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We live amidst a flood of information in the internet and digital revolution era. Due to such indiscriminate information access, there are many problems in accurately recognizing the information desired by the user. Moreover, there are many difficulties with finding accurate information and the articles that individuals want due to indiscriminate advertisements in various online papers such as SNS and internet newspapers. Negative experiences with these advertisements lead to advertisement avoidance; if media users avoid advertisements, the media’s existence is threatened. This system aims to provide high-quality online articles, excluding promotions, by designing a system using a knowledge-based management system (KBMS) and Deep Learning system to solve the problems of advertisement. In other words, this system compares advertisement phrases or general keywords related to a specific company and product promotion with the contents to be searched in the database system of the knowledge-based management service.

Real-time monitoring of suspended particulate matter (PM) has become essential in daily life due to the adverse effects of long-term exposure to PMs on human health and ecosystems. However, conventional techniques for measuring micro-scale particulates commonly require expensive instruments. In this study, a smartphone-based device is developed for real-time monitoring of suspended PMs by integrating a smartphone-based digital holographic microscopy (S-DHM) and deep learning algorithms. The proposed S-DHM-based PM monitoring device is composed of affordable commercial optical components and a smartphone. Overall procedures including digital image processing, deep learning training, and correction process are optimized to minimize the prediction error and computational cost. The proposed device can rapidly measure the mass concentrations of coarse and fine PMs from holographic speckle patterns of suspended polydisperse PMs in water with measurement errors of 22.8 ± 18.1% and 13.5 ± 9.8%, respectively. With further advances in data acquisition and deep learning training, this study would contribute to the development of hand-held devices for monitoring polydisperse non-spherical pollutants suspended in various media.

We evaluated the effectiveness of intravitreal anti-vascular endothelial growth factor (anti-VEGF) antibody injection (IVAI) for the prevention of recurrent vitreous hemorrhage (VH) due to neovascularization on disc (NVD) in patients with proliferative diabetic retinopathy (PDR) after panretinal photocoagulation (PRP). This retrospective case series reviewed the medical records of 12 PDR patients with recurrent VH after PRP from NVD. The interval between IVAIs was decided on the basis of the interval between VH recurrences after the initial IVAI, and NVD regression/recurrence during follow-up. We recorded the success rate of VH prevention, and the interval between IVAIs. Fundus examination revealed NVD regression at 1 month after the injection. However, NVD progressed gradually and VH recurred after 3–4 months. Thereafter, IVAIs were administered every 3–4 months; VH did not recur and visual acuity remained stable during the treatment period. In one case, NVD did not recur after 4 years of periodic injections. No systemic or ocular complications of IVAI were observed. In conclusion, proactive and periodic IVAIs (at 3–4-month intervals) may prevent recurrent VH in association with NVD in PDR patients after PRP.

