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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Biopsy Data: Portal Veins

- 20-11-18 - 1 Formulier, 3 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Liver Biopsy, I. Portal Veins
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Biopsy Diagnosis and Liver Architecture

- 20-11-18 - 1 Formulier, 4 Itemgroepen, 63 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Liver Biopsy, A. Final Diagnosis, B. Liver Architecture
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Estimation of Dose Proportionality of Darapladib - 107038 - Logs and Repeats: Adverse Event

- 13-11-18 - 1 Formulier, 1 Itemgroep, 17 Data-elementen, 1 Taal
Itemgroep: Adverse Events
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

MS CDE Diagnosis and Disease Characteristics Multiple Sclerosis - Diagnosis and Disease Characteristics

- 20-06-18 - 1 Formulier, 7 Itemgroepen, 61 Data-elementen, 1 Taal
Itemgroepen: Diagnosis; Disease Characteristics, Clinical Course MS, Clinical Course NMO, Clinical Course ADEM, Other Clinical Course, Diagnostic critera MS, Medical history disease onset
MS Common Data Elements, Multiple Sclerosis Diagnosis and Disease Characteristics for semantic analysis from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Swedish Stroke Registry RIKSSTROKE - TIA

- 29-11-17 - 1 Formulier, 7 Itemgroepen, 67 Data-elementen, 2 Talen
Itemgroepen: TIA - Patient Information, Sequence of care, Risk Factors TIA, Acute Care/Diagnosis TIA, Pharmaceutical Treatment, Information and Follow-up, ABCD2 score
Schwedisches Schlaganfallregister RIKSSTROKE Quelle: http://www.riksstroke.org/eng/ Riksstroke – a Swedish national quality register for stroke care primarily aimed at health professionals and decision makers in health care. We collect, analyze and follow-up data on morbidity and hospital stay. TIA

Problem/Diagnosis (EHR Archetype) - openEHR-EHR-EVALUATION.problem_diagnosis.v1

- 08-07-17 - 1 Formulier, 1 Itemgroep, 18 Data-elementen, 6 Talen
Itemgroep: openEHR-EHR-EVALUATION.problem_diagnosis.v1.xml
Derived from www.openehr.org . Use for recording details about a single, identified health problem or diagnosis. Clear definitions that enable differentiation between a 'problem' and a 'diagnosis' are almost impossible in practice - we cannot reliably tell when a problem should be regarded as a diagnosis. When diagnostic or classification criteria are successfully met, then we can confidently call the condition a formal diagnosis, but prior to these conditions being met and while there is supportive evidence available, it can also be valid to use the term 'diagnosis'. The amount of supportive evidence required for the label of diagnosis is not easy to define and in reality probably varies from condition to condition. Many standards committees have grappled with this definitional conundrum for years without clear resolution. For the purposes of clinical documentation with this archetype, problem and diagnosis are regarded as a continuum, with increasing levels of detail and supportive evidence usually providing weight towards the label of 'diagnosis'. In this archetype it is not neccessary to classify the condition as a 'problem' or 'diagnosis'. The data requirements to support documentation of either are identical, with additional data structure required to support inclusion of the evidence if and when it becomes available. Examples of problems include: the individual's expressed desire to lose weight, but without a formal diagnosis of Obesity; or a relationship problem with a family member. Examples of formal diagnoses would include a cancer that is supported by historical information, examination findings, histopathological findings, radiological findings and meets all requirements for known diagnostic criteria. In practice, most problems or diagnoses do not sit at either end of the problem-diagnosis spectrum, but somewhere in between. This archetype can be used within many contexts. For example, recording a problem or a clinical diagnosis during a clinical consultation; populating a persistent Problem List; or to provide a summary statement within a Discharge Summary document. In practice, clinicians use many context-specific qualifiers such as past/present, primary/secondary, active/inactive, admission/discharge etc. The contexts can be location-, specialisation-, episode- or workflow-specific, and these can cause confusion or even potential safety issues if perpetuated in Problem Lists or shared in documents that are outside of the original context. These qualifiers can be archetyped separately and included in the ‘Status’ slot, because their use varies in different settings. It is expected that these will be used mostly within the appropriate context and not shared out of that context without clear understanding of potential consequences. For example, a primary diagnosis to one clinician may be a secondary one to another specialist; an active problem can become inactive (or vice versa) and this can impact the safe use of clinical decision support. In general these qualifiers should be applied locally within the context of the clinical system, and in practice these statuses should be manually curated by clinicians to ensure that lists of Current/Past, Active/Inactive or Primary/Secondary Problems are clinically accurate. This archetype will be used as a component within the Problem Oriented Medical Record as described by Larry Weed. Additional archetypes, representing clinical concepts such as condition as an overarching organiser for diagnoses etc, will need to be developed to support this approach. In some situations, it may be assumed that identification of a diagnosis fits only within the expertise of physicians, but this is not the intent for this archetype. Diagnoses can be recorded using this archetype by any healthcare professional.

Patient diagnosis cardiac surgery UKM - Patient diagnosis

- 19-06-17 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 2 Talen
Itemgroepen: Patient demographics, Findings
Patient diagnosis form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Sven Martens.

Diagnosis Nuclear medicine UKM - Diagnosis

- 25-05-17 - 1 Formulier, 3 Itemgroepen, 38 Data-elementen, 2 Talen
Itemgroepen: Patient demographics, Befund, Medical history
Diagnosis form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Michael Schäfers

Efficacy and Safety Ropinirole in Patients Suffering from RLS GSK Study - RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

- 09-05-17 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Header module, CLINICAL INTERVIEW - WORKSHEET
RRL100013 12 Week, Double-Blind, Placebo Controlled, Twice Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Visit 1 Run-In Primary Diagnosis NCT01117584

- 28-01-17 - 1 Formulier, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: Medical Condition
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

University Hospital Essen Changing-History

- 17-01-17 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 1 Taal
Itemgroep: Default Itemgroup
Hospital routine documentation models at the University Hospital Essen. Tables were derived from the Medico Information System. Original table name: x1470elg

Psychiatric outpatient clinic UKM - Diagnosis form

- 05-01-17 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 2 Talen
Itemgroepen: Patient identification, Diagnosis
Diagnosis form outpatient clinic converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Volker Arolt.

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