• Title/Summary/Keyword: clinical trial

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The Effect of Low Molecule Collagen Peptide on Skin Anti-glycation and Collagen Synthesis as a Skin Aging Therapy (피부 노화 치료로서 저분자콜라겐펩타이드의 피부 항당화와 콜라겐 합성 효과)

  • Kim, Hong Seok;Hong, Won Kyu;Lee, Mun Hoe;Kim, Hyeong Min;Chung, Hee Chul;Lee, Jin Hee
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.47 no.2
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    • pp.147-153
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    • 2021
  • Collagen hydrolysate (CH) is known to prevent skin aging by stimulating skin dermal fibroblasts to promote synthesis of extracellular matrix such as collagen and elastin. Recently, among the various factors that cause skin aging, advanced glycation end products (AGEs) have received particular attention. However, the effect of CH on AGE accumulation has not been studied. Since CH could affect AGE accumulation by promoting production of skin structural proteins, clinical trial was performed using low molecule collagen peptide (LMCP), which were CH containing 25% tripeptide and 4% Gly-Pro-Hyp. Skin autofluorescence (SAF) values were measured using an AGE reader to evaluate accumulation of AGE in skin. As a result of applying 0.5% and 1.0% LMCP solutions to the subject's forearm for 8 weeks, the SAF value at the test site significantly decreased compared to the control site. Additionally, in vitro test was performed using CCD-986sk to evaluate the promotion of collagen synthesis in skin fibroblasts by LMCP. As a result, 800 ㎍/mL of LMCP significantly increased synthesis of human pro-collagen Iα1 (COL1A1) in CCD-986sk. Through this study, we have confirmed that tropical LMCP applications can promote collagen synthesis to help anti-glycation effects, suggesting that LMCP has potential as an anti-aging cosmetic material.

Postprandial Asymptomatic Glycemic Fluctuations after Gastrectomy for Gastric Cancer Using Continuous Glucose Monitoring Device

  • Ri, Motonari;Nunobe, Souya;Ida, Satoshi;Ishizuka, Naoki;Atsumi, Shinichiro;Hayami, Masaru;Makuuchi, Rie;Kumagai, Koshi;Ohashi, Manabu;Sano, Takeshi
    • Journal of Gastric Cancer
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    • v.21 no.4
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    • pp.325-334
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    • 2021
  • Purpose: Although dumping symptoms are thought to involve postprandial glycemic changes, postprandial glycemic variability without dumping symptoms remains poorly understood due to the lack of a method that allows the easy and continuous measurement of blood glucose levels. Materials and Methods: Patients having undergone distal gastrectomy with Billroth-I (DG-BI) or Roux-en-Y reconstruction (DG-RY), total gastrectomy with RY (TG-RY) and pylorus preserving gastrectomy (PPG) for gastric cancer 3 months to 3 years prior, diagnosed as pathological stage I or II, were prospectively enrolled from March 2018 to January 2020. The interstitial tissue glycemic levels were measured every 15 min, up to 14 days by continuous glucose monitoring. Moreover, using a diary recording the diet and symptoms, asymptomatic glucose profiles without sugar supplementation within 3 h postprandially were compared among the four procedures. Results: A total of 40 patients were enrolled, 10 patients for each of the four procedures. There were 47 glucose profiles with DG-BI, 46 profiles with DG-RY, 38 profiles with TG-RY, and 46 profiles with PPG. PPG showed the slowest increase with a subsequent gradual decrease in glucose fluctuations, without hyperglycemia or hypoglycemia, among the four procedures. In contrast, TG-RY and DG-RY showed spike-like glycemic variability, sharp rises during meals, and rapid drops. The glucose profiles of DG-BI were milder than those of RY. Conclusions: The asymptomatic glycemic changes after meals differ among the types of surgical procedures for gastric cancer. Given the mild glycemic fluctuations in PPG and the glucose spikes in TG-RY and DG-RY, pylorus preservation and physiological reconstruction without changes in food pathways may optimize postprandial glucose profiles after gastrectomy.

