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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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108 Suchergebnisse.

Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888 - Serology - screen for HIV antibody, hepatitis B and C

- 04.02.19 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Serology - screen for HIV antibody, hepatitis B and C
Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Serology - screen for HIV antibody, hepatitis B and C form. It has to be filled in for screening.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Repeat Test

- 09.01.19 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, HIV repeat test
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about the HIV repeat test, that should be performed at visit 6 and is part of amendment 1

Eligibility HIV NCT01816490

- 02.01.19 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
THISTLE - The HIV-HCV Silibinin Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01816490

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Tobacco use, HIV screen

- 04.12.18 - 1 Formular, 3 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, HISTORY OF TOBACCO USE, SEROLOGY - HIV SCREEN
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 history of tobacco use and the serology - HIV screen form. It has to be filled in for screening.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Confirmation Testing

- 01.11.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, HIV Confirmatory Test
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about the confirmation testing of the subject for HIV. It should be checked at Visit 4 and is part of study amendment 1.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Testing

- 01.11.18 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, HIV Testing
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about testing the subject for HIV. It should be checked at Visit 3 and is part of study amendment 1.

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Drug and Alcohol Screen, Urine Cotinine Test, Serology/HIV Screen

- 20.10.18 - 1 Formular, 3 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Drug And Alcohol Screen Including Cotinine, Serology / HIV Screen
This ODM file contains a form to document the results of the drug and alcohol screen, urine cotinine test, serology and hiv screen. To be assessed at screening. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

HICDEP - Basic follow-up/visit related data (tblVIS)

- 29.01.18 - 26 Formulare, 4 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Basic follow-up/visit related data, Additional questions for adolescents and adults, Additional questions for children and infants, Additional questions for infants
HICDEP stands for HIV Cohorts Data Exchange Protocol. The HIV Cohorts Data Exchange Protocol (HICDEP) is a protocol that allows for simple sharing of data from HIV cohorts by providing a standard format for datasets. It is used by several major HIV Cohort Collaborations such as CASCADE, COHERE, EuroSIDA, PENTA, EPPICC ART-CC and D:A:D. Its first version was presented at the 7th International Workshop on HIV Observational Databases in March 29–30, 2003, Fiuggi, Italy, and a summary was published in Antiviral Therapy. The specification currently consists of 27 tables in a relational structure which cover most medical aspects of HIV patient histories used in clinical research, including pediatric aspects. Subform Descriptions: -tblCEP - Clinical Events and Procedures: holds type and date of adverse events including serious non-AIDS conditions -tblART- Antiretroviral treatment: holds type of antiretroviral drug, start and stop dates and reason for stopping -tblBAS - Basic clinical, background and demographic information: holds basic information such as demographics, basic clinical information, date of AIDS diagnosis, death and drop-out information -tblDELIVERY_CHILD - Delivery information related to the child(ren): This table holds information about a delivery specific to a child. Mother-specific data is kept in tblDELIVERY_MUM. -tblDELIVERY_MUM - Delivery information related to the mother: This table contains information about the delivery specific to the mother. Child-specific information is recorded in tblDELIVERY_CHILD instead. -tblDIS - Opportunistic infections: holds type and date of CDC-C diseases. -tblLAB - Laboratory values: holds type, date, value and unit of laboratory tests -tblLAB_BP - Laboratory values - Blood pressure: holds date, diastolic and systolic values and unit of blood pressure measurements. -tblLAB_CD4 - Laboratory values: holds date and value of CD4 measurements. -tblLAB_RNA - Laboratory values: holds date, value, detection limit and type of viral assay. -tblLAB_RES - Resistance testing: holds background information on the resistance test, laboratory, library, kit, software and type of test -tblLAB_RES_LVL_1 - Nucleotide sequences (PRO, RT, GP41, GP120): holds nucleoside sequence for the PRO and RT sequences. No entry is made if the test was a phenotype test. -tblLAB_RES_LVL_2 - Mutations: holds mutations and positions of PRO and RT sequences. -tblLAB_RES_LVL_3 - Resistance test result: holds resistance result in relation to antiretroviral drug. tblLAB_VIRO - Laboratory values - viro-/serology: holds test results for viro-/serological tests (hepatitis etc.) -tblLTFU - Death and drop-out: holds data in death and drop-out -tblMED - Other medication: holds type, start and stop dates for other medication/treatments. -tblNEWBORN - Newborn: holds information related to newborns -tblNEWBORN_ABNORM - Abnormalities: Abnormalities in newborns are recorded here, one abnormality per row. The absence of a record is to be interpreted as "unknown whether the abnormality existed" since most cohorts only record positive events. -tblOVERLAP - Cross-cohort identification: holds information on the patient's participation in other cohorts -tblPREG - Pregnancy: holds general pregnancy-related information -tblPREG_OBS - Obstetrical problems during pregnancy: This table describes problems during a pregnancy. Abnormalities in newborns are recorded in tblNEWBORN_ABNORM instead. -tblPREG_OUT - Pregnancy outcome: This table describes outcomes of pregnancies described in tblPREG. -tblREFILL - Prescription refill data: holds drug, refill date and supply of prescriptions -tblSAMPLES - Blood Samples: This table contains information on the storage of blood, urine and other samples stored in a laboratory. -tblVIS - Basic follow-up/visit related data: holds visit related information such as weight, wasting, smoking, occupational status etc.

Obstetrical problems during pregnancy (tblPREG_OBS)

1 Itemgruppe, 5 Datenelemente

Cross-cohort identification (tblOVERLAP)

1 Itemgruppe, 4 Datenelemente

Prescription refill data (tblREFILL)

1 Itemgruppe, 4 Datenelemente

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Screening Laboratory Collections

- 18.10.17 - 1 Formular, 7 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative Documentation, Estradiol | FSH, Clinical Chemistry and Haematology, Urinanalysis, Drug Screening (Urine), HIV and Hepatitis B & C, Pregnancy Test
Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

AMC-063 HIV T-Cell Laboratory Values Form (F63)

- 09.10.17 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Header - HIV T-Cell Laboratory Values Form, T-Cell Laboratory Values, Comments
AMC-063 HIV T-Cell Laboratory Values Form (F63) Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=815FD9FC-242E-4365-E040-BB89AD437E9F

AMC-075 Lymphoma Disease Activity and Measurement Form (L01)

- 09.10.17 - 1 Formular, 5 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Header - Lymphoma Disease Activity and Measurement Form, Reporting Period, Nodal Involvement Evaluation, Extra Nodal Involvement Evaluation, Comments
AMC-075 Lymphoma Disease Activity and Measurement Form (L01) Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With Previously Untreated HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F166B5D-4C13-06F1-E040-BB89AD434FAE

AMC-070 Off-Study Summary Form (F50)

- 09.10.17 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Off-Study Summary
AMC-070 Off-Study Summary Form (F50) Lenalidomide in Treating Patients With AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E448E8-A18B-E89F-E040-BB89AD433766