ID

40831

Beskrivning

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01530373

Länk

https://clinicaltrials.gov/show/NCT01530373

Nyckelord

Versioner (1)
  1. 2020-05-20 2020-05-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hot Flashes NCT01530373

Engelsk

Eligibility Hot Flashes NCT01530373

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with a history of invasive breast cancer or dcis
Beskrivning

Gender | Invasive carcinoma of breast | DCIS

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
UMLS CUI [3]
C0007124
currently taking aromatase inhibitors or tamoxifen
Beskrivning

Aromatase Inhibitors | Tamoxifen

Datatyp

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0039286
not receiving hormone replacement therapy for minimum of one month
Beskrivning

Hormone replacement therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282402
UMLS CUI [1,2]
C0332197
age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
self-reported hot flashes greater than seven times per week
Beskrivning

Hot flushes times per week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600142
UMLS CUI [1,2]
C0456698
self-reported hot flashes for at least one month
Beskrivning

Hot flushes Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600142
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, gabapentin, or antidepressants such as venlafaxine, paroxetine, citalopram , sertraline, etc.
Beskrivning

Other treatment Hot flushes | Estrogens | Progestins | Androgens | gabapentin | Antidepressive Agents | venlafaxine | Paroxetine | Citalopram | Sertraline

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2015819
UMLS CUI [1,2]
C0600142
UMLS CUI [2]
C0014939
UMLS CUI [3]
C0033306
UMLS CUI [4]
C0002844
UMLS CUI [5]
C0060926
UMLS CUI [6]
C0003289
UMLS CUI [7]
C0078569
UMLS CUI [8]
C0070122
UMLS CUI [9]
C0008845
UMLS CUI [10]
C0074393
current use of clonidine or solifenacin. (if patients have been off of these for one month, then they are eligible)
Beskrivning

Clonidine | Solifenacin

Datatyp

boolean

Alias
UMLS CUI [1]
C0009014
UMLS CUI [2]
C1099677
history of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
Beskrivning

Renal Insufficiency Severe | Hepatic impairment Moderate | Hepatic impairment Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205082
concurrent or planned chemotherapy or radiotherapy (within next 3 months)
Beskrivning

Chemotherapy | Therapeutic radiology procedure | Chemotherapy Planned | Therapeutic radiology procedure Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C1301732
currently receiving monoamine oxidase inhibitors, l-dopa, piribedil, barbiturates, moxifloxacin, pimozide, or antihypertensive treatment
Beskrivning

Monoamine Oxidase Inhibitors | Levodopa | Piribedil | Barbiturates | moxifloxacin | Pimozide | Antihypertensive therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0023570
UMLS CUI [3]
C0031979
UMLS CUI [4]
C0004745
UMLS CUI [5]
C0536495
UMLS CUI [6]
C0031935
UMLS CUI [7]
C0585941
currently using cyp3a4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, st. john's wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent cyp3a4 inhibitors (i.e., clarithromycin, chloramphenicol, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazodone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
Beskrivning

CYP3A4 Inducers | Aminoglutethimide | Carbamazepine | Dexamethasone | efavirenz | Ethosuximide | Griseofulvin | modafinil | Nafcillin | Nevirapine | oxcarbazepine | Phenobarbital | Phenylbutazone | Phenytoin | Primidone | Rifabutin | Rifampin | rifapentine | Hypericum perforatum | Sulfamethazine | Sulfinpyrazone | troglitazone | CYP3A4 Inhibitors Strong | Clarithromycin | Chloramphenicol | Erythromycin | Imatinib mesylate | Indinavir Sulfate | Itraconazole | Ketoconazole | nefazodone | Nelfinavir Mesylate | Ritonavir | telithromycin | Troleandomycin

