• Title/Summary/Keyword: Trials

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A Phase I/II Trial of $DCVac/IR^{(R)}$ Dendritic Cell Immunotherapy Combined with Irradiation in Cases of Refractory Colorectal Cancer with Multiple Liver Metastases (기존의 치료에 반응하지 않는 다발성 간전이 대장암 환자에서 방사선조사와 병합한 수지상세포 면역치료의 1, 2상 임상시험)

  • Choi, Young-Min;Lee, Hyung-Sik;Kwon, Hyuk-Chan;Han, Sang-Young;Choi, Jong-Cheol;Chung, Ju-Seop;Kim, Chang-Won;Kim, Dong-Won;Kang, Chi-Duk
    • Radiation Oncology Journal
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    • v.26 no.2
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    • pp.104-112
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    • 2008
  • Purpose: To assess the toxicity and tumor response induced by $DCVac/IR^{(R)}$ dendritic cell(DC) immunotherapy combined with irradiation for refractory colorectal cancer patients with multiple liver metastases. Materials and Methods: Between May 2004 and November 2006, applicants from a pool of refractory colorectal cancer patients with multiple liver metastases were enrolled. The patients were registered after having signed the informed consent form, which had been approved by the Institutional Review Board from the Dong-A University and Busan National University Hospital. DCs were obtained from peripheral blood of each patient, and then cultured in vitro. A total of $6{\times}10^6$ DCs were packed into a vial($DCVac/IR^{(R)}$, 0.5 ml) at the convenience of each patient's schedule. On the day before and on the day of each vaccination, each patient received a 4 Gy radiation dose to the target tumor. On the day of vaccination, the indicated dose of autologous DCs was injected into the irradiated tumor using ultrasound-guided needle injection procedures. A total of four vaccinations were scheduled at three 2-week intervals and one 4 week interval at the Dong-A University and Busan National University Hospital. If the tumor status was deemed to be stable or responding to therapy, an additional vaccination dose or two was approved at 4 week intervals beyond the fourth immunization. A tolerance test for DCs was conducted by injecting a range of doses($3{\times}10^6\;to\;12{\times}10^6$ DCs) after the 3rd injection. Moreover, the maximal tolerable dose was applied to additional patients. Treatment safety was evaluated in all patients who had at least one injection. Treatment feasibility was evaluated by the 10th week by assessing the response of patients having at least 4 injections. For systemic toxicities, the evaluation was performed using the National Cancer Institute Common Toxicity Criteria, whereas adverse effects were recorded using common WHO toxicity criteria. Results: Of the 24 registered patients, 22 received the DCs injections. Moreover, of the 14 patients that applied for the tolerance test, only 11 patients completed it because 3 patients withdrew their testing agreement. A grade 3 or more side effect, which was possibly related to the DC injection, did not occur in additional patients. The $12{\times}10^6$ DC injection was identified as the maximum tolerable dose, and was then injected in an additional 8 patients. Patients tolerated the injection fairly well, with no fatal side effects. In order to assess the feasibility of DC immunotherapy, the response was evaluated in other hepatic lesions outside of the targeted hepatic lesion. The response evaluation was performed in 15 of the 17 patients who received at least 4 injections. Stable and progressive disease was found in 4 and 11 patients, respectively. Conclusion: The DC-based immunotherapy and radiotherapy is theoretically synergistic for the local control and systemic control. The $DCVac/IR^{(R)}$ immunotherapy combined with irradiation was tolerable and safe in the evaluated cases of refractory colorectal cancer with multiple liver metastases. Future work should include well designed a phase II clinical trials.

The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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The Results of Curative Radiotherapy for the Uterine Cervical Cancer (자궁경부암의 근치적 방사선치료 성적)

