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CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - CHEST X-RAY (AP AND LATERAL)

- 2017-05-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study part: Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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 TERMINATION CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - STUDY TERMINATION CHEST X-RAY (AP AND LATERAL)

- 2017-05-20 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study part: Study Termination Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

Spine and Femur Bone Density by Dual-Energy X-ray Absorptiometry Protocol PhenX Toolkit

- 2016-04-26 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk
Item-grupp: Dual X-ray Absorptometry Femur Bone Density
The Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam includes instructions for preparing the sample person for the scan, performing quality assurance procedures, and performing the scan of the hip and spine. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

Chest X-Ray 2D ECG Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

- 2017-05-22 - 1 Formulär, 2 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: Chest X-Ray, 2D Echocardiogram
A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - X Ray Pneumonia Confirmation (X-ray)

- 2019-01-08 - 1 Formulär, 2 Item-grupper, 3 Dataelement, 1 Språk
Item-grupper: Administrative data, X Ray Pneumonia Confirmation (X-ray)
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the X Ray Pneumonia Confirmation (X-ray) form. It has to be filled in for each x-ray for pneumonia confirmation performed during trial, if necessary.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - CT Assessment

- 2021-02-22 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative Data, CT Assessment Questions, Lymph Node CT Assessments
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Both of these forms have to be filled out at the observation visits for the cycles of treatment and possible unscheduled visits. The Lymph Node CT Assessments form also has to be filled out at a possible withdrawal visit.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - CT Imaging

- 2021-02-10 - 1 Formulär, 3 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Administrative Data, CT Organ Exam, Lymph node CT screening assessments
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. The CT Organ exam form has to be filled out at the screening visit, cycle 1 and 2 observation visits and possible unscheduled visits. The CT Lymphnode Screening only has to be filled out at screening.

Baseline MRI Visit 08 SirTac NCT02936388 - Baseline MRI Visit 08

- 2017-11-26 - 1 Formulär, 3 Item-grupper, 20 Dataelement, 1 Språk
Item-grupper: Baseline MRI, location liver, Non-target Lesions
Study part: Baseline MRI Visit 08. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

Baseline MRI Visit 06 SirTac NCT02936388 - Baseline MRI Visit 06

- 2017-11-26 - 1 Formulär, 3 Item-grupper, 20 Dataelement, 1 Språk
Item-grupper: Baseline MRI, location liver, Non-target Lesions
Study part: Baseline MRI Visit 06. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

CT Scans Day 1 Pre-Infusion Mepolizumab HES NCT00086658 - CT Scans Day 1 Pre-Infusion

- 2017-06-11 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: CT Scans
Study part: CT Scans Day 1 Pre-Infusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

CT Scans Week 38 Mepolizumab HES NCT00086658 - CT Scans Week 38

- 2017-07-15 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: CT Scans
Study part: CT Scans Week 38/ Early Withdrawal visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Chest X-Ray Data

- 2018-12-04 - 1 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

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