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Table des matières
  1. 1. Essai clinique
    1. 1.1. Inclusion/exclusion
    1. 1.2. Anamnèse
    1. 1.3. Examen médical
    1. 1.4. Score
    1. 1.5. Diagnostic à l’aide d’appareils
    1. 1.6. Laboratoire
    1. 1.7. Pathologie/histologie
    1. 1.8. Informations/consentement
    1. 1.9. Thérapie
    1. 1.10. Rapport opératoire
    1. 1.11. Évènement inopportun
    1. 1.12. Follow-Up
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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20 Résultats de recherche.
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Vital Signs- Follow- Up Pazopanib Macular Degeneration MD1103367 - Vital Signs- Follow- Up

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: Vital signs measurements
Study part: Vital Signs- Follow- Up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 10/10/2017 - 1 Formulaire, 18 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature
Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL

Vital Signs Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Vital Signs Follow- Up (Visit 10)

- 27/09/2021 - 1 Formulaire, 1 Groupe Item, 10 Eléments de données, 1 Langue
Groupe Item: Vital Signs
Study Part: Vital Signs Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Follow Up - Visit 20 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/2016 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 2 Langues
Groupes Item: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Follow Up - Visit 19 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/2016 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 2 Langues
Groupes Item: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Follow Up - Visit 18 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/2016 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 2 Langues
Groupes Item: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Follow Up - Visit 21 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/2016 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 2 Langues
Groupes Item: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Follow-Up Visit und Unscheduled Visit Form

- 20/09/2021 - 1 Formulaire, 3 Groupes Item, 34 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Vital Signs, Physical Examination
This ODM file contains a form for the documention required at the follow-up and unscheduled visits. 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

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

- 15/03/2021 - 1 Formulaire, 5 Groupes Item, 59 Eléments de données, 2 Langues
Groupes Item: 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.

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Follow-Up - Vital Signs; 12-Lead ECG; Pulmonary Function Tests; Pregnancy Test; Local Laboratory; Urinalysis

- 15/02/2021 - 1 Formulaire, 15 Groupes Item, 54 Eléments de données, 1 Langue
Groupes Item: Administrative, Vital Signs, 12-Lead ECG, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities, Pulmonary Function Test - Pre-Dose, Pregnancy Test, Local Laboratory - Clinical Chemistry, Local Laboratory - Clinical Chemistry, Local Laboratory - Haematology, Local Laboratory - Haematology, Urinalysis - Local, Urinalysis - Local, Urinalysis - Microscopy, Urinalysis - Microscopy
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

- 05/12/2020 - 1 Formulaire, 9 Groupes Item, 36 Eléments de données, 1 Langue
Groupes Item: Date of visit/assessment, ECG, Vital Signs - Follow-up 1, Vital Signs - Follow-up 2, Vital Signs - Follow-up 3, Pulmonary Function Tests, Pregnancy Information, Status of Treatment Blind, Study Conclusion
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 25/06/2020 - 1 Formulaire, 10 Groupes Item, 187 Eléments de données, 1 Langue
Groupes Item: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

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