ID

23708

Description

Responsible Party: Johannes W. Dietrich, MD, Senior consultant endocrinologist, Ruhr University of Bochum ClinicalTrials.gov Identifier: NCT01145040 History of Changes Other Study ID Numbers: TFC-UK10 3718-10 ( Other Identifier: Ethics commission of the Ruhr University of Bochum ) U1111-1122-3273 ( Registry Identifier: WHO ICTRP Universal Trial Number (UTN) ) DRKS00003153 ( Registry Identifier: DRKS (German Clinical Trials Register) ) Study First Received: June 14, 2010 Last Updated: April 24, 2017 NOMOTHETICOS: Nonlinear Modelling of Thyroid Hormones' Effect on Thyrotropin Incretion in Confirmed Open-loop Situation (NOMOTHETICOS) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01145040

Link

https://clinicaltrials.gov/ct2/show/NCT01145040

Keywords

Versions (1)
  1. 7/11/17 7/11/17 -
Uploaded on

July 11, 2017

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License

Creative Commons BY 4.0
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Eligibility Thyroid Disease NCT01145040 DRKS00003153

English

Eligibility Thyroid Disease NCT01145040 DRKS00003153

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 14 Years and older (Child, Adult, Senior)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Outpatients with disconnected feedback control due to the following conditions: - Overt primary hypothyroidism with TSH level over 10 mU/l and FT4 level below 0.5 ng/l (Partition 1)
Description

Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020676
Outpatients with disconnected feedback control due to the following conditions: - Overt primary hyperthyroidism with TSH level below 0.1 mU/l and FT4 level over 25 ng/l (Partition 3)
Description

Hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020550
Outpatients with disconnected feedback control due to the following conditions: - All other constellations, if the patient receives substitution therapy with more 1.75 µg Levothyroxin per kg of body mass (Partition 2).
Description

Levothyroxine substitution

Data type

boolean

Alias
UMLS CUI [1]
C0040165
System in equilibrium (e.g. unchanged substitution dose over the past six weeks)
Description

Equilibrium

Data type

boolean

Alias
UMLS CUI [1]
C0014653
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Pituitary or hypothalamic dysfunction
Description

Pituitary or hypothalamic dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0281947
UMLS CUI [2]
C0751230
Severe illness that may be associated with euthyroid sick syndrome (non-thyroidal illness syndrome)
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Medication influencing pituitary function
Description

Drug Interactions

Data type

boolean

Alias
UMLS CUI [1]
C0687133
Pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Missing consent for participation in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Thyroid Disease NCT01145040 DRKS00003153

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Ages Eligible for Study: 14 Years and older (Child, Adult, Senior)
boolean
C0001779 (UMLS CUI [1])
Hypothyroidism
Item
Outpatients with disconnected feedback control due to the following conditions: - Overt primary hypothyroidism with TSH level over 10 mU/l and FT4 level below 0.5 ng/l (Partition 1)
boolean
C0020676 (UMLS CUI [1])
Hyperthyroidism
Item
Outpatients with disconnected feedback control due to the following conditions: - Overt primary hyperthyroidism with TSH level below 0.1 mU/l and FT4 level over 25 ng/l (Partition 3)
boolean
C0020550 (UMLS CUI [1])
Levothyroxine substitution
Item
Outpatients with disconnected feedback control due to the following conditions: - All other constellations, if the patient receives substitution therapy with more 1.75 µg Levothyroxin per kg of body mass (Partition 2).
boolean
C0040165 (UMLS CUI [1])
Equilibrium
Item
System in equilibrium (e.g. unchanged substitution dose over the past six weeks)
boolean
C0014653 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Pituitary or hypothalamic dysfunction
Item
Pituitary or hypothalamic dysfunction
boolean
C0281947 (UMLS CUI [1])
C0751230 (UMLS CUI [2])
Comorbidity
Item
Severe illness that may be associated with euthyroid sick syndrome (non-thyroidal illness syndrome)
boolean
C0009488 (UMLS CUI [1])
Drug Interactions
Item
Medication influencing pituitary function
boolean
C0687133 (UMLS CUI [1])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Informed Consent
Item
Missing consent for participation in the study
boolean
C0021430 (UMLS CUI [1])
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