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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
    1. 7.1. Anästhesie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Geriatrie
    1. 7.5. Gynäkologie/Geburtshilfe
    1. 7.6. Innere Medizin
      1. Hämatologie
      1. Infektiologie
      1. Kardiologie/Angiologie
      1. Pneumologie
      1. Gastroenterologie
      1. Nephrologie
      1. Endokrinologie/Stoffwechsel
      1. Rheumatologie
    1. 7.7. Neurologie
    1. 7.8. Augenheilkunde
    1. 7.9. Palliativmedizin
    1. 7.10. Pathologie/Rechtsmedizin
    1. 7.11. Kinderheilkunde
    1. 7.12. Psychiatrie/Psychosomatik
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Allgemein-/Viszeralchirurgie
      1. Neurochirurgie
      1. Plastische Chirurgie
      1. Herz-/Thoraxchirurgie
      1. Unfallchirurgie/Orthopädie
      1. Gefäßchirurgie
    1. 7.15. Urologie
    1. 7.16. Zahnmedizin/MKG
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Day 1 Predose

- 13.10.20 - 1 Formular, 6 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Assessment Date, Neurologic Examination, Neurologic Symptoms, Associated with, Neoplasms, Vital signs, Randomization, Numbers, Therapeutic regimen
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Period 2

- 16.04.18 - 1 Formular, 6 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: Investigational Product, Pharmacokinetics - Blood, Vital signs, 12-lead ECG, Lab Data, Pregnancy Test
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Period 2

Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257 - Period 1

- 16.04.18 - 1 Formular, 7 Itemgruppen, 38 Datenelemente, 1 Sprache
Itemgruppen: Randomisation, Investigational Product, Pharmacokinetics - Blood, Vital signs, 12-lead ECG, Lab Data, Pregnancy Test
Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension Documentation part: Period 1

Examination_Riliva_CRF_EudraCT - Nr. 2012-000108-13 DRKS00004652 - Examination_Riliva_CRF_EudraCT - Nr. 2012-000108-13

- 15.03.21 - 1 Formular, 5 Itemgruppen, 59 Datenelemente, 2 Sprachen
Itemgruppen: Vital Signs, skin examination, skin examination, LV - Score, skin examination Livedo racemosa
Study documentation part: Examination Week- 4, 8 and 12. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Grge, University Hospital of Mnster. EudraCT - Nr. 2012-000108-13.

Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13 DRKS00004652 - Baseline Inspection_Riliva_CRF_EudraCT - Nr. 2012-000108-13

- 15.03.21 - 1 Formular, 5 Itemgruppen, 58 Datenelemente, 2 Sprachen
Itemgruppen: Vital Signs, skin examination, skin examination, LV - Score, skin examination Livedo racemosa
Study documentation part: Baseline Inspection. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics

- 10.05.21 - 1 Formular, 10 Itemgruppen, 79 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Date of visit/assessment, Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions, Adverse Events, Concomitant Medications, 12-Lead/ Holter/ Telemetry ECG, 12-Lead ECG Abnormalities, Vital Signs, Pharmacokinetics, Orthostatic Vital Signs
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Vital Signs Form

- 11.12.18 - 1 Formular, 5 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Sitting Vitals Signs, Supine Orthostatic Vitals Signs, Sitting Orthostatic Vitals Signs, Standing Orthostatic Vitals Signs
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG

- 10.05.21 - 1 Formular, 17 Itemgruppen, 57 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Date of Visit/ Assessment, Randomisation (only Session 1), Vital Signs, Sitting Vital Signs - Predose, Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins , Orthostatic Vital Signs - Post Dose - Sitting, Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins , Pharmacokinetics Blood - Dosing Date and Time, Pharmacokinetics Blood, Investigational Product, Treatment Confirmation, 12-Lead ECG (only Session 4)
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 4: Vital Signs Form

- 09.01.19 - 1 Formular, 23 Itemgruppen, 89 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 1: Vital Signs Form

- 13.12.18 - 1 Formular, 23 Itemgruppen, 89 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 3: Vital Signs Form

- 13.12.18 - 1 Formular, 23 Itemgruppen, 89 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 2: Vital Signs Form

- 13.12.18 - 1 Formular, 23 Itemgruppen, 89 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Dosing Date and Time, Predose - Semi-supine, Predose Orthostatic - Supine, Predose Orthostatic - Sitting, Predose Orthostatic - Standing, 15 Minutes - Semi-supine, 30 Minutes - Semi-supine, 45 Minutes - Semi-supine, 1 Hour - Semi-supine, 1.5 Hour - Semi-supine, 2 Hours - Semi-supine, 4 Hours - Semi-supine, 6 Hours - Semi-supine, 8 Hours - Semi-supine, 10 Hours - Semi-supine, 10 Hours - Orthostatic- Supine, 10 Hours - Orthostatic- Sitting, 10 Hours - Orthostatic- Standing, 12 Hours - Semi-supine, 24 Hours - Semi-supine, 32 Hours - Semi-supine, 48 Hours - Semi-supine
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

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