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Clinical trial simulation

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https://www.readbyqxmd.com/read/28917227/pharmacoeconomics-of-parenteral-nutrition-in-surgical-and-critically-ill-patients-receiving-structured-triglycerides-in-china
#1
Guo Hao Wu, Alexandra Ehm, Marco Bellone, Lorenzo Pradelli
BACKGROUND AND OBJECTIVES: A prior meta-analysis showed favorable metabolic effects of structured triglyceride (STG) lipid emulsions in surgical and critically ill patients compared with mixed medium-chain/long-chain triglycerides (MCT/LCT) emulsions. Limited data on clinical outcomes precluded pharmacoeconomic analysis. We performed an updated meta-analysis and developed a cost model to compare overall costs for STGs vs MCT/LCTs in Chinese hospitals. METHODS AND STUDY DESIGN: We searched Medline, Embase, Wanfang Data, the China Hospital Knowledge Database, and Google Scholar for clinical trials comparing STGs to mixed MCT/LCTs in surgical or critically ill adults published between October 10, 2013 and September 19, 2015...
2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28915960/pleiotropic-effects-of-metformin-to-rescue-statin-induced-muscle-injury-and-insulin-resistance-a-proposed-mechanism-and-potential-clinical-implications
#2
Nicholas W Carris, Srinivas M Tipparaju, David J Magness, Kalyan C Chapalamadugu, Ronald R Magness
The 2013 American Heart Association Blood Cholesterol Guidelines increased the number of patients recommended for statin therapy in the United States to 56million. Two common statin side effects are muscle pain, referred to as "statin-associated muscle symptoms", and increased risk for new onset type-2-diabetes mellitus. Up to 25% of statin users report muscle symptoms resulting in many patients being switched to lower dose or lower potency statins, or refusing statins altogether. The most likely signaling mechanisms for statin-associated muscle symptoms overlaps with the proposed mechanism of statin-induced insulin resistance...
September 2017: Medical Hypotheses
https://www.readbyqxmd.com/read/28913897/studying-the-progression-of-amyloid-pathology-and-its-therapy-using-translational-longitudinal-model-of-accumulation-and-distribution-of-amyloid-beta
#3
Tatiana Karelina, O Demin, Oleg Demin, Sridhar Duvvuri, Timothy Nicholas
Long term effects of amyloid targeted therapy can be studied using a mechanistic translational model of Aβ distribution and aggregation calibrated on published data in mouse and human species. AD pathology is modelled utilizing age-dependent pathological evolution for rate constants and several variants of explicit functions for Aβ toxicity influencing cognitive outcomes (Adas-cog). Preventive Aβ targeted therapies were simulated to minimize the Aβ difference from healthy physiological levels. Therapeutic targeted simulations provided similar predictions for mouse and human...
September 15, 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28900858/methodological-aspects-in-studies-based-on-clinical-routine-data
#4
REVIEW
Lieven Nils Kennes
Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demonstrated in a recent real-case study based on clinical routine data...
September 12, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28898688/improving-non-technical-skills-teamwork-in-post-partum-haemorrhage-a-grouped-randomised-trial
#5
Pippa M Letchworth, Shane P Duffy, Dan Phillips
OBJECTIVE: To determine the effect of a decision support technology on teamwork and associated non-technical (NTS) and technical skills when teams manage post-partum haemorrhage (PPH) in the simulated environment. METHODS: Multidisciplinary (MDT) maternity teams were taught how to manage post partum haemorrhage. They were randomised to the intervention: using a decision support mobile digital platform or a control group. Each team managed a post-partum simulation, which was recorded and reviewed by assessors...
August 26, 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28892776/clinical-trial-simulations-in-paediatric-oncology-a%C3%A2-feasibility-study-from-the-innovative-therapies-for-children-with-cancer-consortium
#6
Julie M Janssen, C Michel Zwaan, Jan H M Schellens, Jos H Beijnen, Alwin D R Huitema
INTRODUCTION: Paediatric dose-finding studies are challenging to perform due to ethical reasons, the limited number of available patients and restricted number of blood samples. In certain cases, the adult pharmacokinetic (PK) exposure can be used as target for dose finding in paediatrics. The aim of this study was to investigate the performance of a paediatric phase I dose-finding clinical trial in silico. METHODS: Using an adult pharmacokinetic model, clinical trial simulations were performed to determine the power of a proposed clinical trial design...
September 8, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28886277/a-comparison-of-multiple-imputation-methods-for-incomplete-longitudinal-binary-data
#7
Yusuke Yamaguchi, Toshihiro Misumi, Kazushi Maruo
Longitudinal binary data are commonly encountered in clinical trials. Multiple imputation is an approach for getting a valid estimation of treatment effects under an assumption of missing at random mechanism. Although there are a variety of multiple imputation methods for the longitudinal binary data, a limited number of researches have reported on relative performances of the methods. Moreover, when focusing on the treatment effect throughout a period that has often been used in clinical evaluations of specific disease areas, no definite investigations comparing the methods have been available...