Case Report of the Pityriasis Rosea Patient with Pruritus Treated by Korean Medicine Treatment alone (소양감이 동반된 장미색 비강진 환자의 한방단독치료 보고)

  • Lee, Kyoungeun;Kim, Jungpil;Jeong, Seonhyung;Ahn, Joon;Jeong, Hyein;Kim, Kyounghan;Jang, Insoo;Choi, Yoomin;Oh, Yongtaek
    • Herbal Formula Science
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    • v.30 no.1
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    • pp.27-36
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    • 2022
  • Objective : The purpose of this study is to present a case report with the adult patient who needed active treatment of pityriasis rosea with severe pruritus, and did not respond to steroid treatment in the preceding month. Methods : The subject is an adult patient with pityriasis rosea over the age of 40 without any other diseases. We administered Korean medicine treatment with Bangpungtongseong-san (防⾵通聖散) and acupuncture. The effects of the treatment were evaluated via scales including Pruritus score, Pityriasis Rosea Severity Score (PRSS), and picture. Results : After the treatment Pruritus score/PRSS index of the case changed from 8/20 to 0/0. No other severe adverse reactions were reported. No more recurrence or pruritus was confirmed in follow-up. Conclusions : Korean medicine treatment with Bangpungtongseong-san showed marked improvement in pruritus and skin symptoms of pityriasis rosea in need of active care. With the lack of existing clinical reports of pityriasis rosea, we found that Korean medicine treatment could be an effective way, and it is expected that Bangpungtongseong-san could be administered to pityriasis rosea patients. Randomized-controlled trial for further evaluation will be needed in the future.

Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial

  • Chang, Yongjoon;Yun, Hyunjong;Choi, Jong Woo;Suh, Joong Min;Jeong, Woo Shik;Park, Hojin;Kang, Min Kyu;Shin, Yongho;Kim, Kuylhee;Chung, Chul Hoon
    • Archives of Craniofacial Surgery
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    • v.23 no.4
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    • pp.152-162
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    • 2022
  • Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

Anesthetic efficacy of supplemental buccal infiltration versus intraligamentary injection in mandibular first and second molars with irreversible pulpitis: a prospective randomized clinical trial

  • Zargar, Nazanin;Shojaeian, Shiva;Vatankhah, Mohammadreza;Heidaryan, Shirin;Ashraf, Hengameh;Baghban, Alireza Akbarzadeh;Dianat, Omid
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.339-348
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    • 2022
  • Background: To compare the anesthetic efficacy of supplemental buccal infiltration (BI) (1.7 ml) versus intraligamentary (IL) injection containing 0.4 ml of 4% articaine with 1:100.000 epinephrine after an inferior alveolar nerve block (IANB) with 1.7 ml 2% lidocaine in the first and second mandibular molars diagnosed with irreversible pulpitis (IP). Methods: One hundred subjects diagnosed with IP of either the mandibular first (n = 50) or second molars (n = 50) and failed profound anesthesia following an IANB were selected. They randomly received either the IL or BI techniques of anesthesia. Pain scores on a 170 mm Heft-Parker visual analog scale were recorded initially, before, and during supplemental injections. Furthermore, pulse rate was measured before and after each supplemental injection. During the access cavity preparation and initial filing, no or mild pain was assumed to indicate anesthetic success. The chi-square test, Mann-Whitney U test, and independent samples t-test were used for the analyses. Results: The overall success rates were 80% in the IL group and 74% in the BI group, with no significant difference (P = 0.63). In the first molars, there was no significant difference between the two techniques (P = 0.088). In the second molars, IL injection resulted in a significantly higher success rate (P = 0.017) than BI. IL injection was statistically more successful (P = 0.034) in the second molars (92%) than in the first molars (68%). However, BI was significantly more successful (P = 0.047) in the first molars (88%) than in the second molars (64%). The mean pulse rate increase was significantly higher in the IL group than in the BI group (P < 0.001). Conclusions: Both the IL and BI techniques were advantageous when used as supplemental injections. However, more favorable outcomes were observed when the second molars received IL injection and the first molars received BI.

Anesthetic efficacy of primary and supplemental buccal/lingual infiltration in patients with irreversible pulpitis in human mandibular molars: a systematic review and meta-analysis

