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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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186 Search results.

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Lab: Molecular Genetics

- 4/21/18 - 13 forms, 1 itemgroup, 27 items, 1 language
Itemgroup: Molecular Genetics
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Bone Marrow Transplant

1 itemgroup, 13 items

GVHD

3 itemgroups, 11 items

Administrative/Demographic Details

1 itemgroup, 11 items

Lab: Cytology/Cytogenetics/Cytochemistry

1 itemgroup, 29 items
8 more forms meeting the search are available in the detailed view.

Multiple sclerosis studies NCT02461069 NCT02419378 - Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

- 4/13/21 - 18 forms, 3 itemgroups, 31 items, 1 language
Itemgroups: Inclusion criteria, Exclusion criteria, Signature Screening Visit 1
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

2 itemgroups, 48 items

Screening: Medical History Multiple Sclerosis ALAIN01 NCT02419378

2 itemgroups, 5 items

Screening: Demography Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup, 5 items

Screening: EDSS Multiple Sclerosis ALAIN01 NCT02419378

1 itemgroup, 12 items
13 more forms meeting the search are available in the detailed view.

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

- 3/18/21 - 1 form, 13 itemgroups, 46 items, 1 language
Itemgroups: Administrative, Demographics (Enrollment), Investigator Signature, For Coulter Use Only, Demographics (General Medical History), Medical History Date, General Medical History, Prior Therapy, Prior Radiation Therapy, History of Lymphoma, Lymphoma Cell Type, Lymphoma Grade , History of Lymphoma
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Prior Therapy

- 3/15/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Prior Therapy, Pharmaceutical Preparations, Therapeutic radiology procedure; Before
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 Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

- 3/15/21 - 1 form, 12 itemgroups, 64 items, 1 language
Itemgroups: Inform Screening, Subject number, Date of Visit/ Assessment, Local Laboratories, Subject identification, Demography, Disease Characteristics, Metastatic Disease, Status at Screening, Anti-Cancer Therapy, Anti-Cancer Therapy , Medical Conditions
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Yearly Follow-up contact; Anti Cancer Therapy (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 5 itemgroups, 11 items, 1 language
Itemgroups: Adminstrative, Yearly Follow-up - Check for Follow-up contact, End of yearly Follow-up contact, Anti-cancer therapy(ies) following last study treatment administration, Subsequent treatment
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)

- 10/27/20 - 1 form, 9 itemgroups, 51 items, 1 language
Itemgroups: Administrative, MAGE-A3 Expression Test, Tumor Sample (For Re-Test), MAGE-A3 Expression Re-Test, Prior Surgery, Prior Surgery Type, Prior Surgery, Prior Therapy, Prior treatment with systemic immunosuppressants
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy

- 8/20/20 - 1 form, 8 itemgroups, 50 items, 1 language
Itemgroups: Administrative, MAGE-A3 Expression Test, Tumor Sample (For Re-Test), MAGE-A3 Expression Re-Test, Prior Surgery, Prior Surgery Type, Prior Therapy, Prior treatment with systemic immunosuppressants
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Smoking History; RLS Pharmacotherapy History; Vital Signs; 12 Lead ECG Monitoring

- 5/8/20 - 1 form, 6 itemgroups, 30 items, 1 language
Itemgroups: Patient administration, Smoking History (Screening), RLS Pharmacotherapy History (Screening), RLS Pharmacotherapy History (Screening), Vital Signs (Screening), 12 Lead ECG Monitoring
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Subject Diary Card

- 3/5/20 - 1 form, 8 itemgroups, 41 items, 1 language
Itemgroups: Administrative data, Emergency, Diary card, Study drug, Exacerbations, Other medications, Changes in health, Daily Respiratory Symptom Diary for Cystic Fibrosis
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Subject Diary Card form. It has to be filled in at day 2-13, day 15-20 and day 22-27.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Liver events

- 3/5/20 - 1 form, 9 itemgroups, 42 items, 1 language
Itemgroups: Administrative data, Liver event, Investigational product (Liver), Pharmacokinetics (Liver PK), Liver disease medical conditions, Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the liver events form. It has to be filled in if a liver event occurs during the study.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - 12-Lead ECG Abnormalities

- 3/4/20 - 1 form, 8 itemgroups, 92 items, 1 language
Itemgroups: Administrative data, 12 Lead ECG abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other abnormalities
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the ECG Abnormalities form. Fill in if there is a clinical significant ECG Abnormality.