ID

44424

Description

Postpartum Depression: Transdermal Estradiol Versus Sertraline; ODM derived from: https://clinicaltrials.gov/show/NCT00744328

Link

https://clinicaltrials.gov/show/NCT00744328

Keywords

  1. 8/29/18 8/29/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Postpartum Depression NCT00744328

Eligibility Postpartum Depression NCT00744328

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18-45 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
had a baby within the last 3 months
Description

Had Baby Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C3539897
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C0332185
experiencing depression or lasting sadness
Description

Depressive disorder | Sad mood Sustaining

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2,1]
C3536794
UMLS CUI [2,2]
C0443318
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of other therapies for depression, such as antidepressants, psychotherapy, bright light therapy, and herbal remedies such as hypericum st. john's wort
Description

Other Therapy Depressive disorder | Antidepressive Agents | Psychotherapy | Bright light therapy | Herbal medicine | ST. JOHN'S WORT EXTRACT

Data type

boolean

Alias
UMLS CUI [1,1]
C0418967
UMLS CUI [1,2]
C0011581
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0033968
UMLS CUI [4]
C0031765
UMLS CUI [5]
C2240391
UMLS CUI [6]
C0813171
dsm-iv diagnoses of bipolar 1 or 2 disorder or any psychotic episode; substance abuse within last 6 months
Description

Bipolar I disorder | Bipolar II disorder | Psychotic episodes | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
UMLS CUI [3]
C0338614
UMLS CUI [4]
C0038586
previous adverse reaction to sertraline or provera
Description

Adverse reactions Sertraline | Adverse reactions Provera

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0074393
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0699702
no pediatric care: no pediatrician with whom to coordinate breastfeeding and infant care
Description

Pediatric care

Data type

boolean

Alias
UMLS CUI [1]
C3839839
use of medications for medical disorders, except for treatment of hypothyroidism or inhalers for asthma or progestin-only contraceptives
Description

Pharmaceutical Preparations Disease | Exception Therapeutic procedure Hypothyroidism | Exception Inhaler Asthma | Exception Progestin only contraceptive pills

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0020676
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1881212
UMLS CUI [3,3]
C0004096
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C4489413
heavy smoking (>10 cigarettes per day) or intent to resume heavy smoking (unless willing to cut down)
Description

Heavy smoking Number of cigarettes per day | Intent Heavy smoking

Data type

boolean

Alias
UMLS CUI [1,1]
C3845546
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C1283828
UMLS CUI [2,2]
C3845546
personal history of thromboembolic event, hypercoagulability, or first degree relatives with thromboembolic events.
Description

Thromboembolism | Thrombophilia | Thromboembolism First Degree Relative

Data type

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0398623
UMLS CUI [3,1]
C0040038
UMLS CUI [3,2]
C1517194
current or past personal history of breast, uterine, or ovarian cancer.
Description

Breast Carcinoma | Uterine Cancer | Ovarian Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0153567
UMLS CUI [3]
C0029925
brca-positive mother
Description

Mother BRCA gene Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0596223
UMLS CUI [1,3]
C1514241
arterial vascular disease and/or heart disease: increased risk of stroke.
Description

Arterial vascular disease | Heart Disease | Risk Increased Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0852949
UMLS CUI [2]
C0018799
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0205217
UMLS CUI [3,3]
C0038454
liver disease: increased risk of biliary stones, cholestatic jaundice and benign hepatic lesions with e2 treatment.
Description

Liver disease | Risk Increased Biliary calculi | Risk Increased Obstructive Jaundice | Risk Increased Lesion of liver Benign | Estradiol

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0242216
UMLS CUI [3,1]
C0035647
UMLS CUI [3,2]
C0205217
UMLS CUI [3,3]
C0022354
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C0205217
UMLS CUI [4,3]
C0577053
UMLS CUI [4,4]
C0205183
UMLS CUI [5]
C0014912
diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
infants born <32 weeks of gestation
Description

Birth Weeks of gestation

Data type

boolean

Alias
UMLS CUI [1,1]
C0005615
UMLS CUI [1,2]
C1135241
imminent suicidality and/or homicidality: in need of higher level of care than is provided in this study.
Description

Suicidality Impending | Patient homicidal | Patient need for Level of Care High

Data type

boolean

Alias
UMLS CUI [1,1]
C3166387
UMLS CUI [1,2]
C0332190
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0745031
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C1547668
UMLS CUI [3,3]
C0205250

