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TREATMENT CROSSOVER (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

- 02-07-17 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Patient administration, TREATMENT CROSSOVER (UNSCHEDULED)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

TREATMENT CROSSOVER (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 02-07-17 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Patient administration, TREATMENT CROSSOVER (UNSCHEDULED)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 01-07-17 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Patient administration, STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

- 01-07-17 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Patient administration, STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Early Withdrawal

- 08-02-18 - 1 Formulier, 5 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Early Withdrawal

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - End of Study

- 08-02-18 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Status Of Treatment Blind, Pregnancy Information, Study Conclusion
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: End of Study

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Treatment Week 24 - Visit 7

- 08-02-18 - 1 Formulier, 5 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Treatment Week 24 - Visit 7

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Treatment Week 8 - Visit 5

- 08-02-18 - 1 Formulier, 5 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Treatment Week 8 - Visit 5

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Treatment Week 16 - Visit 6

- 08-02-18 - 1 Formulier, 5 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Investigational Product Compliance
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Treatment Week 16 - Visit 6

Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723 - Run-In - Visit 3

- 08-02-18 - 1 Formulier, 6 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Adverse Events, Concomitant Medications, Vital Signs, Central Laboratory, Inclusion Criteria, Subject Continuation
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Run-In - Visit 3

Eligibility NCT00322621 Diabetic Neuropathies - Eligibility

- 11-08-14 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 2 Talen
Itemgroepen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00322621

LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 28-06-17 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Patient administration, LASER ADMINISTRATION STUDY EYE
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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