• 제목/요약/키워드: Non-clinical trial

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Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
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    • 제36권1호
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    • pp.17-24
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    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

스테로이드 반응성 신증후군 환아에서 23-valent pneumococcal polysaccharide vaccine의 예방효과 (Efficacy of 23-valent Pneumococcal Polysaccharide Vaccine in Steroid Responsive Nephrotic Syndrome)

  • 한혜원;하일수;정해일;이환종;최용
    • Childhood Kidney Diseases
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    • 제6권1호
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    • pp.56-60
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    • 2002
  • Streptococcus pneumoniae(폐렴구균)는 소아에서 심각한 질별을 초래하는 주 원인 중의 하나이며, 면역결핍이나 만성 질환을 동반한 환아에서는 낮은 항체가로 인해 침습적 감염의 위험이 더욱 크다. 신증후군 환아에서도 폐렴구균은 중요한 병인균의 하나로, 특히 원발성 복막염의 주요한 원인균이다. 최근까지 23가의 polysaccharide pneumococcal vaccine이 복막염 예방 목적으로 추천되어 왔으나, 새로이 7가의 conjugate vaccine이 소개되면서 신증후군 환아에서 폐렴구균 예방접종의 정립이 필요하다고 생각되어, 현재까지 접종받은 환아들의 의무 기록을 검토하였다. 1980년 이후 20년간 23가의 polysaccharide pneumococcal vaccine을 접종 받은 2세에서 18세 사이의 55명의 환아들을 평균 38.5개월 간 추적 관찰하였다. 폐렴구균에 의한 복막염은 발생하지 않아 임상적으로 효과가 있는 것으로 생각되며, 향후로 conjugate vaccine이 국내에서 상용화되기 전까지 병용하여도 안전할 것으로 생각된다.

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누에생실샘 미세분말을 이용한 베이비파우더 소재 개발에 대한 연구 (A Study on the Development of Baby Powder Using Silk gland Powder of Silkworm)

  • 전정우;권해용;조유영;류강선;이광길;여주홍;강필돈;남성희;박광영;김미자;박명기;손용호;김성현;김상규;임성빈;최병훈;하수연;이희삼
    • 한국잠사곤충학회지
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    • 제50권1호
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    • pp.20-26
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    • 2012
  • In this study, silk gland powder of silkworm were investigated to see the possibility for baby powder cosmetics materials. To test possibility as a baby powder cosmetics, total content rate of amino acids, DPPH free radical scavenging assay, MTT assay, and clinical trial were done. According to the result of the analysis of the amino acids of silk gland powder, serin (26.77%) content was the highest and asparatic acid (15.47%), and glycine (9.62%) were followed. DPPH free radical scavenging activity of silk gland powder was lower than vitamin C by 82.3% and 97%, respectively, which is relatively good. Moisture effect were increased in silk gland powder compared to control cosmetics by 50%. Also, silk gland powder was classified as a practically non-irritating material based on the score 0.05 of primary irritation index. Thus, these results suggest that silk gland powder of silkworm may have beneficial properties as a material for baby powder cosmetics.

