ID

25310

Beschrijving

Intranasal Insulin Treatment in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00575666

Link

https://clinicaltrials.gov/show/NCT00575666

Trefwoorden

Versies (1)
  1. 31-08-17 31-08-17 -
Geüploaded op

31 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00575666

Engels

Eligibility Schizophrenia NCT00575666

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18-65 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
Beschrijving

Schizophrenia Subtype Any | Schizoaffective Disorder Subtype Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0449560
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0036337
UMLS CUI [2,2]
C0449560
UMLS CUI [2,3]
C1552551
3. stable dose of the current antipsychotic drug for at least one month.
Beschrijving

Antipsychotic Agents Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
4. well established compliance with outpatient treatment per treating clinician's judgement.
Beschrijving

Compliance behavior Outpatient Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0029921
UMLS CUI [1,3]
C0087111
5. able to complete the cognitive assessment battery (must be english speaking).
Beschrijving

Cognitive Assessment Test Completion | Able to speak English Languageve

Datatype

boolean

Alias
UMLS CUI [1,1]
C0870300
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376245
6. female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
Beschrijving

Gender Childbearing Potential Lacking | Childbearing Potential Contraceptive methods | Sexual Abstinence | Female Sterilization | Partner Male sterilization | levonorgestrel implants | Contraceptives, Oral | Intrauterine Devices | Barrier Contraception Double | Vaginal Spermicides | Female Condoms | Vaginal contraceptive diaphragm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0036899
UMLS CUI [4]
C0015787
UMLS CUI [5,1]
C0682323
UMLS CUI [5,2]
C0024559
UMLS CUI [6]
C0497802
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0021900
UMLS CUI [9,1]
C0004764
UMLS CUI [9,2]
C0205173
UMLS CUI [10]
C0087145
UMLS CUI [11]
C0221829
UMLS CUI [12]
C0042241
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to provide informed consent.
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
2. current substance abuse.
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
3. psychiatrically unstable per treating clinician's judgement.
Beschrijving

Unstable status Psychiatric

Datatype

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205487
4. significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
Beschrijving

Illness Significant | Uncontrolled hypertension | Diabetic - poor control | Epilepsy Uncontrolled | Cardiovascular Diseases Severe | Cerebrovascular Disorders Severe | Lung diseases Severe | Thyroid Diseases Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0421258
UMLS CUI [4,1]
C0014544
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0007222
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0007820
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0024115
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0040128
UMLS CUI [8,2]
C0205082
5. pregnancy or breastfeeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Schizophrenia NCT00575666

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18-65 years.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Subtype Any | Schizoaffective Disorder Subtype Any
Item
2. diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype.
boolean
C0036341 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0036337 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Antipsychotic Agents Dose Stable
Item
3. stable dose of the current antipsychotic drug for at least one month.
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Compliance behavior Outpatient Therapeutic procedure
Item
4. well established compliance with outpatient treatment per treating clinician's judgement.
boolean
C1321605 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Cognitive Assessment Test Completion | Able to speak English Languageve
Item
5. able to complete the cognitive assessment battery (must be english speaking).
boolean
C0870300 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0564215 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Gender Childbearing Potential Lacking | Childbearing Potential Contraceptive methods | Sexual Abstinence | Female Sterilization | Partner Male sterilization | levonorgestrel implants | Contraceptives, Oral | Intrauterine Devices | Barrier Contraception Double | Vaginal Spermicides | Female Condoms | Vaginal contraceptive diaphragm
Item
6. female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0682323 (UMLS CUI [5,1])
C0024559 (UMLS CUI [5,2])
C0497802 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0004764 (UMLS CUI [9,1])
C0205173 (UMLS CUI [9,2])
C0087145 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
1. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Substance Use Disorders
Item
2. current substance abuse.
boolean
C0038586 (UMLS CUI [1])
Unstable status Psychiatric
Item
3. psychiatrically unstable per treating clinician's judgement.
boolean
C0443343 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
Illness Significant | Uncontrolled hypertension | Diabetic - poor control | Epilepsy Uncontrolled | Cardiovascular Diseases Severe | Cerebrovascular Disorders Severe | Lung diseases Severe | Thyroid Diseases Severe
Item
4. significant medical illnesses including uncontrolled hypertension, diabetes, seizure. disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0014544 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0007222 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0007820 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0024115 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0040128 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Pregnancy | Breast Feeding
Item
5. pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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