ID
4546
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00506688
Link
http://clinicaltrials.gov/show/NCT00506688
Trefwoorden
Versies (3)
- 10-12-13 10-12-13 - Martin Dugas
- 14-04-14 14-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
10 december 2013
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00506688 Cystic Fibrosis
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
History of allergy/hypersensitivity (including medication allergy) that is deemed relevant to the trial by the investigator. Relevance in this context refers to any increased risk of hypersensitivity reaction to trial medication. (Specific concerns currently identified with respect to the use of inhaled glutathione in allergic patients per se are not existing)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0552536
- LOINC Version 232
- MTHU002637
- UMLS CUI 2011AA
- C0205217
- HL7 V3 2006_05
- U
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C1527304
- SNOMED CT 2011_0131
- 421668005
- MedDRA 14.1
- 10001718
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C2699424
- UMLS CUI 2011AA
- CL426883
- UMLS CUI 2011AA
- C0017817
- SNOMED CT 2011_0131
- 55477000
- LOINC Version 232
- MTHU006265
Beschrijving
Concomitant inhaled thiol-containing medications (e.g., inhaled N-acetylcysteine). Such medication had to be finished at least 2 weeks before the screening visit. Oral N-acetylcysteine may be continued.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2347852
- UMLS CUI 2011AA
- CL426883
- UMLS CUI 2011AA
- C0038734
- SNOMED CT 2011_0131
- 115582009
- LOINC Version 232
- MTHU024714
- UMLS CUI 2011AA
- C0332256
- UMLS CUI 2011AA
- C0699252
- SNOMED CT 2011_0131
- 77731008
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0699252
- SNOMED CT 2011_0131
- 77731008
Beschrijving
New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1718097
- LOINC Version 232
- MTHU020983
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- CL426883
- UMLS CUI 2011AA
- C0038734
- SNOMED CT 2011_0131
- 115582009
- LOINC Version 232
- MTHU024714
- UMLS CUI 2011AA
- C0332256
- UMLS CUI 2011AA
- C0699252
- SNOMED CT 2011_0131
- 77731008
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C2347804
Beschrijving
Patient with a known relevant substance abuse, including alcohol or drug abuse.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0740858
- SNOMED CT 2011_0131
- 66214007
- MedDRA 14.1
- 10066169
- LOINC Version 232
- MTHU019364
- UMLS CUI 2011AA
- C0332257
- SNOMED CT 2011_0131
- 55919000
- UMLS CUI 2011AA
- C0085762
- SNOMED CT 2011_0131
- 15167005
- MedDRA 14.1
- 10001584
- LOINC Version 232
- LP36309-0
- ICD-10-CM Version 2010
- F10.1
- ICD-9-CM Version 2011
- 305.0
- UMLS CUI 2011AA
- C0013146
- SNOMED CT 2011_0131
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
Beschrijving
Pregnant or lactating woman or female patient of child bearing potential who is sexually active and not using a medically approved form of contraception such as oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0036864
- SNOMED CT 2011_0131
- 363903009
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0420844
- SNOMED CT 2011_0131
- 169450001
- UMLS CUI 2011AA
- C0009905
- SNOMED CT 2011_0131
- 59261009
- UMLS CUI 2011AA
- C1262153
- MedDRA 14.1
- 10062577
- UMLS CUI 2011AA
- C0021900
- SNOMED CT 2011_0131
- 268460000
- MedDRA 14.1
- 10022745
- UMLS CUI 2011AA
- C0205173
- SNOMED CT 2011_0131
- 1305003
- UMLS CUI 2011AA
- C0004764
- SNOMED CT 2011_0131
- 225370004
- UMLS CUI 2011AA
- CL424926
- UMLS CUI 2011AA
- C0024559
- SNOMED CT 2011_0131
- 399141000
- MedDRA 14.1
- 10065591
- ICD-9-CM Version 2011
- 63.70
- UMLS CUI 2011AA
- C0677582
Beschrijving
Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1301725
- SNOMED CT 2011_0131
- 397934002
- UMLS CUI 2011AA
- C0205322
- UMLS CUI 2011AA
- C2747813
- MedDRA 14.1
- 10069718
- UMLS CUI 2011AA
- C0085469
- SNOMED CT 2011_0131
- 113669008
- UMLS CUI 2011AA
- CL415097
- UMLS CUI 2011AA
- C2242979
- SNOMED CT 2011_0131
- 61594008
Beschrijving
Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205314
- SNOMED CT 2011_0131
- 7147002
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0010674
- SNOMED CT 2011_0131
- 190905008
- MedDRA 14.1
- 10011762
- LOINC Version 232
- MTHU021607
- ICD-10-CM Version 2010
- E84
- ICD-9-CM Version 2011
- 277.0
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C1409616
Beschrijving
Existing cycling medication regimen without completion of at least 3 cycles prior to the screening visit or the drug cycles of other therapies are not in accordance with the 4-week time-schedule for the single visits of this study
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0439596
- SNOMED CT 2011_0131
- 44180009
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- CL031856
- UMLS CUI 2011AA
- C0205257
- SNOMED CT 2011_0131
- 255599008
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
- UMLS CUI 2011AA
- CL428482
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0086960
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Beschrijving
Clinically relevant diseases or medical conditions other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This includes, but is not limited to, significant hematological, hepatic,renal, cardiovascular, and neurological diseases (diabetic patients may participate if their disease is under good control prior to screening).
