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

- 11/14/17 - 1 form, 10 itemgroups, 71 items, 2 languages
Itemgroups: 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)

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

- 11/14/17 - 1 form, 7 itemgroups, 45 items, 2 languages
Itemgroups: Final visit, Physical Examination / Medical History taking, Signs and Symptoms of heart failure, ECG, Utilisation of health care resources since last visit, Hematology, Current medication
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 Final Visit Cardiologist (FV-form)

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Patient visit

- 11/14/17 - 1 form, 7 itemgroups, 43 items, 2 languages
Itemgroups: Patient visit, Physical Examination / Medical History taking, Signs and Symptoms of heart failure, ECG, Utilisation of health care resources since last visit, Hematology, Current medication
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 Patient visit (Z-form)

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - 12-Lead ECG Abnormalities

- 12/17/20 - 1 form, 8 itemgroups, 90 items, 1 language
Itemgroups: Administrative Data, 12-Lead ECG Abnormalities, 12-Lead ECG Rhythm, 12-Lead ECG, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia The 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study. ECG curves are recorded during the Screening, P1 D1, P2 D1, Follow-Up and Repeat Visits.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - 12-Lead ECG

- 12/12/20 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: Administrative Data, Dosing date and time, 12-Lead ECG
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening Visit, the P1 D1 and P2 D1, the Follow-Up Visit and whenever a repeat ECG measurement was conducted during the study.

DZHK Data Catalogue - ECG

- 10/9/19 - 1 form, 3 itemgroups, 51 items, 2 languages
Itemgroups: General ECG information, ECG, Long-term ECG
With permission from the DZHK administrative office. http://dzhk.de The DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.; German Center for Cardiovascular Research) is a joint cooperation of twenty-eight institutions in seven locations throughout Germany to develop a common research strategy. They developed a data catalogue with metadata and data as well as information about available biological materials from all their studies. For more information on the data catalogue and access to actual data and biosamples please visit https://dzhk.de/en/resources/data-manual/ . This version contains the metadata part only. The form ECG (electrocardiogram) is used to document important parameters from ECG and long-term ECG measurements. The documentation is to be performed according to the DZHK's SOPs, which can be accessed at https://dzhk.de/en/resources/sops/ (or https://dzhk.de/ressourcen/sops/ for the German language versions). The SOP for this form is "Resting 12-Lead Surface Electrocardiogram (ECG)" (version 1.0, valid as of 01/09/2014) for the English language version, and "12-Kanal Oberflächen Elektrokardiographie in Ruhe (EKG)" (version 1.0, valid as of 01/09/2014) for the German version.

ECG examination cardiac surgery UKM - ECG examination

- 7/23/17 - 1 form, 2 itemgroups, 32 items, 2 languages
Itemgroups: Patient demographics, Examination
ECG examination form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Sven Martens.

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