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Table des matières
  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
Modèles de données sélectionnés

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- 28/08/2020 - 1 Formulaire, 10 Groupes Item, 68 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Blood sample, Specimen Collection - Blood, Registration of blood samples , Urine sample, Results of urine stick, Registration of urine samples, Liquor collection, Registration of liquor samples, Sample collection according to SOP
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 sample collection form. It contains information about blood sample, urin collection and liquor sample. It has to be filled in for baseline and for all follow-ups.
- 10/10/2019 - 1 Formulaire, 6 Groupes Item, 29 Eléments de données, 2 Langues
Groupes Item: Number of aliquot tubes, Blood and Urine collection, Lab process steps, Sample properties (blood), Sample properties (urine), Comments
With permission from the DZHK administrative office. http://dzhk.de The DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.; German Center for Cardiovascular Research) is a joint cooperation of twenty-eight institutions in seven locations throughout Germany to develop a common research strategy. They developed a data catalogue with metadata and data as well as information about available biological materials from all their studies. For more information on the data catalogue and access to actual data and biosamples please visit https://dzhk.de/en/resources/data-manual/ . This version contains the metadata part only. The form Biobanking Basic Set is used to document the quality of samples of the Basic Set. The Basic Set consists of EDTA plasma, serum, citrate plasma, buffy coat and urine. The documentation is to be performed according to the DZHK's Biobanking SOPs, which can be accessed at https://dzhk.de/en/resources/sops/ (or https://dzhk.de/ressourcen/sops/ for the German language versions). The SOPs for this form are "Collection of Biomaterials from Blood and Urine" (version 1.1, valid as of 15/12/2014) and "Biomaterial Processing Basic Set" (version 1.1, valid as of 15/12/2014) for the English language versions, and "Gewinnung von Biomaterialien aus Blut und Urin" (version 1.1, valid as of 15/12/2014) and "Biomaterialverarbeitung Basis-Set" (versin 1.1, valid as of 15/12/2014) for the German language version. The collection of biomaterials is carried out in accordance with local regulations. Deviations from the following requirements will not result in the exclusion of the patient/test subject from the study. Collection of blood: Appropriate means of disposal for needles, swabs, etc. Period of rest in unaltered body position prior to blood collection: 5 minutes. Site of collection on patient/test subject: cubital vein. Tourniquet time < 1 minute. Specimens should be drawn in the following order: serum, citrate, EDTA. The tourniquet should be released once collection of blood has begun, i.e. when blood flow into the primary receptacle is visible. No repeat clenching of the fist. Invert immediately while exchanging the primary receptacles. Store the primary receptacles vertically in the primary receptacle/tube rack. Collection of urine: Label the urine cup using the sticker intended for that purpose. Inform the patient/test subject using the information sheet “Collecting a Mid-Stream UrineSpecimen”. Spontaneous urine collection. Immediately after urine specimen is given: document the time the urine specimen was collected and the appearance of the urine on the Biomaterial Collection Form. If patient/test subject is actively menstruating: Make a note of this on the Biomaterial Collection Form.
- 17/07/2019 - 1 Formulaire, 4 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Urinalysis Administrative Data, Urinalysis Dipstick, Urinalysis Dipstick details, Urinalysis Microscopy
- 15/01/2019 - 1 Formulaire, 8 Groupes Item, 37 Eléments de données, 1 Langue
Groupes Item: Administrative data, Hematology Data, Clinical Chemistry Data, Urinalysis, Urinalysis: Dip Stick, Urinalysis: Sedimentary Microcopy, Serology Screen, Pregnancy Test
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. The study session 1.1 includes forms for reapeat screening (unscheduled. This document contains the forms: Hematology Data, Clinical Chemistry Data and Urinalysis. It has to filled in for screening, sessions 2, 3, 4, 5, 6 and 7. It also has to be filled in for Session 1.1. It also contains the worksheet for Serology Screen. It has to be filled in for screening (session 1). Furthermore this document contains the form pregnancy test. It has to be filled in for treatment period 1-5.

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