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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

- 4/29/22 - 1 form, 6 itemgroups, 47 items, 1 language
Itemgroups: Pregnancy Test, Drug Screen, Alcohol breath test, Carbon Monoxide test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 28, Pre-dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 1, Pre-dose

- 4/13/22 - 1 form, 6 itemgroups, 47 items, 2 languages
Itemgroups: Pregnancy Test, Drug Screen, Alcohol breath test, Carbon Monoxide test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 1, Pre-Dose.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 14, Pre-dose

- 4/6/22 - 1 form, 3 itemgroups, 35 items, 1 language
Itemgroups: Pregnancy Test, Haematology, Clinical Chemistry
Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 14, Pre-dose.

Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 4/1/22 - 1 form, 3 itemgroups, 18 items, 1 language
Itemgroups: Hematology, Biochemistry, Pregnancy Tests
Sponsor: OSI Pharmaceuticals Information provided by : Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: Baseline Local Laboratory Data

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Follow-Up - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pregnancy Test; Local Laboratory; Urinalysis

- 2/15/21 - 1 form, 15 itemgroups, 54 items, 1 language
Itemgroups: Administrative, Vital Signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Pulmonary Function Test - Pre-Dose, Pregnancy Test, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Local Laboratory - Haematology, Local Laboratory - Haematology, Urinalysis - Local, Urinalysis - Local, Urinalysis - Microscopy, Urinalysis - Microscopy
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Laboratory Collections, Urinalaysis, Pregnancy test follow-up

- 6/21/19 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Laboratory Collection - Clinical chemistry and haematology, Laboratory Collection - Urinalysis, Pregnancy test
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Laboratory Collections, Urinalaysis and Pregnancy test for follow-up form. It has to be filled in at Follow-up.

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Pre- Dose Drug Screening, Pregnancy test, Alcohol test

- 6/21/19 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administrative Data, Drug Screening (Urine), Alcohol test, Pregnancy test
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pre-dose Drug screen, Pre-dose pregnancy test and the pre-dose alcohol test form. It has to be filled in at Day 1.

Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874 - Laboratory test, Influenza serology sample, Urine pregnancy test

- 3/22/19 - 1 form, 4 itemgroups, 10 items, 1 language
Itemgroups: Administrative data, Laboratory tests, Influenza serology sample, HCG urine pregnancy test
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Laboratory test, Influenza serology sample and Urine pregnancy test. The Laboratory test has to be filled in for: Visit 1, Visit 2 and Visit 5. The Influenza serology sample has to be filled in for: Visit 1, Visit 3, Visit 5 and Visit 6. The Urine pregnancy test has to be filled in for: Visit 1 and Visit 3.

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long Term Follow-Up (Visit 14, Year 10) - General Medical History/ Physical Examination; Laboratory Tests; HCG Urine Pregnancy Test; Vaccine Administration; Solicited Adverse Events - Local Symptoms; Solicited Adverse Events - General Symptoms; Unsolicited Adverse Events

- 3/21/19 - 1 form, 10 itemgroups, 87 items, 1 language
Itemgroups: Administration, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192 - Pregnancy Dipstick

- 3/8/19 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Administrative data, Pregnancy Dipstick
Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the Pregnancy Dipstick form. It has to be filled in for Screening (+Baseline), Week 24, Week 52 and fpr early withdrawal.

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

- 10/15/18 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data, Vital Signs, 12-Lead ECG, Laboratory Tests - Clinical Chemistry, Haematology, Pregnancy Test (Complete for Female Subjects Only)
This ODM file contains the form for documentation of the vital signs, the 12-lead ecg, the laboratory testing and the pregnancy test. To be assessed at follow-up visit. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396 - Laboratory Tests, Serology and Pregnancy Test

- 10/4/18 - 1 form, 4 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data, Laboratory Tests - Clinical Chemistry, Haematology, Serology, Pregnancy Test (Complete for Female Subjects Only)
This ODM-file contains a form to fill in findings of the laboratory, serology and pregnancy testing. To be assessed at the screening visit. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

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