keyword
MENU ▼
Read by QxMD icon Read
search

Clinical trial simulation

keyword
https://www.readbyqxmd.com/read/28227468/patient-emulator-a-tool-for-testing-mechanical-ventilation-therapies
#1
Nikolaos Karamolegkos, Antonio Albanese, Fernando Isaza, Nicolas W Chbat, Nikolaos Karamolegkos, Antonio Albanese, Fernando Isaza, Nicolas W Chbat, Nikolaos Karamolegkos, Antonio Albanese, Nicolas W Chbat, Fernando Isaza
Several modes of mechanical ventilation are clinically available. The differences among them in terms of efficacy and patient outcomes are not clear yet. Testing and comparison of mechanical ventilation modes via human or animal trials is a very challenging and costly process. In this paper, we present the patient emulator (PE), a novel system that can be used as a platform for in-silico testing of mechanical ventilation therapies. The system is based on a large-scale integrated mathematical model of the human cardiopulmonary system interfaced with a physical ventilator via a controlled piston-cylinder actuator...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28227083/creating-virtual-ards-patients
#2
Anup Das, Mainul Haque, Marc Chikhani, Wenfei Wang, Jonathan G Hardman, Declan G Bates, Anup Das, Mainul Haque, Marc Chikhani, Wenfei Wang, Jonathan G Hardman, Declan G Bates, Wenfei Wang, Declan G Bates, Anup Das, Mainul Haque, Marc Chikhani, Jonathan G Hardman
This paper presents the methodology used in patient-specific calibration of a novel highly integrated model of the cardiovascular and pulmonary pathophysiology associated with Acute Respiratory Distress Syndrome (ARDS). We focus on data from previously published clinical trials on the static and dynamic cardio-pulmonary responses of three ARDS patients to changes in ventilator settings. From this data, the parameters of the integrated model were identified using an optimization-based methodology in multiple stages...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226974/design-of-an-intraoperative-peritoneal-lavage-device
#3
Maria Ignacia Aguilera, Esteban J Pino, Maria Ignacia Aguilera, Esteban J Pino, Maria Ignacia Aguilera, Esteban J Pino
This paper consists of the design and construction of an intraoperative peritoneal lavage device. It is intended for cleaning the intra-abdominal cavity during a surgical procedure, once the etiology of a peritonitis has been identified and treated. Its purpose is to improve the current standard treatment consisting of simple pouring saline solution. A good washing procedure aids stopping the inflammatory and infectious process generated after the contamination due to the perforation of a hollow viscera. COMSOL Multiphysics software was used to simulate the biomechanical behavior of the liver against localized pressure...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28226770/a-multiscale-model-based-analysis-of-the-multi-tissue-interplay-underlying-blood-glucose-regulation-in-type-i-diabetes
#4
Federico Wadehn, Stephan Schaller, Thomas Eissing, Markus Krauss, Lars Kupfer, Federico Wadehn, Stephan Schaller, Thomas Eissing, Markus Krauss, Lars Kupfer, Federico Wadehn, Markus Krauss, Lars Kupfer, Stephan Schaller, Thomas Eissing
A multiscale model for blood glucose regulation in diabetes type I patients is constructed by integrating detailed metabolic network models for fat, liver and muscle cells into a whole body physiologically-based pharmacokinetic/pharmacodynamic (pBPK/PD) model. The blood glucose regulation PBPK/PD model simulates the distribution and metabolization of glucose, insulin and glucagon on an organ and whole body level. The genome-scale metabolic networks in contrast describe intracellular reactions. The developed multiscale model is fitted to insulin, glucagon and glucose measurements of a 48h clinical trial featuring 6 subjects and is subsequently used to simulate (in silico) the influence of geneknockouts and drug-induced enzyme inhibitions on whole body blood glucose levels...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28225816/bayesian-prediction-of-placebo-analgesia-in-an-instrumental-learning-model
#5
Won-Mo Jung, Ye-Seul Lee, Christian Wallraven, Younbyoung Chae
Placebo analgesia can be primarily explained by the Pavlovian conditioning paradigm in which a passively applied cue becomes associated with less pain. In contrast, instrumental conditioning employs an active paradigm that might be more similar to clinical settings. In the present study, an instrumental conditioning paradigm involving a modified trust game in a simulated clinical situation was used to induce placebo analgesia. Additionally, Bayesian modeling was applied to predict the placebo responses of individuals based on their choices...
2017: PloS One
https://www.readbyqxmd.com/read/28222783/walking-in-fully-immersive-virtual-environments-an-evaluation-of-potential-adverse-effects-in-older-adults-and-individuals-with-parkinson-s-disease
#6
Aram Kim, Nora Darakjian, James M Finley
BACKGROUND: Virtual reality (VR) has recently been explored as a tool for neurorehabilitation to enable individuals with Parkinson's disease (PD) to practice challenging skills in a safe environment. Current technological advances have enabled the use of affordable, fully immersive head-mounted displays (HMDs) for potential therapeutic applications. However, while previous studies have used HMDs in individuals with PD, these were only used for short bouts of walking. Clinical applications of VR for gait training would likely involve an extended exposure to the virtual environment, which has the potential to cause individuals with PD to experience simulator-related adverse effects due to their age or pathology...
