ID

43489

Description

ODM derived from http://clinicaltrials.gov/show/NCT00866684

Link

http://clinicaltrials.gov/show/NCT00866684

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00866684 Kidney Transplantation

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
Description

Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions

Data type

boolean

Alias
UMLS CUI 2011AA
C1709854
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C0040739
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0441766
SNOMED CT 2011_0131
258215001
LOINC Version 232
MTHU035012
UMLS CUI 2011AA
C0441767
SNOMED CT 2011_0131
258219007
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0441771
SNOMED CT 2011_0131
258224005
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0007137
SNOMED CT 2011_0131
28899001
MedDRA 14.1
10041823
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1514391
UMLS CUI 2011AA
C1709160
UMLS CUI 2011AA
C0037284
SNOMED CT 2011_0131
95324001
MedDRA 14.1
10040882
Minimum period of 6 month after renal transplantation
Description

Minimum period of 6 month after renal transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
Stable renal function and a calculated creatinine clearance of at least 40 ml/min
Description

Stable renal function and a calculated creatinine clearance of at least 40 ml/min

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0444686
SNOMED CT 2011_0131
258090004
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Proteinuria <= 800 mg/d at time of enrolment
Description

Proteinuria <= 800 mg/d at time of enrolment

Data type

boolean

Alias
UMLS CUI 2011AA
C0033687
SNOMED CT 2011_0131
29738008
MedDRA 14.1
10037032
ICD-10-CM Version 2010
R80
ICD-9-CM Version 2011
791.0
CTCAE 1105E
E13008
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1516879
Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
Description

Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)

Data type

boolean

Alias
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0280100
MedDRA 14.1
10065252
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Current Sirolimus- or Everolimus-intake
Description

Current Sirolimus- or Everolimus-intake

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
UMLS CUI 2011AA
C0541315
SNOMED CT 2011_0131
428698007
LOINC Version 232
MTHU026817
Instable graft function (creatinine clearance < 40 ml/min)
Description

Instable graft function (creatinine clearance < 40 ml/min)

Data type

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Graft rejection
Description

Graft rejection within the 3 previous months

Data type

boolean

Alias
UMLS CUI 2011AA
C0018129
SNOMED CT 2011_0131
72627004
MedDRA 14.1
10044439
Proteinuria
Description

Proteinuria > 800 mg/d

Data type

boolean

Alias
UMLS CUI 2011AA
C0033687
SNOMED CT 2011_0131
29738008
MedDRA 14.1
10037032
ICD-10-CM Version 2010
R80
ICD-9-CM Version 2011
791.0
CTCAE 1105E
E13008
Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
Description

Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0020473
SNOMED CT 2011_0131
55822004
MedDRA 14.1
10062060
ICD-10-CM Version 2010
E78.5
UMLS CUI 2011AA
C0008377
SNOMED CT 2011_0131
84698008
LOINC Version 232
MTHU003147
UMLS CUI 2011AA
C0041004
SNOMED CT 2011_0131
85600001
LOINC Version 232
MTHU003166
Leukocytopenia
Description

Leucopenia < 2500/nl

Data type

boolean

Alias
UMLS CUI 2011AA
C0023530
SNOMED CT 2011_0131
84828003
MedDRA 14.1
10024384
ICD-10-CM Version 2010
D72.819
ICD-9-CM Version 2011
288.50
CTCAE 1105E
E12232
Thrombocytopenia
Description

Thrombocytopenia < 90/nl

Data type

boolean

Alias
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
Pregnancy or breastfeeding
Description

Pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
Description

Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
Known allergy to macrolides
Description

Known allergy to macrolides

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0282563
SNOMED CT 2011_0131
428787002
Current participation in other studies
Description

Current participation in other studies

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Refusal to sign informed consent form
Description

Refusal to sign informed consent form

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Neoplasm other than defined as inclusion criteria
Description

Neoplasm other than defined as inclusion criteria

Data type

boolean

Alias
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
CL411789
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
CL425202
All contraindications to SRL (see package insert, appendix)
Description

All contraindications to SRL (see package insert, appendix)

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
Persons who are detained officially or legally to an official institute
Description

