• Title/Summary/Keyword: clinical efficacy

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Is conventional radiofrequency ablation of the superolateral branch, one of the three genicular nerves targeted as standard, necessary or not? A non-inferiority randomized controlled trial

  • Osman Albayrak;Canan Sanal Toprak;Osman Hakan Gunduz;Savas Sencan
    • The Korean Journal of Pain
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    • v.37 no.3
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    • pp.264-274
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    • 2024
  • Background: Radiofrequency ablation is an effective treatment modality in the symptomatic treatment of knee osteoarthritis. Our aim was to compare the efficacy of radiofrequency ablation of the superomedial and inferomedial genicular nerves (2 branches) with the superolateral, superomedial, and inferomedial genicular nerves (3 branches) and to show whether the 2-branch procedure is inferior to the 3-branch procedure. Methods: This study is a prospective, randomized, single-blind clinical study. Eligible participants were randomized into 2 groups: group A, which applied the procedure to the superomedial and inferomedial genicular nerves, and group B, which applied it to the superomedial, superolateral and inferomedial genicular nerves. Pain was evaluated with the numerical rating scale, quality of life with the Short Form-36 (SF-36), and disability with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index before, and at 1 and 3 months after the procedure. Results: A total of 41 patients were included. There were no differences between the groups except for the SF-36 physical health sub-score at baseline. A significant improvement was seen in the numeric rating scale (NRS) score, SF-36 sub-scores, WOMAC Index total, as well as pain and physical function scores in both groups, though no significant difference was detected between the groups during follow-up. Conclusions: Although we were unable to establish the noninferiority of conventional radiofrequency ablation (CRFA) applied to 2 branches to CRFA applied to 3 branches, in this trial, significant and similar improvement was observed in NRS, WOMAC total, pain, and physical function and SF-36 scores in both groups.

Aerosol protection using modified N95 respirator during upper gastrointestinal endoscopy: a randomized controlled trial

  • Chawisa Nampoolsuksan;Thawatchai Akaraviputh;Asada Methasate;Jirawat Swangsri;Atthaphorn Trakarnsanga;Chainarong Phalanusitthepha;Thammawat Parakonthun;Voraboot Taweerutchana;Nicha Srisuworanan;Tharathorn Suwatthanarak;Thikhamporn Tawantanakorn;Varut Lohsiriwat;Vitoon Chinswangwatanakul
    • Clinical Endoscopy
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    • v.57 no.3
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    • pp.335-341
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    • 2024
  • Background/Aims: The coronavirus disease 2019 pandemic has affected the worldwide practice of upper gastrointestinal endoscopy. Here we designed a modified N95 respirator with a channel for endoscope insertion and evaluated its efficacy in upper gastrointestinal endoscopy. Methods: Thirty patients scheduled for upper gastrointestinal endoscopy were randomized into the modified N95 (n=15) or control (n=15) group. The mask was placed on the patient after anesthesia administration and particles were counted every minute before (baseline) and during the procedure by a TSI AeroTrak particle counter (9306-04; TSI Inc.) and categorized by size (0.3, 0.5, 1, 3, 5, and 10 ㎛). Differences in particle counts between time points were recorded. Results: During the procedure, the modified N95 group displayed significantly smaller overall particle sizes than the control group (median [interquartile range], 231 [54-385] vs. 579 [213-1,379]×103/m3; p=0.056). However, the intervention group had a significant decrease in 0.3-㎛ particles (68 [-25 to 185] vs. 242 [72-588] ×103/m3; p=0.045). No adverse events occurred in either group. The device did not cause any inconvenience to the endoscopists or patients. Conclusions: This modified N95 respirator reduced the number of particles, especially 0.3-㎛ particles, generated during upper gastrointestinal endoscopy.

Preparation and Performance Evaluation of a Zinc Oxide-Graphene Oxideloaded Chitosan-Based Thermosensitive Gel

