• Title/Summary/Keyword: IRB

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The efficacy evaluation of $PostPlant^{TM}$ Calcium in dental implant placement (임플란트 식립 환자의 $PostPlant^{TM}$ Calcium 투여 효과에 대한 임상연구)

  • Choi, Yu-Sung;Kim, Eun-Kyung;Kim, Se-Won;Cho, In-Ho
    • The Journal of Korean Academy of Prosthodontics
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    • v.48 no.2
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    • pp.128-134
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    • 2010
  • Purpose: The aim of this study was to evaluate the changes in bone density and reduction of time consumed for osteogenesis by $PostPlant^{TM}$ Calcium and to find out efficacy of $PostPlant^{TM}$ Calcium by comparing the group prescribed with $PostPlant^{TM}$ Calcium with the group without $PostPlant^{TM}$ Calcium prescription. Material and methods: The experimental group of 18 patients with 25 dental implant placement and the control group of 7 patients with 9 dental implant placement were randomly selected from the patients who visited prosthetic department of Dankook University Dental Hospital since July, 2006 (IRB Number ; 20060710). The experimental group was instructed to take $PostPlant^{TM}$ Calcium for 6 months after the implant surgery while the control group was instructed not to. Both experimental and control group were assigned for measurement using $Osstell^{TM}$ Mentor and $Periotest^{(R)}$ and radiographic examination was performed using specifically manufactured Aluminum Step Wedge. The results were compared and analyzed. Results: 1. According to the $Osstell^{TM}$ Mentor measurement, both the experimental and control group showed increase in values as time elapses and the experimental group showed significantly higher rate of increase (P < .05). 2. According to the $Periotest^{(R)}$ measurement, both the experimental and control group showed decrease in values as time elapses. In addition, greater decrease can be seen in the experimental group but no statistical significance was found. 3. By examining the radiographic images, both the experimental and control group showed tendency of increase in bone density. In addition, greater increase can be seen in the experimental group but no statistical significance was found. Conclusion: Clinically, taking $PostPlant^{TM}$ Calcium medicine for a long period of time after implant placement is expected for a better prognosis.

Superior Labral Dimension of the Glenohumeral Joint on Direct MR Arthrography (MRA): Relationship with Presence of SLAP (Superior Labrum Anterior to Posterior) Lesion (직접 자기공명 견관절 조영술 상에서 상부 관절순의 크기: 상부 관절순 전후방 파열과의 관계)

  • Im, Tae Seong;Choi, Jung-Ah;Oh, Joo Han
    • Investigative Magnetic Resonance Imaging
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    • v.18 no.3
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    • pp.193-199
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    • 2014
  • Purpose : To evaluate the relationship between superior labral dimension of the glenohumeral joint on direct MRA and presence of SLAP lesion. Materials and Methods: IRB approval was obtained and informed consent was waived for this retrospective study. Direct MRA studies of the shoulder in 296 patients (300 shoulders) with arthroscopic surgery were analyzed by two radiologists blinded to the arthroscopic results, which were used as gold standard. One of the radiologists reviewed the images twice (session 1 and 2) for the evaluation of intra-observer variability. Transverse and longitudinal dimensions of superior labrum on coronal T1-weighted images were measured as base and height of the inverted triangular-shaped superior labrum and compared between patients with SLAP lesions vs. non-SLAP patients. Presence of meniscoid labrum was noted. Statistical analysis was done using unpaired t-test. Results: Among 279 patients (283 shoulders), 122 patients (43.1%) had SLAP lesions. The mean base/height of superior labrum in SLAP and non-SLAP patients measured on T1-weighted MR image were 8.8 mm / 5.2 mm, 8.5 mm / 4.9 mm for reader 1; 8.2 mm / 4.9 mm, 8.1 mm / 4.5 mm for session 1 of reader 2; 8.0 mm / 4.8 mm, 7.6 mm / 4.3 mm for session 2 of reader 2. In SLAP group, the mean labral height was larger than non-SLAP group with statistically significant difference (p<0.05). Fifteen patients (5.3%) had meniscoid labrum according to operation records. Conclusion: In patients with SLAP lesion, the height of the superior glenoid labrum on oblique coronal image of MRA was slightly larger than non-SLAP patients. A larger height of superior glenoid labrum may be associated with SLAP lesions.