  • Kim, Hyoung-Jin;Kim, Jung-Soo;Kwon, Hyoung-Cheol;Kim, Jin-Kee;Oh, Byung-Chan
    • Radiation Oncology Journal
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    • v.14 no.3
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    • pp.191-199
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    • 1996
  • Purpose : To evaluate 5-year survival rate, patterns of failure and complications of cervical cancer treatment, fifty nine patients treated by curative radiotherapy for the uterine cervical cancer were analyzed retrospectively. Materials and Methods : From March 1986 to May 1990, fifty nine patients with histologically proven uterine cervical cancer were analyzed. According to FIGO stage, there were 2 patients ($3.4\%$) in stage Ib, 2 patients ($3.4\%$) in stage IIa, 31 patients ($52.5\%$) in stage IIb, 15 patients ($25.4\%$) in stage IIIb, 9 patients ($15.3\%$) in stage IV. External RT was per formed by 6 MVLINAC with daily 1.8 Gy, 5 times per week and followed by ICR. A point dose of ICR was calculated to 30-43.66 Gy (median: 34.6 Gy). These techniques delivered total A Point dose of 80.4 to 109.8 Gy (median: 85 Gy). Patients had been followed up from 2 to 110 months (median: 61 months) Results : The overall 5-year survival rate & disease free survival rate were $55.9\%$ and $55.0\%$ respectively. According to FIGO stage, the 5-year survival rate for less than IIa, IIb, IIIb, IV were $75.0\%$, $74.8\%$, $26.7\%$, $33.3\%$, respectively. In univariate analysis, the 5-year survival rate for stage IIb and below versus stage IIIa and above revealed $74.8\%$, $29.2\%$ respectively (P<0.005). According to the hemoglobin level during RT, the 5-rear survival rate of was $73.3\%$ for patients with Hg 10 gm/dL or higher, in contrast to $0\%$ for those with lower than 10 gm/dL (p<0.005). In 18 patients with nonbulky tumor (<5cm), the 5-year survival rates were $71.8\%$. The 5-rear survival rates for 18 patients with 5 cm or greater in tumor diameter were $22.2\%$ (p<0.005). The 5-year survival rate for Patient age of above 50 years and below were $65.3\%$ $34.2\%$ respectively (p<0.05). ECOG performance status. pathologic finding, total dose, total treatment time were not statistically significant factors. The significant prognostic factors affecting overall 5-year survival rate by multivariate analysis showed the hemoglobin level during RT (P=0.0001), tumor size (p=0.0390), FIGO stage (p=0.0468). Total recurrence rate was $23.7\%$ local failure $15.2\%$ (9/59), distant metastasis $6.8\%$ (4/59), local and distant metastasis $1.7\%$ (1/59). According to the RTOG/EORTC Soma Scales, the late complication rate was $23.8\%$ (14/59) The late complication rate of colorectum and genitourinary tract were $15.3\%$ (9/59), $8.5\%$ (5/59), respectively: 10 patients ($17.0\%$) were grade 2, 3 Patients ($5.1\%$) were grade 3 and one patient ($1.7\%$) was grade 4. The late complications were radiation proctitis, rectal bleeding, radiation colitis, diarrhea and radiation cystitis in decreasing order. Conclusion : For improvement of therapeutic results, prospective randomized trials are recomended to discover new prognostic factors and more aggressive radiation therapeutic methods are needed for poor prognostic patients. The adjuvant chemotherapy or radiation-sensitizing agents must be considered to inhibit regional and distant metastasis.

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Study on 3D Printer Suitable for Character Merchandise Production Training (캐릭터 상품 제작 교육에 적합한 3D프린터 연구)

