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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - Screening

- 27/09/21 - 1 modulo, 18 itemgroups, 51 elementi, 1 linguaggio
Itemgroups: Date of Visit/Assessment, Subject Identification, Demography, Demography - Geographic Ancestry, Demography_Contraceptive Methods, Eligibility Question, Inclusion/Exclusion Criteria, Screen Failure, investigator signature, Previous Clinical Trial Participation, Vital Signs, PGx-Pharmacogenetic Research Consent, Medical conditions, IHS Headache Classification, Migraine history, Previous treatment for migraine, Other previous treatment for migraine, Treatment satisfaction
Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/21 - 1 modulo, 7 itemgroups, 28 elementi, 1 linguaggio
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 11, Year 8) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/21 - 1 modulo, 7 itemgroups, 28 elementi, 1 linguaggio
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/21 - 1 modulo, 7 itemgroups, 29 elementi, 1 linguaggio
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

- 27/09/21 - 1 modulo, 7 itemgroups, 29 elementi, 1 linguaggio
Itemgroups: Administrative, Informed Consent, Demographics, Laboratory Tests, Follow-Up Studies, Tracking Document - Reason for non participation, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Demographics Screening rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g - Demographics Screening

- 20/09/21 - 1 modulo, 1 ItemGroup, 6 elementi, 1 linguaggio
ItemGroup: Demography
Study part: Demographics Screening . A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

Screening Demographics GOAL Trial B-cell Lymphoma NCT02499003

- 20/09/21 - 1 modulo, 1 ItemGroup, 6 elementi, 1 linguaggio
ItemGroup: Demographics
NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Study part: Demographics (Screening) Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Acute Myeloid Leukemia - Treatment Details

- 20/09/21 - 13 moduli, 6 itemgroups, 39 elementi, 1 linguaggio
Itemgroups: Therapeutic procedure; Details, Adverse Event, Hemopoietic stem cell transplant, Platelet Engraftment, Neutrophil Engraftment, Therapeutic procedure; Status
Acute Myeloid Leukemia Common Data Elements Holz

Medical History

6 itemgroups 20 elementi

Lab: Cytology/Cytogenetics/Cytochemistry

3 itemgroups 43 elementi

Lab: Molecular Genetics, Immunophenotyping, Cytogenetics

1 ItemGroup 1 elemento

Physical Examination/Follow-up

4 itemgroups 27 elementi

Lab: Infectiology

1 ItemGroup 11 elementi

Lab: Molecular Genetics

1 ItemGroup 23 elementi

Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540 - Demography

- 20/09/21 - 1 modulo, 3 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Administrative data, Demography, Geographic Ancestry
Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the demography form. It has to be filled in for screening.

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Screening - Demography; Inclusion Criteria; Exclusion Criteria

- 20/09/21 - 1 modulo, 4 itemgroups, 34 elementi, 1 linguaggio
Itemgroups: Administrative, Demography, Inclusion Criteria, Exclusion Criteria
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 20/09/21 - 1 modulo, 10 itemgroups, 61 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria, Demographics, Medical history, Parkinson's disease Surgical history, Allergies, Parkinson's disease history, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test
Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396 - Demographics and Childbearing Potential

- 20/09/21 - 1 modulo, 3 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Administrative Data, Demography, Child-bearing Potential (Complete for Female Subjects Only)
This ODM-file contains the data collection questions for demographics and childbearing potential. To be assessed at screening. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

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