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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Screening Visit - Eligibility Criteria

- 17.11.21 - 1 modulo, 4 itemgroups, 33 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Eligibility Determination, Inclusion, Exclusion Criteria

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride 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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

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

- 17.09.21 - 1 modulo, 19 itemgroups, 296 elementi, 1 linguaggio

Itemgroups: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Echocardiography, Multiple gated acquisition scanning, Disease, Disease Characteristic, cancer treatment, Prior Therapy, Therapeutic radiology procedure, cancer treatment, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Clinical Trial Subject Unique Identifier

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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Screening

- 13.10.20 - 1 modulo, 24 itemgroups, 273 elementi, 1 linguaggio

Itemgroups: Date of visit, Assessment Date, Trial Screening, Enrollment, Clinical Trial Subject Unique Identifier, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, disease characteristic, disease characteristic, Neoplasm Metastasis, Electrocardiography, Echocardiography; Multiple gated acquisition scanning, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Disease, Relationships, Disease, Clinical Trials, Therapeutic procedures, Relationships, Disease, Cancer treatment, Prior Therapy, Neurologic Examination, Vital signs, Prior Radiation Therapy, Prior Radiation Therapy, Central Nervous System

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Screen

- 31.05.20 - 1 modulo, 19 itemgroups, 203 elementi, 1 linguaggio

Itemgroups: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Clinical Trial Subject Unique Identifier, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Ejaculation, Response Latency, Time, Intravaginal

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Ganetespib in Breast Cancer NCT01677455 - Eligibility Criteria

- 15.06.19 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio

Itemgroups: Inclusion Criteria, Exclusion Criteria

An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01677455 The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.

Oncoxin in Hepatocellular Carcinoma NCT01392131 - Eligibility Criteria

- 14.05.19 - 1 modulo, 2 itemgroups, 9 elementi, 1 linguaggio

Itemgroups: Inclusion Criteria, Exclusion Criteria

Safety and Efficacy of Oncoxin in Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT01392131 Brief Summary: Oncoxin is safe and results in improved survival in patients with hepatocellular carcinoma Detailed Description: To assess therapeutic efficacy and safety of Oncoxin in hepatocellular carcinoma. To see if there is reduction in serum alpha fetoprotein level in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is reduction tumor size and or number in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is improvement of quality of life in hepatocellular carcinoma patients after administration of Oncoxin. To see if there is improved survival in hepatocellular carcinoma patients after administration of oncoxin.

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride (Eligibility Form) - 106218 - Part 2: Demography

- 14.01.19 - 1 modulo, 1 ItemGroup, 4 elementi, 1 linguaggio

ItemGroup: Demography

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride 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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Infanrix Vaccine - 102038 - Elegibility Questionnaire

- 04.03.18 - 1 modulo, 3 itemgroups, 16 elementi, 1 linguaggio

Itemgroups: Elegibility Question, Inclusion Criteria, Exclusion Criteria

Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 0 101468/169 NCT00381472

- 17.09.17 - 1 modulo, 21 itemgroups, 43 elementi, 1 linguaggio

Itemgroups: DIARY INFORMATION, General Information, SUBJECT CONTINUATION, ADVERSE EVENTS PROMPT, CONCOMITANT MEDICATION PROMPT, L-DOPA MEDICATION CHANGES, VITAL SIGNS, CLINICAL GLOBAL IMPRESSION, UNIFIED PARKINSONS DISEASE RATING SCALE, PARKINSON’S DISEASE SLEEP SCALE, BECK DEPRESSION INVENTORY, EPWORTH SLEEPINESS SCALE, PARKINSON’S DISEASE QUALITY OF LIFE QUESTIONNAIRE, ELIGIBILITY QUESTION, INCLUSION CRITERIA, EXCLUSION CRITERIA, INVESTIGATIONAL PRODUCT, COMPLIANCE, DISPENSING, RANDOMISATION NUMBER, DIARY CARD

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Screening 0 form.

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