Technical Note: In silico imaging tools from the VICTRE clinical trial

2019 ◽  
Vol 46 (9) ◽  
pp. 3924-3928 ◽  
Author(s):  
Diksha Sharma ◽  
Christian G. Graff ◽  
Andreu Badal ◽  
Rongping Zeng ◽  
Purva Sawant ◽  
...  
Keyword(s):  
Clinical Trial ◽  
In Silico ◽  
Technical Note

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals Personalised high tibial osteotomy has mechanical safety equivalent to generic device in a case–control in silico clinical trial

2021 ◽  
Vol 1 (1) ◽  
Author(s):  
Alisdair R. MacLeod ◽  
Nicholas Peckham ◽  
Gil Serrancolí ◽  
Ines Rombach ◽  
Patrick Hourigan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Relative Risk ◽  
Knee Osteoarthritis ◽  
High Tibial Osteotomy ◽  
Fatigue Failure ◽  
In Silico ◽  
Odds Ratio ◽  
Case Control ◽  
Tibial Osteotomy ◽  
3D Printed

Abstract Background Despite favourable outcomes relatively few surgeons offer high tibial osteotomy (HTO) as a treatment option for early knee osteoarthritis, mainly due to the difficulty of achieving planned correction and reported soft tissue irritation around the plate used to stablise the osteotomy. To compare the mechanical safety of a new personalised 3D printed high tibial osteotomy (HTO) device, created to overcome these issues, with an existing generic device, a case-control in silico virtual clinical trial was conducted. Methods Twenty-eight knee osteoarthritis patients underwent computed tomography (CT) scanning to create a virtual cohort; the cohort was duplicated to form two arms, Generic and Personalised, on which virtual HTO was performed. Finite element analysis was performed to calculate the stresses in the plates arising from simulated physiological activities at three healing stages. The odds ratio indicative of the relative risk of fatigue failure of the HTO plates between the personalised and generic arms was obtained from a multi-level logistic model. Results Here we show, at 12 weeks post-surgery, the odds ratio indicative of the relative risk of fatigue failure was 0.14 (95%CI 0.01 to 2.73, p = 0.20). Conclusions This novel (to the best of our knowledge) in silico trial, comparing the mechanical safety of a new personalised 3D printed high tibial osteotomy device with an existing generic device, shows that there is no increased risk of failure for the new personalised design compared to the existing generic commonly used device. Personalised high tibial osteotomy can overcome the main technical barriers for this type of surgery, our findings support the case for using this technology for treating early knee osteoarthritis.

scholarly journals Results of a Multicentric In Silico Clinical Trial (ROCOCO): Comparing Radiotherapy with Photons and Protons for Non-small Cell Lung Cancer

2012 ◽  
Vol 7 (1) ◽  
pp. 165-176 ◽  
Author(s):  
Erik Roelofs ◽  
Martijn Engelsman ◽  
Coen Rasch ◽  
Lucas Persoon ◽  
Sima Qamhiyeh ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
In Silico ◽  
Small Cell ◽  
Small Cell Lung

An “in silico” clinical trial comparing free breathing, slow and respiration correlated computed tomography in lung cancer patients

2006 ◽  
Vol 81 (1) ◽  
pp. 73-80 ◽  
Author(s):  
Geert Bosmans ◽  
Jeroen Buijsen ◽  
André Dekker ◽  
Marije Velders ◽  
Liesbeth Boersma ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Cancer Patients ◽  
In Silico ◽  
Free Breathing ◽  
Lung Cancer Patients

scholarly journals In-silico clinical trial using high performance computational modeling of a virtual human cardiac population to assess drug-induced arrhythmic risk

2021 ◽  
Author(s):  
Jazmin Aguado-Sierra ◽  
Constantine Butakoff ◽  
Renee Brigham ◽  
Apollo Baron ◽  
Guillaume Houzeaux ◽  
...  
Keyword(s):  
Clinical Trial ◽  
In Silico ◽  
High Performance ◽  
Drug Induced ◽  
Computational Framework ◽  
Major Health ◽  
Action Potential Prolongation ◽  
Performance Computing ◽  
Major Health Issue

AbstractDrug-induced arrhythmia continues to be a major health issue worldwide. The need for reliable pro-arrhythmic predictors became relevant during early phases of the SarsCoV2 pandemic, when it was uncertain whether the use of hydroxychloroquine (HCQ) and azithromycin (AZM) could be more harmful than beneficial due to their reported pro-arrhythmic effects.In this work we describe a computational framework that employs a gender-specific, in-silico cardiac population to assess cardiac drug-induced QT-prolongation after the administration of a single or a combination of potentially cardiotoxic drugs as HCQ and AZM. This novel computational methodology is capable of reproducing the complex behavior of the clinical electrocardiographic response to drug-induced arrhythmic risk, in-silico. Using high performance computing, the computational framework allows the estimation of the arrhythmic risk in a population, given a variety of doses of one or more drugs in a timely manner and providing markers that can be directly related to the clinical scenario. The pro-arrhythmic behavior observed in subjects within the in-silico trial, was also compared to supplemental in-vitro experiments on a reanimated swine hearts. Evidence of transmurally heterogeneous action potential prolongation after the administration of a large dose of HCQ was an observed mechanism of arrhythmia, both in the in-vitro and the in-silico model. The virtual clinical trial also provided remarkably similar results to recent published clinical data. In conclusion, the in-silico clinical trial on the cardiac population is capable of reproducing and providing evidence of the normal phenotype variants that produce distinct arrhythmogenic outcomes after the administration of one or various drugs.

scholarly journals Bayesian Augmented Clinical Trials in TB Therapeutic Vaccination

2021 ◽  
Vol 3 ◽  
Author(s):  
Dimitrios Kiagias ◽  
Giulia Russo ◽  
Giuseppe Sgroi ◽  
Francesco Pappalardo ◽  
Miguel A. Juárez
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Posterior Distribution ◽  
In Silico ◽  
Therapeutic Vaccination ◽  
Virtual Patients ◽  
Bayesian Hierarchical ◽  
Bayesian Hierarchical Method ◽  
Joint Posterior Distribution

We propose a Bayesian hierarchical method for combining in silico and in vivo data onto an augmented clinical trial with binary end points. The joint posterior distribution from the in silico experiment is treated as a prior, weighted by a measure of compatibility of the shared characteristics with the in vivo data. We also formalise the contribution and impact of in silico information in the augmented trial. We illustrate our approach to inference with in silico data from the UISS-TB simulator, a bespoke simulator of virtual patients with tuberculosis infection, and synthetic physical patients from a clinical trial.

scholarly journals In silico comparative study of SARS-CoV-2 proteins and antigenic proteins in BCG, OPV, MMR and other vaccines: evidence of possible putative protective effect

2020 ◽  
Author(s):  
Sondes Haddad-Boubaker ◽  
Houcemeddine Othman ◽  
Rabeb Touati ◽  
Kaouther Ayouni ◽  
Marwa Lakhal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hepatitis B ◽  
Comparative Study ◽  
Protective Effect ◽  
In Silico ◽  
Severe Pneumonia ◽  
Therapeutic Interventions ◽  
Prediction Tools ◽  
Antigenic Proteins ◽  
Antigenic Properties

Abstract Background:Coronavirus Disease 19 (COVID-19) is a viral pandemic disease that induces severe pneumonia in human. Until now, no effective therapeutic interventions or specific vaccines have been developed. In this paper, we attempt to investigate the putative implication of 12 vaccines, including BCG, OPV and MMR in the protection against COVID-19. First, we compared sequences of the main antigenic proteins in the investigated vaccines and SARS-CoV-2 proteins. Then, we investigated identified segments using a combination of structural and antigenicity prediction tools to assess their immunogenic effect.Results:A total of 14 highly similar segments were identified in investigated vaccines. After mapping on S and N proteins and analysis of the antigenicity prediction, three segments, in Hepatitis B, Tetanus and Measles proteins showed structural and antigenic properties that can induce possible putative protective effect.Conclusions:HBV, Tetanus and Measles vaccines should constitute a good candidate for a clinical trial to evaluate their real protective effect against COVID-19.

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