Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Visit 1 GIMEMA CML0408 NCT00769327 - Visit 1

- 20.09.21 - 1 Formular, 15 Itemgruppen, 150 Datenelemente, 2 Sprachen

Itemgruppen: Previous chemotherapy, Comorbidities, Symptoms, Physical Examination, Complete Blood Count, Biochemistry, Serum Proteins, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 1 Form

Efficacy and Safety of ADVAIR DISKUS Plus Spiriva HandiHaler Versus Spiriva HandiHaler in COPD NCT00784550 - Medical Conditions

- 11.11.20 - 1 Formular, 2 Itemgruppen, 23 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Medical Conditions

Study ID: 111114 Clinical Study ID: 111114 Study Title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR™ DISKUS™ (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00784550 https://clinicaltrials.gov/ct2/show/NCT00784550 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: N/A Trade Name: Tiotropium Bromide, Fluticasone Propionate/Salmeterol Study Indication: Pulmonary Disease, Chronic Obstructive The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. There are a total of 6 visits: Screening (Visit 1), Randomization (Visit 2), and after 4 (Visit 3), 8 (Visit 4), 16 (Visit 5) and 24 (Visit 6) weeks of treatment. This form (Medical Conditions) is to be filled out during the study. Record medical history for current conditions only.

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Interview risk factors (Interview Risikofaktoren)

- 01.10.20 - 1 Formular, 9 Itemgruppen, 54 Datenelemente, 1 Sprache

Itemgruppen: Patient-ID, Risk factors: Smoking Status, Risk factors: former smoking status, Risk factors: Current smoker, Tobacco substitute, Risk factors: Anthropometry, Risk factors: comorbidities, Risk factors: cardiovascular diseases, Risk factors: family history

A central patient cohort within the interdisciplinary Collaborative Research Center / Transregio 240 aims to examine the role and function of platelets in different vascular diseases. Comorbidities and risk factors are collected within a personal interview with the study participant.

ICHOM Inflammatory Bowel Disease - Demographics, Baseline Clinical Factors (Patient reported)

- 30.04.20 - 1 Formular, 3 Itemgruppen, 33 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Demographic Factors, Baseline Clinical Factors

INFLAMMATORY BOWEL DISEASE DATA COLLECTION Version 1.0.1 Revised April 10th, 2017 Based mainly on the above version, additions/modifications August 2019 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 Covered: An adult (>16) with a diagnosis of Inflammatory Bowel Disease (IBD) including Crohn’s disease, ulcerative colitis and indeterminate colitis (or IBD unclassified) Treatment Approaches: Medical | Surgical | Supportive This ODM-file contains Patient reported Forms: Demographics and Baseline Clinical Factors. Timepoints: Mainly Baseline only; Smoking and Infection Status annually, too. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: IBD-Control PROM : IBD-Control is made available to the IBD community without license or fees, but the authors retain copyright and request that the original paper is cited in any published output. For more details, see: Bodger et al. Development and validation of a rapid, generic measure of disease control from the patient’s perspective: the IBD-control questionnaire. Gut 2014;63(7):1092-102. (Please note, only some questions of the IBD-Control questionnaire are asked, therefore a total score is not applicable or requested within this guide). ICHOM was supported for this standard set by Oxford Academic Health Science Network (partly funded by AbbVie). Kim AH, Roberts C, Feagan BG, et al. Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease — an International, Cross-disciplinary Consensus. Journal of Crohn's and Colitis. 2017;1–11. doi:10.1093/ecco-jcc/jjx161 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Cumulative documentation - medical history/ comorbidities (Kumulative Dokumentation - Vor-/ Begleiterkrankung)

- 23.03.20 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Medical history/ comorbidities, Checklist medical history

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the cumulative documentation - medical history/ comorbidities . Prior medical history should be filled in at baseline. If there are newly diagnosed diseases during the study period, add in the course of the study.

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Childbearing Potential, Birth Control Methods and Medical Conditions

- 09.11.18 - 1 Formular, 4 Itemgruppen, 29 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Child-bearing Potential (Complete for Female Subjects Only), Birth Control Methods, Medical Conditions

This ODM-file contains the form to document the childbearing potential, birth control methods and medical conditions of the subject. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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 Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Further Comorbidities Time interval 24 hours before randomization CandiSep Anesthesiology and Intensive Care NCT02734550 - Further Comorbidities Time interval 24 hours before randomization

- 03.07.18 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache

Itemgruppe: Comorbidities

Study part: Further Comorbidities Time interval 24 hours before randomization. (1,3)-β-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with severe sepsis or septic shock and at high risk of invasive Candida infection (CandiSep). Provided by PD Dr. med. Frank Bloos, Ph.D. Clinic for Anesthesiology and Intensive care, University Clinic Jena.

Comorbidity Screening Day -14 to 0 SirTac NCT02936388 - Comorbidity Screening Day -14 to 0

- 26.11.17 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache

Itemgruppe: Comorbidity

Study part: Comorbidity Screening Day -14 to 0. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

GSK Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons Randomisation Visit MEDICAL CONDITIONS NCT00079911 - GSK Study Randomisation Visit MEDICAL CONDITIONS NCT00079911

- 28.07.17 - 1 Formular, 2 Itemgruppen, 23 Datenelemente, 1 Sprache

Itemgruppen: Study administration, MEDICAL CONDITIONS

NCT00079911 Study ID 100181 Clinical Study ID HS2100181 Study Title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons with CD4+ lymphocyte count <100 cells/mm3. Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00079911 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Terminated Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Genital Herpes; HIV infection

End of study PETAL Study NCT00554164 - End of study

- 23.11.16 - 1 Formular, 4 Itemgruppen, 25 Datenelemente, 2 Sprachen

Itemgruppen: Comorbidity, Discontinuation, Adverse event, Footer module

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

Comorbidities at study end LeMLAR-Studie Lymphoma NCT01788189 - Comorbidities at study end

- 22.09.16 - 1 Formular, 1 Itemgruppe, 9 Datenelemente, 1 Sprache

Itemgruppe: Comorbidity

Study part: Comorbidities at study end LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

3.3 Charlson Comorbidity Index (CCI)

- 28.06.16 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache

Itemgruppe: Instrumental Activities of Daily Living (IADL)

Charlson Comorbidity Index (CCI) Part 3.3 Instrumental Activities of Daily Living (IADL) To be completed by: Patient, clinician, nurse or trained coder. Notes: Some domains may not be informative for all people. For example some men (for cultural reasons) may not do the laundry. Therefore each question is preceded by a screening question, to assess relevance. Score: Record total domains which can be scored (i.e. not designated N/A[not applicable]). Record number of domains in which subject is dependent (i.e. scores 0). Source: Charlson et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. 1987. J. Chronic Dis. 40, pp. 373–383.

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