Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Restaging PETAL Study NCT00554164 - Restaging

- 22.11.16 - 1 Formular, 9 Itemgruppen, 63 Datenelemente, 2 Sprachen

Itemgruppen: Patient demographics, Staging, Lab results, Nodal involvement, Extranodal involvement, Overall result, Dscontinuation of therapy, IPI, Footer module

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

Staging PETAL Study NCT00554164 - Staging

- 18.11.16 - 1 Formular, 9 Itemgruppen, 60 Datenelemente, 2 Sprachen

Itemgruppen: Patient demographics, Therapy, Staging, Lab results, Nodal involvement, Extranodal involvement, Overall result, IPI, Footer module

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

ICHOM Heart Failure - Baseline Characteristics, at time of index event

- 30.04.20 - 1 Formular, 5 Itemgruppen, 62 Datenelemente, 1 Sprache

Itemgruppen: Patient ID, Demographic Factors, Baseline health status, Treatment variables, Burden of Care

HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains baseline characteristics. It should be filled in at the time of the index event. The index event represents the entry into the set. This could either be after diagnosis/first encounter in an outpatient setting, or at discharge from hospital if the initial presentation was severe enough to require admission. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Basic documentation PETAL Study NCT00554164 - Basic documentation

- 28.11.16 - 1 Formular, 3 Itemgruppen, 18 Datenelemente, 2 Sprachen

Itemgruppen: Patient identification, Pathology, Footer module

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

Levodopa Test, University Hospital CologneTEST Study - Levodopa Test, University Hospital Cologne

- 14.11.17 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: General Information, UPDRS

Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: Levodopa

MoCA GSK study Chronic Coronary Heart Disease NCT00799903

- 22.12.17 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache

Itemgruppen: MoCA General information, MoCA Eligibility Criteria, Montreal Cognitive Assessment

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Montral Cognitive Assessment (MoCA)

MoCA GSK study Chronic Coronary Heart Disease NCT00799903

- 21.09.17 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache

Itemgruppen: MoCA General information, MoCA Eligibility Criteria, Montreal Cognitive Assessment

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Montral Cognitive Assessment (MoCA)

MMSE GSK study Dyskinesia in Parkinson's disease NCT00363727

- 07.09.17 - 1 Formular, 2 Itemgruppen, 2 Datenelemente, 1 Sprache

Itemgruppen: General information, Mini-Mental State Examination

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: MMSE.

ICHOM Coronary Artery Disease - Peri-Inverventional Clinical Form

- 30.04.20 - 1 Formular, 8 Itemgruppen, 46 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Demographic factors, Baseline health status, Prior Treatments, TREATMENT VARIABLES, Acute complications of treatment, Major surgery complications, Major interventional cardiology complications

CORONARY ARTERY DISEASE DATA COLLECTION Version 2.0.3 Revised: April 5th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Asymptomatic Coronary Artery Disease | Stable Angina | Acute Coronary Syndrome (Includes AMI) Treatment Approaches: Lifestyle Modification | Drug Therapy | Percutaneous Coronary Intervention (PCI) | Coronary Artery Bypass Grafting (CABG) This form contains peri-interventional clinical items. The items cover a timespan from prior to the intervention (e.g. PCI or CABG) until 30 days after it. They should be assessed at the entry event and at any new index event (e.g. new revascularization procedure or new diagnosis of ACS). Questionnaires used in this standard set: Rose Dyspnea Scale: The Rose Dyspnea Scale is free for all health care organizations, and a license is not needed. More information may be found at http://www.ahjonline.com/article/S0002-8703(09)00266-X/abstract Patient Health Questionnaire (PHQ-2): The PHQ-2 is free for all health care organizations, and a license is not needed. Copyright Pfizer, more Information on http://www.phqscreeners.com/ Seattle Angina Questionnaire (SAQ-7): Due to the need for a license for use of the SAQ-7 the actual questions of SAQ-7 will not be part of this version of the standard set. Publication: McNamara RL, Spatz ES, Kelley TA, et al. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). J Am Heart Assoc. 2015;4(5):e001767. Published 2015 May 19. doi:10.1161/JAHA.115.001767 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Clinical Dementia Rating (CDR)

- 20.04.20 - 1 Formular, 4 Itemgruppen, 18 Datenelemente, 2 Sprachen

Itemgruppen: Administrative Data, Clinical Dementia Rating (CDR), modified, Informant, Clinical Dementia Rating (CDR), modified, Subject, Clinical Dementia Rating (CDR), modified, summary

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Clinical Dementia Rating (CDR) form. It has to be filled in for baseline and for all follow-ups. Due to a necessary license agreement for use of the CDR, it will only be included as subscore/result items in this version of DELCODE forms. The respective score items will have a comment in their descriptions about this to distinguish them from score items that were already defined like that by DZNE. For more information see: https://otm.wustl.edu/for-industry/tools/cdr-licensing/