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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
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774 Suchergebnisse.

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 14.11.17 - 1 Formular, 10 Itemgruppen, 71 Datenelemente, 2 Sprachen
Itemgruppen: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 21.04.18 - 13 Formulare, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Global Disease Course, Red Cell Transfusion, Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 Itemgruppen, 14 Datenelemente

Administrative/Demographic Details

1 Itemgruppe, 11 Datenelemente

Apparatus-based Diagnostics

1 Itemgruppe, 4 Datenelemente

CDASH Vital Signs

- 20.06.18 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 2 Sprachen
Itemgruppen: General information, Vital Sign
modified from http://www.cdisc.org

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 10.02.17 - 1 Formular, 13 Itemgruppen, 122 Datenelemente, 1 Sprache
Itemgruppen: Demographics, Diagnoses and Procedures, Vital Signs, Laboratory, Generic Laboratory Data, Medication, Adverse Events, Medical History, Clinical Findings, ECG, Patient Reported Outcome, Substance Use, Study Participation Status
Compilation of Feasibility, Patient Identification & Recruitment and Clinical Trial Execution data inventories. https://www.ncbi.nlm.nih.gov/pubmed/24410735 https://www.ncbi.nlm.nih.gov/pubmed/25991199 https://www.ncbi.nlm.nih.gov/pubmed/27875988

Physical examination findings (EHR Archetype) - openEHR-EHR-OBSERVATION.exam.v1

- 10.07.17 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 7 Sprachen
Itemgruppe: openEHR-EHR-OBSERVATION.exam.v1.xml
Derived from www.openehr.org . Use to record details about findings on physical examination of the subject of care. This may include a narrative description of the findings, a framework in which to nest detailed CLUSTER examination archetypes, and a clinical interpretation of the findings. Examples of detailed CLUSTER examination archetypes include those that describe inspection, palpation, auscultation, percussion and movement of body systems or anatomical structures, such as CLUSTER.exam_pupils. Narrative descriptions of clinical findings from existing clinical systems may be captured using the 'Description' data element. Clinicians may sometimes want to record a summative phrase such as 'chronic otitis media' as an Interpretation of the physical examination. In the context of the physical examination archetype this should only be understood as 'physical signs are consistent with chronic otitis media'. While the summative phrase may appear to represent a diagnosis, safe and consistent querying requires a diagnosis to be recorded using the EVALUATION.problem_diagnosis archetype, even if the phrases are identical.

Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521 - Medical history/ physical examination

- 12.02.19 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Physical Examination, Medical history
Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the general medical history/ physical examination form. It has to be filled in for screening for all workbooks (wb1-4). If deemed necessary by the investigator fill in this document for: WB 1 for "Visit Month 6" WB 2 for "Visit Month 12" WB 3 for "Visit Day 21" and "Visit Month 6" WB 4 for "Visit Day 21" and "Visit Month 12"

Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277 - Medical History / Physical Examination / Birth Control

- 04.02.19 - 1 Formular, 5 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pre-existing conditions, signs or symptoms, General Medical History / General Physical Examination, Counselling on birth control, Physical examination
Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373 - General Medical History/Physical Examination

- 01.02.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, General Medical History, Phyiscal Examination, General Medical History, Phyiscal Examination Record
Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document the subjects general medical history and the physical examination performed at visit 1. Please report medication(s) as specified in the protocol and fill in the Medication section. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888 - Physical examination, medical condition

- 31.01.19 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Physical Examination, Medical condition
Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. 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 furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the physical examination and the medical condition form. It has to be filled in for screening.

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Treatment Period 2 - Day -1 - Physical Examination

- 30.01.19 - 1 Formular, 2 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Physical Examination
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 3

- 23.01.19 - 1 Formular, 14 Itemgruppen, 93 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 2: No Boost Only (UK)

- 23.01.19 - 1 Formular, 19 Itemgruppen, 107 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Vaccine Administration, Vaccine Administration - Vaccine 1, Vaccine Administration - Vaccine 2, Reason for non-administration, Unsolicited Adverse Events, Telephone Contact, Study Conclusion
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis