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

- 23-03-20 - 1 Formulier, 3 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 4 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: 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

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

- 26-11-17 - 1 Formulier, 1 Itemgroep, 10 Data-elementen, 1 Taal
Itemgroep: 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.

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 Formulier, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: 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.

3.2 Charlson Comorbidity Index (CCI)

- 28-06-16 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: G8 Screening tool
Charlson Comorbidity Index (CCI) Part 3.2 G8 geriatric assessment screening tool To be completed by: Clinician, nurse or trained coder. Notes: This screening tool includes 7 items of the Mini Nutritional Assessment and the age of the patient. Score: Total score by adding up coded answers. Ref.: P. Soubeyran et al. Validation of a screening test for elderly patients in oncology. JCO. Vol 26, 15S, 2008 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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