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Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Period 2 Day 23

- 2019-12-01 - 1 Formulär, 7 Item-grupper, 33 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Urine drug screening; Ethanol measurement, Serum pregnancy test (B-HCG), Experimental drug
Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers 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: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

Effect of Ritonavir on Bupropion Pharmacokinetics; 103106 - Period 2 Day 15

- 2019-12-01 - 1 Formulär, 8 Item-grupper, 35 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Urinalysis, Urine drug screening; Ethanol measurement, Serum pregnancy test (B-HCG), Experimental drug, Therapeutic Procedure, Confirmation
Study ID: 103106 Clinical Study ID: WXL103106 Study Title:An open-label, 2-period, sequential treatment, 1-way drug interaction study to evaluate the effect of ritonavir on bupropion pharmacokinetics in healthy volunteers 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: bupropion Trade Name: Wellbutrin,QUOMEM,Elontril,Zyban,ZYNTABAC; Zyban,ZYNTABAC,Wellbutrin,Wellburin,QUOMEM,Prolev,Magerion,Geronplase,Elontril Study Indication: Depressive Disorder

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - Electronically Transferred Lab Data

- 2019-10-30 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: Laboratory Procedures, Pre-dose, Morning
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 2019-10-30 - 1 Formulär, 19 Item-grupper, 82 Dataelement, 1 Språk
Item-grupper: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - Electronically Transferred Lab Data

- 2019-10-29 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: Laboratory Procedures
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data (Lab 24hr)

- 2019-09-21 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: Laboratory Procedures, Dosage, Date in time, Time, Laboratory Procedures, Post-dose, 24 Hours
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data - Day -1

- 2019-08-28 - 1 Formulär, 1 Item-grupp, 9 Dataelement, 1 Språk
Item-grupp: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data

- 2019-08-28 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Laboratory Tests

- 2019-08-16 - 1 Formulär, 5 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Blood Chemical Analysis, Laboratory Procedures, Urinalysis, Laboratory Procedures, Correlative Study, Tissue specimen
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Screening - Electronically Transferred Lab Data; Urinalysis

- 2019-08-04 - 1 Formulär, 3 Item-grupper, 51 Dataelement, 1 Språk
Item-grupper: Electronically Transerred Lab Data, Urinalysis - Dipstick Details, Urinalysis - Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

- 2019-08-04 - 1 Formulär, 10 Item-grupper, 77 Dataelement, 1 Språk
Item-grupper: Date of Visit, Vital Signs - Semi-Supine, Vital Signs - Standing, 12-Lead ECG, Electroniclly Transferred Lab Data - Dosing Date and Time , Electronically Transerred Lab Data, Urinalysis Dipstick Details, Urinalysis - Microscopy Details, Study Conclusion, Pregnancy Information
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Urinalysis incl. Microscopy

- 2019-07-17 - 1 Formulär, 4 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: Urinalysis Administrative Data, Urinalysis Dipstick, Urinalysis Dipstick details, Urinalysis Microscopy
Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains urinalysis and urine microscopy data, which are assessed at Screening, on Day 2 at 0 hrs, Day 3 at 0 hrs, Day 3 at 24 hrs (i.e. Day 4 at 0 hrs), and Follow-Up (for all cohorts). This form can also be used for any repeat/unscheduled urine laboratory tests.

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