Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Holter ECG Results

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 79 Eléments de données, 1 Langue

Groupe Item: Holter ECG Results

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Holter ECG Results

Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061 - Repeat Telemetry Abnormalities

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 78 Eléments de données, 1 Langue

Groupe Item: Repeat Telemetry Abnormalities

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Repeat Telemetry Abnormalities

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - 12-Lead Electrocardiogram

- 20/09/2021 - 1 Formulaire, 2 Groupes Item, 14 Eléments de données, 1 Langue

Groupes Item: Administrative data, 12-Lead Electrocardiogram

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Visit 10 GIMEMA CML0408 NCT00769327 - Visit 10

- 20/09/2021 - 1 Formulaire, 12 Groupes Item, 122 Eléments de données, 2 Langues

Groupes Item: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 10 Form

Visit 16 GIMEMA CML0408 NCT00769327 - Visit 16

- 20/09/2021 - 1 Formulaire, 11 Groupes Item, 117 Eléments de données, 2 Langues

Groupes Item: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 16 Form

Visit 13 GIMEMA CML0408 NCT00769327 - Visit 13

- 20/09/2021 - 1 Formulaire, 5 Groupes Item, 56 Eléments de données, 2 Langues

Groupes Item: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Molecular Biology (peripheral blood)

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 13 Form

Visit 5 GIMEMA CML0408 NCT00769327 - Visit 5

- 20/09/2021 - 1 Formulaire, 4 Groupes Item, 44 Eléments de données, 2 Langues

Groupes Item: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 5 Form

Visit 7 GIMEMA CML0408 NCT00769327 - Visit 7

- 20/09/2021 - 1 Formulaire, 13 Groupes Item, 127 Eléments de données, 2 Langues

Groupes Item: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, NILOTINIB, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 7 Form

Visit 3 GIMEMA CML0408 NCT00769327 - Visit 3

- 20/09/2021 - 1 Formulaire, 5 Groupes Item, 49 Eléments de données, 2 Langues

Groupes Item: Physical Examination, Complete Blood Count, NILOTINIB, Biochemistry, Electrocardiogram

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 3 Form

Visit 1 GIMEMA CML0408 NCT00769327 - Visit 1

- 20/09/2021 - 1 Formulaire, 15 Groupes Item, 150 Eléments de données, 2 Langues

Groupes Item: Previous chemotherapy, Comorbidities, Symptoms, Physical Examination, Complete Blood Count, Biochemistry, Serum Proteins, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 1 Form

Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046 - Unscheduled Holter/Telemetry Abnormalities

- 20/09/2021 - 1 Formulaire, 2 Groupes Item, 86 Eléments de données, 1 Langue

Groupes Item: Holter/Telemetry Abnormalities Administrative Data, Holter/Telemetry Abnormality

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form is to be filled in whenever a Holter ECG or Telemetry reading is abnormal.

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

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