• Title/Summary/Keyword: Clinical trial,

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The Usefulness and Safety of Natural Stent in a Canine Model of Tracheal Stenosis (Nd-YAG laser를 이용한 기관협착 동물모델에서 Natural 스텐트의 안전성 및 유효성 -Dumon 스텐트와의 비교 실험-)

  • Kim, Ho-Joong;Koh, Won-Jung;Suh, Gee-Young;Chung, Man-Pyo;Kim, Jhin-Gook;Suh, Soo-Won;Kwon, O-Jung
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.4
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    • pp.431-438
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    • 2002
  • Background : In order to investigate the usefulness and safety of Natural Stent, we performed this study in a canine model of tracheal stenosis induced using Nd-YAG laser. Materials and Methods : After tracheal stenosis was induced in 12 Mongrel dogs using Nd-YAG laser, either Dumon (n=6) or Natural (n=6) stent was inserted into the trachea. To assess the degree of stent migration and mucostasis, bronchoscopy was performed every week for 4 weeks, after which all stents were removed. One week after stent removal, tracheal stenosis was evaluated by bronchoscopy. Results : The degree of stent migration was not different between the dogs with Dumon stent ($3.0{\pm}0.8$) and those with Natural ($2.0{\pm}1.0$), nor was the degree of mucostasis, at Dumon ($1.7{\pm}0.5$) and Natural Stent ($1.5{\pm}0.6$), respectively. One week after stent removal, the degree of tracheal stenosis was not different between the Dumon ($1.5{\pm}0.5$) and the Natural group ($1.0{\pm}0.4$). In addition, there was no death and the degree of tracheal stenosis remained always within the safe limit (less than 2.0) in all animals. Conclusion : In a canine model of tracheal stenosis induced using Nd-YAG laser, the usefulness and safety of Natural Stent were similar to those of Dumon Stent. A clinical trial is necessary to document the usefulness and safety of Natural Stent in patients with tracheal stenosis.

Antithrombin-III as an early prognostic factor in children with acute lung injury (급성 폐손상 소아 환자에서 조기 예후 인자로서의 antithrombin-III)

  • Lee, Young Seung;Kim, Seonguk;Kang, Eun Kyeong;Park, June Dong
    • Clinical and Experimental Pediatrics
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    • v.50 no.5
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    • pp.443-448
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    • 2007
  • Purpose : To evaluate the potential prognostic value of the antithrombin-III (AT-III) level in the children with acute lung injury (ALI), we analyzed several early predictive factors of death including AT-III level at the onset of ALI and compared the relative risk of them for mortality. Methods : Over a 18-month period, a total of 198 children were admitted to our pediatric intensive care unit and 21 mechanically ventilated patients met ALI criteria, as defined by American-European consensus conference, i.e., bilateral pulmonary infiltrates and $PaO_2/FiO_2$ lower than 300 without left atrial hypertension. Demographic variables, hemodynamic and respiratory parameters, underlying diseases, as well as Pediatric Risk of Mortality-III (PRISM-III) scores and Lung Injury Score (LIS) at admission were collected. AT-III levels were measured within 3 hours after admission. These variables were compared between survivors and non-survivors and entered into a multiple logistic regression analysis to evaluate their independent prognostic roles. Results : The overall mortality rate was 38.1% (8/21). Non-survivors showed lower age, lower lung compliance, higher PEEP, higher oxygenation index (OI), lower arterial pH, lower $PaO_2/FiO_2$, higher PRISM-III score and LIS, and lower AT-III level. PRISM-III score, LIS, OI and decreased AT-III level (less than 70%) were independently associated with a risk of death and the odds ratio of decreased AT-III level for mortality is 2.75 (95% confidence interval; 1.28-4.12) Conclusion : These results suggest that the decreased level of AT-III is an important prognostic factor in children with ALI and the replacement of AT-III may be considered as an early therapeutic trial.

