Modèles de données sélectionnés

Vous devez être connecté pour sélectionner plusieurs modèles de données, les télécharger ou les analyser.

8 Résultats de recherche.
Pertinence Commentaire Plus récent Moins récent

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 2: OUTCOME CASE REPORT FORM

- 11.08.21 - 1 Formulaire, 7 Groupes Item, 195 Eléments de données, 1 Langue
Groupes Item: Participant Identification, Summary of clinical features of current illness, Laboratory results, Imaging and pathogen testing, Treatment, Supportive care, Outcome
Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). This Module is to be completed at time of discharge or death.

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Topotecan Post-Study Minimal Follow-up Report

- 21.08.19 - 1 Formulaire, 5 Groupes Item, 19 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Follow-Up Report, Month, Patient Outcome, Cessation of life, Investigator Signature
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540 - Clinical evaluation, Clinical outcome, Description of Clinical Failure

- 11.03.19 - 1 Formulaire, 4 Groupes Item, 20 Eléments de données, 1 Langue
Groupes Item: Administrative data, Clinical evaluation, Clinical Outcome Determination, Description of Clinical Failure
Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Clinical evaluation, Clinical outcome and Description of Clinical Failure form. It has to be filled in for Visit 2-5. Note for Clinical outcome determination: At the On-Therapy visit, the bacteriology sample and clinical outcome determination was only to be conducted in cases of clinical failure and/or withdrawal.

Concomitant Medication, Adverse Event, SAE - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 15.10.17 - 1 Formulaire, 6 Groupes Item, 77 Eléments de données, 1 Langue
Groupes Item: Concomitant Medication, Concomitant Medication, Adverse event, adverse event, Subject death, Serious adverse event
Concomitant Medication, Adverse Event, SAE - 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

Phase A - Year 2 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 03.09.17 - 1 Formulaire, 20 Groupes Item, 71 Eléments de données, 1 Langue
Groupes Item: Varicella or zoster case, Varicella intensity, Subjective assessment of the illness by investigator, Photographs, Weekdays location, Varicella or zoster index case, Confirmation of index case, Biological sample varicella, Biological sample varicella, Rash, Lesion - Intensity, Vesicles - Intensity, Temperature, Temperature, End Date Varicella or zoster, Health economics, Pain, Complications, Treatment, Outcome
Phase A - Year 2 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

- 29.08.17 - 1 Formulaire, 20 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Varicella or zoster case, Varicella intensity, Subjective assessment of the illness by investigator, Photographs, Weekdays location, Varicella or zoster index case, Confirmation of index case, Biological sample varicella, Biological sample varicella, Rash, Lesion - Intensity, Vesicles - Intensity, Temperature, Temperature, End Date Varicella or zoster, Health economics, Pain, Complications, Treatment, Outcome
Phase A - Year 1 - Varicella /Zoster Case Form - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Varicella /Zoster Case Form

- 24.08.17 - 1 Formulaire, 20 Groupes Item, 72 Eléments de données, 1 Langue
Groupes Item: Varicella or zoster case, Varicella intensity, Subjective assessment of the illness by investigator, Photographs, Weekdays location, Varicella or zoster index case, Confirmation of index case, Biological sample varicella, Biological sample varicella, Rash, Lesion - Intensity, Vesicles - Intensity, Temperature, Temperature, End Date Varicella or zoster, Health economics, Pain, Complications, Treatment, Outcome
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Varicella /Zoster Case Form Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis overall appraisal of treatment - Case Report Form: overall appraisal of treatment

- 26.01.16 - 1 Formulaire, 3 Groupes Item, 7 Eléments de données, 1 Langue
Groupes Item: Appraisal by Investigator, Appraisal by patient, Date and Signature
Prospective,multicentric,double blind and placebo-controlled Phase III clinical trial to determine efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in patients with allergic rhinoconjunctivits caused by grass or rye pollen. EudraCT-Nr. 2008-000513-29 Study-code:CLU-2008-001 Sponsor: ROXALL Medizin GmbH Carl-Petersen-Straße 4 20535 Hamburg Phone:040-8972520 Fax:040-89725223 Project coordinator: Dr.Jenny Uhlig ROXALL Medizin GmbH Head of clinical investigation: Prof.Dr.med.Ludger Klimek An den Quellen 10 65183 Wiesbaden Phone:0611-8904381 Fax:0611-3082360 Monitoring,data management and statistical evaluation: IMSIE- Institut for medical statistics,computer sciences and epidemiology University hospital Cologne Lindenburger Allee 42 50931 Cologne Phone:0221-4783456 Fax:0221-4783465

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial