• 제목/요약/키워드: Clinical trial center

검색결과 697건 처리시간 0.027초

Applicability of Radioguided Occult Lesion Localization for Non-Palpable Benign Breast Lesions, Comparison with Wire Localization, a Clinical Trial

  • Alikhassi, Afsaneh;Saeed, Farzanefar;Abbasi, Mehrshad;Omranipour, Ramesh;Mahmoodzadeh, Habibollah;Najafi, Massoome;Gity, Masoumeh;Kheradmand, Ali
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권7호
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    • pp.3185-3190
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    • 2016
  • Background: This study was designed to compare radioguided versus routine wire localization of nonpalpable non-malignant breast lesions in terms of efficacy for complete excision, ease of use, time saving, and cosmetic outcome. Materials and Methods: Patients with non-palpable breast masses and non-malignant core biopsy results who were candidates for complete surgical lumpectomy were enrolled and randomly assigned to radioguided or wire localization groups. Radiologic, surgical, and pathologic data were collected and analyzed to determine the difficulty and duration of each procedure, ease of use, accuracy, and cosmetic outcomes. Results: This prospective randomized study included 60 patients, randomly divided into wire guided localization (WGL) or radioguided occult lesion localization (ROLL) groups. The mean duration of localization under ultrasound guidance was shorter in the ROLL group (14.4 min) than in the WGL group (16.5 min) (p<0.001). The ROLL method was significantly easier for radiologists (p=0.0001). The mean duration of the surgical procedure was 22.6 min (${\pm}10.3min$) for ROLL and 23.6 min (${\pm}9.6min$) for WGL (p=0.6), a non-significant difference. Radiography of the surgical specimens showed 100% lesion excision with clear margins, as proved by pathologic examination, with both techniques. The surgical specimens were slightly heavier in the ROLL group, but the difference was not significant (p=0.06). Conclusions: The ROLL technique provides effective, fast, and simple localization and excision of non-palpable non-malignant breast lesions.

Fatty Acid Components of Hardy Kiwifruit (Actinidia arguta) as IL-4 Production Inhibitor

  • Park, Hye-Min;Son, Mi-Won;Kim, Dong-Hyun;Kim, Seon-Hee;Kim, Sung-Hoon;Kwon, Hak-Cheol;Kim, Sun-Yeou
    • Biomolecules & Therapeutics
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    • 제19권1호
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    • pp.126-133
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    • 2011
  • The fruit of Actinidia arguta (AA) has been used mainly for the treatment of skin diseases, diuresis, diabetes mellitus and osteoporosis in Korean traditional medicine. It is known that AA (hardy kiwi) fruit extract has an effect on 2-chloro-1,3,5-trinitrobenzene-induced atopic dermatitis-like skin lesions in NC/Nga mice. Mode of action for it is associated with the modulation of biphasic Th1/Th2 cytokines. Furthermore, DA9102 containing AA is a herbal medicine currently under phase II clinical trial for atopic dermatitis in Korea. However, no active principles of AA on the decrease of Th2 cytokines including IL-4 and IL-10 have been identified. In this study, bioactivity-guided fractionation of an alcohol extract from the dried fruits of AA using ELISA assay for IL-4 production led to the isolation of $\alpha$-linolenic acid (I), linoleic acid (II), ethyl linolenate (III), ethyl linoleate (IV) and ethyl stearate (V) as the major active components. These compounds showed the down-regulatory effects of IL-4 production in A23187-stimulated RBL-2H3 cells without cytotoxicity.

Lumbar Spine Kinematics during Anterior and Posterior Pelvic Tilting in Supine and Prone Positions

  • Park, So-Hyun;Yuk, Goon-Chang;Ahn, Sang-Ho;Lee, Dong-Gyu;Choi, Jin-Ho;Oh, Hyun-Ju;Park, Kwan-Yong
    • The Journal of Korean Physical Therapy
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    • 제23권6호
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    • pp.9-14
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    • 2011
  • Purpose: The pelvic tilting exercise is a well recognized rehabilitation maneuver. However, little information is available on the changes of lumbar segmental motion during pelvic tilting. This study was conducted to measure the kinematics of the pelvic tilting exercise on the supine and prone positions via fluoroscopy. Methods: A total of 10 female subjects were enrolled. During anterior, neutral, and posterior pelvic tilting, radiographs were taken in each exercise via fluoroscopy (ARCADIS Orbic, Siemens, USA). Images were sent to the picture archiving communication system (PACS), and the digitized images were analyzed using LabVIEW software (National Instruments, USA). Lumbosacral lordosis and the intervertebral body angle, intervertebral disc angle, and intervertebral displacement were analyzed. Results: The results of lumbar kinematic analysis during three tilting postures in the supine and prone positions demonstrated that lumbosacral lordosis and the intervertebral body angle and intervertebral disc angle were significantly higher when the pelvis was tilted anteriorly (p>0.05). However, there was no significant difference between anterior and neutral tilting in the intervertebral disc angle at the L3/4 level in the prone position (p>0.05), and there was no significant difference among tilting positions in intervertebral body displacement in the prone position (p>0.05). Conclusion: This study provides scientific evidence about the pelvic tilting exercise in lumbosacral segmental motion. Depending on the pelvic tilting exercise, kinematic changes were demonstrated in both positions, especially in the supine position. It is suggested that the supine position is effective for mobility, but it should be used carefully for the LBP (Low back pain) patient with hypermobility.

NEW ANTI-AGING AND ANTI-WRINKLE COSMETIC INGREDIENT : INNER NUTSHELL OF CASTANEA MOLLISIMA BL (CHESTNUT)

  • Kim, Beom-Jun;Kim, Jeong-Ha;Kim, Hyun-Pyo;Heo, Moon-Young
    • 대한화장품학회지
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    • 제24권3호
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    • pp.17-23
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    • 1998
  • Inner nutshell of Castanea mollisima BL (chestnut) has been used as an anti-aging and anti-wrinkle agent from the ancient time in east Asia. In order to develop new anti-aging and anti-wrinkle, ethanolic extract of inner nutshell of Castanea mollisima BL (Cor-285) was prepared and various biological activities were evaluated. Cor-285 showed potent antioxidant activity, Especially, Cor-285 possessed potent free radical scavenging activity in vitro (IC50:7.6 g/ml) compared to gallic acid (IC50:12.5 g/ml), Cor-285 showed the preventive effect against UV-induced cytotoxicity of fibroblast at concentration of 25-250 g/ml. When Cor-285 was evaluated for its anti-allergic activity, it effectively inhibited histamine release from mast cells induced by compound 48/80 (86% inhibition at 10 mg/ml). The inhibitory activity was stronger than that of glycyrrhiznate. Cor-285 also showed in vivo inhibition against delayed hypersensitivity as well as croton-oil induced ear edema in mice when topically applied These results strongly suggest that Cor-285 may reduce immunoregulatory 1 inflammatory skin trouble. From the attempts to isolate the constituents, citropten (simple coumarin) and ellagic acid, a well known radical scavenger, were isolated. In a clinical trial of twenty healthy volunteers with aged skin,6 weeks application of Cor-285 (3% cream) decreased wrinkle about 26% and increased moisturizing 20% on the skin. All of these results indicate that Cor-285 may be an effective anti-aging and anti-wrinkle agent.

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Comparison of pain intensity of anterior middle superior alveolar injection with infiltration anesthetic technique in maxillary periodontal surge

  • Shirmohammadi, Adileh;Faramarzi, Masoumeh;Lafzi, Ardeshir;Kashefimehr, Atabak;Malek, Sepideh
    • Journal of Periodontal and Implant Science
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    • 제42권2호
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    • pp.45-49
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    • 2012
  • Purpose: The aim of the present clinical trial was to compare pain during injection of anterior middle superior alveolar (AMSA) technique with that of infiltration injection technique in the maxilla in periodontal flap surgeries of patients referring to the Department of Periodontics, Faculty of Dentistry, Tabriz University of Medical Sciences. Methods: Twenty subjects with an age range of 20 to 40 years were selected for the present study. One side of the maxilla was randomly selected as the test side and the other as the control side using a flip of a coin. AMSA technique was used on the test side and infiltration technique was used on the control side for anesthesia. On both sides 2% lidocaine containing 1:80,000 epinephrine was used for anesthesia. The operator obtained the visual analogue scale for each patient immediately after the injection and immediately after surgery. Data was analyzed using descriptive statistical methods (frequency percentages, means and standard deviations) and Wilcoxon's test using SPSS ver. 13 (SPSS Inc.). Statistical significance was defined at P<0.05. Results: There were no statistically significant differences in pain during injection between the two techniques (P=0.856). There were statistically significant differences in postoperative pain between the two injection techniques (P=0.024). Conclusions: Postoperative pain in AMSA injection technique was less than that in the infiltration technique. Therefore, the AMSA technique is preferable in the periodontal surgeries for the anesthesia of palatal tissues given the fact that it has other advantages, too.

