Risultati di ricerca - Portale di modelli di dati medici (MDM-Portal)

Itemgroups: Administrative, Concomitant Medication, Concomitant Medication , Adverse Event, Adverse Event , Advrese Event - Investigator’s Signature, Serious Adverse Event, Serious Adverse Event - Relevant Laboratory Data, Serious Adverse Event - Investigator's Signature

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

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Concomitant Medication; Pre-Medication prior to Infusion; RA Concomitant Medications; Corticosteroid Injection; Methotrexate Concomitant Medications

- 31/03/2020 - 1 modulo, 5 itemgroups, 67 elementi, 1 linguaggio

Itemgroups: Concomitant Medications, Pre-Medication prior to Infusion, RA Concomitant Medications , Corticosteroid Injection, Methotrexate Concomitant Medications

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Cumulative documentation - Medication (Kumulative Dokumentation - Medikation)

- 23/03/2020 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative Data, Medication

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the cumulative documentation - medication. Prior medication should be filled in at baseline. Medication that are performed during the study period should be added in the course of the study.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Concomitant medication

- 04/03/2020 - 1 modulo, 2 itemgroups, 18 elementi, 1 linguaggio

Itemgroups: Administrative Data, Concomitant Medication

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the concomitant medication form. It has to be filled in if concomitant medication has been taken by subject during the study.

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Subject Logs - Log Status; Concomitant Medications; Non-Serious Adverse Event; Serious Adverse Events

- 24/02/2020 - 1 modulo, 15 itemgroups, 131 elementi, 1 linguaggio

Itemgroups: Date of Visit/ Assessment, Log Status, Concomitant Medications, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Intensity Changes, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Events - Relevant Medical Conditions/ Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Rechallenge, Serious Adverse Event - Investigational Product, Serious Adverse Event - Non clinical

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Screening - Medical History; PD Stage Prior Med; PR/ Conmeds

- 09/01/2020 - 1 modulo, 8 itemgroups, 34 elementi, 1 linguaggio

Itemgroups: Administrative, General Medical History - Cardiovascular Risk Factors, Family history - Cardiovascular Risk Factors , Medical Conditions, Tobacco Use, Parkinson's Disease History, Pre-study Parkinson's Disease Medication, Prior/ Current Concomitant Medications

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

Brain Penetration by [Carbonyl-11C] GSK1034702; 110771 - Concomitant Medications

- 18/12/2019 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Concomitant Agent

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy 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: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Concomitant Medication

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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Concomitant Medication; Adverse Event; Serious Adverse Event