Search results - Portal of Medical Data Models (MDM-Portal)

dental examination SHIP-Trend-1 DEX: Chewing Gum Test Scan

- 1/24/21 - 1 form, 1 itemgroup, 5 items, 2 languages

Itemgroup: DEX: Chewing Gum Test Scan

DEX: Chewing Gum Test Scan form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.DEX.DEXCGT.DEXCGTSCAN. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

clinic internal medicine B SHIP-Trend-1 operational data lung function

- 1/24/21 - 1 form, 1 itemgroup, 58 items, 2 languages

Itemgroup: operational data lung function

operational data lung function form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.IMB.LUF.LUFOPD. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

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

- 4/30/20 - 1 form, 5 itemgroups, 17 items, 1 language

Itemgroups: 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

- 4/20/20 - 1 form, 5 itemgroups, 17 items, 1 language

Itemgroups: 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)

- 3/23/20 - 1 form, 2 itemgroups, 6 items, 1 language

Itemgroups: 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.

FHIR v4.0.1 - Resource Diagnostic Report (3)

- 3/12/20 - 1 form, 1 itemgroup, 11 items, 1 language

Itemgroup: Diagnostic Report

The form corresponds to an incomplete version of FHIR Resource DiagnosticReport, v4.0.1. It contains all data elements that query a medical issue. The file was created for analysis purposes. https://www.hl7.org/fhir/resourcelist.html 02.01.20

FHIR v4.0.1 - Resource Procedure (3)

- 3/10/20 - 1 form, 1 itemgroup, 18 items, 1 language

Itemgroup: Procedure

The form corresponds to an incomplete version of FHIR Resource Procedure, v4.0.1. It contains all data elements that query a medical issue. The file was created for analysis purposes. https://www.hl7.org/fhir/resourcelist.html 02.01.2020

Sentinel Common Data Model Procedure

- 8/25/19 - 1 form, 1 itemgroup, 8 items, 1 language

Itemgroup: Procedure

Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Procedure Table contains one record per unique combination of PatID, EncounterID, PX, and PX_CodeType. This table should capture all uniquely recorded procedures for all encounters.

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

- 4/28/19 - 1 form, 5 itemgroups, 11 items, 1 language

Itemgroups: 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

- 3/15/19 - 1 form, 2 itemgroups, 10 items, 1 language

Itemgroups: 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)

- 3/12/19 - 1 form, 7 itemgroups, 11 items, 1 language

Itemgroups: 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

- 8/27/18 - 1 form, 7 itemgroups, 51 items, 1 language

Itemgroups: 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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Selected data models