Modelli di dati selezionati

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CDASH Concomitant Medication - Concomitant medication

- 20/06/18 - 1 modulo, 2 itemgroups, 9 elementi, 2 lingue
Itemgroups: General information, Details
translated and modified from CDASH 2011-10-24 http://www.cdisc.org

NINDS CDE Drugs Epilepsy - Drugs

- 25/04/16 - 1 modulo, 4 itemgroups, 58 elementi, 1 linguaggio
Itemgroups: Anti Epileptic Drug (AED) Plasma Concentration Log, Anti Epileptic Drug (AED) Resistance Log, Anti Epileptic Drug (AED) Log, Non Anti Epileptic Medication Log
NINDS Common Data Elements 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.

NINDS CDE Prior and Concomitant Medications Amyotrophic Lateral Sclerosis - Prior and Concomitant Medications

- 15/04/16 - 1 modulo, 1 ItemGroup, 14 elementi, 1 linguaggio
ItemGroup: Prior and Concomitant Medications
NINDS Common Data Elements [Magnetic Resonance Imaging][Amyotrophic Lateral Sclerosis] 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.

EHR4CR CTE Data Inventory

- 21/04/18 - 1 modulo, 14 itemgroups, 133 elementi, 1 linguaggio
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

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

- 18/10/17 - 1 modulo, 8 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: 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.

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

- 18/10/17 - 1 modulo, 11 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: 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.

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

- 18/10/17 - 1 modulo, 10 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: 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 3 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 12 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, WPAI, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, DOSE REDUCTION BETWEEN SCHEDULED VISITS, RAMOS RANDOMISATION AND DISPENSING
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 3 form.

Week 8 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 12 itemgroups, 21 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, PATIENT RATED SCALES, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, DOSE REDUCTION BETWEEN SCHEDULED VISITS, RAMOS RANDOMISATION AND DISPENSING
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 8 form.

Week 7 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 12 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, WPAI, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, DOSE REDUCTION BETWEEN SCHEDULED VISITS, RAMOS RANDOMISATION AND DISPENSING
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 7 form.

Week 5 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 12 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, WPAI, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, DOSE REDUCTION BETWEEN SCHEDULED VISITS, RAMOS RANDOMISATION AND DISPENSING
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 5 form.

Week 4 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/17 - 1 modulo, 12 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, WPAI, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, DOSE REDUCTION BETWEEN SCHEDULED VISITS, RAMOS RANDOMISATION AND DISPENSING
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 4 form.

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