ID
43091
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT01376908
Link
http://clinicaltrials.gov/show/NCT01376908
Stichworte
Versionen (3)
- 17.04.13 17.04.13 - Martin Dugas
- 20.04.14 20.04.14 - Julian Varghese
- 20.09.21 20.09.21 -
Hochgeladen am
20. September 2021
DOI
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Lizenz
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Eligibility NCT01376908 Phenylketonuria (PKU)
Eligibility
- StudyEvent: Eligibility
Beschreibung
Ausschlusskriterien
Beschreibung
Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test.
Datentyp
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
Beschreibung
Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days.
Datentyp
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
Beschreibung
Known hypersensitivity to Kuvan or its excipients.
Datentyp
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
Beschreibung
Known hypersensitivity to other approved or non-approved formulations of tetrahydrobiopterin.
Datentyp
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
Beschreibung
Previous diagnosis of BH4 deficiency.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0332132
- SNOMED CT 2011_0131
- 48318009
- UMLS CUI 2011AA
- C0751436
- MedDRA 14.1
- 10069116
Beschreibung
Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors.
Datentyp
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
Beschreibung
Current use of medications that are known to affect nitric oxide synthesis, metabolism or action.
Datentyp
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
Beschreibung
Current use of levodopa.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0699991
- SNOMED CT 2011_0131
- 15383004
- LOINC Version 232
- MTHU015998
Beschreibung
Current use of experimental/other investigational or unregistered drugs that may affect the study outcomes.
Datentyp
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
Beschreibung
Inability to comply with study procedures.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 371151008
Beschreibung
Inability to tolerate oral intake.
Datentyp
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
Beschreibung
History of organ transplantation.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0029216
- MedDRA 14.1
- 10061890
- LOINC Version 232
- MTHU000173
Beschreibung
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.
Datentyp
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
Beschreibung
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Datentyp
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
Beschreibung
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.
Datentyp
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
Ähnliche Modelle
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)