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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - ITP Therapy, Medical/Surgical procedures

- 5/12/19 - 1 formulario, 3 itemgroups, 29 items, 1 idioma

Itemgroups: Administrative Data, Prior ITP Therapy, Medical/Surgical procedures

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the ITP Therapy and the Medical/Surgical procedures form. It has to be filled in if any ITP Therapy has been performed prior to or during the study or any Medical/Surgical procedures have been performed during the study.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Surgery / Invasive Procedure Information

- 20/10/20 - 1 formulario, 3 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative Data, Surgery or invasive procedure during clinical trial, Surgeries and invasive procedures

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 - See https://clinicaltrials.gov/ct2/show/NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. The Surgery / Invasive Procedure Information Form has to be filled in whenever the patient undergoes surgery or other invasive procedure during the study period.

AB MS PéD Neurologie MS University Hospital Muenster (UKM) Subform

- 26/11/16 - 1 formulario, 3 itemgroups, 29 items, 1 idioma

Itemgroups: General Information, Tube drain, General Information II

Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: AB MS PéD Neurologie.

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Subject Logs - Medical/ Surgical Procedures; Expanded/ Additional Pharmacogenetic Research Consent and Withdrawal

- 24/2/20 - 1 formulario, 3 itemgroups, 20 items, 1 idioma

Itemgroups: Medical/ Surgical Procedures, Expanded/ Additional Pharmacogenetic Research Consent, Expanded/ Additional Pharmacogenetic Research Withdrawal

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

AB MS PéD Allgemein MS University Hospital Muenster (UKM) Subform

- 26/11/16 - 1 formulario, 3 itemgroups, 31 items, 1 idioma

Itemgroups: General information section, Tube drain, General information section II

Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: AB MS PéD Allgemein.

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

- 20/5/20 - 1 formulario, 9 itemgroups, 28 items, 1 idioma

Itemgroups: Administrative, Significant Medical/ Surgical History (Period 1 Day -1), Significant Medical/ Surgical History (Period 2 Day -1), Significant Medical/ Surgical History , Physical Examination (Period 1 Day -1), Physical Examination (Period 2 Day -1), Physical Examination (Follow-Up) , Physical Examination - Investigator's Signature, Pregnancy Test (Females only)

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 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

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

- 30/4/20 - 1 formulario, 5 itemgroups, 17 items, 1 idioma

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

- 20/4/20 - 1 formulario, 5 itemgroups, 17 items, 1 idioma

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

Record description central archive of perioperative data (Zapod) - procedure - Record description central archive of perioperative data-procedures

- 23/6/16 - 1 formulario, 1 itemgroup, 40 items, 1 idioma

Itemgroup: Surgical procedure

Source: Project central archive of perioperative Data (ZaPoD) of the German Society of Anesthesiology and Intensive Care Medicine (DGAI). Project lead: PD Dr. Sven Zenker, http://amp.uni-bonn.de

Procedure (EHR Archetype) - openEHR-EHR-ACTION.procedure.v1

- 8/7/17 - 1 formulario, 1 itemgroup, 24 items, 7 idiomas

Itemgroup: openEHR-EHR-ACTION.procedure.v1.xml

Derived from www.openehr.org . Use to record information about the activities required to carry out a procedure, including the planning, scheduling, performance, suspension, cancellation, documentation and completion. This is done by the recording of data against specific activities, as defined by the 'Pathway' careflow steps in this archetype. The scope of this archetype encompasses activities for a broad range of clinical procedures performed for evaluative, investigative, screening, diagnostic, curative, therapeutic or palliative purposes. Examples range from the relatively simple activities, such as insertion of an intravenous cannula, through to complex surgical operations. Additional structured and detailed information about the procedure can be captured using purpose-specific archetypes inserted into the 'Procedure detail' slot, where required. Timings related to a procedure can be managed in one of two ways: - Using the reference model - the time for performance of any pathway step will use the ACTION time attribute for each step. - Archetyped data elements: --- the 'Scheduled date/time' data element is intended to record the precise time when the procedure is planned. Note: the corresponding ACTION time attribute for the Scheduled pathway step will record the time that the procedure was scheduled into a system, not the intended date/time on which the procedure is intended to be carried out; and --- the 'Final end date/time' is intended to record the precise time when the procedure was ended. It can be used to document the complex procedures with multiple components. Note: the corresponding ACTION time attribute for the 'Procedure performed' will document the time each component performed was commenced. This 'Final end date/time' data element will record the date/time of the final active component of the procedure. This will enable a full duration of the active procedure to be calculated. Within the context of an Operation Report, this archetype will be used to record only what was done during the procedure. Separate archetypes will be used to record the other required components of the Operation Report, including the taking of tissue specimen samples, use of imaging guidance, operation findings, post-operative instructions and plans for follow up. Within the context of a Problem list or summary, this archetype may be used to represent procedures that have been performed. The EVALUATION.problem_diagnosis will be used to represent the patient's problems and diagnoses. In practice, many procedures (for example, in ambulatory care) will occur once and not be ordered in advance. The details about the procedure will be added against the pathway step, 'Procedure completed'. In some cases a recurring procedure will be ordered, and in this situation data against the 'Procedure performed' step will be recorded on each occasion, leaving the instruction in the active state. When the last occurrence is recorded the 'Procedure completed' action is recorded showing that this order is now in the completed state. In other situations, such as secondary care, there may be a formal order for a procedure using a corresponding INSTRUCTION archetype. This ACTION archetype can then be used to record the workflow of when and how the order has been carried out. Recording information using this ACTION archetype indicates that some sort of activity has actually occurred; this will usually be the procedure itself but may be a failed attempt or another activity such as postponing the procedure. If there is a formal order for the procedure, the state of this order is represented by the Pathway step against which the data is recorded. For example, using this archetype the progressing state of a Gastroscopy order may be recorded through separate entries in the EHR progress notes at each 'Pathway' step: - record the scheduled Start date/time for the gastroscopy (Procedure scheduled); and - record that the gastroscopy procedure has been completed, including information about the procedure details (Procedure completed). Please note that in the openEHR Reference Model there is a 'Time' attribute, which is intended to record the date and time at which each pathway step of the Action was performed. This is the attribute to use to record the start of the procedure (using the 'Procedure performed' pathway step) or the time that the procedure was aborted (using the 'Procedure aborted' pathway step).

OP MS URO Sub MS University Hospital Muenster (UKM) Subform

- 27/11/16 - 1 formulario, 1 itemgroup, 15 items, 1 idioma

Itemgroup: Urology | Operative Surgical Procedures

Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: OP MS URO Sub .

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