• Title/Summary/Keyword: human clinical trial

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Reviewing Research on Laser Therapy of Atopic Dermatitis (아토피 피부염의 레이저 치료에 관한 논문 경향 분석)

  • Cho, Jae-Myung;Hong, Eun-Ju;Seo, Hyung-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.1
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    • pp.82-96
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    • 2013
  • Objective : The purpose of this study is to analyze research trends on the effects of laser therapy on atopic dermatitis. Methods : We searched papers using pubmed, First search used the keyword "Laser Therapy, Low-level and Atopic dermatitis". Inclusion criteria were last 10 years, RCT, Clinical trial, Human. Second search used the keyword "LLLT and Atopic dermatitis". Inclusion criteria were Human. Third search used the keyword "Laser and Atopic dermatitis". Inclusion criteria was the same as first search. Finally we searched papers using the keyword "Laser and Atopic dermatitis" in NDSL and RISS. Papers not matched with inclusion criteria were excluded. Results : A total 20 studies were found, 14 studies were excluded and 6 studies were selected and analyzed. They turned out to be effective and no serious side-effect, but there was mild side-effect in 2 papers out of 4 papers using high-level laser. Conclusions : Low-level laser and high-level laser therapy, both can be effectively used as an alternative to the treatment of atopic dermatitis. Thus further attention and studies are needed on this topic in order to reduce the side effects and demonstrate the effectiveness clearly.

Anti-wrinkle Effect of Cosmetics Containing Duchesnea indica Extract (사매추출물을 함유하는 화장품의 주름 개선 효과)

  • Yang, Woong-Suk;Kim, Young-Min;Kim, Ee-Hwa;Seu, Young-Bae;Yang, Yoon-Jung;Kim, Hyun-Woo;Kang, Se Chan
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.36 no.4
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    • pp.281-288
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    • 2010
  • In this study, we investigated anti-oxidative effects of Duchesnea indica extracts by using Oxygen Radical Absorbance Capacity (ORAC). The extracts were prepared with 0 %, 30 %, 50 %, 70 % and 100 % aqueous ethanol respectively. The 30 % EtOH D. indica extract showed higher ORAC activity than the other extracts. Therefore, we performed in vitro studies on cytotoxicity of NIH-3T3 cells and MMP-8 collagenase inhibition using by the 30 % EtOH extract. The 30 % EtOH extract showed no cytotoxicity and significant inhibition on MMP-8 collagenase. And we performed clinical studies for the anti-wrinkle effect of the Di-Wrinkle Free Cream. The cream formula was prepared with 2 % arbutin and 1 % D. indica extract. Twenty one healthy women volunteers, ages of 35 and 50, applied the cream on their faces twice a day for 8 weeks. The skin was evaluated with PRIMOS (phaseshift rapid in vivo measuring of human skin) system and analyzed by the student's paired t-test. The wrinkles on the eye region were reduced by 13 % based on the PRIMOS system after 8 weeks. In the safety study of the Di-Wrinkle Free Cream, no symptoms were observed such as erythema, edema, scaling, itching, stinging, burning, tightness and prickling by visual observation and medical examination of volunteers for 8 weeks. Moreover, there was no noticeable skin disorder during experience period. These results suggested that D. indica extracts could be applied as cosmeceuticals effective for anti-wrinkle.

Clinical outcomes of three- or five-day treatment with clomiphene citrate combined with gonadotropins and a timed intercourse cycle in polycystic ovary syndrome patients

