safety indices
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2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Byunghoon Chung ◽  
Joon Hyun Kim ◽  
David S. Y. Kang ◽  
Dong Jun Kang ◽  
Eung Kweon Kim ◽  
...  

Abstract Background To investigate the surgical outcomes of implantable collamer lens (ICL) implantation in eyes with residual myopia after primary laser vision correction (LVC) surgeries. Methods This study included patients who underwent ICL implantation and had a history of LVC surgery, including photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK). Visual acuity and refractive error were assessed pre and 3-months postoperatively and the efficacy and safety indices calculated accordingly. Results A total of 30 eyes of 17 patients were included in this study. At 3 months, the mean logMAR uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and spherical equivalent were − 0.03 ± 0.11 (include logMAR), − 0.04 ± 0.09 (include logMAR), and − 0.06 ± 0.33 diopters (D), respectively. The 3-month Snellen UDVA was better than 20/20 for 83% of eyes, and 97% of eyes showed an unchanged or improved CDVA after surgery. The mean efficacy and safety indices were 1.11 ± 0.22 and 1.13 ± 0.20, respectively. Further, 93 and 100% of eyes were within ±0.5 and ± 1.0 D of the attempted spherical equivalent refraction, respectively. Conclusions ICL implantation in eyes with myopic regression after previous LVC surgery showed safe, effective, and predictable outcomes. Trial registration retrospectively registered.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Xun Chen ◽  
Xuanqi Wang ◽  
Yilin Xu ◽  
Mingrui Cheng ◽  
Tian Han ◽  
...  

Abstract Background To evaluate the long-term safety, efficacy, predictability, and stability of implantable collamer lens with a central hole (EVO ICL) implantation for correcting high myopia (HM) and super high myopia (SHM). Methods This prospective study evaluated 83 eyes of 46 patients who were divided into groups based on their spherical equivalent refractive error (SE): HM group (− 12 D ≤ SE < − 6 D) and SHM group (SE < − 12 D). They were followed up for 5 years after ICL implantation; assessments of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refractive error, axial length, intraocular pressure, corneal endothelial cell density, and vault were conducted, and a questionnaire was administered. ResuIts At 5 years postoperatively, the safety indices of the HM and SHM groups were 1.03 ± 0.10 and 1.32 ± 0.39, and the efficacy indices were 0.83 ± 0.25 and 0.86 ± 0.32, respectively. In the HM group, 60.47% and 79.07% of the eyes were within ± 0.50 D and ± 1.00 D of the attempted correction, while it was achieved for 22.50% and 47.50% of the eyes in the SHM group, respectively. The SE of the HM group decreased from  − 9.72 ± 1.41 D preoperatively to 0.04 ± 0.39 D 1 month postoperatively and − 0.67 ± 0.57 D 5 years postoperatively, while in the SHM group, it decreased from − 15.78 ± 3.06 D preoperatively to  − 0.69 ± 0.97 D 1 month postoperatively and − 1.74 ± 1.19 D 5 years postoperatively. Conclusion EVO ICL implantation is safe, effective, and predictable for correcting HM and SHM. CDVA improved more after surgery for SHM, but the growth of axial length still needs attention.


2021 ◽  
Author(s):  
Rahul Cheeniyil ◽  
Jan Kubanek

The ability to generate electric fields in deep tissues remotely, without surgically implanting electrodes, could transform diagnoses and treatments of nervous system disorders. Here, we show that focal electrostimulation effects can be elicited remotely by combining two noninvasive forms of energies---magnetic and focused ultrasonic fields. The approach, based in the Lorentz equation and referred to as Lstim, electrically stimulates specified tissue targets with the precision of deep brain or spinal cord stimulation, but does not require electrode implantation. Lstim potentiated the responses of human nerves, enhancing the neuromodulatory effects of ultrasound by 74% on average. The effects showed a double dissociation---a significant and substantial increase in nociceptive responses, yet a significant reduction in tactile responses. In line with the Lorentz equation, Lstim was only observed when nerves were oriented perpendicularly to the magnetic and ultrasonic fields. A sham condition showed no effects. Both the ultrasonic and the induced electric fields were well below the respective safety indices, and no detrimental effects were detected. Lstim uniquely integrates noninvasiveness, sharp focus, and the efficacy of electrical stimulation. The approach has the potential to provide a noninvasive tool to dissect brain function in humans and to diagnose the neural circuits involved in nervous system disorders. Moreover, this effect should be taken into account when ultrasound is applied inside MRI.


