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MARS - Muenster Aging and Retina study Age-related macular degeneration - B. Eye diseases

- 2021-09-20 - 17 Formulär, 1 Item-grupp, 83 Dataelement, 1 Språk
Item-grupp: Eye disease
Age-related macular degeneration (AMD) is a retinal degenerative disease that occurs at an advanced age and is the major cause of central visual acuity loss and old-age blindness in its final stages. The aim of the MARS study is to identify factors that influence the progression and course of age-related macular degeneration in a prospective study. To date, the following studies have been carried out on the MARS cohort: MARS-I: 2001-2003; MARS-II: 2004 - 2007; MARS-III: 2007-2009; MARS +: 2010/11. The study is provided by Prof. Dr. Hense, Institute of Epidemiology and Social medicine, University Clinic of Muenster.

Administrative documentation

1 Item-grupp 16 Dataelement

A. Self-assessment of visual acuity

1 Item-grupp 9 Dataelement

Interview

1 Item-grupp 5 Dataelement

D. Slit lamp biomicroscopy I

1 Item-grupp 18 Dataelement

H.Quality of Life

1 Item-grupp 24 Dataelement

I. Family History

1 Item-grupp 21 Dataelement

dgGaP phs000001.v3.p1 NEI Age-Related Eye Disease Study (AREDS) - pht000370.v2.p1

- 2022-10-12 - 19 Formulär, 1 Item-grupp, 12 Dataelement, 1 Språk
Item-grupp: pht000370.v2.p1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000001.v3.p1 The Age-Related Eye Disease Study (AREDS) was initially designed as a long-term multi-center, prospective study of the clinical course of age-related macular degeneration (AMD) and age-related cataract. In addition to collecting natural history data, AREDS included a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. AREDS participants were 55 to 80 years of age at enrollment and had to be free of any illness or condition that would make long-term follow-up or compliance with study medications unlikely or difficult. On the basis of fundus photographs graded by a central reading center, best-corrected visual acuity and ophthalmologic evaluations, 4,757 participants were enrolled in one of several AMD categories, including persons with no AMD. The clinical trials for AMD and cataract were conducted concurrently. AREDS participants were followed on the clinical trials for a median time of 6.5 years. Subsequent to the conclusion of the clinical trials, participants were followed for an additional 5 years and natural history data were collected. The AREDS research design is detailed in AREDS Report 1. AREDS Report 8 contains the mainline results from the AMD trial; AREDS Report 9 contains the results of the cataract trial. Blood samples were also collected from 3,700+ AREDS participants for genetic research. Genetic samples from 600 AREDS participants (200 controls, 200 Neovascular AMD cases, and 200 Geographic Atrophy cases) were selected using data available in March 2005 and then were evaluated with a genome-wide scan. These data, as well as selected phenotypic data, were made available in the dbGaP. DNA from AREDS participants, which is currently being stored in the AREDS Genetic Repository, is available for research purposes. However, not all of the 3,700+ AREDS participants who submitted a blood sample currently have DNA available. In addition to including the data from the genome-wide scan on the 600 original samples, this second version of the AREDS dbGaP database provides a comprehensive set of data tables with extensive clinical information collected for the 4,757 participants who participated in AREDS. The tables include information collected at enrollment/baseline, during study follow-up, fundus and lens pathology, nutritional estimates, quality of life measures and measures of morbidity and mortality. In November 2010, over 72,000 high quality fundus and lens photographs from 595 AREDS participants (of the original 600 selected for the genome-wide scan) were made available in the AREDS dbGaP. In addition to the genome-wide scan data, the fundus and lens grading data for these participants are also available in the AREDS dbGaP. Details about the ocular photographs that are available are found here. In January 2012, a measure of daily sunlight exposure was added in a separate "sunlight" table. Furthermore, the "followup" table has been revised. The visual acuity for the right eye was inadvertently missing at odd-numbered visits (01, 03, 05, etc.). This data is now part of the table. It is hoped that this resource will better help researchers understand two important diseases that affect an aging population. These data may be applied to examination and inference on genetic and genetic-environmental bases for age-related diseases of public health significance and may also help elucidate the clinical course of both conditions, generate hypotheses, and aid in the design of clinical trials of preventive interventions. *Definitions of Final AMD Phenotype Categories* Please see phd001138.1 for a detailed description of how AREDS participants' final AMD phenotype was categorized. *User's Guide for AREDS Phenotype Data* A detailed User's Guide for the AREDS phenotype data is available. This *User's Guide* is meant to be a comprehensive document which explains the complexities of the AREDS data. *It is recommended that all researchers using AREDS phenotype data make use of this User's Guide*.

pht000371.v2.p1

1 Item-grupp 25 Dataelement

pht000001.v2.p1

1 Item-grupp 142 Dataelement

pht000372.v2.p1

1 Item-grupp 56 Dataelement

pht000379.v2.p1

1 Item-grupp 21 Dataelement

pht000380.v2.p1

1 Item-grupp 7 Dataelement

pht000381.v2.p1

1 Item-grupp 44 Dataelement

44965_dbGaP phs000001 NEI Age-Related Eye Disease Study (AREDS) - pht000378.v2.p1

