• Title/Summary/Keyword: Non-clinical trial

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Improving Effects of Multigrain Feed on Endurance (혼합곡 식이의 지구력 향상 효과)

  • Oh, Hong-Geun;Park, Jung-Woo;Kang, Young-Rye;Kim, Jung-Hoon;Seo, Min-Young;Kim, Min-Gul;Doo, Jae-Kyun;Shin, Dong-Hwa;Jung, Eun-Soo;Chae, Soo-Wan;Kim, Ok-Jin;Lee, Hak-Yong
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.40 no.12
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    • pp.1700-1707
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    • 2011
  • This study evaluated the effect of multigrain supplementation on exercise-related changes in running time and glycogen storage capacity of male SD rats engaged in treadmill exercise. Thirty-six 6-week-old rats were divided into six groups: normal (Nor) fed normal feed, control (Con) fed with 20% normal feed and 80% milled rice, test group one (GI) fed with multigrain feed I, test group two (GII) fed with multigrain feed II, test group three (GIII) fed with multigrain feed III, and test group four (GIV) fed with multigrain feed IV. Endurance tests by treadmill machine were administered after 24 days of multigrain feed supplementation and adaptive training. Running time was extended and glycogen storage capacity increased in the multigrain-treated group compared to the non-treated group. Also, the fatigue indicators of inorganic phosphorous, CPK, and lactate concentration were all reduced in the multigrain feed group compared to the control group after 25 min and/or exhausted exercise. But there was no difference in GOP, GTP, lactate, or LDH concentrations between the groups. Our results demonstrated that endurance improved with multigrain feed in rats. Specifically, running time, glycogen storage capacity, inorganic phosphorous, CPK, and lactate serum concentration increased. Importantly, the improvements in endurance brought about in the GII group fed with waxy barley was the greatest among the experimental groups.

Occupational Therapy for Community Mobility in Stroke Patients : Systematic review (뇌졸중 환자의 지역사회이동을 위한 작업치료 중재: 체계적 고찰)

  • Jo, Eun-Ju;Kam, Kyung-Yoon;Chang, Moon-Young
    • The Journal of Korean society of community based occupational therapy
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    • v.8 no.3
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    • pp.77-89
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    • 2018
  • Objective : The purpose of this study was to analyze occupational therapy intervention on the community mobility for stroke patients, and to provide evidence of intervention in the clinical fields. Methods : A systematic review was executed according to the PRISMA checklist. The accessed database was PubMed, EMBASE, Cochrane Library (CENTRAL), ProQuest Dissertations & thesis (PQDT), RISS, and KoreaMed. We included the articles published from 2005 to September 2018. RoBANS checklist was used to evaluate the quality of the articles. Included articles, totally eight, were categorized according to the type of intervention. Results : The study design of the literature was varied from two-group randomized trial, quasi-experimental study, case-control trial, one group pre-post comparison study, and cross-sectional study. In the evidence level, 6 articles were included in level II (75%). The percentage of low risk of bias in each article ranged from 52.5%~87.5%. Four studies (50%) provided intervention based on virtual reality or virtual environment. The three (37.5%) provided intervention based on the protocol, and the other (12.5%) did wheelchair training. All studies reported significant effects of the intervention. Conclusion : This systematic review provided evidences to use proper intervention in the clinical fields. Various type of studies should be conducted to prove the effect of occupational therapy intervention for community mobility.

Chemotherapy for Malignant Gliomas Based on Histoculture Drug Response Assay : A Pilot Study

  • Gwak, Ho-Shin;Park, Hyeon-Jin;Yoo, Heon;Youn, Sang-Min;Rhee, Chang-Hun;Lee, Seung-Hoon
    • Journal of Korean Neurosurgical Society
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    • v.50 no.5
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    • pp.426-433
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    • 2011
  • Objective : The Histoculture Drug Response Assay (HDRA), which measures chemosensitivity using minced tumor tissue on drug-soaked gelfoam, has been expected to overcome the limitations of in vitro chemosensitivity test in part. We analyzed interim results of HDRA in malignant gliomas to see if the test can deserve further clinical trials. Methods : Thirty-three patients with malignant gliomas were operated and their tumor samples were examined for the chemosensitivity to 10 chosen drugs by HDRA. The most sensitive chemotherapy regimen among those pre-established was chosen based on the number of sensitive drugs or total inhibition rate (IR) of the regimen. The response was evaluated by 3 month magnetic resonance image. Results : Among 13 patients who underwent total resection of the tumor, 12 showed no evidence of disease and one patient revealed progression. The response rate in 20 patients with residual tumors was 55% (3 complete and 8 partial responses). HDRA sensitivity at the cut-off value of more than one sensitive drug in the applied regimen showed a sensitivity of 100%, specificity of 60% and predictability of 70%. Another cut-off value of >80% of total IR revealed a sensitivity of 100%, specificity of 69%, and predictability of 80%. For 12 newly diagnosed glioblastoma patients, median progression-free survival of the HDRA sensitive group was 21 months, while that of the non-sensitive group was 6 months ($p$=0.07). Conclusion : HDRA for malignant glioma was inferred as a feasible method to predict the chemotherapy response. We are encouraged to launch phase 2 clinical trial with chemosensitivity on HDRA.

Non-operative Korean Medicine Treatment for Four Patients with Failed Back Surgery Syndrome after Spinal Fusion Surgery : A Retrospective Case Series

  • Seo, Young Hoon;Lee, Jeong Ryo;Lee, Sang Min;Kim, Min Chul;Kim, Yu Jong;Hong, Je Rak;Kim, She Young;Seo, Young Woo;Kim, Ji Su;Park, Han Sol;Lee, Min ho;Kim, Tae Hun;Kim, Kiok
    • The Journal of Korean Medicine
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    • v.37 no.2
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    • pp.93-103
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    • 2016
  • Objectives: The purpose of this study was to report Four cases of Failed Back Surgery Syndrome (FBSS) patients after spinal fusion surgery who showed significant improvement in pain and function with Complex Korean medical treatment. Methods: This study was a retrospective observational study. We reviewed medical records of Four patients with lumbar pain or radiating leg pain, who have received spinal fusion surgery in the past. All Four patients took complex treatments of Mokhuri Neck and Back hospital which involes Acupuncture, Pharmaco-acupuncture, Gangchuk herbal medicine, Chuna and Physical therapy during about four-week of admission treatment. Visual Analogue Scale (VAS), Oswestry disability index (ODI), Pain Free Walking Distance (PFWD) scores were assessed before and after treatments. Results: The average of hospitalization period was 28.5 days. Mean VAS scores decreased from 6.5 to 2.3, Oswestry Disability Index (ODI) scores decreased from 56.25 to 38.25 and Pain Free Walking Distance (PFWD) also improved from 10m to 166.6m. Conclusion: This study implies that a combination of Korean medical treatments might be effective in relieving pain, and improving the functional status of FBSS patients. Further studies are needed to fully understand the mechanisms underlying the effects.

Collagen Scaffolds in Cartilage Tissue Engineering and Relevant Approaches for Future Development