Datatyp

boolean

Alias
UMLS CUI [1]
C3850041
UMLS CUI [2]
C0002555
UMLS CUI [3]
C0006949
UMLS CUI [4]
C0011777
UMLS CUI [5]
C0674428
UMLS CUI [6]
C0015043
UMLS CUI [7]
C0018242
UMLS CUI [8]
C0066677
UMLS CUI [9]
C0027324
UMLS CUI [10]
C0132326
UMLS CUI [11]
C0069751
UMLS CUI [12]
C0031412
UMLS CUI [13]
C0031463
UMLS CUI [14]
C0031507
UMLS CUI [15]
C0033148
UMLS CUI [16]
C0140575
UMLS CUI [17]
C0035608
UMLS CUI [18]
C0073372
UMLS CUI [19]
C0936242
UMLS CUI [20]
C0038686
UMLS CUI [21]
C0038742
UMLS CUI [22]
C0245514
UMLS CUI [23,1]
C3850053
UMLS CUI [23,2]
C0442821
UMLS CUI [24]
C0055856
UMLS CUI [25]
C0008168
UMLS CUI [26]
C0014806
UMLS CUI [27]
C0939537
UMLS CUI [28]
C0700483
UMLS CUI [29]
C0064113
UMLS CUI [30]
C0022625
UMLS CUI [31]
C0068485
UMLS CUI [32]
C0886530
UMLS CUI [33]
C0292818
UMLS CUI [34]
C0907410
UMLS CUI [35]
C0041165
uncontrolled or poorly controlled closed-angle glaucoma, urinary retention, gastric retention (evaluated from history & physical exam and medical record)
Beskrivning

Angle Closure Glaucoma Uncontrolled | Angle Closure Glaucoma Poorly controlled | Urinary Retention | Gastric retention

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0017605
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0080274
UMLS CUI [4]
C0585136
hypotension (systolic bp < 80)
Beskrivning

Hypotension | Systolic Pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history &
Beskrivning

Coronary artery insufficiency Severe | Abnormal cardiac conduction | Recent myocardial infarction | Cerebrovascular Disorders | Syncope

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0542052
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0232219
UMLS CUI [3]
C1998297
UMLS CUI [4]
C0007820
UMLS CUI [5]
C0039070
physical and medical record)
Beskrivning

ID.16

Datatyp

boolean

history of allergy or adverse reactions to clonidine or solifenacin
Beskrivning

Clonidine allergy | Adverse reactions Clonidine | Hypersensitivity Solifenacin | Adverse reactions Solifenacin

Datatyp

boolean

Alias
UMLS CUI [1]
C0570975
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0009014
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1099677
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C1099677
ecog status >2 (in bed more than 50% of day)
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
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Similar models

