ID

4915

Description

ODM derived from http://clinicaltrials.gov/show/NCT00507832

Lien

http://clinicaltrials.gov/show/NCT00507832

Mots-clés

Versions (3)
  1. 10/12/2013 10/12/2013 - Martin Dugas
  2. 14/04/2014 14/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Téléchargé le

14 avril 2014

DOI

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Licence

Creative Commons BY 4.0
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Eligibility NCT00507832 Prurigo Nodularis

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 18 bis 70 Jahre
Description

age 18 Years to 70 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis: Prurigo nodularis
Description

Diagnosis: Prurigo nodularis

Type de données

boolean

Alias
UMLS CUI 2011AA
C0263353
SNOMED CT 2011_0131
63501000
MedDRA 14.1
10037084
ICD-10-CM Version 2010
L28.1
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Pruritus intensity >VAS 3 (Visual analoge scale 0 to 10)
Description

Pruritus intensity >VAS 3 (Visual analoge scale 0 to 10)

Type de données

boolean

Alias
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
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0042815
SNOMED CT 2011_0131
273903006
Nodules on arms and legs (target areas: arms)
Description

Nodules on arms and legs (target areas: arms)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0028259
SNOMED CT 2011_0131
27925004
MedDRA 14.1
10054107
UMLS CUI 2011AA
C1140618
SNOMED CT 2011_0131
53120007
LOINC Version 232
MTHU011974
UMLS CUI 2011AA
C0023216
SNOMED CT 2011_0131
61685007
LOINC Version 232
MTHU011970
UMLS CUI 2011AA
C1521840
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C1140618
SNOMED CT 2011_0131
53120007
LOINC Version 232
MTHU011974
No effective current external or internal antipruritic medication
Description

No effective current external or internal antipruritic medication

Type de données

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C1553892
HL7 V3 2006_05
CURMEDLIST
UMLS CUI 2011AA
C0521134
UMLS CUI 2011AA
C0205102
SNOMED CT 2011_0131
260521003
UMLS CUI 2011AA
C1579276
Signed informed consent
Description

Signed informed consent

Type de données

boolean

Alias
UMLS CUI 2011AA
C0021430
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
prurigo nodularis with massive excoriations and/or local infections
Description

prurigo nodularis with massive excoriations and/or local infections

Type de données

boolean

Alias
UMLS CUI 2011AA
C0263353
SNOMED CT 2011_0131
63501000
MedDRA 14.1
10037084
ICD-10-CM Version 2010
L28.1
UMLS CUI 2011AA
C0522501
SNOMED CT 2011_0131
46998006
UMLS CUI 2011AA
C0015256
SNOMED CT 2011_0131
400048001
MedDRA 14.1
10049796
UMLS CUI 2011AA
C0406047
MedDRA 14.1
10045995
ICD-10-CM Version 2010
L08.9
ICD-9-CM Version 2011
686.9
atopic dermatitis, predisposition for atopic dermatitis
Description

atopic dermatitis, predisposition for atopic dermatitis

Type de données

boolean

Alias
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012434
ICD-10-CM Version 2010
L20
UMLS CUI 2011AA
C0012655
SNOMED CT 2011_0131
76522002
Itch intensity <VAS 4 (visual analoge scale 0 to 10)
Description

Itch intensity <VAS 4 (visual analoge scale 0 to 10)

Type de données

boolean

Alias
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
UMLS CUI 2011AA
C0522510
SNOMED CT 2011_0131
103370009
UMLS CUI 2011AA
C0042815
SNOMED CT 2011_0131
273903006
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
Description

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0009637
SNOMED CT 2011_0131
13693004
UMLS CUI 2011AA
C1692758
HL7 V3 2006_05
TRM
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0430063
SNOMED CT 2011_0131
166437003
UMLS CUI 2011AA
C2348195
MedDRA 14.1
10036572
LOINC Version 232
2118-8
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0430060
SNOMED CT 2011_0131
166434005
Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
Description

Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.

