Reset filter
Keywords
Multiple Sclerosis ×
Show more Keywords
Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

You must log in to select data models for download or further analysis.

451 Search results.

Relevance Rating New first Old first

REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Follow Up Main Sheet

- 9/20/21 - 9 forms, 4 itemgroups, 15 items, 2 languages
Itemgroups: Allgemeines,Grund dieser Visite bzw. dieses Kontaktes (Mehrfachauswahl),Ist seit der letzten Dokumentation für REGIMS (o. REGIMS-Visite)...,Eigene Bemerkungen / Klinischer Verlauf / Kommentar
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.

Baseline Pregnancy Part 1

5 itemgroups 24 items

Follow Up Pregnancy Part 1

5 itemgroups 24 items

Follow Up Medication Change

3 itemgroups 11 items

NINDS CDE Demographics Multiple Sclerosis - Demographics

- 3/15/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: Demographics
NINDS Common Data Elements, Multiple Sclerosis Demographics 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.

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069 - NON-MS Treatment and symptomatic MS Treatment

- 5/24/16 - 4 forms, 4 itemgroups, 19 items, 1 language
Itemgroups: General Instructions,Medical Examination,Expanded disability status scale (EDSS),Signature
Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Eligibility

3 itemgroups 31 items

Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

7 itemgroups 31 items

Blood samples for safety laboratory tests

4 itemgroups 16 items

Multiple Sclerosis - Patient Questionnaire (REGIMS)

- 12/9/14 - 1 form, 15 itemgroups, 119 items, 2 languages
Itemgroups: General information,First Symptoms,Diagnostic procedure within the past 12 months,Fatigability Multiple Sclerosis,Course,Aid, manufactured,Medical benefits,Medical benefits past 12 months,Treatment satisfaction,Family history,Symptoms within past 12 months,Medication within last 7 days,Demographics,Doctor visit,Quality of life
Patientenfragebogen Multiple Sklerose REGIMS http://epi.uni-muenster.de

Timed 25-Foot Walk (EHR Archetype) - openEHR-EHR-OBSERVATION.timed_25_foot_walk.v1

- 7/10/17 - 1 form, 1 itemgroup, 11 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.timed_25_foot_walk.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Timed 25-Foot Walk test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite (MSFC) assessment, but may be performed independently. The patient is directed to one end of a clearly marked 25-foot (7,62 m) course. Then he is instructed to walk this course as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Assistive devices (in general, customary walking devices) may be used when doing this task. Use the MSFC Manual for detailed administration instructions. The test should only be administred by a suitably trained person.

Paced Auditory Serial Addition Test (EHR Archetype) - openEHR-EHR-OBSERVATION.paced_auditory_serial_addition_test.v1

- 7/10/17 - 1 form, 1 itemgroup, 16 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.paced_auditory_serial_addition_test.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Paced Auditory Serial Addition Test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite, but may be performed independently. 61 single-digit numbers are presented to the subject one by one. During PASAT-3'' a new number is presented every three seconds, in the optional PASAT-2'' every two seconds. In each case the subject is asked to respond with the sum of the last two digits (not the running total). That is, there is a maximum of 60 possible correct sums. Use the MSFC Manual for detailed administration instructions. Prior to the recording of the actual tests at least one practice trial has to be performed (this training sequence is part of the PASAT). If less than three correct answers were given, the practice trial should be repeated (up to three times). If more than two correct answers were given, the PASAT-3'' can be administered (the patient should have understood the task sufficiently). To obtain additional information about the cognitive functions, the PASAT-2'' can be performed optionally after the 3'' test. The tests should only be administered by a suitably trained person.

Nine Hole Peg Test (EHR Archetype) - openEHR-EHR-OBSERVATION.nine_hole_peg_test.v1

- 7/10/17 - 1 form, 1 itemgroup, 18 items, 3 languages
Itemgroup: openEHR-EHR-OBSERVATION.nine_hole_peg_test.v1.xml
Derived from www.openehr.org . Use to record the measurements recorded during a Nine Hole Peg Test. This test is commonly carried out as one component of the Multiple Sclerosis Functional Composite (MSFC) assessment, but may be performed independently. Both the dominant and non-dominant hand of the patient are tested twice (two consecutive trials of the dominant hand, followed by two consecutive trials of the non-dominant hand). For each trial nine pegs are picked one by one from a container, placed in the holes on a pegboard and then separately returned to the container. The subject may only use one hand at each trial, but may hold the pegboard with the free hand. This archetype covers variations of the test. According to Mathiowetz et al. (1985) an untimed practice trial should be administered prior to the timed trial for each hand. The MSFC Manual stipulates two timed trials for each hand, but no practice trial. Use the MSFC Manual or see Mathiowetz et al. (1985) for detailed administration instructions. The test should only be administered by a suitably trained person.