Long-term, real-world safety and effectiveness data are required to support biosimilar use. This analysis pooled 5-year findings from observational studies of infliximab biosimilar CT-P13 treatment in patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and ankylosing spondylitis (AS). Patients enrolled in the CT-P13 4.2, 4.3, or 4.4 Korea/European Union registries were analysed if they had initiated infliximab treatment with CT-P13 (CT-P13 group) or had switched from reference infliximab to CT-P13 (switched to CT-P13 group). The primary objective was to investigate long-term safety by evaluating adverse events of special interest (AESIs) per the CT-P13 risk-management plan. Incidence rates per 100 patient-years (PYs) were calculated. Additional long-term safety endpoints, immunogenicity (assessments optional), and effectiveness were evaluated. Overall, 736 patients (642 CT-P13; 94 switched to CT-P13) were analysed. Median (range) exposure to CT-P13 was 19.433 (0.03–63.11) months overall. The incidence of treatment-emergent adverse events was 69.0% (CT-P13 group) and 60.6% (switched to CT-P13 group). Infusion-related reaction/hypersensitivity/anaphylactic reaction was the most frequent AESI overall, with an incidence of 4.3828 per 100 PY (95% confidence interval: 3.3603–5.6185). For most AESIs, incidence rates per 100 PY were broadly comparable between treatment groups, considering overlapping 95% confidence intervals. At baseline, 42/445 (9.4%) and 21/59 (35.6%) evaluable patients in the CT-P13 and switched to CT-P13 groups, respectively, were antidrug antibody (ADA)-positive. After CT-P13 treatment during the study, 188/425 (44.2%) evaluable patients had ≥ 1 ADA-positive result, including 147/425 (34.6%) patients with negative or no ADA results reported at baseline. Effectiveness tended to increase over time for all indications. The analysis did not identify any new safety findings for patients with RA, IBD, and AS treated with CT-P13 for up to 5 years in those who were infliximab-naive at CT-P13 initiation, or those who had switched from reference infliximab to CT-P13. ClinicalTrials.gov identifiers: NCT02557295 (CT-P13 4.2; retrospectively registered on 23 September 2015); NCT02326155 (CT-P13 4.3; retrospectively registered on 25 December 2014); NCT02557308 (CT-P13 4.4; retrospectively registered on 23 September 2015).

This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT‐P17 to United States‐licensed adalimumab (US‐adalimumab) and European Union‐approved adalimumab (EU‐adalimumab). This double‐blind, parallel‐group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT‐P17, US‐adalimumab, or EU‐adalimumab. Primary end points were PK equivalence in terms of: area under the concentration–time curve from time zero to infinity (AUC0–inf); AUC from time zero to the last quantifiable concentration (AUC0–last); and maximum serum concentration (Cmax). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80–125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT‐P17; 103 US‐adalimumab; 106 EU‐adalimumab), 308 subjects received study drug. AUC0–inf, AUC0–last, and Cmax were equivalent among CT‐P17, US‐adalimumab, and EU‐adalimumab, because 90% CIs for the ratios of GLSMs were within the 80–125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single‐dose administration of CT‐P17, EU‐adalimumab, and US‐adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars.

Background Inflammatory bowel diseases (IBD) is related to uncontrolled immune response. Currently, there is no successful treatment for significant improvement in IBD. Stem cells display their therapeutic effects through their repopulating capacity or secreting factors. Aim To investigate the effects of conditioned mouse adipose-derived stem cells (mADSCs) secretome on colitis-induced mice. Methods mADSCs were isolated from adipose tissue of C57BL/6 mice. Conditioned mADSCs secrectome was obtained by culturing of mADSCs with lipopolysaccharides (LPS, 1 μg/mL) for 24 h. Acute colitis was induced by 2% dextran sulfate sodium (DSS) drinking water for 7 d and then normal drinking water for 4 d. The mice were treated with normal culture medium (NM group), conditioned mADSCs secretome (CM group) or mADSCs (SC group). The length of colon and histopatholgy of colon tissues were evaluated. The mRNA expression levels of inflammatory cytokines in colon tissue and the serum interleukin (IL)-6 levels were determined. Results The isolated mADSCs maintained the mADSCs specific gene expression profiles during experiment. The conditioned mADSCs secretome released by the treatment of mADSCs with LPS contained mainly inflammatory chemokines, colony-stimulating factors and inflammatory cytokines. The loss of body weight and reduction in colon length were ameliorated in the CM group. The conditioned mADSCs secretome reduced the histological score in colon tissue. The expression of IL-1b and IL-6 mRNAs in colon tissues significantly inhibited in the CM group compared to SC group and NM group, respectively. The elevation of serum IL-6 levels was also ameliorated in the CM group. These results indicate that the conditioned mADSCs secretome suppressed the synthesis of inflammatory cytokines in damaged colon tissue and the elevation of serum IL-6 concentration in DSS-induced mice. Conclusion Conditioned mADSCs secretome might play regenerative roles by the suppression of IL-6 in serum and tissue during acute colitis, and may be more effective than stem cells themselves in the regeneration of colon tissue.

Background & aims This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD). Methods This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor–naive patients with active ulcerative colitis (total Mayo score 6–12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220–450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (Ctrough,W22), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%. Results Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for Ctrough,W22 of 1154.17% (90% CI 786.37–1694.00; n = 59 [CT-P13 SC]; n = 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy, safety, and immunogenicity assessments were also broadly comparable between arms, including after switching. Conclusions The pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, and the comparable efficacy, safety, and immunogenicity profiles, support the potential suitability of CT-P13 SC treatment in IBD. ClinicalTrials.gov ID: NCT02883452.

Purpose Equivalent efficacy was demonstrated for the biosimilar CT-P6 and trastuzumab following neoadjuvant therapy for patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer. Following adjuvant treatment, efficacy and safety were comparable between treatments. We report updated safety and efficacy data after up to 3 years’ follow-up. Methods Following neoadjuvant chemotherapy with CT-P6/trastuzumab, patients underwent surgery and continued receiving adjuvant CT-P6/trastuzumab. The primary endpoint (previously reported) was pathological complete response. Time-to-event analyses (disease-free survival [DFS], progression-free survival [PFS], and overall survival [OS]), study drug-related and cardiac adverse events, and immunogenicity were assessed during post-treatment follow-up. Results Most patients entered the follow-up period (CT-P6: 259 [95.6%]; trastuzumab: 269 [96.8%]). After a median follow-up of 38.7 (CT-P6) and 39.6 (trastuzumab) months, medians were not reached for time-to-event parameters; estimated hazard ratios (HRs) and 3-year survival rates were similar between groups. Estimated HRs (95% confidence intervals) for CT-P6 versus trastuzumab were 1.23 (0.78–1.93) for DFS, 1.31 (0.86–2.01) for PFS, and 1.10 (0.57–2.13) for OS (intention-to-treat population). Safety findings were comparable between groups for the overall study and follow-up period, including study drug-related cardiac disorders (CT-P6: 22 [8.1%] patients; trastuzumab: 24 [8.6%] patients [overall]) and decreases in left ventricular ejection fraction. Immunogenicity was similar between groups. Conclusion The similarity of the time-to-event analyses between CT-P6 and trastuzumab supports the equivalence in terms of efficacy established for the primary endpoint. CT-P6 was well tolerated, with comparable safety and immunogenicity to trastuzumab. ClinicalTrials.gov: NCT02162667 (registered June 13, 2014)

AIMS To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT-P17 administered via autoinjector (CT-P17 AI) or prefilled syringe (CT-P17 PFS) in healthy subjects. METHODS This phase I, open-label study (ClinicalTrials.gov: NCT04295356) randomised subjects (1:1) to receive a single 40-mg (100 mg/mL) dose of CT-P17 AI or CT-P17 PFS. Primary endpoint was pharmacokinetic equivalence of CT-P17 AI to CT-P17 PFS for: area under the concentration-time curve from time zero to infinity (AUC0-inf ); area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last ); maximum serum concentration (Cmax ). Equivalence was determined if the 90% confidence interval for the geometric least-squares mean ratio was within the 80-125% equivalence margin. Additional pharmacokinetic endpoints, safety and immunogenicity were evaluated. RESULTS Of 193 subjects who were randomised (98 CT-P17 AI; 95 CT-P17 PFS), 180 received study drug. Pharmacokinetic equivalence was demonstrated: 90% confidence intervals were within the 80-125% equivalence margin (AUC0-inf : 93.98-114.29; AUC0-last : 91.09-121.86; Cmax : 94.08-111.90). Mean serum CT-P17 concentrations, secondary pharmacokinetic parameters and numbers of subjects with antidrug antibodies (ADAs) or neutralising ADAs were comparable between groups. AUC0-inf , AUC0-last and Cmax were numerically lower for ADA-positive than for ADA-negative subjects (both groups); pharmacokinetic equivalence was also demonstrated among ADA-positive subjects. CT-P17 AI and CT-P17 PFS were well tolerated, with comparable overall safety profiles. CONCLUSIONS CT-P17 AI and CT-P17 PFS were pharmacokinetically equivalent. Overall safety and immunogenicity were comparable between the 2 delivery devices.

Cervicovaginal venous malformations are extremely rare. Sclerotherapy is proven to be effective for superficial venous malformations but not for venous malformations in the lower genital tract of female. A 52-year-old female presented with intermittent vaginal bleeding. The amount of vaginal bleeding gradually increased over 3 months. Contrast-enhanced pelvis CT showed several phleboliths and dilated vessels, but pelvic angiography showed no early draining veins, nidus, or feeding artery. We performed transvaginal direct puncture and ethanol sclerotherapy rather than surgical treatment because she wanted to preserve the uterus. After four sessions of sclerotherapy, she had significantly decreased vaginal bleeding without complications. Here, we report the first case of cervicovaginal venous malformations successfully treated with transvaginal direct puncture and ethanol sclerotherapy.

Tillandsia usneoides in epiphytic bromeliads takes up water through the absorptive trichomes on the shoot surface under extreme environmental conditions. Although previous studies revealed the way by which T. usneoides absorbs water and prevents water loss, T. usneoides' water transport is still unclear. We characterized structures of trichome wings of T. usneoides. Wing length-to-thickness ratio with 136 and the trichome interval (d)-to-wing length (l) ratio (d/l) smaller than 1 caused the water film to flatten the wings sequentially, resulting the domino-like water transport. A hinge-like linkage between wing and outer ring cells and the wing size longer than the elastocapillary length (LEC ) brought about this unique reconfiguration, which is the flattening and recovery of wings. T. usneoides transported water rapidly on the surface as the water film propagated on the exterior trichomes with flexible wings and the transport distance at the macroscopic scale grew as tx with x = 0.68 ± 0.04, unlike the conventional scaling of t0.5 . Empirical and theoretical investigations proved our assumption that external water transport with the domino-like effect predominated over internal vascular transport. Biomimetic trichome wings simulated the domino-like water transport, highlighting the important role of flexibility wing arrays.

Sustainable and green energy techniques are in high demand as new energy sources. Over the decades, streaming potential/current has attracted attention as a hydrovoltaic energy technology. However,...

Graphene-based nanomaterials (GBNs) have been widely used in various fields nowadays. However, they are reported to be highly toxic to some aquatic organisms. However, the multi-organ toxicity caused by pristine graphene (pG) and graphene oxide (GO) to the developing zebrafish (Danio rerio) larvae or juvenile and the underlying mechanisms is not fully known. Therefore, in the present study, the effect of pG and GO with environmental concentrations (0, 5, 10, 15, 20, and 25 μg/L of pG; 0, 0.1, 0.2, 0.3, and 0.4 mg/mL of GO) on multi-organ system in developing zebrafish larvae was experimentally assessed. The pG and GO were found to accumulate in the brain tissue that also caused significant changes in the heart beat and survival rate. The sizes of hepatocytes were reduced. Altered axonal integrity, affecting axon length and pattern in "Tg(mbp:eGFP) transgenic lines" was also observed. In addition, the results indicated pathological effects in major organs and with disrupted mitochondrial structure was quite obvious. The pG and GO bioaccumulation leads to multi organ toxicity in zebrafish larvae. In future, the existence of the current study can be extrapolated to other aquatic system in general and in particularly to humans.

