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Study SHIP-START_SHIP2_DER - s2.cvifot1

- 26/10/24 - 21 Formulär, 1 Item-grupp, 10 Dataelement, 2 Språk
Item-grupp: s2.cvifot1
SHIP Study https://doi.org/10.1093/ije/dyac034

s2.cvibes

1 Item-grupp 38 Dataelement

s2.melder

1 Item-grupp 42 Dataelement

s2.meltyp

1 Item-grupp 10 Dataelement

s2.duppid

1 Item-grupp 9 Dataelement

s2.intpid

1 Item-grupp 11 Dataelement

s2.cviklk

1 Item-grupp 11 Dataelement

On-Study - PHYSICAL EXAM - 2407645v1.0 - PHYSICAL EXAM

- 20/9/21 - 1 Formulär, 2 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: PHYSICAL EXAM, COMMENTS
Physical Exam form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01603C3C-DD2D-4BA2-E044-0003BA3F9857

On-Study - PHYSICAL EXAM SCREEN - 2390964v1.0 - PHYSICAL EXAM SCREEN

- 20/9/21 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: PHYSICAL EXAM--SCREENING, COMMENTS
Physical Exam Screening form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FEF2E3DC-3E2D-329B-E034-0003BA3F9857

On-Study - Physical Exam (continued) - 2803398v1.0 - Physical Exam (continued)

- 9/1/15 - 1 Formulär, 3 Item-grupper, 14 Dataelement, 1 Språk
Item-grupper: DCP Template Header, Baseline Medical/Surgical History (continued), DCP Template Footer
The Division of Cancer Prevention's physical exam (continued) case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C120DDA-54D8-39FD-E044-0003BA3F9857

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 10/2/17 - 1 Formulär, 13 Item-grupper, 122 Dataelement, 1 Språk
Item-grupper: Demographics, Diagnoses and Procedures, Vital Signs, Laboratory, Generic Laboratory Data, Medication, Adverse Events, Medical History, Clinical Findings, ECG, Patient Reported Outcome, Substance Use, Study Participation Status
Compilation of Feasibility, Patient Identification & Recruitment and Clinical Trial Execution data inventories. https://www.ncbi.nlm.nih.gov/pubmed/24410735 https://www.ncbi.nlm.nih.gov/pubmed/25991199 https://www.ncbi.nlm.nih.gov/pubmed/27875988

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Physical Examination

- 10/6/20 - 1 Formulär, 2 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Administrative Data, Physical Examination
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 Physical Examination Form is used to record the physical examination at screening visit.

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19/2/22 - 1 Formulär, 10 Item-grupper, 33 Dataelement, 1 Språk
Item-grupper: Subject Identification, Vital Signs, Physical examination, EDSS, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Premature Study Withdrawal Visit

Physical Exam Cardiovascular Health Study (CHS)

- 19/7/16 - 1 Formulär, 6 Item-grupper, 42 Dataelement, 1 Språk
Item-grupper: Measured Walk, Grip Strength, General Physical Examination, Chair stands, Other physical findings/comments, Date of interview
Documentation part: Record 17 Physical Exam 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.

Present aftercare Physician’s questionnaire for aftercare ABC study - Present aftercare Physician’s questionnaire for aftercare

- 20/9/21 - 1 Formulär, 11 Item-grupper, 99 Dataelement, 1 Språk
Item-grupper: Administrative, Medical Examination, Medical consultation, laboratory tests, Aftercare, medical consultation early cancer prevention, vaccination status, cardiovascular risk factor, Rehabilitation measures, Physical therapy, Medication
Study part: Present aftercare Physician’s questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

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

- 23/2/18 - 1 Formulär, 6 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: 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 Demographics and Examination Procedure

- 20/2/18 - 1 Formulär, 6 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Demography, Vital signs, Orthostatic vital signs, Electrocardiogram (12 lead), Laboratory evaluation, Pregnancy Dipstick
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)

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

- 8/9/17 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: General information, Dyskinesia
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: Dyskinesias.

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