ID
3842
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT01376908
Link
http://clinicaltrials.gov/show/NCT01376908
Trefwoorden
Versies (3)
- 17-04-13 17-04-13 - Martin Dugas
- 20-04-14 20-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
17 april 2013
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01376908 Phenylketonuria (PKU)
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Beschrijving
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1995652
- SNOMED CT 2011_0131
- 434239009
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1514821
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
- UMLS CUI 2011AA
- C0552602
- LOINC Version 232
- MTHU002705
- UMLS CUI 2011AA
- C0022885
- SNOMED CT 2011_0131
- 15220000
- MedDRA 14.1
- 10059938
Beschrijving
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0332157
- SNOMED CT 2011_0131
- 24932003
- UMLS CUI 2011AA
- C1995652
- SNOMED CT 2011_0131
- 434239009
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1514821
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205447
- SNOMED CT 2011_0131
- 38112003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
Beschrijving
Known hypersensitivity to Kuvan or its excipients.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C1995652
- SNOMED CT 2011_0131
- 434239009
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
Beschrijving
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C1705957
- UMLS CUI 2011AA
- C0048897
- SNOMED CT 2011_0131
- 432859002
- LOINC Version 232
- MTHU035851
Beschrijving
Previous diagnosis of BH4 deficiency.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0332132
- SNOMED CT 2011_0131
- 48318009
- UMLS CUI 2011AA
- C2057687
- MedDRA 14.1
- 10069116
Beschrijving
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0025677
- SNOMED CT 2011_0131
- 387381009
- LOINC Version 232
- MTHU005020
- UMLS CUI 2011AA
- C0041041
- SNOMED CT 2011_0131
- 32792001
- LOINC Version 232
- MTHU002305
- UMLS CUI 2011AA
- C2911817
Beschrijving
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C1157570
- UMLS CUI 2011AA
- C1158468
Beschrijving
Current use of levodopa.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0699991
- SNOMED CT 2011_0131
- 15383004
- LOINC Version 232
- MTHU015998
Beschrijving
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- CL415205
- UMLS CUI 2011AA
- C0392760
- SNOMED CT 2011_0131
- 247591002
- UMLS CUI 2011AA
- C0683954
Beschrijving
Inability to comply with study procedures.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0525058
Beschrijving
Inability to tolerate oral intake.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C1512806
Beschrijving
History of organ transplantation.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
Beschrijving
Concurrent disease or condition that would interfere with study participation or increase the risk for adverse events, including seizure disorders, corticosteroid administration, active malignancy, diabetes mellitus, severe congenital heart disease, renal or hepatic failure.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C0205217
- HL7 V3 2006_05
- U
- UMLS CUI 2011AA
- C0683481
- UMLS CUI 2011AA
- C0014544
- SNOMED CT 2011_0131
- 84757009, 313307000
- MedDRA 14.1
- 10015037
- LOINC Version 232
- MTHU020586
- ICD-10-CM Version 2010
- G40.9
- ICD-9-CM Version 2011
- 345.9
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C1533734
- SNOMED CT 2011_0131
- 416118004
- 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
- C0011849
- SNOMED CT 2011_0131
- 191044006
- UMLS CUI 2011AA
- C0152021
- SNOMED CT 2011_0131
- 13213009
- MedDRA 14.1
- 10019273
- ICD-10-CM Version 2010
- Q24.9
- UMLS CUI 2011AA
- C1565489
- MedDRA 14.1
- 10038474
- UMLS CUI 2011AA
- C0085605
- SNOMED CT 2011_0131
- 59927004
- MedDRA 14.1
- 10019663
- ICD-10-CM Version 2010
- K72.9
- CTCAE 1105E
- E11211
Beschrijving
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0332196
- SNOMED CT 2011_0131
- 77765009
- UMLS CUI 2011AA
- C0681850
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Beschrijving
Any condition that, in the view of the Principal Investigator renders the subject at high risk for failure to comply with treatment or to complete the study.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1882509
- UMLS CUI 2011AA
- C0681850
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0457432
- SNOMED CT 2011_0131
- 258143003
- UMLS CUI 2011AA
- C0680095
- UMLS CUI 2011AA
- C1554962
- HL7 V3 2006_05
- C
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
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- StudyEvent: Eligibility
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C0031485 (UMLS CUI 2011AA)
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C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
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260676000 (SNOMED CT 2011_0131)
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C1518422 (UMLS CUI 2011AA)
C1514821 (UMLS CUI 2011AA)
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C0048897 (UMLS CUI 2011AA)
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C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
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276140008 (SNOMED CT 2011_0131)
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C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
418634005 (SNOMED CT 2011_0131)
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C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705957 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
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260676000 (SNOMED CT 2011_0131)
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C0683954 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
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371151008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
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MTHU000173 (LOINC Version 232)
64572001 (SNOMED CT 2011_0131)
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260905004 (SNOMED CT 2011_0131)
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78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
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C0683481 (UMLS CUI 2011AA)
C0014544 (UMLS CUI 2011AA)
84757009, 313307000 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (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)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0152021 (UMLS CUI 2011AA)
13213009 (SNOMED CT 2011_0131)
10019273 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C0085605 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10019663 (MedDRA 14.1)
K72.9 (ICD-10-CM Version 2010)
E11211 (CTCAE 1105E)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
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C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
C0680095 (UMLS CUI 2011AA)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)