Similar models

Eligibility Postpartum Depression NCT00744328

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 18-45 years
boolean
C0001779 (UMLS CUI [1])
Had Baby Recently
Item
had a baby within the last 3 months
boolean
C3539897 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Depressive disorder | Sad mood Sustaining
Item
experiencing depression or lasting sadness
boolean
C0011581 (UMLS CUI [1])
C3536794 (UMLS CUI [2,1])
C0443318 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Other Therapy Depressive disorder | Antidepressive Agents | Psychotherapy | Bright light therapy | Herbal medicine | ST. JOHN'S WORT EXTRACT
Item
current use of other therapies for depression, such as antidepressants, psychotherapy, bright light therapy, and herbal remedies such as hypericum st. john's wort
boolean
C0418967 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
C0033968 (UMLS CUI [3])
C0031765 (UMLS CUI [4])
C2240391 (UMLS CUI [5])
C0813171 (UMLS CUI [6])
Bipolar I disorder | Bipolar II disorder | Psychotic episodes | Substance Use Disorders
Item
dsm-iv diagnoses of bipolar 1 or 2 disorder or any psychotic episode; substance abuse within last 6 months
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C0338614 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
Adverse reactions Sertraline | Adverse reactions Provera
Item
previous adverse reaction to sertraline or provera
boolean
C0559546 (UMLS CUI [1,1])
C0074393 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0699702 (UMLS CUI [2,2])
Pediatric care
Item
no pediatric care: no pediatrician with whom to coordinate breastfeeding and infant care
boolean
C3839839 (UMLS CUI [1])
Pharmaceutical Preparations Disease | Exception Therapeutic procedure Hypothyroidism | Exception Inhaler Asthma | Exception Progestin only contraceptive pills
Item
use of medications for medical disorders, except for treatment of hypothyroidism or inhalers for asthma or progestin-only contraceptives
boolean
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0020676 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1881212 (UMLS CUI [3,2])
C0004096 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C4489413 (UMLS CUI [4,2])
Heavy smoking Number of cigarettes per day | Intent Heavy smoking
Item
heavy smoking (>10 cigarettes per day) or intent to resume heavy smoking (unless willing to cut down)
boolean
C3845546 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C1283828 (UMLS CUI [2,1])
C3845546 (UMLS CUI [2,2])
Thromboembolism | Thrombophilia | Thromboembolism First Degree Relative
Item
personal history of thromboembolic event, hypercoagulability, or first degree relatives with thromboembolic events.
boolean
C0040038 (UMLS CUI [1])
C0398623 (UMLS CUI [2])
C0040038 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
Breast Carcinoma | Uterine Cancer | Ovarian Carcinoma
Item
current or past personal history of breast, uterine, or ovarian cancer.
boolean
C0678222 (UMLS CUI [1])
C0153567 (UMLS CUI [2])
C0029925 (UMLS CUI [3])
Mother BRCA gene Positive
Item
brca-positive mother
boolean
C0026591 (UMLS CUI [1,1])
C0596223 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Arterial vascular disease | Heart Disease | Risk Increased Cerebrovascular accident
Item
arterial vascular disease and/or heart disease: increased risk of stroke.
boolean
C0852949 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0035647 (UMLS CUI [3,1])
C0205217 (UMLS CUI [3,2])
C0038454 (UMLS CUI [3,3])
Liver disease | Risk Increased Biliary calculi | Risk Increased Obstructive Jaundice | Risk Increased Lesion of liver Benign | Estradiol
Item
liver disease: increased risk of biliary stones, cholestatic jaundice and benign hepatic lesions with e2 treatment.
boolean
C0023895 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0242216 (UMLS CUI [2,3])
C0035647 (UMLS CUI [3,1])
C0205217 (UMLS CUI [3,2])
C0022354 (UMLS CUI [3,3])
C0035647 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0577053 (UMLS CUI [4,3])
C0205183 (UMLS CUI [4,4])
C0014912 (UMLS CUI [5])
Diabetes Mellitus
Item
diabetes
boolean
C0011849 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Birth Weeks of gestation
Item
infants born <32 weeks of gestation
boolean
C0005615 (UMLS CUI [1,1])
C1135241 (UMLS CUI [1,2])
Suicidality Impending | Patient homicidal | Patient need for Level of Care High
Item
imminent suicidality and/or homicidality: in need of higher level of care than is provided in this study.
boolean
C3166387 (UMLS CUI [1,1])
C0332190 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0745031 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1547668 (UMLS CUI [3,2])
C0205250 (UMLS CUI [3,3])

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