Author(s):  
Zhou Zi-ji ◽  
Zhang Nan ◽  
Sun Qi-kai

In order to explore the random nature of high-speed railway train operation safety indices, the pseudo-excitation method, extreme value theory, and non-stationary harmonic superposition theory are used in this paper to study the statistics of train operation safety indices. The pseudo-excitation load formulation for track irregularity is obtained by the pseudo-excitation method, and the resulting non-stationary random vibration problem is transformed into a deterministic time history problem. The pseudo-excitation method is used to establish the dynamic equations of motion, and the separation iteration method is used to solve the equations, so as to obtain the power spectral density of the wheel-rail interaction forces. The wheel-rail interaction forces are obtained by using a modulation function and the harmonic superposition method. By fitting an extreme value distribution, the maximum values of the train running safety indices are explored. The proposed numerical approach is validated experimentally using the data from a 24.6 m long simply supported concrete bridge by studying the extreme value distributions of driving safety indices. Additional numerical simulation are conducted for varying train speeds and bridge spans. The results show that the Gumbel distribution can fit the extreme value of driving safety parameters for different speeds and different bridge span lengths. It is observed that the higher the speed, the sharper the extreme value distribution of train running safety indices, and the larger the train running safety index values corresponding to 99.87% confidence level. The corresponding extreme values at the 99.87% confidence level are greater than the maximum value of each time-domain sample.


2021 ◽  
Vol 13 (20) ◽  
pp. 1731-1741 ◽  
Author(s):  
Andrew V Stachulski ◽  
Jean-Francois Rossignol ◽  
Sophie Pate ◽  
Joshua Taujanskas ◽  
Craig M Robertson ◽  
...  

Background: The thiazolides, typified by nitazoxanide, are an important class of anti-infective agents. A significant problem with nitazoxanide and its active circulating metabolite tizoxanide is their poor solubility. Results: We report the preparation and evaluation of a series of amine salts of tizoxanide and the corresponding 5-Cl thiazolide. These salts demonstrated improved aqueous solubility and absorption, as shown by physicochemical and in vivo measurements. They combine antiviral activity against influenza A virus with excellent cell safety indices. We also report the x-ray crystal structural data of the ethanolamine salt. Conclusion: The ethanol salt of thiazolide retains the activity of the parent together with an improved cell safety index, making it a good candidate for further evaluation.


2021 ◽  
Author(s):  
Erich Seifritz ◽  
Michael Friede ◽  
Jörg Schnitker

Abstract Background: Brexpiprazole and aripiprazole are atypical antipsychotics that act as partial agonists at the dopamine D2 receptor. No head-to-head trial comparing brexpiprazole and aripiprazole in the treatment of schizophrenia is available. Here, we carry out a systematic review and comparison of the efficacy and safety of brexpiprazole and aripiprazole in schizophrenia treatment.Methods: We employed an indirect meta-analysis to determine effect sizes from randomised placebo-controlled trials with brexpiprazole and aripiprazole in the acute treatment of schizophrenia. We compared responder rates, incidences of adverse events and serious adverse events, the number needed to treat (NNT) for response, number needed to harm (NNH) for adverse events or treatment discontinuation, and likelihood to be helped or harmed (LHH) as efficacy and safety indices of the two drugs. Results: Five studies for each drug were included in the analysis. Similar risk differences vs. placebo were observed for responder rates under brexpiprazole (10.2%, p = 0.0015) and aripiprazole (10.3%, p = 0.0003). Higher incidences of adverse events and serious adverse events were seen under aripiprazole compared with brexpiprazole, however, the risk differences were not statistically significant. The NNT for response was 11 for both substances. For brexpiprazole compared with placebo, we did not find an increase of adverse events (NNH = 27, not significant), however, we found an increased number of adverse events for aripiprazole versus placebo (NNH = 17, p < 0.05). For both drugs, benefits were encountered more often than harms, with an LHH for any adverse event of 2.41 for brexpiprazole and 1.56 for aripiprazole, respectively. Conclusions: The likelihood to be helped rather than harmed was greater with brexpiprazole compared to aripiprazole for the total rate of adverse events (ratio of brexpiprazole LHH/aripiprazole LHH = 1.54).


2021 ◽  
pp. 112067212110334
Author(s):  
Olga Reitblat ◽  
Assaf Gershoni ◽  
Michael Mimouni ◽  
Eitan Livny ◽  
Yoav Nahum ◽  
...  

Purpose: To examine the clinical outcomes, efficacy, safety, and predictability of transepithelial photorefractive keratectomy (Trans-PRK) operations performed on the day of the first screening visit in comparison with operations scheduled at a following appointment. Methods: Data of consecutive patients with myopia of various degrees, who underwent Trans-PRK, were retrospectively analyzed. Findings were compared between patients who underwent Trans-PRK on the same day of first consultation to patients that underwent surgery at subsequent visits, following initial consultation on a different day. Results: The study included 599 eyes treated on the initial visit day and 1936 eyes treated on a subsequent visit. Mean final spherical equivalent was close to emmetropia in both groups ( p = 0.183). Efficacy indices were 0.928 ± 0.192 in the initial-visit group and 0.945 ± 0.163 in the second-visit group ( p = 0.152). Safety indices were 0.954 ± 0.156 and 0.955 ± 0.151 ( p = 0.707), respectively. No differences between the groups were seen in uncorrected visual acuity (UDVA) of ⩾20/20, ⩾20/25, and ⩾20/32. Only the sub-analysis of patients reaching UDVA of 20/40 or better was slightly lower in the first-visit (95.5%) compared with the second-visit group (97.9%, p = 0.001). Results of attempted correction within ±0.50 D were: 63.3% and 69.0%, respectively ( p = 0.009). Complications profiles in the two groups were comparable. Conclusions: Trans-PRK completed on the day of the first screening appointment demonstrated a similar safety outcome compared with subsequent-visits procedures, and slightly lower, yet comparable, results regarding efficacy and predictability.


