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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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22054 Search results.

Eligibility Carcinoma, Non Small Cell Lung NCT01671332

- 10/14/19 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01671332

Eligibility Carcinoma, Hepatocellular NCT01668134

- 10/14/19 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01668134

Eligibility Carcinoma, Hepatocellular NCT01425996

- 10/14/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Dose-escalation Study of Lipotecan® Plus Radiotherapy in Locally Advanced Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01425996

Eligibility Carcinoma, Hepatocellular NCT01387503

- 10/14/19 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Expansion of Conventional Criteria for Liver Transplantation in Hepatocellular Carcinoma Through Downstaging; ODM derived from: https://clinicaltrials.gov/show/NCT01387503

Effects of eltrombopag in infants with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Demography

- 10/14/19 - 1 form, 4 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data, Demography, Ethnicity, Geographic ancestry
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening and three parts. Part one includes week 1 to week 24, part two includes week 1 to week 7 and part three starts at week 8 to week 31. In the following you see the short version for each visit and part, where P represents the parts and W represents the number of week. There can be an early withdrawal at Part 1 Week 24 and Part 3 Week 31. Sreening Day 1 Part 1 Week 1 = P1W1 Part 1 Week 2 = P1W2 Part 1 Week 3 = P1W3 Part 1 Week 4 = P1W4 Part 1 Week 5 = P1W5 Part 1 Week 6 = P1W6 Part 1 Week 7 = P1W7 Part 1 Weeks 8-23 = P1W8-23 Part 1 Week 24/ Early withdrawal = P1W24/EW Part 2 Week 1 = P2W1W Part 2 Week 2 = P2W2 Part 2 Week 3 = P2W3 Part 2 Week 4 = P2W4 Part 2 Week 5 = P2W5 Part 2 Week 6 = P2W6 Part 2 Week 7 = P2W7 Part 3 Weeks 8-30 = P3W8-30 Part 3 Week 31/ Early withdrawal = P3W31/EW Follow-up Week 1 = FUW1 Follow-up Week 2 = FUW2 Follow-up Week 3 = FUW3 Follow-up Week 4 = FUW4 Follow-up Month 3 = FUM3 Follow-up Month 6 = FUM6 This document contains the demography form. It has to be filled in for screening.

Eligibility Carcinoma, Hepatocellular NCT01204177

- 10/14/19 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT01204177

Eligibility Carcinoma, Hepatocellular NCT01096914

- 10/14/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01096914

Minimum Information About BIobank data Sharing (MIABIS) Core 2.0 - Data describing study

- 10/14/19 - 1 form, 8 itemgroups, 67 items, 1 language
Itemgroups: Data describing Study, Contact information, Study design, Sex, Age, Data categories, Material type, Inclusion criteria
The Minimum Information About BIobank data Sharing (MIABIS) aims to standardize data elements used to describe biobanks, research on samples and associated data. MIABIS Core 2.0 represents the minimum information required to initiate collaborations between biobanks and to enable the exchange of biological samples and data. The aim is to facilitate the reuse of bio-resources and associated data by harmonizing biobanking and biomedical research. The attributes are defined in accordance with epidemiological literature and terminology. For MIABIS Core 2.0 purpose, Study represents a set of samples brought together in the context of a research study. A study can combine samples from several sample collections and from several biobanks. One sample can be included in multiple studies. (Merino-Martinez et al. Biopreserv Biobank. 2016; 14(4):298-306). More information can be found at https://github.com/MIABIS/miabis/wiki

Minimum Information About BIobank data Sharing (MIABIS) Core 2.0 - Data describing Biobank

- 10/14/19 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Data describing Biobank, Contact information
The Minimum Information About BIobank data Sharing (MIABIS) aims to standardize data elements used to describe biobanks, research on samples and associated data. MIABIS Core 2.0 represents the minimum information required to initiate collaborations between biobanks and to enable the exchange of biological samples and data. The aim is to facilitate the reuse of bio-resources and associated data by harmonizing biobanking and biomedical research. The attributes are defined in accordance with epidemiological literature and terminology. For MIABIS Core 2.0 purpose, Biobank is defined as an organization or an organizational unit that stores samples and data related to the samples. In MIABIS Core 2.0 biobanks do not contain samples directly, but they are hosting sample collections. On the level of biobanks, only attributes related to the organizational aspect of the biobanks are represented. (Merino-Martinez et al. Biopreserv Biobank. 2016; 14(4):298-306). More information can be found at https://github.com/MIABIS/miabis/wiki

Minimum Information About BIobank data Sharing (MIABIS) Core 2.0 - Data describing Sample Collection

- 10/14/19 - 1 form, 9 itemgroups, 65 items, 1 language
Itemgroups: Data describing Sample Collection, Sex, Age, Data categories, Material type, Storage temperature, Collection type, Disease, Contact information
The Minimum Information About BIobank data Sharing (MIABIS) aims to standardize data elements used to describe biobanks, research on samples and associated data. MIABIS Core 2.0 represents the minimum information required to initiate collaborations between biobanks and to enable the exchange of biological samples and data. The aim is to facilitate the reuse of bio-resources and associated data by harmonizing biobanking and biomedical research. The attributes are defined in accordance with epidemiological literature and terminology. For MIABIS Core 2.0 purpose, Sample Collection represents a set of samples with at least one common characteristic (Merino-Martinez et al. Biopreserv Biobank. 2016; 14(4):298-306). More information can be found at https://github.com/MIABIS/miabis/wiki

DZHK Data Catalogue - Cardiac Catheter

- 10/14/19 - 1 form, 7 itemgroups, 81 items, 2 languages
Itemgroups: Cardiac catheter details, Right heart catheterisation, Left heart catheterisation, Myocardial biopsy, Storage diseases, Histology/Immunohistochemistry/Immunology/Virology report, Procedural complications
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 Cardiac Catheter is used to document a cardiac catheter examination. This examination enables a better phenotyping of cardiomyopathies, an assessment of the degree of severity and of the prognosis. An invasive cardiac assessment is indicated according to the current guidelines. In the context of the objective, this applies especially to patients in whom cardiomyopathy has already been verified by other imaging techniques, unexplained reduced left ventricular systolic function and/or corresponding symptoms. 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 "Cardiac Catheterization. Left and rightheart examination. Left ventriculography. Left and right ventricular myocardial biopsies." (version 1.0, valid as of 01/09/2014) for the English language version, and "Herzkatheter. Links- und Rechtsherzkatheteruntersuchung. Linksventrikuläre Ventrikulographie. Entnahme von links-/ rechtsventrikulären Myokardbiopsien." (version 1.0, valid as of 01/09/2014) for the German version.

DZHK Data Catalogue - Cardiomyopathy Diagnostics

- 10/14/19 - 1 form, 2 itemgroups, 31 items, 2 languages
Itemgroups: General Diagnostic Information, Cardiomyopathy Diagnostics
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 Cardiomyopathy Diagnostics is used to document analyzing parameters of cardiomyopathy examinations. 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). As of 09/10/2019, there are no specific SOPs for this form.