• Title/Summary/Keyword: Non-clinical outcomes

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Peri-implant crevicular fluid levels of cathepsin-K, RANKL, and OPG around standard, short, and mini dental implants after prosthodontic loading

  • Alan, Raif;Marakoglu, Ismail;Haliloglu, Seyfullah
    • Journal of Periodontal and Implant Science
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    • v.45 no.5
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    • pp.169-177
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    • 2015
  • Purpose: Despite the high success rates of endosseous dental implants, their placement is restricted according to the height and volume of bone available. The use of short or mini dental implants could be one way to overcome this limitation. Thus, this study aimed to compare standard, short, and mini dental implants with regard to associated clinical parameters and peri-implant crevicular fluid (PICF) levels of cathepsin-K (CTSK), RANK ligand (RANKL), and osteoprotegerin (OPG), after prosthodontic loading. Methods: A total of 78 non-submerged implants (Euroteknika, $Aesthetica^{+2}$, Sallanches, France) were installed in 30 subjects (13 male, 17 female; range, 26-62 years) who visited the clinic of the Periodontology Department, Faculty of Dentistry, Selcuk University. Sampling and measurements were performed on the loading date (baseline) and 2, 14, and 90 days after loading. Assessment of the peri-implant status for the implant sites was performed using the pocket probing depth (PPD), modified plaque index, modified gingival index, modified sulcular bleeding index, and radiographic signs of bone loss. PICF samples collected from each implant were evaluated for CTSK, RANKL, and OPG levels using the ELISA method. Keratinized tissue and marginal bone loss (MBL) were also noted. Results: Clinical parameters statistically significantly increased in each group but did not show statistical differences between groups without PPD. Although implant groups showed a higher MBL in the upper jaw, only the standard dental group demonstrated a statistically significant difference. At 90 days, the OPG:sRANKL ratio and total amounts of CTSK for each group did not differ from baseline. Conclusions: Within the limitations of this study, both short and mini dental implants were achieving the same outcomes as the standard dental implants in the early period after loading.

Food Protein-induced Enterocolitis Syndrome: an Update on Clinical Approaches and Its Pathophysiology (식품 단백질 유발성 장염 증후군: 임상적 접근과 병태생리의 최신 지견)

  • Hwang, Jin-Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.10 no.2
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    • pp.117-128
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    • 2007
  • Food protein-induced enterocolitis syndrome (FPIES) is a non-IgE mediated hypersensitivity disorder, which is associated with mainly gastrointestinal symptoms and has a delayed onset. The vomiting and/or diarrheal symptoms of FPIES typically begin in the first month of life in association with a failure to thrive, metabolic acidosis, and shock. Therefore, the differential diagnosis of FPIES and neonatal or infantile sepsis-like illnesses or gastroenteritis is difficult. The early recognition of indexes of suspicion for FPIES may help in the diagnosis and treatment of this disorder. The diagnosis of FPIES is generally made through clinical practice and food-specific IgE test findings are typically negative in this condition. Therefore, oral cow's milk challenge (OCC) remains the valid diagnostic standard for FPIES. An investigation of positive OCC outcomes helps to find out a diagnostic algorithm of criteria of a positive challenge in FPIES. Moreover, it has not been clearly determined in infantile FPIES when $1^{st}$ follow up-oral food challenge (FU-OFC) should be performed, with what kind of food protein (e.g., cow's milk, soy), and how much protein should be administered. Hence, to prevent the risk of inappropriate FU-OFC or accidental exposure and achieve appropriate dietary management, it is necessary to identify tolerance rates to major foods under the careful follow up of infantile FPIES patients. On the other hand, small intestinal enteropathy with villous atrophy is observed in FPIES and this enteropathy seems to be in part induced by both of epithelial apoptosis and intercellular junctional complex breakdown. The purpose of this report is to introduce an update on diagnostic and therapeutic approaches in FPIES and suggest the possible histopathological evidences in this disorder.

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Clinical Value of Intraoperative Flow Measurements of Brachiocephalic Arteriovenous Fistulas for Hemodialysis

  • Lee, Jonggeun;Lee, Seogjae;Chang, Jee Won;Kim, Su Wan;Song, Jung-Kook
    • Journal of Chest Surgery
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    • v.53 no.3
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    • pp.121-126
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    • 2020
  • Background: The aim of this study was to analyze the clinical outcomes of autogenous brachiocephalic arteriovenous fistulas and to investigate the factors associated with 1-year patency after initiation of hemodialysis. Methods: We retrospectively reviewed the medical records of 41 patients who underwent surgery to create an autogenous brachiocephalic arteriovenous fistula between January 2015 and December 2017, received hemodialysis at the same hospital for longer than 1 year, and were monitored for their vascular access status. Intraoperative flow was measured using transit-time ultrasonography. Results: The 1-year primary and secondary patency rates were 61% (n=25) and 87.8% (n=36), respectively. The functional group (subjects who required no intervention to maintain patency within the first year after hemodialysis initiation) displayed a significantly higher median intraoperative flow rate (450 mL/min) than the non-functional group (subjects who required intervention at least once regardless of 1-year patency) (275 mL/min) (p=0.038). Based on a receiver operating characteristic curve analysis, all patients were additionally subdivided into a high-flow group (>240 mL/min) and a low-flow group (≤240 mL/min). The high-flow group included a significantly greater number of functional brachiocephalic arteriovenous fistulas than the low-flow group (74.2% vs. 20%, respectively; p=0.007). Conclusion: Transit-time flow, as measured with intraoperative transit-time ultrasonography, was associated with patency without the need for intervention at 1 year after initiation of hemodialysis.

Challenges in the Management of Breast Cancer in a Low Resource Setting in South East Asia

  • Ley, P;Yip, CH;Hong, C;Varughese, J;Camp, L;Bouy, Sok;Maling, E
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.7
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    • pp.3459-3463
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    • 2016
  • Background: Breast cancer is the second most common cancer in women in Cambodia, a low income country in South-East Asia. The Sihanouk Hospital Centre of Hope (SHCH) is a charity hospital set up by an international non-governmental organisation, HOPE Worldwide. In 2008, SHCH partnered with AmeriCares, a global health organisation to set up and deliver a breast cancer programme to provide education, diagnosis and treatment for women with breast cancer. The objective of this study is to characterise the presentation, diagnosis, treatment and outcomes of women treated under this program. Materials and Methods: A total of 215 women newly diagnosed with breast cancer from 1 March 2008 until 31 March 2011 were studied. Age at diagnosis, tumour size, histological type, tumour grade, ER, lymph node involvement, treatment modalities (surgery, radiotherapy, chemotherapy, hormone therapy) were recorded. Data on mortality at 3 years were obtained whenever possible. Results: The median age was 47 years old. Some 77.8% were diagnosed with stage 3 and 4 lesions, and 78.5% underwent mastectomy, of which 28.4% the intent was palliative. Of those whose ER status were known, only 48.3% were ER positive. Only 6 patients could afford chemotherapy while only 1 patient had radiotherapy. Hormone therapy was provided free for those who were ER positive. The overall survival rate at 3 years was 39.1%. Conclusions: Breast cancer presents at a late stage, and because treatment is suboptimal, survival is poor in Cambodia. A more aggressive approach to early detection and treatment needs to be developed to improve outcome from this potentially curable disease.

Endovascular Stroke Therapy Focused on Stent Retriever Thrombectomy and Direct Clot Aspiration : Historical Review and Modern Application

  • Kang, Dong-Hun;Park, Jaechan
    • Journal of Korean Neurosurgical Society
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    • v.60 no.3
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    • pp.335-347
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    • 2017
  • Intravenous recombinant tissue plasminogen activator had been the only approved treatment for acute ischemic stroke since its approval in 1995. However, the restrictive time window, numerous contraindications, and its low recanalization rate were all limitations of this modality. Under those circumstances, endovascular stroke therapy went through a great evolution during the past two decades of intravenous thrombolysis. The results of the 2013 randomized trials for endovascular stroke therapy were neutral, although they were limited by insufficient imaging screening at enrollment, early-generation devices with less efficacy, and treatment delays. Huge progress was made in 2015, as there were five randomized clinical trials which all demonstrated the safety and efficacy of endovascular stroke treatment. Despite differences in detail patient enrollment criteria, all 5 trials employed key factors for good functional recovery; (1) screening with non-invasive imaging to identify the proximal occlusion and exclude a large infarct core, (2) using highly effective modern thrombectomy devices mainly with stent retriever, and (3) establishment of a fast workflow to achieve effective reperfusion. The results of those trials indicate that modern thrombectomy devices can allow for faster and more effective reperfusion, which can lead to improved clinical outcomes compared to intravenous thrombolysis alone. These advances in mechanical thrombectomy are promising in the global fight against ischemic stroke-related disability and mortality. Two current mainstreams among such mechanical thrombectomy techniques, "stent retriever thrombectomy" and "direct clot aspiration", are the topic of this review. Stent retriever thrombectomy using Solitaire and Trevo retriever will be firstly discussed. And, the commonalities and the differences between two major clot aspiration thrombectomy techniques; a direct aspiration first pass technique (ADAPT) and forced arterial suction thrombectomy (FAST), will be additionally explained. Finally, details regarding the combination of direct clot aspiration and stent retriever thrombectomy, the switching strategy and the Solumbra technique, will be described.