Persons who are detained officially or legally to an official institute

Data type

boolean

Alias
UMLS CUI 2011AA
C0027361
SNOMED CT 2011_0131
125676002
HL7 V3 2006_05
PSN
UMLS CUI 2011AA
C0680725
UMLS CUI 2011AA
C0442681
SNOMED CT 2011_0131
257656006
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
Item
Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
boolean
C1709854 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0040739 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0441766 (UMLS CUI 2011AA)
258215001 (SNOMED CT 2011_0131)
MTHU035012 (LOINC Version 232)
C0441767 (UMLS CUI 2011AA)
258219007 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0441771 (UMLS CUI 2011AA)
258224005 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1514391 (UMLS CUI 2011AA)
C1709160 (UMLS CUI 2011AA)
C0037284 (UMLS CUI 2011AA)
95324001 (SNOMED CT 2011_0131)
10040882 (MedDRA 14.1)
Minimum period of 6 month after renal transplantation
Item
Minimum period of 6 month after renal transplantation
boolean
C1524031 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Stable renal function and a calculated creatinine clearance of at least 40 ml/min
Item
Stable renal function and a calculated creatinine clearance of at least 40 ml/min
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Proteinuria <= 800 mg/d at time of enrolment
Item
Proteinuria <= 800 mg/d at time of enrolment
boolean
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)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
Item
Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
boolean
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0280100 (UMLS CUI 2011AA)
10065252 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Current Sirolimus- or Everolimus-intake
Item
Current Sirolimus- or Everolimus-intake
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0541315 (UMLS CUI 2011AA)
428698007 (SNOMED CT 2011_0131)
MTHU026817 (LOINC Version 232)
Instable graft function (creatinine clearance < 40 ml/min)
Item
Instable graft function (creatinine clearance < 40 ml/min)
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Graft rejection within the 3 previous months
Item
Graft rejection
boolean
C0018129 (UMLS CUI 2011AA)
72627004 (SNOMED CT 2011_0131)
10044439 (MedDRA 14.1)
Proteinuria > 800 mg/d
Item
Proteinuria
boolean
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)
Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
Item
Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0020473 (UMLS CUI 2011AA)
55822004 (SNOMED CT 2011_0131)
10062060 (MedDRA 14.1)
E78.5 (ICD-10-CM Version 2010)
C0008377 (UMLS CUI 2011AA)
84698008 (SNOMED CT 2011_0131)
MTHU003147 (LOINC Version 232)
C0041004 (UMLS CUI 2011AA)
85600001 (SNOMED CT 2011_0131)
MTHU003166 (LOINC Version 232)
Leucopenia < 2500/nl
Item
Leukocytopenia
boolean
C0023530 (UMLS CUI 2011AA)
84828003 (SNOMED CT 2011_0131)
10024384 (MedDRA 14.1)
D72.819 (ICD-10-CM Version 2010)
288.50 (ICD-9-CM Version 2011)
E12232 (CTCAE 1105E)
Thrombocytopenia < 90/nl
Item
Thrombocytopenia
boolean
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
Pregnancy or breastfeeding
Item
Pregnancy or breastfeeding
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)
Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
Item
Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Known allergy to macrolides
Item
Known allergy to macrolides
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0282563 (UMLS CUI 2011AA)
428787002 (SNOMED CT 2011_0131)
Current participation in other studies
Item
Current participation in other studies
boolean
C2348568 (UMLS CUI 2011AA)
Refusal to sign informed consent form
Item
Refusal to sign informed consent form
boolean
C0021430 (UMLS CUI 2011AA)
Neoplasm other than defined as inclusion criteria
Item
Neoplasm other than defined as inclusion criteria
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
CL425202 (UMLS CUI 2011AA)
All contraindications to SRL (see package insert, appendix)
Item
All contraindications to SRL (see package insert, appendix)
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
Persons who are detained officially or legally to an official institute
Item
Persons who are detained officially or legally to an official institute
boolean
C0027361 (UMLS CUI 2011AA)
125676002 (SNOMED CT 2011_0131)
PSN (HL7 V3 2006_05)
C0680725 (UMLS CUI 2011AA)
C0442681 (UMLS CUI 2011AA)
257656006 (SNOMED CT 2011_0131)
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