ID
3842
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01376908
Link
http://clinicaltrials.gov/show/NCT01376908
Palabras clave
Versiones (3)
- 17/4/13 17/4/13 - Martin Dugas
- 20/4/14 20/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
17 de abril de 2013
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01376908 Phenylketonuria (PKU)
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Descripción
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
Tipo de datos
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
Descripción
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Tipo de datos
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
Descripción
Known hypersensitivity to Kuvan or its excipients.
Tipo de datos
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
Descripción
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Tipo de datos
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
Descripción
Previous diagnosis of BH4 deficiency.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0332132
- SNOMED CT 2011_0131
- 48318009
- UMLS CUI 2011AA
- C2057687
- MedDRA 14.1
- 10069116
Descripción
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Tipo de datos
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
Descripción
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Tipo de datos
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
Descripción
Current use of levodopa.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0699991
- SNOMED CT 2011_0131
- 15383004
- LOINC Version 232
- MTHU015998
Descripción
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Tipo de datos
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
Descripción
Inability to comply with study procedures.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0525058
Descripción
Inability to tolerate oral intake.
Tipo de datos
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
Descripción
History of organ transplantation.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
Descripción
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.
Tipo de datos
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
Descripción
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Tipo de datos
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
Descripción
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.
Tipo de datos
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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Eligibility
- StudyEvent: Eligibility
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258706009 (SNOMED CT 2011_0131)
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418634005 (SNOMED CT 2011_0131)
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416118004 (SNOMED CT 2011_0131)
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363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
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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)
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258143003 (SNOMED CT 2011_0131)
C0680095 (UMLS CUI 2011AA)
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110465008 (SNOMED CT 2011_0131)