February 21, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/28222778/sample-size-considerations-for-trials-using-cerebral-white-matter-hyperintensity-progression-as-an-intermediate-outcome-at-1%C3%A2-year-after-mild-stroke-results-of-a-prospective-cohort-study
#7
Francesca M Chappell, Maria Del Carmen Valdés Hernández, Stephen D Makin, Kirsten Shuler, Eleni Sakka, Martin S Dennis, Paul A Armitage, Susana Muñoz Maniega, Joanna M Wardlaw
BACKGROUND: White matter hyperintensities (WMHs) are commonly seen on in brain imaging and are associated with stroke and cognitive decline. Therefore, they may provide a relevant intermediate outcome in clinical trials. WMH can be measured as a volume or visually on the Fazekas scale. We investigated predictors of WMH progression and design of efficient studies using WMH volume and Fazekas score as an intermediate outcome. METHODS: We prospectively recruited 264 patients with mild ischaemic stroke and measured WMH volume, Fazekas score, age and cardiovascular risk factors at baseline and 1 year...
February 21, 2017: Trials
https://www.readbyqxmd.com/read/28219331/a-comparison-of-videolaryngoscopes-for-tracheal-intubation-in-predicted-difficult-airway-a-feasibility-study
#8
Maria Vargas, Antonio Pastore, Fulvio Aloj, John G Laffey, Giuseppe Servillo
BACKGROUND: Videolaryngoscopy has become increasingly attractive for the routine management of the difficult airway. Glidescope® is well studied in the literature while imago V-Blade® is a recent videolaryngoscope. This is a feasibility study with 1:1 case-control sequential allocation comparing Imago V-Blade ® and Glidescope® in predicted difficult airway settings. METHODS: Two senior anesthesiologists with no clinical experience in video assisted intubation but previously trained in a simulated scenario, performed the endotracheal intubations with Imago V-Blade® and Glidescope®...
February 20, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28217765/personalized-medicine-enrichment-design-for-dha-supplementation-clinical-trial
#9
Yang Lei, Matthew S Mayo, Susan E Carlson, Byron J Gajewski
Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28215045/a-generalized-partially-linear-mean-covariance-regression-model-for-longitudinal-proportional-data-with-applications-to-the-analysis-of-quality-of-life-data-from-cancer-clinical-trials
#10
Xueying Zheng, Guoyou Qin, Dongsheng Tu
Motivated by the analysis of quality of life data from a clinical trial on early breast cancer, we propose in this paper a generalized partially linear mean-covariance regression model for longitudinal proportional data, which are bounded in a closed interval. Cholesky decomposition of the covariance matrix for within-subject responses and generalized estimation equations are used to estimate unknown parameters and the nonlinear function in the model. Simulation studies are performed to evaluate the performance of the proposed estimation procedures...
February 19, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28211193/sequential-allocation-trial-design-in-anesthesia-an-introduction-to-methods-modeling-and-clinical-applications
#11
REVIEW
Matthias Görges, Guohai Zhou, Rollin Brant, J Mark Ansermino
Estimation of the dose-response curve for new anesthetic protocols typically focuses on identifying minimum effective doses. The application of a sequential experimental method is appropriate, as it minimizes sample size requirements by updating dose assignments based on information accrued from successive subjects. One approach is the up-and-down method for estimating the median effective dose in a patient population (ED50 ). Designs better suited for achieving greater than 50% effectiveness, include the biased coin approach, and continual reassessment method...
February 17, 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28211076/comparison-of-conditional-bias-adjusted-estimators-for-interim-analysis-in-clinical-trials-with-survival-data
#12
Masashi Shimura, Masahiko Gosho, Akihiro Hirakawa
Group sequential designs are widely used in clinical trials to determine whether a trial should be terminated early. In such trials, maximum likelihood estimates are often used to describe the difference in efficacy between the experimental and reference treatments; however, these are well known for displaying conditional and unconditional biases. Established bias-adjusted estimators include the conditional mean-adjusted estimator (CMAE), conditional median unbiased estimator, conditional uniformly minimum variance unbiased estimator (CUMVUE), and weighted estimator...
February 17, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28205038/clinical-trial-simulations-and-pharmacometric-analysis-in-pediatrics-application-to-inhaled-loxapine-in-children-and-adolescents
#13
Min Dong, Tsuyoshi Fukuda, Sally Selim, Mark A Smith, Laura Rabinovich-Guilatt, James V Cassella, Alexander A Vinks
BACKGROUND AND OBJECTIVES: Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetic study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to the predicted likelihood of achieving the target exposure associated with therapeutic effect in adults...
February 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28205004/maturation-of-oxycodone-pharmacokinetics-in-neonates-and-infants-a-population-pharmacokinetic-model-of-three-clinical-trials
#14
Pyry Välitalo, Merja Kokki, Veli-Pekka Ranta, Klaus T Olkkola, Andrew C Hooker, Hannu Kokki
PURPOSE: The aim of the current population pharmacokinetic study was to quantify oxycodone pharmacokinetics in children ranging from preterm neonates to children up to 7 years of age. METHODS: Data on intravenous or intramuscular oxycodone administration were obtained from three previously published studies (n = 119). The median [range] postmenstrual age of the subjects was 299 days [170 days-7.8 years]. A population pharmacokinetic model was built using 781 measurements of oxycodone plasma concentration...
