ID
43439
Description
ODM derived from http://clinicaltrials.gov/show/NCT00750282
Link
http://clinicaltrials.gov/show/NCT00750282
Keywords
Versions (3)
- 12/6/13 12/6/13 - Martin Dugas
- 4/16/14 4/16/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00750282 Alzheimer Disease
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Has any contraindication to MRI examination scan
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0917711
- UMLS CUI 2011AA
- C0582103
- SNOMED CT 2011_0131
- 225886003
Description
Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0086960
- UMLS CUI 2011AA
- C0038895
- UMLS CUI 2011AA
- C0348025
- SNOMED CT 2011_0131
- 129236007
- MedDRA 14.1
- 10053756
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- C0917914
- UMLS CUI 2011AA
- CL025718
Description
Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0917914
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0002092
- SNOMED CT 2011_0131
- 90260006
- UMLS CUI 2011AA
- C0155877
- SNOMED CT 2011_0131
- 389145006
- MedDRA 14.1
- 10001705
- ICD-10-CM Version 2010
- J45
- ICD-9-CM Version 2011
- 493.0
Description
is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0010340
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C0443343
- SNOMED CT 2011_0131
- 263922001
- UMLS CUI 2011AA
- C0681842
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0750729
- SNOMED CT 2011_0131
- 288524001
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0332149
- SNOMED CT 2011_0131
- 371930009
Description
Has a history of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0015333
- SNOMED CT 2011_0131
- 218190002
- MedDRA 14.1
- 10063155
- ICD-9-CM Version 2011
- E926.9
- UMLS CUI 2011AA
- C0521127
- SNOMED CT 2011_0131
- 87923000
- UMLS CUI 2011AA
- C0034619
Description
Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL428482
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C0231241
- SNOMED CT 2011_0131
- 255341006
- UMLS CUI 2011AA
- C0205488
- SNOMED CT 2011_0131
- 57407000
- UMLS CUI 2011AA
- C0220806
- SNOMED CT 2011_0131
- 441900009
- HL7 V3 2006_05
- CHEM
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C0549193
- SNOMED CT 2011_0131
- 246446004
- UMLS CUI 2011AA
- C0879626
- SNOMED CT 2011_0131
- 281647001
- MedDRA 14.1
- 10067484
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
Description
Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C1516879
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0008972
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C0182638
- SNOMED CT 2011_0131
- 349358000
Description
Has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0006118
- SNOMED CT 2011_0131
- 126952004
- MedDRA 14.1
- 10061019
- ICD-9-CM Version 2011
- 239.6
- UMLS CUI 2011AA
- C0521653
- SNOMED CT 2011_0131
- 95638000
- UMLS CUI 2011AA
- C0234558
- SNOMED CT 2011_0131
- 2432006
- UMLS CUI 2011AA
- C0020258
- SNOMED CT 2011_0131
- 30753002
- MedDRA 14.1
- 10029773
- ICD-10-CM Version 2010
- G91.2
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0018674
- SNOMED CT 2011_0131
- 82271004
- MedDRA 14.1
- 10019196
- ICD-10-CM Version 2010
- S09.90
- ICD-9-CM Version 2011
- 959.01
- UMLS CUI 2011AA
- C0195775
- SNOMED CT 2011_0131
- 70586009
- MedDRA 14.1
- 10061732
Description
Has an inflammatory or infectious CNS disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0333348
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 40733004
- MedDRA 14.1
- 10021881
- LOINC Version 232
- MTHU034915
- ICD-9-CM Version 2011
- 136.9
- UMLS CUI 2011AA
- C0007682
- SNOMED CT 2011_0131
- 23853001
- MedDRA 14.1
- 10007943
- ICD-10-CM Version 2010
- G96.9
- UMLS CUI 2011AA
- C0026769
- SNOMED CT 2011_0131
- 24700007
- MedDRA 14.1
- 10028245
- LOINC Version 232
- MTHU020805
- ICD-10-CM Version 2010
- G35
- ICD-9-CM Version 2011
- 340
- UMLS CUI 2011AA
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- C0039128
- SNOMED CT 2011_0131
- 76272004
- MedDRA 14.1
- 10062120
- ICD-10-CM Version 2010
- A53.9
- ICD-9-CM Version 2011
- 097.9
- UMLS CUI 2011AA
- C0022336
- SNOMED CT 2011_0131
- 792004
- MedDRA 14.1
- 10011384
- ICD-10-CM Version 2010
- A81.00
- ICD-9-CM Version 2011
- 046.1
Description
Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0311392
- SNOMED CT 2011_0131
- 72670004
- LOINC Version 232
- MTHU001426
- UMLS CUI 2011AA
- C0587081
- SNOMED CT 2011_0131
- 118246004
- UMLS CUI 2011AA
- C0011923
- SNOMED CT 2011_0131
- 363679005
- UMLS CUI 2011AA
- C0243095
- UMLS CUI 2011AA
- CL335836
- 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
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
Description
Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0678908
- UMLS CUI 2011AA
- C0042847
- SNOMED CT 2011_0131
- 190634004
- MedDRA 14.1
- 10047609
- ICD-10-CM Version 2010
- E53.8
- UMLS CUI 2011AA
- C0016412
- SNOMED CT 2011_0131
- 190633005
- MedDRA 14.1
- 10016880
- ICD-10-CM Version 2010
- E53.8
- UMLS CUI 2011AA
- C0348024
- SNOMED CT 2011_0131
- 264580006
- MedDRA 14.1
- 10013907
Description
Has a history of alcohol or drug abuse
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- 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
Description
Has history of severe persistent depression
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205322
- UMLS CUI 2011AA
- C0588008
- SNOMED CT 2011_0131
- 310497006
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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10042244 (MedDRA 14.1)
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60132005 (SNOMED CT 2011_0131)
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62914000 (SNOMED CT 2011_0131)
10008196 (MedDRA 14.1)
I67.9 (ICD-10-CM Version 2010)
437.9 (ICD-9-CM Version 2011)
133932002 (SNOMED CT 2011_0131)
10007664 (MedDRA 14.1)
C2827364 (UMLS CUI 2011AA)
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10019196 (MedDRA 14.1)
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10061732 (MedDRA 14.1)
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10021881 (MedDRA 14.1)
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10028245 (MedDRA 14.1)
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10062120 (MedDRA 14.1)
A53.9 (ICD-10-CM Version 2010)
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74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
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290-319.99 (ICD-9-CM Version 2011)
64572001 (SNOMED CT 2011_0131)
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23981006 (SNOMED CT 2011_0131)
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260379002 (SNOMED CT 2011_0131)
C0678908 (UMLS CUI 2011AA)
C0042847 (UMLS CUI 2011AA)
190634004 (SNOMED CT 2011_0131)
10047609 (MedDRA 14.1)
E53.8 (ICD-10-CM Version 2010)
C0016412 (UMLS CUI 2011AA)
190633005 (SNOMED CT 2011_0131)
10016880 (MedDRA 14.1)
E53.8 (ICD-10-CM Version 2010)
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264580006 (SNOMED CT 2011_0131)
10013907 (MedDRA 14.1)
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10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
392521001 (SNOMED CT 2011_0131)
C0205322 (UMLS CUI 2011AA)
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)