Correlation of the Speed of Enhancement of Hepatic Hemangiomas with Intravoxel Incoherent Motion MR Imaging (간혈관종의 조영증강속도와 복셀내비결집운동 MR영상과의 상관관계)

  • Yang, Dal Mo;Jahng, Geon-Ho;Kim, Hyun Cheol;Kim, Sang Won;Kim, Hyug-Gi
    • Investigative Magnetic Resonance Imaging
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    • v.18 no.3
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    • pp.208-218
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    • 2014
  • Purpose : To evaluate the relationship between the speed of enhancement of hepatic hemangiomas on gadolinium-enhanced MRI and ADC values by using various parameters, including the D, f, $D^*$ and $ADC_{fit}$ on intravoxel incoherent motion (IVIM) MR Imaging. Materials and Methods: The institutional review board approved this retrospective study. A total of 47 hepatic hemangiomas from 39 patients were included (20 men and 19 women). The hemangiomas were classified into three types according to the enhancement speed of the hepatic hemangiomas on gadolinium-enhanced dynamic T1-weighted images: rapid (Type A), intermediate (Type B), and slow (Type C) enhancement. The D, f, $D^*$ and $ADC_{fit}$ values were calculated using IVIM MR imaging. The diffusion/perfusion parameters and ADC values were compared among the three types of hemangiomas. Results: Both the $ADC_{fit}$ and D values of type C were significantly lower than those of type A (P = 0.0022, P = 0.0085). However, for the f and $D^*$, there were no significant differences among the three types. On DWI with all b values (50, 200, 500 and $800sec/mm^2$), the ADC values of type C were significantly lower than those of the type A (P < 0.012). For b values with $800sec/mm^2$, the $ADC_{800}$ values of the type C hemangiomas were significantly lower than those of type B (P = 0.0021). We found a negative correlation between hepatic hemangioma enhancement type and $ADC_{50}$ (${\rho}=-0.357$, P = 0.014), $ADC_{200}$ (${\rho}=-0.537$, P = 0.0001), $ADC_{500}$ (${\rho}=-0.614$, P = 0.0001), and $ADC_{800}$ (${\rho}=-0.607$, P = 0.0001). Therefore, four ADC values of $ADC_{50}$, $ADC_{200}$, $ADC_{500}$, and $ADC_{800}$ were decreased with decreasing enhancement speed. Conclusion: Hepatic hemangiomas had variable ADCs according to the type of enhancement, and the reduced ADCs in slowly enhancing hemangiomas may be related to the reduced pure molecular diffusion (D).

High-Resolution Contrast-Enhanced 3D-Spoiled Gradient-Recalled Imaging for Evaluation of Intracranial Vertebral Artery and Posterior Inferior Cerebellar Artery in Lateral Medullary Infarction (고해상도 조영증강 삼차원 회손기울기 회상 영상을 이용한 측면연수경색 환자의 두개내 척추동맥 및 뒤아래소뇌동맥 평가)

  • Yoon, Youngno;Ahn, Sung Jun;Suh, Sang Hyun;Park, Ah Young;Chung, Tae-Sub
    • Investigative Magnetic Resonance Imaging
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    • v.18 no.1
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    • pp.17-24
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    • 2014
  • Purpose : To determine whether high-resolution contrast-enhanced three dimensional imaging with spoiled gradient-recalled sequence (HR-CE 3D-SPGR) plays a meaningful role in the assessment of intracranial vertebral artery (ICVA) and posterior inferior cerebellar artery (PICA) in lateral medullary infarction (LMI). Materials and Methods: Twenty-five patients confirmed with LMI were retrospectively enrolled with approval by the IRB of our institute, and 3T MRI with HR-CE 3D-SPGR and contrast-enhanced magnetic resonance angiography (CE-MRA) were performed. Two radiologists who were blinded to clinical information and other brain MR images including diffusion weighted image independently evaluated arterial lesions in ICVA and PICA. The demographic characteristics, the area of LMI and cerebellar involvement were analyzed and compared between patients with arterial lesion in ICVA only and patients with arterial lesions in both ICVA and PICA on HR-CE 3D-SPGR. Results: Twenty-two of twenty-five LMI patients had arterial lesions in ICVA or PICA on HR-CE 3D SPGR. However twelve arterial lesions in PICA were not shown on CE-MRA. Concurrent cerebellar involvement appeared more in LMI patients with arterial lesion in ICVA and PICA than those with arterial lesion in ICVA alone (p = 0.069). Conclusion: HR-CE 3D-SPGR can help evaluate arterial lesions in ICVA and PICA for LMI patients.

