Resultados de la búsqueda - Portal de Modelos de Datos Médicos (MDM-Portal)

ICHOM Macular Degeneration - Each Clinical Visit - Clinical Form

- 30/4/20 - 1 formulario, 8 itemgroups, 35 items, 1 idioma

Itemgroups: Administrative Data, Clinical status, Other ocular treatments, Treatment variables, Burden of treatment, Complications of treatment, Disease activity, Visual functioning and health related quality of life

ICHOM Macular Degeneration - Annually - Clinical Form

- 30/4/20 - 1 formulario, 2 itemgroups, 8 items, 1 idioma

Itemgroups: Administrative Data, Medical History

ICHOM Macular Degeneration data collection Version 3.0.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Annually - Clinical Form. It has to be filled in annually from baseline. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Macular Degeneration - Baseline - Patient-reported

- 30/4/20 - 1 formulario, 3 itemgroups, 4 items, 1 idioma

Itemgroups: Administrative Data, Demographics, Visual functioning and health related quality of life

ICHOM Macular Degeneration data collection Version 3.0.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Macular Degeneration, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Neovascular Macular Degeneration Neovascular Age Related Macular Degeneration | Polypoidal Choroidal Vasculopathy | Myopic Neovascular Macular Degeneration | Other Forms of Neovascular Macular Degeneration (includes Post-Traumatic, Inflammatory, Idiopathic, Macular Telangiectasia Type 2) Non-Neovascular Age Related Macular Degeneration Treatment approaches: Intravitreal anti-VEGF treatment | Other intravitreal treatment | Photodynamic therapy | Thermal laser photocoagulation | Retinal radiation therapy | Transpupillary thermotherapy | Retinal surgical treatment This document contains the Baseline - Patient-reported form. It has to be filled in at Patient's entrance into outcome tracking system for Macular Degeneration. Collecting Patient-Reported Outcome Measure: Brief Impact of Vision Impairment Questionnaire (Brief IVI): The Brief IVI includes costs for commercial use, and requires an agreement license. Therefore this questionnaire is not included in this Version of the standard set. Reference: Rodrigues IA, Sprinkhuizen SM, Barthelmes D, et al. Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration. American Journal of Opthalmology. 2016;168:1–12. doi: 10.1016/j.ajo.2016.04.012 The Standard set of ICHOM was supported by the WillsEye Hospital (America’s First World’s Best), Retina Suisse, St. Erik Eye Hospital, Macular Society, The Retina Society, Save sight Institute and The Macula Foundation (Preserving and Restoring Vision). For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Cataracts - Patient-Reported Visual Function (pre- and post-operative)

- 30/4/20 - 1 formulario, 2 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative Data, Patient-reported visual function

CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 2017, International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. By Mats Lundström This ODM-file contains pre- and post-operative patient froms. To be filled in by patient prior to and within 3 months after surgery. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Cataracts - Post-operative Clinical Form - Outcomes

- 30/4/20 - 1 formulario, 3 itemgroups, 16 items, 1 idioma

Itemgroups: Administrative Data, Post-operative visual status, Post-operative complications

CATARACTS DATA COLLECTION Version 2.0.1 Revised: March 8th, 2017, International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Symptomatic Cataract | Asymptomatic Cataract Treatment Approaches: Phacoemulsification | Sutured Extracapsular Cataract Extraction | Sutureless Extracapsular Cataract Extraction | Intracapsular Cataract Extraction Scores: Catquest-9SF - The Catquest-9SF is free for all health care organizations, and a license is not needed for use. By Mats Lundström et al. This ODM-file contains the post-operative clinical form. The items are to be filled in with clinical or administrative data, collected within three months after cataract surgery. Publication: Mahmud I, Kelley T, Stowell C, et al. A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery. JAMA Ophthalmol. 2015;133(11):1247–1252. doi:10.1001/jamaophthalmol.2015.2810 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Diabetic Retinopathy NCT02232503

- 21/11/19 - 1 formulario, 2 itemgroups, 11 items, 1 idioma

Itemgroups: Inclusion Criteria, Exclusion Criteria

Prevalence of DIAbetic RETinopathy and Impact of Genetic Factors in the Development of Diabetic Retinopathy of Patients With Type 1 and 2 Diabetes Mellitus in SlovaKia; ODM derived from: https://clinicaltrials.gov/show/NCT02232503

Eligibility Diabetic Retinopathy NCT01746563

- 21/11/19 - 1 formulario, 2 itemgroups, 15 items, 1 idioma

Itemgroups: Inclusion Criteria, Exclusion Criteria

Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy; ODM derived from: https://clinicaltrials.gov/show/NCT01746563