Thromboxane A2 Synthetase Inhibitor Plus Low Dose Aspirin : Can It Be a Salvage Treatment in Acute Stroke Beyond Thrombolytic Time Window

  • An, Gyu-Hwan;Sim, Sook-Young;Jwa, Cheol-Su;Kim, Gang-Hyeon;Lee, Jong-Yun;Kang, Jae-Kyu
    • Journal of Korean Neurosurgical Society
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    • v.50 no.1
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    • pp.1-5
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    • 2011
  • Objective : There is no proven regimen to reduce the severity of stroke in patients with acute cerebral infarction presenting beyond the thrombolytic time window. Ozagrel sodium, a selective thromboxane A2 synthetase inhibitor, has been known to suppress the development of infarction. The antiplatelet effect is improved when aspirin is used together with a thromboxane synthetase inhibitor. Methods : Patients with non-cardiogenic acute ischemic stroke who were not eligible for thrombolysis were randomly assigned to two groups; one group received ozagrel sodium plus 100 mg of aspirin (group 1, n=43) and the other 100 mg of aspirin alone (group 2, n=43). Demographic data, cardiovascular risk factors, initial stroke severity [National Institute of Health Stroke Scale (NIHSS) and motor strength scale] and stroke subtypes were analyzed in each group. Clinical outcomes were analyzed by NIHSS and motor strength scale at 14 days after the onset of stroke. Results : There were no significant differences in the mean age, gender proportion, the prevalence of cardiovascular risk factors, stroke subtypes, and baseline neurological severity between the two groups. However, the clinical outcome for group 1 was much better at 14 days after the onset of stroke compared to group 2 (NIHSS score, p=0.007, Motor strength scale score, p<0.001). There was one case of hemorrhagic transformation in group 1, but there was no statistically significant difference in bleeding tendency between two groups. Conclusion : In this preliminary study, thromboxane A2 synthetase inhibitor plus a low dose of aspirin seems to be safe and has a favorable outcome compared to aspirin alone in patients with acute ischemic stroke who presented beyond the thrombolytic time window.

A Study on Single Dose Toxicity of Mecasin Pharmacopuncture Injection in Muscle

  • Cha, Eunhye;Jeong, Hohyun;Lee, Jongchul;Lee, Seongjin;Park, Manyong;Kim, Sungchul
    • The Journal of Korean Medicine
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    • v.36 no.2
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    • pp.36-42
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    • 2015
  • Objectives: This study was carried out to analyze the single dose toxicity of Mecasin(Gami-Jakyak Gamcho buja Decoction) pharmacopuncture in muscle of Sprague-Dawley rats. Methods: All experiments were performed at the Medvill, an institution acknowledged to conduct non-clinical studies, under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen in this pilot study. The reason Sprague-Dawley rats were chosen is that they have been widely used in safety test in the field of medicine, so the results can be easily compared with many other databases. Doses of Mecasin pharmacopuncture, 0, 500, 1,000, and 2,000mg/kg, were registered to the experimental groups, and a dose of normal saline solution, 10 ml/kg, was registered to the control group. Mecasin pharmacopuncture and normal saline were injected into the thigh of the rats by disposable syringes at intervals of six hours twice a day. This study was performed under the approval of the Institutional Animal Ethic Committee. Results: There is no death or abnormality in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To inspect abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with Mecasin pharmacopuncture is relatively safe. Further evaluations and studies on this subject are needed to prove more concrete evidence.

Clinical Analysis of Blunt Abdominal Trauma in Childhood (소아에서 발생한 복부 둔상의 임상적 고찰)

  • Kim, Young-Yuk;Jeong, Yeon-Jun;Jung, Sung-Hoo;Kim, Jae-Chun
    • Advances in pediatric surgery
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    • v.16 no.2
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    • pp.177-189
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    • 2010
  • Traumatic injury is one of the leading causes of morbidity and mortality in children. This is a clinical review of pediatric blunt abdominal trauma. A retrospective analysis of the 112 children with blunt abdominal trauma aged 15 years or less treated at the Department of Pediatric Surgery, Chonbuk National University Hospital was performed. The analysis included age, sex, injury mechanism, number and site of the injured organ, management and outcomes. The average age of occurrence was 7.6 years, and the peak age was between 6 and 8 years. There was a male preponderance with a male to female ratio of 2.3:1. The most common cause of blunt abdominal trauma was traffic accidents (61.6 %), principally involving pedestrians (79.7 %). The accident prone times were between 8:00 AM and 8:00 PM, the weekends (40.2 %), and the winter respectively. Thirthy-five patients (31.2 %) had multiple intra-abdominal organ injuries and the most common injured organ was the liver. Seventy-four cases (66.1 %) were managed non-operatively and eleven cases (9.8 %) expired. Of the patients who were treated surgically or were to be operated on one patient died before surgery, the remainder died during or after surgery. Risk factors such as number of injured organ, systolic and diastolic blood pressure, and trauma scores by Glasgow coma scale (GCS), Pediatric trauma score (PTS), revised trauma score (RTS), injury severe score (ISS), TRISS were significantly correlated with mortality rate.

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Discrepancy between Clinical and Final Pathological Evaluation Findings in Early Gastric Cancer Patients Treated with Endoscopic Submucosal Dissection

  • Kim, Young-Il;Kim, Hyoung Sang;Kook, Myeong-Cherl;Cho, Soo-Jeong;Lee, Jong Yeul;Kim, Chan Gyoo;Ryu, Keun Won;Kim, Young-Woo;Choi, Il Ju
    • Journal of Gastric Cancer
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    • v.16 no.1
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    • pp.34-42
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    • 2016
  • Purpose: Early gastric cancer cases that are estimated to meet indications for treatment before endoscopic submucosal resection are often revealed to be out-of-indication after the treatment. We investigated the short-term treatment outcomes in patients with early gastric cancer according to the pretreatment clinical endoscopic submucosal resection indications. Materials and Methods: We retrospectively reviewed the medical records of patients with early gastric cancer that met the pretreatment endoscopic submucosal resection indications, from 2004 to 2011. Curative resection rate and proportion of out-of-indication cases were compared according to the pre-endoscopic submucosal resection indications. Pre-endoscopic submucosal resection factors associated with out-of-indication in the final pathological examination were analyzed. Results: Of 756 cases, 660 had absolute and 96 had expanded pre-endoscopic submucosal resection indications. The curative resection rate was significantly lower in the patients with expanded indications (64.6%) than in those with absolute indications (81.7%; P<0.001). The cases with expanded indications (30.2%) were revealed to be out-of-indication more frequently than the cases with absolute indications (13.8%; P<0.001). Age of >65 years, tumor size of >2 cm, tumor location in the upper-third segment of the stomach, and undifferentiated histological type in pre-endoscopic submucosal resection evaluations were significant risk factors for out-of-indication after endoscopic submucosal resection. Conclusions: Non-curative resection due to out-of-indication occurred in approximately one-third of the early gastric cancer cases that clinically met the expanded indications before endoscopic submucosal resection. The possibility of additional surgery should be empha-sized for patients with early gastric cancers that clinically meet the expanded indications.

Single-dose Toxicity of ShinYangHur Herbal Acupuncture

  • Cha, Eunhye;Lee, Jongcheol;Lee, Seongjin;Park, Manyong;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.18 no.2
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    • pp.67-75
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    • 2015
  • Objectives: This study was carried out to analyze the single-dose toxicity of ShinYangHur (SYH) herbal acupuncture injected into the muscles of Sprague-Dawley (SD) rats. Methods: The SYH herbal acupuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, Korea-Good Manufacturing Practice, K-GMP). After the mixing process with sterile distilled water, the pH was controlled to between 7.0 and 7.5. Then, NaCl was added to make a 0.9% isotonic solution by using sterilized equipment. All experiments were conducted at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of SYH herbal acupuncture, 0.25, 0.5, and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy was used to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with SYH herbal acupuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.