• Title/Summary/Keyword: Clinical trial,

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The effect of oral breast milk on pain response of the neonates during heel lancing (모유경구투여가 발뒤꿈치 천자 시 신생아의 통증반응에 미치는 효과)

  • Kim, Kyunghwa;Park, Youngim;Kim, Taeim
    • Journal of the Korean Data and Information Science Society
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    • v.27 no.1
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    • pp.203-215
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    • 2016
  • This study was performed in order to investigate the effect of breast milk on pain relief in newborn during heel lancing. Nonequivalent control group pretest-posttest design by double blinded experiment was used. 50 neonates were randomized to receive breast milk (experimental group, n=25) or no treatment (control group, n=25) before undergoing heel lancing. Informed consent was obtained from parents of 50 neonates. Neonatal infant pain scale (NIPS), respiration rate, heart rate, oxygen saturation, and crying duration were used to assess subjects' pain reaction. Data were analyzed using SPSS 18.0. The experimental and control group showed a statistically significant differences in NIPS score (F=28.89, p<.001), heart rate (F=14.03, p<.001), respiration rate (F=4.79, p=.001), oxygen saturation (F=2.69, p=.027), and crying duration (t=-8.78, p <.001) at each time points (during heel lancing, right after heel lancing, 1, 2, 3 minutes after heel lancing). The result suggest that oral administration of expressed breast milk is safe and natural agents for reducing procedural pain of neonates. Another clinical trial study with more samples is recommended.

What is the effect of initial implant position on the crestal bone level in flap and flapless technique during healing period?

  • Al-Juboori, Mohammed Jasim;Ab Rahman, Shaifulizan;Hassan, Akram;Ismail, Ikmal Hisham Bin;Tawfiq, Omar Farouq
    • Journal of Periodontal and Implant Science
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    • v.43 no.4
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    • pp.153-159
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    • 2013
  • Purpose: The level of the implant above the marginal bone and flap design have an effect on the bone resorption during the healing period. The aim of this study is to detect the relationship between the level of the implant at the implant placement and the bone level at the healing period in the mesial and distal side of implants placed with flapless (FL) and full-thickness flap (FT) methods. Methods: Twenty-two nonsubmerged implants were placed with the FL and FT technique. Periapical radiographs were taken of the patient at implant placement, and at 6 and 12 weeks. By using computer software, bone level measurements were taken from the shoulder of the healing cap to the first bone implant contact in the mesial and distal side of the implant surface. Results: At 6 weeks, the correlation between the crestal bone level at the implant placement and crestal bone level of the FT mesially was significant (Pearson correlation coefficient=0.675, P<0.023). At 12 weeks, in the FT mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.297, P<0.346). At 6 weeks in the FT distally, the correlation was nonsignificant (Pearson correlation coefficient=0.512, P<0.107). At 12 weeks in the FT distally, the correlation was significant (Spearman correlation coefficient=0.730, P<0.011). At 6 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient=0.083, P<0.809). At 12 weeks in the FL mesially, the correlation was nonsignificant (Spearman correlation coefficient= 0.062, P<0.856). At 6 weeks in the FL distally, the correlation was nonsignificant (Spearman correlation coefficient=0.197, P<0.562). At 12 weeks in the FL distally, the correlation was significant (Pearson correlation coefficient=0.692, P<0.018). Conclusions: A larger sample size is recommended to verify the conclusions in this preliminary study. The bone level during the healing period in the FT was more positively correlated with the implant level at implant placement than in the FL.

Effects of Taegeuk Acupuncture on the Autonomic Nervous System by Analyzing Heart Rate Variability in 20's Soeumin (태극침법이 정신적 스트레스를 가한 20대 소음인 남성의 심박변이도에 미치는 영향)