후반고리관 양성돌발두위현훈의 치료에서 재평가 시기에 대한 피로 현상의 영향 (Influence of Fatigability on the Timing of Reassessment in the Treatment of Posterior Canal Benign Paroxysmal Positional Vertigo)

  • 김창희;신정은;신용국;송미현;심대보
    • Korean Journal of Otorhinolaryngology-Head and Neck Surgery
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    • 제61권12호
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    • pp.658-662
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    • 2018
  • Background and Objectives The early assessment of treatment is not done for benign paroxysmal positional vertigo (BPPV) since the well-known phenomenon of fatigability after a repeated positional test can mimic successful treatment. The aim of this study is to evaluate the clinical implication of 'fatigability' after Epley maneuver and to identify the therapeutic efficacy of Epley maneuver in posterior canal BPPV (PC-BPPV). Subjects and Method This study was prospectively conducted by two dizziness clinics on 51 consecutive patients diagnosed with PC-BPPV. All patients included in the study received Epley maneuver treatment. The therapeutic results were reassessed immediately after a single trial of Epley maneuver. After 30 minutes, results were reassessed repeatedly to confirm the fatigability of diagnostic procedure immediately after treatment. If the treatment was not successful after 30 minutes, Epley maneuver was repeatedly performed until complete resolution. Results Immediately after the first maneuver, 45 of 51 (88.2%) patients had neither vertigo nor nystagmus during the positional test. All patients demonstrated complete resolution after receiving one to three Epley maneuvers on the day of diagnosis. 'Fatigability (false negative result)' was confirmed for only one case (1 of 6 patients, 16.7%), in which nystagmus was observed after 30 minutes but not identified immediately after the first Epley maneuver. Conclusion The therapeutic efficacy of Epley maneuver is very high in PC-BPPV. Considering the possibility of fatigability when reassessment is performed immediately after therapeutic maneuver, clinicians should avoid assessing the outcome immediately after treatment in patients with PC-BPPV.

The Effects of Myrtle (Myrtus communis) and Clindamycin Topical Solution in the Treatment of Mild to Moderate Acne Vulgaris: A Comparative Split-Face Study

  • Salmanian, Mahboobeh;Shirbeigi, Laila;Hashem-Dabaghian, Fataneh;Mansouri, Parvin;Azizkhani, Mohammad;Alavi, Shiva;Ghobadi, Ali
    • 대한약침학회지
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    • 제23권4호
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    • pp.220-229
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    • 2020
  • Objectives: Although Acne vulgaris is a chronic skin disease, which its standard treatment causes therapeutic limitations and some common adverse effects, medicinal plants can be effective in treatment with low adverse effects as combination therapy. Myrtle (Myrtus Communis) has some beneficial properties, which has been administered topically and orally for some skin diseases in Persian medicine. This study aimed to compare the efficacy and safety of Myrtle formula and 1% clindamycin topical solution. Methods: This was a split-face clinical trial that was done on 55 patients with mild to moderate acne vulgaris for 16 weeks. The patients received topical Myrtle solution to the right side of the face (group 1) and clindamycin solution to the left side (group 2) twice daily for 12 weeks. All participants were examined for the acne severity index (ASI) and total acne lesions counting (TLC) at certain times during the study. Then, they stopped using them for four weeks. They also did not take the drug in the final four weeks of the study. Results: Forty-eight patients completed the study for 16 weeks; 40 (83.2%) patients were female and the rest of them were male. The mean age and standard deviation were 25.62 ± 7.62 years. After 12 weeks, the percentage changes of comedones, inflammatory lesions, ASI and TLC were significantly reduced in both groups (p < 0.001). The percentage change of inflammatory lesions and ASI decrease was significantly higher in the group 1 (p = 0.03). There was no significant difference in the incidence of side effects between the two groups. There was a more significant decrease in sebum percentage change in the group 1 (p = 0.003). Conclusion: Myrtle lotion was effective and safe for the treatment of mild to moderate acne vulgaris.

