ID

24580

Beschreibung

Cimicoxib for the Treatment of Major Depression (SECIM); ODM derived from: https://clinicaltrials.gov/show/NCT00510822

Link

https://clinicaltrials.gov/show/NCT00510822

Stichworte

Versionen (1)
  1. 07.08.17 07.08.17 -
Hochgeladen am

7. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depression NCT00510822

Englisch

Eligibility Major Depression NCT00510822

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depression diagnosed by psychiatrist
Beschreibung

Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
dsm iv tr: 296.2x single depressive episode or 296.3x recurrent depressive episode
Beschreibung

Single major depressive episode | Recurrent major depressive episodes

Datentyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0154409
hamd-17 score ≥ 22
Beschreibung

Hamilton rating scale for depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0451203
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychotic depression, bipolar disorder, obsessive compulsive disorder, anxiety disorder, personality disorder, drug or alcohol abuse, schizoaffective disorders, schizophrenia
Beschreibung

Depression, psychotic | Bipolar Disorder | Obsessive-Compulsive Disorder | Anxiety Disorders | Personality Disorders | Substance Use Disorders | Schizoaffective Disorder | Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0743072
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0028768
UMLS CUI [4]
C0003469
UMLS CUI [5]
C0031212
UMLS CUI [6]
C0038586
UMLS CUI [7]
C0036337
UMLS CUI [8]
C0036341
all dsm iv tr axis-i disorders except depression
Beschreibung

Axis I diagnosis | Exception Depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011581
all dsm iv tr axis-ii disorders without exception
Beschreibung

Axis II diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0270288
unsuccessful treatment with more than 2 antidepressant medications
Beschreibung

Antidepressive Agents Quantity Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1272705
concomitant use of psychotropic drugs, including mood stabilizers
Beschreibung

Psychotropic Drugs | Mood Stabilizers

Datentyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C4020582
immediate risk of suicidal behaviour
Beschreibung

Suicidal behavior Risk Immediate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1760428
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0205253
women who are pregnant, breast feeding or planning to become pregnant during the course of study, women who are not post-menopausal, surgically sterilized or using an effective method of contraception
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Postmenopausal state Absent | Gender Female Sterilization Absent | Gender Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0232970
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0015787
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0700589
UMLS CUI [6,3]
C0332268
any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or a history of peripheral arterial embolism
Beschreibung

Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Cerebrovascular accident | Congestive heart failure | Uncontrolled hypertension | Peripheral arterial insufficiency | Claudication Symptomatic | Peripheral arterial embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0018802
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0281943
UMLS CUI [8,1]
C1456822
UMLS CUI [8,2]
C0231220
UMLS CUI [9]
C0564750
history of coronary heart disease (chd) or any other heart disease
Beschreibung

Coronary heart disease | Heart Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0018799
history of upper or lower gastrointestinal (gi) ulceration, perforation and/or obstruction
Beschreibung

Ulceration Upper Gastrointestinal Tract | Ulceration Lower Gastrointestinal Tract | UPPER GASTROINTESTINAL PERFORATION | Gastrointestinal perforation Lower Tract | Obstruction Upper Gastrointestinal Tract | Obstruction Lower Gastrointestinal Tract

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3887532
UMLS CUI [1,2]
C3203348
UMLS CUI [2,1]
C3887532
UMLS CUI [2,2]
C0226875
UMLS CUI [3]
C0749862
UMLS CUI [4,1]
C0151664
UMLS CUI [4,2]
C0226875
UMLS CUI [5,1]
C0028778
UMLS CUI [5,2]
C3203348
UMLS CUI [6,1]
C0028778
UMLS CUI [6,2]
C0226875
history of upper or lower gi bleeding within the previous year
Beschreibung

Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0041909
UMLS CUI [2]
C0024050
history of inflammatory bowel disease
Beschreibung

Inflammatory Bowel Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0021390
other protocol-defined inclusion/exclusion criteria may apply
Beschreibung

