• Title/Summary/Keyword: Clinical safety

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Development and evaluation of a triplex real-time quantitative reverse transcription-polymerase chain reaction for rapid and differential detection of three feline respiratory viral pathogens

  • Ji-Su Baek;Jong-Min Kim;Hye-Ryung Kim;Ji-Hoon Park;Yeun-Kyung Shin;Hae-Eun Kang;Jung-Hoon Kwon;Won-Jae Lee;Min Jang;Sang-Kwon Lee;Ho-Seong Cho;Yeonsu Oh;Oh-Deog Kwon;Choi-Kyu Park
    • Korean Journal of Veterinary Service
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    • v.46 no.4
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    • pp.269-281
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    • 2023
  • In this study, a new triplex real-time quantitative reverse transcription polymerase chain reaction (tqRT-PCR) assay was developed for the rapid and differential detection of three feline viral pathogens including feline calicivirus (FCV), feline herpesvirus 1 (FHV-1), and influenza A virus (IAV) in a single reaction. The assay specifically amplified three targeted viral genes with a detection limit of below 10 copies/reaction. The assay showed high repeatability and reproducibility, with intra- and inter-assay coefficients of variation of less than 1%. Based on the diagnostic results of the assay using 120 clinical samples obtained from cats with feline respiratory disease complex (FRDC)-suspected signs, the prevalence of FCV, FHV-1, or IAV was 43.3%, 22.5%, or 0%, respectively, indicating that the diagnostic sensitivity was comparable or superior to those of previously reported monoplex qRT-PCR/qPCR assays. The dual infection rate for FCV and FHV-1 was 8.3%. These results indicate that FCV and FHV-1 are widespread and that co-infection with FCV and FHV-1 frequently occur in the Korean cat population. The developed tqRT-PCR assay will serve as a promising tool for etiological and epidemiological studies of these three bacterial pathogens, and the prevalence data for three feline viruses obtained in this study will contribute to expanding knowledge about the epidemiology of FRDC in the current Korean cat population.

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
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    • v.22 no.2
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    • pp.179-188
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    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

Comparison of Kinematics and Myoelectrical Activity during Deadlift, with and without Variable Banded Resistance, in Healthy, Trained Athletes

  • Everett B. Lohman;Mansoor Alameri;Fulden Cakir;Chih Chieh Chia;Maxine Shih;Owee Mulay;Kezia Marceline;Simran Jaisinghani;Gurinder Bains;Michael DeLeon;Noha Daher
    • Physical Therapy Rehabilitation Science
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    • v.13 no.1
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    • pp.53-70
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    • 2024
  • Background: The conventional deadlift is a popular exercise for enhancing trunk, core, and lower extremity strength. However, its use in sports medicine is constrained by concerns of lumbar injuries, despite evidence supporting its safety and rehabilitative benefits. To optimize muscle activation using resistive bands in variable resistance therapy, we explored their feasibility in the deadlift. Design: Comparative experimental design Methods: Surface electromyography recorded muscle activity in the trunk and lower extremities during lifting, with normalization to the isometric Floor Lift using Maximal Voluntary Contraction. Kinematics were measured using inclinometer sensors to track hip and trunk sagittal plane angles. To prevent fatigue, each subject only used one of the three pairs of bands employed in the study. Results: Our study involved 45 healthy subjects (mean age: 30.4 ± 6.3 years) with similar baseline characteristics, except for years of lifting and strength-to-years-of-lifting ratio. Various resistance band groups exhibited significantly higher muscle activity than conventional deadlifts during different phases. The minimal resistance band group had notably higher muscle activity in the trunk, core, and lower extremity muscles, particularly in the end phase. The moderate resistance band group showed increased muscle activity in the mid-and end-phases. The maximum resistance band group demonstrated greater muscle activity in specific muscles during the early phase and overall higher activity in all trunk and lower extremity muscles in the mid and end phases of the deadlift (p<0.05). Conclusion: Our findings provide valuable insights into muscle activation with various resistance bands during deadlift exercise in clinical and gym settings. There appears to be a dose-response relationship between increased resistance bandwidth, external load, myoelectric activation, and range.