September 8, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28886190/correlation-among-baseline-variables-yields-non-uniformity-of-p-values
#8
Rebecca A Betensky, Sy Han Chiou
A recent paper in Neurology used statistical techniques to investigate the integrity of the randomization in 33 clinical trials conducted by a group of investigators. Without justification, the approach assumed that there would be no impact of correlation among baseline variables. We investigated the impact of correlation on the conclusions of the approach in several large-scale simulation studies that replicated the sample sizes and baseline variables of the clinical trials in question and utilized proper randomization...
2017: PloS One
https://www.readbyqxmd.com/read/28884844/an-open-label-clinical-trial-assessing-the-efficacy-and-safety-of-bend-skincare-anti-aging-formula-on-minimal-erythema-dose-in-skin
#9
Nancy L Morse, Anna-Jean Reid, Marc St-Onge
BACKGROUND/PURPOSE: Sunburn and other health risks associated with excess sun exposure place huge economic burdens on societies, and create discomfort and disease within susceptible individuals. Oral supplements that reduce sunburn may be advantageous. This study evaluated the safety and efficacy of Bend Skincare Anti-Aging Formula to ameliorate sunburn induced with a solar simulator. METHODS: Subjects (n= 28) with Fitzpatrick skin phototypes I, II or III took four capsules daily of the supplement providing 1400 mg of eicosapentaenoic acid (EPA)+ docosahexaenoic acid (DHA), 120 mg of gamma-linolenic acid (GLA), 5 mg of lutein, 2...
September 8, 2017: Photodermatology, Photoimmunology & Photomedicine
https://www.readbyqxmd.com/read/28882196/simultaneous-determination-of-acetylsalicylic-acid-hydrochlorothiazide-enalapril-and-atorvastatin-in-a-polypill-based-quaternary-mixture-by-tlc
#10
Anna Maślanka, Mariusz Stolarczyk, Anna Apola, Anna Kwiecień, Urszula Hubicka, Włodzimierz Opoka
A new chromatographic-densitometric method has been developed for the qualitative and quantitative determination of the active ingredients in a simulated mixture corresponding to the PolyIran polypill, composed of acetylsalicylic acid, hydrochlorothiazide (HCT), enalapril (ENA), and atorvastatin (ATR), whose efficacy in the treatment and prevention of cardiovascular disease has been documented in clinical trials. Chromatographic separation was performed using TLC silica gel 60 plates with fluorescent indicator F254 as the stationary phase and a mixture of n-hexane-ethyl acetate-methanol-water-acetic acid (8...
September 7, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28881249/cost-effectiveness-analysis-of-pet-ct-guided-management-for-locally-advanced-head-and-neck-cancer
#11
A F Smith, P S Hall, C T Hulme, J A Dunn, C C McConkey, J K Rahman, C McCabe, H Mehanna
BACKGROUND: A recent large United Kingdom (UK) clinical trial demonstrated that positron-emission tomography-computed tomography (PET-CT)-guided administration of neck dissection (ND) in patients with advanced head and neck cancer after primary chemo-radiotherapy treatment produces similar survival outcomes to planned ND (standard care) and is cost-effective over a short-term horizon. Further assessment of long-term outcomes is required to inform a robust adoption decision. Here we present results of a lifetime cost-effectiveness analysis of PET-CT-guided management from a UK secondary care perspective...
September 4, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28875168/ceftazidime-avibactam-has-potent-sterilizing-activity-against-highly-drug-resistant-tuberculosis
#12
Devyani Deshpande, Shashikant Srivastava, Moti Chapagain, Gesham Magombedze, Katherine R Martin, Kayle N Cirrincione, Pooi S Lee, Thearith Koeuth, Keertan Dheda, Tawanda Gumbo
There are currently many patients with multidrug-resistant and extensively drug-resistant tuberculosis. Ongoing transmission of the highly drug-resistant strains and high mortality despite treatment remain problematic. The current strategy of drug discovery and development takes up to a decade to bring a new drug to clinical use. We embarked on a strategy to screen all antibiotics in current use and examined them for use in tuberculosis. We found that ceftazidime-avibactam, which is already used in the clinic for multidrug-resistant Gram-negative bacillary infections, markedly killed rapidly growing, intracellular, and semidormant Mycobacterium tuberculosis in the hollow fiber system model...
August 2017: Science Advances
https://www.readbyqxmd.com/read/28872908/pharmacokinetic-profile-of-edaravone-a-comparison-between-japanese-and-caucasian-populations
#13
Yoshinobu Nakamaru, Shuji Kinoshita, Atsuhiro Kawaguchi, Koji Takei, Joseph Palumbo, Masayuki Suzuki
BACKGROUND: Amyotrophic lateral sclerosis (ALS) affects persons of all races, and there continues to be a need for effective therapies to treat the disease. OBJECTIVE: To compare the pharmacokinetics (PK) of edaravone between Japanese and Caucasian populations. METHODS: Data from five PK studies among Japanese and Caucasian healthy volunteers were pooled and evaluated. In population PK (PPK) modelling, compartment models and other models with linear elimination were evaluated for appropriateness...