Favorable Outcome in Elderly Asian Patients with Metastatic Renal Cell Carcinoma Treated with Everolimus: The Osaka Urologic Oncology Group

  • Inamoto, Teruo;Azuma, Haruhito;Nonomura, Norio;Nakatani, Tatsuya;Matsuda, Tadashi;Nozawa, Masahiro;Ueda, Takeshi;Kinoshita, Hidefumi;Nishimura, Kazuo;Kanayama, Hiro-Omi;Miki, Tsuneharu;Tomita, Yoshihiko;Yoshioka, Toshiaki;Tsujihata, Masao;Uemura, Hirotsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.4
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    • pp.1811-1815
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    • 2014
  • Background: In clinical trials with no upper age limit, the proportion of older patients is usually small, probably reflecting the more conservative approach adopted by clinicians when treating the elderly. An exploratory analysis of elderly patients in the RECORD-1 Trial showed that patients ${\geq}$ 65 y.o. had superior median PFS than overall RECORD-1 population (5.4 months and 4.9 months, respectively). We investigated the efficacy, relative benefit and safety of Everolimus (EVE) as sequential therapy after failure of VEGFr-TKI therapy for older patients with metastatic renal cell cancer (mRCC), in daily practice. Materials and Methods: 172 consecutive IRB approved patients with mRCC (median age 65, M:F 135/37, 78% clear cell) who received salvage EVE at 39 tertiary institutions between October 2009 and August 2011 were included in this analysis. Some 31% had progressed on sunitinib, 22% on sorafenib, 1% on axitinib, 41% on sequential therapy, and 5% had received other therapy. Patients with brain metastases were not included and 95% of the patients had a ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 or 1. Previous radiotherapy was an exclusion criterion, but prior chemotherapy was permitted. Adequate organ function and hematologic parameters were mandatory. EVE administration was approved by the institutional review board at each participating institution and signed informed consent was obtained from all patients. Results: Median time of the whole cohort to last follow-up was 3.5 months (range 0.4-15.2 months). Forty four percent were continuing to take EVE at last followup. There were 86 (50%) patients ${\geq}$ 65 y.o. and 86 (50%) <65 y.o. The percentage of patients who showed PR/SD was higher in the older group than in the younger one (5.9%/61.2% vs 1.2%/46.5%, respectively). Median survival of older patients was also significantly longer (3.5 +/- 0.31 vs 3.1 +/- 0.34, hazard ratio=0.45, CI; 0.255-0.802). Analysis using Cox regression model adjusted for gender, PS, number of metastases, site of metastases, histology, smoking history and age detected an association between age and PFS (p=0.011). The frequency of adverse events in elderly patients treated with EVE was no greater than that in younger patients, although such toxicity may have had a greater impact on their quality of life. Conclusions: Older patients should not generally be excluded from accepted therapies (mTOR inhibitors after failure of VEGFr-TKI therapy) for mRCC.

Predictability of Impending Events for Death within 48 Hours in Terminal Cancer Patients (말기암환자에서 임박사건 간 48시간 임종예측도 비교)

  • Hwang, In-Cheol;Choi, Chung-Hyun;Kim, Kyoung-Kon;Lee, Kyoung-Shik;Suh, Heuy-Sun;Shim, Jae-Yong
    • Journal of Hospice and Palliative Care
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    • v.14 no.1
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    • pp.28-33
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    • 2011
  • Purpose: Recognition of impending death is crucial not only for efficient communication with the caregiver of the patient, but also determination of the time to refer to a separate room. Current studies simply list the events 'that have already occurred' around 48 hours before the death. This study is to analyze the predictability of each event by comparing the time length from 'change' to death. Methods: Subjects included 160 patients who passed away in a palliative care unit in Incheon. The analysis was limited to 80 patients who had medical records for the last week of their lives. We determined 9 symptoms and 8 signs, and established the standard of 'significant change' of each event before death. Results: The most common symptom was increased sleeping (53.8%) and the most common sign was decreased blood pressure (BP) (87.5%). The mean time to death within 48 hours was 46.8% in the case of resting dyspnea, 13.6% in the ease of low oxygen saturation, and 36.9% in the case of decreased BP. The symptom(s) which had the highest positive predictive value (PV) for death within 48 hours was shown to be resting dyspnea (83%), whereas the combination of resting dyspnea and confusion/delirium (65%) had the highest negative PV. As for the most common signs before death within 48 hours, the positive PVs were more than 95%, and the negative PV was the highest when decreased BP and low oxygen saturation were combined. The difference in survival patterns between symptoms and signs was significant. Conclusion: The most reliable symptoms to predict the impending death are resting dyspnea and confusion/delirium, and decline of oxygen saturation and BP are the reliable signs to predict the event.

