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  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
    1. 7.1. Anesthésie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Gériatrie
    1. 7.5. Gynécologie/obstétrique
    1. 7.6. Médecine interne
      1. Hématologie
      1. Infectiologie
      1. Cardiologie/angiologie
      1. Pneumologie
      1. Gastroentérologie
      1. Néphrologie
      1. Endocrinologie/métabolisme
      1. Rhumatologie
    1. 7.7. Neurologie
    1. 7.8. Ophtalmologie
    1. 7.9. Médecine palliative
    1. 7.10. Pathologie/médécine légale
    1. 7.11. Pédiatrie
    1. 7.12. Psychiatrie/psychosomatique
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Chirurgie générale/viscérale
      1. Neurochirurgie
      1. Chirurgie plastique
      1. Chirurgie cardiaque/thoracique
      1. Chirurgie traumatologique/orthopédie
      1. Chirurgie vasculaire
    1. 7.15. Urologie
    1. 7.16. Médecine dentaire/MKG
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Screening Part 4 - ECG and Pulmonary function (exhaled nitric oxide and AMP Challenge)

- 10/04/2018 - 1 Formulaire, 7 Groupes Item, 43 Eléments de données, 1 Langue
Groupes Item: 12-Lead ECG, Exhaled nitric oxide, Pulmonary function tests / FEV 1, Pulmonary function tests: Pre-AMP Challenge, Pulmonary function tests: AMP Challenge, Pulmonary function tests: Post-AMP Challenge, PC20 (AMP Challenge)
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 Screening Part 4 - ECG and Pulmonary function parts Exhaled nitric oxide and AMP Challenge.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - 12-LEAD ECG

- 28/11/2018 - 1 Formulaire, 1 Groupe Item, 12 Eléments de données, 1 Langue
Groupe Item: 12-lead ECG
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 11 Eléments de données, 1 Langue
Groupe Item: Electrocardiogram Abnormalities
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - ECG Abnormalities Form Part 2

- 06/04/2018 - 1 Formulaire, 4 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Conduction, Myocardial infarction, Depolarisation/Repolarisation, QRS-T, Other abnormalities
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 ECG Abnormalities Form Part 2.

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - ECG Abnormalities Form Part 1

- 06/04/2018 - 1 Formulaire, 3 Groupes Item, 41 Eléments de données, 1 Langue
Groupes Item: Date and Time of ECG, Rhythm, P-wave and QRS morphology
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 ECG Abnormalities Form Part 1.

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

- 09/01/2021 - 1 Formulaire, 6 Groupes Item, 36 Eléments de données, 1 Langue
Groupes Item: Administrative, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities , Pulmonary Function Tests, Inhaler Device Training
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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Day 1 - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pharmacodynamics; Local Laboratory; Urinalysis; Randomisation Number

- 22/01/2021 - 1 Formulaire, 16 Groupes Item, 57 Eléments de données, 1 Langue
Groupes Item: Administrative, Vital Signs - Pre-Dose, 12-Lead ECG (Pre-Dose), 12-Lead ECG Abnormalities , 12-Lead ECG Abnormalities, Pulmonary Function Tests (Pre-Dose), Pharmacodynamics - Blood Sample (Pre-Dose), Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis Microscopy Test, Urinalysis Microscopy Test, Randomisation Number
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

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Treatment Period 1- 5 - Investigational Product; Treatment Confirmation; Carbon Monoxide Test; Urine Test for Drugs of Abuse; Vital Signs; 12-Lead ECG; Pulmonary Function Test

- 08/02/2021 - 1 Formulaire, 11 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: Administrative, Investigational Product Day 1 - 7, Treatment Corfirmation Day 1 - 7, Carbon Monoxide Test - Day 6 PM, Urine Test for Drugs of Abuse, Urine Test for Drugs of Abuse , Vital Signs - Day 7, 12-Lead ECG - Day 7, 12-Lead ECG Abnormalities - Day 7, 12-Lead ECG Abnormalities - Day 7, Pulmonary Function Test - Day 7
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

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

- 15/02/2021 - 1 Formulaire, 15 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: 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

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Vital Signs and ECG - Screening

- 12/10/2018 - 1 Formulaire, 3 Groupes Item, 19 Eléments de données, 1 Langue
Groupes Item: Vital signs, Blood Pressure; heart rate, 12 lead ECG
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Electronically Transverred Lab Data, Vital Signs, ECG, Investigational Product, Pharmacodynamics Blood, Cortisol and Results -Period 2; Day 11 - 13