  • Kwon, Dong-Hyun
    • Cartoon and Animation Studies
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    • s.41
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    • pp.455-486
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    • 2015
  • The 3D printing technology, which started from the patent registration in 1986, was a technology that did not attract attention other than from some companies, due to the lack of awareness at the time. However, today, as expiring patents are appearing after the passage of 20 years, the price of 3D printers have decreased to the level of allowing purchase by individuals and the technology is attracting attention from industries, in addition to the general public, such as by naturally accepting 3D and to share 3D data, based on the generalization of online information exchange and improvement of computer performance. The production capability of 3D printers, which is based on digital data enabling digital transmission and revision and supplementation or production manufacturing not requiring molding, may provide a groundbreaking change to the process of manufacturing, and may attain the same effect in the character merchandise sector. Using a 3D printer is becoming a necessity in various figure merchandise productions which are in the forefront of the kidult culture that is recently gaining attention, and when predicting the demand by the industrial sites related to such character merchandise and when considering the more inexpensive price due to the expiration of patents and sharing of technology, expanding opportunities and sectors of employment and cultivating manpower that are able to engage in further creative work seems as a must, by introducing education courses cultivating manpower that can utilize 3D printers at the education field. However, there are limits in the information that can be obtained when seeking to introduce 3D printers in school education. Because the press or information media only mentions general information, such as the growth of the industrial size or prosperous future value of 3D printers, the research level of the academic world also remains at the level of organizing contents in an introductory level, such as by analyzing data on industrial size, analyzing the applicable scope in the industry, or introducing the printing technology. Such lack of information gives rise to problems at the education site. There would be no choice but to incur temporal and opportunity expenses, since the technology would only be able to be used after going through trials and errors, by first introducing the technology without examining the actual information, such as through comparing the strengths and weaknesses. In particular, if an expensive equipment introduced does not suit the features of school education, the loss costs would be significant. This research targeted general users without a technology-related basis, instead of specialists. By comparing the strengths and weaknesses and analyzing the problems and matters requiring notice upon use, pursuant to the representative technologies, instead of merely introducing the 3D printer technology as had been done previously, this research sought to explain the types of features that a 3D printer should have, in particular, when required in education relating to the development of figure merchandise as an optional cultural contents at cartoon-related departments, and sought to provide information that can be of practical help when seeking to provide education using 3D printers in the future. In the main body, the technologies were explained by making a classification based on a new perspective, such as the buttress method, types of materials, two-dimensional printing method, and three-dimensional printing method. The reason for selecting such different classification method was to easily allow mutual comparison of the practical problems upon use. In conclusion, the most suitable 3D printer was selected as the printer in the FDM method, which is comparatively cheap and requires low repair and maintenance cost and low materials expenses, although rather insufficient in the quality of outputs, and a recommendation was made, in addition, to select an entity that is supportive in providing technical support.

The Jurisdictional Precedent Analysis of Medical Dispute in Dental Field (치과임상영역에서 발생된 의료분쟁의 판례분석)

  • Kwon, Byung-Ki;Ahn, Hyoung-Joon;Kang, Jin-Kyu;Kim, Chong-Youl;Choi, Jong-Hoon
    • Journal of Oral Medicine and Pain
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    • v.31 no.4
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    • pp.283-296
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    • 2006
  • Along with the development of scientific technologies, health care has been growing remarkably, and as the social life quality improves with increasing interest in health, the demand for medical service is rapidly increasing. However, medical accident and medical dispute also are rapidly increasing due to various factors such as, increasing sense of people's right, lack of understanding in the nature of medical practice, over expectation on medical technique, commercialize medical supply system, moral degeneracy and unawareness of medical jurisprudence by doctors, widespread trend of mutual distrust, and lack of systematized device for solution of medical dispute. This study analysed 30 cases of civil suit in the year between 1994 to 2004, which were selected among the medical dispute cases in dental field with the judgement collected from organizations related to dentistry and department of oral medicine, Yonsei university dental hospital. The following results were drawn from the analyses: 1. The distribution of year showed rapid increase of medical dispute after the year 2000. 2. In the types of medical dispute, suit associated with tooth extraction took 36.7% of all. 3. As for the cause of medical dispute, uncomfortable feeling and dissatisfaction with the treatment showed 36.7%, death and permanent damage showed 16.7% each. 4. Winning the suit, compulsory mediation and recommendation for settlement took 60.0% of judgement result for the plaintiff. 5. For the type of medical organization in relation to medical dispute, 60.0% was found to be the private dental clinics, and 30.0% was university dental hospitals. 6. For the level of trial, dispute that progressed above 2 or 3 trials was of 30.0%. 7. For the amount of claim for damage, the claim amounting between 50 million to 100 million won was of 36.7%, and that of more than 100 million won was 13.3%, and in case of the judgement amount, the amount ranging from 10 million to 30 million won was of 40.0%, and that of more than 100 million won was of 6.7%. 8. For the number of dentist involved in the suit, 26.7% was of 2 or more dentists. 9. For the amount of time spent until the judgement, 46.7% took 11 to 20 months, and 36.7% took 21 to 30 months. 10. For medical malpractice, 46.7% was judged to be guilty, and 70% of the cases had undergone medical judgement or verification of the case by specialists during the process of the suit. 11. In the lost cases of doctors(18 cases), 72.2% was due to violence of carefulness in practice and 16.7% was due to missing of explanation to patient. Medical disputes occurring in the field of dentistry are usually of relatively less risky cases. Hence, the importance of explanation to patient is emphasized, and since the levels of patient satisfaction are subjective, improvement of the relationship between the patient and the dentist and recovery of autonomy within the group dentist are essential in addition to the reduction of technical malpractice. Moreover, management measure against the medical dispute should be set up through complement of the current doctors and hospitals medical malpractice insurance which is being conducted irrationally, and establishment of system in which education as well as consultation for medical disputes lead by the group of dental clinicians and academic scholars are accessible.

