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Inhaltsverzeichnis
  1. 1. Klinische Studie
    1. 1.1. Ein-/Ausschluss
    1. 1.2. Anamnese
    1. 1.3. Körperliche Untersuchung
    1. 1.4. Score
    1. 1.5. Apparative Diagnostik
    1. 1.6. Labor
    1. 1.7. Pathologie/Histologie
    1. 1.8. Aufklärung/Einverständis
    1. 1.9. Therapie
    1. 1.10. Operationsbericht
    1. 1.11. Unerwünschtes Ereignis
    1. 1.12. Follow-Up
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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22 Suchergebnisse.
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Electrocardiogram Abnormalities Form - GSK Milveterol COPD 100527

- 20.09.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: Electrocardiogram Abnormalities
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

Visit 10 GIMEMA CML0408 NCT00769327 - Visit 10

- 20.09.21 - 1 Formular, 12 Itemgruppen, 122 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 10 Form

Visit 16 GIMEMA CML0408 NCT00769327 - Visit 16

- 20.09.21 - 1 Formular, 11 Itemgruppen, 117 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 16 Form

Visit 13 GIMEMA CML0408 NCT00769327 - Visit 13

- 20.09.21 - 1 Formular, 5 Itemgruppen, 56 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Molecular Biology (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 13 Form

Visit 5 GIMEMA CML0408 NCT00769327 - Visit 5

- 20.09.21 - 1 Formular, 4 Itemgruppen, 44 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 5 Form

Visit 7 GIMEMA CML0408 NCT00769327 - Visit 7

- 20.09.21 - 1 Formular, 13 Itemgruppen, 127 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, NILOTINIB, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 7 Form

Visit 3 GIMEMA CML0408 NCT00769327 - Visit 3

- 20.09.21 - 1 Formular, 5 Itemgruppen, 49 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination, Complete Blood Count, NILOTINIB, Biochemistry, Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 3 Form

Visit 1 GIMEMA CML0408 NCT00769327 - Visit 1

- 20.09.21 - 1 Formular, 15 Itemgruppen, 150 Datenelemente, 2 Sprachen
Itemgruppen: Previous chemotherapy, Comorbidities, Symptoms, Physical Examination, Complete Blood Count, Biochemistry, Serum Proteins, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 1 Form

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 17.04.21 - 1 Formular, 9 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Continuous Holter ECG

- 17.06.20 - 1 Formular, 4 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Predose Continuous 24 hour Holter ECG (Day 1), Continuous 24 hour Holter ECG (Day 3), Continuous 48 hour Holter ECG (Day 5)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - 12-Lead ECG

- 15.06.20 - 1 Formular, 4 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: Administrative, 12-Lead ECG (Screening and Follow-up), 12-Lead ECG (Day 3 and 5), 12-Lead ECG (Unscheduled)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Continuous Holter ECG Abnormalities

- 08.06.20 - 1 Formular, 2 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Continuous Holter ECG
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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