  • Kim, Nam Sik;Kim, Jin Youp;Kwak, Sang Gyu;Shin, Im Hee;Nam, Sang Soo;Kim, Yong Suk
    • Journal of Acupuncture Research
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    • v.30 no.3
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    • pp.39-49
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    • 2013
  • Objectives : The purpose of this study is to assess the effect of Taegeuk acupuncture on reducing mental stress by analyzing heart rate variability in Soeumin. Methods : Six Soeumin-diagnosed men participated in this study. They were randomly divided into group A and group B. Each participant went through 4 sessions every week with 1 week of washout period in between each session. HRV was measured three times at every session; at baseline, after administering mentally stressful circumstances and after applying Soeumin Taegeuk acupuncture or Soyangin Taegeuk acupuncture. This study was designed as a crossover clinical trial. Group A participants were treated with two sets of Soeumin Taegeuk and Soyangin Taegeuk acupuncture treatment in respective order (i.e. Soeumin Taegeuk - Soyangin Taegeuk - Soeumin Taegeuk - Soyangin Taegeuk acupuncture treatment). Group B participants were treated with reverse-ordered acupuncture treatment (i.e. Soyangin Taegeuk - Soeumin Taegeuk - Soyangin Taegeuk - Soeumin Taegeuk acupuncture treatment ). Bayesian analysis was performed by using WinBUGS(Ver. 1.4.3) for comparison between Soeumin Taegeuk acupuncture and Soyangin Taegeuk acupuncture. Results : Overall, Soeumin Taegeuk acupuncture tends to reduce LF/HF ratio, LF, HF, LF(Norm) and increase HF(Norm) more than Soyangin Taegeuk acupuncture, but the difference was not statistically significant. In one participant, however, Soeumin Taegeuk acupuncture reduced LF/HF ratio, LF(Norm) and increased HF(Norm) more than Soyangin Taegeuk acupuncture, and the difference was stastatistically significant. Conclusions : This study suggests that Soeumin Taegeuk acupuncture might be an effective means of stabilizing mental stress-induced imbalance of autonomic nervous system for Soeumin.

Effect of ${\beta}$-Mannanase (CTCZYME$^{(R)}$) on the Growth of Young Calf (${\beta}$-Mannanase (CTCZYME$^{(R)}$) 첨가가 어린 송아지의 성장에 미치는 영향)

  • Lee, Se-Young;Lee, Sang-Moon;Kim, Jong-Hyeong;Ki, Kwang-Seok;Kim, Hyeon-Shup;Kam, Dong-Keun;Lee, Jae-Hwan;Lee, Jung-Jin;Bae, Gui-Seck;Seo, Seong-Won
    • Korean Journal of Agricultural Science
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    • v.37 no.2
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    • pp.239-243
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    • 2010
  • The objective of this study was to evaluate effects of supplementation of ${\beta}$-mannanase (CTCZYME$^{(R)}$, CTCBIO, Inc.) on feed intake, growth performance and fecal health of calves fed two levels (3% vs. 8%) of palm kernel meal (PKM). A total of nine Holstein calves were divided into three groups, and fed a conventional starter containing 3% PKM (CON), CON+0.1% CTCZYME$^{(R)}$ (TRT1), or a starter containing 8% PKM+0.1% CTCZYME$^{(R)}$ (TRT2). No clinical symptom of calves was observed through the trial. We did not find significant differences among the treatments on mean feed intake, growth performance, or fecal health during the four-week experimental period. Feed efficiency tended to be improved by adding CTCZYME$^{(R)}$ (0.46, 0.87 and 0.52 for CON, TRT1 and TRT2, respectively). Compared with CON (921 g/d and 786 g/d), TRT2 had lower feed intake (727 g/d) and average daily gain (ADG, 631 g/d) before weaning. However, feed intake (2300 g/d) and ADG (1012 g/d) were similar or even higher in TRT2 than CON (2269 g/d and 560 g/d) after weaning. This was probably due to the effect of a large amount of mannan-oligosaccharide released from PKM by ${\beta}$-mannanase. Salmonella was not detected any fecal samples. No significant difference was observed in the number of fecal E. coli or fecal properties including color, smell, and watery indexes among the treatments. We conclude that a calf starter containing 8% PKM with 0.1% CTCZYME$^{(R)}$ is comparable with a conventional starter in feed intake and growth performance of calf, which is beneficial in terms of reduction in feed cost.