  • Gupta, Alpa;Sahai, Aarushi;Aggarwal, Vivek;Mehta, Namrata;Abraham, Dax;Jala, Sucheta;Singh, Arundeep
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.4
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    • pp.283-309
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    • 2021
  • Achieving profound anesthesia in mandibular molars with irreversible pulpitis is a tedious task. This review aimed at evaluating the success of buccal/lingual infiltrations administered with a primary inferior alveolar nerve block (IANB) injection or as a supplemental injection after the failure of the primary injection in symptomatic and asymptomatic patients with irreversible pulpitis in human mandibular molars. The review question was "What will be the success of primary and supplemental infiltration injection in the endodontic treatment of patients with irreversible pulpitis in human mandibular molars?" We searched electronic databases, including Pubmed, Scopus, and Ebsco host and we did a comprehensive manual search. The review protocol was framed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist. We included clinical studies that evaluated and compared the anesthetic outcomes of primary IANB with primary and/or supplementary infiltration injections. Standard evaluation of the included studies was performed and suitable data and inferences were assessed. Twenty-six studies were included, of which 13 were selected for the meta-analysis. In the forest plot representation of the studies evaluating infiltrations, the combined risk ratio (RR) was 1.88 (95% CI: 1.49, 2.37), in favor of the secondary infiltrations with a statistical heterogeneity of 77%. The forest plot analysis for studies comparing primary IANB + infiltration versus primary IANB alone showed a low heterogeneity (0%). The included studies had similar RRs and the combined RR was 1.84 (95% CI: 1.44, 2.34). These findings suggest that supplemental infiltrations given along with a primary IANB provide a better success rate. L'Abbe plots were generated to measure the statistical heterogeneity among the studies. Trial sequential analysis suggested that the number of patients included in the analysis was adequate. Based on the qualitative and quantitative analyses, we concluded that the infiltration technique, either as a primary injection or as a supplementary injection, given after the failure of primary IANB, increases the overall anesthetic efficacy.

Programmed-release intraosseus anesthesia as an alternative to lower alveolar nerve block in lower third molar extraction: a randomized clinical trial

  • Pol, Renato;Ruggiero, Tiziana;Bezzi, Marta;Camisassa, Davide;Carossa, Stefano
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.3
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    • pp.217-226
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    • 2022
  • Background: Intraosseous anesthesia is the process by which an anesthetic solution, after penetration of the cortical bone, is directly injected into the spongiosa of the alveolar bone supporting the tooth. This study aimed to compare the effectiveness of the traditional inferior alveolar nerve block (IANB) and computerized intraosseous anesthesia in the surgical extraction of impacted lower third molars, compare their side effects systemically by monitoring heart rate, and assess patients' a posteriori preference of one technique over the other. Methods: Thirty-nine patients with bilaterally impacted third molars participated in this study. Each patient in the sample was both a case and control, where the conventional technique was randomly assigned to one side (group 1) and the alternative method to the contralateral side (group 2). Results: The traditional technique was faster in execution than anesthesia delivered via electronic syringe, which took 3 min to be administered. However, it was necessary to wait for an average of 6 ± 4 min from the execution to achieve the onset of IANB, while the latency of intraosseous anesthesia was zero. Vincent's sign and lingual nerve anesthesia occurred in 100% of cases in group 1. In group 2, Vincent's sign was recorded in 13% of cases and lingual anesthesia in four cases. The average duration of the perceived anesthetic effect was 192 ± 68 min in group 1 and 127 ± 75 min in group 2 (P < 0.001). The difference between the heart rate of group 1 and group 2 was statistically significant. During infiltration in group 1, heartbeat frequency increased by 5 ± 13 beats per minute, while in group 2, it increased by 22 ± 10 beats per minute (P < 0.001). No postoperative complications were reported for either technique. Patients showed a preference of 67% for the alternative technique and 20% for the traditional, and 13% of patients were indifferent. Conclusion: The results identified intraosseous anesthesia as a valid alternative to conventional anesthesia in impacted lower third molar extraction.

Animal Skin Irritation and Skin Sensitization Tests of High Intensity Focused Ultrasound System Cartridges (집속형초음파자극시스템 카트리지의 동물실험을 통한 피부자극시험 및 피부 감작성시험)

  • Jun-tae, Kim;Ju-hee, Kim;Kyu-tai, Joo;Kyung-ah, Kim;Ahnryul, Choi;Jae-hyun, Jo;Jin-houng, Jeong
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.15 no.6
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    • pp.477-484
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    • 2022
  • In this study, the cartridge part of the focused ultrasound stimulation system was used as a sample to conduct a skin irritation test and a skin sensitization test through animal experiments among the tests related to GLP (Good Laboratory Practice), a medical device safety evaluation standard. The test was conducted after IACUC approval using 6 female New Zeland White Rabbits. The polar and non-polar stimulation indices were all '0.0'. In addition, in the case of skin sensitization evaluation, 30 guinea pigs approved by IACUC were divided into control and experimental groups, and all induction and induction steps were applied using the eluate itself without separate dilution of the test sample and blank test solution. As a result of the experiment, the skin reaction grade of the control animal was 0 grade, and there was no animal showing more than 1 grade in the skin reaction of the test animal. As a result of both tests, no abnormal skin symptoms were observed, and when applied to the human body to treat patients, the test materials used in the tests will investigate the stability of whether any diseases that cause skin abnormal symptoms will occur.