It is still a challenge to develop gene replacement therapy for retinal disorders caused by mutations in large genes, such as Stargardt disease (STGD). STGD is caused by mutations in ABCA4 gene. Previously, we have developed an effective non-viral gene therapy using self-assembled nanoparticles of a multifunctional pH-sensitive amino lipid ECO and a therapeutic ABCA4 plasmid containing rhodopsin promoter (pRHO–ABCA4). In this study, we modified the ABCA4 plasmid with simian virus 40 enhancer (SV40, pRHO–ABCA4–SV40) for enhanced gene expression. We also prepared and assessed the formulations of ECO/pDNA nanoparticles using sucrose or sorbitol as a stablilizer to develop consistent and stable formulations. Results demonstrated that ECO formed stable nanoparticles with pRHO–ABCA4–SV40 in the presence of sucrose, but not with sorbitol. The transfection efficiency in vitro increased significantly after introduction of SV40 enhancer for plasmid pCMV-ABCA4–SV40 with a CMV promoter. Sucrose didn’t affect the transfection efficiency, while sorbitol resulted in a fluctuation of the in vitro transfection efficiency. Subretinal gene therapy in Abca4(−/−) mice using ECO/pRHO–ABCA4 and ECO/pRHO–ABCA4–SV40 nanoparticles induced 36% and 29% reduction in A2E accumulation respectively. Therefore, the ECO/pABCA4 based nanoparticles are promising for non-viral gene therapy for Stargardt disease and can be expended for applications in a variety of visual dystrophies with mutated large genes.

The recent Coronavirus Disease 2019 pandemic has highlighted the importance of indoor ventilation. In particular, ventilation is crucial in residential spaces and workspaces, where people spent most of their day. Natural ventilation is a cost-effective method for improving indoor ventilation. It can provide safe and comfortable residential and working environments without additional energy consumption. In this study, the ventilation performance was experimentally studied by measuring the concentration of ultrafine particulate matter according to the opening conditions of the windows and door of an office model in a wind tunnel. Furthermore, the internal flow structure in the office model was quantitatively analyzed through particle image velocimetry to determine the factors that affected the ventilation performance. The mean velocity inside the model and the ventilation performance increased with the opening angle of the windows. In particular, the opening condition of the door strongly affected the ventilation performance. This study is expected to provide a guideline for effectively improving the ventilation performance in indoor spaces.

Background We evaluated clinical effectiveness of regdanvimab (CT-P59), a severe acute respiratory syndrome coronavirus 2 neutralizing monoclonal antibody, in reducing disease progression and clinical recovery time in patients with mild-to-moderate coronavirus disease 2019 (COVID-19), primarily Alpha variant. Methods This was phase 3 of a phase 2/3 parallel-group, double-blind, randomized clinical trial. Outpatients with mild-to-moderate COVID-19 were randomized to single-dose regdanvimab 40 mg/kg (n = 656) or placebo (n = 659), alongside standard of care. The primary endpoint was COVID-19 disease progression up to day 28 among “high-risk” patients. Key secondary endpoints were disease progression (all randomized patients) and time to recovery (high-risk and all randomized patients). Results Of 1315 randomized patients, 880 were high risk; the majority were infected with Alpha variant. The proportion with disease progression was lower (14/446, 3.1% [95% confidence interval {CI}, 1.9%–5.2%] vs 48/434, 11.1% [95% CI, 8.4%–14.4%]; P Conclusions Regdanvimab was an effective treatment for patients with mild-to-moderate COVID-19, significantly reducing disease progression and clinical recovery time without notable safety concerns prior to the emergence of the Omicron variant. Clinical Trials Registration NCT04602000; 2020-003369-20 (EudraCT).

Purpose To compare visual improvements between initial intravitreal t-PA with gas injection before anti-vascular endothelial growth factor (VEGF) and anti-VEGF injection monotherapy for submacular haemorrhage (SMH) associated with age-related macular degeneration (AMD). Methods We retrospectively reviewed medical records of naive patients treated with intravitreal t-PA with gas injection before anti-VEGF (Group 1) or only with intravitreal anti-VEGF injection (Group 2) for SMH [disc area (DA) ≥ 2] associated with AMD from two institutions. Both groups received 3 monthly loads of anti-VEGF injections followed by injections as needed for AMD treatment. Changes in best-corrected visual acuity (BCVA, logMAR) between the initial visit and after 6 months of treatment were compared between two groups. Results A total of 82 patients were enroled. Of these, 32 patients and 50 patients were grouped in Groups 1 and 2, respectively. The mean change in BCVA over 6 months for Group 1 was -0.52 ± 0.88, which was significantly larger (p = 0.044) than the mean change for Group 2 (-0.15 ± 0.58). We compared visual improvements between the two groups based on the following SMH size categories: ≤5, >5, and ≤15, and >15 DA. When the SMH size was ≤5, or >5 and ≤15 DA, the mean change in BCVA was larger for Group 1 than for Group 2, but this difference was not significant. When SMH size was >15 DA, Group 1 patients exhibited a mean visual improvement of -0.79 ± 0.80, which was significantly greater (p = 0.029) than that of Group 2 (-0.06 ± 0.67). Conclusions Patients that were primarily treated for SMH associated with AMD using t-PA and gas injection (followed by anti-VEGF injection) exhibited better visual improvement than those treated with anti-VEGF monotherapy, especially in patients exhibiting larger SMH sizes (>15 DA) at the initial visit.

Background To investigate the effect of intravitreal dexamethasone implant (DEX implant) on hard exudate (HE) accompanying diabetic macular edema (DME). Methods This study was a non-comparative non-randomized 1-year prospective interventional study. Patients with DME and HE were treated using DEX implant two or three times. Color fundus photography and optical coherence tomography (OCT) were performed at every visit. HE area was measured semi-automatically from the fundus photographs. Results Thirty-five patients completed the study. Eleven patients (31.4%) received two injections, while the remaining received three times. HE area (primary outcome) significantly decreased from 1.404±2.094 mm2 (baseline) to 0.212±0.592 mm2 (last visit), which was 24% of the baseline HE area (PPP= 0.008). Central macular thickness (CMT) decreased from 455.8±23.6 μm to 366.8±31.1 μm (P=0.009). Repetitive measurements for entire study duration was analyzed using generalized estimating equations (GEE), where BCVA was related to age, CMT, and HE1500 area in multivariate analyses. Conclusion DEX implant could reduce and suppress HE in DME for one year with two or three injections. And centrally located HE area (HE1500 area) is related to vision. Trial registration ClinicalTrials.gov, NCT02399657, Registered 26 March 2015.

The abnormal growth of tissue, called pannus, is frequently found in patients who have an implanted prosthetic heart valve. Its growth is related to the valve dysfunction and disturbed blood flow in the aorta. We performed in vitro experiments to demonstrate the effects of pannus formation on hemodynamics and valvular function. The results showed that the opening angle of the heart valve changes depending on the size and shape of the pannus. The circular pannus decreased the maximum opening angle of the heart valve. Although the opening motion of the valve was not affected by the semi-circular pannus, one of the valve leaflets obstructed by the semi-circular pannus had a closing dysfunction during the cardiac cycle, implying aortic insufficiency and regurgitation in the patients with this type of pannus formation. The experimentally measured pressure gradient and velocity-based transvalvular pressure gradient estimation increased with the growth of the pannus, although a discrepancy between the two estimations was observed.