The Usefulness of Noninvasive Positive Pressure Ventilation in Patients With Acute Respiratory Failure after Extubation (기관내 관 제거 후 발생한 급성 호흡부전에서 비침습적 양압 환기법의 유용성)

  • Na, Joo-Ock;Lim, Chae-Man;Shim, Tae-Sun;Park, Joo-Hun;Lee, Ki-Man;Lee, Sang-Do;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong;Koh, Youn-Suck
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.3
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    • pp.350-362
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    • 1999
  • Background: Acute Respiratory failure which is developed after extubation in the weaning process from mechanical ventilation is an important cause of weaning failure. Once it was developed, endotracheal reintubation has been done for respiratory support. Noninvasive Positive Pressure Ventilation (NIPPV) has been used in the management of acute or chronic respiratory failure, as an alternative to endotracheal intubation, using via nasal or facial mask. In this study, we evaluated the usefulness of NIPPV as an alternative method of reintubation in patients who developed acute respiratory failure after extubation. Method: We retrospectively analyzed thirty one patients(eighteen males and thirteen females, mean ages $63\pm13.2$ years) who were developed acute respiratory failure within forty eight hours after extubation, or were extubated unintentionally at medical intensive care unit(MICU) of Asan Medical Center. NIPPV was applied to the patients. Ventilatory mode of NIPPV, level of ventilatory support and inspiratory oxygen concentration were adjusted according to the patient condition and results of blood gas analysis by the attending doctors at MICU. NIPPV was completely weaned when the patients maintained stable clinical condition under 8 $cmH_2O$ of pressure support level. Weaning success was defined as maintenance of stable spontaneous breathing more than forty eight hours after discontinuation of NIPPV. Respiratory rate, heart rate, arterial blood gas analysis, level of pressure support, and level of PEEP were monitored just before extubation, at thirty minutes, six hours, twenty four hours after initiation of NIPPV. They were also measured at just before weaning from NIPPV in success group, and just before reintubation in failure group. Results: NIPPV was successfully applied to thirty-one patients of thirty-two trials and one patient could not tolerated NIPPV longer than thirty minutes. Endotracheal reintubation was successfully obviated in fourteen patients (45%) among them. There was no difference in age, sex, APACHE III score on admission at MICU, duration of intubation, interval from extubation to initiation of NIPPV, baseline heart rate, respiratory rate, arterial blood gas, and $PaO_2/FiO_2$ between the success and the failure group. Heart rate and respiration rate were significantly decreased with increase $SaO_2$ after thirty minutes of NIPPV in both groups(p<0.05). However, in the patients of failure group, heart rate and respiratory rate were increased again with decrease in $SaO_2$ leading to endotracheal reintubation. The success rate of NIPPV treatment was significantly higher in the patients with COPD compared to other diseases(62% vs 39%) (p=0.007). The causes of failure were deterioration of arterial blood gas without aggravation of underlying disease(n=9), aggravation of undelying disease(n=5), mask intolerance(n=2), and retained airway secretion(n=l). Conclusion: NIPPV would be a useful therapeutic alternative which can avoid reintubation in patient who developed acute respiratory failure after extubation.

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Differential Effects of Recovery Efforts on Products Attitudes (제품태도에 대한 회복노력의 차별적 효과)

