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  2. 2. Routine Documentation
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Urinanalysis (EHR Archetype) - openEHR-EHR-OBSERVATION.urinalysis.v1

- 7/10/17 - 1 form, 1 itemgroup, 18 items, 5 languages
Itemgroup: openEHR-EHR-OBSERVATION.urinalysis.v1.xml
Derived from www.openehr.org . Use to record the results of a qualitative and semi-quantitative test array performed on a sample of urine, using reagent test strips. On exposure to urine, chemical pads on the reagent test strip change colour and the test result is read by visual comparison to a color chart at specified times after exposure or by an automated device. Different commercial products carry a variety of test /reagent pads. This archetype is heavily influenced by the commonly available Multistix test strips in Australia, recording ten commonly used analytes, but is intended to be generically applicable. If requirements for other parameters become apparent to meet the requirements for other test strips then product-specific urinalysis archetypes may need to be developed.

The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

- 4/6/22 - 1 form, 16 itemgroups, 158 items, 1 language
Itemgroups: Administrative,Vital Signs,12-Lead ECG,Laboratory Results Data (Haematology) - Pre-Dose,Laboratory Results Data (Clinical Chemistry) - Pre-Dose,Urinalysis - Pre-Dose,Randomisation Number,Investigational Product,Treatment Confirmation,PET Scan (2),fMRI Scan - Post-PET Scan,PET Scan (3),Pharmacokinetics - Blood,Laboratory Results Data (Haematology) - 24hrs Post-Dose,Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose,Urinalysis - 24hrs Post-Dose
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 9/20/21 - 1 form, 8 itemgroups, 58 items, 1 language
Itemgroups: Local Laboratory,Urinalysis | Local,Vital signs,12 lead ECG,Electrocardiogram abnormal,Drug Kinetics; Blood,12 lead ECG | Holter Electrocardiography | Summary Report,Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

- 9/20/21 - 1 form, 24 itemgroups, 323 items, 1 language
Itemgroups: Date of Visit,Summary Holter,Summary Holter Abnormalities,Electroniclly Transferred Lab Data - Dosing Date and Time,Electronically Transerred Lab Data - Pre-dose,Electronically Transerred Lab Data - 1 Hour,Electronically Transerred Lab Data - 2 Hour ,Electronically Transerred Lab Data - 4 Hour,Electronically Transerred Lab Data - 8 Hour ,Electronically Transerred Lab Data - 24 Hour,Electronically Transerred Lab Data - 36 Hour ,Electronically Transerred Lab Data - 48 Hour,Electronically Transerred Lab Data - 72 Hour ,Pharmacokinetics Blood,Pharmacokinetics Blood - Extra Scheduled Samples Entry ,Urinalysis - Dosing Date and Time ,Urinalysis Dipstick Details - Pre-Dose,Urinalysis Dipstick Details - 2 Hour Post-Dose,Urinalysis Dipstick Details - 4 Hour Post-Dose ,Urinalysis Dipstick Details - 8 Hour Post-Dose ,Urinalysis Dipstick Details - 24 Hour Post-Dose ,Urinalysis Dipstick Details -36 Hour Post-Dose,Urinalysis Dipstick Details -48 Hour Post-Dose ,Urinalysis - Local: Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Urinalysis Test Results Screening Ropinirole Parkinson Disease 101468/165 - Urinalysis Test Results Screening

- 9/20/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: URINALYSIS TEST RESULTS,Dip stick
Study Part: Urinalysis Test Results Screening. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day -1 - 12-Lead ECG; Summary Holter; Summary Holter Abnormalities; Vital Signs; Electronically Transferred Lab Data; Urinalysis; PET; Functional MRI Scan; MRI Scan; Randomisation Number

- 9/17/21 - 1 form, 12 itemgroups, 107 items, 1 language
Itemgroups: Date of Visit,12-Lead ECG,Summary Holter,Summary Holter Abnormalities,Vital Signs - Pre-Baseline Scan,Electronically Transerred Lab Data ,Urinalysis - Dipstick Details ,Urinalysis - Microscopy Details ,PET - Scan Baseline,Functional MRI Scan,MRI Scan,Randomisation Number
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

NINDS CDE Laboratory Test Recommendations Table 6 – Urinalysis Multiple Sclerosis - Laboratory Test Recommendations Table 6 – Urinalysis

- 9/17/21 - 1 form, 1 itemgroup, 22 items, 1 language
Itemgroup: Urinalysis
NINDS Common Data Elements, Multiple Sclerosis Laboratory Test Recommendations Table 6 – Urinalysis Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 4/28/21 - 1 form, 4 itemgroups, 21 items, 1 language
Itemgroups: Administrative,Laboratory Tests - Haematology,Laboratory Tests - Blood Chemistry,Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Laboratory Tests - Haematology; Blood Chemistry; Urinalysis

- 4/21/21 - 1 form, 4 itemgroups, 28 items, 1 language
Itemgroups: Administrative,Laboratory Tests - Haematology,Laboratory Tests - Blood Chemistry,Laboratory Tests - Urinalysis
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection

- 3/11/21 - 1 form, 13 itemgroups, 80 items, 1 language
Itemgroups: Concomitant Medication,12-Lead ECG/ Holter/ Telemetry ECG,ECG Abnormalities,Vital Signs,Local Laboratory,Local Laboratory - Haematology ,Local Laboratory - Clinical Chemistry,Urinalysis - Local,Urinalysis - Local: Dipstick Details,Urinalysis - Local: Microscopy Details,Pulmonary Function Tests,Nasal Airflow Resistance,Nasal Inspection
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Follow-Up - 12-Lead ECG; Vital Signs; Pulmonary Function Tests; Laboratory; Urinalysis

- 3/2/21 - 1 form, 11 itemgroups, 38 items, 1 language
Itemgroups: Date of Visit,12-Lead ECG/ Holter/ Telemetry ECG,Vital Signs,Pulmonary Function Tests,Local Laboratory - Haematology,Local Laboratory - Haematology ,Local Laboratory - Clinical Chemistry,Local Laboratory - Clinical Chemistry,Urinalysis - Local,Urinalysis - Local: Dipstick Details,Urinalysis - Local: Microscopy Details
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Screening - Demography; 12-Lead ECG; Vital Signs; Local Laboratory; Urinalysis; Nasal Inspection

- 3/2/21 - 1 form, 15 itemgroups, 64 items, 1 language
Itemgroups: Inform Screening,Inform Enrolment,Date of Visit,Demography,12-Lead ECG,Vital Signs - Measurement 1,Vital Signs - Measurement 2 and 3 ,Local Laboratory - Haematology,Local Laboratory - Haematology ,Local Laboratory - Clinical Chemistry,Local Laboratory - Clinical Chemistry,Urinalysis - Local,Urinalysis - Local: Dipstick Details,Urinalysis - Local: Microscopy Details,Nasal Inspection
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

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