The Characteristic of Research Regulation in Recent Japanese Medical World (최근 일본의 의학계 연구규율의 특색)

  • Song, Young-mi
    • The Korean Society of Law and Medicine
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    • v.20 no.2
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    • pp.173-206
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    • 2019
  • This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

Reverse Total Shoulder Arthroplasty in Patients with Severe Rotator Cuff-Deficient Shoulder - A Minimum Three-Year Follow-up Study - (심한 회전근 개 부전을 동반한 환자에 대한 역형 견관절 전치환술 - 최소 3년 추시 결과 -)

  • Kim, Myung-Sun;Yeo, Je-Hyoung
    • Clinics in Shoulder and Elbow
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    • v.16 no.2
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    • pp.73-83
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    • 2013
  • Purpose: The goal of this study is to evaluate the minimum three-year follow-up results of reverse total shoulder arthroplasty (RTSA) for glenohumeral (GH) arthritic and pseudoparalytic patients with severe rotator cuff deficiency. Materials and Methods: We evaluated 13 patients (three males and 10 females) who underwent RTSA from July 2007 to July 2010. The average follow-up duration was 54.2 months (range, 37~74 months). Clinical results were evaluated using the Visual Analog Scale (VAS) for pain, active Range of Motion (ROM): active forward flexion (aFF); active external rotation at the side (aERs); active internal rotation to the back (aIRb), American Shoulder and Elbow Surgeons (ASES) score, Korean Shoulder Score (KSS), and intraoperative and postoperative complications. Results: VAS score improved from 7.5(6~10) points to 1.5(0~4), and ROM of active forward elevation improved from $42.7(10{\sim}100)^{\circ}$ to $129.1(110{\sim}180)^{\circ}$. In addition, ASES score improved from preoperative 32.9 (11.7~46.7) points to 80.2(58.3~95.0) postoperatively, and KSS score improved from 36.8(24~47) points to 78.4 (61~92). Twelve out of 13 cases showed various degrees of scapular notching at the last follow-up. There was one case of intraoperative anterior glenoid fracture and two cases of temporary nerve injury. Revision surgery was performed in two cases for treatment of delayed postoperative deep infection. Conclusion: According to minimum three-year follow-up results, RTSA may be an effective treatment option for glenohumeral (GH) arthritic and pseudoparalytic patients. However, considering the possibility of complications related to delayed deep infection or surgeon's technique, RTSA should be judiciously and carefully indicated by expert surgeons.

Spiritual Welling-Being, Attitude to Death and Perception of Hospice Care in College Students (대학생의 영적안녕과 죽음에 대한 태도 및 호스피스 인식)

  • Lee, Young Eun;Choi, Eun Ah;Lee, Kyoung Eun
    • Journal of Hospice and Palliative Care
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    • v.18 no.4
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    • pp.294-305
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    • 2015
  • Purpose: The purpose of this study is to provide baseline data for the development of an educational program for hospice care for college students. Methods: A survey was conducted at three universities in B city with 143 students from September 5, 2014 through September 26, 2014. The data were analyzed by the SPSS 18 program. This study was approved by IRB. Results: The college students' spiritual well-being was at a medium level. Their attitudes to death were neutral, and perception of hospice care was at a medium level. Most of the participants (93.0%) had no training in hospice care. The participants' awareness of the purpose of hospice care was at a relatively high level. Their awareness of the need for hospice care was at a moderate level. The participants' spiritual well-being and their attitudes to death showed a weak but positive correlation (r=0.179, P=0.030). The relationship between their spiritual well-being and awareness of hospice care were positively correlated (r=0.203, P=0.015). Conclusion: The participants' perception of hospice care was low. Most of them had no experience of hospice care education. Also, the higher the spiritual stability was, the higher the participants' perception of the purpose and the necessity of hospice care was. And their perception of the hospice care varied depending on their family relationship, satisfaction with school life, and cognition of hospice care. Therefore, we need consider these variables to develop a hospice education program to enhance college students' attitudes to death and their perception of hospice care.

