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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

- 9/20/21 - 1 form, 5 itemgroups, 33 items, 1 language
Itemgroups: 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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Central Pathology Assessment and Description

- 9/20/21 - 1 form, 7 itemgroups, 21 items, 1 language
Itemgroups: Biopsy, Biopsy , Lymphoma, Non-Hodgkin | Classification, Pathologist evaluation | Central, Basis of Assessment, Pathologist evaluation | Central | Description, Administrative
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Headache Classification

- 9/20/21 - 1 form, 4 itemgroups, 12 items, 1 language
Itemgroups: Administrative Information, IHS Headache Classification, Migraine History, Subject Recruitment
https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 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 Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

FACIT UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 11/5/16 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: FACIT
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

SF36 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 11/2/16 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: SF36v2
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Induction Period - Visit 1 Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 10/24/16 - 1 form, 6 itemgroups, 32 items, 2 languages
Itemgroups: Date of Visit, LDH, Vital signs, Six-Minute Walk Test, Circulatory Symptoms, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

TISS Day 90 and Adverse Events Day 84 to 90 Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 10/4/16 - 1 form, 10 itemgroups, 43 items, 1 language
Itemgroups: Patient identification, TISS, TISS ventilation, Cardiovascular Support, Kidney supportive measures, Neurologic, Specific intervention, Adverse Events Day 84 to 90, Serious adverse event 84 to 90, Other
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

TISS Day 83 and Adverse Events Day 77 to 83 Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 10/4/16 - 1 form, 10 itemgroups, 43 items, 1 language
Itemgroups: Patient identification, TISS, TISS ventilation, Cardiovascular Support, Kidney supportive measures, Neurologic, Specific intervention, Adverse Events Day 77 to 83, Serious adverse event 77 to 83, Other
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

TISS Day 76 and Adverse Events Day 70 to 76 Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 10/4/16 - 1 form, 10 itemgroups, 43 items, 1 language
Itemgroups: Patient identification, TISS, TISS ventilation, Cardiovascular Support, Kidney supportive measures, Neurologic, Specific intervention, Adverse Events Day 70 to 76, Serious adverse event 70 to 76, Other
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

TISS Day 55 and Adverse Events Day 49 to 55 Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 10/4/16 - 1 form, 10 itemgroups, 43 items, 1 language
Itemgroups: Patient identification, TISS, TISS ventilation, Cardiovascular Support, Kidney supportive measures, Neurologic, Specific intervention, Adverse Events Day 49 to 55, Serious adverse event 49 to 55, Other
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

TISS Day 69 and Adverse Events Day 63 to 69 Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 10/4/16 - 1 form, 10 itemgroups, 43 items, 1 language
Itemgroups: Patient identification, TISS, TISS ventilation, Cardiovascular Support, Kidney supportive measures, Neurologic, Specific intervention, Adverse Events Day 63 to 69, Serious adverse event 63 to 69, Other
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

TISS Day 62 and Adverse Events Day 56 to 62 Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 10/4/16 - 1 form, 10 itemgroups, 43 items, 1 language
Itemgroups: Patient identification, TISS, TISS ventilation, Cardiovascular Support, Kidney supportive measures, Neurologic, Specific intervention, Adverse Events Day 56 to 62, Serious adverse event 56 to 62, Other
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

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