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0010674
- SNOMED CT 2011_0131
- 190905008
- MedDRA 14.1
- 10011762
- LOINC Version 232
- MTHU021607
- ICD-10-CM Version 2010
- E84
- ICD-9-CM Version 2011
- 277.0
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C1113679
- UMLS CUI 2011AA
- C1331008
- UMLS CUI 2011AA
- C0332257
- SNOMED CT 2011_0131
- 55919000
- UMLS CUI 2011AA
- C0018939
- SNOMED CT 2011_0131
- 191124002
- MedDRA 14.1
- 10061590
- ICD-10-CM Version 2010
- D75.9
- ICD-9-CM Version 2011
- 289.9
- UMLS CUI 2011AA
- C1869009
- MedDRA 14.1
- 20000005
- UMLS CUI 2011AA
- C0022658
- SNOMED CT 2011_0131
- 90708001
- MedDRA 14.1
- 10029151
- ICD-10-CM Version 2010
- N18.9
- UMLS CUI 2011AA
- C0007222
- SNOMED CT 2011_0131
- 105980002
- MedDRA 14.1
- 10007649
- ICD-9-CM Version 2011
- 429.2
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
Beschrijving
Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- UMLS CUI 2011AA
- C0018517
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1554196
- HL7 V3 2006_05
- ENC
Beschrijving
The patient is an employee of the investigator or the institution with direct involvement in the trial or other trials under the direction of the investigator or their members.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0599987
- SNOMED CT 2011_0131
- 224528001
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- C0021622
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
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- StudyEvent: Eligibility
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J06.9 (ICD-10-CM Version 2010)
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C0332197 (UMLS CUI 2011AA)
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10068288 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0559680 (UMLS CUI 2011AA)
281790008 (SNOMED CT 2011_0131)
C0559681 (UMLS CUI 2011AA)
281791007 (SNOMED CT 2011_0131)
CL426883 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0001617 (UMLS CUI 2011AA)
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C0439231 (UMLS CUI 2011AA)
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C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
CL371980 (UMLS CUI 2011AA)
CL426375 (UMLS CUI 2011AA)
C0220845 (UMLS CUI 2011AA)
CL415116 (UMLS CUI 2011AA)
C0600657 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
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C1554196 (UMLS CUI 2011AA)
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MTHU006265 (LOINC Version 232)
CL426883 (UMLS CUI 2011AA)
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115582009 (SNOMED CT 2011_0131)
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77731008 (SNOMED CT 2011_0131)
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10013654 (MedDRA 14.1)
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10036586 (MedDRA 14.1)
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224526002 (SNOMED CT 2011_0131)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0036864 (UMLS CUI 2011AA)
363903009 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
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169450001 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0205173 (UMLS CUI 2011AA)
1305003 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
CL424926 (UMLS CUI 2011AA)
C0024559 (UMLS CUI 2011AA)
399141000 (SNOMED CT 2011_0131)
10065591 (MedDRA 14.1)
63.70 (ICD-9-CM Version 2011)
C0677582 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0205322 (UMLS CUI 2011AA)
C2747813 (UMLS CUI 2011AA)
10069718 (MedDRA 14.1)
C0085469 (UMLS CUI 2011AA)
113669008 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C2242979 (UMLS CUI 2011AA)
61594008 (SNOMED CT 2011_0131)
7147002 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
CL428482 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0010674 (UMLS CUI 2011AA)
190905008 (SNOMED CT 2011_0131)
10011762 (MedDRA 14.1)
MTHU021607 (LOINC Version 232)
E84 (ICD-10-CM Version 2010)
277.0 (ICD-9-CM Version 2011)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1113679 (UMLS CUI 2011AA)
C1331008 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
224528001 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0021622 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)