  • Bae, Sung-Ah;Joo, Jong-Kil;Choi, Jong-Ryeol;Kim, Sun-Suk;Lee, Kyu-Sup
    • Clinical and Experimental Reproductive Medicine
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    • v.42 no.3
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    • pp.106-110
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    • 2015
  • Objective: This study aimed to investigate the effect of a new clomiphene citrate (CC) regimen on preventing thin endometrial lining in polycystic ovary syndrome (PCOS) patients receiving CC plus gonadotropin treatment with a timed intercourse cycle. Methods: A total of 114 women with PCOS were included in this trial. Patients were divided into two groups and treated in accordance with the controlled ovarian stimulation (COS) protocol. In group A, 104 COS cycles in 67 patients were included, and in each cycle 150 mg CC was given for three days, starting from day 3. In group B, 69 COS cycles in 47 patients were included, in which 100 mg CC was given for five days, starting from day 3. The thickness of the endometrium was measured on the day of human chorionic gonadotropin (hCG) injection. Timed intercourse was recommended at 24 and 48 hours after the hCG injection. Results: Additional doses of human menopausal gonadotropin and the number of days of hCG administration were not significantly different between the two groups. Endometrial thickness on the day of hCG administration was significantly larger in group A than group B (4$9.4{\pm}2.1mm$ vs. $8.5{\pm}1.7mm$, p=0.004). The pregnancy rate was significantly higher in group A than in group B (38.4% vs. 21.7%, p=0.030). Conclusion: Three-day CC treatment resulted in a significantly higher pregnancy rate than the standard five-day CC treatment in a timed intercourse cycle in PCOS patients. Facilitating adequate endometrial growth via the early discontinuation of CC might be a crucial factor in achieving a higher pregnancy rate.

Systematic review on the Randomized Controlled Clinical Trials of Qigong in the Korean Journals (국내 기공관련 무작위 임상연구에 대한 현황 검토)

  • Han, Chang-Hyun;Lee, Sang-Nam;Park, Ji-Ha;Ahn, Sang-Woo
    • Korean Journal of Acupuncture
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    • v.26 no.1
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    • pp.27-40
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    • 2009
  • Background : Qigong is an energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although qigong-neither itself nor its postulated mechanism of action-are within the paradigm of modern Western medical science, its effects on the human body could be possible. Objectives : This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Method : The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'qi', 'qigong', 'doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Result : Since the 1990s, Qigong papers in the Korean Literature are increased. The articles on Korean traditional medicine had been published more than those on physical education or nursing etc. However, since the majority of the trials determine questionnaire, it was difficult to determine the efficacy of a specific intervention. The methodological quality of the trials was generally low (Jadad score: mean, 1.3; range, 1 to 4), questioning their reliability. Conclusions : More profound studies for Qigong are needed. Further rigorous clinical trials with more objective outcome measures that include sham procedures should be performed. Specifically, we think it should be clinical studies and qualitative research methods for evaluation are needed.

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Research clinical trends on Gigong(氣功, Qigong) in the Korean Journal (한국(韓國) 저널에 게재(揭載)된 기공관련(氣功關聯) 임상(臨床) 연구(硏究) 동향(動向) 분석(分析) )

  • Han, Chang-Hyun;Lee, Sang-Nam;Kwon, Young-Kyu;Ahn, Sang-Woo;Choi, Sun-Mi
    • Journal of Korean Medical classics
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    • v.21 no.3
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    • pp.297-306
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    • 2008
  • Background : Gigong(氣功, Qigong) is one energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although Gigong(氣功, Qigong) - neither itself nor its postulated mechanism of action - are within the paradigm of modern Western medical science, effects on the human body could be possible. Objectives : This study aims to review the bibliography, biological responses and therapeutic effects of Gigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Method : The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'Gi(氣, Qi)', 'Gigong(氣功, Qigong)', 'Doin(導引)', 'Training', 'Bioenergy', 'life nurturing' and random or Korean language terms related to Gigong. Several specialized journals were also manually searched for relevant articles. Result : Since the 1990's, Gigong papers in the Korean Literature is increased. Clinical research studies are among the most control design study. Research subjects are less patient than the general public. The most common treatment disease was Musculo-skeletal disorder Conclusions : The depth study for the each Gigong(氣功, Qigong) is needed. Specifically, I think it should be a clinical studies and qualitative research methods for evaluation are needed.

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Research Trends on the Clinical Studies of Qigong in the Korean Journal (한국 저널에 게재된 기공관련 대조군 임상연구 현황 분석)

  • Han, Chang-Hyun;Kwon, Young-Kyu;Lee, Sang-Nam;Park, Ji-Ha;Ahn, Sang-Woo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.23 no.2
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    • pp.319-324
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    • 2009
  • Qigong is one energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although qigong -neither itself nor its postulated mechanism of action- are within the paradigm of modern Western medical science, effects on the human body could be possible. This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'qi', 'qigong', 'doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Since the 1990s, Qigong papers in the Korean Literature is increased. Clinical research studies are among the most control design study. Research subjects are less patient than the general public. The most common treatment disease was hypertension. The depth study for the each Qigong is needed. Specifically, I think it should be a clinical studies and qualitative research methods for evaluation are needed.