  • Kim, Cheon-GIl;Choi, Jung-Mi
    • Journal of Global Scholars of Marketing Science
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    • v.18 no.1
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    • pp.33-58
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    • 2008
  • Previous research has presupposed that the evaluation of consumer who received any recovery after experiencing product failure should be better than the evaluation of consumer who did not receive any recovery. The major purposes of this article are to examine impacts of product defect failures rather than service failures, and to explore effects of recovery on postrecovery product attitudes. First, this article deals with the occurrence of severe and unsevere failure and corresponding service recovery toward tangible products rather than intangible services. Contrary to intangible services, purchase and usage are separable for tangible products. This difference makes it clear that executing an recovery strategy toward tangible products is not plausible right after consumers find out product failures. The consumers may think about backgrounds and causes for the unpleasant events during the time gap between product failure and recovery. The deliberation may dilutes positive effects of recovery efforts. The recovery strategies which are provided to consumers experiencing product failures can be classified into three types. A recovery strategy can be implemented to provide consumers with a new product replacing the old defective product, a complimentary product for free, a discount at the time of the failure incident, or a coupon that can be used on the next visit. This strategy is defined as "a rewarding effort." Meanwhile a product failure may arise in exchange for its benefit. Then the product provider can suggest a detail explanation that the defect is hard to escape since it relates highly to the specific advantage to the product. The strategy may be called as "a strengthening effort." Another possible strategy is to recover negative attitude toward own brand by giving prominence to the disadvantages of a competing brand rather than the advantages of its own brand. The strategy is reflected as "a weakening effort." This paper emphasizes that, in order to confirm its effectiveness, a recovery strategy should be compared to being nothing done in response to the product failure. So the three types of recovery efforts is discussed in comparison to the situation involving no recovery effort. The strengthening strategy is to claim high relatedness of the product failure with another advantage, and expects the two-sidedness to ease consumers' complaints. The weakening strategy is to emphasize non-aversiveness of product failure, even if consumers choose another competitive brand. The two strategies can be effective in restoring to the original state, by providing plausible motives to accept the condition of product failure or by informing consumers of non-responsibility in the failure case. However the two may be less effective strategies than the rewarding strategy, since it tries to take care of the rehabilitation needs of consumers. Especially, the relative effect between the strengthening effort and the weakening effort may differ in terms of the severity of the product failure. A consumer who realizes a highly severe failure is likely to attach importance to the property which caused the failure. This implies that the strengthening effort would be less effective under the condition of high product severity. Meanwhile, the failing property is not diagnostic information in the condition of low failure severity. Consumers would not pay attention to non-diagnostic information, and with which they are not likely to change their attitudes. This implies that the strengthening effort would be more effective under the condition of low product severity. A 2 (product failure severity: high or low) X 4 (recovery strategies: rewarding, strengthening, weakening, or doing nothing) between-subjects design was employed. The particular levels of product failure severity and the types of recovery strategies were determined after a series of expert interviews. The dependent variable was product attitude after the recovery effort was provided. Subjects were 284 consumers who had an experience of cosmetics. Subjects were first given a product failure scenario and were asked to rate the comprehensibility of the failure scenario, the probability of raising complaints against the failure, and the subjective severity of the failure. After a recovery scenario was presented, its comprehensibility and overall evaluation were measured. The subjects assigned to the condition of no recovery effort were exposed to a short news article on the cosmetic industry. Next, subjects answered filler questions: 42 items of the need for cognitive closure and 16 items of need-to-evaluate. In the succeeding page a subject's product attitude was measured on an five-item, six-point scale, and a subject's repurchase intention on an three-item, six-point scale. After demographic variables of age and sex were asked, ten items of the subject's objective knowledge was checked. The results showed that the subjects formed more favorable evaluations after receiving rewarding efforts than after receiving either strengthening or weakening efforts. This is consistent with Hoffman, Kelley, and Rotalsky (1995) in that a tangible service recovery could be more effective that intangible efforts. Strengthening and weakening efforts also were effective compared to no recovery effort. So we found that generally any recovery increased products attitudes. The results hint us that a recovery strategy such as strengthening or weakening efforts, although it does not contain a specific reward, may have an effect on consumers experiencing severe unsatisfaction and strong complaint. Meanwhile, strengthening and weakening efforts were not expected to increase product attitudes under the condition of low severity of product failure. We can conclude that only a physical recovery effort may be recognized favorably as a firm's willingness to recover its fault by consumers experiencing low involvements. Results of the present experiment are explained in terms of the attribution theory. This article has a limitation that it utilized fictitious scenarios. Future research deserves to test a realistic effect of recovery for actual consumers. Recovery involves a direct, firsthand experience of ex-users. Recovery does not apply to non-users. The experience of receiving recovery efforts can be relatively more salient and accessible for the ex-users than for non-users. A recovery effort might be more likely to improve product attitude for the ex-users than for non-users. Also the present experiment did not include consumers who did not have an experience of the products and who did not perceive the occurrence of product failure. For the non-users and the ignorant consumers, the recovery efforts might lead to decreased product attitude and purchase intention. This is because the recovery trials may give an opportunity for them to notice the product failure.

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Prognostic Value of TNM Staging in Small Cell Lung Cancer (소세포폐암의 TNM 병기에 따른 예후)

  • Park, Jae-Yong;Kim, Kwan-Young;Chae, Sang-Cheol;Kim, Jeong-Seok;Kim, Kwon-Yeop;Park, Ki-Su;Cha, Seung-Ik;Kim, Chang-Ho;Kam, Sin;Jung, Tae-Hoon
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.2
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    • pp.322-332
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    • 1998
  • Background: Accurate staging is important to determine treatment modalities and to predict prognosis for the patients with lung cancer. The simple two-stage system of the Veteran's Administration Lung Cancer study Group has been used for staging of small cell lung cancer(SCLC) because treatment usually consists of chemotherapy with or without radiotherapy. However, this system does not accurately reflect segregation of patients into homogenous prognostic groups. Therefore, a variety of new staging system have been proposed as more intensive treatments including either intensive radiotherapy or surgery enter clinical trials. We evaluate the prognostic importance of TNM staging, which has the advantage of providing a uniform detailed classification of tumor spread, in patients with SCLC. Methods: The medical records of 166 patients diagnosed with SCLC between January 1989 and December 1996 were reviewed retrospectively. The influence of TNM stage on survival was analyzed in 147 patients, among 166 patients, who had complete TNM staging data. Results: Three patients were classified in stage I / II, 15 in stage III a, 78 in stage IIIb and 48 in stage IV. Survival rate at 1 and 2 years for these patients were as follows: stage I / II, 75% and 37.5% ; stage IIIa, 46.7% and 25.0% ; stage III b, 34.3% and 11.3% ; and stage IV, 2.6% and 0%. The 2-year survival rates for 84 patients who received chemotherapy(more than 2 cycles) with or without radiotherapy were as follows: stage I / II, 37.5% ; stage rna, 31.3% ; stage IIIb 13.5% ; and stage IV 0%. Overall outcome according to TNM staging was significantly different whether or not received treatment. However, there was no significant difference between stage IIIa and stage IIIb though median survival and 2-year survival rate were higher in stage IIIa than stage IIIb. Conclusion: These results suggest that the TNM staging system may be helpful for predicting the prognosis of patients with SCLC.

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Clinical Applications and Efficacy of Korean Ginseng (고려인삼의 주요 효능과 그 임상적 응용)

  • Nam, Ki-Yeul
    • Journal of Ginseng Research
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    • v.26 no.3
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    • pp.111-131
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    • 2002
  • Korean ginseng (Panax ginseng C.A. Meyer) received a great deal of attention from the Orient and West as a tonic agent, health food and/or alternative herbal therapeutic agent. However, controversy with respect to scientific evidence on pharmacological effects especially, evaluation of clinical efficacy and the methodological approach still remains to be solved. Author reviewed those articles published since 1980 when pharmacodynamic studies on ginseng have intensively started. Special concern was paid on metabolic disorders including diabetes mellitus, circulatory disorders, malignant tumor, sexual dysfunction, and physical and mental performance to give clear information to those who are interested in pharmacological study of ginseng and to promote its clinical use. With respect to chronic diseases such as diabetes mellitus, atherosclerosis, high blood pressure, malignant disorders, and sexual disorders, it seems that ginseng plays preventive and restorative role rather than therapeutics. Particularly, ginseng plays a significant role in ameliorating subjective symptoms and preventing quality of life from deteriorating by long term exposure of chemical therapeutic agents. Also it seems that the potency of ginseng is mild, therefore it could be more effective when used concomitantly with conventional therapy. Clinical studies on the tonic effect of ginseng on work performance demonstrated that physical and mental dysfunction induced by various stresses are improved by increasing adaptability of physical condition. However, the results obtained from clinical studies cannot be mentioned in the indication, which are variable upon the scientist who performed those studies. In this respect, standardized ginseng product and providing planning of the systematic clinical research in double-blind randomized controlled trials are needed to assess the real efficacy for proposing ginseng indication. Pharmacological mode of action of ginseng has not yet been fully elucidated. Pharmacodynamic and pharmacokinetic researches reveal that the role of ginseng not seem to be confined to a given single organ. It has been known that ginseng plays a beneficial role in such general organs as central nervous, endocrine, metabolic, immune systems, which means ginseng improves general physical and mental conditons. Such multivalent effect of ginseng can be attributed to the main active component of ginseng,ginsenosides or non-saponin compounds which are also recently suggested to be another active ingredients. As is generally the similar case with other herbal medicines, effects of ginseng cannot be attributed as a given single compound or group of components. Diversified ingredients play synergistic or antagonistic role each other and act in harmonized manner. A few cases of adverse effect in clinical uses are reported, however, it is not observed when standardized ginseng products are used and recommended dose was administered. Unfavorable interaction with other drugs has also been suggested, which the information on the products and administered dosage are not available. However, efficacy, safety, interaction or contraindication with other medicines has to be more intensively investigated in order to promote clinical application of ginseng. For example, daily recommended doses per day are not agreement as 1-2g in the West and 3-6 g in the Orient. Duration of administration also seems variable according to the purpose. Two to three months are generally recommended to feel the benefit but time- and dose-dependent effects of ginseng still need to be solved from now on. Furthermore, the effect of ginsenosides transformed by the intestinal microflora, and differential effect associated with ginsenosides content and its composition also should be clinically evaluated in the future. In conclusion, the more wide-spread use of ginseng as a herbal medicine or nutraceutical supplement warrants the more rigorous investigations to assess its effacy and safety. In addition, a careful quality control of ginseng preparations should be done to ensure an acceptable standardization of commercial products.

The Classification System and Information Service for Establishing a National Collaborative R&D Strategy in Infectious Diseases: Focusing on the Classification Model for Overseas Coronavirus R&D Projects (국가 감염병 공동R&D전략 수립을 위한 분류체계 및 정보서비스에 대한 연구: 해외 코로나바이러스 R&D과제의 분류모델을 중심으로)

  • Lee, Doyeon;Lee, Jae-Seong;Jun, Seung-pyo;Kim, Keun-Hwan
    • Journal of Intelligence and Information Systems
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    • v.26 no.3
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    • pp.127-147
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    • 2020
  • The world is suffering from numerous human and economic losses due to the novel coronavirus infection (COVID-19). The Korean government established a strategy to overcome the national infectious disease crisis through research and development. It is difficult to find distinctive features and changes in a specific R&D field when using the existing technical classification or science and technology standard classification. Recently, a few studies have been conducted to establish a classification system to provide information about the investment research areas of infectious diseases in Korea through a comparative analysis of Korea government-funded research projects. However, these studies did not provide the necessary information for establishing cooperative research strategies among countries in the infectious diseases, which is required as an execution plan to achieve the goals of national health security and fostering new growth industries. Therefore, it is inevitable to study information services based on the classification system and classification model for establishing a national collaborative R&D strategy. Seven classification - Diagnosis_biomarker, Drug_discovery, Epidemiology, Evaluation_validation, Mechanism_signaling pathway, Prediction, and Vaccine_therapeutic antibody - systems were derived through reviewing infectious diseases-related national-funded research projects of South Korea. A classification system model was trained by combining Scopus data with a bidirectional RNN model. The classification performance of the final model secured robustness with an accuracy of over 90%. In order to conduct the empirical study, an infectious disease classification system was applied to the coronavirus-related research and development projects of major countries such as the STAR Metrics (National Institutes of Health) and NSF (National Science Foundation) of the United States(US), the CORDIS (Community Research & Development Information Service)of the European Union(EU), and the KAKEN (Database of Grants-in-Aid for Scientific Research) of Japan. It can be seen that the research and development trends of infectious diseases (coronavirus) in major countries are mostly concentrated in the prediction that deals with predicting success for clinical trials at the new drug development stage or predicting toxicity that causes side effects. The intriguing result is that for all of these nations, the portion of national investment in the vaccine_therapeutic antibody, which is recognized as an area of research and development aimed at the development of vaccines and treatments, was also very small (5.1%). It indirectly explained the reason of the poor development of vaccines and treatments. Based on the result of examining the investment status of coronavirus-related research projects through comparative analysis by country, it was found that the US and Japan are relatively evenly investing in all infectious diseases-related research areas, while Europe has relatively large investments in specific research areas such as diagnosis_biomarker. Moreover, the information on major coronavirus-related research organizations in major countries was provided by the classification system, thereby allowing establishing an international collaborative R&D projects.