ID

19238

Description

Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00063297

Lien

https://clinicaltrials.gov/show/NCT00063297

Mots-clés

Versions (1)
  1. 14/12/2016 14/12/2016 -
Téléchargé le

14 décembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Schizophrenia NCT00063297

Anglais

Eligibility Schizophrenia NCT00063297

1 Formulaires  
Criteria
Description

Criteria

adults aged 18-60
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
current diagnosis of schizophrenia
Description

Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
Description

Symptoms Negative Significant | Symptoms Positive Few | Hallucinations | Delusions | Major Depressive Disorder Evidence

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0205388
UMLS CUI [3]
C0018524
UMLS CUI [4]
C0011253
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C3887511
female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
Description

Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
subjects must be able to provide consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
must be healthy based on medical exam, laboratory tests and electrocardiogram
Description

Healthy | Medical Examination | Laboratory Procedures | Electrocardiography

Type de données

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0582103
UMLS CUI [3]
C0022885
UMLS CUI [4]
C1623258
exclusion:
Description

Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
female subjects who are either pregnant or nursing.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute or unstable medical conditions
Description

Medical condition | Medical condition Unstable

Type de données

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
diseases of the central nervous system
Description

CNS disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0007682
subjects who are judged clinically to be at serious risk for suicide or violence
Description

At risk for suicide Serious | At risk for violence Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0231418
UMLS CUI [2,2]
C0205404
subjects with delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
Description

Delusional disorder | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Attention deficit hyperactivity disorder | Major Depressive Disorder | Substance Dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0011251
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0036358
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0005586
UMLS CUI [6]
C1263846
UMLS CUI [7]
C1269683
UMLS CUI [8]
C0038580
Retour au début de la page

Similar models

Eligibility Schizophrenia NCT00063297

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Adult | Age
Item
adults aged 18-60
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Schizophrenia
Item
current diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Symptoms Negative Significant | Symptoms Positive Few | Hallucinations | Delusions | Major Depressive Disorder Evidence
Item
significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
boolean
C1457887 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0205388 (UMLS CUI [2,3])
C0018524 (UMLS CUI [3])
C0011253 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C3887511 (UMLS CUI [5,2])
Childbearing Potential Pregnancy test negative
Item
female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
subjects must be able to provide consent
boolean
C0021430 (UMLS CUI [1])
Healthy | Medical Examination | Laboratory Procedures | Electrocardiography
Item
must be healthy based on medical exam, laboratory tests and electrocardiogram
boolean
C3898900 (UMLS CUI [1])
C0582103 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female subjects who are either pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition | Medical condition Unstable
Item
acute or unstable medical conditions
boolean
C3843040 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
CNS disorder
Item
diseases of the central nervous system
boolean
C0007682 (UMLS CUI [1])
At risk for suicide Serious | At risk for violence Serious
Item
subjects who are judged clinically to be at serious risk for suicide or violence
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0231418 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Delusional disorder | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Attention deficit hyperactivity disorder | Major Depressive Disorder | Substance Dependence
Item
subjects with delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
boolean
C0011251 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C1263846 (UMLS CUI [6])
C1269683 (UMLS CUI [7])
C0038580 (UMLS CUI [8])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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