MSFC Score (EHR Archetype) - openEHR-EHR-OBSERVATION.msfc_score.v1

- 7/9/17 - 1 form, 1 itemgroup, 5 items, 2 languages
Itemgroup: openEHR-EHR-OBSERVATION.msfc_score.v1.xml
Derived from www.openehr.org . Use to record the MSFC Score and the reference data set, as well as links to the measured results of the three individual tests (Timed 25-Foot Walk, Nine Hole Peg Test and Paced Auditory Serial Addition Test). The MSFC Score is a computed value based on the average of each test result, adjusted to the reference population. I.e. MSFC Score = 1/3 * (Z_arm,avg. + Z_leg,avg. + Z_cognitive), where Z_x = Z-score of each test result. This score has to be computed externally, only the resulting value is to be recorded here. Use the MSFC Manual for further scoring instructions, formulas and background information.

REGIMS - SUE Report

- 9/27/21 - 1 form, 10 itemgroups, 43 items, 2 languages
Itemgroups: SUE,Patientenangaben,SUE: Beschreibung,SUE: Behandlung,SUE: Ausgang,SUE: MS-Medikation,SUE: Begleitmedikation,SUE: Relevante Vorerkrankung / Sypmtome,Ergebnisse der relevanten Diagnostischen Untersuchungen,Kontaktdaten des Berichterstatters
Schwerwiegendes unerwünschtes Ereignis (SUE) in der Therapie SUE Berichtsformular Bitte ausfüllen und faxen oder senden an: Westfälische Wilhelms-Universität Münster, Institut für Epidemiologie und Sozialmedizin, Albert-Schweitzer-Campus 1, Gebäude 03, 48149 Münster Fax: (0251) 83-55300, E-Mail: regims@uni-muenster.de http://epi.uni-muenster.de

Multiple Sclerosis - Base Sheet (REGIMS)

- 1/19/15 - 1 form, 9 itemgroups, 38 items, 2 languages
Itemgroups: General information,Disease-specific information,Current Symptoms Multiple Sclerosis,Past treatment Multiple Sclerosis,Current Therapy Multiple Sclerosis,Cortisone,MRT,Disease history,Pregnancy, current
Medizinischer Basisbogen Multiple Sklerose http://epi.uni-muenster.de

dbGaP phs001833 Genetic Model of MS Severity Predicts Future Accumulation of Disability - F.1

- 5/12/22 - 4 forms, 1 itemgroup, 2 items, 1 language
Itemgroup: IG.1
https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001833.v1.p1 NCT00794352 The goal of "Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the CNS" is to define the pathophysiological mechanisms underlying the development of disability in immune-mediated disorders of the central nervous system (CNS) and to distinguish these from physiological (and often beneficial) responses of the human immune system to CNS injury. The long-term objective of the trial is to acquire knowledge that would allow us to therapeutically inhibit the pathogenic mechanisms and enhance repair mechanisms in immune-mediated CNS diseases, thereby minimizing the extent of CNS tissue damage and promoting recovery. To date, 460 patients with a confirmed diagnosis of multiple sclerosis (MS) have been enrolled into the natural history clinical trial. In addition to standardized clinical, functional, neuroimaging and molecular/immunological data, blood samples were also collected for genetic research. However, only 299 study participants with confirmed MS currently have whole genome sequencing data available. In addition to the genome-wide data available for the 299 MS patients, this dbGaP submission provides demographic and phenotypic information for each subject collected at various points throughout the trial. We include race and family history of MS collected at the baseline visit as well as age and measures of disease severity collected at the most recent visit. As these data were randomized into discovery and validation cohorts, we also indicate the assigned group in the phenotypic data. It is hoped that these data may be applied to the development of clinically-useful tools such as diagnostic tests and new, sensitive scales of neurological disability, disease severity and CNS tissue destruction. Principal Investigator: Bibiana Bielekova, PhD. National Institutes of Health, Bethesda, MD, USA Funding Sources: Intramural Research Program of the National Institute of Allergy and Infectious Diseases. National Institutes of Health, Bethesda, MD, USA Acknowledgement Statement: Please cite/reference the use of dbGaP data by including the dbGaP accession phs001833.v1.p1.

F.2

1 itemgroup 2 items

F.3

1 itemgroup 7 items

F.4

1 itemgroup 5 items

Multiple Sclerosis - In-/Exclusion Criteria (REGIMS)

- 12/12/14 - 1 form, 3 itemgroups, 8 items, 2 languages
Itemgroups: Inclusion criteria,Exclusion criteria,Comments
REGIMS Multiple Sklerose-Register http://epi.uni-muenster.de

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial