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

- 20.09.21 - 9 formularios, 4 itemgroups, 15 items, 2 idiomas

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

Baseline Pregnancy Part 2

5 itemgroups 21 items

Follow Up Pregnancy Part 2

5 itemgroups 21 items

Follow Up Multiple Sclerosis Progression

2 itemgroups 8 items

NINDS CDE Demographics Multiple Sclerosis - Demographics

- 15.03.21 - 1 formulario, 1 itemgroup, 8 items, 1 idioma

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

- 24.05.16 - 4 formularios, 4 itemgroups, 19 items, 1 idioma

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)

- 09.12.14 - 1 formulario, 15 itemgroups, 119 items, 2 idiomas

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

- 10.07.17 - 1 formulario, 1 itemgroup, 11 items, 2 idiomas

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

- 10.07.17 - 1 formulario, 1 itemgroup, 16 items, 2 idiomas

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

- 10.07.17 - 1 formulario, 1 itemgroup, 18 items, 3 idiomas

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

- 09.07.17 - 1 formulario, 1 itemgroup, 5 items, 2 idiomas

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

- 27.09.21 - 1 formulario, 10 itemgroups, 43 items, 2 idiomas

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)

- 19.01.15 - 1 formulario, 9 itemgroups, 38 items, 2 idiomas

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

Multiple Sclerosis - In-/Exclusion Criteria (REGIMS)

- 12.12.14 - 1 formulario, 3 itemgroups, 8 items, 2 idiomas

Itemgroups: Inclusion criteria, Exclusion criteria, Comments

REGIMS Multiple Sklerose-Register http://epi.uni-muenster.de

dbGaP phs000944 eMERGE Clinical Center at Partners HealthCare - Eligibility

- 27.11.24 - 6 formularios, 2 itemgroups, 11 items, 1 idioma

Itemgroups: IG.elig, IG.elig

Principal Investigator: Scott T. Weiss, MD, MS, Partners HealthCare System, Boston, MA, USA MeSH: Hypercholesterolemia,Asthma,Arthritis, Rheumatoid,Attention Deficit Disorder with Hyperactivity,Bipolar Disorder,Coronary Disease,Depression,Heart Failure,Inflammatory Bowel Diseases,Multiple Sclerosis,Schizophrenia,Stroke https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000944 The Partners HealthCare Biobank is a large research data and sample repository working within the framework of Partners Personalized Medicine. It provides researchers access to high quality, consented samples to help foster research, advance understanding of the causes of common diseases, and advance the practice of medicine. The Partners Biobank provides banked samples (plasma, serum and DNA) collected from consented patients. These samples are available for distribution to Partners HealthCare investigators with appropriate approval from the Partners Institutional Review board (IRB). They are linked to clinical data that originates in the Electronic Medical Record (EMR), as well as additional health information collected in a self-reported survey. The Partners Biobank will be genotyping 25,000 subjects with the Illumina Multiethnic Beadchip 1.6 million SNPs with exome and custom content ( 60,000 LoFs). Of the participants genotyped so far, 4929 of 4962 (99.3%) individuals have genotype data that passed the default quality thresholds for the Infinium array (call rate = 0.99). We are submitting the genotype data to dbGaP for 4929 subjects with 12 phenotypes (based on icd9 codes). We will do annual releases until we reach the full 25,000 genotyped subjects.

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