ID

23708

Beschreibung

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

Stichworte

Versionen (1)
  1. 11.07.17 11.07.17 -
Hochgeladen am

11. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Thyroid Disease NCT01145040 DRKS00003153

Englisch

Eligibility Thyroid Disease NCT01145040 DRKS00003153

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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)
Beschreibung

Hypothyroidism

Datentyp

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)
Beschreibung

Hyperthyroidism

Datentyp

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).
Beschreibung

Levothyroxine substitution

Datentyp

boolean

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

Equilibrium

Datentyp

boolean

Alias
UMLS CUI [1]
C0014653
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

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

Pituitary or hypothalamic dysfunction

Datentyp

boolean

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

Comorbidity

Datentyp

boolean

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

Drug Interactions

Datentyp

boolean

Alias
UMLS CUI [1]
C0687133
Pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
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Ähnliche Modelle

Eligibility Thyroid Disease NCT01145040 DRKS00003153

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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