• Title/Summary/Keyword: Clinical Trials

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Biochemical Biomarkers for Alzheimer's Disease in Cerebrospinal Fluid and Peripheral Blood (뇌척수액과 말초혈액 내 알츠하이머병의 생화학적 생체표지자)

  • Lee, Young Min;Choi, Won-Jung;Park, Minsun;Kim, Eosu
    • Journal of Korean geriatric psychiatry
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    • v.16 no.1
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    • pp.17-23
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    • 2012
  • The diagnosis of Alzheimer's disease (AD) is still obscure even to specialists. To improve the diagnostic accuracy, to find at-risk people as early as possible, to predict the efficacy or adverse reactions of pharmacotherapy on an individual basis, to attain more reliable results of clinical trials by recruiting better defined participants, to prove the disease-modifying ability of new candidate drugs, to establish prognosis-based therapeutic plans, and to do more, is now increasing the need for biomarkers for AD. Among AD-related biochemical markers, cerebrospinal beta-amyloid and tau have been paid the most attention since they are materials directly interfacing the brain interstitium and can be obtained through the lumbar puncture. Level of beta-amyloid is reduced whereas tau is increased in cerebrospinal fluid of AD patients relative to cognitively normal elderly people. Remarkably, such information has been found to help predict AD conversion of mild cognitive impairment. Despite inconsistent findings from previous studies, plasma beta-amyloid is thought to be increased before the disease onset, but show decreasing change as the disease progress. Regarding other peripheral biochemical markers, omics tools are being widely used not only to find useful biomarkers but also to generate novel hypotheses for AD pathogenesis and to lead new personalized future medicine.

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.

Individualized Therapy to Manage Quadriplegic Spastic Cerebral Palsy with Unani Treatment Modalities

  • Fahmida Kousar;Arshiya Sultana;Shahzadi Sultana;Taseen Banu;Arfa Begum
    • CELLMED
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    • v.13 no.14
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    • pp.16.1-16.14
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    • 2023
  • Objective: Cerebral palsy (CP) is a neurodevelopment disorder attributed to an insult or injury to the developing brain with abnormalities in muscular tone, movement and motor skill. Improvement in quality of life and ameliorating symptoms can be achieved. Therefore, this case report details a distinctive approach to treating a 5-year-old male child with quadriplegic spastic cerebral palsy utilizing Unani treatment modalities. Methods: The treatment regimen commenced with 'Habb Ayarij for constipation followed by Sharbat Ustukhuddus administered orally. Notably, Sharbat Ustukhuddus was combined with Melia Azedarach L. leaves vapour bath. Subsequently, Roghan Babunna douche was performed followed by Dalk Layyin andcontinued until symptomatic improvement was observed. Majun Falasfa, Khamira Marwareed and Khameera Gauzaban were administered for 30 days. The therapeutic outcome included anthropometrical measurements, developmental milestones, spasm/reflex scale, and muscle power grading. Results and conclusion: Over the course of a 2-year follow-up, several clinical findings emerged. These included notable improvements in anthropometric measurements, developmental milestones such as improved head control and sitting ability, and a reduction in spasticity of the upper limbs, along with decreased muscle spasms. The therapeutic outcome of this individualized and holistic approach is potentially due to the multifaceted properties of medicinal plants (Musakkin wa Muharrik wa Muqawwi-i- A'sab wa Dimāgh, Munawwim, Dafi-i-Tashannuj, Muqawwi-i-Qalb-i-Ruh). Furthermore, the use of Dalk and Naṭūl was instrumental in providing nourishment to musculoskeletal cells and initiating intracellular signaling cascades. While these findings are encouraging, further research in the form of case series andrandomized controlled trials is warranted to validate the efficacy of this unique holistic approach.

Limited in vitro differentiation of porcine induced pluripotent stem cells into endothelial cells

  • In-Won Lee;Hyeon-Geun Lee;Dae-Ky Moon;Yeon-Ji Lee;Bo-Gyeong Seo;Sang-Ki Baek;Tae-Suk Kim;Cheol Hwangbo;Joon-Hee Lee
    • Journal of Animal Reproduction and Biotechnology
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    • v.38 no.3
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    • pp.109-120
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    • 2023
  • Background: Pluripotent stem cells (PSCs) including embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) offer the immense therapeutic potential in stem cell-based therapy of degenerative disorders. However, clinical trials of human ESCs cause heavy ethical concerns. With the derivation of iPSCs established by reprogramming from adult somatic cells through the transgenic expression of transcription factors, this problems would be able to overcome. In the present study, we tried to differentiate porcine iPSCs (piPSCs) into endothelial cells (ECs) for stem cell-based therapy of vascular diseases. Methods: piPSCs (OSKMNL) were induced to differentiation into ECs in four differentiation media (APEL-2, APEL-2 + 50 ng/mL of VEGF, EBM-2, EBM-2 + 50 ng/mL of VEGF) on cultured plates coated with matrigel® (1:40 dilution with DMEM/F-12 medium) for 8 days. Differentiation efficiency of these cells were exanimated using qRT-PCR, Immunocytochemistry, Western blotting and FACS. Results: As results, expressions of pluripotency-associated markers (OCT-3/4, SOX2 and NANOG) were higher observed in all porcine differentiated cells derived from piPSCs (OSKMNL) cultured in four differentiation media than piPSCs as the control, whereas endothelial-associated marker (CD-31) in the differentiated cells was not expressed. Conclusions: It can be seen that piPSCs (OSKMNL) were not suitable to differentiate into ECs in the four differentiation media unlike porcine epiblast stem cells (pEpiSCs). Therefore, it would be required to establish a suitable PSCs for differentiating into ECs for the treatment of cardiovascular diseases.

Impact of the COVID-19 vaccine booster strategy on vaccine protection: a pilot study of a military hospital in Taiwan

  • Yu-Li Wang;Shu-Tsai Cheng;Ching-Fen Shen;Shu-Wei Huang;Chao-Min Cheng
    • Clinical and Experimental Vaccine Research
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    • v.12 no.4
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    • pp.337-345
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    • 2023
  • Purpose: The global fight against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has led to widespread vaccination efforts, yet the optimal dosing schedule for SARS-CoV-2 vaccines remains a subject of ongoing research. This study aims to investigate the effectiveness of administering two booster doses as the third and fourth doses at different intervals to enhance vaccine protection. Materials and Methods: This study was conducted at a military regional hospital operated by the Ministry of National Defense in Taiwan. A cohort of vaccinated individuals was selected, and their vaccine potency was assessed at various time intervals following their initial vaccine administration. The study participants received booster doses as the third and fourth doses, with differing time intervals between them. The study monitored neutralizing antibody titers and other relevant parameters to assess vaccine efficacy. Results: Our findings revealed that the potency of the SARS-CoV-2 vaccine exhibited a significant decline 80 days after the initial vaccine administration. However, a longer interval of 175 days between booster injections resulted in significantly higher neutralizing antibody titers. The individuals who received the extended interval boosters exhibited a more robust immune response, suggesting that a vaccine schedule with a 175-day interval between injections may provide superior protection against SARS-CoV-2. Conclusion: This study underscores the importance of optimizing vaccine booster dosing schedules to maximize protection against SARS-CoV-2. The results indicate that a longer interval of 175 days between the third and fourth doses of the vaccine can significantly enhance the neutralizing antibody response, potentially offering improved protection against the virus. These findings have important implications for vaccine distribution and administration strategies in the ongoing battle against the SARS-CoV-2 pandemic. Further research and largescale trials are needed to confirm and extend these findings for broader public health implications.

Diffusion-Weighted Imaging as a Stand-Alone Breast Imaging Modality (독립적 검사 방법으로서의 확산강조 자기공명영상검사)

  • Hee Jung Shin;Su Hyun Lee;Woo Kyung Moon
    • Journal of the Korean Society of Radiology
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    • v.82 no.1
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    • pp.29-48
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    • 2021
  • Diffusion-weighted magnetic resonance imaging (DW MRI) is a fast unenhanced technique that shows promise as a stand-alone modality for cancer screening and characterization. Currently, DW MRI may have lower sensitivity than that of dynamic contrast-enhanced MRI as a standalone modality for breast cancer detection but superior to that of mammography, which may provide a useful alternative for supplemental screening. Standardized acquisition and interpretation of DW MRI can improve the image quality and reduce the variability of the results. Furthermore, high-resolution DW MRI, with advanced techniques and postprocessing, will facilitate better detection and characterization of subcentimeter cancers and reduce false-negatives and false-positives. Future results from ongoing prospective multicenter clinical trials using standardized and optimized protocols will facilitate the use of DW MRI as a stand-alone modality.

Surgical Treatment for Primary Lymphedema: A Systematic Review of the Literature

  • Miguel Angel Gaxiola-Garcia;Joseph M. Escandon;Oscar J. Manrique;Kristin A. Skinner;Beatriz Hatsue Kushida-Contreras
    • Archives of Plastic Surgery
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    • v.51 no.2
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    • pp.212-233
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    • 2024
  • This is a retrospective review of surgical management for primary lymphedema. Data were extracted from 55 articles from PubMed MEDLINE, Web of Science, SCOPUS, and Cochrane Central Register of Controlled Trials between the database inception and December 2022 to evaluate the outcomes of lymphaticovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT), and outcomes of soft tissue extirpative procedures such as suction-assisted lipectomy (SAL) and extensive soft tissue excision. Data from 485 patients were compiled; these were treated with LVA (n = 177), VLNT (n = 82), SAL (n = 102), and excisional procedures (n = 124). Improvement of the lower extremity lymphedema index, the quality of life (QoL), and lymphedema symptoms were reported in most studies. LVA and VLNT led to symptomatic relief and improved QoL, reaching up to 90 and 61% average circumference reduction, respectively. Cellulitis reduction was reported in 25 and 40% of LVA and VLNT papers, respectively. The extirpative procedures, used mainly in patients with advanced disease, also led to clinical improvement from the volume reduction, as well as reduced incidence of cellulitis, although with poor cosmetic results; 87.5% of these reports recommended postoperative compression garments. The overall complication rates were 1% for LVA, 13% for VLNT, 11% for SAL, and 46% for extirpative procedures. Altogether, only one paper lacked some kind of improvement. Primary lymphedema is amenable to surgical treatment; the currently performed procedures have effectively improved symptoms and QoL in this population. Complication rates are related to the invasiveness of the chosen procedure.

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.