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NINDS CDE Headache Mail Questionnaire - Headache Mail Questionnaire

- 23/4/19 - 1 formulario, 1 itemgroup, 86 items, 1 idioma
Itemgroup: Headache Mail Questionnaire
NINDS Common Data Elements (Headache Mail Questionnaire) Used 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.

NINDS CDE Headache Diagnosis - Headache Diagnosis

- 15/6/16 - 1 formulario, 3 itemgroups, 26 items, 1 idioma
Itemgroups: Demographics, Headache Diagnosis, Additional Pediatric-specific Elements
NINDS Common Data Elements (Headache Diagnosis; Headache) Used 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.

NINDS CDE Pregnancy Information Headache - Pregnancy Information

- 15/6/16 - 1 formulario, 4 itemgroups, 32 items, 1 idioma
Itemgroups: Demographics, Pregnancy Information, Current Pregnancy, Pregnancy History
NINDS Common Data Elements (Pregnancy Information; Headache) Used 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.

NINDS CDE Pregnancy Outcome Headache - Pregnancy Outcome

- 15/6/16 - 1 formulario, 3 itemgroups, 40 items, 1 idioma
Itemgroups: Demographics, Pregnancy History, Details of Most Recent Live Birth
NINDS Common Data Elements (Pregnancy Outcome; Headache) Used 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.

NINDS CDE General Health History Headache - General Health History

- 1/6/16 - 1 formulario, 1 itemgroup, 552 items, 1 idioma
Itemgroup: Medical and Family History
NINDS Common Data Elements (General Health History; Headache) Used 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.

NINDS CDE Symptoms, Frequency and Severity - Headache - Symptoms, Frequency and Severity - Baseline

- 15/6/16 - 1 formulario, 2 itemgroups, 27 items, 1 idioma
Itemgroups: Demographics, Symptoms, Frequency and Severity - Baseline
NINDS Common Data Elements (Symptoms, Frequency and Severity - Baseline; Headache) Used 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.

NINDS CDE Medical and Family History of Headache/Migraine - Medical and Family History of Headache/Migraine

- 15/6/16 - 1 formulario, 1 itemgroup, 122 items, 1 idioma
Itemgroup: Medical and Family History of Migraine Headache
NINDS Common Data Elements (Medical and Family History of Headache/Migraine) Used 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.

NINDS CDE Vital Signs Headache - Vital Signs

- 20/6/16 - 1 formulario, 1 itemgroup, 35 items, 1 idioma
Itemgroup: Vital Signs
NINDS Common Data Elements [Vital Signs][Headache] Used 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.

NINDS CDE Participant/Subject Characteristics Headache - Demographics and Social Status

- 4/5/16 - 1 formulario, 2 itemgroups, 58 items, 1 idioma
Itemgroups: Demographics, Social Status
NINDS Common Data Elements (Participant/Subject Characteristics; Headache) Used 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.

Migraine Protocol PhenX Toolkit

- 20/9/21 - 1 formulario, 1 itemgroup, 25 items, 2 idiomas
Itemgroup: PhenX - migraine protocol
The Self-Administered Questionnaire for Migraine is a 20-item questionnaire that assesses the frequency of severe headaches, the level of pain, whether the person is taking medications, and associated complications such as nausea. 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.

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Headache Classification

- 20/9/21 - 1 formulario, 4 itemgroups, 12 items, 1 idioma
Itemgroups: Administrative Information, IHS Headache Classification, Migraine History, Subject Recruitment
https://www.gsk-clinicalstudyregister.com/study/101998#rs Study ID:101998 Clinical Study ID :101998 Study Title :A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data :Study Listed on ClinicalStudyDataRequest.com Sponsor :GlaxoSmithKline Sponsor Identification Number :TRX101998 Collaborators :N/A Phase :Phase 3 Study Recruitment Status :Completed Generic Name :sumatriptan Trade Name :Imitrex ,Imiject ,Imigran Study Indication :Migraine Disorders This form uses the IHS headache classification to evluate the subjects symptoms of headache and migraine and should be filled out at the screening visit.

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