• Title/Summary/Keyword: e-Clinical Trials

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A Study for the Establishment of the Diagnostic Definition of Sanhupung (U32.7) using the Delphi Method (산후풍의 진단적 정의 확립을 위한 전문가 델파이 조사 연구)

  • Oh, Su-Kyoung;Noh, Eun-Ji;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.2
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    • pp.16-30
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    • 2021
  • Objectives: The aim of this study was to establish a clear diagnostic definition of Sanhupung using the Delphi method. Methods: This study used the Delphi technique. A panel consisting of 21 experts of Korean medicine, particularly in of gynecologic medicine, participated in the Delphi examination that included answering the 4th round survey. The Delphi examination was carried out through evaluating and correcting the questionnaire by e-mail. Results: Through the Delphi survey, we have reached on an agreement regarding the basic concepts, time, cause, essential symptoms, and accessory symptoms of Sanhupung. They are as follows: 1) Sanhupung is a culture bound syndrome reflecting Korea's cultural specificity. 2) Sanhupung can be diagnosed even after the miscarriage. 3) For the diagnosis of Sanhupung, the main cause of symptoms should not be classified as other disease. 4) Sanhupung can be diagnosed based on essential symptoms and accessory symptoms. 5) Essential symptoms include local symptoms such as joint pain at specific areas, partial sensory impairment and general symptoms including pain of all the joints, whole body sensory impairment, increased sweating, feeling of wind coming into the body, worsened symptoms with the cold, intolerance to cold, and pain of all the muscles. Conclusions: The basic concepts and diagnostic definition of Sanhupung were suggested based on the Delphi survey among experts in the field. Further research is necessary to improve reliability and validity of diagnostic definition of Sanhupung in clinical trials.

Recent Progress in Immunotherapy for Gastric Cancer

  • Jeesun Yoon;Tae-Yong Kim;Do-Youn Oh
    • Journal of Gastric Cancer
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    • v.23 no.1
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    • pp.207-223
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    • 2023
  • Gastric cancer (GC) is the fourth leading cause of cancer-related deaths worldwide. Under the standard of care, patients with advanced GC (AGC) have a median survival time of approximately 12-15 months. With the emergence of immunotherapy as a key therapeutic strategy in medical oncology, relevant changes are expected in the systemic treatment of GC. In the phase III ATTRACTION-2 trial, nivolumab, a monoclonal anti-programmed cell death 1 (PD-1) antibody, as a third- or later-line treatment improved overall survival (OS) compared with placebo in patients with AGC. Furthermore, nivolumab in combination with 5-fluorouracil and platinum as a first-line treatment improved OS in patients with human epidermal growth factor receptor-2 (HER2)-negative AGC in the global phase III CheckMate-649 study. Another anti-PD-1 antibody, pembrolizumab, in combination with trastuzumab and cytotoxic chemotherapy as a first-line treatment, significantly improved the overall response rate in patients with HER2-positive AGC. Therefore, immune checkpoint inhibitors (ICIs) are essential components of the current treatment of GC. Subsequent treatments after ICI combination therapy, such as ICI rechallenge or combination therapy with agents having other modes of action, are being actively investigated to date. On the basis of the success of immunotherapy in the treatment of AGC, various clinical trials are underway to apply this therapeutic strategy in the perioperative and postoperative settings for patients with early GC. This review describes recent progress in immunotherapy and potential immunotherapy biomarkers for GC.

