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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
    1. 7.1. Anästhesie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Geriatrie
    1. 7.5. Gynäkologie/Geburtshilfe
    1. 7.6. Innere Medizin
      1. Hämatologie
      1. Infektiologie
      1. Kardiologie/Angiologie
      1. Pneumologie
      1. Gastroenterologie
      1. Nephrologie
      1. Endokrinologie/Stoffwechsel
      1. Rheumatologie
    1. 7.7. Neurologie
    1. 7.8. Augenheilkunde
    1. 7.9. Palliativmedizin
    1. 7.10. Pathologie/Rechtsmedizin
    1. 7.11. Kinderheilkunde
    1. 7.12. Psychiatrie/Psychosomatik
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Allgemein-/Viszeralchirurgie
      1. Neurochirurgie
      1. Plastische Chirurgie
      1. Herz-/Thoraxchirurgie
      1. Unfallchirurgie/Orthopädie
      1. Gefäßchirurgie
    1. 7.15. Urologie
    1. 7.16. Zahnmedizin/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)

- 10.04.18 - 1 Formular, 7 Itemgruppen, 43 Datenelemente, 1 Sprache
Itemgruppen: 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

- 28.11.18 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache
Itemgruppe: 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

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: 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

- 06.04.18 - 1 Formular, 4 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: 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

- 06.04.18 - 1 Formular, 3 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: 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

- 09.01.21 - 1 Formular, 6 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: 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

- 22.01.21 - 1 Formular, 16 Itemgruppen, 57 Datenelemente, 1 Sprache
Itemgruppen: 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

- 08.02.21 - 1 Formular, 11 Itemgruppen, 54 Datenelemente, 1 Sprache
Itemgruppen: 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

- 15.02.21 - 1 Formular, 15 Itemgruppen, 54 Datenelemente, 1 Sprache
Itemgruppen: 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

- 12.10.18 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: 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 and Results -Period 2; Day 5 - 10

- 21.10.18 - 1 Formular, 49 Itemgruppen, 297 Datenelemente, 1 Sprache
Itemgruppen: 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

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

- 21.10.18 - 1 Formular, 40 Itemgruppen, 272 Datenelemente, 1 Sprache
Itemgruppen: 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

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