ID
4914
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00506688
Länk
http://clinicaltrials.gov/show/NCT00506688
Nyckelord
Versioner (3)
- 2013-12-10 2013-12-10 - Martin Dugas
- 2014-04-14 2014-04-14 - Julian Varghese
- 2021-09-20 2021-09-20 -
Uppladdad den
14 april 2014
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT00506688 Cystic Fibrosis
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
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)
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
New oral or inhaled thiol-containing medications (e.g., inhaled or oral N-acetylcysteine) throughout the study period.
Datatyp
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
Beskrivning
Patient with a known relevant substance abuse, including alcohol or drug abuse.
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
Patient with a documented persistent colonization with B. cepacia (defined as >1 positive culture within the past year).
Datatyp
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
Beskrivning
Start of a new concomitant or chronic medication for CF within 4 weeks of screening.
Datatyp
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
Beskrivning
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
Datatyp
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
Beskrivning
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).
Datatyp
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
Beskrivning
Participation in another study with an investigational drug within one month or 6 halflives(whichever is greater) preceding the screening visit.
Datatyp
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
Beskrivning
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.
Datatyp
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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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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J06.9 (ICD-10-CM Version 2010)
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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)
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C0001617 (UMLS CUI 2011AA)
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77731008 (SNOMED CT 2011_0131)
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10062577 (MedDRA 14.1)
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10022745 (MedDRA 14.1)
C0205173 (UMLS CUI 2011AA)
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225370004 (SNOMED CT 2011_0131)
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10065591 (MedDRA 14.1)
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397934002 (SNOMED CT 2011_0131)
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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)
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C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
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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)