Improved postoperative recovery profile in pediatric oral rehabilitation with low-dose dexmedetomidine as an opioid substitute for general anesthesia: a randomized double-blind clinical trial

  • Naveen, Naik B;Jaiswal, Manoj Kumar;Ganesh, Venkata;Singh, Ajay;Meena, Shyam Charan;Amburu, Vamsidhar;Soni, Shiv Lal
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.357-367
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    • 2022
  • Background: Low-dose dexmedetomidine may be a suitable alternative to opioids for pediatric ambulatory procedures under general anesthesia (GA). However, the recovery profile remains unclear. Herein, we aimed to evaluate the effects of low-dose dexmedetomidine on the recovery profile of children. Methods: Seventy-two children undergoing ambulatory oral rehabilitation under GA were randomly and equally distributed into two groups (D and F). Group D received an infusion of dexmedetomidine 0.25 ㎍/kg for 4 min for induction, followed by maintenance of 0.4 ㎍/kg/h. Group F received an infusion of fentanyl 1 ㎍/kg over 4 min for induction, followed by maintenance at 1 ㎍/kg/h. The primary outcome was the extubation time. The secondary outcomes were awakening time, end-tidal sevoflurane (ET-Sevo) requirement, change in hemodynamic parameters, Richmond Agitation-Sedation Scale (RASS), Children's Hospital of Eastern Ontario pain scale (CHEOPS) score, length of PACU stay, and incidence of adverse events. Results: Statistically significant differences were observed in the recovery profile between the groups: the median time for extubation was 3.65 (3.44-6.2) vs. 6.25 (4.21-7) minutes in groups D vs. F (P=0.001), respectively, while the corresponding awakening times were 19 (18.75-21) and 22.5 (22-24) minutes, respectively (P < 0.001). The mean ET-Sevo was low in group D (1.1 vs. 1.2; P < 0.001). The heart rate was significantly low across all time points in group D, without resulting in bradycardia. The median RASS and CHEOPS scores were also significantly lower in group D. No significant differences were observed in the mean arterial pressure, incidence of adverse events, or length of PACU stay. Conclusion: Low-dose dexmedetomidine was more effective than fentanyl as an opioid substitute at providing a better recovery profile in pediatric ambulatory oral rehabilitation under GA. Dexmedetomidine also significantly reduced sevoflurane consumption without causing adverse events or prolonging hospital stay.

Effectiveness of Auricular Blood-letting Therapy for Headaches: A Systematic Review and Meta-Analysis (두통에 대한 이혈 방혈요법의 유효성 분석: 체계적 문헌고찰 및 메타분석)

  • Kyoungeun Lee;Min-Ryeong Park;Ji-Won Lee;In-Jun Hwang;Boram Lee;Jong Cheol Seo;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.259-274
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    • 2023
  • Objectives: The purpose of this study was to provide clinical evidence to support the use of auricular blood-letting therapy (ABT) for headaches. Methods: Studies were identified by a comprehensive search of five databases. Randomized controlled trials (RCTs) that investigated the effects of the ABT for headaches were included. Two authors independently extracted the data and assessed the methodological quality of the included studies using Cochrane's risk-of-bias tool. If two or more studies reported the same outcome, a meta-analysis was performed. Meta-analysis results for dichotomous variables are expressed as risk ratios (RRs) and 95% confidence intervals (CIs). Results: A total of eight RCTs were included in this review. The total effective rate (TER) was the most commonly used outcome measurement. Among the eight RCTs, five were included in the metaanalysis. The TER was not statistically significantly different in the ABT group compared to the medication group (two studies, n=55, RR=1.24, 95% CI: 0.78 to 1.96, p=0.36, I2 =86%). However, the TER of the combined ABT and medication group was significantly different compared to the medication alone group (four studies, n=159, RR=1.23, 95% CI: 1.12 to 1.35, p<0.0001, I2 = 0%). Pain and mental health-related outcomes in the combined ABT and medication group were significantly different from the control groups. The methodological quality of the included RCTs was generally low. Conclusions: ABT combined with medication may be effective for treating headaches. However, the number of studies included was small, so the results were insufficient, and statistically significant effects were not confirmed for a single implementation of ABT. Thus, well-designed further studies based on the findings of this study are recommended.