ID

4415

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00823173

Link

http://clinicaltrials.gov/show/NCT00823173

Palavras-chave

Uveitis anterior

Transferido a

9 de dezembro de 2013

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00823173 Anterior Uveitis

model
Detalhes

Eligibility

1 Formulários

StudyEvent: Eligibility
1. Eligibility

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

Einschlusskriterien

CL425202 (UMLS CUI 2011AA)

age at least 18 Years

Item

Alter mindestens 18 Jahre

boolean

C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)

Signed and dated informed consent.

Item

Signed and dated informed consent.

boolean

C1519316 (UMLS CUI 2011AA)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
C0021430 (UMLS CUI 2011AA)

Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).

Item

Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).

boolean

C0019740 (UMLS CUI 2011AA)
34453005 (SNOMED CT 2011_0131)
MTHU012533 (LOINC Version 232)
CL415097 (UMLS CUI 2011AA)
C0701807 (UMLS CUI 2011AA)
4927003 (SNOMED CT 2011_0131)
H20.0 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
CL414713 (UMLS CUI 2011AA)
C0042165 (UMLS CUI 2011AA)
410692006 (SNOMED CT 2011_0131)
10046852 (MedDRA 14.1)
C1272517 (UMLS CUI 2011AA)
385315009 (SNOMED CT 2011_0131)

2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.

Item

2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.

boolean

C2827735 (UMLS CUI 2011AA)
C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0038136 (UMLS CUI 2011AA)
C0042164 (UMLS CUI 2011AA)
128473001 (SNOMED CT 2011_0131)
10046851 (MedDRA 14.1)
H20.9 (ICD-10-CM Version 2010)
E10442 (CTCAE 1105E)
C0600281 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0183355 (UMLS CUI 2011AA)
397247004 (SNOMED CT 2011_0131)

Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.

Item

boolean

C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C1304680 (UMLS CUI 2011AA)
216299002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)

Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).

Item

Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).

boolean

C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0279752 (UMLS CUI 2011AA)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)

Patients with a negative QuantiFERON TB Gold test result.

Item

Patients with a negative QuantiFERON TB Gold test result.

boolean

C1875713 (UMLS CUI 2011AA)
C1334932 (UMLS CUI 2011AA)

Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.

Item

Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.

boolean

C1518422 (UMLS CUI 2011AA)
C0019740 (UMLS CUI 2011AA)
34453005 (SNOMED CT 2011_0131)
MTHU012533 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0241886 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)

Patients who are willing and able to cooperate with study requirements.

Item

Patients who are willing and able to cooperate with study requirements.

boolean

C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)

Exclusion Criteria

Item Group

Ausschlusskriterien

CL425201 (UMLS CUI 2011AA)

IOP elevation requiring therapy.

Item

IOP elevation requiring therapy.

boolean

C0234708 (UMLS CUI 2011AA)
112222000 (SNOMED CT 2011_0131)
10022806 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)

Uncontrolled diabetes mellitus and diabetic retinopathy.

Item

Uncontrolled diabetes mellitus and diabetic retinopathy.

boolean

C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)

Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.

Item

Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.

boolean

C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0450042 (UMLS CUI 2011AA)
257492003 (SNOMED CT 2011_0131)
C1827708 (UMLS CUI 2011AA)
422673001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)

Patients with <= 1+ anterior chamber cells.

Item

Zellen in der Augenvorderkammer <= 1+

boolean

C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)

Patients with 3+ or 4+ anterior chamber cells or hypopyon.

Item

Patients with 3+ or 4+ anterior chamber cells or hypopyon.

boolean

C2827736 (UMLS CUI 2011AA)
C2827737 (UMLS CUI 2011AA)
C0423282 (UMLS CUI 2011AA)
246993000 (SNOMED CT 2011_0131)
10053781 (MedDRA 14.1)
C0020641 (UMLS CUI 2011AA)
87807004 (SNOMED CT 2011_0131)
10021086 (MedDRA 14.1)
H20.05 (ICD-10-CM Version 2010)
364.05 (ICD-9-CM Version 2011)

Patients in whom the time of the beginning of the current attack can not be determined.

