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Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Screening - Eligibility Question; Subject Identification

- 22/02/21 - 1 modulo, 2 itemgroups, 2 elementi, 1 linguaggio
Itemgroups: Eligibility Question, Subject Identification
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 modulo, 17 itemgroups, 48 elementi, 1 linguaggio
Itemgroups: 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

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Inform Screening

- 05/02/21 - 1 modulo, 2 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: Administrative Data, Inform Screening
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit.

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Serious Adverse Event; Local Laboratory; Urinalysis; Serology - Screen for HIV Antibody and Hepatitis B & C

- 12/01/21 - 1 modulo, 19 itemgroups, 32 elementi, 1 linguaggio
Itemgroups: Administrative, Serious Adverse Event, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry , Local Laboratory - Haematology, Local Laboratory - Haematology , Urinalysis - Local, Urinalysis - Local , Urinalysis - Microscopy, Urinalysis - Microscopy , Local Laboratory - Unscheduled Clinical Chemistry, Local Laboratory - Unscheduled Clinical Chemistry , Local Laboratory - Unscheduled Haematology, Local Laboratory - Unscheduled Haematology , Unscheduled Urinalysis - Local, Unscheduled Urinalysis - Local, Urinalysis - Microscopy (Unscheduled), Urinalysis - Microscopy (Unscheduled) , Serology - Screen for HIV Antibody and Hepatitis B&C
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) - Screening - 12 Lead ECG; 12-Lead ECG Abnormalities; Pulmonary Function Tests; Inhaler Device Training

- 09/01/21 - 1 modulo, 6 itemgroups, 36 elementi, 1 linguaggio
Itemgroups: 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

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021 - Screening

- 05/12/20 - 1 modulo, 3 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: Administrative Data, Informed Consent, Demographics
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening) is to be filled out at Visit 1 (Day -28 to day 0). Informed Consent has to be obtained prior to any study procedure.

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021 - Screening Conclusion

- 05/12/20 - 1 modulo, 3 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Administrative Data, Screening Conclusion, Investigator's signature
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening Conclusion) is to be filled out at Visit 1 (Day -28 to day 0).

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Screening - Eligibility Question; Subject Identification, Randomisation Number

- 29/11/20 - 1 modulo, 4 itemgroups, 6 elementi, 1 linguaggio
Itemgroups: Date of visit/assessment, Eligibility Question, Subject Identification, Randomisation Number
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Screening - Inform Screening; Inform Enrolment; Date of visit/assessment; Genotype

- 29/11/20 - 1 modulo, 5 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Inform Screening, Inform Enrolment, Date of visit/assessment, Demography, Genotype
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Screen Conclusion (Annex Report 2 Final)

- 29/10/20 - 1 modulo, 3 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Administrative, Screening Conclusion, Investigator's Signature
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Laboratory Tests (Annex Report 2 Final)

- 28/10/20 - 1 modulo, 8 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Administrative, Laboratory Tests, Laboratory Assay, Haematology, Biochemistry, Hepatic Function, Renal Function, HCG Urine or Blood Pregnancy Test
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics (Annex Report 2 Final)

- 27/10/20 - 1 modulo, 5 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Administrative, Informed Consent, Optional Translational Research and other Research, Demographics, Cutaneous Melanoma: Disease chracteristics
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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