Type de données

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C1692758
HL7 V3 2006_05
TRM
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
active psychosomatic and psychiatric diseases
Description

active psychosomatic and psychiatric diseases

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0033931
SNOMED CT 2011_0131
37057007
MedDRA 14.1
10049587
ICD-10-CM Version 2010
F45.9
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
History of active malignancy of any organ system
Description

History of active malignancy of any organ system

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0460002
SNOMED CT 2011_0131
91689009
actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
Description

actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)

Type de données

boolean

Alias
UMLS CUI 2011AA
C2707252
LOINC Version 232
MTHU031865
UMLS CUI 2011AA
C0686904
SNOMED CT 2011_0131
103325001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
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
UMLS CUI 2011AA
C0011155
SNOMED CT 2011_0131
129453003
UMLS CUI 2011AA
C0302583
SNOMED CT 2011_0131
3829006
LOINC Version 232
MTHU004837
UMLS CUI 2011AA
C0043481
SNOMED CT 2011_0131
86739005
LOINC Version 232
MTHU001006
Systemic immunosuppression
Description

Systemic immunosuppression

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
Description

Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry

Type de données

boolean

Alias
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0085149
SNOMED CT 2011_0131
386975001
LOINC Version 232
MTHU001849
UMLS CUI 2011AA
C1099414
SNOMED CT 2011_0131
385580005
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0006931
SNOMED CT 2011_0131
95995002
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake-inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
Description

current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake-inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.

Type de données

boolean

Alias
UMLS CUI 2011AA
C1553892
UMLS CUI 2011AA
C1273865
SNOMED CT 2011_0131
394829006
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0003360
SNOMED CT 2011_0131
372806008
LOINC Version 232
MTHU003328
UMLS CUI 2011AA
C2911187
ICD-10-CM Version 2010
Z79.52
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0070122
SNOMED CT 2011_0131
372595009
LOINC Version 232
MTHU004267
UMLS CUI 2011AA
C0085228
SNOMED CT 2011_0131
372905008
LOINC Version 232
MTHU002297
UMLS CUI 2011AA
C0360105
SNOMED CT 2011_0131
373225007
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0011581
SNOMED CT 2011_0131
35489007
MedDRA 14.1
10012401
ICD-10-CM Version 2010
F32.9
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1516026
UMLS CUI 2011AA
C0027360
SNOMED CT 2011_0131
373546002
LOINC Version 232
MTHU002303
UMLS CUI 2011AA
C0041626
SNOMED CT 2011_0131
363695005
MedDRA 14.1
10046850
ICD-9-CM Version 2011
99.82
wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
Description

wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0859336
MedDRA 14.1
10048037
UMLS CUI 2011AA
C0743223
UMLS CUI 2011AA
C0022548
SNOMED CT 2011_0131
58405006
MedDRA 14.1
10023329
ICD-10-CM Version 2010
L91.0
ICD-9-CM Version 2011
701.4
UMLS CUI 2011AA
C1553892
HL7 V3 2006_05
CURMEDLIST
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C0205217
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0585033
SNOMED CT 2011_0131
307154001
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0918269
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C1579830
SNOMED CT 2011_0131
417237009
UMLS CUI 2011AA
C0038638
SNOMED CT 2011_0131
274441001
LOINC Version 232
MTHU020990
History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
Description

History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1099414
SNOMED CT 2011_0131
385580005
UMLS CUI 2011AA
C0020268
SNOMED CT 2011_0131
396458002
LOINC Version 232
MTHU035101
Participation in other clinical studies within the last 4 weeks
Description

