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  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
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Basic documentation B2 LeMLAR-Studie Lymphoma NCT01788189 - Basic documentation B2

- 3/15/21 - 1 form, 3 itemgroups, 26 items, 1 language
Itemgroups: medical history, Inclusion Criteria, Exclusion Criteria
Study part: Basic documentation B2 LeMLAR-Studie. LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Eligibility Type 2 Diabetes NCT02459496

- 1/19/19 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Diabetological Dietary Strategies and Perspectives / DDS-P (Deutsche Diabetes-Studie Potsdam); ODM derived from: https://clinicaltrials.gov/show/NCT02459496

Eligibility Colon Endoscopy DRKS00006283 NCT02182466 DRKS00006283 - Eligibility Colon Endoscopy NCT02182466 DRKS00006283

- 7/4/17 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Responsible Party: Jorg Albert, [Dokumentation von Kolonkapsel-Endoskopien im Rahmen einer bundesweiten Studie], Johann Wolfgang Goethe University Hospitals ClinicalTrials.gov Identifier: NCT02182466 History of Changes Other Study ID Numbers: 265/13 DRKS-ID: DRKS00006283 ( Other Identifier: German Clinical Trials Registry ) Study First Received: June 27, 2014 Last Updated: July 2, 2014 German Colon Capsule Registry (DEKOR) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02182466

DESCRIBE (DZNE – Clinical Register Study of neurodegenerative Disorders) CRF Diagnostic Criteria - CRF Diagnostic Criteria

- 9/20/21 - 1 form, 20 itemgroups, 378 items, 1 language
Itemgroups: Date of visit, Mild cognitive impairment (MCI), Dementia in Alzheimer's Disease (AD), Posterior cortical atrophy (PCA), Vascular dementia, Frontotemporal dementia, behavioral variant, Primary progressive aphasia (PPA), Progressive nonfluent aphasia (PNFA), Logopenic progressive aphasia (LPA), Semantic dementia (SemD), Idiopathic Parkinson's disease (IPS), Morbus parkinson along with MCI (PD-MCI), Dementia in Parkinsons disease, Dementia with Lewy bodies (DLB), Progressive supranuclear palsy, Corticobasal degeneration (CBD), Multiple system atrophy (MSA), Essential tremor (ET), Amyotrophic lateral sclerosis (ALS), Depression
Background and Purpose: The purpose of the DESCRIBE study is to document the natural course of diseases in context of medical care of neurodegenerative disorders as well as cerebrovascular diseases and to perform phenotyping of the test persons. Disease-spanning analyses of the measured clincial data, the results of the imaging processes, results of the analysis of the biometerials including genetic analysis are planed. Principal Investigator: Prof. Klockgether, Dr. Spottke DZNE, Bonn. Source: DESCRIBE-Studie http://www.dzne.de/forschung/forschungsbereiche/klinische-forschung/studien/describe-bn006.html Participating Study Sites: Berlin, Bonn, Göttingen, Dresden, Köln, Magdeburg, München, Rostock/Greifswald, Tübingen

MRT SHIP-Trend-0 MRT and general facts

- 12/6/17 - 1 form, 1 itemgroup, 88 items, 2 languages
Itemgroup: MRT and general facts
MRT and general facts form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MRT.MRTUNT.MRTALLG. 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-0 MRT pre-exclusion

- 12/6/17 - 1 form, 1 itemgroup, 17 items, 2 languages
Itemgroup: MRT pre-exclusion
MRT pre-exclusion form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MRT.MRTPRE.MRTEXPRE. 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

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039 - Visit 1: Eligibility Criteria

- 6/6/19 - 1 form, 4 itemgroups, 6 items, 1 language
Itemgroups: Administrative data, Eligibility Check, Inclusion Criteria, Exclusion Criteria
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This form is to be completed at Visit 1.

Genetic Screening For HLA-B*5701 n Patients with HIV Day 1 NCT00340080 - Genetic Screening For HLA-B*5701 Day 1 NCT00340080

- 6/20/17 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: Day 1
NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Day 1 (Cohort Study) Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Completion Period: Vital Signs

- 11/19/18 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative data, Study Completion, Double-Blind Method
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731

- 9/9/17 - 1 form, 14 itemgroups, 44 items, 1 language
Itemgroups: study continuation, Blood sample, Concomitant vaccination, Concomitant vaccination, Medication, Medication, Medical status, Disease, Follow-up Studies, serious adverse event, Pregnancy, Elimination criteria, Study conclusion, Investigator's signature
Visit 4, Concomitant vaccination, medication and study conclusion- GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731 Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Eligibility Acute Lymphoblastic Leukemia NCT02010931

- 12/21/15 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02010931

Eligibility Lesions NCT00861172

- 1/17/19 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy; ODM derived from: https://clinicaltrials.gov/show/NCT00861172

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