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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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128 Suchergebnisse.

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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

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Study conclusion, Investigator Comment Log, Investigator's signature

- 07.12.18 - 1 Formular, 4 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Study conclusion, Investigator Comment Log, Investigator's signature
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 Study conclusion, Investigator Comment Log, Investigator's signature. It has to be filled in for the end of study.

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Concomitant Medications

- 07.12.18 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Concomitant medication
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 Concomitant Medications form. It has to be filled in if concomitant medications were taken by subject during study.

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Pharmacogenetic (PGx) research

- 07.12.18 - 1 Formular, 5 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Consent for pharmacogenetic (PGx) research, Blood sample collection, Withdrawl of consent, Blood sample destruction
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 Pharmacogenetic (PGx) research form. It has to be filled in if a PGx was done during study.

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Investigational product, treatment confirmation

- 07.12.18 - 1 Formular, 3 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Investigational product, Treatment confirmation
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 investigational product and treatment confirmation form. It has to be filled in for study visit.

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Liver events

- 07.12.18 - 1 Formular, 10 Itemgruppen, 33 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Liver events, Liver events assessment, Treatment periods applicable to the onset of ALT≥2x ULN, Liver events, Diagnositics, Alcohol intake, LIVER DISEASE MEDICAL CONDITIONS, DRUG RELATED LIVER DISEASE CONDITIONS, OTHER LIVER DISEASE CONDITIONS, OTHER MEDICAL CONDITIONS
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 liver events form. It has to be filled in if a liver event occurs during study (including screening and study visit).

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Pregnancy notification form (subject's partner)

- 07.12.18 - 1 Formular, 7 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Mothers relevant medical/family history, Number of previous pregnancies, Fathers relevant medical/family history, DRUG EXPOSURES, Withdraw from study, REPORTING INVESTIGATOR 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 Pregnancy notification form (subject's partner). Complete this form for each subject's partner who becomes pregnant during the study period. This form should be completed according to the protocol reporting requirements. Complete this form for each subject's partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject's Case Report Form. Note: This form does not routinely need to be completed for subject's partner pregnancy unless there is specific instruction to do so stated in the protocol.

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Liver biopsy

- 07.12.18 - 1 Formular, 14 Itemgruppen, 145 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Liver biopsy, Final diagnosis, Liver Architecture, Description of Liver Cells or Hepatocytes, Liver Cell or Hepatocyte Inclusions or Vacuoles, Hepatocyte or Liver Cell Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal veins, Liver Infections, Parasites or Ova, Histologic Staining or Additional Studies Obtained
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 liver biopsy form. It has to be filled in if during study (inclusion screening and study visit) a liver event occurs.

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

- 05.12.18 - 1 Formular, 12 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demographics Domain, Serious Adverse Event, Experimental drug, Serious Adverse Event, Causations, Serious Adverse Event, Disease, Serious Adverse Event, Risk Factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental Drug, Details, Serious Adverse Event, Evaluation, Details, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature, Investigator Name
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 - Non-Serious Adverse Events

- 05.12.18 - 1 Formular, 1 Itemgruppe, 12 Datenelemente, 1 Sprache
Itemgruppe: Non-Serious Adverse Events
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 - Concomitant Medications

- 05.12.18 - 1 Formular, 1 Itemgruppe, 13 Datenelemente, 1 Sprache
Itemgruppe: Concomitant Agent
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