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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Tobacco use, HIV screen

- 4/12/18 - 1 formulario, 3 itemgroups, 6 items, 1 idioma

Itemgroups: Administrative data, HISTORY OF TOBACCO USE, SEROLOGY - HIV SCREEN

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 history of tobacco use and the serology - HIV screen form. It has to be filled in for screening.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - History of Tobacco Use

- 28/11/18 - 1 formulario, 1 itemgroup, 3 items, 1 idioma

Itemgroup: History of tobacco use

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Substance Use

- 3/10/18 - 1 formulario, 5 itemgroups, 21 items, 1 idioma

Itemgroups: Administrative Data, Alcohol Intake, Tobacco Use, Drug and Alcohol Screen, Laboratory Tests - Urine Cotinine

This ODM file contains the form to collect data about the substance use of the patient. To be assessed at Screening. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Medical Conditions, Alcohol Intake and History of Tobacco Use

- 8/6/18 - 1 formulario, 3 itemgroups, 6 items, 1 idioma

Itemgroups: Medical Conditions, Alcohol intake, History of Tobacco Use

This ODM file contains Medical Conditions, alcohol intake and History of Tobacco use. To be filled in at screening visit (Date on Administrative Data, Demography and Child-Bearing Potential Form). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

openEHR-EHR-OBSERVATION.tobacco_use.v1

- 10/4/18 - 1 formulario, 1 itemgroup, 14 items, 1 idioma

Itemgroup: openEHR-EHR-OBSERVATION.tobacco_use.v1.xml

http://openehr.org/ckm/ Use to record details of the use of all common forms of tobacco and tobacco-containing products. This includes actual use at specific point in time and average use over intervals of time. A smoking or tobacco use diary could be built up over time by recording the use of tobacco on multiple, sequential days - recording actual consumptions using the 'Specified Day' event for each daily entry. A record of typical tobacco use during a period can be recorded by recording the amount of tobacco used using the 'Average use' event - the mean use over a specified period of time.

ALCOHOL / TOBACCO USE HISTORY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 8/6/17 - 1 formulario, 2 itemgroups, 15 items, 1 idioma

Itemgroups: Patient administration, ALCOHOL / TOBACCO USE HISTORY (SCREENING)

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

ALCOHOL / TOBACCO USE HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

- 8/6/17 - 1 formulario, 2 itemgroups, 15 items, 1 idioma

Itemgroups: Patient administration, ALCOHOL / TOBACCO USE HISTORY (SCREENING)

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Penultimate Trial Medication Tobacco Use PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

- 23/3/17 - 1 formulario, 4 itemgroups, 11 items, 1 idioma

Itemgroups: Trial Medication Compliance, Discontinuation Of Trial Medication, Discontinuation Of Trial Medication, Tobacco Use Status

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Penultimate Visit (Next to last Visit) Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

End of Trial Medication Compliance Discontinuation Tobacco Use PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

- 21/2/17 - 2 formularios, 4 itemgroups, 12 items, 1 idioma

Itemgroups: Trial Medication Compliance, Discontinuation Of Trial Medication, 5. Discontinuation Of Trial Medication, Tobacco Use Status

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. End of Trial Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00153062?term=NCT00153062&rank=1

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Tobacco Use Alcohol Consumption PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

- 16/2/17 - 1 formulario, 3 itemgroups, 17 items, 1 idioma

Itemgroups: 1. Tobacco Use, 2. Type of tobacco use, Alcohol Consumption

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one. Alcohol consumption: Regular alcohol consumption: respond yes if consumption is >1 drink per week. (1 drink=1 glass beer, 1.5 ounces/50 mis or more of hard liquor or 1 glass of wine).

Treatment Visit 2 Month 1 PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

- 15/2/17 - 1 formulario, 4 itemgroups, 8 items, 1 idioma

Itemgroups: Concomitant Medication, ACE Inhibitors, Restricted Concomitant Medication, Tobacco Use Status

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.

Visit 1 Run-In Substance Use: Tobacco History NCT01117584

- 28/1/17 - 1 formulario, 1 itemgroup, 7 items, 1 idioma

Itemgroup: General Information

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

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