The European Association of Echocardiography (EAE) has developed the present recommendations to assist clinical researchers in the design, implementation, and conduction of echocardiographic protocols for clinical trials and to guarantee their quality. Clinical trials should be designed and conducted based on the knowledge of the pathophysiology of the clinical condition studied, the technical characteristics of the echo-Doppler modalities, and the variability of the tested parameters. These procedures are important to choose the most reliable and reproducible techniques and parameters. Quality assurance must be guaranteed by adequate training of peripheral site operators to obtain optimal echo-Doppler data and by using a core laboratory for accurate and reproducible data analysis.
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http://dx.doi.org/10.1093/ejechocard/jer051 | DOI Listing |
Ann Med
December 2025
Department of Hematology, Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine, Hangzhou, China.
Background: The management of high-risk acute myeloid leukaemia (AML) remains challenging, highlighting the need for innovative conditioning strategies beyond current regimens.
Methods: In the present single-arm study, a FACT regimen comprised of low-dose total body irradiation (TBI) with fludarabine, cytarabine and cyclophosphamide was employed to treat cytogenetically high-risk AML patients exhibiting pre-transplant active disease. This clinical trial is registered in the Chinese Clinical Trial Registry with the registration number ChiCTR2000035111.
Zh Nevrol Psikhiatr Im S S Korsakova
December 2024
S.D. Asfendiyarov Kazakh National Medical University, Almaty, Republic of Kazakhstan.
Chronic cerebral ischemia (CCI) is one of the most common forms of cerebrovascular disease, which affects a significant number of patients, often leading to disability, cognitive impairment and dementia. The analysis of modern data on the pathogenesis and risk factors for the development of CCI, as well as on the mechanisms of action of Mexidol on various links in the pathogenesis of CCI. A systematic search was conducted in the PubMed, MEDLINE and Google Scholar databases, on Russian and English-language sites with open access publications on the problem of CCI and on the drug Mexidol in the period from 2014 to 2024.
View Article and Find Full Text PDFZh Nevrol Psikhiatr Im S S Korsakova
December 2024
Novosibirsk State Medical University, Novosibirsk, Russia.
Objective: To evaluate the effectiveness of complex rehabilitation measures using the drug Cortexin in children with neuropsychiatric pathology during a one-year follow-up.
Material And Methods: A promising dynamic examination and treatment of 323 children with neuropsychiatric pathology from the age of 7 days to 1 year, age 3.2±1.
Zh Nevrol Psikhiatr Im S S Korsakova
December 2024
GUTA-CLINIC LLC, Moscow, Russia.
Objective: Evaluation of the safety and effectiveness of Relatox, botulinum toxin type A in patients with focal spasticity (FS) of the upper limb as a result of a cerebrovascular accident (CVA) or traumatic brain injury (TBI).
Material And Methods: A multicenter, prospective, single-blinded, randomized, comparative clinical study included 210 patients of both sexes aged 18-75 years after moderate to severe TBI and CVA in seven sites in the Russian Federation. The patients were randomized into two groups.
Pharm Stat
December 2024
Biostatistics, Daiichi Sankyo Inc, Basking Ridge, USA.
In early phase drug development of combination therapy, the primary objective is to preliminarily assess whether there is additive activity from a novel agent when combined with an established monotherapy. Due to potential feasibility issues for conducting a large randomized study, uncontrolled single-arm trials have been the mainstream approach in cancer clinical trials. However, such trials often present significant challenges in deciding whether to proceed to the next phase of development due to the lack of randomization in traditional two-arm trials.
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