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Lungenkrankheiten, chronisch obstruktive ×
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Inhaltsverzeichnis
  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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136 Suchergebnisse.

Screening - GSK Milveterol COPD 100527

- 18.06.17 - 1 Formular, 9 Itemgruppen, 132 Datenelemente, 1 Sprache
Itemgruppen: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
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

Eligibility NCT00525512 Pulmonary Disease, Chronic Obstructive - Eligibility

- 14.04.14 - 1 Formular, 2 Itemgruppen, 23 Datenelemente, 2 Sprachen
Itemgruppen: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00525512

Eligibility Multiple Conditions NCT01597882

- 17.01.19 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Improving Monitoring of Patients Receiving Case Management; ODM derived from: https://clinicaltrials.gov/show/NCT01597882

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

- 17.01.19 - 1 Formular, 5 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Status of treatment blind, End of Study Record, Investigator Comment Log, Investigator's statement
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.

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - Pharmacokinetic Blood and Urine Sampling

- 17.01.19 - 1 Formular, 3 Itemgruppen, 18 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pharmacokinetic blood sampling, Pharmacokinetic urine sampling
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 This form contains information about pharmacokinetic blood and urine sampling. It has to be filled in in Session 2.

Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682) - Serious Adverse Event (SAE)

- 17.01.19 - 1 Formular, 15 Itemgruppen, 64 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Serious Adverse Events, Demography, Serious adverse events, Possible Causes of SAE other than lnvestigational Product(s), Seriousness of SAE, Relevant Medical Conditions, Other relevant risk factors, Details of lnvestigational Product(s), Relevant Concomitant Medications, Narrative / Comments, Details of relevant Assessments, Reporting lnvestigator, Additional or follow-up information, Reporting lnvestigator
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. This form contains information about serious adverse events and should be completed only in case of occurrence of serious adverse events.

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

- 17.01.19 - 1 Formular, 5 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Consent for Pharmacogenetic Research, Blood Sample Collection, Withdrawal of Consent, Blood Sample Destruction
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.

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Pharmacogenetic (PGx) Research

- 18.12.18 - 1 Formular, 4 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Sampling, Pharmacogenetic Test, Consent withdrawn, Pharmacogenetic Test, Blood Specimen, Destruction
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Follow-Up

- 14.12.18 - 1 Formular, 7 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: Physical Examination, Vital Signs, 12 lead ECG, 12 lead ECG, Abnormality, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Eligibility Chronic Obstructive Pulmonary Disease NCT02162095

- 12.12.18 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Is COPD a Risk Factor for Cardiovascular Disease?; ODM derived from: https://clinicaltrials.gov/show/NCT02162095

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Serious Adverse Event (SAE)

- 12.12.18 - 1 Formular, 13 Itemgruppen, 62 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Section 1 Serious Adverse Events, Section 2 Seriousness, Section 3 Demography Data, Section 4 Recurrence of Adverse event after further investigational product, SECTION 5 Possible Causes of SAE other than Investigational Product(s), Section 6 Relevant Medical Conditions, SECTION 7 Other Relevant Risk Factors, SECTION 8 Relevant Concomitant Medications, SECTION 9 Details of Investigational Product(s), SECTION 10 Details of Relevant Assessments, SECTION 11 Narrative Remarks, Section 12 Additional/Follow-up information
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the form of SAE. It has to be filled in if the subject has experienced an SAE.

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Study Period

- 11.12.18 - 1 Formular, 17 Itemgruppen, 85 Datenelemente, 1 Sprache
Itemgruppen: Drug Screen, Ethanol Measurement, Physical Examination, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis, Pharmacokinetic aspects, Blood, Vital signs, 12-Lead-ECG, 12 lead ECG, Abnormality, Randomization, Numbers, Experimental drug, Therapeutic procedure, Confirmation, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood, Metabolite, Pharmacokinetic aspects, Urine, Pharmacokinetic aspects, Faeces, Entero string test
Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive