ID

39172

Beschreibung

A Study to Evaluate the Efficacy and Safety of Add-on Therapy of Wuling Capsule in Epilepsy Patients With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01125241

Link

https://clinicaltrials.gov/show/NCT01125241

Stichworte

Versionen (1)
  1. 07.12.19 07.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Dezember 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Epilepsy NCT01125241

Englisch

Eligibility Epilepsy NCT01125241

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Epilepsy NCT01125241
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects for this study will meet the following criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. age greater than or equal to 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. the duration to the latest seizure must be longer than 24 hours.
Beschreibung

Epilepsy | Antiepileptic Agents Regular | Seizure

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0003299
UMLS CUI [2,2]
C0205272
UMLS CUI [3]
C0036572
3. score of a 17 item hamilton depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks.
Beschreibung

Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressive Symptoms Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2,1]
C0086132
UMLS CUI [2,2]
C0449238
4. haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks.
Beschreibung

Anti-Anxiety Agents Absent | Antidepressive Agents Absent | Antipsychotic Agents Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040616
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0332197
5. must sign the informed consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. now accepting or have accepted other drugs clinical trial in the last month.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
2. history of serious psychiatric illness other than depression.
Beschreibung

Serious mental illness | Exception Depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C3841614
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011581
3. having suicide ideas or suicide behaviors.
Beschreibung

Suicidal ideas | Suicidal behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0850335
UMLS CUI [2]
C1760428
4. progressive illness of central nervous system, such as degenerative disease or tumor.
Beschreibung

CNS disorder Progressive | Degenerative Diseases, Central Nervous System | Central Nervous System Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0205329
UMLS CUI [2]
C0270715
UMLS CUI [3]
C0085136
5. history of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors.
Beschreibung

Heart Disease Serious | Lung disease Serious | Liver Dysfunction | Renal dysfunction | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0086565
UMLS CUI [4]
C3279454
UMLS CUI [5]
C0006826
6. the value of alt or ast is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul.
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0200633
7. during pregnant or lactation period.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. the person who is disabled or mentally disabled.
Beschreibung

Disabled Person | Mental handicap

Datentyp

boolean

Alias
UMLS CUI [1]
C0018576
UMLS CUI [2]
C1306341
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Epilepsy NCT01125241

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Epilepsy NCT01125241
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
subjects for this study will meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
1. age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
Epilepsy | Antiepileptic Agents Regular | Seizure
Item
2. must be in accordance with the diagnostic criteria of epilepsy and have taken antiepileptic drugs regularly at least for 6 months, which will not be changed recently. the duration to the latest seizure must be longer than 24 hours.
boolean
C0014544 (UMLS CUI [1])
C0003299 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0036572 (UMLS CUI [3])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressive Symptoms Duration
Item
3. score of a 17 item hamilton depression is greater than or equal to 17 and depressive symptoms have lasted for at least 2 weeks.
boolean
C3639712 (UMLS CUI [1])
C0086132 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Anti-Anxiety Agents Absent | Antidepressive Agents Absent | Antipsychotic Agents Absent
Item
4. haven't taken any anti-anxiety, anti-depressant and anti-psychotic drugs in recent 2 weeks.
boolean
C0040616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040615 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
5. must sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
1. now accepting or have accepted other drugs clinical trial in the last month.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Serious mental illness | Exception Depressive disorder
Item
2. history of serious psychiatric illness other than depression.
boolean
C3841614 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
Suicidal ideas | Suicidal behavior
Item
3. having suicide ideas or suicide behaviors.
boolean
C0850335 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
CNS disorder Progressive | Degenerative Diseases, Central Nervous System | Central Nervous System Neoplasms
Item
4. progressive illness of central nervous system, such as degenerative disease or tumor.
boolean
C0007682 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0270715 (UMLS CUI [2])
C0085136 (UMLS CUI [3])
Heart Disease Serious | Lung disease Serious | Liver Dysfunction | Renal dysfunction | Malignant Neoplasms
Item
5. history of serious cardiac or pulmonary disease, hepatic and renal dysfunction, and malignant tumors.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0086565 (UMLS CUI [3])
C3279454 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
Alanine aminotransferase increased | Aspartate aminotransferase increased | White Blood Cell Count procedure | Neutrophil count
Item
6. the value of alt or ast is higher than 1.5 times normal range, or the number of white blood cells is less than 2500/ul, or the number of neutrophil granulocyte is less than 1000/ul.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
7. during pregnant or lactation period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disabled Person | Mental handicap
Item
8. the person who is disabled or mentally disabled.
boolean
C0018576 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video