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

  • Shin, Dong-Seong;Carroll, Christopher P.;Elghareeb, Mohammed;Hoh, Brian L.;Kim, Bum-Tae
    • Journal of Korean Neurosurgical Society
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    • 제63권2호
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    • pp.137-152
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    • 2020
  • In spite of the developing endovascular era, large (15-25 mm) and giant (>25 mm) wide-neck cerebral aneurysms remained technically challenging. Intracranial flow-diverting stents (FDS) were developed to address these challenges by targeting aneurysm hemodynamics to promote aneurysm occlusion. In 2011, the first FDS approved for use in the United States market. Shortly thereafter, the Pipeline of Uncoilable or Failed Aneurysms (PUFS) study was published demonstrating high efficacy and a similar complication profile to other intracranial stents. The initial FDA instructions for use (IFU) limited its use to patients 22 years old or older with wide-necked large or giant aneurysms of the internal carotid artery (ICA) from the petrous segment to superior hypophyseal artery/ophthalmic segment. Expanded IFU was tested in the Prospective Study on Embolization of Intracranial Aneurysms with PipelineTM Embolization Device (PREMIER) trial. With further post-approval clinical data, the United States FDA expanded the IFU to include patients with small or medium, wide-necked saccular or fusiform aneurysms from the petrous ICA to the ICA terminus. However, IFU is more restrictive in South Korea than in United States. Several systematic reviews and meta-analyses have sought to evaluate the overall efficacy of FDS for the treatment of cerebral aneurysms and consistently identify FDS as an effective technique for the treatment of aneurysms broadly with complication rates similar to other traditional techniques. A growing body of literature has demonstrated high efficacy of FDS for small aneurysms; distal artery aneurysms; non-saccular aneurysms posterior circulation aneurysms and complication rates similar to traditional techniques. In the short interval since the Pipeline Embolization Device was first introduced, FDS has been firmly entrenched as a powerful tool in the endovascular armamentarium. As new FDS are developed, established FDS are refined, and delivery systems are improved the uses for FDS will only expand further. Researchers continue to work to optimize the mechanical characteristics of the FDS themselves, aiming to optimize deploy ability and efficacy. With expanded use for small to medium aneurysms and posterior circulation aneurysms, FDS technology is firmly entrenched as a powerful tool to treat challenging aneurysms, both primarily and as an adjunct to coil embolization. With the aforementioned advances, the ease of FDS deployment will improve and complication rates will be further minimized. This will only further establish FDS deployment as a key strategy in the treatment of cerebral aneurysms.

한국청소년에서 자가비만인식도와 정신건강과의 관련성 (Association with Self-Perception for Obesity and Mental Health among Korean Adolescent)

  • 황인철;이경식;박동균;정은영;최충현;조성진;배승민
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • 제22권2호
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    • pp.112-119
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    • 2011
  • Objectives : Obesity has been linked to various psychological problems as well as medical complications, especially among adolescents. Previous studies have suggested an association between body weight and depression or self-esteem ; however, there has been little evidence on self-perception of weight and mental health. The aim of this study was to examine the association of perceptional weight status with mental health in Korean adolescents. Methods : This study was based on data obtained from the third Korean National Health and Nutritional Examination Survey (2005). The study sample consisted of 583 adolescents (268 boys, 315 girls) aged 12-18 years, who had completed the health survey, the health examination, and the nutritional survey. Participants were divided into two groups based on the actual or perceptional weight status: non-obese and obese. Questionnaires for stress, depressive mood, and suicidal thoughts were utilized as mental health indicators. Results : The agreement between actual and perceptional weight status was moderate (k value, 0.585 ; p<0.01). The influencing factors for the discrepancy between actual and perceptional weight status were body mass index of subjects and their parents' education. The obese group was likely to have higher stress levels and more experience of depressive mood or suicidal ideation in regard to both actual and perceptional weight status. A multiple logistic regression analysis revealed that girls who had perceived themselves as obese were more likely to have an experience of depressive mood than other girls (unadjusted OR, 4.98 ; adjusted OR, 5.15). Conclusion : An experience of depressive mood was significantly associated with the perception of weight status and not actual weight status in Korean female adolescents.

Polydeoxyribonucleotide Improves Peripheral Tissue Oxygenation and Accelerates Angiogenesis in Diabetic Foot Ulcers

  • Kim, Seoyoung;Kim, Junhyung;Choi, Jaehoon;Jeong, Woonhyeok;Kwon, Sunyoung
    • Archives of Plastic Surgery
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    • 제44권6호
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    • pp.482-489
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    • 2017
  • Background Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers. Methods This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension ($TcPO_2$) was evaluated using the Periflux System 5000 with $TcPO_2/CO_2$ unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated. Results Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient. Conclusions In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.