Analysis and Evaluation of Glycemic Indices and Glycemic Loads of Frequently Consumed Carbohydrate-Rich Snacks according to Variety and Cooking Method (탄수화물 간식류 식품 및 조리방법에 따른 혈당지수 및 혈당부하지수)

  • Kim, Do Yeon;Lee, Hansongyi;Choi, Eun Young;Lim, Hyunjung
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.44 no.1
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    • pp.14-23
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    • 2015
  • This study examined the glycemic indices (GIs) and glycemic loads of carbohydrate-rich snacks in Korea according to variety and cooking method. The most popular carbohydrate snacks (corn, potatoes, sweet potatoes, chestnuts, and red beans) from the Korean National Health and Nutrition Examination Survey nutrient database were cooked using a variety of conventional cooking methods (steaming, baking, porridge, puffing, and frying). The GIs of foods were measured in 60 healthy males after receiving permission from the University Hospital institutional review board (KMC IRB 1306-01). Blood glucose and insulin levels were then measured at 0, 15, 30, 60, 90, and 120 min after consuming glucose, and each test food contained 50 g of carbohydrates (corn: 170.0 g, potatoes: 359.7 g, sweet potatoes: 160.3 g, chestnuts: 134.8 g, red beans: 73.1 g). GI values for test foods were calculated based on the increase in the area under the blood glucose response curve for each subject. Steamed potatoes ($93.6{\pm}11.6$), corn porridge ($91.8{\pm}19.5$), baked sweet potatoes ($90.9{\pm}9.6$), baked potatoes ($78.2{\pm}14.5$), steamed corn ($73.4{\pm}9.9$), and steamed sweet potatoes ($70.8{\pm}6.1$) were shown to be considered high GI foods, whereas baked chestnuts ($54.3{\pm}6.3$), red bean porridge ($33.1{\pm}5.5$), steamed red beans ($22.1{\pm}3.2$), fried potatoes ($41.5{\pm}7.8$), and ground and pan-fried potatoes ($28.0{\pm}5.1$) were considered as low GI foods. The results suggest that the cooking method of carbohydrate-rich snacks is an important determinant of GI values.

A Study on the Frequency of Falls, Fear of Falling, and Perceived Health Status according to Cognitive Function in Community-dwelling Elderly Women (지역사회 여성노인의 인지기능에 따른 낙상발생빈도, 낙상두려움 및 지각된 건강상태)

  • Shin, Kyung-Rim;Kang, Younhee;Jung, Dukyoo;Kim, Miyoung;Yun, Eun-Suk;Ma, Rye-Won
    • 한국노년학
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    • v.31 no.4
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    • pp.1155-1167
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    • 2011
  • The purpose of this study was to investigate the frequency of falls, fear of falling, perceived health status, and number of disease according to cognitive function in community-dwelling the elderly women. This study utilized a descriptive survey design. Data were collected for six months with 311 elderly women who visited in public health center at S city. After obtaining Institutional Review Board(IRB) approval, a face-to-face, and private interview was conducted with each participant who was eligible and agreed to participate in this study by trained graduate-level nursing students. The questionnaires consisted of MoCA-K, K-MMSE, Fall Efficacy Scale, PHS scale. The collected data were analyzed with SPSS/WIN 17.0 program, which was used descriptive statistics, Chi-Square test and t-test, Correlation. The major findings of this study were as follows; 1) The average age of the subjects was 71.68±5.13 and cognitive function score was 22.14±4.32. approximately 35% of participants had fallen within one year. 2) there were significant differences in perceived health status according to cognitive function. 3) fear of fall and cognitive function, perceived health status and cognitive function were significant correlation. In conclusion, this study will contribute to establish strategies for preventing fall. Interventions for fall prevention and fear of fall enhancement should be developed with the consideration of the level of cognitive function in the elderly. Reducing the fear of falling through the comprehensive nursing intervention will ultimately improve the quality of life in the elderly.