• Title/Summary/Keyword: Clinical Trial Design

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The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
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    • v.14 no.4
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    • pp.322-333
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    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • v.23 no.6
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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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.

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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Comparison of Dental Biofilm Reduction between Rolling Method and Modified Stillman Method (회전법과 변형스틸맨법의 치면세균막 감소 효과 비교)

  • Han, Ye-Seul;Lim, Soon-Ryun;Cho, Young-Sik
    • Journal of dental hygiene science
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    • v.12 no.6
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    • pp.660-665
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    • 2012
  • The purpose of this study was to use basic data of dental hygiene curriculum by comparing the rolling method and modified stillman method. Plaque measurement method, Q-ray examination of the clinical utilization value shall review. True experimental design is randomized controlled trial to the intervention group and the control group. Measurements are plaque control record (PCR; O'Leary index) measurements and Quantitative Light induced fluorescnece Digital (QLFD) shooting as a pre-test was conducted. Intervention group is modified stillman method, control group is rolling method. Intervention after 5 weeks, PCR measurement and QLFD shooting was carried out as a post-test. Rolling method and modified stillman method plaque reduction did not differ. Intervention before and after the results of the comparison showed reduced plaque score after brushing law education. Also, Plaque reduction differences were more pronounced modified stillman method than rolling method. PCR and QLFD values of the correlation was not confirmed but SPS Score and the lower value of the ${\Delta}R$ value of the correlation. Plaque of maturity tooth that are not observed visually.

Incidence of postoperative pain after using single continuous, single reciprocating, and full sequence continuous rotary file system: a prospective randomized clinical trial

  • Umesh Kumar;Pragnesh Parmar;Ruchi Vashisht;Namita Tandon;Charan Kamal Kaur
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.23 no.2
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    • pp.91-99
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    • 2023
  • Background: Extrusion of debris is a major factor that results in postoperative pain during root canal treatment with various instruments and instrumentation techniques. Therefore, instrumentation techniques that extrude minimal debris into the periapical area while reducing pain are desirable. This study aimed to compare the incidence of postoperative pain and intake of analgesic medication (frequency and quantity) after endodontic treatment of mandibular posterior teeth using two single files and full-sequence continuous rotary systems with different kinematic motions. Methods: Thirty-five of 105 patients were assigned equally to three groups according to the instrumentation system used: ProTaper Next (PN) X2, 25/06 (Dentsply, Maillefer, Ballaigues, Switzerland), One Shape (OS), #0.25/06 (Micro Mega, Besancon, France), and Wave One Gold (WG), Red - #0.25, 0.07 (Dentsply, Maillefer, Ballaigues, Switzerland). Five specialists were included in this study design; each professional prepared 21 teeth, and randomly selected 7 per instrument system. The VAS sheet ranging from 0 to 10 was used to record the initial and postoperative pains at 24, 48, and 72 h, and 7th day after single visit endodontic treatment in mandibular premolars and molars with a diagnosis of asymptomatic irreversible pulpitis with or without apical periodontitis. Postoperatively, an analgesic, ibuprofen 400 mg was administered for intolerable pain at a dose of 1 tablet for 6 h. The patients were asked over the telephone regarding postoperative pain at intervals of 24, 48, and 72 h, and 7th day using a visual analogue scale. Result: There were no statistically significant differences among the PN, OS, and WG systems (P > 0.05) with regard to the incidence of postoperative pain at any of the four time points assessed. Conclusion: The intensity of postoperative pain, frequency, and analgesic intake were similar across all three types of instrument systems; however, the reciprocating single file (WG) was associated with less postoperative pain than the full sequence continuous rotary file.

Dosimetric Analysis of a Phase I Study of PSMA-Targeting Radiopharmaceutical Therapy With [177Lu]Ludotadipep in Patients With Metastatic Castration-Resistant Prostate Cancer

  • Seunggyun Ha;Joo Hyun O;Chansoo Park;Sun Ha Boo;Ie Ryung Yoo;Hyong Woo Moon;Dae Yoon Chi;Ji Youl Lee
    • Korean Journal of Radiology
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    • v.25 no.2
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    • pp.179-188
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    • 2024
  • Objective: 177Lutetium [Lu] Ludotadipep is a novel prostate-specific membrane antigen targeting therapeutic agent with an albumin motif added to increase uptake in the tumors. We assessed the biodistribution and dosimetry of [177Lu]Ludotadipep in patients with metastatic castration-resistant prostate cancer (mCRPC). Materials and Methods: Data from 25 patients (median age, 73 years; range, 60-90) with mCRPC from a phase I study with activity escalation design of single administration of [177Lu]Ludotadipep (1.85, 2.78, 3.70, 4.63, and 5.55 GBq) were assessed. Activity in the salivary glands, lungs, liver, kidneys, and spleen was estimated from whole-body scan and abdominal SPECT/CT images acquired at 2, 24, 48, 72, and 168 h after administration of [177Lu]Ludotadipep. Red marrow activity was calculated from blood samples obtained at 3, 10, 30, 60, and 180 min, and at 24, 48, and 72 h after administration. Organand tumor-based absorbed dose calculations were performed using IDAC-Dose 2.1. Results: Absorbed dose coefficient (mean ± standard deviation) of normal organs was 1.17 ± 0.81 Gy/GBq for salivary glands, 0.05 ± 0.02 Gy/GBq for lungs, 0.14 ± 0.06 Gy/GBq for liver, 0.77 ± 0.28 Gy/GBq for kidneys, 0.12 ± 0.06 Gy/GBq for spleen, and 0.07 ± 0.02 Gy/GBq for red marrow. The absorbed dose coefficient of the tumors was 10.43 ± 7.77 Gy/GBq. Conclusion: [177Lu]Ludotadipep is expected to be safe at the dose of 3.7 GBq times 6 cycles planned for a phase II clinical trial with kidneys and bone marrow being the critical organs, and shows a high tumor absorbed dose.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

3D analysis of soft tissue around implant after flap folding suture (Flap folding suture를 활용한 판막의 고정에 따른 임플란트 주변 연조직 3차원 부피 변화 관찰)

  • Jung, Sae-Young;Kang, Dae-Young;Shin, Hyun-Seung;Park, Jung-Chul
    • Journal of Dental Rehabilitation and Applied Science
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    • v.37 no.3
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    • pp.130-137
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    • 2021
  • Purpose: The various suture techniques can be utilized in order to maximize the keratinized tissue healing around dental implants. The aim of this study is to compare the soft tissue healing pattern between two different suture techniques after implant placement. Materials and Methods: 15 patients with 18 implants were enrolled in this study. Simple implant placement without any additional bone graft was performed. Two different suture techniques were used to tug in the mobilized flap near the healing abutment after paramarginal flap design. Digital intraoral scan was performed at baseline, post-operation, stitch out, and 3 months after operation. The scan data were aligned using multiple points such as cusp, fossa of adjacent teeth, and/or healing abutment. After subtracting scan data at baseline with other time-point results, closed space indicating volume increment of peri-implant mucosa was selected. The volume of the close space was measured in mm3. The volume between two suture techniques at three time-points was compared using nonparametric rank-based analysis. Results: Healing was uneventful in both groups. Both suture technique groups showed increased soft tissue volume immediately after surgery. The amount of volume increment significantly decreased after 3 months (P < 0.001). Flap folding suture group showed higher median of volume increment than interrupted suture group after 3 months without any statistical significance (P > 0.05). Conclusion: After paramarginal flap reflection, the raised flaps stabilized by flap folding suture showed relatively higher volume maintenance after 3-month healing period. However, further studies are warranted.