February 15, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28202839/cost-outcome-description-of-peg-ifn-%C3%AE-2b-rbv-for-hepatitis-c-results-based-on-the-interferon-database
#15
Maiko Akutagawa, Yohei Kawasaki, Atsuko Kawasaki, Kazuki Ide, Hiroshi Yamada, Naohiko Masaki
Economic evaluation of drugs is used in decision-making on medical care and public policy. Recently, real-world data (RWD) have been used in the analysis. In this study, we discuss the risk and benefits of using RWD for economic evaluation. We conducted a cost-outcome description with RWD from a nationwide registry providing information on hepatitis treatment in Japan and estimated the utility of the analysis. We evaluated the cost-outcome description of peginterferon plus ribavirin (PEG-IFN-α2b + RBV) treatment in hepatitis C virus (HCV)-infected patients...
February 15, 2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28199931/a-personalized-3d-printed-prosthetic-joint-replacement-for-the-human-temporomandibular-joint-from-implant-design-to-implantation
#16
David C Ackland, Dale Robinson, Michael Redhead, Peter Vee Sin Lee, Adrian Moskaljuk, George Dimitroulis
Personalized prosthetic joint replacements have important applications in cases of complex bone and joint conditions where the shape and size of off-the-shelf components may not be adequate. The objective of this study was to design, test and fabricate a personalized 3D-printed prosthesis for a patient requiring total joint replacement surgery of the temporomandibular joint (TMJ). The new 'Melbourne' prosthetic TMJ design featured a condylar component sized specifically to the patient and fixation screw positions that avoid potential intra-operative damage to the mandibular nerve...
February 6, 2017: Journal of the Mechanical Behavior of Biomedical Materials
https://www.readbyqxmd.com/read/28197619/evaluating-a-modular-decision-support-application-for-colorectal-cancer-screening
#17
Laura G Militello, Julie B Diiulio, Morgan R Borders, Christen E Sushereba, Jason J Saleem, Donald Haverkamp, Thomas F Imperiale
BACKGROUND: There is a need for health information technology evaluation that goes beyond randomized controlled trials to include consideration of usability, cognition, feedback from representative users, and impact on efficiency, data quality, and clinical workflow. This article presents an evaluation illustrating one approach to this need using the Decision-Centered Design framework. OBJECTIVE: To evaluate, through a Decision-Centered Design framework, the ability of the Screening and Surveillance App to support primary care clinicians in tracking and managing colorectal cancer testing...
February 15, 2017: Applied Clinical Informatics
https://www.readbyqxmd.com/read/28195544/on-stratified-adjusted-tests-by-binomial-trials
#18
Asanao Shimokawa, Etsuo Miyaoka
To estimate or test the treatment effect in randomized clinical trials, it is important to adjust for the potential influence of covariates that are likely to affect the association between the treatment or control group and the response. If these covariates are known at the start of the trial, random assignment of the treatment within each stratum would be considered. On the other hand, if these covariates are not clear at the start of the trial, or if it is difficult to allocate the treatment within each stratum, completely randomized assignment of the treatment would be performed...
February 14, 2017: International Journal of Biostatistics
https://www.readbyqxmd.com/read/28192533/improving-medication-safety-development-and-impact-of-a-multivariate-model-based-strategy-to-target-high-risk-patients
#19
Tri-Long Nguyen, Géraldine Leguelinel-Blache, Jean-Marie Kinowski, Clarisse Roux-Marson, Marion Rougier, Jessica Spence, Yannick Le Manach, Paul Landais
BACKGROUND: Preventive strategies to reduce clinically significant medication errors (MEs), such as medication review, are often limited by human resources. Identifying high-risk patients to allow for appropriate resource allocation is of the utmost importance. To this end, we developed a predictive model to identify high-risk patients and assessed its impact on clinical decision-making. METHODS: From March 1st to April 31st 2014, we conducted a prospective cohort study on adult inpatients of a 1,644-bed University Hospital Centre...
2017: PloS One
https://www.readbyqxmd.com/read/28188841/bayesian-clinical-trial-design-using-markov-models-with-applications-to-autoimmune-disease
#20
Barry S Eggleston, Joseph G Ibrahim, Diane Catellier
Immune Thrombocytopenia is an autoimmune disease associated with bleeding that is treated by increasing the platelet count to a level where the chance of uncontrollable bleeding is low. Failure occurs when platelet counts are not raised sufficiently (initial failure), or when high platelet counts are not maintained after initial success (relapse). In this paper, we propose a Bayesian clinical trial design that uses a Markov multistate model along with a power prior for the parameters which incorporates historical control data to estimate transition rates among two randomized groups as defined by the model...
February 7, 2017: Contemporary Clinical Trials
keyword
keyword
36338
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"