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Pre-study PD medications GSK study Dyskinesia in Parkinson's disease NCT00363727

- 07.09.17 - 1 formulario, 3 itemgroups, 21 items, 1 idioma

Itemgroups: General information, Prior L-Dopa medication, Prior Parkinson's medication

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: Pre-study PD medications

Rotavirus Vaccine RIX4414 Study NCT00289172 - Visit 1

- 04.04.18 - 1 formulario, 12 itemgroups, 53 items, 1 idioma

Itemgroups: Header, Informed consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation/ Treatment Allocation, General Medical History / Physical Examination, General medical history / physical examination, Laboratory tests, Vaccine administration, Unsolicited Adverse Events

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 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 CRF Seiten: 375-430

German Hodgkin Study Group Study HD16/HD17/HD18 Anamnesis Report G6AN DRKS00003455 DRKS00003457 - Deutsche Hodgkin Studiengruppe: G6AN Anamnesebogen

- 01.11.18 - 1 formulario, 7 itemgroups, 48 items, 1 idioma

Itemgroups: Form Header, Patient complaints, Laboratory, Activity index, Concomitant diseases, Family medical history, Comments

HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de

Neurological History Cardiovascular Health Study (CHS)

- 13.04.21 - 1 formulario, 9 itemgroups, 191 items, 1 idioma

Itemgroups: Stroke, TIA, Sudden loss or change of speech, Sudden loss of vision, Double vision, Sudden numbness or tingling, Sudden paralysis or weakness, Dizziness or loss of balance, Date of interview

Documentation part: Record 22 Neurological History The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Medical Conditions

- 10.06.20 - 1 formulario, 2 itemgroups, 4 items, 1 idioma

Itemgroups: Administrative Data, Medical Conditions

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Medical Conditions Form is used to record current and past medical conditions at screening visit.

Ewing Study Medical History DRKS00003588 NCT00824083 - Anamnese Ewing Studie NCT00824083

- 27.06.15 - 1 formulario, 2 itemgroups, 14 items, 2 idiomas

Itemgroups: Allgemeine Anamnese, Time to diagnosis

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

On-Study - Baseline Medical/Surgical History - 2764025v1.0 - Baseline Medical/Surgical History

- 09.01.15 - 1 formulario, 3 itemgroups, 17 items, 1 idioma

Itemgroups: DCP Template Header, Baseline Medical/Surgical History, DCP Template Footer

The Division of Cancer Prevention's baseline medical/surgical history case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5199EB1D-38BD-6DDA-E044-0003BA3F9857

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Significant medical/surgical history, physical examination and medication

- 23.02.18 - 1 formulario, 6 itemgroups, 18 items, 1 idioma

Itemgroups: Medical/Surgical condition, Medical/Surgical condition, Prior and concomitant medication, Prior and concomitant medication, RLS Pharmacotherapy history, RLS Pharmacotherapy history

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - RLS history and diagnostic criteria

- 20.02.18 - 1 formulario, 3 itemgroups, 21 items, 1 idioma

Itemgroups: Administration, RLS Screen History, RLS Diagnostic Criteria

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Demography GSK study Chronic Coronary Heart Disease NCT00799903

- 12.12.17 - 1 formulario, 1 itemgroup, 18 items, 1 idioma

Itemgroup: Demography

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: Demography

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Medical history cognition 3 (Anamnese Kognition 3)

- 09.04.20 - 1 formulario, 2 itemgroups, 8 items, 1 idioma

Itemgroups: Administrative Data, Medical history cognition (supplementary information)

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 medical history cognition 3 form. It has to be filled in for Baseline and all Follow-ups. Note: The Form "Medical history cognition 1" has to be filled in with subject whereas the form "Medical history cognition 2" with the informant and the form "Medical history cognition 3" by the physician/ medical person.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Medical history cognition 1 (Anamnese Kognition 1)

- 09.04.20 - 1 formulario, 3 itemgroups, 44 items, 1 idioma

Itemgroups: Administrative Data, Medical history cognition (open initial question to subject), Medical history cognition (structured interview to cognitive disorders)

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 medical history cognition 1 form. It has to be filled in for Baseline and all Follow-ups. Note: The Form "Medical history cognition 1" has to be filled in with subject whereas the form "Medical history cognition 2" with the informant and the form "Medical history cognition 3" by the physician/ medical person.

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