The Effect of Dextranase-Containing Mouthwash in Human Experimental Gingivitis (실험적 치은염에서 dextranase 함유 구강 세정액의 양치 효과)

  • Son, Eun-Ju;Kim, Young-Jun;Kim, Do-Man;Chung, Hyun-Ju
    • Journal of Periodontal and Implant Science
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    • v.31 no.2
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    • pp.401-420
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    • 2001
  • A novel glucanhydrolase from a mutant of Lipomyces starkeyi(KSM 22)has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependent adherent microbial film and Lipomyces starkeyi KSM 22 dextranase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi KSM 22 dextranase are desirable for its application as a dental plaque control agent. This study was performed to determine oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 dextranase)-containing mouthwash in human experimental gingivitis. This 3-week clinical trial was placebo-controlled double-blind design evaluating 1U/ml dextranase mouthwash and 0.12% chlorhexidine mouthwash. A total 39 systemically healthy subjects, who had moderate levels of plaque and gingivitis were included. At baseline, 1, 2 and 3 weeks, subjects were scored for plaque(Silness and $L{\ddot{o}e$ plaque index and plaque severity index), gingivitis($L{\ddot{o}e$ and Silness gingival index), and at baseline and 3 weeks of experiment, subjects were scored for plaque(Turesky-Quingley-Hein's plaque index and plaque severity index), tooth stain(Area and severity index system by Lang et al). Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Two weeks after pre-experiment examinations and a professional prophylaxis, the subjects provided with allocated mousewash and instructed to use 20-ml volumes for 30s twice dailywithout toothbrushing. All the groups showed significant increase in plaque accumulation since 1 week of experiment. During 3 weeks' period, the dextranase group showed the least increase in plaque accumulation of Silness and $L{\ddot{o}e$ plaque index, compared to the chlorhexidine and placebo groups, but chlorhexidine group showed the least increase inplaque accumulation of Turesky-Quingley-Hein's plaque index. As for gingival inflammation, all the groups showed significant increase during 3 weeks of experiment. The dextranase group also showed the least increase in gingival index score, compared to the chlorhexidine as well as the placebo groups. Whereas the tooth stain was increased significantly in the chlorhexidine group, compared to the baseline score and the placebo group since 3 weeks of mouthrinsing. It was significantly increased after 3 weeks in the dextranase group, still less severe than the chlorhexidine group. As for the oral side effect, the dextranase group showed less tongue accumulation, bad taste, compared to the chlorhexidine group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase was comparable to 0.12% chlorhexidine mouthwashin inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, in human experimental gingivitis. All data had provided positive evidence for Lipomyces starkeyi KSM 22 dextranase as an antiplaque agent and suggested that further development of dextranase formulations for plaque control are warranted.

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The Effects of the Epithelial Cells of Genital Tract on the Development of Mouse Early Embryos and Human Fertilized Oocytes (생쥐 초기배아와 사람의 수정란의 발생에 미치는 생식수관 상피세포의 영향에 관한 연구)

  • Lee, H.J.;Byun, H.K.;Kim, J.W.;Hwang, J.H.;Jun, J.Y.;Kim, M.K.
    • Clinical and Experimental Reproductive Medicine
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    • v.21 no.3
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    • pp.315-323
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    • 1994
  • Mammalian oviductal epithelial cells have been known to improve in vitro fertilization and embryonic development. Recently, co-cultured human embryos with the epithelial cells in human genital tract has been reported to improve the pregnancy rate. The purpose of the study was to investigate the effects of the epithelial cells of human genital tract on the development of mouse early embryos and human fertilized oocytes. The epithelial cells of human genital tract were collected from the fallopian tubes which were obtained during hysterectomy in fertile women and from the endometrium during endometrium biopsy. Collected human ampullary cells(HACs) and endometrial cells(HECs) were cultured for 10 days to establish primary monolayer. Second passaged HACs and HECs were obtained by trypsinization were cryopreserved in PBS with 1.5 M DMSO for later use. To investigate the effect when co-cultured with HACs and HECs, we tried to apply strict quality control on mouse embryo, from two cell to blastocyst prior to human trial. The results of quality control were as follows; In Group I (Ham's F10 with 10% FCS), Group IT (co-cultured with HACs) and Group ill (co-cultured with HECs), developmental rates to blastocyst were 63.3%(253/400), 76.0%(304/ 400),74.0%(296/400), respectively. Hatching rates were 36.8%(147/400), 41.80/0(167/400), 38.0%(152/400), respectively(p<0.05). To perform the human IVF, cryopreserved HACs were thawed at 37$^{\circ}C$ waterbath, seeded on the well dish and cultured for 48 hI'S. The pronuclear stage embryos were transferred to the seeded well dish. After 24 hRS, co-cultured embryos were examined and transferred to patient's uterus. The results of human IVF when co-cultured with HACs were that fertilization and developmental rates were 61.8% (256/414), 95.3% (244/256) as compared with 57.2% (279/488) and 94.6%(264/279) in Ham's F10 supplemented with 10% FCS(control). However, 62.9% (161/256) of co-cultured human embryos showed good embryos(no or slight fragmentation) as compared with 53.8 % (150/279) in control(p < 0.05). Pregnancy rate was 40.0% (12/30) when co-cultured with HACs whereas 30.6%(11/36) in control. In conclusions, co-culture system using HACs and HECs improved the developmental and hatching rates of mouse embryo. Also, in human IVF system when co-cultured with HACs, it improved both the quality of human embryos and the pregnancy rate.

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Sanguinarine Increases Sensitivity of Human Gastric Adenocarcinoma Cells to TRAIL-mediated Apoptosis by Inducing DR5 Expression and ROS Generation (AGS 인체 위암세포에서 DR5의 발현 및 ROS 생성의 증가를 통한 sanguinarine과 TRAIL 혼합처리의 apoptosis 유도 활성 촉진)

  • Lee, Taek Ju;Im, Yong Gyun;Choi, Woo Young;Choi, Sung Hyun;Hwang, Won Deok;Choi, Yung Hyun
    • Journal of Life Science
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    • v.24 no.9
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    • pp.927-934
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    • 2014
  • Sanguinarine, a benzophenanthridine alkaloid originally derived from the root of Sanguinaria canadensis, has been shown to possess antimicrobial, antioxidant, and anti-cancer properties. Although tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) is known to induce apoptosis in cancer cells, but not most normal cells and has shown efficacy in a phase 2 clinical trial, development of resistance to TRAIL by tumor cells is a major roadblock. Our previous study indicated that treatment with TRAIL in combination with subtoxic concentrations of sanguinarine sensitized TRAIL-mediated apoptosis in TRAIL-resistant human gastric carcinoma AGS cells; however, the detailed mechanisms are not fully understood. In this study, we show that sanguinarine sensitizes AGS cells to TRAIL-mediated apoptosis as detected by MTT assay, agarose gel electrophoresis, chromatin condensation and flow cytometry analysis. Combined treatment with sanguinarine and TRAIL effectively induced expression of death receptor (DR) 5 but did not affect expression of DR4 and mitogen activated protein kinases signaling molecules. Moreover, the combined treatment with sanguinarine and TRAIL increased the generation of reactive oxygen species (ROS); however, N-acetylcysteine, ROS scavenger, significantly recovered growth inhibition induced by the combined treatment. Taken together, our results indicate that sanguinarine can potentiate TRAIL-mediated apoptosis through upregulation of DR5 expression and ROS generation.

Study on the Repeatability and Reproductivity of a Moire Body Shape Analyser (모아레를 이용한 체형분석의 반복성 재현성에 관한 연구)

