ID

4949

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00663364

Link

http://clinicaltrials.gov/show/NCT00663364

Stichworte

Versionen (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 15.04.14 15.04.14 - Julian Varghese
Hochgeladen am

15. April 2014

DOI

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Eligibility NCT00663364 Eczema

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Eczema
Beschreibung

Eczema

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0013595
SNOMED CT 2011_0131
43116000
MedDRA 14.1
10014184
ICD-10-CM Version 2010
L30.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Willing to apply skin care for 2 to 4 weeks, twice daily
Beschreibung

Willing to apply skin care for 2 to 4 weeks, twice daily

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
CL025718
UMLS CUI 2011AA
C0150773
SNOMED CT 2011_0131
225360001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0585361
SNOMED CT 2011_0131
229799001
HL7 V3 2006_05
BID
Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching
Beschreibung

Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0034394
UMLS CUI 2011AA
C0442519
SNOMED CT 2011_0131
264362003
UMLS CUI 2011AA
C0376660
UMLS CUI 2011AA
C0242498
SNOMED CT 2011_0131
225510008
UMLS CUI 2011AA
C0859038
MedDRA 14.1
10040918
UMLS CUI 2011AA
C0237849
SNOMED CT 2011_0131
14411002
MedDRA 14.1
10040844
LOINC Version 232
MTHU015271
ICD-10-CM Version 2010
R23.4
UMLS CUI 2011AA
C1705492
UMLS CUI 2011AA
C0678578
UMLS CUI 2011AA
C1123023
SNOMED CT 2011_0131
39937001
LOINC Version 232
MTHU001414
UMLS CUI 2011AA
C1527305
UMLS CUI 2011AA
C0235108
SNOMED CT 2011_0131
263897001
MedDRA 14.1
10016368
UMLS CUI 2011AA
C0033774
SNOMED CT 2011_0131
418363000
MedDRA 14.1
10037087
ICD-10-CM Version 2010
L29
ICD-9-CM Version 2011
698.9
CTCAE 1105E
E13686
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Participation in any other research study during the previous 4 weeks.
Beschreibung

Participation in any other research study during the previous 4 weeks.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0681814
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Previous participation in this study.
Beschreibung

Previous participation in this study.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2348568
Concurrent participation in any other research study involving an investigational product.
Beschreibung

Concurrent participation in any other research study involving an investigational product.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0681814
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C1514468
Current need for the use of topical steroids.
Beschreibung

Current need for the use of topical steroids.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2064827
History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.
Beschreibung

History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.

Datentyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0036667
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
CL414967
Subjects considered unable or unlikely to fulfill diaries.
Beschreibung

Subjects considered unable or unlikely to fulfill diaries.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0376660
Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
Beschreibung

Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0599987
SNOMED CT 2011_0131
224528001
UMLS CUI 2011AA
C1707500
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0086282
SNOMED CT 2011_0131
303071001
HL7 V3 2006_05
FAMMEMB
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C0680063
SNOMED CT 2011_0131
160499008
UMLS CUI 2011AA
C0030551
SNOMED CT 2011_0131
40683002
HL7 V3 2006_05
PARNT
UMLS CUI 2011AA
C0037047
SNOMED CT 2011_0131
375005
LOINC Version 232
MTHU016169
HL7 V3 2006_05
SIB
UMLS CUI 2011AA
C0680063
SNOMED CT 2011_0131
160499008
UMLS CUI 2011AA
C0599987
SNOMED CT 2011_0131
224528001
History of neoplastic disease
Beschreibung

History of cancer.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0006826
LOINC Version 232
MTHU034770
Recent immunization (< 10 days prior to the use of the test product).
Beschreibung

