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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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Study SHIP-TREND_TREND0_SAQ - t0.saq_eingabe_assi

- 26.10.24 - 11 Formulare, 1 Itemgruppe, 9 Datenelemente, 2 Sprachen
Itemgruppe: t0.saq_eingabe_assi
SHIP Study https://doi.org/10.1093/ije/dyac034

t0.ble_phq

1 Itemgruppe 18 Datenelemente

t0.ble_vertreibung

1 Itemgruppe 1 Datenelement

t0.saq_beschwer

1 Itemgruppe 41 Datenelemente

t0.saq_health

1 Itemgruppe 13 Datenelemente

t0.saq_qol

1 Itemgruppe 50 Datenelemente

t0.ble_tas

1 Itemgruppe 20 Datenelemente

Quality of Life LenaMain-Study - Quality of Life EORTC QLQ-C30

- 16.03.16 - 1 Formular, 6 Itemgruppen, 30 Datenelemente, 1 Sprache
Itemgruppen: EORTC QLQ-C30 (version 3) Quality of life questionnaire, EORTC1 Past Week, EORTC2 past week, EORTC3 past week, EORTC4 past week, EORTC5 past week
A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Quality of Life Cardiovascular Health Study (CHS) - Quality of Life Cardiovascular Health Study (CHS)

- 29.06.16 - 1 Formular, 4 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Adminstrative data, Quality of life, Interviewer questions, Date of interview
Documentation part: Record 3 Quality of Life The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Colorectal Cancer NCT01167725 On-Study - USMCI 8214/Z6091: Quality of Life Questionnaires (cover sheet) - 2891901v1.0 - USMCI 8214/Z6091: Quality of Life Questionnaires (cover sheet)

- 09.01.15 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Header Module, Header
USMCI 8214/Z6091: Quality of Life Questionnaires (cover sheet) Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AFDAEC3-1F36-0D02-E040-BB89AD4312D1

Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

- 04.02.17 - 1 Formular, 1 Itemgruppe, 45 Datenelemente, 1 Sprache
Itemgruppe: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 7 / Early Termination ADDQoL [QS_2] NCT01117584

- 04.02.17 - 1 Formular, 1 Itemgruppe, 45 Datenelemente, 1 Sprache
Itemgruppe: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 2 Baseline ADDQoL [QS_2] NCT01117584

- 28.01.17 - 1 Formular, 1 Itemgruppe, 45 Datenelemente, 1 Sprache
Itemgruppe: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 24 (Week 240) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 10 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 24 (Week 240)

Visit 20 (Week 192) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17.02.22 - 1 Formular, 10 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 20 (Week 192)

Visit 16 (Week 144) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.06.16 - 1 Formular, 10 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 16 (Week 144)

Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584

- 20.09.21 - 1 Formular, 9 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 9 Follow-up Diab-MedSat [QS_3] NCT01117584

- 20.09.21 - 1 Formular, 9 Itemgruppen, 24 Datenelemente, 1 Sprache
Itemgruppen: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

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