ID

36409

Description

Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer's Disease or Mild AD; ODM derived from: https://clinicaltrials.gov/show/NCT02221622

Lien

https://clinicaltrials.gov/show/NCT02221622

Mots-clés

Versions (1)
  1. 12/05/2019 12/05/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

12 mai 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Mild Cognitive Impairment NCT02221622

Anglais

Eligibility Mild Cognitive Impairment NCT02221622

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or postmenopausal women
Description

Gender | Postmenopausal state

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
55 years of age or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of mci due to ad or mild ad
Description

Mild cognitive disorder Due to Alzheimer's Disease | Mild cognitive disorder Due to Alzheimer's Disease Mild

Type de données

boolean

Alias
UMLS CUI [1,1]
C1270972
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0002395
UMLS CUI [2,1]
C1270972
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0002395
UMLS CUI [2,4]
C2945599
mmse > 20 at screen
Description

Mini-mental state examination

Type de données

boolean

Alias
UMLS CUI [1]
C0451306
capacity to provide informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
residing in the community with a caregiver able to accompany the patient to clinic visits
Description

Community Dwelling | Caregiver

Type de données

boolean

Alias
UMLS CUI [1]
C4045975
UMLS CUI [2]
C0085537
no medical contraindications to participation
Description

Medical contraindication Absent Participation

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0679823
willingness to comply with study procedures
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the gaba-a receptor complex
Description

Benzodiazepines | Hypnotics and Sedatives | Anticonvulsants | Antipsychotic Agents | Pharmaceutical Preparations Interaction GABA-A receptor complex

Type de données

boolean

Alias
UMLS CUI [1]
C0005064
UMLS CUI [2]
C0020592
UMLS CUI [3]
C0003286
UMLS CUI [4]
C0040615
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0687133
UMLS CUI [5,3]
C3823126
seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy
Description

Epilepsy | Cerebrovascular accident | Lesion of brain Focal | Traumatic Brain Injury | Substance Use Disorders | Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0221505
UMLS CUI [3,2]
C0205234
UMLS CUI [4]
C0876926
UMLS CUI [5]
C0038586
UMLS CUI [6]
C0006826
clinically significant laboratory or ecg abnormality
Description

Laboratory test result abnormal | ECG abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
mri indicative of any other significant abnormality, including but not limited to evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
Description

Abnormality Significant Magnetic Resonance Imaging | Cerebral Contusion | Encephalomalacia | Aneurysm | Vascular anomaly | Hematoma, Subdural | Space-occupying lesion

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C0750971
UMLS CUI [3]
C0014068
UMLS CUI [4]
C0002940
UMLS CUI [5]
C0158570
UMLS CUI [6]
C0018946
UMLS CUI [7]
C0332562
any condition that would contraindicate an mri such as the presence of metallic objects in the eyes, skin, heart, or body
Description

Medical contraindication Magnetic Resonance Imaging | Metallic Object Eye | Metallic Object Skin | Metallic Object Heart | Metallic Object Body

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C2826620
UMLS CUI [2,2]
C0015392
UMLS CUI [3,1]
C2826620
UMLS CUI [3,2]
C1123023
UMLS CUI [4,1]
C2826620
UMLS CUI [4,2]
C0018787
UMLS CUI [5,1]
C2826620
UMLS CUI [5,2]
C1318419
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Similar models

Eligibility Mild Cognitive Impairment NCT02221622

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state
Item
men or postmenopausal women
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Age
Item
55 years of age or older
boolean
C0001779 (UMLS CUI [1])
Mild cognitive disorder Due to Alzheimer's Disease | Mild cognitive disorder Due to Alzheimer's Disease Mild
Item
diagnosis of mci due to ad or mild ad
boolean
C1270972 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0002395 (UMLS CUI [1,3])
C1270972 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0002395 (UMLS CUI [2,3])
C2945599 (UMLS CUI [2,4])
Mini-mental state examination
Item
mmse > 20 at screen
boolean
C0451306 (UMLS CUI [1])
Informed Consent
Item
capacity to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Community Dwelling | Caregiver
Item
residing in the community with a caregiver able to accompany the patient to clinic visits
boolean
C4045975 (UMLS CUI [1])
C0085537 (UMLS CUI [2])
Medical contraindication Absent Participation
Item
no medical contraindications to participation
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
Protocol Compliance
Item
willingness to comply with study procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Benzodiazepines | Hypnotics and Sedatives | Anticonvulsants | Antipsychotic Agents | Pharmaceutical Preparations Interaction GABA-A receptor complex
Item
use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other drugs that might interact with the gaba-a receptor complex
boolean
C0005064 (UMLS CUI [1])
C0020592 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0687133 (UMLS CUI [5,2])
C3823126 (UMLS CUI [5,3])
Epilepsy | Cerebrovascular accident | Lesion of brain Focal | Traumatic Brain Injury | Substance Use Disorders | Malignant Neoplasms
Item
seizure disorder, history of stroke, focal brain lesion, traumatic brain injury, substance abuse, malignancy
boolean
C0014544 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0221505 (UMLS CUI [3,1])
C0205234 (UMLS CUI [3,2])
C0876926 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
Laboratory test result abnormal | ECG abnormal
Item
clinically significant laboratory or ecg abnormality
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
Abnormality Significant Magnetic Resonance Imaging | Cerebral Contusion | Encephalomalacia | Aneurysm | Vascular anomaly | Hematoma, Subdural | Space-occupying lesion
Item
mri indicative of any other significant abnormality, including but not limited to evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions
boolean
C1704258 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0750971 (UMLS CUI [2])
C0014068 (UMLS CUI [3])
C0002940 (UMLS CUI [4])
C0158570 (UMLS CUI [5])
C0018946 (UMLS CUI [6])
C0332562 (UMLS CUI [7])
Medical contraindication Magnetic Resonance Imaging | Metallic Object Eye | Metallic Object Skin | Metallic Object Heart | Metallic Object Body
Item
any condition that would contraindicate an mri such as the presence of metallic objects in the eyes, skin, heart, or body
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C2826620 (UMLS CUI [2,1])
C0015392 (UMLS CUI [2,2])
C2826620 (UMLS CUI [3,1])
C1123023 (UMLS CUI [3,2])
C2826620 (UMLS CUI [4,1])
C0018787 (UMLS CUI [4,2])
C2826620 (UMLS CUI [5,1])
C1318419 (UMLS CUI [5,2])
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