Identification of an effective and safe bolus dose and lockout time for patient-controlled sedation (PCS) using dexmedetomidine in dental treatments: a randomized clinical trial

  • Seung-Hyun Rhee;Young-Seok Kweon;Dong-Ok Won;Seong-Whan Lee;Kwang-Suk Seo
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.1
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    • pp.19-35
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    • 2024
  • Background: This study investigated a safe and effective bolus dose and lockout time for patient-controlled sedation (PCS) with dexmedetomidine for dental treatments. The depth of sedation, vital signs, and patient satisfaction were investigated to demonstrate safety. Methods: Thirty patients requiring dental scaling were enrolled and randomly divided into three groups based on bolus doses and lockout times: group 1 (low dose group, bolus dose 0.05 ㎍/kg, 1-minute lockout time), group 2 (middle dose group, 0.1 ㎍/kg, 1-minute), and group 3 (high dose group, 0.2 ㎍/kg, 3-minute) (n = 10 each). ECG, pulse, oxygen saturation, blood pressure, end-tidal CO2, respiratory rate, and bispectral index scores (BIS) were measured and recorded. The study was conducted in two stages: the first involved sedation without dental treatment and the second included sedation with dental scaling. Patients were instructed to press the drug demand button every 10 s, and the process of falling asleep and waking up was repeated 1-5 times. In the second stage, during dental scaling, patients were instructed to press the drug demand button. Loss of responsiveness (LOR) was defined as failure to respond to auditory stimuli six times, determining sleep onset. Patient and dentist satisfaction were assessed before and after experimentation. Results: Thirty patients (22 males) participated in the study. Scaling was performed in 29 patients after excluding one who experienced dizziness during the first stage. The average number of drug administrations until first LOR was significantly lower in group 3 (2.8 times) than groups 1 and 2 (8.0 and 6.5 times, respectively). The time taken to reach the LOR showed no difference between groups. During the second stage, the average time required to reach the LOR during scaling was 583.4 seconds. The effect site concentrations (Ce) was significantly lower in group 1 than groups 2 and 3. In the participant survey on PCS, 8/10 in group 3 reported partial memory loss, whereas 17/20 in groups 1 and 2 recalled the procedure fully or partially. Conclusion: PCS with dexmedetomidine can provide a rapid onset of sedation, safe vital sign management, and minimal side effects, thus facilitating smooth dental sedation.

Outcomes of partially covered self-expandable metal stents with different uncovered lengths in endoscopic ultrasound-guided hepaticogastrostomy: a Japanese retrospective study

  • Takeshi Okamoto;Takashi Sasaki;Tsuyoshi Takeda;Tatsuki Hirai;Takahiro Ishitsuka;Manabu Yamada;Hiroki Nakagawa;Takafumi Mie;Takaaki Furukawa;Akiyoshi Kasuga;Masato Ozaka;Naoki Sasahira
    • Clinical Endoscopy
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    • v.57 no.4
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    • pp.515-526
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    • 2024
  • Background/Aims: The optimal length of the uncovered portion of partially covered self-expandable metal stents (PCSEMSs) used in endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) remains unclear. This study investigated the safety and efficacy of PCSEMSs with different uncovered lengths, with a focus on stent migration and time to recurrent biliary obstruction (RBO). Methods: Outcomes of patients undergoing EUS-HGS using PCSEMSs with 5-mm and 20-mm uncovered portions at our institution from January 2016 to December 2021 were compared. Results: Sixty-two patients underwent EUS-HGS using PCSEMS (5/20-mm uncovered portions: 32/30). Stent migration occurred only in the 5-mm group. There were no differences in RBO rates (28.1% vs. 40.0%) or median time to RBO (6.8 vs. 7.1 months) between the two groups. Median overall survival (OS) was longer in the 20-mm group (3.1 vs. 4.9 months, p=0.037) due to the higher number of patients that resumed chemotherapy after EUS-HGS (56.7% vs. 28.1%, p=0.029). Good performance status, absence of hepatic metastases, and chemotherapy after EUS-HGS were independent predictors of longer OS. Conclusions: No migration was observed in patients treated with PCSEMS with 20-mm uncovered portions. Patients treated with PCSEMS with 20-mm uncovered portions performed at least as well as those treated with 5-mm uncovered portions in all material respects.

Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI

  • You-Jeong Ki;Bong Ki Lee;Kyung Woo Park;Jang-Whan Bae;Doyeon Hwang;Jeehoon Kang;Jung-Kyu Han;Han-Mo Yang;Hyun-Jae Kang;Bon-Kwon Koo;Dong-Bin Kim;In-Ho Chae;Keon-Woong Moon;Hyun Woong Park;Ki-Bum Won;Dong Woon Jeon;Kyoo-Rok Han;Si Wan Choi;Jae Kean Ryu;Myung Ho Jeong;Kwang Soo Cha;Hyo-Soo Kim;HOST-RP-ACS investigators
    • Korean Circulation Journal
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    • v.52 no.4
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    • pp.304-319
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    • 2022
  • Background and Objectives: De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-ST-segment elevation ACS (NSTE-ACS). Methods: This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. Results: Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48-0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48-2.26; p=0.915; p for interaction=0.271). Conclusions: Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

Modified application of SAMe-TT2R2 scoring system in Asian patients with atrial fibrillation for the selection of oral anticoagulants

  • Seong Won Jeon;Nuri Lee;Ki Hong Lee;Minjeong Ha;Changhyun Kim;Yoo Ri Kim;Nam Sik Yoon;Hyung Wook Park
    • The Korean journal of internal medicine
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    • v.39 no.3
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    • pp.458-468
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    • 2024
  • Background/Aims: The SAMe-TT2R2 score is used for assessing anticoagulation control (AC) quality with warfarin. However, it is hard to apply SAMe-TT2R2 score in Asian patients with atrial fibrillation (AF), because it has not been proven in those populations. This study aimed to validate the SAMe-TT2R2 score in Asian patients with AF and suggest a modified SAMe-TT2R2 score for this population. Methods: We analyzed 710 Korean patients with AF who were using warfarin. The AC quality was assessed as the mean time in therapeutic range (TTR). Each component of SAMe-TT2R2 score was evaluated for the relationship with AC. Further clinical factors that predict AC were analyzed. Identified factors were re-assorted and constructed as SA2Me-TTR scoring system. Results: Of the components of the SAMe-TT2R2 score, female, age, and rhythm control were associated with AC. Heart failure and renal insufficiency were newly identified factors associated with AC. The modified SA2Me-TTR score was reconstructed with the relevant risk factors (S, female gender, 1 point; A, age < 60 yr, 2 points; Me, medical history of heart failure, 1 point; T, treatment for rhythm control, 1 point; T, history of stroke or transient ischemic attack, 1 point; R, renal insufficiency, 1 point). The modified SA2Me-TTR score demonstrated an excellent relationship with the grading of AC. The modified SA2Me-TTR score ≤ 1 identified patients with good AC (hazard ratio 2.46, 95% CI 1.75-3.47). Conclusions: The modified SA2Me-TTR score was useful for guiding oral anticoagulants selection in Asian patients with AF.

A retrospective study on the efficacy of Roxadustat in peritoneal dialysis patients with erythropoietin hyporesponsiveness

  • Jie Liu;Shuang Li;Fan Yang;Tianyu Li;Rui Li;Yousuf Waheed;Chen Meng;Shulin Li;Kun Liu;Yanshan Tong;Haisheng Xu;Chuankuo Tian;Xinglei Zhou
    • The Korean journal of internal medicine
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    • v.39 no.3
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    • pp.488-500
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    • 2024
  • Background/Aims: Roxadustat, an oral medication for treating renal anemia, is a hypoxia-inducible factor prolyl hydroxylase inhibitor used for regulating iron metabolism and promoting erythropoiesis. To investigate the efficacy and safety of roxadustat in patients undergoing peritoneal dialysis (PD) with erythropoietin hyporesponsiveness. Methods: Single-center, retrospective study, 81 PD patients (with erythropoietin hyporesponsiveness) were divided into the roxadustat group (n = 61) and erythropoiesis-stimulating agents (ESAs) group (n = 20). Hemoglobin (Hb), total cholesterol, intact parathyroid hormone (iPTH), brain natriuretic peptide (BNP), related indicators of cardiac function and high-sensitivity C-reactive protein (hs-CRP) were collected. Additionally, adverse events were also recorded. The follow-up period was 16 weeks. Results: The two groups exhibited similar baseline demographic and clinical characteristics. At baseline, the roxadustat group had a mean Hb level of 89.8 ± 18.9 g/L, while the ESAs group had a mean Hb level of 95.2 ± 16.0 g/L. By week 16, the Hb levels had increased to 118 ± 19.8 g/L (p < 0.05) in the roxadustat group and 101 ± 19.3 g/L (p > 0.05) in the ESAs group. The efficacy of roxadustat in improving anemia was not influenced by baseline levels of hs-CRP and iPTH. Cholesterol was decreased in the roxadustat group without statin use. An increase in left ventricular ejection fraction and stabilization of BNP were observed in the roxadustat group. Conclusions: For PD patients with erythropoietin hyporesponsiveness, roxadustat can significantly improve renal anemia. The efficacy of roxadustat in improving renal anemia was not affected by baseline levels of hs-CRP0 and iPTH.

