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  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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Eligibility Stem Cell Transplantation NCT00822770

- 9/15/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin; ODM derived from: https://clinicaltrials.gov/show/NCT00822770

Eligibility Squamous Cell Carcinoma of the Oropharynx NCT01586182

- 9/15/21 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01586182

Eligibility Parkinson Disease NCT00821743

- 8/18/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Pedunculo-Pontin Nucleus (PPN) - Deep Brain Stimulation (DBS) in Gait and Balance Disturbance in Parkinson's Disease (PPN-GAB-PARK Study); ODM derived from: https://clinicaltrials.gov/show/NCT00821743

Eligibility Nodular Basal Cell Carcinoma NCT02018679

- 8/18/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02018679

Eligibility Nodular Basal Cell Carcinoma NCT01808950

- 7/28/21 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC); ODM derived from: https://clinicaltrials.gov/show/NCT01808950

Eligibility Pharmacokinetics of Caffeine NCT02225093

- 7/17/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02225093

Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

- 6/15/21 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Safety Study of AMG 557 in Subjects With Lupus Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01683695

Hib-MenAC vaccine administered intramuscularly in infants at 6 10 and 14 weeks of age - 104430 - Visit 5 ( Month 7.5)

- 3/15/21 - 1 form, 8 itemgroups, 30 items, 1 language
Itemgroups: Administrative data, ELIMINATION CRITERIA DURING THE STUDY, Contraindications and precautions for further doses, DEMOGRAPHICS, PRE-VACCINATION ASSESSMENT, THROAT SWAB (for subject’s parents/guardians), THROAT SWAB (for subject), VACCINE ADMINISTRATION
Study ID: 104430 Clinical Study ID: 104430 Study Title: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1/2 Study Recruitment Status: Completed Generic Name: Hib-MenAC vaccine Trade Name: Tritanrix-HepB, Hiberix Study Indication: Immune, Inflammatory & Infections - Other

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Liver Events Assessment

- 2/9/21 - 1 form, 10 itemgroups, 125 items, 1 language
Itemgroups: Administrative Data, Liver Events Assessment, Liver Events, Investigational Product (Liver), Local Laboratory Lab Tests Exclusive to Liver Events (Liver Lab), Pharmacokinetics (Liver PK), Medical Conditions at Onset of Liver Event (LIVER MEDHX), Other Liver Disease Conditions at Onset of Liver Event, Other Medical Conditions at Onset of Liver Event, Alcohol Intake at Onset of Liver Event (Liver Alcohol)
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents any liver events that might happen during the study.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Liver imaging

- 1/26/21 - 1 form, 11 itemgroups, 60 items, 1 language
Itemgroups: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents any liver imaging, if taken during the study.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Pharmacogenetic Research

- 1/23/21 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: Administrative Data, PGx-Pharmacogenetic Research Consent, PGx-Pharmacogenetic Research Withdrawal of Consent
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents if a consent for PGx-Pharmacogenetic Research has been given and/or withdrawn.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Serious Adverse Events (SAE)

- 1/23/21 - 1 form, 13 itemgroups, 85 items, 1 language
Itemgroups: Administrative Data, Type of Report, Randomisation, Serious Adverse Event Entry, Intensity Changes, Serious Adverse Event, Seriousness of Adverse Event, Medications relevant to SAE, Medical Conditions/Risk Factors relevant to SAE, Diagnostic test results relevant to SAE, Rechallenge, Investigational Product, General narrative comments, Non Clinical
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the serious adverse event documentation. If you wish to record a new SAE please determine if the new SAE is clinically or temporally related to an SAE previously entered on this form. If yes, record it in the same instance of the form. If not clinically or temporally related, create a new instance of the SAE form. Do not record pre and post randomization events on the same form.

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