ID

39889

Beschreibung

Rapid Diagnostics for HIV and Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT02190305

Link

https://clinicaltrials.gov/show/NCT02190305

Stichworte

Versionen (1)
  1. 29.02.20 29.02.20 -
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See clinicaltrials.gov

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29. Februar 2020

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Eligibility HIV Infections NCT02190305

Englisch

Eligibility HIV Infections NCT02190305

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
all subjects:
Beschreibung

Study Subject All

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
13 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
Beschreibung

Informed Consent | Informed Consent Parent | Informed Consent Guardian

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
willing to complete the risk assessment questionnaire, and
Beschreibung

Risk Assessment Questionnaire Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086930
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (k2 edta) tubes.
Beschreibung

Availability of Blood specimen | Finger-prick sampling Drop Quantity | Serum Separator Tube Quantity | Anticoagulant Microcapillary blood collection tube K2EDTA Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0457575
UMLS CUI [2,2]
C4048603
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1553430
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C3872453
UMLS CUI [4,3]
C1265611
population 1 - diagnostic trial "at risk" group (n = 2000-3000)
Beschreibung

Population At risk Group

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0441833
subjects must meet one or more of the following inclusion criteria to be enrolled in population 1:
Beschreibung

Inclusion criteria Quantity Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
have at least one risk factor for infection with hepatitis b or c,
Beschreibung

Risk factors Quantity Hepatitis B | Risk factors Quantity Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0019163
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0019196
have at least one risk factor for infection with hiv,
Beschreibung

Risk factors Quantity HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0019693
present with signs and symptoms of hepatitis,
Beschreibung

Signs and Symptoms Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0019158
be a known hiv-positive individual (previous positive hiv test result, may comprise up to 500 individuals)
Beschreibung

HIV Seropositivity | HIV test Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C1321876
UMLS CUI [2,2]
C1514241
population 1a - additional known hiv-positive individuals (n = ~500)
Beschreibung

Population Group HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0019699
subjects must:
Beschreibung

Study Subject Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
• be a known hiv-positive individual (previous positive hiv test result).
Beschreibung

HIV Seropositivity | HIV test Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C1321876
UMLS CUI [2,2]
C1514241
population 1b - additional known hbv-positive individuals (n = ~500)
Beschreibung

Population Group Hepatitis B Virus Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0019169
UMLS CUI [1,3]
C1514241
subjects must:
Beschreibung

Study Subject Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
• be known to have current or past hbv infection, as evidenced by hbv serology results.
Beschreibung

Hepatitis B | Serology positive Hepatitis B Virus

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019169
population 1c - additional known hcv-positive individuals (n = ~500)
Beschreibung

Population Group Hepatitis C Virus Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C4330254
subjects must:
Beschreibung

Study Subject Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
• be known to be infected with hcv, as evidenced by previous positive hcv test results.
Beschreibung

Hepatitis C | Hepatitis C virus test Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C2363789
UMLS CUI [2,2]
C1514241
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects do not meet the inclusion criteria
Beschreibung

Study Subject Inclusion criteria failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C0231175
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility HIV Infections NCT02190305

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Age
Item
13 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Risk Assessment Questionnaire Completion
Item
willing to complete the risk assessment questionnaire, and
boolean
C0086930 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Availability of Blood specimen | Finger-prick sampling Drop Quantity | Serum Separator Tube Quantity | Anticoagulant Microcapillary blood collection tube K2EDTA Quantity
Item
willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (k2 edta) tubes.
boolean
C0470187 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0457575 (UMLS CUI [2,1])
C4048603 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1553430 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003280 (UMLS CUI [4,1])
C3872453 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Population At risk Group
Item
population 1 - diagnostic trial "at risk" group (n = 2000-3000)
boolean
C1257890 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
Inclusion criteria Quantity Fulfill
Item
subjects must meet one or more of the following inclusion criteria to be enrolled in population 1:
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Risk factors Quantity Hepatitis B | Risk factors Quantity Hepatitis C
Item
have at least one risk factor for infection with hepatitis b or c,
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Risk factors Quantity HIV Infection
Item
have at least one risk factor for infection with hiv,
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
Signs and Symptoms Hepatitis
Item
present with signs and symptoms of hepatitis,
boolean
C0037088 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
HIV Seropositivity | HIV test Positive
Item
be a known hiv-positive individual (previous positive hiv test result, may comprise up to 500 individuals)
boolean
C0019699 (UMLS CUI [1])
C1321876 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Population Group HIV Seropositivity
Item
population 1a - additional known hiv-positive individuals (n = ~500)
boolean
C1257890 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
Study Subject Criteria Fulfill
Item
subjects must:
boolean
C0681850 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
HIV Seropositivity | HIV test Positive
Item
• be a known hiv-positive individual (previous positive hiv test result).
boolean
C0019699 (UMLS CUI [1])
C1321876 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Population Group Hepatitis B Virus Positive
Item
population 1b - additional known hbv-positive individuals (n = ~500)
boolean
C1257890 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Study Subject Criteria Fulfill
Item
subjects must:
boolean
C0681850 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hepatitis B | Serology positive Hepatitis B Virus
Item
• be known to have current or past hbv infection, as evidenced by hbv serology results.
boolean
C0019163 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
Population Group Hepatitis C Virus Positive
Item
population 1c - additional known hcv-positive individuals (n = ~500)
boolean
C1257890 (UMLS CUI [1,1])
C4330254 (UMLS CUI [1,2])
Study Subject Criteria Fulfill
Item
subjects must:
boolean
C0681850 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hepatitis C | Hepatitis C virus test Positive
Item
• be known to be infected with hcv, as evidenced by previous positive hcv test results.
boolean
C0019196 (UMLS CUI [1])
C2363789 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Inclusion criteria failed
Item
subjects do not meet the inclusion criteria
boolean
C0681850 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
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