ID

31458

Beskrivning

Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00892450

Länk

https://clinicaltrials.gov/show/NCT00892450

Nyckelord

Versioner (2)
  1. 2018-08-23 2018-08-23 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00892450

Engelsk

Eligibility Parkinson's Disease NCT00892450

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of idiopathic pd (icd9=332.0)
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
mmse 24, able to give informed consent and complete questionnaires and voiding diaries.
Beskrivning

Mini-mental state examination | Informed Consent | Questionnaires Completion | Maintain voiding diary

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C0034394
UMLS CUI [3,2]
C0205197
UMLS CUI [4]
C3161951
urological work-up within 3 months of enrollment to:
Beskrivning

Work up Urologic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750430
UMLS CUI [1,2]
C0042077
rule out treatable causes of urinary symptoms
Beskrivning

Rule out Causes Reversible Urinary symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332196
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205343
UMLS CUI [1,4]
C0426359
urinalysis (ua)
Beskrivning

Urinalysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0042014
post-void residual ultrasound (pvr)
Beskrivning

Ultrasound PVR

Datatyp

boolean

Alias
UMLS CUI [1]
C2052173
urinary cytology
Beskrivning

Cytology urinary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0010818
UMLS CUI [1,2]
C1524119
documented symptoms oab on screening 3-day voiding diary:
Beskrivning

Symptoms Overactive Bladder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0878773
average of 1 urgency episode / 24 hours, and
Beskrivning

Urgency Episode Quantity per day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085606
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
average of 8 micturitions / 24 hours
Beskrivning

Urination Quantity per day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042034
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439505
subjective complaints of symptoms for 3 months
Beskrivning

Complaints Symptoms Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3469071
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0449238
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
Beskrivning

Exposure to Anticholinergic Agents | Exposure to Antispasmodics | Atropine | tolterodine | Benztropine | Trihexyphenidyl | Dicyclomine | Hyoscyamine | Scopolamine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0242896
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0037766
UMLS CUI [3]
C0004259
UMLS CUI [4]
C0388753
UMLS CUI [5]
C0005098
UMLS CUI [6]
C0041009
UMLS CUI [7]
C0012125
UMLS CUI [8]
C0596004
UMLS CUI [9]
C0036442
exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
Beskrivning

Exposure to Pharmaceutical Preparations Affecting Cognition | Opioids | Benzodiazepines | Sedating antihistamine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0009240
UMLS CUI [2]
C0242402
UMLS CUI [3]
C0005064
UMLS CUI [4]
C0360183
exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome p450 enzyme, primarily cyp3a4). these include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
Beskrivning

Exposure to Pharmaceutical Preparations Contraindicated | Pharmaceutical Preparations Use of Cytochrome P450 | Pharmaceutical Preparations Use of Cytochrome P-450 CYP3A4 | Ketoconazole | Itraconazole | Miconazole | Erythromycin | Clarithromycin | Ritonavir | Nelfinavir | nefazodone | Flecainide | Thioridazine | Tricyclic Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0010762
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C3714798
UMLS CUI [4]
C0022625
UMLS CUI [5]
C0064113
UMLS CUI [6]
C0025942
UMLS CUI [7]
C0014806
UMLS CUI [8]
C0055856
UMLS CUI [9]
C0292818
UMLS CUI [10]
C0525005
UMLS CUI [11]
C0068485
UMLS CUI [12]
C0016229
UMLS CUI [13]
C0039943
UMLS CUI [14]
C0003290
nonpharmacological treatment of oab within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
Beskrivning

Therapeutic procedure Overactive Bladder | Exception Pharmacotherapy | Biofeedback | Physical therapy | Acupuncture procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0878773
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013216
UMLS CUI [3]
C0005491
UMLS CUI [4]
C0949766
UMLS CUI [5]
C0394664
uncontrolled narrow angle glaucoma
Beskrivning

Angle Closure Glaucoma Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
history of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
Beskrivning

Gastric retention | Urinary Retention | Dysmotility of stomach | Dysmotility urinary | Ulcerative Colitis | Myasthenia Gravis | Severe constipation

Datatyp

boolean

Alias
UMLS CUI [1]
C0585136
UMLS CUI [2]
C0080274
UMLS CUI [3]
C0431579
UMLS CUI [4,1]
C0679316
UMLS CUI [4,2]
C1524119
UMLS CUI [5]
C0009324
UMLS CUI [6]
C0026896
UMLS CUI [7]
C1855664
history of hepatic or renal impairment
Beskrivning

Hepatic impairment | Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
history of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
Beskrivning

Severe gastroesophageal reflux | Diphosphonates | Patients At risk Esophagitis

Datatyp

boolean

Alias
UMLS CUI [1]
C1857946
UMLS CUI [2]
C0012544
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0014868
previous exposure to anticholinergic for oab symptoms that resulted in side effects that caused cessation of the medication
Beskrivning

Exposure to Anticholinergic Agents | Anticholinergic Agents Symptoms Overactive Bladder | Symptoms Overactive Bladder Resulting in Adverse effects | Adverse effects Causing Medication stop

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0242896
UMLS CUI [2,1]
C0242896
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0878773
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0878773
UMLS CUI [3,3]
C0332294
UMLS CUI [3,4]
C0879626
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0850893
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Similar models