- 2022-10-12 - 19 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: pht000378
Principal Investigator: Susan B. Bressler, MD, Wilmer Eye Institute, The Johns Hopkins Medical Institutions, Baltimore, MD MeSH: Macular Degeneration,Cataract https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000001 The Age-Related Eye Disease Study (AREDS) was initially designed as a long-term multi-center, prospective study of the clinical course of age-related macular degeneration (AMD) and age-related cataract. In addition to collecting natural history data, AREDS included a clinical trial of high-dose vitamin and mineral supplements for AMD and a clinical trial of high-dose vitamin supplements for cataract. AREDS participants were 55 to 80 years of age at enrollment and had to be free of any illness or condition that would make long-term follow-up or compliance with study medications unlikely or difficult. On the basis of fundus photographs graded by a central reading center, best-corrected visual acuity and ophthalmologic evaluations, 4,757 participants were enrolled in one of several AMD categories, including persons with no AMD. The clinical trials for AMD and cataract were conducted concurrently. AREDS participants were followed on the clinical trials for a median time of 6.5 years. Subsequent to the conclusion of the clinical trials, participants were followed for an additional 5 years and natural history data were collected. The AREDS research design is detailed in AREDS Report 1. AREDS Report 8 contains the mainline results from the AMD trial; AREDS Report 9 contains the results of the cataract trial. Blood samples were also collected from 3,700+ AREDS participants for genetic research. Genetic samples from 600 AREDS participants (200 controls, 200 Neovascular AMD cases, and 200 Geographic Atrophy cases) were selected using data available in March 2005 and then were evaluated with a genome-wide scan. These data, as well as selected phenotypic data, were made available in the dbGaP. DNA from AREDS participants, which is currently being stored in the AREDS Genetic Repository, is available for research purposes. However, not all of the 3,700+ AREDS participants who submitted a blood sample currently have DNA available. In addition to including the data from the genome-wide scan on the 600 original samples, this second version of the AREDS dbGaP database provides a comprehensive set of data tables with extensive clinical information collected for the 4,757 participants who participated in AREDS. The tables include information collected at enrollment/baseline, during study follow-up, fundus and lens pathology, nutritional estimates, quality of life measures and measures of morbidity and mortality. In November 2010, over 72,000 high quality fundus and lens photographs from 595 AREDS participants (of the original 600 selected for the genome-wide scan) were made available in the AREDS dbGaP. In addition to the genome-wide scan data, the fundus and lens grading data for these participants are also available in the AREDS dbGaP. Details about the ocular photographs that are available are found here. In January 2012, a measure of daily sunlight exposure was added in a separate "sunlight" table. Furthermore, the "followup" table has been revised. The visual acuity for the right eye was inadvertently missing at odd-numbered visits (01, 03, 05, etc.). This data is now part of the table. It is hoped that this resource will better help researchers understand two important diseases that affect an aging population. These data may be applied to examination and inference on genetic and genetic-environmental bases for age-related diseases of public health significance and may also help elucidate the clinical course of both conditions, generate hypotheses, and aid in the design of clinical trials of preventive interventions. *Definitions of Final AMD Phenotype Categories* Please see phd001138.1 for a detailed description of how AREDS participants' final AMD phenotype was categorized. *User's Guide for AREDS Phenotype Data* A detailed User's Guide for the AREDS phenotype data is available. This *User's Guide* is meant to be a comprehensive document which explains the complexities of the AREDS data. *It is recommended that all researchers using AREDS phenotype data make use of this User's Guide*.

pht000379.v2.p1

1 Item-grupp 21 Dataelement

pht000380.v2.p1

1 Item-grupp 7 Dataelement

pht000381.v2.p1

1 Item-grupp 44 Dataelement

pht000382.v2.p1

1 Item-grupp 16 Dataelement

pht002478.v1.p1

1 Item-grupp 6 Dataelement

pht002477.v1.p1

1 Item-grupp 2 Dataelement

Personal and Family History of Eye Disease and Treatments Protocol PhenX Toolkit

- 2017-09-27 - 1 Formulär, 1 Item-grupp, 23 Dataelement, 1 Språk
Item-grupp: PhenX - personal and family history of eye disease and treatments protocol
Questions are asked to determine personal and family history of glaucoma, macular degeneration, cataract, and diabetic retinopathy. Questions are also asked to determine the participant’s history of laser and/or eye surgery for cataract, glaucoma and diabetic retinopathy. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

LASER ADMINISTRATION FELLOW EYE (UNSCHEDULED) CRFs Roche FVF4170G Macular Edema NCT00473382

- 2017-06-28 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Patient administration, LASER ADMINISTRATION STUDY EYE
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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

- 2018-07-09 - 2 Formulär, 6 Item-grupper, 23 Dataelement, 2 Språk
Item-grupper: Follow-up status, Final control, Visual Acuity right eye, Visual Acuity left eye, Conditions of operated eye, Responsible Physician for final follow-up
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 2A: 2018 års kataraktregistrering - Uppföljningsformulär (Follow-up Form for registering of cataracs in 2018, Part A)

8 Item-grupper 17 Dataelement

Study Eye Selection Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Study Eye Selection Screening

- 2018-03-18 - 1 Formulär, 1 Item-grupp, 7 Dataelement, 1 Språk
Item-grupp: study eye
Study part: Study Eye Selection Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Study Eye Selection Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g - Study Eye Selection Screening

- 2018-03-20 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: study eye
Study part: Study Eye Selection Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Study Eye Selection Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Study Eye Selection Screening

- 2018-03-21 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: study eye
Study part: Study Eye Selection Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

STUDY EYE SELECTION (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

- 2017-06-08 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: Patient administration, Eligibility Criteria
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

LASER ADMINISTRATION STUDY EYE (UNSCHEDULED) CRFs Roche FVF4168G Macular Edema NCT00473330

- 2017-06-28 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Patient administration, LASER ADMINISTRATION STUDY EYE
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

ICHOM Cataracts - Post-operative Clinical Form - Outcomes

- 2020-04-30 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: 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.

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