Resultados da pesquisa - Portal para modelos de dados médicos (portal MDM)

EHR4CR CTE Data Inventory

- 21/04/2018 - 1 Formulário, 14 Grupos de itens, 133 Elementos de dados, 1 Idioma

Grupos de itens: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs

Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

CDASH Concomitant Medication - Concomitant medication

- 20/06/2018 - 1 Formulário, 2 Grupos de itens, 9 Elementos de dados, 2 Idiomas

Grupos de itens: General information, Details

translated and modified from CDASH 2011-10-24 http://www.cdisc.org

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 18/11/2021 - 9 Formulários, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma

Grupo de itens: Subject details

Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 Grupos de itens 84 Elementos de dados

On-Treatment 2

13 Grupos de itens 62 Elementos de dados

On-Treatment 4

12 Grupos de itens 62 Elementos de dados

On-Treatment 6

12 Grupos de itens 62 Elementos de dados

On-Treatment 7

13 Grupos de itens 67 Elementos de dados

On-Treatment 8

13 Grupos de itens 67 Elementos de dados

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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Logs and Repeats and Concomitant Medications

- 20/09/2021 - 1 Formulário, 3 Grupos de itens, 23 Elementos de dados, 1 Idioma

Grupos de itens: Date of visit/ assessment, Adverse event | Concomitant Medication Ongoing | Evaluation, Pharmaceutical Preparations Concomitant Therapy

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Prior Medication

- 20/09/2021 - 1 Formulário, 3 Grupos de itens, 11 Elementos de dados, 1 Idioma

Grupos de itens: Administrative, Prior Medication, Prior Medication

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Logs and Repeats

- 20/09/2021 - 1 Formulário, 16 Grupos de itens, 156 Elementos de dados, 1 Idioma

Grupos de itens: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

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

- 20/09/2021 - 1 Formulário, 18 Grupos de itens, 90 Elementos de dados, 1 Idioma

Grupos de itens: 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

- 20/09/2021 - 1 Formulário, 17 Grupos de itens, 88 Elementos de dados, 1 Idioma

Grupos de itens: 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

Visit 3 GIMEMA CML0408 NCT00769327 - Visit 3

- 20/09/2021 - 1 Formulário, 5 Grupos de itens, 49 Elementos de dados, 2 Idiomas

Grupos de itens: Physical Examination, Complete Blood Count, NILOTINIB, Biochemistry, Electrocardiogram

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 3 Form

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Screening; Prior Medication

- 20/09/2021 - 1 Formulário, 3 Grupos de itens, 10 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Documentation, Prior Medication, Prior Medication

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers 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: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

Medications Cardiovascular Health Study (CHS)

- 20/09/2021 - 1 Formulário, 4 Grupos de itens, 24 Elementos de dados, 1 Idioma

Grupos de itens: Section A Medication Reception, Section B Prescription Medications, Selection C Selected Over-The-Counter Medications and Supplements, Date of interview

Documentation part: Record 6 Medications The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; Vital Signs; 12-Lead ECG Abnormalities

- 17/09/2021 - 1 Formulário, 4 Grupos de itens, 43 Elementos de dados, 1 Idioma

Grupos de itens: Concomitant Medication, 12-Lead /Holter/Telemetry ECG, Vital Signs, 12-Lead ECG Abnormalities

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

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