2021 ◽  
Vol 11 (14) ◽  
pp. 6366
Author(s):  
Abdullah Rasul ◽  
Jaho Seo ◽  
Amir Khajepour

This article presents the sensing and safety algorithms for autonomous excavators operating on construction sites. Safety is a key concern for autonomous construction to reduce collisions and machinery damage. Taking this point into consideration, our study deals with LiDAR data processing that allows for object detection, motion tracking/prediction, and track management, as well as safety evaluation in terms of potential collision risk. In the safety algorithm developed in this study, potential collision risks can be evaluated based on information from excavator working areas, predicted states of detected objects, and calculated safety indices. Experiments were performed using a modified mini hydraulic excavator with Velodyne VLP-16 LiDAR. Experimental validations prove that the developed algorithms are capable of tracking objects, predicting their future states, and assessing the degree of collision risks with respect to distance and time. Hence, the proposed algorithms can be applied to diverse autonomous machines for safety enhancement.


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Solomon Rajkumar ◽  
Renuka Nayar ◽  
Kavitha Rajagopal ◽  
Eaknath B. Chakurkar ◽  
Vismitha Shree Venkatesh ◽  
...  

PurposeThe purpose of this paper is to assess food safety knowledge, choice behavior and health hazard concerns of ethnic Goan pork sausage consumers through various consumer food safety indices and also to evaluate socio-demographic influences on various consumer food safety indices.Design/methodology/approachPrimary data in the form of 210 questionnaire responses were collected from Goan pork sausage consumers. Based on the responses, seven various consumer food safety indices were derived. The cumulative score of all the indices were normalized (0–1). The association between socio-demographic variables and consumer indices were evaluated using linear regression analysis, Pearson's correlation matrix, principal component analysis (PCA) and correspondence analysis (CA).FindingsThe results of the analysis indicate that the consumption of Goan pork sausages is most prevalent amongst younger people with high education having higher income. A majority of consumers have high score for the four consumer indices. The results of correlation analysis, regression analysis, PCA and CA revealed a significant association of consumer indices with socio-demographic variables.Originality/valueThe results of this study will provide a way forward for the evaluation of existing overall food safety concerns in the target population and in the future would be used for the promotion of good handling practices and health of Goan pork sausage consumers.


2021 ◽  
Vol 17 (4) ◽  
pp. 400-415
Author(s):  
Yen Hai Tran ◽  
Huy Dinh Minh Tran ◽  
Ly Thi-Hai Tran ◽  
Dung Thi Mong Nguyen ◽  
Chuong Nguyen Thao Le ◽  
...  

Purpose: To compare safety, efficacy, stability, and predictability of implantable collamer lens (ICL) with femtosecond-laser in situ keratomileusis (FS-LASIK) or small incision lenticule extraction (SMILE) for the correction of moderate-to-high myopia/myopic astigmatism. Study design: We retrospectively collected data from patients with moderate-to-high myopia/myopic astigmatism (spherical equivalent [SE] ≥ −3.00 diopters [D]) who underwent ICL (48 eyes), FS-LASIK (36 eyes), or SMILE (86 eyes) at Hai Yen Eye Center from October 2016 to February 2018. Materials and methods: The Wilcoxon Mann-Whitney U test was used to compare pre- and postoperative patients’ characteristics of ICL with SMILE or FS-LASIK. Generalized linear models with unstructured correlation matrix and robust standard errors were used to analyze efficacy and safety indices; logistic regression was used for cylinder predictability. Results: After controlling for age, preoperative SE, and preoperative corrected distance visual acuity (pCDVA), SMILE had significantly lower safety indices (Coefficient = −0.04, 95% CI = −0.07–−0.01) and efficacy indices (Coefficient = −0.10, 95% CI = −0.20–−0.01) than did ICL, while FS-LASIK was not significantly different from ICL (Coefficient = −0.02, 95% CI = −0.06–0.02 and Coefficient = −0.01, 95% CI= −0.10–0.09, respectively). ICL SEswere stable over 12 months after surgery. However, in FS-LASIK and SMILE, SEs significantly decreased at 12 months compared with 6 months after surgery. The percentage of eyes that underwent FS-LASIK and had target SEs within ±0.5 D at 12 months was significantly lower than those that underwent ICL (OR = 0.14, 95% CI = 0.02–0.85), after controlling for age, preoperative SE, and pCDVA. Conclusion: For the correction of moderate-to-high myopia/myopic astigmatism, ICL seems to perform better than SMILE and FS-LASIK.


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