ID
43091
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT01376908
Länk
http://clinicaltrials.gov/show/NCT01376908
Nyckelord
Versioner (3)
- 2013-04-17 2013-04-17 - Martin Dugas
- 2014-04-20 2014-04-20 - Julian Varghese
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT01376908 Phenylketonuria (PKU)
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Beskrivning
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
Datatyp
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
Beskrivning
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Datatyp
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
Beskrivning
Known hypersensitivity to Kuvan or its excipients.
Datatyp
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
Beskrivning
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Datatyp
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
Beskrivning
Previous diagnosis of BH4 deficiency.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0332132
- SNOMED CT 2011_0131
- 48318009
- UMLS CUI 2011AA
- C0751436
- MedDRA 14.1
- 10069116
Beskrivning
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Datatyp
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
Beskrivning
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Datatyp
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
Beskrivning
Current use of levodopa.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0699991
- SNOMED CT 2011_0131
- 15383004
- LOINC Version 232
- MTHU015998
Beskrivning
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Datatyp
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
Beskrivning
Inability to comply with study procedures.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 371151008
Beskrivning
Inability to tolerate oral intake.
Datatyp
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
Beskrivning
History of organ transplantation.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
Beskrivning
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.
Datatyp
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
- C1281905
- 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
Beskrivning
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Datatyp
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
Beskrivning
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.
Datatyp
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
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0031485 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0021270 (UMLS CUI 2011AA)
133931009 (SNOMED CT 2011_0131)
10021731 (MedDRA 14.1)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0205474 (UMLS CUI 2011AA)
80534008 (SNOMED CT 2011_0131)
C0031485 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
9130008 (SNOMED CT 2011_0131)
C0871261 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
252129004 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
260370003 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0031453 (UMLS CUI 2011AA)
63004003 (SNOMED CT 2011_0131)
MTHU003552 (LOINC Version 232)
C0013220 (UMLS CUI 2011AA)
228432001 (SNOMED CT 2011_0131)
10052804 (MedDRA 14.1)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0031485 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C1171369 (UMLS CUI 2011AA)
C0457976 (UMLS CUI 2011AA)
182927005 (SNOMED CT 2011_0131)
C0770246 (UMLS CUI 2011AA)
226282004 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0428204 (UMLS CUI 2011AA)
365727002 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1521840 (UMLS CUI 2011AA)
C1514721 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C1274041 (UMLS CUI 2011AA)
394619001 (SNOMED CT 2011_0131)
MTHU014954 (LOINC Version 232)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1514821 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0552602 (UMLS CUI 2011AA)
MTHU002705 (LOINC Version 232)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
9130008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C1995652 (UMLS CUI 2011AA)
434239009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1514821 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
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)
T78.40 (ICD-10-CM Version 2010)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705957 (UMLS CUI 2011AA)
C0048897 (UMLS CUI 2011AA)
432859002 (SNOMED CT 2011_0131)
MTHU035851 (LOINC Version 232)
48318009 (SNOMED CT 2011_0131)
C0751436 (UMLS CUI 2011AA)
10069116 (MedDRA 14.1)
260676000 (SNOMED CT 2011_0131)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0041041 (UMLS CUI 2011AA)
32792001 (SNOMED CT 2011_0131)
MTHU002305 (LOINC Version 232)
C2911817 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C1157570 (UMLS CUI 2011AA)
C1158468 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0699991 (UMLS CUI 2011AA)
15383004 (SNOMED CT 2011_0131)
MTHU015998 (LOINC Version 232)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
CL415205 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0683954 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
371151008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C1512806 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
64572001 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C1281905 (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)
C1882509 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
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)