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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    2. 1.2. Medical History
    3. 1.3. Physical Examination
    4. 1.4. Assessment Score
    5. 1.5. Apparative Diagnostics
    6. 1.6. Laboratory
    7. 1.7. Pathology/Histology
    8. 1.8. Consent
    9. 1.9. Therapy
    10. 1.10. Operative Report
    11. 1.11. Adverse Event
    12. 1.12. Follow-Up
  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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18646 Search results.

Screening - GSK Milveterol COPD 100527

- 9/20/21 - 1 form, 9 itemgroups, 132 items, 1 language
Itemgroups: Inclusion/Exclusion criteria, Demography, Duration of Asthma, Vital Signs, 12-Lead Electrocardiogram, Pulmonary function, Hematology, Clinical Chemistry, Urinalysis
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

NCI Standard Demography Template

- 9/20/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Demography, Demography, conditional, Demography, optional
The collection of CDEs used in the demography module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E63D0F-0BF0-E8D1-E040-BB89AD430251

EHR4CR data inventory for patient identification and recruitment

- 9/20/21 - 1 form, 10 itemgroups, 150 items, 2 languages
Itemgroups: Demographics, Medical History, Medical device, Diagnosis, Procedure, Findings, Laboratory Findings, Medication, Scores&Classifications, Patient Characteristics
EHR4CR data inventory for patient identification and recruitment Referenced by https://www.ncbi.nlm.nih.gov/pubmed/25991199

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

- 9/20/21 - 1 form, 1 itemgroup, 2 items, 2 languages
Itemgroup: LAB Abnormal result
modified from http://www.cdisc.org

Sepsis Case Report Form MEDUSA project - SAPS II- Score Report Form

- 11/17/20 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Header module, SAPS II- Score
The MEDUSA project (medical education for sepsis source control and antibiotics) is a scientific study of the integrated research and treatment center "Center for Sepsis Control and Care" (CSCC) of the University Hospital Jena, Thuringia, Germany. Its aim is to investigate whether a multimodal and interdisciplinary training concept for the early recognition and standardized treatment of patients with sepsis improves time to administration of first antibiotic and survival of patients. Original forms obtained from: http://www.medusa.uniklinikum-jena.de/Datenerfassung.html

Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 3/24/20 - 1 form, 5 itemgroups, 90 items, 2 languages
Itemgroups: Logistics , Physical examination, ECG, 6MWT, Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

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

- 9/20/21 - 1 form, 6 itemgroups, 71 items, 1 language
Itemgroups: 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

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

- 9/20/21 - 1 form, 6 itemgroups, 49 items, 1 language
Itemgroups: 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)

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

- 9/20/21 - 1 form, 6 itemgroups, 72 items, 1 language
Itemgroups: 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)

EHR4CR CTE Data Inventory

- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Eligibility Type 2 Diabetes NCT00641251

- 4/21/18 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00641251

Eligibility Type 2 Diabetes NCT00508599

- 4/21/18 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00508599