HIV-1 Vaccine Development: Need For New Directions

  • Cho Michael W.
    • Proceedings of the Microbiological Society of Korea Conference
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    • 2000.10a
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    • pp.78-82
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    • 2000
  • The AIDS epidemic continues unabated in many part of the world. After near two decades, no vaccine is available to combat the spread of this deadly disease. Much of the HIV -1 vaccine effort during the past decade has focused on the viral envelope glycoprotein, largely because it is the only protein that can elicit neutralizing antibodies (Nabs). Eliciting broadly cross-reactive Nabs has been a primary goal. The intrinsic genetic diversity of the viral envelope, however, has been one of the major impediments in vaccine development. We have recently completed a comprehensive study examining whether it is possible to elicit broadly acting Nabs by immunizing monkeys with mixtures of envelope proteins from multiple HIV -1 isolates. We compared the humoral immune responses elicited by vaccination with either single or multiple envelope proteins and evaluated the importance of humoral and non-humoral immune response in protection against a challenge virus with a homologous or heterologous envelope protein. Our results show that (1) Nab is the correlate of sterilizing immunity, (2) Nabs against primary HIV -1 isolates can be elicited by the live vector-prime/protein boost approach, and (3) polyvalent envelope vaccines elicit broader Nab response than monovalent vaccines. Nonetheless, our findings clearly indicate that the increased breadth of Nab response is by and large limited to strains included in the vaccine mixture and does not extend to heterologous non-vaccine strains. Our study strongly demonstrates how difficult it may be to elicit broadly reactive Nabs using envelope proteins and sadly predicts a similar fate for many of the vaccine candidates currently being evaluated in clinical trials. We have started to evaluate other vaccine candidates (e.g. genetically modified envelope proteins) that might elicit broadly reactive Nabs. We are also exploring other vaccine strategies to elicit potent cytotoxic T lymphocyte responses. Preliminary results from some of these experiments will be discussed.

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Recent Advances in the Prevention of RSV in Neonates and Young Infants

  • Ki Wook Yun
    • Pediatric Infection and Vaccine
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    • v.30 no.1
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    • pp.1-11
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    • 2023
  • Respiratory syncytial virus (RSV) is a pathogen with a high burden of disease and social cost among infants worldwide, but the development of a vaccine has been delayed. The recent understanding of the pathogenesis of RSV, progress in reverse genetics, and successful implementation of other maternal immunizations have prompted the recent rapid development of monoclonal antibodies (mAbs) and vaccines for RSV prevention. Phase 3 clinical trials for two next-generation mAbs (nirsevimab and clesrovimab) and two maternal RSV pre-F vaccines are currently underway or have been recently completed. Soon, we might be able to protect young infants through long-acting mAbs and/or maternal immunization. Additionally, the development of live-attenuated vaccine candidates that are capable of avoiding enhanced RSV disease is ongoing. We need to gain familiarity with these newly developed strategies and collect epidemiological data on domestic RSV to adequately prepare for a new era of RSV prevention.

The Effects of Digital Therapy for Stroke Patients in Korea: Meta-analysis (국내 뇌졸중 환자를 위한 디지털 치료의 효과: 메타분석)

  • Jae-Hun Jung
    • Journal of The Korean Society of Integrative Medicine
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    • v.11 no.4
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    • pp.1-15
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    • 2023
  • Purpose : This study investigates the effectiveness of digital therapy for stroke patients in Korea. Methods : A comprehensive database search was performed using KCI, Science on, e-article, RISS, KISS and Korea OpenMed databases for randomized controlled trials (RCTs) that studied the effects of digital therapy on patients who had a stroke. This study includes RCTs published from January 2000 to July 15, 2022, which fulfilled the inclusion and exclusion criteria. A total 697 studies were screened and 30 studies were included in the final analysis. Methodological quality was assessed with the Cochrane's RoB (risk of bias) tool. Meta-analysis was performed using CMA 4.0 software. Results : A total of 56 effect sizes were calculated from the 30 selected studies. As a result of the analysis, the overall effect size of digital therapy was .59 (95 % CI=.43-.74). When classified according to type of intervention, VR (virtual reality) (g=.58, 95 % CI=.40-.75), and CACR (computer assisted cognitive rehabilitation) (g=.62, 95 % CI=.30-.95) were statistically significant. VR showed medium to large effect sizes in cognitive function (g=.78, 95 % CI=.20-1.37), psychosocial function (g=.63, 95 % CI=.20-1.07), and physical function (g=.61, 95 % CI=.38-.83). In the CACR, there was a large effect size in cognitive function (g=.84, 95 % CI=.52-1.15), but there was no significant difference in psychosocial function. Also, there was no significant difference between the two interventions in activities of daily living and no significant difference in the effect size of both interventions according to the intervention session. Furthermore, medium to large effect sizes were found for subacute and chronic stroke patients according to the duration of disease. Conclusion : This study presents evidence that digital therapy has a positive effect on various functions of stroke patients in Korea. The researchers expect to actively accept the new paradigm of digital therapy and continue to apply digital therapy in clinical practice.

