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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Liver Imaging Form

- 07.12.18 - 1 Formular, 11 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Date of hepatic or liver imaging test, What method was used for this imaging test?, Are images technically adequate?, Indicate the liver size, Indicate the liver texture, Grade the diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Are focal hepatic lesions characterisable?, Gallstones or gallbladder lesions?, Billary ductal lesions, Portal/Hepatic vein abnormalities?
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

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

- 04.12.18 - 1 Formular, 12 Itemgruppen, 63 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Liver imaging, Method of imaging test, Image quality, Liver size, Liver texture, Ddiffuse and/or geographic fatty infiltrate of liver, Ascites, Focal Hepatic Lesions, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
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 imaging form. It has to be filled in during study, if a liver imaging was taken from subject.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Imaging Form 2

- 21.11.18 - 1 Formular, 9 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Liver Size, Liver texture, Diffuse and Geographic Fatty Infiltrate, Ascites present, Focal Hepatic Lesions, Gallstones or gallbladder lesions, Biliary Ductal Lesions, Abnormalities
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Imaging Form 1

- 21.11.18 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Complete a separate form for each individual imaging test performed., Image Quality
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pancreatitis Diagnostic Studies

- 19.11.18 - 1 Formular, 4 Itemgruppen, 25 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Abdominal Ultrasound, CT Scan, MRI
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Liver Imaging

- 13.11.18 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Imaging of liver
Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125 - Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy

- 31.10.18 - 1 Formular, 11 Itemgruppen, 103 Datenelemente, 1 Sprache
Itemgruppen: Pharmacogenetic Research Consent, Pharmacogenetic Research withdrawal of consent, Liver Events, Investigational Product (Liver), Pharmacokinetics (Liver), Medical conditions at onset of liver event, Other Liver Disease Conditions, Other medical conditions, Alcohol intake at onset of liver event, Liver imaging, Liver biopsy
Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Liver Event DoV, Liver Events, Investigational product (liver), Pharmacokinetics (liver), Medical conditions (liver), Alcohol intake, Liver imaging repeating, Liver biopsy

- 14.09.18 - 1 Formular, 10 Itemgruppen, 92 Datenelemente, 1 Sprache
Itemgruppen: Liver | Adverse event | Date of visit, Liver function | Adverse event, Experimental drug | Liver, Drug Kinetics; Liver function, Liver diseases, Liver diseases; Other, Disease | Other, Alcohol consumption, Imaging of liver, Liver Biopsy
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Disease Staging Baseline

- 18.08.18 - 1 Formular, 5 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: X-Ray Computed Tomography; Result | Diagnostic Imaging;Radiologic; Result, Bone Marrow Biopsy, Measurable Lymphoma Disease, Non- Measurable Disease, Administrative
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Liver Imaging

- 03.07.18 - 1 Formular, 7 Itemgruppen, 62 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Liver imaging, General Liver imaging results, Focal Hepatic Lesions, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
This ODM file contains Information about Liver Imaging. Complete a separate form for each individual imaging test performed. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Focus search CandiSep Anesthesiology and Intensive Care NCT02734550 - Focus search

- 03.07.18 - 1 Formular, 1 Itemgruppe, 14 Datenelemente, 1 Sprache
Itemgruppe: Search of Source of infection
Study part: Focus search Time interval 24 hours before randomization, Time interval after randomization and Day 1 to 14. (1,3)-β-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with severe sepsis or septic shock and at high risk of invasive Candida infection (CandiSep). Provided by PD Dr. med. Frank Bloos, Ph.D. Clinic for Anesthesiology and Intensive care, University Clinic Jena.

MRT SHIP-3 measure values of heart measure - measure values of heart measure

- 19.06.18 - 1 Formular, 1 Itemgruppe, 299 Datenelemente, 2 Sprachen
Itemgruppe: measure values of heart measure
measure values of heart measure form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html.
 Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617