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

- 17.09.21 - 1 Formular, 1 Itemgruppe, 22 Datenelemente, 1 Sprache
Itemgruppe: 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.

Urinanalysis (EHR Archetype) - openEHR-EHR-OBSERVATION.urinalysis.v1

- 10.07.17 - 1 Formular, 1 Itemgruppe, 18 Datenelemente, 5 Sprachen
Itemgruppe: 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.

Follow-Up GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18.10.17 - 1 Formular, 8 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

Early Withdrawal GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18.10.17 - 1 Formular, 10 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: STUDY MEDICATION RECORD SINCE LAST VISIT, RLS RATING SCALE, PATIENT RATED SCALES, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK, CLINICAL GLOBAL IMPRESSION
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Early Withdrawal form.

Week 12 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18.10.17 - 1 Formular, 11 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, PATIENT RATED SCALES, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK, CLINICAL GLOBAL IMPRESSION
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Week 12 form.

Screening Repeat Tests GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18.10.17 - 1 Formular, 5 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: General Information, ELECTROCARDIOGRAM (12 LEAD), PHYSICAL EXAMINATION, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Screening Repeat Tests form.

26072_GSK Ropinirole in Patients Suffering from Restless Legs Syndrome follow-up 101468/190 - GSK Ropinirole in Patients Suffering from Restless Legs Syndrome follow-up 101468/190

- 11.10.17 - 1 Formular, 8 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: General Information, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, LABORATORY EVALUATION, URINE DIPSTICK
Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the mandatory 7 day follow-up assessment form.

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