Recent immunization (< 10 days prior to the use of the test product).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C0020971
SNOMED CT 2011_0131
127785005
MedDRA 14.1
10021431
HL7 V3 2006_05
IMMUNIZ
UMLS CUI 2011AA
C0547044
SNOMED CT 2011_0131
263796003
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0392366
SNOMED CT 2011_0131
272393004
UMLS CUI 2011AA
C1514468
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Eczema
Item
Eczema
boolean
C0013595 (UMLS CUI 2011AA)
43116000 (SNOMED CT 2011_0131)
10014184 (MedDRA 14.1)
L30.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Willing to apply skin care for 2 to 4 weeks, twice daily
Item
Willing to apply skin care for 2 to 4 weeks, twice daily
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
CL025718 (UMLS CUI 2011AA)
C0150773 (UMLS CUI 2011AA)
225360001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0585361 (UMLS CUI 2011AA)
229799001 (SNOMED CT 2011_0131)
BID (HL7 V3 2006_05)
Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching
Item
Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0034394 (UMLS CUI 2011AA)
C0442519 (UMLS CUI 2011AA)
264362003 (SNOMED CT 2011_0131)
C0376660 (UMLS CUI 2011AA)
C0242498 (UMLS CUI 2011AA)
225510008 (SNOMED CT 2011_0131)
C0859038 (UMLS CUI 2011AA)
10040918 (MedDRA 14.1)
C0237849 (UMLS CUI 2011AA)
14411002 (SNOMED CT 2011_0131)
10040844 (MedDRA 14.1)
MTHU015271 (LOINC Version 232)
R23.4 (ICD-10-CM Version 2010)
C1705492 (UMLS CUI 2011AA)
C0678578 (UMLS CUI 2011AA)
C1123023 (UMLS CUI 2011AA)
39937001 (SNOMED CT 2011_0131)
MTHU001414 (LOINC Version 232)
C1527305 (UMLS CUI 2011AA)
C0235108 (UMLS CUI 2011AA)
263897001 (SNOMED CT 2011_0131)
10016368 (MedDRA 14.1)
C0033774 (UMLS CUI 2011AA)
418363000 (SNOMED CT 2011_0131)
10037087 (MedDRA 14.1)
L29 (ICD-10-CM Version 2010)
698.9 (ICD-9-CM Version 2011)
E13686 (CTCAE 1105E)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Participation in any other research study during the previous 4 weeks.
Item
Participation in any other research study during the previous 4 weeks.
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0681814 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Previous participation in this study.
Item
Previous participation in this study.
boolean
C2348568 (UMLS CUI 2011AA)
Concurrent participation in any other research study involving an investigational product.
Item
Concurrent participation in any other research study involving an investigational product.
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0681814 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C1517586 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
Current need for the use of topical steroids.
Item
Current need for the use of topical steroids.
boolean
C2064827 (UMLS CUI 2011AA)
History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.
Item
History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0036667 (UMLS CUI 2011AA)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
CL414967 (UMLS CUI 2011AA)
Subjects considered unable or unlikely to fulfill diaries.
Item
Subjects considered unable or unlikely to fulfill diaries.
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0750558 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0376660 (UMLS CUI 2011AA)
Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
Item
Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
boolean
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
C1707500 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0086282 (UMLS CUI 2011AA)
303071001 (SNOMED CT 2011_0131)
FAMMEMB (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C0680063 (UMLS CUI 2011AA)
160499008 (SNOMED CT 2011_0131)
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0037047 (UMLS CUI 2011AA)
375005 (SNOMED CT 2011_0131)
MTHU016169 (LOINC Version 232)
SIB (HL7 V3 2006_05)
C0680063 (UMLS CUI 2011AA)
160499008 (SNOMED CT 2011_0131)
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
History of cancer.
Item
History of neoplastic disease
boolean
C0006826 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
Recent immunization (< 10 days prior to the use of the test product).
Item
Recent immunization (< 10 days prior to the use of the test product).
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0020971 (UMLS CUI 2011AA)
127785005 (SNOMED CT 2011_0131)
10021431 (MedDRA 14.1)
IMMUNIZ (HL7 V3 2006_05)
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0392366 (UMLS CUI 2011AA)
272393004 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
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