생리, 약학적 관점에서 fibroblast growth factor 21 (FGF21)의 대사 효과 고찰 (The Metabolic Effects of FGF21: From Physiology to Pharmacology)

  • 송박용
    • 생명과학회지
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    • 제30권7호
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    • pp.640-650
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    • 2020
  • 간, 췌장 및 지방 조직에서 많은 수준으로 합성되는 섬유 아세포 성장 인자 21(FGF21)은 FGF19과 FGF23와 함께 FGF 패밀리의 비정형 구성원에 속해 있다. FGF21은 발현 조직에 따라 endo/paracrine특징을 보여주며, 포도당 대사 및 에너지 항상성을 포함하는 많은 종류의 대사 경로를 조절하고 있다. 생리학적 조건 하에서 많은 종류의 스트레스가 조직 별 FGF21의 합성을 유도한다고 알려져 있고, 이렇게 증가한 FGF21은 위와 같은 스트레스에 적응하거나 방어하기 위한 세포 내 기전을 활성화 시키게 된다. 이 과정에서 peroxisome proliferator-activated receptor gamma (PPARγ) 및 peroxisome proliferator-activated receptor alpha (PPARα)가 지방 및 간 조직에서 FGF21의 발현을 조절하는 대표적인 전사 조절자로 알려져 있다. 지난 10년간의 연구를 통해 약리학적 FGF21 투여는 체중을 감소시키고 비만 마우스 및 2 형 당뇨병 환자에서 인슐린 감수성 및 지단백질 프로파일을 개선시키는 것으로 보고되었고, 이를 바탕으로 FGF21은 제 2 형 당뇨병, 비만 및 비 알콜 성 지방간 질환(NAFLD)의 치료제로서 큰 주목을 받아 왔다. 그러나 조직 별 상이한 FGF21 발현의 역설적 조건 및 생리 약학적 기능의 차이로 인해 FGF21의 이해는 여전히 부족한 수준에 있다. 따라서 본 총설을 통해 FGF21의 조직 특정 기능 및 해당 동작 메커니즘을 포함한 이전 연구들에서 발생하였던 흥미로운 문제를 논의하고, FGF21 아날로그를 이용한 임상 시험의 현 상황을 요약하고자 한다.

적응 요인에 따른 보조부화술 (Assited Hatching, AH)의 효과 (The Effects of Assisted Hatching (AH) According to the Indications)

  • 김지수;강승호;권윤정;손인표;최규완;김수경;전한식;이제규;이승재;박종민
    • Clinical and Experimental Reproductive Medicine
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    • 제25권2호
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    • pp.123-128
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    • 1998
  • Implantation rates remain low following human in vitro fertilization (IVF). Suboptimal culture conditions may limit the ability of embryos to hatch as blastocysts, and artificial opening of the zona pellucida has been proposed as a means to promote subsequent hatching (assisted hatching). In this study, assisted hatching (AH) by zona drilling using acidic Tyrode's solution was performed in 320 patients, due to their age of more than 38 years (group A), the thick zona pellucida (group Z; $ZP\geq0.18{\mu}m$), and failures in implantation more than 3 times in previous IVF-ET trial (group P). This study was designed firstly, to study the effects of AH on the outcomes of IVF-ET according to the indications and secondly, to verify the appropriate application of AH. The results were as follows; 1. There was no difference in pregnancy rate between AH group (26.6%) and non-AH group (26.5%). 2. Assisted hatching (AH) showed significantly higher pregnancy rate of the patients with thick zona pellucid a than those of the patients with age factor and with the history of repeated implantation failure. But in the patients with age factor only, AH resulted in higher pregnancy rate. 3. Interestingly, the patients with complex factors including zona factor (Z: 33.9%; ZA: 30.4%; ZP: 31.6%; ZAP: 21.4%) showed higher pregnancy rates than other complex factors excluding zona factor (A: 24.4%, P: 0%; AP: 10.8%). From these results, AH is more helpful to the patients with thick zona pellucida rather than patients with older age and/or previous repeated implantation failure.