Comparing Conventional Suture Method Versus Wound Closure Using Tissue Glue(Histoacryl Blue®): a Prospective Randomized Clinical Trial (기존의 창상봉합과 Histoacryl Blue®를 이용한 창상봉합의 비교 분석: 전향적 무작위 임상실험)

  • Choi, Jong Woo;Hyun, Kyung Bae;Kim, Yong Oock;Park, Beyoung Yun
    • Archives of Plastic Surgery
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    • v.32 no.1
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    • pp.19-23
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    • 2005
  • Tissue adhesives have gained popularity for quicker and painless closure of lacerations. The use of tissue glue is currently popular for the closure of superficial lacerations, especially in children. Histoacryl $Blue^{(R)}$(2-N-butylcyanoacrylate) is a topical wound closure that precludes the need for foreign bodies to close wounds. The purpose of this study was to compare the applications of Histoacryl $Blue^{(R)}$(HAB) and conventional suture, regarding cosmetic outcome. To compare the short term and long term results of various repair methods, we designed the prospective, randomized, blind study. Patients with laceration undergoing repair were randomly allocated to conventional suture, subcutaneous suture plus HAB, and HAB only groups. The exclusion criterions were large wound that require large tension for repair or avulsion wound. An independent, blinded observer assessed cosmetic result at 7-10 days after repair and 3-9 months postoperatively. Physician's satisfaction with wound appearance was recorded on 100 mm Visual Analogue Scale(VAS)(0=worst, 100=best). The difference in VAS score between conventional suture method and subcutaneous suture plus HAB methods were not significant. Tissue glue being easy to use with no complications and still resulting in equivalent cosmetic outcomes has several benefits. Especially in the case of children, the wound closure with Histoacryl $Blue^{(R)}$ could be a good alternative for repair of laceration in emergency room.

Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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    • pp.37-48
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    • 2020
  • Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

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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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Effects of Whey Protein-rich Meal Substitute in 4-Week Diet Trial on Body Weight, Body Fat, and Body Composition of Overweight or Obese Females (유청단백 함유 체중조절용 식사대체제를 이용한 4주 다이어트 프로그램이 과체중 및 비만 여성의 체중, 체지방 및 체성분에 미치는 영향)

  • Xi, Mei-Zhu;Zhang, Yi-Lin;Choi, Young-Bin;Jeong, Gi-Hee;Kim, Gun-Woo;Park, Yong-Woo;Lee, Bog-Hieu
    • Journal of the East Asian Society of Dietary Life
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    • v.26 no.1
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    • pp.25-33
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    • 2016
  • The study was performed to investigate the effects of whey protein-rich meal substitute added with vitamins, minerals, and lactobacillus powder probiotics on weight loss, body fat, and body composition in 24 female volunteers for 4 weeks. Whey protein-rich meal substitute was consumed with low-fat, high calcium milk (1% fat, 260 mg/200 mL) twice a day. Subjects submitted 3-day diet records and a life-style questionnaire before the study. During the study, subjects were required to turn in a diet record every day and consume the meal substitute formula in the metabolic ward at C university for 4 weeks. Anthropometric measurements were carried out weekly by Inbody 7.0. The dietary intake and anthropometric data were analyzed to compare changes before and after the study by paired t-test with SPSS version 23.0. The subjects were mostly early 20's and either overweight or obese and highly motivated to lose weight. Most of the subjects consumed three meals per day regularly and spent mostly 10~15 minutes for a meal. Their caloric intake was relatively low and decreased from 1,360 kcal at week 0 to 1,100 kcal after 4 weeks. However, total protein intake increased while carbohydrate and fat intakes decreased (p<0.05) after the trial. Nine vitamin intakes after the study improved compared to those before the study (p<0.05). After the study, subjects showed lower body weight (-1.8 kg), body fat (-0.94 kg), percent body fat (-0.86%), as well as waist circumference (-4.52 cm), hip circumference (-0.44 cm), waist hip ratio (-0.05), and triceps skinfold thickness (-2.39 mm) compared to those at week 0 (p<0.05). Muscle mass tended to be less compared to week 0, although there was no significant differences between weeks 0 and 4. In conclusion, diet trial with whey protein-rich meal substitute induced weight loss and positively changed body fat parameters and body composition.