Objective To assess non-inferiority of s.c. to i.v. CT-P13 in RA. Methods Patients with active RA and inadequate response to MTX participated in this phase I/III double-blind study at 76 sites. Patients received CT-P13 i.v. 3 mg/kg [week (W) 0 and W2] before randomization (1:1) at W6 to CT-P13 s.c. via pre-filled syringe (PFS) 120 mg biweekly until W28, or CT-P13 i.v. 3 mg/kg every 8 weeks until W22. Randomization was stratified by country, W2 serum CRP and W6 body weight. From W30, all patients received CT-P13 s.c. In a usability sub-study, patients received CT-P13 s.c. via auto-injector (W46–54) then PFS (W56–64). The primary endpoint was change (decrease) from baseline in disease activity score in 28 joints (DAS28)-CRP at W22 (non-inferiority margin: −0.6). Results Of 357 patients enrolled, 343 were randomized to CT-P13 s.c. (n = 167) or CT-P13 i.v. (n = 176) at W6. The least-squares mean change (decrease) from baseline (standard error) in DAS28-CRP at W22 was 2.21 (0.22) for CT-P13 s.c. (n = 162) and 1.94 (0.21) for CT-P13 i.v. [n = 168; difference 0.27 (95% CI: 0.02, 0.52)], establishing non-inferiority. Efficacy findings were similar between arms at W54. Safety was similar between arms throughout: 92 (54.8%; CT-P13 s.c.) and 117 (66.9%; CT-P13 i.v.) patients experienced treatment-emergent adverse events (from W6). There were no treatment-related deaths or new safety findings. Usability was similar for CT-P13 s.c. via auto-injector or PFS. Conclusion CT-P13 s.c. was non-inferior to CT-P13 i.v. in active RA. The convenience of s.c. administration could benefit patients. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03147248.

Purpose To investigate optic opacification of hydrophobic acrylic intraocular lens (IOL) depending on hydration and temperature conditions. Methods IOL (Acrysof® MA60BM Alcon, Fort Worth, Texas, USA) extracted from a 55-year-old male who underwent binocular cataract 11 years ago were used for the analysis. On slit lamp examination, the binocular IOL optics showed homogenous opacification. After extraction of the IOLs, the IOL opacification disappeared during dry storage at 4°C. To investigate the changes in IOL opacification according to temperature and hydration, an extracted IOL was stored in either dry conditions or normal saline at 4°C, room temperature, or 37°C for 24 hours, and then the degree of haziness was examined. To investigate the impact of an opaque optic on visual function, light transmission was performed using an ultraviolet-visible spectrophotometer (U-3000, Hitachi High-Technologies Corp., Tokyo, Japan). Results The extracted IOL optics at 4°C, room temperature, and 37°C were transparent at dry conditions. When the dried IOL was immersed in normal saline at room temperature and 37°C, opacification appeared. However, when the dried IOL was immersed in normal saline at 4°C, opacification of the IOL did not appear. When compared with the control, light transmission of the extracted IOLs from the right and left eyes stored in 37°C normal saline decreased by 4.7% at 453 nm and by 5.1% at 482 nm, respectively. Conclusion In acrylic hydrophobic IOLs, optic opacification can occur depending on temperature and hydration conditions.

To elucidate the differences in muscle bundle and satellite cells in medial rectus muscle through histological and Immunofluorescence studies of intermittent exotropia patients and normal controls....

In 2017, Food and Drug Administration (FDA) circulated a draft guidance on analytical similarity assessment to assist the sponsors for providing totality-of-the-evidence in support of the demonstra...

Radiation therapy is an important mode of treatment for patients with head and neck cancers, but some associated complications can reduce the quality of life. We investigated whether N-acetylcysteine inhalation therapy improved the quality of life of such patients. We designed a prospective, non-randomized controlled multi-center study involving 10 institutions. We enrolled 120 patients (80 in the experimental group and 40 in the control group). Patients in the experimental group inhaled nebulized liquid N-acetylcysteine (2400 mg daily) for 8 weeks from the start of radiation therapy. Quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire H&N 35. N-acetylcysteine inhalation was not associated with any side effect or discomfort. The reduction in painkiller use from the end of N-acetylcysteine inhalation therapy to the 1-month follow-up was greater in the experimental group than in the control group (P = 0.014). Dry mouth symptoms also improved significantly in the experimental group (P = 0.019). N-acetylcysteine inhalation improves the quality of life of patients with head and neck cancers who are receiving radiation therapy, without any specific side effect.