  • Hao Huang;Rui Han;Ping-Ping Huang;Chuan-Yue Qiao;Shuang Bian;Han Xiao;Lei Ma
    • Journal of Microbiology and Biotechnology
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    • v.34 no.6
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    • pp.1229-1238
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    • 2024
  • This study aimed to develop and assess a chitosan biomedical antibacterial gel ZincOxide-GrapheneOxide/Chitosan/β-Glycerophosphate (ZnO-GO/CS/β-GP) loaded with nano-zinc oxide (ZnO) and graphene oxide (GO), known for its potent antibacterial properties, biocompatibility, and sustained drug release. ZnO nanoparticles (ZnO-NPs) were modified and integrated with GO sheets to create 1% and 3% ZnO-GO/CS/β-GP thermo-sensitive hydrogels based on ZnO-GO to Chitosan (CS) mass ratio. Gelation time, pH, structural changes, and microscopic morphology were evaluated. The hydrogel's antibacterial efficacy against Porphyromonas gingivalis, biofilm biomass, and metabolic activity was examined alongside its impact (MC3T3-e1). The findings of this study revealed that both hydrogel formulations exhibited temperature sensitivity, maintaining a neutral pH. The ZnO-GO/CS/β-GP formulation effectively inhibited P. gingivalis bacterial activity and biofilm formation, with a 3% ZnO-GO/CS/β-GP antibacterial rate approaching 100%. MC3T3-e1 cells displayed good biocompatibility when cultured in the hydrogel extract.The ZnO-GO/CS/β-GP thermo-sensitive hydrogel demonstrates favorable physical and chemical properties, effectively preventing P. gingivalis biofilm formation. It exhibits promising biocompatibility, suggesting its potential as an adjuvant therapy for managing and preventing peri-implantitis, subject to further clinical investigations.

Ketone ester supplementation of Atkins-type diet prolongs survival in an orthotopic xenograft model of glioblastoma

  • Hassan Azari;Angela Poff;Dominic D'Agostino;Brent Reynolds
    • Anatomy and Cell Biology
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    • v.57 no.1
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    • pp.97-104
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    • 2024
  • Heavy reliance on glucose metabolism and a reduced capacity to use ketone bodies makes glioblastoma (GBM) a promising candidate for ketone-based therapies. Ketogenic diet (KD) is well-known for its promising effects in controlling tumor growth in GBM. Moreover, synthetic ketone ester (KE) has demonstrated to increase blood ketone levels and enhance animal survival in a metastatic VM-M3 murine tumor model. Here, we compared the efficacy of a KE-supplemented Atkins-type diet (ATD-KE) to a classic KD in controlling tumor progression and enhancing survival in a clinically relevant orthotopic patient-derived xenograft GBM model. Our findings demonstrate that ATD-KE preserves body weight (percent change from the baseline; 112±2.99 vs. 116.9±2.52 and 104.8±3.67), decreases blood glucose (80.55±0.86 vs. 118.6±9.51 and 52.35±3.89 mg/dl), and increases ketone bodies in blood (1.15±0.03 mM vs. 0.55±0.04 and 2.66±0.21 mM) and brain tumor tissue (3.35±0.30 mM vs. 2.04±0.3 and 4.25±0.25 mM) comparable to the KD (results presented for ATD-KE vs. standard diet [STD] and KD, respectively). Importantly, the ATD-KE treatment significantly enhanced survival compared to the STD and was indistinguishable from the KD (47 days in STD vs. 56 days in KD and ATD-KE), suggesting that a nutritionally balanced low carbohydrate ATD combined with KE may be as effective as the KD alone in reducing brain tumor progression. Overall, these data support the rationale for clinical testing of KE-supplemented low-carb diet as an adjunct treatment for brain tumor patients.

Inferring B-cell derived T-cell receptor induced multi-epitope-based vaccine candidate against enterovirus 71: a reverse vaccinology approach

  • Subrat Kumar Swain;Subhasmita Panda;Basanta Pravas Sahu;Soumya Ranjan Mahapatra;Jyotirmayee Dey;Rachita Sarangi;Namrata Misra
    • Clinical and Experimental Vaccine Research
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    • v.13 no.2
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    • pp.132-145
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    • 2024
  • Purpose: Enterovirus 71, a pathogen that causes hand-foot and mouth disease (HFMD) is currently regarded as an increasing neurotropic virus in Asia and can cause severe complications in pediatric patients with blister-like sores or rashes on the hand, feet, and mouth. Notwithstanding the significant burden of the disease, no authorized vaccine is available. Previously identified attenuated and inactivated vaccines are worthless over time owing to changes in the viral genome. Materials and Methods: A novel vaccine construct using B-cell derived T-cell epitopes from the virulent polyprotein found the induction of possible immune response. In order to boost the immune system, a beta-defensin 1 preproprotein adjuvant with EAAAK linker was added at the N-terminal end of the vaccine sequence. Results: The immunogenicity of the designed, refined, and verified prospective three-dimensional-structure of the multi-epitope vaccine was found to be quite high, exhibiting non-allergenic and antigenic properties. The vaccine candidates bound to toll-like receptor 3 in a molecular docking analysis, and the efficacy of the potential vaccine to generate a strong immune response was assessed through in silico immunological simulation. Conclusion: Computational analysis has shown that the proposed multi-epitope vaccine is possibly safe for use in humans and can elicit an immune response.

