age 18 Years to 85 Years
Item
Alter 18 bis 85 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
Item
Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
boolean
C0024140 (UMLS CUI 2011AA)
239891002 (SNOMED CT 2011_0131)
10057903 (MedDRA 14.1)
L93.1 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0024138 (UMLS CUI 2011AA)
200938002 (SNOMED CT 2011_0131)
10013072 (MedDRA 14.1)
L93.0 (ICD-10-CM Version 2010)
C0406636 (UMLS CUI 2011AA)
200941006 (SNOMED CT 2011_0131)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
Item
Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
CL424941 (UMLS CUI 2011AA)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0419530 (UMLS CUI 2011AA)
268464009 (SNOMED CT 2011_0131)
C0205195 (UMLS CUI 2011AA)
89780004 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0493327 (UMLS CUI 2011AA)
368441006 (SNOMED CT 2011_0131)
10007183 (MedDRA 14.1)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
Item
Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0520483 (UMLS CUI 2011AA)
77543007 (SNOMED CT 2011_0131)
10044722 (MedDRA 14.1)
Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
Item
Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
boolean
C0392337 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
Item
Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
boolean
C1511795 (UMLS CUI 2011AA)
C0037284 (UMLS CUI 2011AA)
95324001 (SNOMED CT 2011_0131)
10040882 (MedDRA 14.1)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
Signed informed consent form after the nature of the study has been fully explained.
Item
Signed informed consent form after the nature of the study has been fully explained.
boolean
C0021430 (UMLS CUI 2011AA)
Pregnancy or lactation and women with positive pregnancy test.
Item
Pregnancy or lactation and women with positive pregnancy test.
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0240802 (UMLS CUI 2011AA)
250423000 (SNOMED CT 2011_0131)
10036575 (MedDRA 14.1)
Known hypersensitivity or allergic contact reactions to components of the study agents.
Item
Known hypersensitivity or allergic contact reactions to components of the study agents.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0700624 (UMLS CUI 2011AA)
C0443191 (UMLS CUI 2011AA)
263726009 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Treatment with photosensitizing drugs.
Item
Treatment with photosensitizing drugs.
boolean
C0039798 (UMLS CUI 2011AA)
C0162713 (UMLS CUI 2011AA)
108817007 (SNOMED CT 2011_0131)
Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
Item
Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
boolean
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0038817 (UMLS CUI 2011AA)
49926000 (SNOMED CT 2011_0131)
C0205296 (UMLS CUI 2011AA)
510009 (SNOMED CT 2011_0131)
C2004457 (UMLS CUI 2011AA)
71967004 (SNOMED CT 2011_0131)
C0041625 (UMLS CUI 2011AA)
41355003 (SNOMED CT 2011_0131)
C0004600 (UMLS CUI 2011AA)
123961009 (SNOMED CT 2011_0131)
MTHU001427 (LOINC Version 232)
History of another photodermatosis, except polymorph light eruption (PLE).
Item
History of another photodermatosis, except polymorph light eruption (PLE).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0920193 (UMLS CUI 2011AA)
10051246 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0031736 (UMLS CUI 2011AA)
238525001 (SNOMED CT 2011_0131)
10036087 (MedDRA 14.1)
L56.4 (ICD-10-CM Version 2010)
Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
Item
Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
boolean
C0007114 (UMLS CUI 2011AA)
372130007 (SNOMED CT 2011_0131)
10040808 (MedDRA 14.1)
C44.9 (ICD-10-CM Version 2010)
C0043346 (UMLS CUI 2011AA)
44600005 (SNOMED CT 2011_0131)
10048220 (MedDRA 14.1)
Q82.1 (ICD-10-CM Version 2010)
Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
Item
Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
boolean
C1704686 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C2347524 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0430551 (UMLS CUI 2011AA)
87724004 (SNOMED CT 2011_0131)
Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
Item
Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
boolean
C1517925 (UMLS CUI 2011AA)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0430551 (UMLS CUI 2011AA)
87724004 (SNOMED CT 2011_0131)
C0004600 (UMLS CUI 2011AA)
123961009 (SNOMED CT 2011_0131)
MTHU001427 (LOINC Version 232)
Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
Item
Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
Item
Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL426143 (UMLS CUI 2011AA)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
Item
Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
boolean
C2747927 (UMLS CUI 2011AA)
10069914 (MedDRA 14.1)
C0034580 (UMLS CUI 2011AA)
4613005 (SNOMED CT 2011_0131)
0104 (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
Item
Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
boolean
C0036749 (UMLS CUI 2011AA)
370469003 (SNOMED CT 2011_0131)
10058556 (MedDRA 14.1)
C0032231 (UMLS CUI 2011AA)
196075003 (SNOMED CT 2011_0131)
10035618 (MedDRA 14.1)
R09.1 (ICD-10-CM Version 2010)
511 (ICD-9-CM Version 2011)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0232267 (UMLS CUI 2011AA)
7036007 (SNOMED CT 2011_0131)
10049759 (MedDRA 14.1)
C0031039 (UMLS CUI 2011AA)
373945007 (SNOMED CT 2011_0131)
10034474 (MedDRA 14.1)
E10172 (CTCAE 1105E)
Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
Item
Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
boolean
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0033687 (UMLS CUI 2011AA)
29738008 (SNOMED CT 2011_0131)
10037032 (MedDRA 14.1)
R80 (ICD-10-CM Version 2010)
791.0 (ICD-9-CM Version 2011)
E13008 (CTCAE 1105E)
C0427895 (UMLS CUI 2011AA)
250445004 (SNOMED CT 2011_0131)
Neurologic disorder: seizures or psychosis without other cause.
Item
Neurologic disorder: seizures or psychosis without other cause.
boolean
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0033975 (UMLS CUI 2011AA)
69322001 (SNOMED CT 2011_0131)
10061920 (MedDRA 14.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE 1105E)
Patients with a documented HIV and/or hepatitis B or C infection.
Item
Patients with a documented HIV and/or hepatitis B or C infection.
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
Item
Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0750558 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C1522577 (UMLS CUI 2011AA)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)