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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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227 Search results.

Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812 - Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging

- 5/26/21 - 1 form, 10 itemgroups, 76 items, 1 language
Itemgroups: Administrative, Liver Events Assessment, Liver Biopsy, Liver Events, Alcohol Intake, Liver Disease Medical Conditions, Drug Related Liver Disease Conditions, Other Liver Disease Conditions, Other Medical Conditions, Liver Imaging
Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

NINDS CDE Non-Imaging Diagnostics Recommendations Multiple Sclerosis - Non-Imaging Diagnostics Recommendations

- 4/13/21 - 1 form, 6 itemgroups, 52 items, 1 language
Itemgroups: ECG, Pulmonary Function Tests, Scalp Electroencephalogram, Immune Cell, Electrophysiology, Studies Nerve Conduction
NINDS Common Data Elements, Multiple Sclerosis Non-Imaging Diagnostics Recommendations Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314 - Baseline

- 4/13/21 - 16 forms, 13 itemgroups, 77 items, 1 language
Itemgroups: Current examination, Cardiologic Examination, Laboratory results, Tumor marker, Surrogate endpoint, Quality of life, Diagnostic Imaging, MRT / CT findings, Local MRT/ CT assessment, MIBG scintiscan, Bone Marrow Examination, Other examination, General assessment
NCT02641314 Phase 2 Trial of Metronomic Treatment in Children and Adolescents With Recurrent or Progressive Neuroblastoma (NB). The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected. Prof. Dr. Frank Berthold Abt. für Kinderonkologie und –hämatologie Zentrum für Kinder- und Jugendmedizin Universität zu Köln

Therapy and toxicity cycle 10-13

16 itemgroups, 68 items

Therapy and toxicity cycle 1-3

16 itemgroups, 68 items

Therapy and toxicity cycle 4-6

16 itemgroups, 68 items

Therapy and toxicity cycle 7-9

16 itemgroups, 68 items
11 more forms meeting the search are available in the detailed view.

RADIOTHERAPY TREATMENT WHILE ON STUDY Roche H0650g Breast Cancer - RADIOTHERAPY TREATMENT WHILE ON STUDY

- 3/15/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: RADIOTHERAPY
Study part: Radiotherapy treatment while on study. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

medical examination SHIP-Trend-0 sono thyroid

- 3/15/21 - 1 form, 1 itemgroup, 27 items, 2 languages
Itemgroup: sono thyroid
sono thyroid form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MEX.ULTRASOU.THYROIDU. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html.
 Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

MRT SHIP-Trend-1 WORMS Reading

- 2/13/21 - 1 form, 1 itemgroup, 227 items, 2 languages
Itemgroup: WORMS Reading
WORMS Reading form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MRT.MRTASS.MRTWORMS. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

MRT SHIP-Trend-1 OA-Grading

- 2/7/21 - 1 form, 1 itemgroup, 33 items, 2 languages
Itemgroup: OA-Grading
OA-Grading form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MRT.MRTASS.MRTOA. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

reading of ultrasound examinations SHIP-Trend-1 echo findings

- 2/6/21 - 1 form, 1 itemgroup, 85 items, 2 languages
Itemgroup: echo findings
echo findings form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.RUE.READECHO.ECHOREADING_S. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

medical examination SHIP-Trend-1 sono thyroid

- 1/30/21 - 1 form, 1 itemgroup, 40 items, 2 languages
Itemgroup: sono thyroid
sono thyroid form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MEX.ULTRASOU.THYROIDU. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Liver imaging

- 1/26/21 - 1 form, 11 itemgroups, 60 items, 1 language
Itemgroups: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents any liver imaging, if taken during the study.

MRT SHIP-Trend-1 MRT-Befundung: Zufallsbefundung

- 1/24/21 - 1 form, 1 itemgroup, 199 items, 2 languages
Itemgroup: MRT-Befundung: Zufallsbefundung
MRT-Befundung: Zufallsbefundung form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MRT.MRTBEF.MRTGES. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

MRT SHIP-Trend-1 MRTSAQ: MRT questionnaire

- 1/20/21 - 1 form, 1 itemgroup, 14 items, 2 languages
Itemgroup: MRTSAQ: MRT questionnaire
MRTSAQ: MRT questionnaire form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MRT.MRTUNT.MRTSAQ. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617