ID

22748

Beschreibung

A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00686140

Link

https://clinicaltrials.gov/show/NCT00686140

Stichworte

Versionen (2)
  1. 11.06.17 11.06.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

11. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00686140

Englisch

Eligibility Schizophrenia NCT00686140

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of schizophrenia or schizophreniform disorder;
Beschreibung

schizophrenia, schizophreniform disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
duration of symptoms not longer than 60 months;
Beschreibung

duration of symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1457887
no prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
Beschreibung

prior therapy, antipsychotic medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0040615
between 16 and 40 years of age; and
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
current psychotic symptoms of moderate severity.
Beschreibung

current psychotic symptoms of moderate severity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0871189
UMLS CUI [1,3]
C0205081
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a dsm-iv axis i diagnosis other than schizophrenia or schizophreniform;
Beschreibung

dsm-iv axis i diagnosis other than schizophrenia or schizophreniform

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0270287
UMLS CUI [1,3]
C0338607
documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, parkinson's disease, huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
Beschreibung

central nervous system disease, stroke, tumor, parkinson's disease, huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0085136
UMLS CUI [4]
C0030567
UMLS CUI [5]
C0020179
UMLS CUI [6]
C0014544
UMLS CUI [7,1]
C0876926
UMLS CUI [7,2]
C0221099
UMLS CUI [8]
C0151317
acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
Beschreibung

severe comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
a clinically significant ecg abnormality in the opinion of the investigator;
Beschreibung

ecg abnormality

Datentyp

boolean

Alias
UMLS CUI [1]
C1832603
pregnant or breast-feeding female;
Beschreibung

pregnancy, breast feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
use of disallowed concomitant therapy;
Beschreibung

disallowed concomitant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1707479
history of severe allergy or hypersensitivity.
Beschreibung

history of severe allergy or hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2945656
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Ähnliche Modelle

Eligibility Schizophrenia NCT00686140

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
schizophrenia, schizophreniform disorder
Item
diagnosis of schizophrenia or schizophreniform disorder;
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
duration of symptoms
Item
duration of symptoms not longer than 60 months;
boolean
C0449238 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
prior therapy, antipsychotic medication
Item
no prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;
boolean
C1514463 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
age
Item
between 16 and 40 years of age; and
boolean
C0001779 (UMLS CUI [1])
current psychotic symptoms of moderate severity
Item
current psychotic symptoms of moderate severity.
boolean
C0521116 (UMLS CUI [1,1])
C0871189 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
dsm-iv axis i diagnosis other than schizophrenia or schizophreniform
Item
a dsm-iv axis i diagnosis other than schizophrenia or schizophreniform;
boolean
C0220952 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C0338607 (UMLS CUI [1,3])
central nervous system disease, stroke, tumor, parkinson's disease, huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection
Item
documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, parkinson's disease, huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;
boolean
C0007682 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0085136 (UMLS CUI [3])
C0030567 (UMLS CUI [4])
C0020179 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0876926 (UMLS CUI [7,1])
C0221099 (UMLS CUI [7,2])
C0151317 (UMLS CUI [8])
severe comorbidity
Item
acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
ecg abnormality
Item
a clinically significant ecg abnormality in the opinion of the investigator;
boolean
C1832603 (UMLS CUI [1])
pregnancy, breast feeding
Item
pregnant or breast-feeding female;
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
disallowed concomitant therapy
Item
use of disallowed concomitant therapy;
boolean
C1707479 (UMLS CUI [1])
history of severe allergy or hypersensitivity
Item
history of severe allergy or hypersensitivity.
boolean
C0020517 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2])
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