Modelos de dados selecionados

Deve ter sessão iniciada para selecionar vários modelos de dados e para os transferir ou analisar.

18 Resultados da pesquisa.
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NINDS CDE Vital Signs Headache - Vital Signs

- 20/06/2016 - 1 Formulário, 1 Grupo de itens, 35 Elementos de dados, 1 Idioma
Grupo de itens: Vital Signs
NINDS Common Data Elements [Vital Signs][Headache] 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.

Start-up Resource - NINDS Stroke CDE Recommendations - ODM-UMLS: Summary of Stroke CDE Recommendations

- 20/09/2021 - 1 Formulário, 3 Grupos de itens, 52 Elementos de dados, 2 Idiomas
Grupos de itens: Core CDEs for all NINDs Studies, Core CDEs for Stroke Studies, Supplemental/Highly Recommended CDEs for Types of Stroke Studies
Modified Form Summary of Core/Supplemental - Highly Recommended or Supplemental Recommendations: Stroke CDEs Updated: October 13, 2015 This modified form used the National Institute of Neurological Disorders and Stroke Common Data Elements (http://www.commondataelements.ninds.nih.gov/) The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. References section: 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.

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Visit 1: Demographic Data

- 28/11/2018 - 1 Formulário, 2 Grupos de itens, 9 Elementos de dados, 1 Idioma
Grupos de itens: Administrative data, Demographics
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 33 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Head Impact Test (HIT-6) Score, IHS Headache Classification1, Migraine History, Previous Treatment for Migraine
This ODM-file contains the form to document the Head impact test (HIT-6) Score, the IHS Headache classification, the migraine history and the previous migraine treatment. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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

- 18/10/2017 - 1 Formulário, 8 Grupos de itens, 14 Elementos de dados, 1 Idioma
Grupos de itens: 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

- 18/10/2017 - 1 Formulário, 11 Grupos de itens, 18 Elementos de dados, 1 Idioma
Grupos de itens: 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

- 18/10/2017 - 1 Formulário, 10 Grupos de itens, 18 Elementos de dados, 1 Idioma
Grupos de itens: 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 2 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulário, 12 Grupos de itens, 15 Elementos de dados, 1 Idioma
Grupos de itens: 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 2 form.

Week 1 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulário, 12 Grupos de itens, 15 Elementos de dados, 1 Idioma
Grupos de itens: 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 1 form.

Week 3 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulário, 12 Grupos de itens, 15 Elementos de dados, 1 Idioma
Grupos de itens: 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.

Day 2 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulário, 10 Grupos de itens, 13 Elementos de dados, 1 Idioma
Grupos de itens: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, 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 Day 2 form.

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

- 18/10/2017 - 1 Formulário, 5 Grupos de itens, 11 Elementos de dados, 1 Idioma
Grupos de itens: 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.

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