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Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069 - NON-MS Treatment and symptomatic MS Treatment

- 2016-05-24 - 4 Formulär, 4 Item-grupper, 19 Dataelement, 1 Språk
Item-grupper: General Instructions, Medical Examination, Expanded disability status scale (EDSS), Signature
Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Eligibility

3 Item-grupper 31 Dataelement

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

7 Item-grupper 31 Dataelement

Blood samples for safety laboratory tests

4 Item-grupper 16 Dataelement

Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 2015-01-09 - 1 Formulär, 3 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: Header, Endocrine therapy, Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

Eligibility NCT00156338 Fluid Management - Eligibility

- 2011-11-25 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00156338

CDASH Lab Result Assessment (Scenario 3, Part 2) - CDASH LAB Result Assessment (Scenario 3, Part 2)

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 2 Dataelement, 2 Språk
Item-grupp: LAB Abnormal result
modified from http://www.cdisc.org

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 2017-11-14 - 1 Formulär, 10 Item-grupper, 71 Dataelement, 2 Språk
Item-grupper: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

CDASH ECG – Scenario 2 (local processing) - ECG – Scenario 2 (local processing)

- 2018-06-20 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 2 Språk
Item-grupper: General information, ECG Information (Local processing), ECG Results
modified from http://www.cdisc.org

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 71 Dataelement, 1 Språk
Item-grupper: Chemistry, Haematology, Liver Chemistry Assessments, Renal Laboratory Parameters, Urinalysis Dipstick, Other Laboratory Screenings
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00516321 https://clinicaltrials.gov/ct2/show/NCT00516321 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab Panels NCT00529568

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 72 Dataelement, 1 Språk
Item-grupper: Chemistry, Haematology, Liver Chemistry Assessments, Renal Laboratory Parameters, Urinalysis Dipstick, Other Laboratory Screenings
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00529568 https://clinicaltrials.gov/ct2/show/NCT00529568 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216

- 2021-09-20 - 1 Formulär, 6 Item-grupper, 49 Dataelement, 1 Språk
Item-grupper: Clinical Chemistry, Haematology, Liver Chemistry, Renal Assessments, Urinalysis Dipstick, Other Laboratory Screenings
The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy. NCT00996216 https://clinicaltrials.gov/ct2/show/NCT00996216 Study Type: Interventional Study Design: Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)

NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template - 2748814v1.0 - NCI Standard Adverse Event/Serious Adverse Event CTCAE v3 Template

- 2021-04-13 - 1 Formulär, 4 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: Mandatory Adverse Event Questions, Conditional Adverse Event Questions, Optional Adverse Event Questions, Optional Serious Adverse Event Questions
The collection of CDEs used in the Adverse Events/Serious Adverse Events module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4D0BC7DD-57DD-63BE-E044-0003BA3F9857

CDASH Medical History

- 2018-06-20 - 1 Formulär, 4 Item-grupper, 13 Dataelement, 3 Språk
Item-grupper: General information, High Blood Pressure, Appendectomy, Other
modified from http://www.cdisc.org

RECIST - Response Evaluation Criteria in Solid Tumors

- 2016-02-22 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 2 Språk
Item-grupp: RECIST
Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 https://en.wikipedia.org/wiki/Response_Evaluation_Criteria_in_Solid_Tumors https://de.wikipedia.org/wiki/Response_Evaluation_Criteria_in_Solid_Tumors http://www.ncbi.nlm.nih.gov/pubmed/19097774

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