  • Irawan, Vincent;Sung, Tzu-Cheng;Higuchi, Akon;Ikoma, Toshiyuki
    • Tissue Engineering and Regenerative Medicine
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    • v.15 no.6
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    • pp.673-697
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    • 2018
  • BACKGROUND: Cartilage tissue engineering (CTE) aims to obtain a structure mimicking native cartilage tissue through the combination of relevant cells, three-dimensional scaffolds, and extraneous signals. Implantation of 'matured' constructs is thus expected to provide solution for treating large injury of articular cartilage. Type I collagen is widely used as scaffolds for CTE products undergoing clinical trial, owing to its ubiquitous biocompatibility and vast clinical approval. However, the long-term performance of pure type I collagen scaffolds would suffer from its limited chondrogenic capacity and inferior mechanical properties. This paper aims to provide insights necessary for advancing type I collagen scaffolds in the CTE applications. METHODS: Initially, the interactions of type I/II collagen with CTE-relevant cells [i.e., articular chondrocytes (ACs) and mesenchymal stem cells (MSCs)] are discussed. Next, the physical features and chemical composition of the scaffolds crucial to support chondrogenic activities of AC and MSC are highlighted. Attempts to optimize the collagen scaffolds by blending with natural/synthetic polymers are described. Hybrid strategy in which collagen and structural polymers are combined in non-blending manner is detailed. RESULTS: Type I collagen is sufficient to support cellular activities of ACs and MSCs; however it shows limited chondrogenic performance than type II collagen. Nonetheless, type I collagen is the clinically feasible option since type II collagen shows arthritogenic potency. Physical features of scaffolds such as internal structure, pore size, stiffness, etc. are shown to be crucial in influencing the differentiation fate and secreting extracellular matrixes from ACs and MSCs. Collagen can be blended with native or synthetic polymer to improve the mechanical and bioactivities of final composites. However, the versatility of blending strategy is limited due to denaturation of type I collagen at harsh processing condition. Hybrid strategy is successful in maximizing bioactivity of collagen scaffolds and mechanical robustness of structural polymer. CONCLUSION: Considering the previous improvements of physical and compositional properties of collagen scaffolds and recent manufacturing developments of structural polymer, it is concluded that hybrid strategy is a promising approach to advance further collagen-based scaffolds in CTE.

Intraperitoneal Paclitaxel Combined with S-1 Plus Oxaliplatin for Advanced Gastric Cancer with Peritoneal Metastasis: a Phase I Study

  • Kim, Dong-Wook;Seo, Won Jun;Youn, Sang Il;Jee, Ye Seob;Jang, You-Jin;Kim, Jong-Han
    • Journal of Gastric Cancer
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    • v.21 no.4
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    • pp.418-425
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    • 2021
  • Purpose: We designed a new regimen by combining intraperitoneal (IP) paclitaxel (PTX) with systemic S-1 plus oxaliplatin (SOX) for the treatment of advanced gastric cancer with peritoneal metastasis. This dose-escalation study aimed to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IP PTX administered weekly to patients. Materials and Methods: Eight cycles of IP PTX plus SOX regimen were administered to the patients. S-1 was administered orally twice daily at a dose of 80 mg/m2/day for 14 consecutive days, followed by 7 days of rest. Intravenous oxaliplatin was administered at a fixed dose of 100 mg/m2 on day 1, while IP PTX was administered on days 1 and 8. The initial dose of IP PTX was 40 mg/m2, and the dose escalation was set in units of 20 mg/m2 up to 80 mg/m2. Dose-limiting toxicities (DLTs) were defined as grade 3 non-hematologic toxicities, grade 4 leukopenia, grade 3 febrile neutropenia, and grade 3 thrombocytopenia. Results: Nine patients were included in the study. No DLTs were observed in any of the enrolled patients. Therefore, the MTD was not reached, and the RD of IP PTX was determined to be 80 mg/m2. Four patients (44%) showed a decreased peritoneal cancer index score on second-look laparoscopic examination. Conclusions: The present study determined the dose for further clinical trials of IP PTX to be 80 mg/m2, when combined with a systemic SOX regimen.

A novel amnion-chorion allograft membrane combined with a coronally advanced flap: a minimally invasive surgical therapy to regenerate interdental papillary soft tissue recession - a six-month postoperative image analysis-based clinical trial

  • Pitale, Unnati;Pal, Pritish Chandra;Boyapati, Ramanarayana;Bali, Ashish;Varma, Manish;Khetarpal, Shaleen
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.47 no.6
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    • pp.438-444
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    • 2021
  • Objectives: Loss of the interdental papilla is multi-factorial and creates a multitude of problems. Autogenous connective tissue/biomaterial-based regeneration has been attempted for decades to reconstitute the black space created due to the loss of papilla. The aim of this present study was to regenerate papillary recession defects using an amnion-chorion membrane (ACM) allograft and to evaluate the clinical outcome up to six months postoperatively. Materials and Methods: Twenty patients with 25 Nordland and Tarnow's Class I/II interdental papillary recession defects were treated with ACM and coronal advancement of the gingivo-papillary unit via a semilunar incision on the labial aspect followed by a sulcular incision in the area of interest. A photographic image analysis was carried out using the GNU Image Manipulation software program from the baseline to three and six months postoperatively. The black triangle height (BTH) and the black triangle width (BTW) were calculated using the pixel size and were then converted into millimeters. The mean and standard deviation values were determined at baseline and then again at three and six months postoperatively. The probability values (P<0.05 and P≤0.01) were considered statistically significant and highly significant, respectively. An analysis of variance and post hoc Bonferroni test were carried out to compare the mean values. Results: Our evaluation of the BTH and BTW showed a statistically and highly significant difference from the baseline until both three and six months postoperatively (P=0.01). A post hoc Bonferroni test disclosed a statistically significant variance from the baseline until three and six months postoperatively (P<0.05) and a non-significant difference from three to six months after the procedure (P≥0.05). Conclusion: An ACM allograft in conjunction with a coronally advanced flap could be a suitable minimally invasive alternative for papillary regeneration.

The Impact of Fractional Flow Reserve on Clinical Outcomes after Coronary Artery Bypass Grafting: A Meta-analysis

  • Yoonjin, Kang;Heeju, Hong;Suk Ho, Sohn;Myoung-jin, Jang;Ho Young, Hwang
    • Journal of Chest Surgery
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    • v.55 no.6
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    • pp.442-451
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    • 2022
  • Background: This meta-analysis was conducted to evaluate the effect of fractional flow reserve (FFR) on clinical outcomes after coronary artery bypass grafting (CABG). Methods: Five online databases were searched for studies that (1) enrolled patients who underwent isolated CABG or CABG with aortic valve replacement and (2) demonstrated the effect of an FFR-guided strategy on major adverse cardiac events (MACE) after surgery based on a randomized controlled trial or adjusted analysis. MACE included cardiac death, acute myocardial infarction (MI), and repeated revascularization. The primary outcomes were all MACE outcomes and a composite of all-cause death and MI, and the secondary outcomes were the individual MACE outcomes. Publication bias was assessed using a funnel plot and the Egger test. Results: Six articles (3 randomized and 3 non-randomized studies: n=1,027) were selected. MACE data were extracted from 4 studies. The pooled analyses showed that the risk of MACE was not significantly different between patients who underwent FFR-guided CABG and those who underwent angiography-guided CABG (hazard ratio [HR], 0.80; 95% CI, 0.57-1.12). However, the risk of the composite of death or MI was significantly lower in patients undergoing FFR-guided CABG (HR, 0.62; 95% CI, 0.41-0.94). The individual MACE outcomes were not significantly different between FFR-guided and angiography-guided CABG. Conclusion: FFR-guided CABG might be beneficial in terms of the composite outcome of death or MI compared with angiography-guided CABG although data are limited.

Safety and Efficacy of the Mandibular Advancement Device 'Bioguard' for the Treatment of Obstructive Sleep Apnea : A Prospective, Multi-Center, Single Group, and Non-Inferiority Trial (폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치-'바이오가드'의 안전성과 유효성 검증을 위한 전향적, 다기관, 단일군 및 비열등성 연구)

  • Kim, Hyoung Wook;Hwang, Chungpoong;Eun, Hun Jeong
    • Sleep Medicine and Psychophysiology
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    • v.23 no.2
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    • pp.84-92
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    • 2016
  • Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), 'Bioguard,' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose 'Bioguard' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD 'Bioguard' should be considered as an alternative treatment option for OSA patients.

The Effects of Ecklonia stolonifera Extracts on Improvement of Hepatic Function: a Double-Blind, Randomized, Placebo-Controlled Clinical Study (곰피추출물의 간기능 개선 효과 평가를 위한 12주, 무작위배정, 이중맹검, 위약-대조 인체적용시험)

  • Kim, Junghee;Kim, Eun Jin;Kang, Dahye;Kim, Hyung-Bin;Jang, Jae Young;Om, Ae-Son;Kim, Jongwook
    • Journal of Food Hygiene and Safety
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    • v.37 no.3
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    • pp.198-205
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    • 2022
  • Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.