Eligibility Parkinson's Disease NCT00892450

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
diagnosis of idiopathic pd (icd9=332.0)
boolean
C0030567 (UMLS CUI [1])
Mini-mental state examination | Informed Consent | Questionnaires Completion | Maintain voiding diary
Item
mmse 24, able to give informed consent and complete questionnaires and voiding diaries.
boolean
C0451306 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0034394 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C3161951 (UMLS CUI [4])
Work up Urologic
Item
urological work-up within 3 months of enrollment to:
boolean
C0750430 (UMLS CUI [1,1])
C0042077 (UMLS CUI [1,2])
Rule out Causes Reversible Urinary symptoms
Item
rule out treatable causes of urinary symptoms
boolean
C0332196 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C0426359 (UMLS CUI [1,4])
Urinalysis
Item
urinalysis (ua)
boolean
C0042014 (UMLS CUI [1])
Ultrasound PVR
Item
post-void residual ultrasound (pvr)
boolean
C2052173 (UMLS CUI [1])
Cytology urinary
Item
urinary cytology
boolean
C0010818 (UMLS CUI [1,1])
C1524119 (UMLS CUI [1,2])
Symptoms Overactive Bladder
Item
documented symptoms oab on screening 3-day voiding diary:
boolean
C1457887 (UMLS CUI [1,1])
C0878773 (UMLS CUI [1,2])
Urgency Episode Quantity per day
Item
average of 1 urgency episode / 24 hours, and
boolean
C0085606 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
Urination Quantity per day
Item
average of 8 micturitions / 24 hours
boolean
C0042034 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
Complaints Symptoms Duration
Item
subjective complaints of symptoms for 3 months
boolean
C3469071 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Exposure to Anticholinergic Agents | Exposure to Antispasmodics | Atropine | tolterodine | Benztropine | Trihexyphenidyl | Dicyclomine | Hyoscyamine | Scopolamine
Item
exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
boolean
C0332157 (UMLS CUI [1,1])
C0242896 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0037766 (UMLS CUI [2,2])
C0004259 (UMLS CUI [3])
C0388753 (UMLS CUI [4])
C0005098 (UMLS CUI [5])
C0041009 (UMLS CUI [6])
C0012125 (UMLS CUI [7])
C0596004 (UMLS CUI [8])
C0036442 (UMLS CUI [9])
Exposure to Pharmaceutical Preparations Affecting Cognition | Opioids | Benzodiazepines | Sedating antihistamine
Item
exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
boolean
C0332157 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0009240 (UMLS CUI [1,4])
C0242402 (UMLS CUI [2])
C0005064 (UMLS CUI [3])
C0360183 (UMLS CUI [4])
Exposure to Pharmaceutical Preparations Contraindicated | Pharmaceutical Preparations Use of Cytochrome P450 | Pharmaceutical Preparations Use of Cytochrome P-450 CYP3A4 | Ketoconazole | Itraconazole | Miconazole | Erythromycin | Clarithromycin | Ritonavir | Nelfinavir | nefazodone | Flecainide | Thioridazine | Tricyclic Antidepressive Agents
Item
exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome p450 enzyme, primarily cyp3a4). these include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
boolean
C0332157 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0010762 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C3714798 (UMLS CUI [3,3])
C0022625 (UMLS CUI [4])
C0064113 (UMLS CUI [5])
C0025942 (UMLS CUI [6])
C0014806 (UMLS CUI [7])
C0055856 (UMLS CUI [8])
C0292818 (UMLS CUI [9])
C0525005 (UMLS CUI [10])
C0068485 (UMLS CUI [11])
C0016229 (UMLS CUI [12])
C0039943 (UMLS CUI [13])
C0003290 (UMLS CUI [14])
Therapeutic procedure Overactive Bladder | Exception Pharmacotherapy | Biofeedback | Physical therapy | Acupuncture procedure
Item
nonpharmacological treatment of oab within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
boolean
C0087111 (UMLS CUI [1,1])
C0878773 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0005491 (UMLS CUI [3])
C0949766 (UMLS CUI [4])
C0394664 (UMLS CUI [5])
Angle Closure Glaucoma Uncontrolled
Item
uncontrolled narrow angle glaucoma
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Gastric retention | Urinary Retention | Dysmotility of stomach | Dysmotility urinary | Ulcerative Colitis | Myasthenia Gravis | Severe constipation
Item
history of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
boolean
C0585136 (UMLS CUI [1])
C0080274 (UMLS CUI [2])
C0431579 (UMLS CUI [3])
C0679316 (UMLS CUI [4,1])
C1524119 (UMLS CUI [4,2])
C0009324 (UMLS CUI [5])
C0026896 (UMLS CUI [6])
C1855664 (UMLS CUI [7])
Hepatic impairment | Renal Insufficiency
Item
history of hepatic or renal impairment
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Severe gastroesophageal reflux | Diphosphonates | Patients At risk Esophagitis
Item
history of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
boolean
C1857946 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0014868 (UMLS CUI [3,3])
Exposure to Anticholinergic Agents | Anticholinergic Agents Symptoms Overactive Bladder | Symptoms Overactive Bladder Resulting in Adverse effects | Adverse effects Causing Medication stop
Item
previous exposure to anticholinergic for oab symptoms that resulted in side effects that caused cessation of the medication
boolean
C0332157 (UMLS CUI [1,1])
C0242896 (UMLS CUI [1,2])
C0242896 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0878773 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0878773 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0879626 (UMLS CUI [3,4])
C0879626 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0850893 (UMLS CUI [4,3])
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