Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.

IMPORTANCE: Patient outcomes in heart failure clinical trials are generally better than those observed in real-world settings. This may be related to stricter inclusion and exclusion criteria in clinical trials. OBJECTIVE: We study sought to characterize the clinical implications of differences between patients in clinical trials and those in a real-world registry of patients receiving left ventricular assist devices (LVADs). DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included all patients in INTERMACS (the Interagency Registry for Mechanically Assisted Circulatory Support) who were implanted with an axial flow LVAD from 2010 to 2015 to allow for equivalent comparisons. MAIN OUTCOMES AND MEASURES: Differences in patient characteristics and 2-year rates of adverse outcomes with those reported in the ENDURANCE and MOMENTUM 3 clinical trials. Survival analyses were used to assess the relationships between prespecified patient factors and clinical outcomes. RESULTS: Of the 10,937 LVAD recipients identified in INTERMACS between 2010-2015, 44% met at least 1 clinical trial exclusion criterion. The 2-year incidence of stroke and death amongst LVAD recipients in INTERMACS and the landmark clinical trials differed significantly (P<0.04, both). Nevertheless, patients who would have been excluded from the clinical trials did not have dramatically different 2-year mortality outcomes in INTERMACS [2y survival estimate: 66.4%, 95% CI (64.9-67.9%) versus 71.9%, 95% CI (70.6-73.1%)]. Clinical interventions driving a significantly increased risk of death were relatively rare (<5% of implants) and included mechanical ventilation, ECMO, severe thrombocytopenia, and dialysis. CONCLUSIONS AND RELEVANCE: Most exclusion criteria used in LVAD clinical trials did not afford a substantially greater risk to patients in the real-world setting. In the relatively infrequent cases of end stage renal disease, thrombocytopenia, respiratory failure, and need for ECMO, the risks and benefits of LVAD therapy need careful weighting and further study.

Mulibrey Nanism Syndrome: A Case for Heart Transplantation.

Mulibrey nanism syndrome is a rare genetic disorder affecting multiple organ systems. The cardiovascular system is one of the most significantly affected, with simultaneous myocardial and pericardial disease. These patients are usually managed by pericardiectomy to resolve the milieu of hemodynamic problems ensuing due to concurrent constrictive and restrictive pathologies. We highlight the use of cardiac transplantation as a definitive management for a hemodynamically decompensated patient with Mulibrey nanism syndrome.

Hybrid machine learning technique for forecasting Dhaka stock market timing decisions.

Forecasting stock market has been a difficult job for applied researchers owing to nature of facts which is very noisy and time varying. However, this hypothesis has been featured by several empirical experiential studies and a number of researchers have efficiently applied machine learning techniques to forecast stock market. This paper studied stock prediction for the use of investors. It is always true that investors typically obtain loss because of uncertain investment purposes and unsighted assets. This paper proposes a rough set model, a neural network model, and a hybrid neural network and rough set model to find optimal buy and sell of a share on Dhaka stock exchange. Investigational findings demonstrate that our proposed hybrid model has higher precision than the single rough set model and the neural network model. We believe this paper findings will help stock investors to decide about optimal buy and/or sell time on Dhaka stock exchange.

Influence of fulvic acid and hydroxy propyl-beta-cyclodextrin on aspirin degradation.

OBJECTIVE: The degradation of aspirin (ASA) was investigated to reveal information about the influence of complexation with fulvic acid (FA), as a new complexing agent and compared with hydroxy propyl-beta-cyclodextrin complex. MATERIALS AND METHODS: ASA was complexed with FA in the molar ratio 1:0.5, 1:1, and 1:2 by different methods through lyophilization, solvent evaporation, and spray drying. Spray-dried (1:1) ASA-hydroxy propyl-beta-cyclodextrin complex was prepared and compared with optimized complex of FA. All the complexes and ASA alone were packaged in well-labeled sealed polythene-lined aluminum pouches and stored in stability chamber at 40 +/- 2 degrees C and 75 +/- 5% relative humidity for 120 days. Samples were analyzed for salicylic acid content at 0, 30, 60, 90, and 120 days. RESULTS: Overall 4.31% salicylic acid was formed in 1:1 ASA-FA spray-dried complex, which was optimized stable complex among other complexes of FA prepared by different methods in different molar ratios. However, 2.35% salicylic acid was measured with 1:1 spray-dried ASA-hydroxy propyl-beta-cyclodextrin complex. Stability of ASA increased more when complexed with hydroxy propyl-beta-cyclodextrin as compared to FA. CONCLUSIONS: A novel complexing agent in the form of FA was investigated to increase the stability of ASA. A marked improvement in stability of ASA was observed when complexed with hydroxy propyl-beta-cyclodextrin (1:1) by spray drying as compared to 1:1 spray-dried ASA-FA complex.

Complexation of furosemide with fulvic acid extracted from shilajit: a novel approach.

The aim of the present work was to complex furosemide (FSM) with fulvic acid (FA) extracted from shilajit with the hope of having a better understanding of the complexation behavior. The effect of FA on the aqueous solubility, dissolution rate, and permeability of FSM was investigated. Different techniques, such as grinding, freeze drying, solvent evaporation, and so forth, were used for the preparation of the complex. The complexes were prepared in molar ratios of 1:1 and 1:2 FSM:FA and were evaluated for drug inclusion, solubility, differential scanning calorimetry, Fourier transform infrared spectroscopy, X-ray diffraction, scanning electron microscopy, dissolution study, and permeation study. These methods confirm the formation of an amorphous inclusion complex of FSM with FA.