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Riliva_CRF_EudraCT - Nr. 2012-000108-13- Screening DRKS00004652 - Screening II

- 17-09-21 - 2 Formulieren, 4 Itemgroepen, 41 Data-elementen, 2 Talen
Itemgroepen: Basic data, Inclusion Criteria, Exclusion Criteria, Urine pregnancy test
Study documentation part: Screening. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.

Screening I

4 Itemgroepen 44 Data-elementen

Examination_Riliva_CRF_EudraCT - Nr. 2012-000108-13 DRKS00004652 - Examination_Riliva_CRF_EudraCT - Nr. 2012-000108-13

- 15-03-21 - 1 Formulier, 5 Itemgroepen, 59 Data-elementen, 2 Talen
Itemgroepen: Vital Signs, skin examination, skin examination, LV - Score, skin examination Livedo racemosa
Study documentation part: Examination Week- 4, 8 and 12. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Grge, University Hospital of Mnster. EudraCT - Nr. 2012-000108-13.

Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13 DRKS00004652 - Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13

- 15-03-21 - 1 Formulier, 5 Itemgroepen, 58 Data-elementen, 2 Talen
Itemgroepen: Vital Signs, skin examination, skin examination, LV - Score, skin examination Livedo racemosa
Study documentation part: Baseline Inspection. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Total Nasal Symptom Scores; VAS; Pharmacogenetic Research Content; Pharmacogenetic Research Withdrawal of Consent

- 11-03-21 - 1 Formulier, 4 Itemgroepen, 19 Data-elementen, 1 Taal
Itemgroepen: Total Nasal Symptom Scores, VAS, Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Visit 2, 4, 6 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 25-02-21 - 1 Formulier, 21 Itemgroepen, 59 Data-elementen, 1 Taal
Itemgroepen: Date of Visit, Challenge Date and Time (0-4 Hr), Pulmonary Function Tests - Challenge Date and Time, Pulmonary Function Tests - Start of Challenge, Pulmonary Function Tests - 1 hr Post Challenge Start, Pulmonary Function Tests - 2 hr Post Challenge Start , Pulmonary Function Tests - 3 hr Post Challenge Start, Pulmonary Function Tests - 4 hr Post Challenge Start , Nasal Allergen Challenge - Challenge Date and Time, Nasal Allergen Challenge - Start of Challenge, Nasal Allergen Challenge, Nasal Airflow Resistance - Challenge Date and Time, Nasal Airflow Resistance - 30 Min Post-Challenge, Nasal Airflow Resistance, Nasal Secretions - Challenge Date and Time, Nasal Secretions - Start of Challenge, Nasal Secretions, VAS - Challenge Date and Time, VAS - Dosing Date and Time, VAS - Start of Challenge, VAS
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Visit 1, 3, 5 - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 25-02-21 - 1 Formulier, 25 Itemgroepen, 68 Data-elementen, 1 Taal
Itemgroepen: Challenge Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Challenge Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Dosing Date and Time (Visit 1, 3, 5), Pulmonary Function Tests - Start of Challenge (Visit 1, 3, 5), Pulmonary Function Tests - 1 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 2 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 3 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 4 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 5 hr Post Challenge Start (Visit 1, 3, 5), Pulmonary Function Tests - 6 hr Post Challenge Start (Visit 1, 3, 5), Nasal Allergen Challenge - Challenge Date and Time (Visit 1, 3, 5), Nasal Allergen Challenge - Dosing Date and Time (Visit 1, 3, 5), Nasal Allergen Challenge - Start of Challenge (Visit 1, 3, 5), Nasal Allergen Challenge (Visit 1, 3, 5), Nasal Airflow Resistance - Challenge Date and Time (Visit 1, 3, 5), Nasal Airflow Resistance - 30 Min Post-Challenge (Visit 1, 3, 5), Nasal Airflow Resistance (Visit 1, 3, 5), Nasal Secretions - Challenge Date and Time (Visit 1, 3, 5), Nasal Secretions - Dosing Date and Time (Visit 1, 3, 5), Nasal Secretions - Start of Challenge (Visit 1, 3, 5), Nasal Secretions (Visit 1, 3, 5), VAS - Challenge Date and Time (Visit 1, 3, 5), VAS - Dosing Date and Time (Visit 1, 3, 5), VAS - Start of Challenge (Visit 1, 3, 5), VAS (Visit 1, 3, 5)
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Screening - Challenge Date and Time; Pulmonary Function Tests; Nasal Allergen Challenge; Nasal Airflow Resistance; Nasal Secretions; VAS

- 19-02-21 - 1 Formulier, 17 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Challenge Date and Time, Pulmonary Function Tests - Challenge Date and Time, Pulmonary Function Tests - Start of Challenge, Pulmonary Function Tests - 1 hr Post Challenge Start, Pulmonary Function Tests - 2 hr Post Challenge Start , Nasal Allergen Challenge - Challenge Date and Time, Nasal Allergen Challenge - Pre-Dose, Nasal Allergen Challenge - 20 Min; 40 Min; 1 Hr; 1 Hr 20 Min; 1 Hr 40 Min; 2 Hr, Nasal Airflow Resistance - Challenge Date and Time, Nasal Airflow Resistance - 30 Min Post-Challenge, Nasal Airflow Resistance - 1 Hr 30 Min Post Challenge, Nasal Secretions - Challenge Date and Time, Nasal Secretions - Start of Challenge, Nasal Secretions - 1 Hr and 2 Hr Post-Challenge Start , VAS - Challenge Date and Time, VAS - Pre-Dose, VAS - 20 Min; 40 Min; 1 Hr; 1 Hr 20 Min; 1 Hr 40 Min; 2 Hr
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Visual Analogue Scale (Period 1 - 5; Day 1 - Day 16)

- 06-11-19 - 1 Formulier, 5 Itemgroepen, 53 Data-elementen, 1 Taal
Itemgroepen: Visual Analogue Scale - Dosing Date and Time (Period 1 - 5) , Visual Analogue Scale (Period 1 - 5), Visual Analogue Scale (Day 3 - Day 13), Visual Analogue Scale - Dosing date/ time (Day 14 - 16), Visual Analogue Scale (Day 14 - 16)
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination

- 29-10-19 - 1 Formulier, 5 Itemgroepen, 51 Data-elementen, 1 Taal
Itemgroepen: 12-Lead ECG, 12-Lead ECG Abnormalities, Repeat Pharmacokinetics Blood, Repeat Visual Analogue Scale, Repeat Visual Nasal Endoscopy
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Pruritus Visual Analogue Scale (VAS) Week 36 Mepolizumab HES NCT00086658 - Pruritus Visual Analogue Scale (VAS) Week 36

- 15-07-17 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: Assessment using visual analog scale Pruritus
Study part: Pruritus Visual Analogue Scale (VAS) Week 36/ Early Withdrawal Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Pruritus Visual Analogue Scale (VAS) Week 32 Mepolizumab HES NCT00086658 - Pruritus Visual Analogue Scale (VAS) Week 32

- 05-06-17 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: Assessment using visual analog scale Pruritus
Study part: Pruritus Visual Analogue Scale (VAS) Week 32.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Pruritus Visual Analogue Scale (VAS) Week 38 Mepolizumab HES NCT00086658 - Pruritus Visual Analogue Scale (VAS) Week 38

- 05-06-17 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: Assessment using visual analog scale Pruritus
Study part: Pruritus Visual Analogue Scale (VAS) Week 38.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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