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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
Ausgewählte Datenmodelle

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153 Suchergebnisse.

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 21.04.18 - 13 Formulare, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 Itemgruppen, 14 Datenelemente

Administrative/Demographic Details

1 Itemgruppe, 11 Datenelemente

Apparatus-based Diagnostics

1 Itemgruppe, 4 Datenelemente

Multiple sclerosis studies NCT02461069 NCT02419378 - Visit 1 (Screening) Part 2/2, Lab; Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

- 29.01.19 - 18 Formulare, 7 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: Date of blood sampling, Hematology, Liver Function, Renal function, Medical Examination, Expanded disability status scale (EDSS), Signature
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

7 Itemgruppen, 31 Datenelemente

Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

3 Itemgruppen, 31 Datenelemente

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

2 Itemgruppen, 48 Datenelemente

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Infusion Record Dosimetric Dose - Day 0 (Visit 2)

- 18.08.18 - 1 Formular, 9 Itemgruppen, 32 Datenelemente, 1 Sprache
Itemgruppen: Date administered, HAMA, Time started, Time finished, Doses, Infusion rate, Record Vital Signs, Adverse Experience, Compliance
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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Prior Therapy

- 18.08.18 - 1 Formular, 3 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Prior Therapy, Pharmaceutical Preparations, Therapeutic radiology procedure; Before
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

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Prior Therapy

- 12.07.18 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, xxx
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin Please record all prior therapies for NHL (e.g. chemotherapy, immunotherapy, steroidal therapy).

CDASH Drug accountability(1) - Drug accountability (1)

- 20.06.18 - 1 Formular, 3 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: General information, Study Treatment – Returned Amount, Study Treatment – Dispensed Amount
modified from http://www.cdisc.org

CDASH Drug accountability (2) - Drug accountability (2)

- 20.06.18 - 1 Formular, 4 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Study Treatment – Returned, Study Treatment – Returned Amount, Study Treatment – Dispensed, Study Treatment – Dispensed Amount
modified from http://www.cdisc.org

CDASH Drug accountability (3) - Drug accountability (3)

- 20.06.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: General information, Study Treatment
modified from http://www.cdisc.org

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664 - Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7

- 23.05.18 - 1 Formular, 4 Itemgruppen, 56 Datenelemente, 1 Sprache
Itemgruppen: Dosimetric Dose - Day 0, Vital Signs, Therapy Dose - Day 7, Vital Signs
https://clinicaltrials.gov/show/NCT00989664 Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Interim Visit HOMe aFers 1 NCT02905539

- 29.12.17 - 1 Formular, 12 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Adverse events, Pre- and concomitant therapy, Vital parameters, Physical Examination, Collection of biological samples_interim visit, Signature for interim visit, Medical history, Intercurrent diseases, Adverse events, Serious adverse events, Pre- and concomitant therapy
Interim visit form Interimsvisite NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Visit 5 HOMe aFers 1 NCT02905539

- 29.12.17 - 1 Formular, 12 Itemgruppen, 49 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Adverse events, Pre- and concomitant therapy, Questionnaire 1, Questionnaire 2, Questionnaire 3, Vital parameters, Anthropometric Data, Physical Examination, 12-lead ECG, Collection of biological samples_visit 5, Signature for visit 5
Visit 5 form Visite 5 NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Eligibility HOMe aFers 1 NCT02905539

- 28.12.17 - 1 Formular, 4 Itemgruppen, 36 Datenelemente, 2 Sprachen
Itemgruppen: Inclusion criteria, Exclusion criteria, Result of eligibility criteria verification, Administrative data
Eligibility form Prüfung der Eignung zur Studienteilnahme NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes