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Eligibility Locally Advanced Breast Cancer NCT01367288

- 03/07/20 - 1 modulo, 2 itemgroups, 21 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT01367288

Eligibility Locally Advanced HER2-positive Breast Cancer NCT01329640

- 03/07/20 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Feasibility Study of Metronomic Chemotherapy for Locally Advanced Her2- Positive Breast Cancer (TraQ-Me 01); ODM derived from: https://clinicaltrials.gov/show/NCT01329640

Eligibility Locally Advanced HER2-negative Breast Cancer NCT01329627

- 03/07/20 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01329627

Eligibility Locally Advanced Breast Cancer (LABC) NCT01240681

- 02/07/20 - 1 modulo, 2 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01240681

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - PGx

- 25/06/20 - 1 modulo, 3 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Date of visit, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breastn

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 25/06/20 - 1 modulo, 10 itemgroups, 187 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Period 2 Visit

- 25/06/20 - 1 modulo, 8 itemgroups, 288 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Experimental drug, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Period 1 Visit

- 25/06/20 - 1 modulo, 9 itemgroups, 298 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Experimental drug, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, CYP2C19 gene, Genotype
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Eve of Period 2 Visit

- 25/06/20 - 1 modulo, 2 itemgroups, 5 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Day 1

- 15/06/20 - 1 modulo, 7 itemgroups, 180 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - End of Period 1 Visit

- 15/06/20 - 1 modulo, 2 itemgroups, 5 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Eligibility Gestational Diabetes Mellitus NCT01441518

- 10/06/20 - 1 modulo, 2 itemgroups, 12 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia; ODM derived from: https://clinicaltrials.gov/show/NCT01441518

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