ID

23158

Beschreibung

Responsible Party: Dimitris Repantis, Dr. med., Charite University, Berlin, Germany ClinicalTrials.gov Identifier: NCT02071615 History of Changes Other Study ID Numbers: 2012-003882-17 DRKS00005219 ( Registry Identifier: Deutsche Register Klinischer Studien (DRKS) ) Study First Received: February 15, 2014 Last Updated: April 16, 2014 Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers (MKM) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02071615

Link

https://clinicaltrials.gov/ct2/show/NCT02071615

Stichworte

Versionen (1)
  1. 2017-06-26 2017-06-26 -
Hochgeladen am

26 juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Modafinil, Caffeine and Methylphenidatein Healthy Volunteers DRKS00005219 NCT02071615 DRKS00005219

Englisch

Eligibility Modafinil, Caffeine and Methylphenidatein Healthy Volunteers NCT02071615 DRKS00005219

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Men
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
18 - 35 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Written consent (according to Arzneimittelgesetz (AMG) § 40 (1) 3b)
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Good knowledge of German
Beschreibung

Language Ability

Datentyp

boolean

Alias
UMLS CUI [1]
C1145677
Right-handedness
Beschreibung

Handedness

Datentyp

boolean

Alias
UMLS CUI [1]
C0023114
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Known hypersensitivity to the study medication
Beschreibung

Hypersensitivity to study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
All contraindications to the study medication: arrhythmia, hyperthyroidism , glaucoma , pheochromocytoma , congestive heart failure , diabetes mellitus, known liver and kidney dysfunction, vascular disease , angina, haemodynamically significant congenital heart disease , cardiomyopathy , myocardial infarction, channelopathies, arterial hypertension , cerebrovascular diseases , such as cerebral aneurysm , vascular abnormalities , including vasculitis and stroke.
Beschreibung

Contraindications to study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0304229
Participation in other clinical trials during or within one month prior to this clinical trial
Beschreibung

Study Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Medical or psychological circumstances that may endanger the proper conduct of the trial
Beschreibung

Hazard to Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0598697
UMLS CUI [1,2]
C2348563
Existing serious somatic diseases, even if they are not covered by the contraindications according to product information
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Existing psychiatric disorders and psychiatric disorders in prehistory
Beschreibung

Mental Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
Smoker or ex-smoker for less than 5 years
Beschreibung

Smoking Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1519386
Regular caffeine consumption > 4 cups per day
Beschreibung

Caffeine consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0948365
Subjects with irregular day -night rhythm (eg shift workers )
Beschreibung

Day/night cycles

Datentyp

boolean

Alias
UMLS CUI [1]
C2371703
Unwillingness to the storage and disclosure of pseudonymous data as part of the clinical trial
Beschreibung

Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0558080
Accommodation in an institution by court or administrative order (according to AMG § 40 (1) 4 )
Beschreibung

Accommodation

Datentyp

boolean

Alias
UMLS CUI [1]
C0595920
MRI contraindications ( eg pacemakers , metallic or electronic implants , metallic splinters , tinnitus, surgical clips )
Beschreibung

MRI contraindications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1301624
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Ähnliche Modelle

Eligibility Modafinil, Caffeine and Methylphenidatein Healthy Volunteers NCT02071615 DRKS00005219

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender
Item
Men
boolean
C0079399 (UMLS CUI [1])
Age
Item
18 - 35 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Written consent (according to Arzneimittelgesetz (AMG) § 40 (1) 3b)
boolean
C0021430 (UMLS CUI [1])
Language Ability
Item
Good knowledge of German
boolean
C1145677 (UMLS CUI [1])
Handedness
Item
Right-handedness
boolean
C0023114 (UMLS CUI [1])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Hypersensitivity to study medication
Item
Known hypersensitivity to the study medication
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Contraindications to study medication
Item
All contraindications to the study medication: arrhythmia, hyperthyroidism , glaucoma , pheochromocytoma , congestive heart failure , diabetes mellitus, known liver and kidney dysfunction, vascular disease , angina, haemodynamically significant congenital heart disease , cardiomyopathy , myocardial infarction, channelopathies, arterial hypertension , cerebrovascular diseases , such as cerebral aneurysm , vascular abnormalities , including vasculitis and stroke.
boolean
C1301624 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Study Participation Status
Item
Participation in other clinical trials during or within one month prior to this clinical trial
boolean
C2348568 (UMLS CUI [1])
Hazard to Study Protocol
Item
Medical or psychological circumstances that may endanger the proper conduct of the trial
boolean
C0598697 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Comorbidity
Item
Existing serious somatic diseases, even if they are not covered by the contraindications according to product information
boolean
C0009488 (UMLS CUI [1])
Mental Disorder
Item
Existing psychiatric disorders and psychiatric disorders in prehistory
boolean
C0004936 (UMLS CUI [1])
Smoking Status
Item
Smoker or ex-smoker for less than 5 years
boolean
C1519386 (UMLS CUI [1])
Caffeine consumption
Item
Regular caffeine consumption > 4 cups per day
boolean
C0948365 (UMLS CUI [1])
Day/night cycles
Item
Subjects with irregular day -night rhythm (eg shift workers )
boolean
C2371703 (UMLS CUI [1])
Unwilling
Item
Unwillingness to the storage and disclosure of pseudonymous data as part of the clinical trial
boolean
C0558080 (UMLS CUI [1])
Accommodation
Item
Accommodation in an institution by court or administrative order (according to AMG § 40 (1) 4 )
boolean
C0595920 (UMLS CUI [1])
MRI contraindications
Item
MRI contraindications ( eg pacemakers , metallic or electronic implants , metallic splinters , tinnitus, surgical clips )
boolean
C0024485 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
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