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

- 20/09/2021 - 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

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

- 30/04/2020 - 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

- 20/04/2020 - 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

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

- 23/03/2020 - 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.

GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172 - Visit 3

- 28/04/2019 - 1 Formular, 5 Itemgruppen, 11 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Continuation status, Clinical Trials, Collection of blood specimen for laboratory procedure, Post-vaccination precautions, Gastroenteritis, Episode of, Body Height, Body Weight

Study ID: 103792 Clinical Study ID: 103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus

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

- 15/03/2019 - 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)

- 12/03/2019 - 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

- 27/08/2018 - 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

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Medical Procedures

- 03/11/2017 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache

Itemgruppe: Medical Procedures

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of 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: Requip Study Indication: Parkinson Disease Module: Medical Procedures

transition dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 16/08/2017 - 1 Formular, 2 Itemgruppen, 4 Datenelemente, 1 Sprache

Itemgruppen: administrative data, transition dyspnoea index

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

baseline dyspnoea index salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 08/08/2017 - 1 Formular, 11 Itemgruppen, 28 Datenelemente, 1 Sprache

Itemgruppen: administrative data, baseline dyspnoea index, job, housework, shopping, leisure activities, gardening, social participation, washing, dressing, at rest, other aspect, baseline dyspnoea index score, date

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

visit 1 (medical evaluation) salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 08/08/2017 - 1 Formular, 17 Itemgruppen, 47 Datenelemente, 1 Sprache

Itemgruppen: administrative data, demography, medical condition, tobacco use, COPD, oropharyngeal candidasis examination, Chest x-ray, modified medical research council dyspnoea scale, 12-lead ECG, pulmonary function testing, pulmonary funtion testing: FEV1, pulmonary function testing: FVC, pulmonary function testing: FEV1 /FVC ratio, fat free mass, laboratory blood, St. George's respiratory questionnaire, baseline dyspnoea index

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

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