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) - Formulär 1: Basregistret för 2018 års kataraktoperationer (Base register for 2018 cataract surgeries)

- 16/1/19 - 1 formulario, 16 itemgroups, 43 items, 2 idiomas

Itemgroups: Hospital Number, Person Number, Eye to be operated, Preoperative visual acuity, NIKE Indication group, Waiting list entry, Date of surgery, Ocular Comorbidities in eye to be operated, Type of Surgery, Material of Lens, Special Properties of lens, peroperative difficulties, intracameral Antibiotics, Peroperative damage posterior capsule or zonule, Postoperative prophylaxis of inflammation, Surgeon's signature

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) Head of Registry: Anders Behndig, Professor, Norrland University Hospital, Umeå, Sweden. Adress of Registry: Nationella Kataraktregistret Landstinget Blekinge 371 81 KARLSKRONA Sweden Source: http://rcsyd.se/kataraktreg/registrering/formular-nationella-kataraktregistret This ODM-File is derived from "Formulär 1: Basregistret för 2018 års kataraktoperationer" (Base register for cataract surgeries of the year 2018). To be filled separately for each eye (even if bilateral surgery on the same day). English translation not validated.

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) - Formulär 2A: 2018 års kataraktregistrering - Uppföljningsformulär (Follow-up Form for registering of cataracs in 2018, Part A)

- 9/7/18 - 2 formularios, 8 itemgroups, 17 items, 2 idiomas

Itemgroups: Administrative Data, Hospital number, Eye, Person Identifier, Preoperative K-value, Planned refraktion, Axis length, Lens formula

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) Head of Registry: Anders Behndig, Professor, Norrland University Hospital, Umeå, Sweden. Adress of Registry: Nationella Kataraktregistret Landstinget Blekinge 371 81 KARLSKRONA Sweden Source: http://rcsyd.se/kataraktreg/registrering/formular-nationella-kataraktregistret This ODM-File is derived from "Formulär 2A/B: 2018 års kataraktregistrering - Uppföljningsformulär" (Follow-up Form for registering of cataracs in 2018). Part A to be filled after surgery, Part B to be filled when medical checks after the current cataract surgery are not longer needed and glasses can be prescribed, but not later than 3 months after surgery. In practice, the end date is between 6 weeks and 3 months after surgery depending on type of cataract surgery and postoperative course. Attention: All varibales are mandatory. English translation not validated.

Formulär 2B: 2018 års kataraktregistrering - Uppföljningsformulär (Follow-up Form for registering of cataracs in 2018, Part B)

6 itemgroups 23 items

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) - Formulär 3A: 2018 års Endoftalmit-Uppföljning (Follow-up Form for Endophthalmitis in 2018, Part A)

- 9/7/18 - 2 formularios, 7 itemgroups, 7 items, 2 idiomas

Itemgroups: Name, Hospital number, Person number, Endophthalmitis diagnosed, Eye, Culture, Responsible physician

Swedish National Quality Registry for Cataracts (NCR Nationella Kataraktregistret) Head of Registry: Anders Behndig, Professor, Norrland University Hospital, Umeå, Sweden. Adress of Registry: Nationella Kataraktregistret Landstinget Blekinge 371 81 KARLSKRONA Sweden Source: http://rcsyd.se/kataraktreg/registrering/formular-nationella-kataraktregistret This ODM-File is derived from "Formulär 3A/B: 2018 års Endoftalmit-uppföjning" (Follow-up Form for Endophthalmitis in 2018). To be filled in case of endophthalmitis after cataract surgery. English translation not validated.

Formulär 3B: 2018 års Endoftalmit-Uppföljning (Follow-up Form for Endophthalmitis in 2018, Part B)

7 itemgroups 22 items

Administrative Data 2 Pazopanib Macular Degeneration MD1103367 - Administrative Data 2

- 2/7/18 - 1 formulario, 4 itemgroups, 6 items, 1 idioma

Itemgroups: Randomisation number, Regimen, Subject number, Investigational product dose

Study part: Administrative Data 2 (RANDOMISATION NUMBER (Rand), REGIMEN (Regimen)- Day 1,SUBJECT IDENTIFICATION (Subj ID),INVESTIGATIONAL PRODUCT (Dose) – Day 1-14 ). A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

PGx- Pharmacogenetic Pazopanib Macular Degeneration MD1103367 - PGx- Pharmacogenetic

- 2/7/18 - 1 formulario, 2 itemgroups, 10 items, 1 idioma

Itemgroups: Pharmacogenetic; consent, consent withdrawal; pharmacogenetic

Study part: PGx- Pharmacogenetic. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

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