Participation in other clinical studies within the last 4 weeks

Type de données

boolean

Alias
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
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Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 18 Years to 70 Years
Item
Alter 18 bis 70 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis: Prurigo nodularis
Item
Diagnosis: Prurigo nodularis
boolean
C0263353 (UMLS CUI 2011AA)
63501000 (SNOMED CT 2011_0131)
10037084 (MedDRA 14.1)
L28.1 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Pruritus intensity >VAS 3 (Visual analoge scale 0 to 10)
Item
Pruritus intensity >VAS 3 (Visual analoge scale 0 to 10)
boolean
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)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0042815 (UMLS CUI 2011AA)
273903006 (SNOMED CT 2011_0131)
Nodules on arms and legs (target areas: arms)
Item
Nodules on arms and legs (target areas: arms)
boolean
C0028259 (UMLS CUI 2011AA)
27925004 (SNOMED CT 2011_0131)
10054107 (MedDRA 14.1)
C1140618 (UMLS CUI 2011AA)
53120007 (SNOMED CT 2011_0131)
MTHU011974 (LOINC Version 232)
C0023216 (UMLS CUI 2011AA)
61685007 (SNOMED CT 2011_0131)
MTHU011970 (LOINC Version 232)
C1521840 (UMLS CUI 2011AA)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C1140618 (UMLS CUI 2011AA)
53120007 (SNOMED CT 2011_0131)
MTHU011974 (LOINC Version 232)
No effective current external or internal antipruritic medication
Item
No effective current external or internal antipruritic medication
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C1553892 (UMLS CUI 2011AA)
CURMEDLIST (HL7 V3 2006_05)
C0521134 (UMLS CUI 2011AA)
C0205102 (UMLS CUI 2011AA)
260521003 (SNOMED CT 2011_0131)
C1579276 (UMLS CUI 2011AA)
Signed informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
prurigo nodularis with massive excoriations and/or local infections
Item
prurigo nodularis with massive excoriations and/or local infections
boolean
C0263353 (UMLS CUI 2011AA)
63501000 (SNOMED CT 2011_0131)
10037084 (MedDRA 14.1)
L28.1 (ICD-10-CM Version 2010)
C0522501 (UMLS CUI 2011AA)
46998006 (SNOMED CT 2011_0131)
C0015256 (UMLS CUI 2011AA)
400048001 (SNOMED CT 2011_0131)
10049796 (MedDRA 14.1)
C0406047 (UMLS CUI 2011AA)
10045995 (MedDRA 14.1)
L08.9 (ICD-10-CM Version 2010)
686.9 (ICD-9-CM Version 2011)
atopic dermatitis, predisposition for atopic dermatitis
Item
atopic dermatitis, predisposition for atopic dermatitis
boolean
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012434 (MedDRA 14.1)
L20 (ICD-10-CM Version 2010)
C0012655 (UMLS CUI 2011AA)
76522002 (SNOMED CT 2011_0131)
Itch intensity <VAS 4 (visual analoge scale 0 to 10)
Item
Itch intensity <VAS 4 (visual analoge scale 0 to 10)
boolean
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)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0042815 (UMLS CUI 2011AA)
273903006 (SNOMED CT 2011_0131)
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
Item
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Pregnancy should be ruled out before stating the study by a b-subunit HCG test.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0009637 (UMLS CUI 2011AA)
13693004 (SNOMED CT 2011_0131)
C1692758 (UMLS CUI 2011AA)
TRM (HL7 V3 2006_05)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0750484 (UMLS CUI 2011AA)
C0430063 (UMLS CUI 2011AA)
166437003 (SNOMED CT 2011_0131)
C2348195 (UMLS CUI 2011AA)
10036572 (MedDRA 14.1)
2118-8 (LOINC Version 232)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0430060 (UMLS CUI 2011AA)
166434005 (SNOMED CT 2011_0131)
Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
Item
Females of childbearing potential and not practicing a medically approved, highly effective (low failure rate) method of contraception during and up to at least 4 weeks after the end of treatment. 'Medically approved' contraception may include implants, injectables, combined oral contraceptives, some IUDs (e.g. intrauterine device), sexual abstinence or if the woman has a vasectomized partner.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C1692758 (UMLS CUI 2011AA)
TRM (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
active psychosomatic and psychiatric diseases
Item
active psychosomatic and psychiatric diseases