Hip Resurfacing Arthroplasty after Failure of Tantalum Rod Insertion in Patients with Osteonecrosis of the Femoral Head

  • Yoon Je Cho;Kee Hyung Rhyu;Young Soo Chun;Hyun Gon Gwak
    • Hip & pelvis
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    • v.34 no.4
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    • pp.219-226
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    • 2022
  • Purpose: The purpose of this study was to examine the clinical outcomes and efficacy of hip resurfacing arthroplasty (HRA) in patients with osteonecrosis of the femoral head after the failure of porous tantalum rod insertion without rod removal. Materials and Methods: Conversion to hip resurfacing arthroplasty was performed in 10 patients (11 hips) with a mean period of 14.9 months after the primary surgery. The mean follow-up period was 73.7 months. Analysis of pre and postoperative range of motion (ROM), University of California at Los Angeles (UCLA) activity score, modified Harris hip score, and visual analog scale (VAS) pain score was performed. Radiographic analysis of component loosening and osteolysis was performed. Results: The postoperative ROM showed significant improvement (P<0.05), excluding flexion contracture. The modified Harris hip score showed improvement from 65.82 to 96.18, the UCLA score showed improvement from 4.18 to 8.00, and the VAS pain score was reduced from 6.09 to 1.80. All scores showed statistically significant improvement (P<0.05). No component loosening or osteolysis was detected by radiographic analysis. Conclusion: Satisfactory results were obtained from conversion hip resurfacing arthroplasty after failure of porous tantalum rod insertion without rod removal. The findings of this study demonstrate the advantages of HRA, including no risk of trochanteric fracture and no bone loss around the tantalum rod. In addition, the remaining porous tantalum rod provided mechanical support, which reduced the potential risk of femoral neck fracture or loosening. This technique can be regarded as a favorable treatment option.

Endoscopic submucosal dissection in colorectal neoplasia performed with a waterjet system-assisted knife: higher en-bloc resection rate than conventional technique

  • Paolo Cecinato;Matteo Lucarini;Francesco Azzolini;Mariachiara Campanale;Fabio Bassi;Annalisa Cippitelli;Romano Sassatelli
    • Clinical Endoscopy
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    • v.55 no.6
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    • pp.775-783
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    • 2022
  • Background/Aims: Colorectal endoscopic submucosal dissection (ESD) is burdened by its associated high risk of adverse events and long procedure time. Recently, a waterjet-assisted knife was introduced to simplify and speed up the procedure. The aim of this study was to evaluate the efficacy and safety of waterjet-assisted ESD (WESD) compared to that of the conventional ESD (CESD) technique. Methods: The charts of 254 consecutive patients who underwent colorectal ESD between January 2014 and February 2021 for colorectal neoplasms were analyzed. The primary outcome was the en-bloc resection rate. Secondary outcomes were complete and curative resection rates, the need to switch to a hybrid ESD, procedure speed, the adverse event rates, and the recurrence rates. Results: Approximately 174 neoplasias were considered, of which, 123 were removed by WESD and 51 by CESD. The en-bloc resection rate was higher in the WESD group (94.3% vs. 84.3%). Complete resection rates and curative resection rates were similar. The need to switch to a hybrid ESD was greater during CESD (39.2% vs. 13.8%). Procedure speed and adverse event rates were similar. During follow-up, one recurrence occurred after a WESD. Conclusions: WESD allows a high rate of en-bloc resections and less frequently requires a rescue switch to the hybrid ESD compared to CESD.

Colorectal Cancer Screening with Computed Tomography Colonography: Single Region Experience in Kazakhstan

  • Jandos Amankulov;Dilyara Kaidarova;Zhamilya Zholdybay;Marianna Zagurovskaya;Nurlan Baltabekov;Madina Gabdullina;Akmaral Ainakulova;Dias Toleshbayev;Alexandra Panina;Elvira Satbayeva;Zhansaya Kalieva
    • Clinical Endoscopy
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    • v.55 no.1
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    • pp.101-112
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    • 2022
  • Background/Aims: The aim of our study was to determine the efficacy of computed tomography colonography (CTC) in screening for colorectal cancer (CRC). Methods: A total of 612 females and 588 males aged 45 to 75 years were enrolled in CTC screening. CTC was performed following standard bowel preparation and colonic insufflation with carbon dioxide. The main outcomes were the detection rate of CRC and advanced adenoma (AA), prevalence of colorectal lesions in relation to socio-demographic and health factors, and overall diagnostic performance of CTC. Results: Overall, 56.5% of the 1,200 invited subjects underwent CTC screening. The sensitivity for CRC and AA was 0.89 and 0.97, respectively, while the specificity was 0.71 and 0.99, respectively. The prevalence of CRC and AA was 3.0% (18/593) and 7.1% (42/593), respectively, with the highest CRC prevalence in the 66-75 age group (≥12 times; odds ratio [OR], 12.11; 95% confidence interval [CI], 4.45-32.92). CRC and AA prevalence were inversely correlated with Asian descent, physical activity, and negative fecal immunochemical test results (OR=0.43; 95% CI, 0.22-0.83; OR=0.16; 95% CI, 0.04-0.68; OR=0.5; 95% CI, 0.07-3.85, respectively). Conclusions: Our study revealed high accuracy of CTC in diagnosing colonic neoplasms, good compliance with CTC screening, and high detection rate of CRC.

