EUDRACT


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AcronymDefinition
EUDRACTEuropean Union Drug Regulating Authorities Clinical Trials (database)
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References in periodicals archive ?
REIMAGINE-AD (EudraCT Number 2019-001436-54) is interrogating aggression in a moderate Alzheimer's disease population.
(113.) EudraCT Number: 2015-001265-11, A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for 6 Months or Less by Leber Hereditary Optic Neuropathy Due to the G11778A Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene.
ORTHOUNION is a multicentre, open, comparative, randomized, clinical trial with three parallel arms to evaluate the efficacy at one and two years of two doses of an ATMP against iliac bone autograft to enhance bone healing in patients with long bone nonunion (EudraCT number 2015-000431-32).
This study was registered as EudraCT #2013-004807-38 and was approved by the Ethics Committee of the academic hospital (CHU of Liege).
INSPIRE II (NCT01190111) was a single-arm trial conducted in the United States and Canada, whereas INSPIRE III (EudraCT; number 2010-019773-15) was a dual arm trial with 3: 1 randomization of r-hIL-7 versus control conducted in South Africa and Europe.
The clinical study was registered at Clinicaltrials.gov NCT01083329 and EudraCT 2009-012124-85.
The study was done in accordance to national and international ethical guidelines (Declaration of Helsinki) and approved by the local Ethics Committee of Clinical Research (CEIC) from Parc de Salut Mar (Code IMIMFTCL/GH/2) and the Spanish Medicines Agency (EUDRACT number 2012-003695-38).
(28) The European Parliament required registration on a European database (European Union Drug Regulating Authorities Clinical Trials (EudraCT)) (29) in the Clinical Trials Directive (Directive 2001/20/EC).
[6.] SIOP-RTSG:SIOP WT 2001 Nephroblastoma clinical trial and study, 2001 EudraCT number 2007-004591-39.
The study was approved by the local Ethics Committee (H-4-2011-007), the Danish Medicines Agency (EudraCT no.