ID

32221

Beskrivning

Heart Rate Changes in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine; ODM derived from: https://clinicaltrials.gov/show/NCT01047215

Länk

https://clinicaltrials.gov/show/NCT01047215

Nyckelord

Versioner (1)
  1. 2018-10-23 2018-10-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01047215

Engelsk

Eligibility Schizophrenia NCT01047215

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age between 20 to 50, all genders.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. psychiatry doctor diagnosed who met dsm-iv-tr criteria schizophrenia or bipolar patients and using antipsychotics.
Beskrivning

Schizophrenia | Bipolar Disorder | Antipsychotic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0040615
3. psychiatry doctor first diagnosed who met dsm-iv-tr criteria schizophrenia or bipolar patients and without using antipsychotics.
Beskrivning

Schizophrenia | Bipolar Disorder | Antipsychotic Agents Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0005586
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0332197
4. participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. participants need to understand the procedure of this study.
Beskrivning

Comprehension Study Protocol | Cooperative Behavior Heart rate Change Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0009964
UMLS CUI [2,2]
C0018810
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0242485
5. participants voluntarily join this interview, approximately 30-45min.
Beskrivning

Participation Voluntary Patient interview

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0439656
UMLS CUI [1,3]
C0683518
6. clinical reviewed patient's condition need to use quetiapine or aripiprazole.
Beskrivning

Patient need for Quetiapine | Patient need for Aripiprazole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0123091
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0299792
control group
Beskrivning

Control Group

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
1. age between 20 to 50, all genders.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. psychiatry doctor diagnosed who exclude dsm-iv-tr schizophrenia or bipolar patients.
Beskrivning

Schizophrenia Exclude | Bipolar Disorder Exclude

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0005586
UMLS CUI [2,2]
C0332196
3. participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. participants need to understand the procedure of this study.
Beskrivning

Comprehension Study Protocol | Cooperative Behavior Heart rate Change Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0009964
UMLS CUI [2,2]
C0018810
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0242485
4. participants voluntarily join this interview, approximately 30-45min.
Beskrivning

Participation Voluntary Patient interview

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0439656
UMLS CUI [1,3]
C0683518
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
experimential group:
Beskrivning

Group Experimental

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C1517586
1. participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
Beskrivning

Comprehension Study Protocol failed | Uncooperative behavior Heart rate Change Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0424350
UMLS CUI [2,2]
C0018810
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0242485
2. participant has another major mental disease other than the inclusion criteria.
Beskrivning

Mental disorder Major | Exception Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
3. participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
Beskrivning

Cardiovascular Diseases | Diabetes Mellitus | Liver Cirrhosis | Kidney Diseases | Substance Use Disorders | Exception Tobacco use | Long-term use of antipsychotic medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0023890
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0038586
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0543414
UMLS CUI [7]
C4510152
4. participant has combination diseases, it could seriously influence diagnosis.
Beskrivning

Combination Disease Influence Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205195
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C0011900
5. psychopathy or psychosis can not be categorized in defined group.
Beskrivning

Categorization Mental disorder Unsuccessful | Categorization Psychotic Disorder Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0008902
UMLS CUI [2,2]
C0033975
UMLS CUI [2,3]
C1272705
6. clinical reviewed patient's condition need to switch other medicine.
Beskrivning

Patient need for Change of medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0580105
7. clinical reviewed patient's condition need to quite this experiment and record reasons.
Beskrivning

Patient need for Discontinuation Experiment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0681814
8. participants decide to quite experiment without any conditions.
Beskrivning

Study Subject Decision Experiment Discontinue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0681814
UMLS CUI [1,4]
C1444662
control group
Beskrivning

Control Group

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
1. participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
Beskrivning

Comprehension Study Protocol failed | Uncooperative behavior Heart rate Change Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0424350
UMLS CUI [2,2]
C0018810
UMLS CUI [2,3]
C0392747
UMLS CUI [2,4]
C0242485
2. participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
Beskrivning

Cardiovascular Diseases | Diabetes Mellitus | Liver Cirrhosis | Kidney Diseases | Substance Use Disorders | Exception Tobacco use | Long-term use of antipsychotic medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0023890
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0038586
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0543414
UMLS CUI [7]
C4510152
3. participants decide to quite experiment without any conditions.
Beskrivning