- 21/10/2018 - 1 Formulaire, 40 Groupes Item, 272 Eléments de données, 1 Langue
Groupes Item: Electronically transferred lab data - Day 10, Dosing date and time- Vital Signs, Blood Pressure and Heart rate - Pre Dose, Blood Pressure and Heart rate - 15 M, Blood Pressure and Heart rate - 30 M, Blood Pressure and Heart rate - 45 M , Blood Pressure and Heart rate -1 H, Blood Pressure and Heart rate -1.5 H , Blood Pressure and Heart rate -2 H , Blood Pressure and Heart rate -3 H , Blood Pressure and Heart rate -4 H , Blood Pressure and Heart rate -5 H , Blood Pressure and Heart rate -6 H , Blood Pressure and Heart rate -8 H, Blood Pressure and Heart rate -12 H , Blood Pressure and Heart rate -24 H , Dosing date and time - ECG, 12 lead ECG - Pre Dose, 12-Lead ECG - 15 M, 12-Lead ECG - 30 M , 12-Lead ECG - 45 M , 12-Lead ECG - 1 H, 12-Lead ECG - 1.5 H , 12-Lead ECG - 2 H, 12-Lead ECG - 3 H , 12-Lead ECG - 4 H, 12-Lead ECG - 5 H , 12-Lead ECG - 6 H, 12-Lead ECG - 8 H , 12-Lead ECG - 12 H , 12-Lead ECG - 24 H, Investigational Product (Dose) - Day 11, Pharmacokinetics Blood - FF/GW642444M, Pharmacodynamics - Cortisol , Dosing date and time - Pharmacodynamics Results - Potassium, Pharmacodynamics Results - Potassium - Pre Dose, Pharmacodynamics Results - Potassium - 30 M, Pharmacodynamics Results - Potassium - 1 H, Pharmacodynamics Results - Potassium - 2 H, Pharmacodynamics Results - Potassium - 4 H
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Electronically Transverred Lab Data, Vital Signs, ECG, Investigational Product, Pharmacodynamics Blood and Results -Period 2; Day 5 - 10

- 21/10/2018 - 1 Formulaire, 49 Groupes Item, 297 Eléments de données, 1 Langue
Groupes Item: Electronically transferred lab data, Dosing date and time- Vital Signs, Blood Pressure and Heart rate - Pre Dose, Blood Pressure and Heart rate - 15 M, Blood Pressure and Heart rate - 30 M, Blood Pressure and Heart rate - 45 M , Blood Pressure and Heart rate -1 H, Blood Pressure and Heart rate -1.5 H , Blood Pressure and Heart rate -2 H , Blood Pressure and Heart rate -3 H , Blood Pressure and Heart rate -4 H , Blood Pressure and Heart rate -5 H , Blood Pressure and Heart rate -6 H , Blood Pressure and Heart rate -8 H, Blood Pressure and Heart rate -12 H , Blood Pressure and Heart rate -24 H , Dosing date and time - ECG, 12 lead ECG - Pre Dose, 12-Lead ECG - 15 M, 12-Lead ECG - 30 M , 12-Lead ECG - 45 M , 12-Lead ECG - 1 H, 12-Lead ECG - 1.5 H , 12-Lead ECG - 3 H , 12-Lead ECG - 4 H, 12-Lead ECG - 5 H , 12-Lead ECG - 6 H, 12-Lead ECG - 8 H , 12-Lead ECG - 12 H , 12-Lead ECG - 24 H, Investigational Product (Dose) - Day 5, Investigational Product (Dose) - Day 6, Investigational Product (Dose) - Day 7, Investigational Product (Dose) - Day 8, Investigational Product (Dose) - Day 9, Investigational Product (Dose) - Day 10, Pharmacokinetics Blood - FF/GW642444M, Dosing date and time - Pharmacodynamics Results - Potassium, Pharmacodynamics Results - Potassium - Pre Dose, Pharmacodynamics Results - Potassium - 30 M, Pharmacodynamics Results - Potassium - 1 H, Pharmacodynamics Results - Potassium - 2 H, Pharmacodynamics Results - Potassium - 4 H , Dosingdate and time - Pharmacodynamics Results - Glucose, Pharmacodynamics Results - Glucose - Pre Dose, Pharmacodynamics Results - Glucose - 30 M, Pharmacodynamics Results - Glucose - 1 H, Pharmacodynamics Results - Glucose - 2 H , Pharmacodynamics Results - Glucose - 4 H
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

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