Clinical Trial Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Major Depression NCT00510822

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
major depression diagnosed by psychiatrist
boolean
C1269683 (UMLS CUI [1])
Single major depressive episode | Recurrent major depressive episodes
Item
dsm iv tr: 296.2x single depressive episode or 296.3x recurrent depressive episode
boolean
C0024517 (UMLS CUI [1])
C0154409 (UMLS CUI [2])
Hamilton rating scale for depression
Item
hamd-17 score ≥ 22
boolean
C0451203 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Depression, psychotic | Bipolar Disorder | Obsessive-Compulsive Disorder | Anxiety Disorders | Personality Disorders | Substance Use Disorders | Schizoaffective Disorder | Schizophrenia
Item
psychotic depression, bipolar disorder, obsessive compulsive disorder, anxiety disorder, personality disorder, drug or alcohol abuse, schizoaffective disorders, schizophrenia
boolean
C0743072 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0003469 (UMLS CUI [4])
C0031212 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
C0036337 (UMLS CUI [7])
C0036341 (UMLS CUI [8])
Axis I diagnosis | Exception Depressive disorder
Item
all dsm iv tr axis-i disorders except depression
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
Axis II diagnosis
Item
all dsm iv tr axis-ii disorders without exception
boolean
C0270288 (UMLS CUI [1])
Antidepressive Agents Quantity Unsuccessful
Item
unsuccessful treatment with more than 2 antidepressant medications
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Psychotropic Drugs | Mood Stabilizers
Item
concomitant use of psychotropic drugs, including mood stabilizers
boolean
C0033978 (UMLS CUI [1])
C4020582 (UMLS CUI [2])
Suicidal behavior Risk Immediate
Item
immediate risk of suicidal behaviour
boolean
C1760428 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Gender Postmenopausal state Absent | Gender Female Sterilization Absent | Gender Contraceptive methods Lacking
Item
women who are pregnant, breast feeding or planning to become pregnant during the course of study, women who are not post-menopausal, surgically sterilized or using an effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0015787 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0332268 (UMLS CUI [6,3])
Cardiovascular Diseases | Angina Pectoris | Myocardial Infarction | Cerebrovascular accident | Congestive heart failure | Uncontrolled hypertension | Peripheral arterial insufficiency | Claudication Symptomatic | Peripheral arterial embolism
Item
any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or a history of peripheral arterial embolism
boolean
C0007222 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0281943 (UMLS CUI [7])
C1456822 (UMLS CUI [8,1])
C0231220 (UMLS CUI [8,2])
C0564750 (UMLS CUI [9])
Coronary heart disease | Heart Diseases
Item
history of coronary heart disease (chd) or any other heart disease
boolean
C0010068 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Ulceration Upper Gastrointestinal Tract | Ulceration Lower Gastrointestinal Tract | UPPER GASTROINTESTINAL PERFORATION | Gastrointestinal perforation Lower Tract | Obstruction Upper Gastrointestinal Tract | Obstruction Lower Gastrointestinal Tract
Item
history of upper or lower gastrointestinal (gi) ulceration, perforation and/or obstruction
boolean
C3887532 (UMLS CUI [1,1])
C3203348 (UMLS CUI [1,2])
C3887532 (UMLS CUI [2,1])
C0226875 (UMLS CUI [2,2])
C0749862 (UMLS CUI [3])
C0151664 (UMLS CUI [4,1])
C0226875 (UMLS CUI [4,2])
C0028778 (UMLS CUI [5,1])
C3203348 (UMLS CUI [5,2])
C0028778 (UMLS CUI [6,1])
C0226875 (UMLS CUI [6,2])
Upper gastrointestinal hemorrhage | Lower gastrointestinal hemorrhage
Item
history of upper or lower gi bleeding within the previous year
boolean
C0041909 (UMLS CUI [1])
C0024050 (UMLS CUI [2])
Inflammatory Bowel Diseases
Item
history of inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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