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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Pharmacogenetic Research

- 2018-04-19 - 1 Formulär, 4 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: Consent for Pharmacogenetic Research, Blood sample collection, Withdrawal of consent, Blood Sample Destruction
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Pharmacogenetic Research.

Pharmacogenetic research Withdrawal of consent GSK study Chronic Coronary Heart Disease NCT00799903 - Pharmacogenetic research Withdrawal of consent Subject Identification GSK study Chronic Coronary Heart Disease NCT00799903

- 2018-01-11 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Withdrawal of consent for PGx (DNA) / Blood sample destruction
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacogenetic research Withdrawal of consent

Pharmacogenetic research GSK study Chronic Coronary Heart Disease NCT00799903

- 2017-10-23 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: Pharmacogenetic research (PGx) consent / Blood sample collection
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacogenetic research

7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690 - Treatment Phase

- 2017-10-23 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Administrative Documentation, Pharmacogenetic Research
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

PGX consent / withdrawal - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876

- 2017-09-16 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: pharmacogenetics consent, Pharmacogenetics withdraw consent
PGX consent / withdrawal - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

pharmacogenetic research salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

- 2017-08-08 - 1 Formulär, 6 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: administrative data, Default Itemgroup, consent for pharmacogenetic research, blood sample collection, withdrawal of consent, blood sample destruction
Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

PGx- Pharmacogenetic Research Screening Visit Mepolizumab HES NCT00086658 - PGx- Pharmacogenetic Research Screening Visit

- 2017-06-11 - 1 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk
Item-grupp: Pharmacogenetic
Study part: PGx- Pharmacogenetic Research Screening Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Pharmacogenetic Research Mepolizumab HES NCT00086658 - PGx- Pharmacogenetic Research

- 2017-06-05 - 1 Formulär, 4 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: consent Pharmacogenetic Test, BLOOD SAMPLE COLLECTION, WITHDRAWAL OF CONSENT, BLOOD SAMPLE DESTRUCTION
Study part: PGx- Pharmacogenetic Research.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

M.Alzheimer GSK - Pharmacogenetic and Pharmacogenomic Research NCT00334568/ GSK-AVA100193 - NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Pharmacogenetic and Pharmacogenomic Research

- 2016-12-05 - 1 Formulär, 5 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: General Information, PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic Research, Blood sample collection (DNA), Withdrawal of consent, Blood sample Destruction
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Pharmacogenetic and Pharmacogenomic Research.

CALGB: Pharmacogenomic Submission and Quality Assurance Form

- 2015-06-18 - 1 Formulär, 5 Item-grupper, 29 Dataelement, 1 Språk
Item-grupper: Header, Patient demographics, Biopsy specimen, Biopsy and Cytology Specimens collection, Biopsy and Cytology Specimens shipment
The Pharmacogenomic Submission and Quality Assurance Form, a CDE-compliant CALGB CRF to be used on most CALGB protocols. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01347EC9-2FD9-7195-E044-0003BA3F9857

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