A Randomized, Double-Blind, Placebo-Controlled Parallel Study on the Efficacy and Safety of Centella asiatica L. Extract for Reducing Alanine Transaminase (ALT) Level in Subjects with Elevated ALT

The liver is an important organ that detoxifies various metabolites, synthesizes proteins, and produces biochemicals necessary for life. There are many medications on the market to treat liver diseases, but these can be a strain on the liver due to the need for a detoxification process in the organ. Herbal medicines are replacing synthetic drugs. In the present study, we aimed to evaluate the efficacy and safety of Centella aisatica L. extract for reducing alanine transaminase (ALT) levels using a randomized, double-blind, placebo-controlled parallel study. Investigators performed a clinical trial in which an herbal treatment was administered every morning for 12 weeks to 80 patients in two groups. The study protocol number was SYN/RM/CA-008. The results demonstrated improved ALT levels with a positive change in the investigational product (IP) group (−19.9) compared to the placebo group (1.8) (p < 0.0001). In addition, IP treatment was safe and non-toxic. The current data indicate that CA-HE50 exhibits clinically significant changes for all hepatoprotective efficacy parameters, suggesting potential for development and applicability as a hepatoprotective substance.

LEGO MINDSTORMS EV3 Robot in TRICK Studio environment as a new performer for teaching algorithmization and the basics of robotics in a school informatics course

The article discusses the methodological aspects of teaching algorithmization and the basics of robotics using the educational constructor LEGO MINDSTORMS EV3 in the TRIK Studio environment. The advantages of using the TRIK Studio programming environment to control both a real robot "live" and a virtual one in simulation mode are shown. Based on the methodology for introducing basic algorithmic constructions and types of algorithms by I.G. Semakin, examples of solving a system of problems using commands to control the EV3 robot in the TRIK Studio environment are given. The LEGO MINDSTORMS EV3 Robot is seen as a new performer in the TRIK Studio environment. The article highlights directions and provides examples of tasks for further mastering the basics of robotics and algorithmization. The parallel study of the basics of robotics with the study of the algorithmization section based on the task approach allows you to organize the learning process in the informatics course based on interdisciplinary and STEM approaches, to implement the requirements of the Approximate Basic Educational Program of Basic General Education (2015).

APOS—antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms

Background It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree. Methods This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. Discussion As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures. Trial registration DRKS—German Clinical Trials Register—DRKS00022838; EudraCT No. 2020-001397-30. Registered on 29 March 2021

Pharmacokinetic/Pharmacodynamic Modeling of Spiramycin against Mycoplasma synoviae in Chickens

This research aimed to assess the pharmacokinetics/pharmacodynamics (PK/PD) and tissue residues of spiramycin in chickens. The PK of spiramycin were determined in 12 chickens using a parallel study design in which each group of chickens (n = 6) received a single dose of spiramycin at 17 mg/kg intravenously (IV) or orally. Plasma samples were collected at assigned times for up to 48 h to measure spiramycin concentrations. Additionally, a tissue depletion study was performed in 42 chickens receiving spiramycin at 17 mg/kg/day orally for 7 days. The area under the plasma concentration–time curve values were 29.94 ± 4.74 and 23.11 ± 1.83 µg*h/mL after IV and oral administrations, respectively. The oral bioavailability was 77.18%. The computed withdrawal periods of spiramycin were 11, 10, and 7 days for liver, muscle, and skin and fat, respectively. The minimum inhibitory concentration for spiramycin against Mycoplasma synoviae (M. synoviae) strain 1853 was 0.0625 µg/mL. Using the PK/PD integration, the appropriate oral dose of spiramycin against M. synoviae was estimated to be 15.6 mg/kg. Thus, we recommend an oral dose of 15.6 mg spiramycin/kg against M. synoviae in chickens and a withdrawal period of 11 days following oral treatment with 17 mg spiramycin/kg/day for 7 days.

Non-Equivalence at Idiomatic and Expressional Level and the Strategies to Deal With: English Translation into Persian in Animal Farm by George Orwell

This paper makes an effort to investigate the obstacles in nonequivalence at the idiomatic and expressional level and then presents some certain factors to face such difficulties in Animal Farm novel (1945) by George Orwell and its translation by Amir Amirshahi (1969). The researchers in the current study try by analyzing six certain strategies as using an idiomatic expression of similar meaning and form, similar meaning but dissimilar form, borrowing the source language, translation by paraphrase, translation by the omission of a play on idiomatic expression and translation by the omission of entire idiomatic expression (Baker, 2011). Moreover, the present research is a descriptive, non-judgmental, comparative and corpus-based analysis of EnglishPersian parallel study. The findings demonstrate the fact that the practical ways in the translation of idiomatic expressions presented by Baker (2011) are applicable, and the most useable strategy is using an idiomatic expression of similar meaning but dissimilar form at 35.96%.

A STUDY ON IMMEDIATE AND LONG-TERM EFFECTS OF A NOVEL MINERAL-VITAMIN COMPLEX FOR STRENGTHENING THE NAIL PLATE

We conducted a randomized, blind, comparative, placebo-controlled, parallel study of a biologically active food supplement designed to normalize the condition of the nail plate. The paper presents the results of studying the effectiveness of this vitamin and mineral complex. It was experimentally established that a course intake of the study drug improves the appearance of the nail plate, the effect is observed in 93% of all studied cases. In respondents who used the drug, an increase in the strength of the nail plate was confirmed. It was found that a six-week course of daily intake of the product in recommended doses fully provides the nail plate with all necessary vitamins and minerals. There were no side effects during the observation period.

APOS - Antibiotic Prophylaxis For Preventing Infectious Complications In Orthognathic Surgery: Study Protocol For A Phase III, Multicentre, Randomised, Controlled, Double Blinded, Clinical Trial With Two Parallel Study Arms

Background: It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree.Methods: This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. Discussion: As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures.Trial registration: DRKS - German Clinical Trials Register - DRKS00022838; EudraCT No. 2020-001397-30

A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects

Objective: This study explored the bioequivalence of a proposed biosimilar HOT-3010 vs. its reference product (adalimumab) among healthy Chinese male subjects. The study also investigated the tolerance, immunogenicity, and pharmacokinetics (PK).Methods: A randomized, double-blind, two-arm, parallel study was performed to examine the bioequivalence of HOT-3010 (40 mg) with that of adalimumab (Humira®, AbbVie) as a reference drug. The study subjects were followed up for 71 days.Results: PK properties exhibited by HOT-3010 (N = 66) and adalimumab (N = 68) groups were similar. The 90% confidence intervals of the ratios for Cmax, AUC0-t, and AUC0∞ were observed to be in the range 80–125% on comparing the two groups. For anti-drug antibodies (ADA), the number of subjects found to be positive in the HOT-3010 group and adalimumab group were 29 (43.94%) and 32 (47.06%), whereas 27 (40.91%) and 27 (39.71%) subjects were found to be positive for NAb, respectively. Treatment-related treatment-emergent adverse events (TEAEs) were recorded in 32 subjects each in both the groups, respectively.Conclusion: The PK characteristics and immunogenicity exhibited by HOT-3010 were similar to that of the reference product, adalimumab. The safety profiles were similar in both the treatment groups with mild-moderate adverse effects.