Eligibility Hot Flashes NCT01530373

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast | DCIS
Item
women with a history of invasive breast cancer or dcis
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Aromatase Inhibitors | Tamoxifen
Item
currently taking aromatase inhibitors or tamoxifen
boolean
C0593802 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
Hormone replacement therapy Absent
Item
not receiving hormone replacement therapy for minimum of one month
boolean
C0282402 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Hot flushes times per week
Item
self-reported hot flashes greater than seven times per week
boolean
C0600142 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
Hot flushes Duration
Item
self-reported hot flashes for at least one month
boolean
C0600142 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Other treatment Hot flushes | Estrogens | Progestins | Androgens | gabapentin | Antidepressive Agents | venlafaxine | Paroxetine | Citalopram | Sertraline
Item
receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, gabapentin, or antidepressants such as venlafaxine, paroxetine, citalopram , sertraline, etc.
boolean
C2015819 (UMLS CUI [1,1])
C0600142 (UMLS CUI [1,2])
C0014939 (UMLS CUI [2])
C0033306 (UMLS CUI [3])
C0002844 (UMLS CUI [4])
C0060926 (UMLS CUI [5])
C0003289 (UMLS CUI [6])
C0078569 (UMLS CUI [7])
C0070122 (UMLS CUI [8])
C0008845 (UMLS CUI [9])
C0074393 (UMLS CUI [10])
Clonidine | Solifenacin
Item
current use of clonidine or solifenacin. (if patients have been off of these for one month, then they are eligible)
boolean
C0009014 (UMLS CUI [1])
C1099677 (UMLS CUI [2])
Renal Insufficiency Severe | Hepatic impairment Moderate | Hepatic impairment Severe
Item
history of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Chemotherapy | Therapeutic radiology procedure | Chemotherapy Planned | Therapeutic radiology procedure Planned
Item
concurrent or planned chemotherapy or radiotherapy (within next 3 months)
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Monoamine Oxidase Inhibitors | Levodopa | Piribedil | Barbiturates | moxifloxacin | Pimozide | Antihypertensive therapy
Item
currently receiving monoamine oxidase inhibitors, l-dopa, piribedil, barbiturates, moxifloxacin, pimozide, or antihypertensive treatment
boolean
C0026457 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
C0031979 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0536495 (UMLS CUI [5])
C0031935 (UMLS CUI [6])
C0585941 (UMLS CUI [7])
CYP3A4 Inducers | Aminoglutethimide | Carbamazepine | Dexamethasone | efavirenz | Ethosuximide | Griseofulvin | modafinil | Nafcillin | Nevirapine | oxcarbazepine | Phenobarbital | Phenylbutazone | Phenytoin | Primidone | Rifabutin | Rifampin | rifapentine | Hypericum perforatum | Sulfamethazine | Sulfinpyrazone | troglitazone | CYP3A4 Inhibitors Strong | Clarithromycin | Chloramphenicol | Erythromycin | Imatinib mesylate | Indinavir Sulfate | Itraconazole | Ketoconazole | nefazodone | Nelfinavir Mesylate | Ritonavir | telithromycin | Troleandomycin
Item
currently using cyp3a4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, st. john's wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent cyp3a4 inhibitors (i.e., clarithromycin, chloramphenicol, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazodone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
boolean
C3850041 (UMLS CUI [1])
C0002555 (UMLS CUI [2])
C0006949 (UMLS CUI [3])
C0011777 (UMLS CUI [4])
C0674428 (UMLS CUI [5])
C0015043 (UMLS CUI [6])
C0018242 (UMLS CUI [7])
C0066677 (UMLS CUI [8])
C0027324 (UMLS CUI [9])
C0132326 (UMLS CUI [10])
C0069751 (UMLS CUI [11])
C0031412 (UMLS CUI [12])
C0031463 (UMLS CUI [13])
C0031507 (UMLS CUI [14])
C0033148 (UMLS CUI [15])
C0140575 (UMLS CUI [16])
C0035608 (UMLS CUI [17])
C0073372 (UMLS CUI [18])
C0936242 (UMLS CUI [19])
C0038686 (UMLS CUI [20])
C0038742 (UMLS CUI [21])
C0245514 (UMLS CUI [22])
C3850053 (UMLS CUI [23,1])
C0442821 (UMLS CUI [23,2])
C0055856 (UMLS CUI [24])
C0008168 (UMLS CUI [25])
C0014806 (UMLS CUI [26])
C0939537 (UMLS CUI [27])
C0700483 (UMLS CUI [28])
C0064113 (UMLS CUI [29])
C0022625 (UMLS CUI [30])
C0068485 (UMLS CUI [31])
C0886530 (UMLS CUI [32])
C0292818 (UMLS CUI [33])
C0907410 (UMLS CUI [34])
C0041165 (UMLS CUI [35])
Angle Closure Glaucoma Uncontrolled | Angle Closure Glaucoma Poorly controlled | Urinary Retention | Gastric retention
Item
uncontrolled or poorly controlled closed-angle glaucoma, urinary retention, gastric retention (evaluated from history & physical exam and medical record)
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0017605 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0080274 (UMLS CUI [3])
C0585136 (UMLS CUI [4])
Hypotension | Systolic Pressure
Item
hypotension (systolic bp < 80)
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Coronary artery insufficiency Severe | Abnormal cardiac conduction | Recent myocardial infarction | Cerebrovascular Disorders | Syncope
Item
severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history &
boolean
C0542052 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0232219 (UMLS CUI [2])
C1998297 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C0039070 (UMLS CUI [5])
ID.16
Item
physical and medical record)
boolean
Clonidine allergy | Adverse reactions Clonidine | Hypersensitivity Solifenacin | Adverse reactions Solifenacin
Item
history of allergy or adverse reactions to clonidine or solifenacin
boolean
C0570975 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0009014 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1099677 (UMLS CUI [3,2])
C0559546 (UMLS CUI [4,1])
C1099677 (UMLS CUI [4,2])
ECOG performance status
Item
ecog status >2 (in bed more than 50% of day)
boolean
C1520224 (UMLS CUI [1])
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