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0033931 (UMLS CUI 2011AA)
37057007 (SNOMED CT 2011_0131)
10049587 (MedDRA 14.1)
F45.9 (ICD-10-CM Version 2010)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
History of active malignancy of any organ system
Item
History of active malignancy of any organ system
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
Item
actual diseases which need therapy and may induce pruritus (e.g. deficiency of iron, zinc)
boolean
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
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)
C0011155 (UMLS CUI 2011AA)
129453003 (SNOMED CT 2011_0131)
C0302583 (UMLS CUI 2011AA)
3829006 (SNOMED CT 2011_0131)
MTHU004837 (LOINC Version 232)
C0043481 (UMLS CUI 2011AA)
86739005 (SNOMED CT 2011_0131)
MTHU001006 (LOINC Version 232)
Systemic immunosuppression
Item
Systemic immunosuppression
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
Item
Topical use of tacrolimus, pimecrolimus, steroids or capsaicin within 2 weeks prior to study entry
boolean
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C1099414 (UMLS CUI 2011AA)
385580005 (SNOMED CT 2011_0131)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0006931 (UMLS CUI 2011AA)
95995002 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake-inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
Item
current and past (within 2 weeks prior to study entry) systemic use of antihistamines, steroids, cyclosporin A and other immunosuppressants, paroxetin, fluvoxamine (selective serotonin reuptake-inhibitors, study possible in case of medication since 6 months due to depression without having any Antipruritic effect) naltrexone and UV-therapy.
boolean
C1553892 (UMLS CUI 2011AA)
C1273865 (UMLS CUI 2011AA)
394829006 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0003360 (UMLS CUI 2011AA)
372806008 (SNOMED CT 2011_0131)
MTHU003328 (LOINC Version 232)
C2911187 (UMLS CUI 2011AA)
Z79.52 (ICD-10-CM Version 2010)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0070122 (UMLS CUI 2011AA)
372595009 (SNOMED CT 2011_0131)
MTHU004267 (LOINC Version 232)
C0085228 (UMLS CUI 2011AA)
372905008 (SNOMED CT 2011_0131)
MTHU002297 (LOINC Version 232)
C0360105 (UMLS CUI 2011AA)
373225007 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
CL420107 (UMLS CUI 2011AA)
C0011581 (UMLS CUI 2011AA)
35489007 (SNOMED CT 2011_0131)
10012401 (MedDRA 14.1)
F32.9 (ICD-10-CM Version 2010)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1516026 (UMLS CUI 2011AA)
C0027360 (UMLS CUI 2011AA)
373546002 (SNOMED CT 2011_0131)
MTHU002303 (LOINC Version 232)
C0041626 (UMLS CUI 2011AA)
363695005 (SNOMED CT 2011_0131)
10046850 (MedDRA 14.1)
99.82 (ICD-9-CM Version 2011)
wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
Item
wound healing disturbances, disposition for keloids, current medication which leads to increased bleeding during procedure e.g. acetylsalicylic acid (ASS), marcumar (no suction blister possible)
boolean
C0859336 (UMLS CUI 2011AA)
10048037 (MedDRA 14.1)
C0743223 (UMLS CUI 2011AA)
C0022548 (UMLS CUI 2011AA)
58405006 (SNOMED CT 2011_0131)
10023329 (MedDRA 14.1)
L91.0 (ICD-10-CM Version 2010)
701.4 (ICD-9-CM Version 2011)
C1553892 (UMLS CUI 2011AA)
CURMEDLIST (HL7 V3 2006_05)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0205217 (UMLS CUI 2011AA)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0585033 (UMLS CUI 2011AA)
307154001 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0918269 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C1579830 (UMLS CUI 2011AA)
417237009 (SNOMED CT 2011_0131)
C0038638 (UMLS CUI 2011AA)
274441001 (SNOMED CT 2011_0131)
MTHU020990 (LOINC Version 232)
History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
Item
History of hypersensitivity to pimecrolimus 1% cream or hydrocortisone 1% cream
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1099414 (UMLS CUI 2011AA)
385580005 (SNOMED CT 2011_0131)
C0020268 (UMLS CUI 2011AA)
396458002 (SNOMED CT 2011_0131)
MTHU035101 (LOINC Version 232)
Participation in other clinical studies within the last 4 weeks
Item
Participation in other clinical studies within the last 4 weeks
boolean
C0679823 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
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