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Emergency MS Outpatient Department Neurology University Hospital Essen - Emergency

- 27.03.17 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache

Itemgruppe: Emergency

Documentation form "Notfall" converted to ODM format. Routine documentation of University Hospital of Essen. Publication granted by: Priv.-Doz. Dr. med. Benedikt, University Hospital of Essen, Essen, Germany.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Cumulative documentation - Procedures (Kumulative Dokumentation - Prozeduren)

- 23.03.20 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Procedures

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 cumulative documentation - procedures. Prior procedures should be filled in at baseline. Procedures that are performed during the study period should be added in the course of the study.

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

- 20.09.21 - 1 Formular, 20 Itemgruppen, 378 Datenelemente, 1 Sprache

Itemgruppen: 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

FEES Neurology, University Hospital Cologne

- 20.04.17 - 1 Formular, 4 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: FEES, FEES at rest, Evaluation of swallowing without food, Evaluation of swallowing with food

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

BE MS Neuro USD LSTM Sub MS University Hospital Muenster (UKM) Subform

- 27.11.16 - 1 Formular, 1 Itemgruppe, 21 Datenelemente, 1 Sprache

Itemgruppe: General information section

Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: BE MS Neuro USD LSTM Sub.

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination

- 30.04.20 - 1 Formular, 5 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Demography, RLS Diagnostic Criteria, Significant Medical / Surgical History and Physical Examination, Significant Medical / Surgical History and Physical Examination

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination

- 20.04.20 - 1 Formular, 5 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Demography, RLS Diagnostic Criteria, Significant Medical / Surgical History and Physical Examination, Significant Medical / Surgical History and Physical Examination

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192 - Medical Procedures

- 15.03.19 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Medical Procedures

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the medical procedure form. It has to be filled in for each visit.

Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192 - Checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion)

- 12.03.19 - 1 Formular, 7 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Concomitant Medication, Medical Procedure, RLS Rating Scales, Adverse Experiences, Clinical Global Impression, Exclusion Criterion

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion) form. Exclusion criterion has to be filled in only for baseline. RLS Rating and CGI Rating have to be checked for each visit. Medical procedure, concomitant medication and adverse experience have to be checked for: Screening/Baseline, Day 2, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 52, Early withdrawal and Follow-up

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Non- Serious and Serious Adverse Event

- 27.08.18 - 1 Formular, 7 Itemgruppen, 51 Datenelemente, 1 Sprache

Itemgruppen: Non-serious Adverse Event, Serious Adverse Event, Pharmaceutical Preparations | Concomitant Therapy, Disease | risk factors, diagnostic procedure; Result, Experimental drug, Comment

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

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