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CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - CHEST X-RAY (AP AND LATERAL)

- 2017-05-16 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study part: Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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 TERMINATION CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - STUDY TERMINATION CHEST X-RAY (AP AND LATERAL)

- 2017-05-20 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Chest X-Ray
Study part: Study Termination Chest X- ray. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

MRI Site Evaluation MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

- 2017-01-30 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: MRI Evaluation: Site Screening Documentation, MS Diagnostic Criteria
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form is to be obtained in Screening.

History of Stroke - Ischemic Infarction and Hemorrhage Protocol PhenX Toolkit

- 2016-04-26 - 1 Formulär, 1 Item-grupp, 33 Dataelement, 1 Språk
Item-grupp: PhenX - history of stroke protocol
The Stroke Symptoms Form from the Jackson Heart Study is an interviewer-administered questionnaire that captures the history of stroke(s) and associated symptoms such as slurred speech, double vision, loss of vision and paralysis. 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.

Vertigo Protocol PhenX Toolkit

- 2017-02-19 - 1 Formulär, 1 Item-grupp, 25 Dataelement, 2 Språk
Item-grupp: PhenX - vertigo protocol
The Dizziness Handicap Inventory (DHI) assesses perceived disability due to dizziness (i.e., vertigo). This 25-item self-administered questionnaire contains three subscales which cover the areas of function, emotion, and physical aspects. Points from each subscale can be combined to assign a total score, or they can be combined by subscale. 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 German translation: Kurre A, van Gool CJ, Bastianen CH et al. Translation, cross-cultural adaptation and reliability of the German version of the Dizziness Handicap Inventory. Otol Neurotol 2009; 30: 359–367 Permission to publish granted by Carol M. Hamilton.

Eligibility Multiple Sclerosis NCT00947232

- 2018-07-06 - 1 Formulär, 2 Item-grupper, 15 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
inMotion Clinical Study: Using Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI; ODM derived from: https://clinicaltrials.gov/show/NCT00947232

Multiple sclerosis studies NCT02461069 NCT02419378 - Baseline: MRI Multiple Sclerosis ALAIN01 NCT02419378

- 2021-09-20 - 18 Formulär, 1 Item-grupp, 15 Dataelement, 1 Språk
Item-grupp: MRI
Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Screening: MRI Multiple Sclerosis ALAIN01 NCT02419378

1 Item-grupp 16 Dataelement

Baseline: Repitition of Assessments: MRI Multiple Sclerosis ALAIN01 NCT02419378

1 Item-grupp 15 Dataelement

Baseline 1st cycle Trial Medication Multiple Sclerosis ALAIN01 NCT02419378

2 Item-grupper 16 Dataelement

Baseline: CSF Multiple Sclerosis ALAIN01 NCT02419378

1 Item-grupp 32 Dataelement

Eligibility Multiple Sclerosis NCT02200718

- 2015-08-30 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Study of NeuroVax, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02200718 Principal Investigator: Dennis Bourdette, MD F.A.A.N.

Bladder Control Scale CRFs Multiple Sklerosis Tysabri NCT00027300

- 2017-01-30 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: Bladder Control Scale (BLCS)
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form ist to be obtained in week 24, week 52, week 104, week, 120, week, 128 and Premature Study Withdrawl.

Tinnitus Protocol PhenX Toolkit

- 2016-12-18 - 1 Formulär, 1 Item-grupp, 25 Dataelement, 2 Språk
Item-grupp: PhenX - tinnitus protocol
The Tinnitus Handicap Inventory is a 25-item self-administered questionnaire that assesses the impact of tinnitus on the respondent’s general well-being. The Tinnitus Handicap Inventory includes a functional subscale (11 items) that measures limitations of mental, social, and physical functioning; an emotional subscale (9 items) that assesses affective responses such as anger and frustration; and a catastrophic subscale (5 items) that measures items such as desperation. The protocol also includes scoring instructions. 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.

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

Chest X-Ray 2D ECG Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

- 2017-05-22 - 1 Formulär, 2 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: Chest X-Ray, 2D Echocardiogram
A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

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