Sökresultat - Portal för medicinska datamodeller (MDM-portal)

ToFingo Screening V1 Study relevant assessments NCT02325440

- 2016-06-03 - 1 Formulär, 1 Item-grupp, 3 Dataelement, 1 Språk

Item-grupp: Study relevant assessments

Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Pregnancy Test

- 2018-10-07 - 1 Formulär, 2 Item-grupper, 5 Dataelement, 1 Språk

Item-grupper: Administrative Data, Pregnancy Test (Complete for Female Subjects Only)

This ODM file contains the form to record the results of the pregnancy test. To be assessed at Day -1 of Period 1 and 2. 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

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet 106396 - Laboratory Tests, Serology and Pregnancy Test

- 2018-10-04 - 1 Formulär, 4 Item-grupper, 10 Dataelement, 1 Språk

Item-grupper: Administrative Data, Laboratory Tests - Clinical Chemistry, Haematology, Serology, Pregnancy Test (Complete for Female Subjects Only)

This ODM-file contains a form to fill in findings of the laboratory, serology and pregnancy testing. To be assessed at the screening visit. 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

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Vital Signs, 12-Lead ECG, Laboratory Tests and Pregnancy Test (Follow-up Visit)

- 2018-10-15 - 1 Formulär, 5 Item-grupper, 14 Dataelement, 1 Språk

Item-grupper: Administrative Data, Vital Signs, 12-Lead ECG, Laboratory Tests - Clinical Chemistry, Haematology, Pregnancy Test (Complete for Female Subjects Only)

This ODM file contains the form for documentation of the vital signs, the 12-lead ecg, the laboratory testing and the pregnancy test. To be assessed at follow-up visit. 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

Serum HCG Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

- 2017-05-30 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk

Item-grupp: Serum HCG Pregnancy Test (Females only)

A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1 This form is to be completed in Screening Period 1 and after 12 Months +/- 1 week.

Screening Visit Form 4/4 Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study NCT01416116

- 2016-07-23 - 1 Formulär, 4 Item-grupper, 18 Dataelement, 1 Språk

Item-grupper: Pregnancy Test, Identification of Painful Area, NPRS 'average pain' score, NPRS 'pain now' score

Study Sponsor: Astellas Study Title Tolerability of QUTENZA™ When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study Medicine or Vaccine (generic name) capsaicin Sponsor Identification Number QTZ-EC-0002 Trial Registry Identification Number(#'s) NCT01416116 EudraCT Number: 2010-023258-34 Medical Condition Neuropathic pain Phase Phase 4 http://clinicaltrials.gov/show/NCT01416116 Screening Visit: Pregnancy Test Identification of Painful Area NPRS 'average pain' score NPRS 'pain now' score

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 15 - Visit 13: 7-Day Follow-up

- 2018-04-19 - 1 Formulär, 4 Item-grupper, 16 Dataelement, 1 Språk

Item-grupper: Vital Signs, Pregnancy Test, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing

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 Week 15 - Visit 13: 7-Day Follow-up.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 6 - Visit 8

- 2018-04-19 - 1 Formulär, 3 Item-grupper, 12 Dataelement, 1 Språk

Item-grupper: Vital Signs, Pregnancy Test, Psychiatric Evaluation

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 Week 6 - Visit 8.

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

- 2020-05-20 - 1 Formulär, 9 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: Administrative, Significant Medical/ Surgical History (Period 1 Day -1), Significant Medical/ Surgical History (Period 2 Day -1), Significant Medical/ Surgical History , Physical Examination (Period 1 Day -1), Physical Examination (Period 2 Day -1), Physical Examination (Follow-Up) , Physical Examination - Investigator's Signature, Pregnancy Test (Females only)

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

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

- 2020-05-05 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk

Item-grupper: Administrative, Pregnancy Test

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

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Follow-up (Form 20) - GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 2 (Form 5)

- 2019-10-30 - 1 Formulär, 15 Item-grupper, 58 Dataelement, 1 Språk

Item-grupper: General Information, RLS rating scale, Vital signs, Laboratory Evaluation, Investigational product and compliance record, Investigational product interruption, Dose reduction due to adverse experiences, Medical Procedures, Specification of Medical Procedures, Concomitant Medication, Specification of Concomitant Medication, Adverse Experiences (Non-Serious), Specification of Adverse Experiences (Non-Serious), Pregnancy Information, Study Conclusion

Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Laboratory Collections, Urinalaysis, Pregnancy test follow-up

- 2019-06-21 - 1 Formulär, 4 Item-grupper, 17 Dataelement, 1 Språk

Item-grupper: Administrative Data, Laboratory Collection - Clinical chemistry and haematology, Laboratory Collection - Urinalysis, Pregnancy test

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Laboratory Collections, Urinalaysis and Pregnancy test for follow-up form. It has to be filled in at Follow-up.

Nyckelord

Innehållsförteckning

Valda datamodeller