October 2017: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
https://www.readbyqxmd.com/read/28871238/overcoming-therapeutic-inertia-in-multiple-sclerosis-care-a-pilot-randomized-trial-applying-the-traffic-light-system-in-medical-education
#14
Gustavo Saposnik, Jorge Maurino, Angel P Sempere, Maria A Terzaghi, Christian C Ruff, Muhammad Mamdani, Philippe N Tobler, Xavier Montalban
BACKGROUND: Physicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI). Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI. OBJECTIVES: To evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS). METHODS: We conducted a pilot double-blind, parallel-group, randomized clinical trial...
2017: Frontiers in Neurology
https://www.readbyqxmd.com/read/28868630/a-model-based-conditional-power-assessment-for-decision-making-in-randomized-controlled-trial-studies
#15
Baiming Zou, Jianwen Cai, Gary G Koch, Haibo Zhou, Fei Zou
Conditional power based on summary statistic by comparing outcomes (such as the sample mean) directly between 2 groups is a convenient tool for decision making in randomized controlled trial studies. In this paper, we extend the traditional summary statistic-based conditional power with a general model-based assessment strategy, where the test statistic is based on a regression model. Asymptotic relationships between parameter estimates based on the observed interim data and final unobserved data are established, from which we develop an analytic model-based conditional power assessment for both Gaussian and non-Gaussian data...
September 4, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28866479/type-1-diabetes-patient-decision-simulator-for-in-silico-testing-safety-and-effectiveness-of-insulin-treatments
#16
M Vettoretti, A Facchinetti, G Sparacino, C Cobelli
OBJECTIVE: Type 1 diabetes (T1D) treatment requires exogenous insulin administrations finely tuned based on glucose monitoring to avoid hyper/hypoglycemia. The safety and effectiveness of insulin treatments is commonly assessed in clinical trials, which are time demanding and expensive. These limitations can be overtaken by in silico clinical trials (ISCT) that require realistic patient and treatment models. The aim is to develop a T1D patient decision simulator usable to perform reliable ISCT...
August 29, 2017: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/28863023/evaluation-of-the-augmented-infant-resuscitator-a-monitoring-device-for-neonatal-bag-valve-mask-resuscitation
#17
Desmond J Bennett, Taiga Itagaki, Christopher T Chenelle, Edward A Bittner, Robert M Kacmarek
BACKGROUND: Annually, 6 million newborns require bag-valve-mask resuscitation, and providing live feedback has the potential to improve the quality of resuscitation. The Augmented Infant Resuscitator (AIR), a real-time feedback device, has been designed to identify leaks, obstructions, and inappropriate breath rates during bag-valve-mask resuscitation. However, its function has not been evaluated. METHODS: The resistance of the AIR was measured by attaching it between a ventilator and a ventilator tester...
August 31, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28863020/validating-the-physiologic-model-hummod-as-a-substitute-for-clinical-trials-involving-acute-normovolemic-hemodilution
#18
Charles R Sims, Luis R Delima, Arthur Calimaran, Robert Hester, W Andrew Pruett
BACKGROUND: Blood conservation strategies and transfusion guidelines remain a heavily debated clinical topic. Previous investigational trials have shown that acute isovolemic hemodilution does not limit adequate oxygen delivery; however, a true critical hemoglobin level has never been investigated or defined due to safety concerns for human volunteers. Validated physiologic modeling may be useful to investigate hemodilution at critical hemoglobin levels without the ethical or safety hazards of clinical trials...
August 31, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28861507/a-conversion-of-oral-cannabidiol-to-delta9-tetrahydrocannabinol-seems-not-to-occur-in-humans
#19
Gerhard Nahler, Franjo Grotenhermen, Antonio Waldo Zuardi, José A S Crippa
Cannabidiol (CBD), a major cannabinoid of hemp, does not bind to CB1 receptors and is therefore devoid of psychotomimetic properties. Under acidic conditions, CBD can be transformed to delta9-tetrahydrocannabinol (THC) and other cannabinoids. It has been argued that this may occur also after oral administration in humans. However, the experimental conversion of CBD to THC and delta8-THC in simulated gastric fluid (SGF) is a highly artificial approach that deviates significantly from physiological conditions in the stomach; therefore, SGF does not allow an extrapolation to in vivo conditions...
2017: Cannabis and Cannabinoid Research
https://www.readbyqxmd.com/read/28858566/a-bayesian-adaptive-design-for-cancer-phase-i-trials-using-a-flexible-range-of-doses
#20
Mourad Tighiouart, Galen Cook- Wiens, André Rogatko
We present a Bayesian adaptive design for dose finding in cancer phase I clinical trials. The goal is to estimate the maximum tolerated dose (MTD) after possible modification of the dose range during the trial. Parametric models are used to describe the relationship between the dose and the probability of dose limiting toxicity (DLT). We investigate model reparameterization in terms of the probabilities of DLT at the minimum and maximum available doses at the start of the trial. Trial design proceeds using escalation with overdose control (EWOC), where at each stage of the trial, we seek the dose of the agent such that the posterior probability of exceeding the MTD of this agent is bounded by a feasibility bound...
August 31, 2017: Journal of Biopharmaceutical Statistics
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