  • Lee, Dong-Yup;Park, Young-Bae;Oh, Hwan-Sub
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.10 no.2
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    • pp.121-131
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    • 2006
  • Background : As each human has a look in the face of oneself, he or she has a look of him or herself in the shape of the body also. And for the shape of the body which gives a big clue in diagnosis in musculoskeletal disorders. Therefor many means are used and developed for diagnosis through body shape or posture analysis for musculoskeletal disorders. X-ray, CT, MRI has been used for diagnosis through image in this way to tell about the inside of the human body. On the other side, moire topography was used for information about the exterior of the human body, but yet only minimal information such as the number of contour lines in each side was available. Therefor there were a few studies to use moire topography or other methods to get information about the surface of the human body in numeric values. The instrument used in this study which is a laser projection moire, is another trial to get numeric data about the surface of the human body. The instrument is composed of laser projector and a computer software to recompose and analyse the image data into depth, height, angle and length. Objectives : The study was focused on whether the instrument is reliable for clinic use, and to seek the proper environment and posture for the examination, and among the data the software provides, which items are more reliable and useful. Methods : For reproductivity and repeatability, 4 testers tested 2 persons. And to how if the body shape changes according to the posture and which posture gives the most reliable data, the test was performed in 6 different positions. Results : Result, the instrument showed sufficient repeatability and reproductivity for clinical use. And among the items the software provides, the length of the back, the angle of the back in the sagittal and coronal plane showed reliable results. And there was difference in the results according to the posture, and Therefor, in following studies using this instrument or similar type of posture analysing instruments, the length of the back, the angle of the back in the sagittal and coronal plane could be reliable item to use.

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A Randomized Comparative Study of a Standard Anterior Capsular Release versus Inferior Extended Release for the Treatment of Shoulder Stiffness

  • Alzeyadi, Ahmed Abdullah;Kim, Yang-Soo;Lee, Hyo-Jin;Park, Sung-Ryeoll;Sung, Gwang Young;Kim, Dong-Jin;Jung, Ji-Hwan;Kim, Jong-Ho
    • Clinics in Shoulder and Elbow
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    • v.20 no.3
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    • pp.117-125
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    • 2017
  • Background: To compare the clinical outcomes of arthroscopic capsular release in patients with and without inferior capsular release for shoulder stiffness. Methods: Between January 2010 and December 2015, 39 patients who underwent arthroscopic capsular release for shoulder stiffness were enrolled and randomized into two groups. In group I, 19 patients underwent arthroscopic capsular release of the rotator interval and anterior capsule. In group II, 20 patients underwent arthroscopic capsular release of the anterior to inferior capsule, including the rotator interval. The American Shoulder and Elbow Surgeons score, Constant scoring system, Simple Shoulder Test, visual analogue scale for pain, and range of motion (ROM) were used for evaluation before surgery, at 3, 6, and 12 months after surgery and on the last follow-up. Results: Preoperative demographic data revealed no significant differences (p>0.05). The average follow-up was 16.07 months. Both groups showed significantly increased ROM at the last follow-up compared with preoperative (p<0.05). At the last follow-up, no statistical differences were found (p>0.05) between groups I and II in functional scores and ROM (forward flexion, p=0.91; side external rotation, p=0.17; abduction external rotation, p=0.72; internal rotation, p=0.61). But we found that group II gained more flexion compared to group I at 3 months and 6 months (p<0.05) after the surgery. Conclusions: Both techniques of capsular release are effective for stiffness shoulder. However, the extended inferior capsular release shows superiority in forward flexion over anterior capsular release alone during 6 months of follows-up (level of evidence: Level I, therapeutic randomized controlled trial).

The Anticaries Activity of Hot Water Extracts from Foeniculum vulgare (회향열수 추출물의 치면 세균막 형성 억제 효과)

  • Kim, Sang-Moo;Choi, Chang-Hyuk;Kim, Jang-Won;Won, Se-Ra;Rhee, Hae-Ik
    • Applied Biological Chemistry
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    • v.51 no.1
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    • pp.84-87
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    • 2008
  • In this research, we screened for glucosyltransferase (GTase) inhibitors that effectively prevent the dental caries from 420 kinds of boiled water extracts of herbs and wild plants and searched for GTase inhibitory activities. Among them, 13 kinds of hot water extracts had high GTase inhibitory activities and especially, we focused on Foeniculum vulgare which showed the highest inhibitory activity on GTase. The boiled water extract of F. vulgare was stable at high temperature and showed as a mixed type of competitive and uncompetitive inhibition kinetic behavior. It did not have antibacterial effect on Streptococcus mutans and had inhibitory activity on GTase. Specially, in the clinical trial, the group treated by boiled water extract of F. vulgare showed more decrease of plague index at 4.8 point than untreated group. These results suggested that boiled water extract of F. vulgare can effectively suppress the plague formation as it inhibits the GTase activity.