ID

42759

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00791492

Link

http://clinicaltrials.gov/show/NCT00791492

Stichworte

Versionen (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Eligibility NCT00791492 Familial Amyloid Polyneuropathy

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Beschreibung

age 18 Years to 75 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Familial Amyloid Polyneuropathy
Beschreibung

Familial Amyloid Polyneuropathy

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0206245
SNOMED CT 2011_0131
42295001
MedDRA 14.1
10057949
ICD-10-CM Version 2010
E85.1
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Inclusion Criteria: Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study:
Beschreibung

Inclusion Criteria: Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study:

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Patient has completed the Month 18 visit of Study Fx-005.
Beschreibung

Patient has completed the Month 18 visit of Study Fx-005.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication.
Beschreibung

If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0015787
SNOMED CT 2011_0131
169549004
MedDRA 14.1
10056199
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements.
Beschreibung

Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study.
Beschreibung

Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).
Beschreibung

Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
C0593507
SNOMED CT 2011_0131
387207008
LOINC Version 232
MTHU004262
UMLS CUI 2011AA
C0132515
If female, patient is pregnant or breast feeding.
Beschreibung

If female, patient is pregnant or breast feeding.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) >2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
Beschreibung

Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) >2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0151766
SNOMED CT 2011_0131
166603001
MedDRA 14.1
10024690
ICD-10-CM Version 2010
R94.5
ICD-9-CM Version 2011
794.8
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0232744
SNOMED CT 2011_0131
77981007
MedDRA 14.1
10019673
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Familial Amyloid Polyneuropathy
Item
Familial Amyloid Polyneuropathy
boolean
C0206245 (UMLS CUI 2011AA)
42295001 (SNOMED CT 2011_0131)
10057949 (MedDRA 14.1)
E85.1 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Inclusion Criteria: Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study:
Item
Inclusion Criteria: Male and non-pregnant female patients meeting all of the following criteria are eligible for enrollment in this study:
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Patient has completed the Month 18 visit of Study Fx-005.
Item
Patient has completed the Month 18 visit of Study Fx-005.
boolean
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication.
Item
If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study. (A condom alone is not considered an acceptable method of birth control.) If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424941 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements.
Item
Patient is, in the opinion of the investigator, willing and able to comply with the study medication regimen and all other study requirements.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study.
Item
Patient agrees not to participate in another investigational drug or device study while participating in this open-label extension study.
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).
Item
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3-4 times/month (ibuprofen and nimesulide will be permitted).
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0593507 (UMLS CUI 2011AA)
387207008 (SNOMED CT 2011_0131)
MTHU004262 (LOINC Version 232)
C0132515 (UMLS CUI 2011AA)
If female, patient is pregnant or breast feeding.
Item
If female, patient is pregnant or breast feeding.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) >2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
Item
Patient has liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) >2 times upper limit of normal (ULN) that in the medical judgment of the investigator are due to reduced liver function or active liver disease.
boolean
C0151766 (UMLS CUI 2011AA)
166603001 (SNOMED CT 2011_0131)
10024690 (MedDRA 14.1)
R94.5 (ICD-10-CM Version 2010)
794.8 (ICD-9-CM Version 2011)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
CL420107 (UMLS CUI 2011AA)
C0232744 (UMLS CUI 2011AA)
77981007 (SNOMED CT 2011_0131)
10019673 (MedDRA 14.1)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
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