automated computer-aided treatment (Digital Thyroid, DigiThy) | Device | Semi-automated computer-aided treatment based on a mathematical model |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices | The performance index is the deviation from the desired free thyroxine (fT4) value | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison in terms of cumulative methimazole dosing | Comparison in terms of cumulative methimazole dosing | 18 months |
| Comparison based on free thyroxine (fT4) target range | Comparison based on free thyroxine (fT4) target range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Verena Theiler-Schwetz, MD, PhD | Contact | ++4331638582383 | verena.schwetz@medunigraz.at | |
| Stefan Pilz, MD, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Pilz, MD, PhD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8044 | Austria |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| Usual care | Procedure | Guiding methimazole therapy based on the treating physician's decision |
|
| 18 months |
| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |