• Title/Summary/Keyword: Clinical safety

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Development of Novel Sulforaphane Contained-composition to Increase Antioxidant and Whitening Effects (항산화와 미백효과를 증진시킨 새로운 Sulforaphane 함유 혼합 조성의 개발)

  • Lee, Ji Hye;Choi, Kang Hyun;Park, Young Kum;Kim, Eung-Gook;Shin, Eun-Young
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.44 no.4
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    • pp.437-445
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    • 2018
  • In this study, we analyzed two components, sulforaphane and PF-3758309 to prove that the mixed composition of them has more effective antioxidant and whitening functions compared to each component. We analyzed the cellular toxicity of each component and also the mixed composition to find the safe concentration level for cell viability. From the single component treatment, we discovered that sulforaphane was safe up to $10{\mu}M$, and PF-3758309 up to 100 nM. Combination treatment of $10{\mu}M$ sulforaphane and 1 nM PF-3758309 did not affect the cell viability. The LPS-stimulated NO generation was significantly reduced by the mixed composition of sulforaphane and PF-3758309. Melanogenesis by ${\alpha}$-melanocyte stimulating hormone (${\alpha}$-MSH) was also inhibited by the mixed composition. In order to confirm the possibility as the cosmetic material, we carried out clinical studies for the mixed composition samples. Skin safety evaluation using patch test was judged to be unstimulated, skin whitening effect was increased, and melanin deposition was suppressed by treatment of mixed composition samples. These results provide us with the opportunity for applying it into the development of new functional cosmetics.

Evaluation for the Usefulness of Automated Blood Typing Analyzer (혈액은행 자동화 장비 도입의 유용성 평가)

  • Kim, Ha-na;Kim, Hee-Bum;Park, Hyun-Sang;Lee, Hyun-Im;Hong, Myung-Kook;Shin, Gyoung-Sook;Suh, In-Bum
    • The Journal of the Korea Contents Association
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    • v.19 no.6
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    • pp.565-574
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    • 2019
  • In this study, we evaluated the usefulness of an automatic blood typing analyzer using QWALYS-2 up (Diagast, Loos Cedex, France). During a month( 01OCT2013 - 31OCT2013) we performed 1,636 tests for ABO & RhD blood typing, 1,374 tests for antibody screen & identification tests and compared the results by automatic blood type analyzer with previous manual methods and column agglutination tests. And we analyzed the economic performance by comparison the test unit price between automatic blood type analyzer and manual methods. In ABO & RhD blood typing tests, there were complete concordances between manual and automated blood typing analyzer for 200 clinical samples. In Antibody screen tests, the concordance rate between manual and automated blood typing analyzer was 98.5% and more strong reaction in automated blood typing analyzer than manual methods. Therefore, the introduction of an automated blood typing analyzer, reagents costs were increased but labor costs were decreased. Considering the importance of transfusion safety and economic advantages, the introduction of an automated blood typing analyzer was very useful.

Effectiveness of the Trauma Team-Staffed Helicopter Emergency Medical Service (헬리콥터 응급의료서비스의 외상팀 탑승 여부와 외상환자의 생존율)

  • Kim, Tea-youn;Lee, Sang Ah;Park, Eun-Cheol;Huh, Yo;Jung, Kyoungwon;Kwon, Junsik;Moon, Jonghwan;Kim, Jiyoung;Kim, Juryang;Hwang, Kyungjin;Yun, Seong Keun;Lee, John Cook-Jong
    • Health Policy and Management
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    • v.28 no.4
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    • pp.411-422
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    • 2018
  • Background: Whether there is a difference in outcomes for trauma patients transferring to the helicopter emergency medical service (HEMS) according to their previous team composition is controversial. The purpose of this study is to evaluate the effectiveness of trauma team-staffed-HEMS (TTS-HEMS) when transferring to a trauma center. Methods: A retrospective comparison was conducted on patients transported to a trauma center over a 6-year period by the TTS-HEMS and paramedic-staffed-HEMS (119-HEMS). Inclusion criteria were blunt trauma with age ${\geq}15years$. Patient outcomes were compared with the Trauma and Injury Severity Score (TRISS) (30-day mortality) and the Cox proportional hazard ratio of mortality (in hospital). Results: There were 321 patients of TTS-HEMS and 92 patients of 119-HEMS. The TTS-HEMS group had a higher Injury Severity Score and longer transport time but a significantly shorter time to emergency surgery. The prehospital data showed that the trauma team performed more aggressive interventions during transport. An additional 7.6 lives were saved per 100 TTS-HEMS deployments. However, the TRISS results in the 119-HEMS group were not significant. In addition, after adjusting for confounders, the hazard ratio of mortality in the 119-HEMS group was 2.83 times higher than that in the TTS-HEMS group. Conclusion: HEMS was likely to improve the survival rate of injured patients when physicians were involved in TTS-HEMS. Survival benefits in the TTS-HEMS group appeared to be related to the fact that the trauma team performed both more aggressive prehospital resuscitation and clinical decision making during transportation.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
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    • v.15 no.2
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

The Study of Correlation Between the Balance, Cognition and Activity of Daily Living in Stroke Patients (뇌졸중 환자의 균형, 인지, 일상생활 평가의 상관성 연구)

  • Kang, Bo-Ra;Jeong, Eun-Song;Kim, Jae-Hee;Ha, Yoo-Na
    • Journal of Korean Society of Neurocognitive Rehabilitation
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    • v.10 no.2
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    • pp.45-52
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    • 2018
  • The purpose of the present study was to determine correlations between the Berg Balance Scale (BBS), Montreal Cognitive Assessment-Korean (MoCA-K) and Modified Barthel Index (MBI) targeting stroke patients, and it seeks to analyze the influence among each factor to establish the fundamental research in evaluating the functional performance capability of stroke patients. The study was conducted between December 2017 and March 2018 and the target of the study was 34 stroke patients who are hospitalized and treated in Y rehabilitation hospital located in Goyang city. Following in criteria of how participants were selected. First, a person without the onset of 6months or more. Second, a person who can communicate and score over 20 points on MMSE-K. Third, a person without unilateral neglect. Fourth, a person without lower motor neuron lesion and orthopedic disease on the bilateral lower extremity. Fifth, a person without audiovisual problem and history of using drug or surgery that influence athletic function. sixth, patients who agreed on participating in the study. The evaluation was processed by measuring BBS, MoCA-K, and MBI with the occupational therapist and physical therapist. Also, one assistant was participated in measuring balanced ability for the safety reason. It was found that significantly correlates (p<.01) with BBS and MoCA-K (r=.459), BBS and MBI (r=.550), MoCA-K and MBI (r=.565). This study is meaningful that it provided the basis for the active use of BBS, MoCA-K and MBI as a clinical evaluation tool and its usefulness.

Oncologic Feasibility of Proximal Gastrectomy in Upper Third Advanced Gastric and Esophagogastric Junctional Cancer

  • Yun, Won-Gun;Lim, Myung-Hoon;Kim, Sarah;Kim, Sa-Hong;Park, Ji-Hyeon;Kong, Seong-Ho;Park, Do Joong;Lee, Hyuk-Joon;Yang, Han-Kwang
    • Journal of Gastric Cancer
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    • v.21 no.2
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    • pp.169-178
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    • 2021
  • Purpose: The aim of this study was to investigate the oncologic safety and identify potential candidates for proximal gastrectomy (PG) in upper third advanced gastric cancer (AGC) and esophagogastric junction (EGJ) cancers. Materials and Methods: Among 5,665 patients who underwent gastrectomy for gastric adenocarcinoma between January 2011 and December 2017, 327 patients who underwent total gastrectomy with standard lymph node (LN) dissection for upper third AGC and Siewert type II EGJ cancers were enrolled. We analyzed the correlation between the metastatic rates of distal LNs (No. 4d, 5, 6, and 12a) around the lower part of the stomach and the clinicopathological characteristics. We identified subgroups with no metastasis to the distal LNs. Results: The metastatic rate of distal LNs in proximal AGC and Siewert type II EGJ cancers was 7.0% (23 of 327 patients). On multivariate analysis, pathological T stage (P=0.001), tumor size (P=0.043), and middle third invasion (P=0.003) were significantly associated with distal LN metastases. Pathological 'T2 stage' (n=88), or 'T3 stage with ≤5 cm tumor size' (n=87) showed no metastasis in distal LNs, regardless of middle third invasion. Pathological T3 stage with tumor size > 5 cm (n=61) and T4 stage (n=91) had metastasis in the distal LNs. Conclusions: In the upper third AGC and Siewert type II EGJ cancer, pathological T2 and small-sized T3 stage groups are possible candidates for PG in cases without distal LN metastasis. Further validation studies are required for clinical application.

The Current Research Status of Complementary and Integrative Medicine in Practice-Based Research Networks: A Systematic Review (개원의중심연구망에서 수행된 보완통합의학 관련 연구 현황: 체계적 문헌고찰)

  • Won, Jiyoon;Han, Gajin;Kim, Yejin;Park, Jae Rang;Noh, Eunyoung;Ji, Yu-jin;Adams, Jon;Lee, Hyangsook
    • Korean Journal of Acupuncture
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    • v.37 no.4
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    • pp.209-230
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    • 2020
  • Objectives : Practice-Based Research Networks (PBRNs), collaborations of practitioners and academic researchers, have provided platforms for conducting research to address clinical questions generated from daily routine care. This review aimed to critically analyse articles from PBRNs that are related to complementary and integrative medicine (CIM) and to suggest future directions for a PBRN which is appropriate for Korean Medicine (KM). Methods : PubMed, PBRN registries in Agency for Healthcare Research and Quality and relevant PBRN websites were searched up to November 2019 for research articles from PBRNs that focused on CIM regardless of study design. Methodological quality of the included studies was assessed. The included studies were read in full, classified and summarised according to their topics. Results : A total of 51 articles published from 1998 through 2020 were included in this review. They were categorised into three principal themes based on research questions and findings: health services research (embracing researches examining characteristics of patients and CIM practitioners/practices, and communication between patients and practitioners); effectiveness and safety of CIM practices/interventions; and feasibility studies of instruments and interventions in PBRN settings. The study designs varied including surveys (n=30), prospective observational studies (n=6), 2ndary analyses of existing studies (n=7), protocols (n=7), retrospective chart review (n=1) and qualitative study (n=1). Quality of the included studies greatly varied. Conclusions : PBRNs can serve as a feasible platform for conducting practice-relevant research on KM and CIM. Considering growing demands on evidence-base for routine practice of KM amid various stakeholders, a PBRN in KM community and further researches nested within PBRN designs are warranted.

A study on the scope of future oriented work of dental hygienists (치과위생사의 미래지향적 업무 범위에 대한 고찰)

  • Ahn, Eunsuk;Kim, Sun-Mi;Kim, Bo-Ra;Jeong, Soon-Jeong;Hwang, Soo-Jeong;Han, Ji-Hyoung
    • Journal of Korean Academy of Dental Administration
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    • v.8 no.1
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    • pp.15-23
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    • 2020
  • The aim of this study is to identify future-oriented tasks for Korean dental hygienists based on a literature review. A literature search is performed using 14 keywords related to tasks carried out by dental hygienists, and included articles published from 2000 to 2019 in the databases KISS, RISS, DBpia, NDSL, Papersearch, Pubmed, and Google Scholar. Six reviewers assessed the titles and abstracts of articles, and an article was selected if the study was considered to cover future-oriented tasks for Korean dental hygienists. Based on the results six local studies and two foreign studies were used for literature review and data extraction. In total, 38 tasks were classified as future-oriented tasks of dental hygienists according to the following criteria: 1) tasks that were specifically referred to as future-oriented tasks, and 2) tasks that could be classified as future-oriented tasks although no specific reference was made. Of these, the most frequently mentioned tasks were measuring periodontal pocket depth, dental hygiene assessment, providing dietary advice, infiltration anesthesia, and root planing. These were extracted from five of the eight studies, including both local and foreign studies. Dental hygiene planning, emergency, emergency management, and smoking cessation were the next most common tasks based on four studies. Even though some of these future-oriented tasks for Korean dental hygienists are included in the dentistry curriculum, and are currently performed as clinical practice for dental hygienists. Nonetheless, the reference to the legal scope is unclear. It is necessary to reconsider the scope of tasks of dental hygienists to reflect changes in domestic and foreign dental care delivery, thereby contributing to the oral health promotion of the public, where safety is guaranteed under legal protection.

TLC, HPTLC FINGERPRINTING AND ACUTE ORAL TOXICITY EVALUATION OF HABB-E-AZARAQI: A NUX-VOMICA-BASED TRADITIONAL UNANI FORMULATION

  • Ara, Shabnam Anjum;Viquar, Uzma;Zakir, Mohammed;Husain, Gulam Mohammed;Naikodi, Mohammed Abdul Rasheed;Urooj, Mohd;Kazmi, Munawwar Husain
    • CELLMED
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    • v.11 no.3
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    • pp.13.1-13.9
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    • 2021
  • Background and Objective: Nux-vomica based traditional Unani formulation, Habb-e-Azaraqi (HAZ) is an important drug used by Unani physicians since several decades. It possesses Muqawwi-i-A'sab (nervine tonic), Muharrik-i-A'sab (nervine stimulant) properties and is an effective treatment option for diseases like Laqwa (facial palsy), Falij (paralysis), Niqris (gout) and Waja'al-Mafasil (arthritis) etc. The aim of the study is to access and provide information of HAZ for its TLC, HPTLC Fingerprinting defining its clear qualitative perspective and acute oral toxicity evaluation for its safety assessment which was not done earlier, thus contributing in the field of research. Materials and Methods: The chief ingredient, nux-vomica was detoxified as per method mentioned in Unani Pharmacopeia before its use in formulation. TLC and HPTLC was developed under four detection system i.e., UV 366nm, UV 254nm, exposure to iodine vapours and after derivatization with anisaldehyde sulphuric acid. Acute toxicity studies were performed as per OECD Guidelines 425 at a limit dose of 2000 mg/kg. Observations were done for signs of toxicity, body weight, and feed consumption at regular intervals followed by haematological and biochemistry evaluation. Results: The generated data proved the authenticity and established the TLC and HPTLC profile of the formulation. Acute toxicity revealed no significant differences in HAZ-treated animals with respect to body weight gain, feed consumption, haematology, clinical biochemistry evaluation. No significant gross pathological observation was noticed in necropsy. Conclusion: Data of the present study is substantial and scientific proof of HAZ in terms of standardization and toxicity study that can be utilize in future research activities.

Does dexmedetomidine combined with levobupivacaine in inferior alveolar nerve blocks among patients undergoing impacted third molar surgery control postoperative morbidity?

  • Patil, Shweta Murlidhar;Jadhav, Anendd;Bhola, Nitin;Hingnikar, Pawan;Kshirsagar, Krutarth;Patil, Dipali
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.2
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    • pp.145-153
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    • 2022
  • Background: Postoperative analgesia (POA) is an important determinant of successful treatment. Dexmedetomidine (DEX) has recently gained attention as a promising adjuvant to local anesthetics (LA). The present study aimed to evaluate the efficacy and safety of levobupivacaine (LB) as an adjuvant during inferior alveolar nerve block (IANB) in the extraction of lower impacted third molars (LITM). Methods: A prospective, randomized, placebo-controlled, triple-blind, parallel-arm, and clinical study was performed on 50 systemically healthy participants who required removal of an asymptomatic LITM. Using a 1:1 distribution, the participants were randomized into two groups (n = 25). Group L (control group) received 1.8 mL of 0.5% LB and 0.2 mL normal saline (placebo) and Group D (study group) received a blend of 1.8 mL of 0.5% LB and 0.2 mL (20 ㎍) DEX. The primary outcome variable was the duration of POA and hemodynamic stability, and the secondary variable was the total number of analgesics required postoperatively for up to 72 h. The participants were requested to record the time of rescue analgesic use and the total number of rescue analgesics taken. The area under the curve was plotted for the total number of analgesics administered. The pain was evaluated using the visual analog scale. Data analysis was performed using paired students and unpaired t-test, Mann-Whitney U test, Chi-square test, and receiver operating characteristic analysis. Statistical significance was set at P < 0.05. Results: The latency, profoundness of anesthesia, and duration of POA were statistically significant (P < 0.05). The differences between mean pain scores at 6, 12, 24, 48, and 72 h were found to be significant (each P = 0.0001). Fewer analgesics were required by participants in group D (2.12 ± 0.33) than in L (4.04 ± 0.67), with a significant difference (P = 0.0001). Conclusion: Perineurally administered LA with DEX is a safe, effective, and therapeutic approach for improving latency, providing profound POA, and reducing the need for postoperative analgesia.