ID

42572

Descrição

Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00192621

Link

https://clinicaltrials.gov/show/NCT00192621

Palavras-chave

Versões (2)
  1. 24/09/2016 24/09/2016 -
  2. 02/09/2021 02/09/2021 -
Transferido a

2 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility HIV Infections NCT00192621

Inglês

Eligibility HIV Infections NCT00192621

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
be able to provide written consent to perform in the trial.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
hiv antibody negative and hiv dna negative at time of entry to the study.
Descrição

HIV antibody negative | Human immunodeficiency virus DNA Negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1142096
UMLS CUI [2,1]
C0486959
UMLS CUI [2,2]
C1513916
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
Descrição

Mental disorders Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited | Myocardial Ischemia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
UMLS CUI [3]
C0151744
history of type i or type ii diabetes mellitus or previous treatment with antidiabetic medication.
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0935929
prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
Descrição

Testosterone | Estrogens | Growth Hormone | Glucocorticoids Oral | Anabolic steroids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0039601
UMLS CUI [2]
C0014939
UMLS CUI [3]
C0037663
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0002845
alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
Descrição

Substance Use Disorders Study Subject Participation Status Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
Descrição

Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Post-Exposure Prophylaxis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0599685
UMLS CUI [2]
C0033607
UMLS CUI [3]
C1373111
UMLS CUI [4]
C1373120
UMLS CUI [5,1]
C0599685
UMLS CUI [5,2]
C1517586
UMLS CUI [6]
C1275666
UMLS CUI [7]
C1443861
prior use of any retinoid-containing compound within the previous six months.
Descrição

Compound Containing Retinoids

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0035339
abnormal coagulation.
Descrição

Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
previous allergic reaction or known allergy to local anaesthetic.
Descrição

Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0002934
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0002934
previous use of psychotropic medications.
Descrição

Psychotropic Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033978
concomitant use of medications, including those metabolised by cyp3a4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
Descrição

Pharmaceutical Preparations Affecting Protocol Compliance | drug metabolism Due to CYP3A4

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0683140
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1142644
any grade-three laboratory abnormality recorded from screening bloods.
Descrição

Blood Screening LABORATORY ABNORMALITIES Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1511226
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C0441800
any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
Descrição

Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1511226
UMLS CUI [1,2]
C1853129
UMLS CUI [1,3]
C0441800
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0439801
gastrointestinal disorders, which may affect drug absorption.
Descrição

Gastrointestinal Diseases Affecting drug absorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
Descrição

screening examination Finding Study Subject Participation Status Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0281974
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
pregnancy
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
evidence of acute or chronic active hepatitis b virus infection by serology performed at baseline.
Descrição

Hepatitis B Evidence Serologic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
evidence of hepatitis c infection by serology performed at baseline.
Descrição

Hepatitis C Evidence Serologic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
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Similar models

Eligibility HIV Infections NCT00192621

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >18
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
be able to provide written consent to perform in the trial.
boolean
C0021430 (UMLS CUI [1])
HIV antibody negative | Human immunodeficiency virus DNA Negative
Item
hiv antibody negative and hiv dna negative at time of entry to the study.
boolean
C1142096 (UMLS CUI [1])
C0486959 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Mental disorders Study Subject Participation Status Limited | Physical Condition Study Subject Participation Status Limited | Myocardial Ischemia
Item
any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
boolean
C0004936 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0151744 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics
Item
history of type i or type ii diabetes mellitus or previous treatment with antidiabetic medication.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
Testosterone | Estrogens | Growth Hormone | Glucocorticoids Oral | Anabolic steroids
Item
prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months.
boolean
C0039601 (UMLS CUI [1])
C0014939 (UMLS CUI [2])
C0037663 (UMLS CUI [3])
C0017710 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0002845 (UMLS CUI [5])
Substance Use Disorders Study Subject Participation Status Limited
Item
alcohol or substance abuse which in the opinion of the investigator would affect the subject's ability to participate in the trial.
boolean
C0038586 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Anti-Retroviral Agents | Protease Inhibitors | Nucleoside Reverse Transcriptase Inhibitors | Non-Nucleoside Reverse Transcriptase Inhibitors | Anti-Retroviral Agents Investigational | Fusion inhibitor | Post-Exposure Prophylaxis
Item
prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).
boolean
C0599685 (UMLS CUI [1])
C0033607 (UMLS CUI [2])
C1373111 (UMLS CUI [3])
C1373120 (UMLS CUI [4])
C0599685 (UMLS CUI [5,1])
C1517586 (UMLS CUI [5,2])
C1275666 (UMLS CUI [6])
C1443861 (UMLS CUI [7])
Compound Containing Retinoids
Item
prior use of any retinoid-containing compound within the previous six months.
boolean
C1706082 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0035339 (UMLS CUI [1,3])
Blood Coagulation Disorders
Item
abnormal coagulation.
boolean
C0005779 (UMLS CUI [1])
Allergic Reaction Local Anesthetics | Hypersensitivity Local Anesthetics
Item
previous allergic reaction or known allergy to local anaesthetic.
boolean
C1527304 (UMLS CUI [1,1])
C0002934 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0002934 (UMLS CUI [2,2])
Psychotropic Drugs
Item
previous use of psychotropic medications.
boolean
C0033978 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Protocol Compliance | drug metabolism Due to CYP3A4
Item
concomitant use of medications, including those metabolised by cyp3a4 enzyme system, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0683140 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1142644 (UMLS CUI [2,3])
Blood Screening LABORATORY ABNORMALITIES Grade
Item
any grade-three laboratory abnormality recorded from screening bloods.
boolean
C1511226 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Blood Screening LABORATORY ABNORMALITIES Grade | Protocol Compliance Limited
Item
any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
boolean
C1511226 (UMLS CUI [1,1])
C1853129 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Gastrointestinal Diseases Affecting drug absorption
Item
gastrointestinal disorders, which may affect drug absorption.
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
screening examination Finding Study Subject Participation Status Limited
Item
any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
boolean
C0281974 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Hepatitis B Evidence Serologic
Item
evidence of acute or chronic active hepatitis b virus infection by serology performed at baseline.
boolean
C0019163 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
Hepatitis C Evidence Serologic
Item
evidence of hepatitis c infection by serology performed at baseline.
boolean
C0019196 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
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