Structure of SARS-CoV-2 Spike Glycoprotein for Therapeutic and Preventive Target

  • Jaewoo Hong;Hyunjhung Jhun;Yeo-Ok Choi;Afeisha S. Taitt;Suyoung Bae;Youngmin Lee;Chang-seon Song;Su Cheong Yeom;Soohyun Kim
    • IMMUNE NETWORK
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    • v.21 no.1
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    • pp.8.1-8.17
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    • 2021
  • The global crisis caused by the coronavirus disease 2019 (COVID-19) led to the most significant economic loss and human deaths after World War II. The pathogen causing this disease is a novel virus called the severe acute respiratory syndrome coronavirus 2 (SARSCoV-2). As of December 2020, there have been 80.2 million confirmed patients, and the mortality rate is known as 2.16% globally. A strategy to protect a host from SARS-CoV-2 is by suppressing intracellular viral replication or preventing viral entry. We focused on the spike glycoprotein that is responsible for the entry of SARS-CoV-2 into the host cell. Recently, the US Food and Drug Administration/EU Medicines Agency authorized a vaccine and antibody to treat COVID-19 patients by emergency use approval in the absence of long-term clinical trials. Both commercial and academic efforts to develop preventive and therapeutic agents continue all over the world. In this review, we present a perspective on current reports about the spike glycoprotein of SARS-CoV-2 as a therapeutic target.

Induction of Peptide-specific CTL Activity and Inhibition of Tumor Growth Following Immunization with Nanoparticles Coated with Tumor Peptide-MHC-I Complexes

  • Sang-Hyun Kim;Ha-Eun Park;Seong-Un Jeong;Jun-Hyeok Moon;Young-Ran Lee;Jeong-Ki Kim;Hyunseok Kong;Chan-Su Park;Chong-Kil Lee
    • IMMUNE NETWORK
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    • v.21 no.6
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    • pp.44.1-44.15
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    • 2021
  • Tumor peptides associated with MHC class I molecules or their synthetic variants have attracted great attention for their potential use as vaccines to induce tumor-specific CTLs. However, the outcome of clinical trials of peptide-based tumor vaccines has been disappointing. There are various reasons for this lack of success, such as difficulties in delivering the peptides specifically to professional Ag-presenting cells, short peptide half-life in vivo, and limited peptide immunogenicity. We report here a novel peptide vaccination strategy that efficiently induces peptide-specific CTLs. Nanoparticles (NPs) were fabricated from a biodegradable polymer, poly(D,L-lactic-co-glycolic acid), attached to H-2Kb molecules, and then the natural peptide epitopes associated with the H-2Kb molecules were exchanged with a model tumor peptide, SIINFEKL (OVA257-268). These NPs were efficiently phagocytosed by immature dendritic cells (DCs), inducing DC maturation and activation. In addition, the DCs that phagocytosed SIINFEKL-pulsed NPs potently activated SIINFEKL-H2Kb complex-specific CD8+ T cells via cross-presentation of SIINFEKL. In vivo studies showed that intravenous administration of SIINFEKL-pulsed NPs effectively generated SIINFEKL-specific CD8+ T cells in both normal and tumor-bearing mice. Furthermore, intravenous administration of SIINFEKL-pulsed NPs into EG7.OVA tumor-bearing mice almost completely inhibited the tumor growth. These results demonstrate that vaccination with polymeric NPs coated with tumor peptide-MHC-I complexes is a novel strategy for efficient induction of tumor-specific CTLs.

Baseline Serum Interleukin-6 Levels Predict the Response of Patients with Advanced Non-small Cell Lung Cancer to PD-1/PD-L1 Inhibitors

  • Da Hyun Kang;Cheol-Kyu Park;Chaeuk Chung;In-Jae Oh;Young-Chul Kim;Dongil Park;Jinhyun Kim;Gye Cheol Kwon;Insun Kwon;Pureum Sun;Eui-Cheol Shin;Jeong Eun Lee
    • IMMUNE NETWORK
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    • v.20 no.3
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    • pp.27.1-27.11
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    • 2020
  • Although various studies on predictive markers in the use of PD-1/PD-L1 inhibitors are in progress, only PD-L1 expression levels in tumor tissues are currently used. In the present study, we investigated whether baseline serum levels of IL-6 can predict the treatment response of patients with advanced non-small cell lung cancer (NSCLC) treated with PD-1/PD-L1 inhibitors. In our cohort of 125 NSCLC patients, the objective response rate (ORR) and disease control rate (DCR) were significantly higher in those with low IL-6 (<13.1 pg/ml) than those with high IL-6 (ORR 33.9% vs. 11.1%, p=0.003; DCR 80.6% vs. 34.9%, p<0.001). The median progression-free survival was 6.3 months (95% confidence interval [CI], 3.9-8.7) in the low IL-6 group, significantly longer than in the high IL-6 group (1.9 months, 95% CI, 1.6-2.2, p<0.001). The median overall survival in the low IL-6 group was significantly longer than in the high IL-6 group (not reached vs. 7.4 months, 95% CI, 4.8-10.0). Thus, baseline serum IL-6 levels could be a potential biomarker for predicting the efficacy and survival benefit of PD-1/PD-L1 inhibitors in NSCLC.

Middle meningeal artery embolization for chronic subdural hematoma in elderly patients at high risk of surgical treatment

  • Jin Hoo Seok;Jong Hyun Kim;Taek Hyun Kwon;Joonho Byun;Won Ki Yoon
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.25 no.1
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    • pp.28-35
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    • 2023
  • Objective: The purpose of this study was to evaluate the effectiveness of middle meningeal artery embolization (MMAE) in elderly high-risk patients with symptomatic chronic subdural hematoma (CSDH) in terms of reduction in hematoma volume and recurrence rate. Methods: We retrospectively reviewed data prospectively collected from nine patients who underwent 13 MMAE for CSDH between June 2017 and May 2022. The volume of the subdural hematoma was measured using a computer-aided volumetric analysis program. Hematoma volume changes during the follow-up period were analyzed and clinical outcomes were evaluated. Results: The mean follow-up period was 160 days (range, 46-311 days). All procedures were technically successful and there were no procedure-related complications. Of the 13 MMAE, 84% (11 out of 13 hemispheres) showed mean 88% of reduction on follow-up volumetric study with eight cases of complete resolution. There was one refractory case with MMAE which had been performed multiple burr-hole trephinations, for which treatment was completed by craniotomy and meticulous resection of multiple pseudomembranes. There was no recurrent case during the follow-up period, except for refractory case. Conclusions: MMAE for CSDH in selected high-risk elderly patients and relapsed patients might be effective. Despite the small cohort, our findings showed a high rate of complete resolution with no complications. Further prospective randomized trials are warranted to evaluate its usefulness as a primary treatment option for CSDH.

Evaluation of Color Change according to Process Step of Fused Porcelain to SLM Method (치과용 레이저 선택가공 금속체의 도재 소성단계에 따른 색조변화 관찰)

  • Kim, Chi-Young;Chung, In-Sung
    • The Journal of the Korea Contents Association
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    • v.10 no.12
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    • pp.236-242
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    • 2010
  • The porcelain fused metal was made through the progressive fused process of porcelain on substructure of metal material. The substructure was made using novel SLM method. The objective of this study was to observe the color change of porcelain using spectrophotometer equipment according to porcelain fused step and production methods after conducting the process of casting and SLM method of the substructure. The color change by step was indicated that fused opaque porcelain groups(CN1, CC1, CT1, SC1, ST1) had color difference(${\Delta}E$=30) by comparison with fused body porcelain groups(CN2, CC2, CT2, SC2, ST2) and fused glazing porcelain groups(CN3, CC3, CT3, SC3, ST3) (p<0.05). and there was no color difference between the substrates(CN, CC, CT) made by the casting method and the substrates(SC, ST) made by the SLM method. so, the color change was expressed by fused change of porcelain, and this study showed that the color of porcelain fused metal made by the SLM method can be applied clinical trials.