A new strategy for transcatheter closure of patent ductus arteriosus with recent-generation devices (경피적 동맥관 폐쇄술에서 최근의 기구들의 전략적 이용과 결과)

  • Kim, Sang Yee;Lee, Soo Hyun;Kim, Nam Kyun;Choi, Jae Young;Sul, Jun Hee
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.488-493
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    • 2009
  • Purpose : The aim of this study was to assess the efficacy and safety of recent-generation patent ductus arteriosus (PDA) closure devices applied by a new selection strategy according to the characteristics of each PDA. Methods : From February 2003 to January 2006, 138 patients underwent transcatheter closure of PDA (study group). According to the size and morphology of each ductus, a COOK Detachable Coil or 'flex' PFM Nit-Occlud was used for a small ductus (group 1, n=43); 'medium' PFM Nit-Occlud (group 2, n=49) for a moderate ductus; and an Amplatzer Duct Occluder (group 3, n=46) for a large ductus. The 83 patients who underwent transcatheter closure of PDA from February 2000 to January 2003 were defined as the comparison group. The Qp/Qs ratio, pulmonary/aorta pressure ratio, and MD of the ductus were compared. Immediate and follow-up results including residual shunts and complications were also evaluated and compared among groups. Results : In all 138 patients, complete occlusions were confirmed without major complications, while procedure failure (n=2, 2.2%), device embolization (n=1, 1.1%), and persistent residual shunt (n=4, 4.5%) were documented in the comparison group. Total complication rates were lower in the study group than in the comparison group (study group, 1.4%; comparison group, 9.0%; P<0.05). Conclusion : A novel strategy adopting the merits of various recent-generation devices for transcatheter closure of PDA provides excellent clinical results with minimal risk.

Analysis of Global Gene Expression Profile of Human Adipose Tissue Derived Mesenchymal Stem Cell Cultured with Cancer Cells (암세포주와 공동 배양된 인간 지방 조직 유래 중간엽 줄기 세포의 유전자 발현 분석)

  • Kim, Jong-Myung;Yu, Ji-Min;Bae, Yong-Chan;Jung, Jin-Sup
    • Journal of Life Science
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    • v.21 no.5
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    • pp.631-646
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    • 2011
  • Mesenchymal stem cells (MSC) are multipotent and can be isolated from diverse human tissues including bone marrow, fat, placenta, dental pulp, synovium, tonsil, and the thymus. They function as regulators of tissue homeostasis. Because of their various advantages such as plasticity, easy isolation and manipulation, chemotaxis to cancer, and immune regulatory function, MSCs have been considered to be a potent cell source for regenerative medicine, cancer treatment and other cell based therapy such as GVHD. However, relating to its supportive feature for surrounding cell and tissue, it has been frequently reported that MSCs accelerate tumor growth by modulating cancer microenvironment through promoting angiogenesis, secreting growth factors, and suppressing anti-tumorigenic immune reaction. Thus, clinical application of MSCs has been limited. To understand the underlying mechanism which modulates MSCs to function as tumor supportive cells, we co-cultured human adipose tissue derived mesenchymal stem cells (ASC) with cancer cell lines H460 and U87MG. Then, expression data of ASCs co-cultured with cancer cells and cultured alone were obtained via microarray. Comparative expression analysis was carried out using DAVID (Database for Annotation, Visualization and Integrated Discovery) and PANTHER (Protein ANalysis THrough Evolutionary Relationships) in divers aspects including biological process, molecular function, cellular component, protein class, disease, tissue expression, and signal pathway. We found that cancer cells alter the expression profile of MSCs to cancer associated fibroblast like cells by modulating its energy metabolism, stemness, cell structure components, and paracrine effect in a variety of levels. These findings will improve the clinical efficacy and safety of MSCs based cell therapy.