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Valda datamodeller

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- 2017-11-14 - 1 Formulär, 10 Item-grupper, 71 Dataelement, 2 Språk
Item-grupper: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
- 2017-06-04 - 1 Formulär, 3 Item-grupper, 33 Dataelement, 2 Språk
Item-grupper: Maternal Family History, Paternal Family History, Siblings Family History
- 2018-06-20 - 1 Formulär, 4 Item-grupper, 13 Dataelement, 3 Språk
Item-grupper: General information, High Blood Pressure, Appendectomy, Other
- 2017-02-10 - 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
- 2014-05-21 - 1 Formulär, 13 Item-grupper, 111 Dataelement, 2 Språk
- 2019-11-10 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: Administrative Data, Medical Conditions
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on Identifier: NCT00992160 Links: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). The purpose of this form is to record the subjects current medical conditions and should be filled out at Visit 1 (Screening) and Visit 2.