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  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
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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

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

- 4/20/22 - 1 form, 24 itemgroups, 70 items, 2 languages
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Hematology (discipline) ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,plasma concentration; Antiepileptic Agents,Plasma specimen
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12

- 4/20/22 - 1 form, 22 itemgroups, 64 items, 2 languages
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,Urine Specimen Collection
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments and Clinical Laboratory Examination - Treatment Phase Study Week 10

- 4/7/22 - 1 form, 21 itemgroups, 60 items, 1 language
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG)
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples - Treatment Phase Study Week 14

- 4/7/22 - 1 form, 24 itemgroups, 70 items, 1 language
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Hematology (discipline) ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,plasma concentration; Antiepileptic Agents,Plasma specimen
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

- 4/7/22 - 1 form, 28 itemgroups, 87 items, 1 language
Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Electrocardiography ,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Hematology (discipline) ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,plasma concentration; Antiepileptic Agents,Urine creatinine measurement,Plasma specimen,Clinical status,Clinical status; Finding
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

- 4/6/22 - 1 form, 16 itemgroups, 158 items, 1 language
Itemgroups: Administrative,Vital Signs,12-Lead ECG,Laboratory Results Data (Haematology) - Pre-Dose,Laboratory Results Data (Clinical Chemistry) - Pre-Dose,Urinalysis - Pre-Dose,Randomisation Number,Investigational Product,Treatment Confirmation,PET Scan (2),fMRI Scan - Post-PET Scan,PET Scan (3),Pharmacokinetics - Blood,Laboratory Results Data (Haematology) - 24hrs Post-Dose,Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose,Urinalysis - 24hrs Post-Dose
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/19/22 - 1 form, 10 itemgroups, 33 items, 1 language
Itemgroups: Subject Identification,Vital Signs,Physical examination,EDSS,Functional System Scores, EDSS,Additional and Results,Visual Function Test,Contrast Sensitivity Evaluation Binocular,Study Drug Accountability,Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Premature Study Withdrawal Visit

Visit 12 (Week 96) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/19/22 - 1 form, 10 itemgroups, 41 items, 1 language
Itemgroups: Subject Identification,Vital Signs,Physical examination,EDSS Evaluation,Functional System Scores, EDSS,Additional and Results,Visual Function Test,Contrast Sensitivity Evaluation Binocular,Study Drug Accountability,Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 12 (Week 96)

Visit 15 (Week 132): Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/19/22 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Subject Identification,Vital Signs,Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 15 (Week 132)

Baseline Visit (Day 1): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 2/19/22 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Subject Identification,Vital Signs,Physical examination
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Baseline Visit (Day 1)

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