Item

Patients in whom the time of the beginning of the current attack can not be determined.

boolean

C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0439659 (UMLS CUI 2011AA)
246062003 (SNOMED CT 2011_0131)
MTHU026300 (LOINC Version 232)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1304680 (UMLS CUI 2011AA)
216299002 (SNOMED CT 2011_0131)
C0439673 (UMLS CUI 2011AA)
261665006 (SNOMED CT 2011_0131)

Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.

Item

Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.

boolean

C0010043 (UMLS CUI 2011AA)
91514001 (SNOMED CT 2011_0131)
10011060 (MedDRA 14.1)
H16.0 (ICD-10-CM Version 2010)
370.0 (ICD-9-CM Version 2011)
E10359 (CTCAE 1105E)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1274320 (UMLS CUI 2011AA)
402891002 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1262170 (UMLS CUI 2011AA)
10062639 (MedDRA 14.1)

Patients currently treated with topical corticosteroids.

Item

Patients currently treated with topical corticosteroids.

boolean

C2827774 (UMLS CUI 2011AA)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)

Patients treated with systemic immunosuppressive therapy within the last 2 months.

Item

Patients treated with systemic immunosuppressive therapy within the last 2 months.

boolean

C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)

Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.

Item

Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.

boolean

C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1521801 (UMLS CUI 2011AA)
C1562242 (UMLS CUI 2011AA)
416897008 (SNOMED CT 2011_0131)

Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.

Item

Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.

boolean

C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
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)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)

Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.

Item

Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.

boolean

C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)

Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.

Item

Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.

boolean

C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)

Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.

Item

boolean

CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0239998 (UMLS CUI 2011AA)
10067860 (MedDRA 14.1)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0151317 (UMLS CUI 2011AA)
177010002 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C0039128 (UMLS CUI 2011AA)
76272004 (SNOMED CT 2011_0131)
10062120 (MedDRA 14.1)
A53.9 (ICD-10-CM Version 2010)
097.9 (ICD-9-CM Version 2011)
C0019348 (UMLS CUI 2011AA)
88594005 (SNOMED CT 2011_0131)
10019948 (MedDRA 14.1)
B00 (ICD-10-CM Version 2010)
054 (ICD-9-CM Version 2011)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0019186 (UMLS CUI 2011AA)
C0019655 (UMLS CUI 2011AA)
12962009 (SNOMED CT 2011_0131)
10020141 (MedDRA 14.1)
B39.9 (ICD-10-CM Version 2010)
115.90 (ICD-9-CM Version 2011)
C0004030 (UMLS CUI 2011AA)
65553006 (SNOMED CT 2011_0131)
10003488 (MedDRA 14.1)
B44 (ICD-10-CM Version 2010)
117.3 (ICD-9-CM Version 2011)
C0262426 (UMLS CUI 2011AA)

Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.

Item

Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.

boolean

C0578862 (UMLS CUI 2011AA)
302157000 (SNOMED CT 2011_0131)
C0042164 (UMLS CUI 2011AA)
128473001 (SNOMED CT 2011_0131)
10046851 (MedDRA 14.1)
H20.9 (ICD-10-CM Version 2010)
E10442 (CTCAE 1105E)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0441988 (UMLS CUI 2011AA)
255209002 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)

Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.

Item

Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.

boolean

C0449439 (UMLS CUI 2011AA)
246098006 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
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)

Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.

Item

Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.

boolean

CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011304 (UMLS CUI 2011AA)
32693004 (SNOMED CT 2011_0131)
10012305 (MedDRA 14.1)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C0029134 (UMLS CUI 2011AA)
66760008 (SNOMED CT 2011_0131)
10030942 (MedDRA 14.1)
H46.9 (ICD-10-CM Version 2010)
377.30 (ICD-9-CM Version 2011)

Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.

Item

Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.

boolean

C1875713 (UMLS CUI 2011AA)
C1335447 (UMLS CUI 2011AA)
CL427836 (UMLS CUI 2011AA)
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C2732789 (UMLS CUI 2011AA)
444507004 (SNOMED CT 2011_0131)

Patients with known coexisting malignancy.

Item

Patients with known coexisting malignancy.

boolean

CL415222 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)

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ID

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Comentários do grupo de itens para :

Comentários do item para :

Eligibility NCT00823173 Anterior Uveitis

Eligibility

Descrição

Alias

Descrição

Tipo de dados

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