Outcomes of endoscopic submucosal dissection for superficial esophageal neoplasms in patients with liver cirrhosis

  • Young Kwon Choi;Jin Hee Noh;Do Hoon Kim;Hee Kyong Na;Ji Yong Ahn;Jeong Hoon Lee;Kee Wook Jung;Kee Don Choi;Ho June Song;Gin Hyug Lee;Hwoon-Yong Jung
    • Clinical Endoscopy
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    • v.55 no.3
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    • pp.381-389
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    • 2022
  • Background/Aims: The treatment of superficial esophageal neoplasms (SENs) in cirrhotic patients is challenging and rarely investigated. We evaluated the outcomes of endoscopic submucosal dissection (ESD) to determine the efficacy and safety of treating SENs in patients with liver cirrhosis. Methods: The baseline characteristics and treatment outcomes of patients who underwent ESD for SENs between November 2005 and December 2017 were retrospectively reviewed. Results: ESD was performed in 437 patients with 481 SENs, including 15 cirrhotic patients with 17 SENs. En bloc resection (88.2% vs. 97.0%) and curative resection (64.7% vs. 78.9%) rates were not different between the cirrhosis and non-cirrhosis groups (p=0.105 and p=0.224, respectively). Bleeding was more common in cirrhotic patients (p=0.054), and all cases were successfully controlled endoscopically. The median procedure and hospitalization duration did not differ between the groups. Overall survival was lower in cirrhotic patients (p=0.003), while disease-specific survival did not differ between the groups (p=0.85). Conclusions: ESD could be a safe and effective treatment option for SENs in patients with cirrhosis. Detailed preprocedural assessments are needed, including determination of liver function, esophageal varix status, and remaining life expectancy, to identify patients who will obtain the greatest benefit.

Laser-cut-type versus braided-type covered self-expandable metallic stents for distal biliary obstruction caused by pancreatic carcinoma: a retrospective comparative cohort study

  • Koh Kitagawa;Akira Mitoro;Takahiro Ozutsumi;Masanori Furukawa;Yukihisa Fujinaga;Kenichiro Seki;Norihisa Nishimura;Yasuhiko Sawada;Kosuke Kaji;Hideto Kawaratani;Hiroaki Takaya;Kei Moriya;Tadashi Namisaki;Takemi Akahane;Hitoshi Yoshiji
    • Clinical Endoscopy
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    • v.55 no.3
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    • pp.434-442
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    • 2022
  • Background/Aims: Covered self-expandable metallic stents (CMSs) are widely used for malignant distal biliary obstructions (MDBOs) caused by pancreatic carcinoma. This study compared the efficacy and safety of the laser-cut-type and braided-type CMSs. Methods: To palliate MDBOs caused by pancreatic carcinoma, the laser-cut-type CMSs was used from April 2014 to March 2017, and the braided-type CMSs was used from April 2017 to March 2019. The tested self-expandable metallic stents were equipped with different anti-migration systems. Results: In total, 47 patients received CMSs for MDBOs (24 laser-cut type, 23 braided-type). The time to recurrent biliary obstruction (TRBO) was significantly longer in the braided-type CMSs (p=0.0008), and the median time to stent dysfunction or patient death was 141 and 265 days in the laser-cut-type CMSs and braided-type CMSs, respectively (p=0.0023). Stent migration was the major cause of stent dysfunction in both groups, which occurred in 37.5% of the laser-cut-type CMSs and 13.0% of the braided-type CMSs. There were no differences in the survival duration between the groups. Conclusions: The TRBO was significantly longer for the braided-type CMSs with an anti-migration system than for the laser-cut-type. Stent migration tended to be less frequent with the braided-type CMSs than with the laser-cut-type CMSs.