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ePflegebericht (electronic nursing report) - Body

- 20/09/2021 - 2 Formulaires, 9 Groupes Item, 52 Eléments de données, 2 Langues
Groupes Item: Care problem, Score, Care goal, Nursing procedure, Activities of daily living, Homecare Status, Social Environment, Legal Aspects, Medical information
ePflegebericht Prof. Dr. Ursula Hübner Forschungsgruppe Informatik im Gesundheitswesen Hochschule Osnabrück Fakultät Wirtschafts- und Sozialwissenschaften http://wiki.hl7.de/index.php?title=IG:Pflegebericht

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3 Groupes Item 18 Eléments de données

Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277) - Annex 2: RAP version of cleaning report defining ELIM code criterion to use

- 20/09/2021 - 1 Formulaire, 13 Groupes Item, 95 Eléments de données, 1 Langue
Groupes Item: RAP version of cleaning report defining ELIM code criterion to use, Summary, Serious adverse events, Pregnancies, Elimination from safety and immunology analysis, Elimination from immunology analysis, Extra Elimination from analysis, Other points to consider - Inform Consent procedure not respected, Other points to consider, Replacement Treatment Number, Pending Queries not to be resolved, Others, Signature
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

EBMT Amyloidosis

- 20/09/2021 - 1 Formulaire, 21 Groupes Item, 284 Eléments de données, 1 Langue
Groupes Item: GENERAL INFORMATION TEAM, GENERAL INFORMATION PATIENT, DISEASE, AL AMYLOIDOSIS INITIAL DIAGNOSIS, ORGAN INVOLVEMENT AT DIAGNOSIS, PRE-HSCT TREATMENT, HSCT, STATUS OF DISEASE AT COLLECTION (AUTOGRAFTS ONLY), STATUS OF DISEASE AT START OF CONDITIONING FOR BMT, STATUS OF DISEASE AT 100 DAYS AFTER HSCT, ORGAN-SPECIFIC RESPONSES AT 100 DAYS AFTER HSCT, FORMS TO BE FILLED IN, FOLLOW UP AL AMYLOIDOSIS, PATIENT LAST SEEN, GRAFT VERSUS HOST DISEASE (GvHD) SINCE LAST REPORT, OTHER COMPLICATIONS SINCE LAST REPORT, GRAFT ASSESSMENT AND HAEMOPOIETIC CHIMAERISM, ADDITIONAL THERAPIES SINCE LAST FOLLOW UP, FIRST EVIDENCE OF DISEASE WORSENING SINCE LAST HSCT, LAST DISEASE AND PATIENT STATUS, ADDITIONAL NOTES IF APPLICABLE
ODM form derived from Amyloidosis EBMT refer to: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx

Visit 0 GIMEMA CML0408 NCT00769327 - Visit 0

- 20/09/2021 - 1 Formulaire, 4 Groupes Item, 55 Eléments de données, 2 Langues
Groupes Item: Enrollment, Symptoms, Physical Examination, Complete Blood Count
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 0 form.

EHR General report - General report

- 20/09/2021 - 1 Formulaire, 1 Groupe Item, 95 Eléments de données, 2 Langues
Groupe Item: General report
EHR General report

Systemic lupus erythematosus EBMT General Information Form

- 17/09/2021 - 1 Formulaire, 16 Groupes Item, 118 Eléments de données, 1 Langue
Groupes Item: GENERAL INFORMATION, Patient, Disease, SYSTEMIC LUPUS ERITHEMATOSUS (SLE), INITIAL DIAGNOSIS, DIAGNOSTIC CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS, FIRST LINE THERAPIES, DATE OF HSCT, STATUS OF DISEASE AT MOBILISATION, SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score, LABORATORY VALUES, PATIENT’S SELF ASSESSMENT PRIOR TO MOBILISATION, HEALTH ASSESSMENT QUESTIONNAIRE (HAQ), STATUS OF DISEASE AT HSCT, ADDITIONAL TREATMENT POST-HSCT, FORMS TO BE FILLED IN
ODM form derived from 119pp EBMT SLE 16SLE please refer to: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx

PCORnet Common Data Model (CDM) - General observation V4.1

- 17/09/2021 - 1 Formulaire, 1 Groupe Item, 19 Eléments de données, 1 Langue
Groupe Item: General Observation
PCORnet Common Data Model (CDM) Clinical Observation 4.1 Table to store everything else. PCORnet Common Data Model (CDM) The PCORnet Common Data Model (CDM) is a specification that defines a standard organization and representationof data for the PCORnet Distributed Research Network. The PCORnet CDM is a key component of the PCORnet Distributed Research Network (DRN) infrastructure. http://www.pcornet.org/pcornet-common-data-model/

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - General aspects Baseline (Allgemein, Baseline)

- 25/03/2020 - 1 Formulaire, 7 Groupes Item, 40 Eléments de données, 2 Langues
Groupes Item: Administrative Data, Life situation, Education and employment, Occupational status, Nicotine consumption, Alcohol consumption, Vital signs
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 General aspects Baseline form. It has to be filled in at the baseline of the study.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - General aspects follow-ups (Allgemein, Folgevisite)

- 23/03/2020 - 1 Formulaire, 8 Groupes Item, 29 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Cumulative documentation, Informed consent, Life situation, Occupational status, Nicotine consumption, Alcohol consumption, Vital signs
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 General aspects form. It has to be filled in at follow-up visits of the study.

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - CRF Tracking/Review Forms

- 22/08/2019 - 1 Formulaire, 2 Groupes Item, 13 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Clinical Trial Regulatory Tracking Document
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - CRF Tracking/Review Form (TRF)

- 25/03/2019 - 1 Formulaire, 3 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Clinical Trial Regulatory Tracking Document, Signature
Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Pregnancy notification form (subject's partner)

- 07/12/2018 - 1 Formulaire, 7 Groupes Item, 42 Eléments de données, 1 Langue
Groupes Item: Administrative data, Mothers relevant medical/family history, Number of previous pregnancies, Fathers relevant medical/family history, DRUG EXPOSURES, Withdraw from study, REPORTING INVESTIGATOR INFORMATION
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Pregnancy notification form (subject's partner). Complete this form for each subject's partner who becomes pregnant during the study period. This form should be completed according to the protocol reporting requirements. Complete this form for each subject's partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject's Case Report Form. Note: This form does not routinely need to be completed for subject's partner pregnancy unless there is specific instruction to do so stated in the protocol.

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