Comparison of BARD®LIFESTREAM™ Covered Balloon-Expandable Stent Versus GORE® VIABAHN™ Covered Self-Expandable Stent in Treatment of Aortoiliac Obstructive Disease: Study Protocol for a Prospective Randomized Controlled Trial(NEONATAL Trial)

2021 ◽  
Author(s):  
Yu-Han Qi ◽  
Jiarong Wang ◽  
Jichun Zhao ◽  
Bing Huang ◽  
Fei Xiong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Target Lesion ◽  
Bare Metal Stent ◽  
Covered Stent ◽  
Stent Group ◽  
Randomized Controlled ◽  
Obstructive Disease ◽  
Disease Study

Abstract Background Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with higher patency rate compared to bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD up to date. Therefore, this study aims to compare the efficacy and safety of CBE stent (BARD®LIFESTR`EAM™) and CSE stent (GORE® VIABAHN™) in AIOD. Methods This trial is a prospective, single center, paralleled, non-inferiority, randomized controlled trial. A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or CSE stent group. The primary end point of the study is occurrence of Target Lesion Revascularization (TLR) at 12 months after the intervention. Discussion To our knowledge, the NEONATAL trial is the first RCT to compare CBE and CSE stent in AIOD patients. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in treatment of AIOD patients. Trial registration: ChiCTR2100046734; Registered on 27 May, 2021 in Chinese Clinical Trials Registry.

scholarly journals Mitochondrial Reprogramming—What Is the Benefit of Hypothermic Oxygenated Perfusion in Liver Transplantation?

2021 ◽  
Vol 2 (2) ◽  
pp. 149-161
Author(s):  
Rebecca Panconesi ◽  
Mauricio Flores Carvalho ◽  
Matteo Mueller ◽  
Philipp Dutkowski ◽  
Paolo Muiesan ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Cohort Studies ◽  
Controlled Trial ◽  
Machine Perfusion ◽  
Randomized Controlled ◽  
Hypothermic Perfusion ◽  
Underlying Mechanisms ◽  
Circulatory Death

Although machine perfusion is a hot topic today, we are just at the beginning of understanding the underlying mechanisms of protection. Recently, the first randomized controlled trial reported a significant reduction of ischemic cholangiopathies after transplantation of livers donated after circulatory death, provided the grafts were treated with an endischemic hypothermic oxygenated perfusion (HOPE). This approach has been known for more than fifty years, and was initially mainly used to preserve kidneys before implantation. Today there is an increasing interest in this and other dynamic preservation technologies and various centers have tested different approaches in clinical trials and cohort studies. Based on this, there is a need for uniform perfusion settings (perfusion route and duration), and the development of general guidelines regarding the duration of cold storage in context of the overall donor risk is also required to better compare various trial results. This article will highlight how cold perfusion protects organs mechanistically, and target such technical challenges with the perfusion setting. Finally, the options for viability testing during hypothermic perfusion will be discussed.

Testing Meldonium: Assessing Soviet pragmatic alternatives to the randomized controlled trial

2021 ◽  
pp. 174077452110085
Author(s):  
Anastasiya Chirkova ◽  
Alexander Petrenko ◽  
Pavel Vasilyev
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Soviet Union ◽  
Drug Testing ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Experimental Drugs ◽  
The Soviet Union ◽  
Experimental Drug ◽  
Second World

Background/aims Current research largely tends to ignore the drug-testing model that was developed in the “Second World” as an explicit alternative to the randomized controlled trial. This system can be described as “socialist pharmapolitics,” accounting for the specific features of state socialism that influenced the development and testing of experimental drugs. The clinical trials model employed in the “Second World” was heavily influenced by the Soviet Union, which was by far the most influential player in the socialist bloc during the Cold War. Based on extensive archival research, this article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It accounts for the divergences between the official model prescribed by the Soviet authorities and the messy realities of healthcare practice. It further outlines different factors that ultimately shaped how clinical trials were organized in Soviet institutions “on the ground.” Accordingly, this article presents a “real-life” history of “socialist pharmapolitics” and outlines the problems that this system faced in practice. Methods Archival research was conducted at the Russian State Archive of Scientific and Technical Documentation in Moscow. Archival files include scientific, technical, and registration documentation such as biochemical, pharmacological, and clinical descriptions of the experimental drug Meldonium, letters between various hospitals, research institutes and the Soviet regulatory body, as well as 26 reports of completed clinical trials. Manual content analysis was used for the interpretation of results. Results This article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It demonstrates some key differences from the randomized controlled trial model. This article also highlights some of the discrepancies between the model that was officially prescribed by the Soviet authorities and the realities of experimental drug testing in the Soviet Union in the late 1980s and early 1990s. In particular, it notes some elements of randomization, double-blinding, and the use of placebo that were present in Meldonium trials despite being formally denounced by Soviet bioethics. Conclusion The Soviet model for testing experimental drugs differed from the Western one substantially in a number of respects. This difference was not only proclaimed officially by the Soviet authorities, but was for the most part enforced in clinical trials in practice. At the same time, our research demonstrates that there were important differences between the official model and the clinical realities on the ground.

scholarly journals Recruiting to Clinical Trials on the Telephone – a randomized controlled trial

Trials ◽  
2016 ◽  
Vol 17 (1) ◽  
Author(s):  
Kim Thestrup Foss ◽  
Jesper Kjærgaard ◽  
Lone Graff Stensballe ◽  
Gorm Greisen
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Preparación psicológica para la intervención quirúrgica: Revisión sistemática de la literatura

Psychologia ◽  
2016 ◽  
Vol 10 (2) ◽  
pp. 73-85
Author(s):  
Francisco Cázares de León ◽  
Stefano Vinaccia ◽  
Japcy Quiceno ◽  
Blanca Montoya
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Psychological Preparation ◽  
Randomized Controlled ◽  
Palabras Clave ◽  
Revisión Sistemática

El objetivo de este artículo de revisión fue examinar y analizar la eficacia de los tipos de preparación psicológica empleados en los últimos ocho años para disminuir el estrés, la ansiedad y otras emociones de los pacientes ante un procedimiento quirúrgico. Método: Se realizó una revisión de literatura sobre la preparación psicológica en diferentes intervenciones quirúrgicas. Se realizó una búsqueda en la base de datos Medline y SCielo, utilizando las palabras clave: «psychological preparation for surgery» «psychological intervention and surgery» y se delimitó la búsqueda con las palabras «clinical trials» y «randomized controlled trial». Los criterios de inclusión fueron: ensayos clínicos controladosaleatorizados con resultados relacionados con la eficacia de la reducción del estrés, ansiedad y otras emociones. Se encontraron 17 ensayos clínicos que cumplieron los criterios de inclusión en la base de datos PubMed. En base de datos SciELO solo se encontraron dos estudios. Los datos nos muestran que las tendencias en preparación psicológica se han enfocado más a los procedimientos como la cirugía electiva, cirugía pediátrica, procedimientos con agujas, cirugías de corazón, cirugías para el cáncer y para la cirugía bariátrica. Sin embargo, la perspectiva de estas investigaciones tal vez pudiera centrarse en las enfermedades crónica degenerativas y con más estudios mejorados metodológicamente

Digital instruments for reporting of gastrointestinal symptoms in clinical trials: comparison of end-of-day diaries versus experience sampling method (Preprint)

2021 ◽  
Author(s):  
Abraham B. Beckers ◽  
Johanna T.W. Snijkers ◽  
Zsa Zsa R.M. Weerts ◽  
Lisa Vork ◽  
Tim Klaassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Sampling Method ◽  
Sampling Methods ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Irritable Bowel

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.

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