VR 콘텐츠를 이용한 신체검사 개발 및 사용자 만족도 연구 (A Study on the Development of Physical Examination with VR Content and User Satisfaction)

  • 안호원;김준민
    • 한국콘텐츠학회논문지
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    • 제21권6호
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    • pp.318-326
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    • 2021
  • 본 연구는 고령화 및 저출산에 따라 보건의료분야의 만성질환의 증가 및 전문 인력부족 등의 문제를 해결하고 효율적인 헬스케어를 제공하고자 VR 콘텐츠를 이용한 신체검사의 효과성을 연구하였다. 이에 본 연구는 HTC VIVE Pro VR과 스틱 컨트롤러를 착용하여 원스톱 VR 콘텐츠 신체검사 시스템을 구현하였다. 시스템은 1단계부터 5단계까지이며, 색각테스트, 기억력테스트, 청력테스트, 반응속도테스트, 순간인지능력테스트의 5단계를 순차적으로 거쳐 최종 신체 나이를 판별하는 솔루션으로 구성된다.또한 본 연구가 개발한 원스톱 VR 콘텐츠 신체검사 시스템에 대해 대전 소재 A 상급종합병원 건강검진센터 및 VR/AR 임상시험 센터에 내원한 정상인을 대상으로 사용자 만족도를 검증한 결과, 전체적인 만족도와 재이용의사가 높게 나타났고, 성별에 따라 5단계 순간인지테스트는 유의한 차이가 있었으며, 연령에 따라서 4단계 반응속도테스트, 5단계 순간인지테스트에서 유의한 차이가 나타났다.

Low-level Laser Therapy with Novel Array of Light Source and Individualized Program for Treatment of Androgenetic Alopecia: A 16-week, Randomized, Double-blind, Sham Device-controlled Study

  • Kim, Jee-Woo;Kwon, Yeo-Seon;Chang, Yoon-Young;Hong, Sung-Ho;Shin, Jung-Won;Na, Jung-Im;Huh, Chang-Hun
    • Medical Lasers
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    • 제9권2호
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    • pp.150-158
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    • 2020
  • Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm2 at eight weeks and 13.67 counts/cm2 at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

Breakthroughs in the Systemic Treatment of HER2-Positive Advanced/Metastatic Gastric Cancer: From Singlet Chemotherapy to Triple Combination

  • Sun Young Rha;Hyun Cheol Chung
    • Journal of Gastric Cancer
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    • 제23권1호
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    • pp.224-249
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    • 2023
  • Gastric cancer is heterogeneous in morphology, biology, genomics, and treatment response. Alterations in human epidermal growth factor receptor 2 (HER2) overexpression, microsatellite instability (MSI) status, programmed death-ligand 1 (PD-L1) levels, and fibroblast growth factor receptor 2 (FGFR2) can be used as biomarkers. Since the combination of fluoropyrimidine/platinum plus trastuzumab that was investigated in the ToGA trial was approved as a standard of care in HER2-positive patients in 2010, no other agents showed efficacy in the first- (HELOISE, LOGiC, JACOB trials) and second- (TyTAN, GATSBY, T-ACT trials) line treatments. Despite the success in treating breast cancer, various anti-HER2 agents, including a monoclonal antibody (pertuzumab), an antibody-drug conjugate (ADC; trastuzumab emtansine [T-DM1]), and a small molecule (lapatinib) failed to translate into clinical benefits until the KEYNOTE-811 (first-line) and DESTINY-Gastri01 (≥second-line) trials were conducted. The incorporation of HER2-directed treatment with immune checkpoint inhibitors in the form of a monoclonal antibody or ADC is now approved as a standard treatment. Despite the promising results of new agents (engineered monoclonal antibodies, bi-specific antibodies, fusion proteins, and small molecules) in the early phase of development, the management of HER2-positive gastric cancer requires further optimization to achieve precision medicine with a chemotherapeutic backbone. Treatment resistance is a complex process that can be overcome using a combination of chemotherapy, targeted agents, and immune checkpoint inhibitors, including novel agents. HER2 status must be reassessed in patients undergoing anti-HER2 treatment with disease progression after the first-line treatment. As a general guideline, patients who need systemic treatment should receive chemotherapy plus targeted agents, anti-angiogenic agents, immune checkpoint inhibitors, or their combinations.