ID

32219

Beskrivning

Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01012830

Länk

https://clinicaltrials.gov/show/NCT01012830

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 NCT01012830

Engelsk

Eligibility Schizophrenia NCT01012830

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 19-59
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of schizophrenia by mini
Beskrivning

Schizophrenia Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0451306
3. cognition score 1 standard deviation below published norms in controls
Beskrivning

Cognitive Assessment Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870300
UMLS CUI [1,2]
C0449820
4. clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and stable dose for at least 4 weeks
Beskrivning

Clinical status Stable | Antipsychotic Agent Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449440
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
5. have no more than moderate severity rating on hallucinations, delusions formal thought disorder (bprs), negative symptoms (panss_n)
Beskrivning

Hallucinations Moderate BPRS | Delusions Moderate BPRS | Disorder of form of thought Moderate BPRS | PANSS Symptoms Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018524
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0029941
UMLS CUI [2,1]
C0011253
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0029941
UMLS CUI [3,1]
C0233636
UMLS CUI [3,2]
C0205081
UMLS CUI [3,3]
C0029941
UMLS CUI [4,1]
C4086747
UMLS CUI [4,2]
C1457887
UMLS CUI [4,3]
C1513916
6. minimal eps (simpson-angus <6)
Beskrivning

Extrapyramidal symptoms Minimal | Rating scale Extrapyramidal tract Side effects

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0234133
UMLS CUI [1,2]
C0547040
UMLS CUI [2,1]
C0681889
UMLS CUI [2,2]
C0015372
UMLS CUI [2,3]
C0879626
7. minimal depression (calgary <10)
Beskrivning

Minimal depression | Depression scale Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C4305327
UMLS CUI [2,1]
C0679604
UMLS CUI [2,2]
C0036341
8. stable dose of other psychotropics (2 months)
Beskrivning

Psychotropic Drugs Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
9. not pregnant.
Beskrivning

Pregnancy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of active peptic ulcer disease within 1 year of screening
Beskrivning

Peptic Ulcer Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0872146
2. clinically significant cardiac arrhythmia
Beskrivning

Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0003811
3. resting pulse less than 50
Beskrivning

Pulse Rate At rest

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0443144
4. active cancer (skin tumors other than melanoma are not excluded)
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
5. history of clinically significant stroke
Beskrivning

Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
6. current evidence or history in the past 2 years of epilepsy, focal brain lesion
Beskrivning

Epilepsy | Lesion of brain Focal

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0221505
UMLS CUI [2,2]
C0205234
7. start of cholinesterase inhibitors/ cognitive enhancers (galantamine, rivastigmine, donepezil, vitamin e and memantine) within 2 months of screening, 8. use of medications with significant central nervous system anticholinergic activity within 2 months of screening.
Beskrivning

Cholinesterase Inhibitors | Nootropic Agents | Galantamine | rivastigmine | donepezil | Vitamin E | Memantine | Anticholinergic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0008425
UMLS CUI [2]
C0242913
UMLS CUI [3]
C0016967
UMLS CUI [4]
C0649350
UMLS CUI [5]
C0527316
UMLS CUI [6]
C0042874
UMLS CUI [7]
C0025242
UMLS CUI [8]
C0242896
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Similar models

Eligibility Schizophrenia NCT01012830

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 19-59
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Mini-mental state examination
Item
2. diagnosis of schizophrenia by mini
boolean
C0036341 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Cognitive Assessment Score
Item
3. cognition score 1 standard deviation below published norms in controls
boolean
C0870300 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Clinical status Stable | Antipsychotic Agent Dose Stable
Item
4. clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and stable dose for at least 4 weeks
boolean
C0449440 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Hallucinations Moderate BPRS | Delusions Moderate BPRS | Disorder of form of thought Moderate BPRS | PANSS Symptoms Negative
Item
5. have no more than moderate severity rating on hallucinations, delusions formal thought disorder (bprs), negative symptoms (panss_n)
boolean
C0018524 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0029941 (UMLS CUI [1,3])
C0011253 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0029941 (UMLS CUI [2,3])
C0233636 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0029941 (UMLS CUI [3,3])
C4086747 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C1513916 (UMLS CUI [4,3])
Extrapyramidal symptoms Minimal | Rating scale Extrapyramidal tract Side effects
Item
6. minimal eps (simpson-angus <6)
boolean
C0234133 (UMLS CUI [1,1])
C0547040 (UMLS CUI [1,2])
C0681889 (UMLS CUI [2,1])
C0015372 (UMLS CUI [2,2])
C0879626 (UMLS CUI [2,3])
Minimal depression | Depression scale Schizophrenia
Item
7. minimal depression (calgary <10)
boolean
C4305327 (UMLS CUI [1])
C0679604 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Psychotropic Drugs Dose Stable
Item
8. stable dose of other psychotropics (2 months)
boolean
C0033978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Pregnancy Absent
Item
9. not pregnant.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Peptic Ulcer Disease length
Item
1. history of active peptic ulcer disease within 1 year of screening
boolean
C0030920 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Cardiac Arrhythmia
Item
2. clinically significant cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1])
Pulse Rate At rest
Item
3. resting pulse less than 50
boolean
C0232117 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Skin carcinoma
Item
4. active cancer (skin tumors other than melanoma are not excluded)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Cerebrovascular accident
Item
5. history of clinically significant stroke
boolean
C0038454 (UMLS CUI [1])
Epilepsy | Lesion of brain Focal
Item
6. current evidence or history in the past 2 years of epilepsy, focal brain lesion
boolean
C0014544 (UMLS CUI [1])
C0221505 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
Cholinesterase Inhibitors | Nootropic Agents | Galantamine | rivastigmine | donepezil | Vitamin E | Memantine | Anticholinergic Agents
Item
7. start of cholinesterase inhibitors/ cognitive enhancers (galantamine, rivastigmine, donepezil, vitamin e and memantine) within 2 months of screening, 8. use of medications with significant central nervous system anticholinergic activity within 2 months of screening.
boolean
C0008425 (UMLS CUI [1])
C0242913 (UMLS CUI [2])
C0016967 (UMLS CUI [3])
C0649350 (UMLS CUI [4])
C0527316 (UMLS CUI [5])
C0042874 (UMLS CUI [6])
C0025242 (UMLS CUI [7])
C0242896 (UMLS CUI [8])
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