ID

37154

Descrizione

Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis); ODM derived from: https://clinicaltrials.gov/show/NCT02481180

collegamento

https://clinicaltrials.gov/show/NCT02481180

Keywords

versioni (1)
  1. 04/07/19 04/07/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

4 luglio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Rheumatoid Arthritis NCT02481180

Inglese

Eligibility Rheumatoid Arthritis NCT02481180

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-45 years old;
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with active ra;
Descrizione

Rheumatoid Arthritis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003873
dmards therapy must not be used for at least 28 days prior to baseline;
Descrizione

Antirheumatic Drugs, Disease-Modifying

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0242708
if a patient has received nsaids，current nsaids therapy must have been at a stable dose for at least 28 days prior to baseline;
Descrizione

NSAIDs Dose Stable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patient or patient's legal representative able to give written informed consent for participation in the trial.
Descrizione

Informed Consent | Informed Consent Patient Representative

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute or chronic infection, or history of active tuberculosis;
Descrizione

Communicable Disease | Chronic infectious disease | Tuberculosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0041296
history of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
Descrizione

CNS disorder | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Liver function Index Specified | Digestive System Disorders | Respiration Disorders | Metabolic Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5,1]
C0232741
UMLS CUI [5,2]
C0918012
UMLS CUI [5,3]
C0205369
UMLS CUI [6]
C0012242
UMLS CUI [7]
C0035204
UMLS CUI [8]
C0025517
patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease);
Descrizione

High risk of Communicable Disease | Communicable Disease | Chronic infectious disease | Communicable Disease Serious

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009450
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0151317
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205404
patients who use 5 unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
Descrizione

Tuberculin unit Quantity | Tuberculin (skin test) positive | Scleroma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1532464
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C3161220
UMLS CUI [3]
C0035468
patients who currently have, or who have a history of, malignancy;
Descrizione

Malignant Neoplasms

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
patients who lack of understanding ,communication or collaboration, and can't comply with the protocols;
Descrizione

Comprehension Lacking | Communication Lacking | Compliance behavior Lacking | Protocol Compliance Unable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0009452
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C1299582
female patients who are breastfeeding or pregnant, who are of childbearing potential.
Descrizione

Breast Feeding | Pregnancy | Childbearing Potential

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C3831118
Ritorna all'inizio della pagina

Similar models

Eligibility Rheumatoid Arthritis NCT02481180

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-45 years old;
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
diagnosed with active ra;
boolean
C0003873 (UMLS CUI [1])
Antirheumatic Drugs, Disease-Modifying
Item
dmards therapy must not be used for at least 28 days prior to baseline;
boolean
C0242708 (UMLS CUI [1])
NSAIDs Dose Stable
Item
if a patient has received nsaids，current nsaids therapy must have been at a stable dose for at least 28 days prior to baseline;
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Informed Consent | Informed Consent Patient Representative
Item
patient or patient's legal representative able to give written informed consent for participation in the trial.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Chronic infectious disease | Tuberculosis
Item
acute or chronic infection, or history of active tuberculosis;
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
CNS disorder | Cardiovascular Diseases | Kidney Diseases | Liver diseases | Liver function Index Specified | Digestive System Disorders | Respiration Disorders | Metabolic Diseases
Item
history of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
boolean
C0007682 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0232741 (UMLS CUI [5,1])
C0918012 (UMLS CUI [5,2])
C0205369 (UMLS CUI [5,3])
C0012242 (UMLS CUI [6])
C0035204 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
High risk of Communicable Disease | Communicable Disease | Chronic infectious disease | Communicable Disease Serious
Item
patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease);
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Tuberculin unit Quantity | Tuberculin (skin test) positive | Scleroma
Item
patients who use 5 unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
boolean
C1532464 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3161220 (UMLS CUI [2])
C0035468 (UMLS CUI [3])
Malignant Neoplasms
Item
patients who currently have, or who have a history of, malignancy;
boolean
C0006826 (UMLS CUI [1])
Comprehension Lacking | Communication Lacking | Compliance behavior Lacking | Protocol Compliance Unable
Item
patients who lack of understanding ,communication or collaboration, and can't comply with the protocols;
boolean
C0162340 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0009452 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Breast Feeding | Pregnancy | Childbearing Potential
Item
female patients who are breastfeeding or pregnant, who are of childbearing potential.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial