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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
  7. 7. Medical Specialty
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823 Search results.

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

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics

- 5/10/21 - 1 form, 10 itemgroups, 79 items, 1 language
Itemgroups: Administrative, Date of visit/assessment, Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions, Adverse Events, Concomitant Medications, 12-Lead/ Holter/ Telemetry ECG, 12-Lead ECG Abnormalities, Vital Signs, Pharmacokinetics, Orthostatic Vital Signs
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG

- 5/10/21 - 1 form, 17 itemgroups, 57 items, 1 language
Itemgroups: Administrative, Date of Visit/ Assessment, Randomisation (only Session 1), Vital Signs, Sitting Vital Signs - Predose, Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins , Orthostatic Vital Signs - Post Dose - Sitting, Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins, Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins , Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins , Pharmacokinetics Blood - Dosing Date and Time, Pharmacokinetics Blood, Investigational Product, Treatment Confirmation, 12-Lead ECG (only Session 4)
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Screen: Demography; Vital Signs; 12-Lead ECG; Eligibility Question; Subject Identification

- 5/5/21 - 1 form, 8 itemgroups, 29 items, 1 language
Itemgroups: Administrative, Date of Visit/ Assessment, Demography, Vital Signs, Orthostatic Vital Signs (3 Readings) - Supine, 12-Lead ECG (Screening Reading 1), Eligibility Question, Subject Number
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 2 - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 4/29/21 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Administrative, Serious Adverse Experiences, Vital Signs , 12-Lead Electrocardiogram
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

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

- 4/27/21 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Administrative, Serious Adverse Experiences, Vital Signs , 12-Lead Electrocardiogram
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

Eligibility, Medical History, Vital Signs - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 4/13/21 - 1 form, 10 itemgroups, 61 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria, Demographics, Medical history, Parkinson's disease Surgical history, Allergies, Parkinson's disease history, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test
Eligibility, Medical History, Vital Signs - 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

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Module 1 - Screening (Demography; Vital Signs; History of Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer

- 4/8/21 - 1 form, 8 itemgroups, 29 items, 1 language
Itemgroups: Administrative, Demography, Vital Signs, History of Small Cell Lung Cancer, Previous Surgical Procedures for Small Cell Lung Cancer, Previous Surgical Procedures for Small Cell Lung Cancer , Previous Radiotherapy for Small Cell Lung Cancer, Previous Radiotherapy for Small Cell Lung Cancer
lung 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

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Visit Maintenance 1 +2; Early Withdrawal; Follow up; Optional Visit; Unscheduled - PR/Conmeds; SOOS; Vitals

- 3/15/21 - 1 form, 8 itemgroups, 54 items, 1 language
Itemgroups: Administrative, Prior/ Current Concomitant Medications, Prior/ current non-drug therapies, Non-drug therapies, Sudden Onset of Sleep Questionnaire, Vital Signs - Semi supine , Vital Signs - Standing , Physical Exam
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease