Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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