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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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786 Search results.

Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 3/24/20 - 1 form, 5 itemgroups, 90 items, 2 languages
Itemgroups: Logistics , Physical examination, ECG, 6MWT, Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

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

- 11/14/17 - 1 form, 10 itemgroups, 71 items, 2 languages
Itemgroups: 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) - Lab: Molecular Genetics

- 4/21/18 - 13 forms, 1 itemgroup, 27 items, 1 language
Itemgroup: Molecular Genetics
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

Bone Marrow Transplant

1 itemgroup, 13 items

GVHD

3 itemgroups, 11 items

Administrative/Demographic Details

1 itemgroup, 11 items

Lab: Cytology/Cytogenetics/Cytochemistry

1 itemgroup, 29 items
8 more forms meeting the search are available in the detailed view.

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 2/10/17 - 1 form, 13 itemgroups, 122 items, 1 language
Itemgroups: 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

CDASH Vital Signs

- 6/20/18 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: General information, Vital Sign
modified from http://www.cdisc.org

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

- 7/10/17 - 1 form, 1 itemgroup, 8 items, 7 languages
Itemgroup: 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.

Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840 - Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration

- 5/29/21 - 1 form, 6 itemgroups, 22 items, 1 language
Itemgroups: Administrative, General Medical History/ Physical Examination, General Medical History/ Physical Examination , Laboratory Tests, Vaccine Administration, Vaccine Administration
Study ID: 108708 Clinical Study ID: 108708 Study Title: A phase IIb, controlled, randomized, multicentre, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years previously vaccinated in FLU-LD-002 clinical trial Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00385840 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination

- 4/17/21 - 1 form, 9 itemgroups, 20 items, 1 language
Itemgroups: Administrative, Toxicities related to previous Radiotherapy for SCLC, Toxicities related to previous Radiotherapy for SCLC, 12-Lead Electrocardiogram, Diagnostic Studies for Tumor Assessment, Ongoing Medical Conditions Associated with SCLC, Ongoing Medical Conditions Associated with SCLC, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 4/13/21 - 1 form, 18 itemgroups, 90 items, 1 language
Itemgroups: Note, Inclusion Criteria, Exclusion Criteria, Physical examination, Pregnancy test, Alcohol test, Urine drug screening, orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Randomization, High fat breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - post dosing, Pharmacokinetic sampling post dosing, Discharge
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

PART A - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 4/13/21 - 1 form, 17 itemgroups, 88 items, 1 language
Itemgroups: Note, Inclusion Criteria, Exclusion Criteria, Physical examination, orthostatic blood pressure / Pulse - Predose, Pregnancy test, Patient diary, Alcohol test, Urine drug screening, Concomitant medication, Adverse event, Randomization, Standard Breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - 4 hours post dosing, Discharge
PART A - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response

- 4/1/21 - 1 form, 16 itemgroups, 59 items, 1 language
Itemgroups: Administrative, Physical Examination (Follow-Up), Physical Examination (Follow-Up), Laboratory Results - Hematology/ Chemistry (Follow-Up), Laboratory Results (Follow-Up) - Hematology, Laboratory Results (Follow-Up) - Hematology, Laboratory Results (Follow-Up) - Chemistry, Laboratory Results (Follow-Up) - Chemistry, Post-Treatment Response (Follow -Up), Post-Treatment Response (Follow-Up) - CT or other Radiological Imaging Results, Post-Treatment Response (Follow-Up) - Bone Marrow Biopsy, Post-Treatment Response (Follow-Up) - Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Response, Signature of Investigator
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Week 3 - 13 and 25 - Laboratory Results; Physical Examination; Post-Treatment Response

- 3/30/21 - 1 form, 19 itemgroups, 62 items, 1 language
Itemgroups: Administrative, Laboratory Results (Week 3-13, 25) - Hematology, Laboratory Results (Week 3-13, 25) - Hematology, Laboratory Results (Week 25) - Hematology , Laboratory Results (Week 3, 13, 25) - Chemistry, Laboratory Results (Week 3 and 13) - Chemistry, Laboratory Results (Week 7) - Chemistry, Laboratory Results (Week 7) - Chemistry , Laboratory Results (Week 25) - Chemistry , Physical Examination (Week 7, 13, 25), Physical Examination (Week 7, 13, 25), Post-Treatment Response (Week 7, 13, 25) - CT or other Radiological Imaging Results, Post-Treatment Response (Week 7, 13, 25) - Bone Marrow Biopsy, Post-Treatment Response (Week 7 and 13) - Received medication/transfusion, Post-Treatment Response (Week 7, 13, 25) - Measurable Lymphoma Disease, Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Week 7, 13, 25) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Week 7, 13, 25) - Response, Signature of Investigator
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin