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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

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

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.

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/

PDQ39 - Questionnaire GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08.09.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: General information, Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
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: PDQ39 - Questionnaire.

Beck Depression Inventory GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08.09.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: General information, Beck Depression Inventory
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: Beck Depression Inventory.

CGI-S Questionnaire GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08.09.17 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: General information, Clinical Global Impression
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: CGI-S Questionnaire.

CGI-I Questionnaire GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08.09.17 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: General information, Clinical Global Impression
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: CGI-I Questionnaire.

UPDRS Part V GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08.09.17 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache
Itemgruppen: General information, Modified Hoehn and Yahr Parkinson's Disease Staging
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 Study part: UPDRS Part V.

Patient Administration Intermittent Prone Positioning Posttraumatic Lung Injury Study

- 25.09.16 - 1 Formular, 6 Itemgruppen, 38 Datenelemente, 2 Sprachen
Itemgruppen: Patient identification, Patient administration, Inclusion criteria, Exclusion criteria, Prognostic factors, Randomization
Intermittent prone positioning in the treatment of severe and moderate posttraumatic lung injury (1999). Background: Severe posttraumatic lung injury is characterized by impairment of gas exchange and pulmonary densities. The influence of intermittent prone positioning on pulmonary gas exchange and parenchymal densities was investigated prospectively in patients with pulmonary injury after multiple trauma with blunt chest trauma. Publication granted by Claudia Ose, ZKS UK Essen. Multizentrische prospektive randomisierte Studie zur Überprüfung der prognostischen und therapeutischen Effektivität der dorsoventralen Wechsellagerung bei Patienten mit posttraumatischem akutem Lungenversagen. Freigegeben durch Frau Claudia Ose, ZKS Essen.

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