ID

44402

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00892450

Stichworte

Versionen (2)
  1. 23.08.18 23.08.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Parkinson's Disease NCT00892450

Englisch

Eligibility Parkinson's Disease NCT00892450

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Parkinson Disease

Datentyp

boolean

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

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

Datentyp

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:
Beschreibung

Work up Urologic

Datentyp

boolean

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

Rule out Causes Reversible Urinary symptoms

Datentyp

boolean

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

Urinalysis

Datentyp

boolean

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

Ultrasound PVR

Datentyp

boolean

Alias
UMLS CUI [1]
C2052173
urinary cytology
Beschreibung

Cytology urinary

Datentyp

boolean

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

Symptoms Overactive Bladder

Datentyp

boolean

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

Urgency Episode Quantity per day

Datentyp

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
Beschreibung

Urination Quantity per day

Datentyp

boolean

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

Complaints Symptoms Duration

Datentyp

boolean

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

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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]
C1955826
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.
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Angle Closure Glaucoma Uncontrolled

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Hepatic impairment | Renal Insufficiency

Datentyp

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
Beschreibung

Severe gastroesophageal reflux | Diphosphonates | Patients At risk Esophagitis

Datentyp

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
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Parkinson's Disease NCT00892450

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
C1955826 (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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video