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Study on Application of Skin Care Cosmetic and Stabilization of Idebenone by Forming Niosome Vesicle Technology

  • Kim, In-Young
    • 한국응용과학기술학회지
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    • 제36권2호
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    • pp.592-599
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    • 2019
  • This study is to stabilize insoluble and unstable active ingredient which is Idebenone (INCI name: hydroxydecyl ubiquinone) in a multi-lamellar vesicle (MLV) and to stabilize it in the skin care cosmetics. Idebenone is good effective raw material in the treatment of Alzheimer's disease in the medical field and a powerful antioxidant in dermatology. It is well known as a substance that inhibits the formation of melanin and cleans the skin pigment. However, it did not dissolve in any solvent and it was difficult to apply in cosmetic applications. Niosome vesicle was able to develop a nano-particle by making a multi-layer of idebenone encapsulated with a nonionic surfactant, hydrogenated lecithin and glycine soja (soybean) sterols and passing it through a high pressure microfluidizer. Idebenone niosome vesicle (INV) has been developed to have the ability to dissolve transparently in water and to promote transdermal penetration. The appearance of the INV was a yellowish liquid having specific odor, and the particle size distribution of INV was about 10~80 nm. The pH was 5~8 (mean=6.8). This capsulation with idebenone was stored in a $45^{\circ}C$ incubator for 3 months and its stability was observed and quantitatively measured by HPLC. As a result, the stability of the sample encapsulated in the niosome vesicle (97.5%) was about 66.3% higher than that of the non-capsule sample of 32.5%. Idebenone 1% INV was used for the efficacy test and clinical trial evaluation as follows. The anti-oxidative activity of INV was 38.2%, which was superior to that of 12.8% tocopherol (control). The melanin-reducing effect of B16 melanoma cells was better than INV (17.4%) and Albutin (control) (9.6%). Pro-collagen synthesis rate was 128.2% for INV and 89.3% for tocopherol (control). The skin moisturizing effect was 15.5% better than the placebo sample. The elasticity effect was 9.7% better than the placebo sample. As an application field, INV containing 1% of idebenone is expected to be able to develop various functional cosmetic formulations such as skin toner, ampoule essence, cream, eye cream and sunblock cream. In addition, it is expected that this encapsulated material will be widely applicable to emulsifying agents for skin use in the pharmaceutical industry as well as the cosmetics industry.

Orthodontic pain control following arch wire placement; a comparison between pre-emptive tenoxicam and chewing gum: a randomized clinical trial

  • Basam, Lakshman Chowdary;Singaraju, Gowri Sankar;Obili, Sobitha;Keerthipati, Thejasree;Basam, Ram Chowdary;Prasad, Mandava
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권2호
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    • pp.107-116
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    • 2022
  • Background: Pain during fixed orthodontic treatment can have a detrimental effect on patient treatment compliance. To overcome this, there is a definite need to establish the best pain-relieving methods suitable for orthodontic patients in terms of efficacy and use. The objective of this study was to compare the effect of chewing gum and pre-emptive tenoxicam on pain after initial archwire placement and to evaluate the pain perceptions of orthodontic patients in the two groups while performing various functions at specific time intervals. Methods: Forty-two patients were selected and randomly divided into two groups: group A (chewing gum) and group B (pre-emptive tenoxicam). Pain perception was documented by patients immediately; at 4 h; at bedtime on the day of archwire placement; the next morning; at 24 h; and at bedtime on the 2nd, 3rd, and 7th day after the initial archwire placement. Pain scores were noted during fitting of the posterior teeth, biting, and chewing using a visual analog scale. The data obtained were subjected to statistical analysis. Results: Group A showed a significant increase in pain until the next morning while fitting the posterior teeth, biting, and chewing [36.2, 52.0, 33.4, respectively]], followed by a gradual decrease by the 7th day. Group B showed a significant increase in pain at bedtime on biting, with a peak value of 47.5. Pain on chewing, fitting posterior teeth, peaked the morning of the next day (100.0, 45.0). The Freidman test showed a statistically significant difference with a p-value of < 0.01. Higher pain scores were observed while chewing and biting compared with that while fitting the posterior teeth in both groups. The overall comparison of pain control between the two groups was not statistically significant [P > 0.05] between the two groups. Conclusions: Chewing gum was not inferior to pre-emptive tenoxicam. Thus, chewing gum is a non-pharmacological alternative to analgesics for orthodontic pain control that eliminates the chance of adverse reactions and can be used in the absence of adult observation.