Study Subject Decision Experiment Discontinue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0681814
UMLS CUI [1,4]
C1444662
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Similar models

Eligibility Schizophrenia NCT01047215

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age between 20 to 50, all genders.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Bipolar Disorder | Antipsychotic Agents
Item
2. psychiatry doctor diagnosed who met dsm-iv-tr criteria schizophrenia or bipolar patients and using antipsychotics.
boolean
C0036341 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
Schizophrenia | Bipolar Disorder | Antipsychotic Agents Absent
Item
3. psychiatry doctor first diagnosed who met dsm-iv-tr criteria schizophrenia or bipolar patients and without using antipsychotics.
boolean
C0036341 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Comprehension Study Protocol | Cooperative Behavior Heart rate Change Measurement
Item
4. participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. participants need to understand the procedure of this study.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0009964 (UMLS CUI [2,1])
C0018810 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
Participation Voluntary Patient interview
Item
5. participants voluntarily join this interview, approximately 30-45min.
boolean
C0679823 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
C0683518 (UMLS CUI [1,3])
Patient need for Quetiapine | Patient need for Aripiprazole
Item
6. clinical reviewed patient's condition need to use quetiapine or aripiprazole.
boolean
C0686904 (UMLS CUI [1,1])
C0123091 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
Control Group
Item
control group
boolean
C0009932 (UMLS CUI [1])
Age
Item
1. age between 20 to 50, all genders.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Exclude | Bipolar Disorder Exclude
Item
2. psychiatry doctor diagnosed who exclude dsm-iv-tr schizophrenia or bipolar patients.
boolean
C0036341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0005586 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Comprehension Study Protocol | Cooperative Behavior Heart rate Change Measurement
Item
3. participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. participants need to understand the procedure of this study.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0009964 (UMLS CUI [2,1])
C0018810 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
Participation Voluntary Patient interview
Item
4. participants voluntarily join this interview, approximately 30-45min.
boolean
C0679823 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
C0683518 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Group Experimental
Item
experimential group:
boolean
C0441833 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Comprehension Study Protocol failed | Uncooperative behavior Heart rate Change Measurement
Item
1. participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0424350 (UMLS CUI [2,1])
C0018810 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
Mental disorder Major | Exception Inclusion criteria
Item
2. participant has another major mental disease other than the inclusion criteria.
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Cardiovascular Diseases | Diabetes Mellitus | Liver Cirrhosis | Kidney Diseases | Substance Use Disorders | Exception Tobacco use | Long-term use of antipsychotic medication
Item
3. participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
boolean
C0007222 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0543414 (UMLS CUI [6,2])
C4510152 (UMLS CUI [7])
Combination Disease Influence Diagnosis
Item
4. participant has combination diseases, it could seriously influence diagnosis.
boolean
C0205195 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,4])
Categorization Mental disorder Unsuccessful | Categorization Psychotic Disorder Unsuccessful
Item
5. psychopathy or psychosis can not be categorized in defined group.
boolean
C0008902 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0008902 (UMLS CUI [2,1])
C0033975 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Patient need for Change of medication
Item
6. clinical reviewed patient's condition need to switch other medicine.
boolean
C0686904 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
Patient need for Discontinuation Experiment
Item
7. clinical reviewed patient's condition need to quite this experiment and record reasons.
boolean
C0686904 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0681814 (UMLS CUI [1,3])
Study Subject Decision Experiment Discontinue
Item
8. participants decide to quite experiment without any conditions.
boolean
C0681850 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0681814 (UMLS CUI [1,3])
C1444662 (UMLS CUI [1,4])
Control Group
Item
control group
boolean
C0009932 (UMLS CUI [1])
Comprehension Study Protocol failed | Uncooperative behavior Heart rate Change Measurement
Item
1. participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0424350 (UMLS CUI [2,1])
C0018810 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
Cardiovascular Diseases | Diabetes Mellitus | Liver Cirrhosis | Kidney Diseases | Substance Use Disorders | Exception Tobacco use | Long-term use of antipsychotic medication
Item
2. participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
boolean
C0007222 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0543414 (UMLS CUI [6,2])
C4510152 (UMLS CUI [7])
Study Subject Decision Experiment Discontinue
Item
3. participants decide to quite experiment without any conditions.
boolean
C0681850 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0681814 (UMLS CUI [1,3])
C1444662 (UMLS CUI [1,4])
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