Clinical Efficacy of Belotecan (CKD-602), Newly Developed Camptothecin Analog, in the 2nd Line Treatment of Relapsed Small Cell Lung Cancer (재발된 소세포폐암환자에서 이차 약제로 사용되는 Belotecan (CKD-602)의 임상적 효용성)

  • Ban, Hee-Jung;Oh, In-Jae;Kim, Kyu-Sik;Ju, Jin-Yung;Kwon, Yong-Soo;Kim, Yu-Il;Lim, Sung-Chul;Kim, Young-Chul
    • Tuberculosis and Respiratory Diseases
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    • v.66 no.2
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    • pp.93-97
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    • 2009
  • Background: Belotecan (Camtobell, CKD-602, Chongkundang Pharm., Korea), a camptothecin derivative, has anticancer effects by inhibiting topoisomerase I such as topotecan. This study observed the response, survival and toxicity of belotecan monotherapy after the failure of etoposide and platinum (EP). Methods: Forty nine small cell lung cancer (SCLC) patients (M/F=41/8; age, 64.5${\pm}$7.6 (mean${\pm}$SD) years), who failed in their first line chemotherapy were enrolled in this study. Twenty one SCLC patients showed relapsed lung cancer more than 90 days after their priorEP chemotherapy (sensitive relapse group, SR) and 28 patients relapsed within 90 days (refractory relapse group, RR). Results: The response rate was 25%. Eleven patients showed partial responses and 5 patients could not be checked. The response rate of the SR and RR patients was similar. The relative dose intensity was lower in the responders (78${\pm}$15%) than non-responders (83${\pm}$13%, p=0.03). The median survival time (MST) was 10.3 months (290 days). The MST of the non-responders and responders was 186 days (95% CI; 67-305) and 401 days (95% CI; 234-568, p=0.07), respectively. The median progression free survival (MPFS) was similar in the SR (79 days) and RR (67 days) patients. Grade 3-4 neutropenia, anemia, and thrombocytopenia were observed in 59.6%, 12.8% and 23.4% of patients, respectively. Conclusion: The efficacy and survival were demonstrated in the second-line setting. However, a randomized comparative trial with topotecan will be needed.

The Relation of BMI, Smoking and Drinking with Biomedical Parameters in 20s and 30s Men (20~30대 성인 남성에서 체질량지수, 흡연량 및 음주량과 혈액검사치의 관련성)

  • Kim, Chul-Gyu
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.10
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    • pp.4425-4433
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    • 2011
  • The purpose of this study was to explore the relation of BMI, smoking and drinking with biomedical parameters in 20s and 30s men. This was a retrospective exploratory study and the subjects were 603 men who participated in health check-up for clinical trial at a tertiary hospital between October 2006 and June 2011. RBC, hemoglobin(Hb), hematocrit(Hct), triglyceride(TG), uric acid(UA), ALT in obese group were significantly higher than those of normal weight group. WBC and Hb in smokers were significantly higher than those of nonsmokers, protein in smokers was significantly lower than that of nonsmokers. Platelet in moderate smokers who smoke 10~19 cigarettes a day was significantly higher than that of nonsmokers and light smokers who smoke below 10 cigarettes a day, albumin in moderate smokers was significantly lower than that of nonsmokers and light smokers. TG in moderate smokers was significantly higher than that of nonsmokers, and blood glucose(BG) in moderate smokers was significantly lower than that of nonsmokers. AST and ALT in drinkers who drink over 10g a day were significantly higher than those of nondrinkers. In regression, BMI was significant factors of increasing RBC, Hb, Hct, total cholesterol(TC), TG, BG, UA, AST and ALT. Smoking amount was significant factors of increasing WBC, Hb, Hct and TG, and was significant factors of decreasing BG and Ca. Smoking amount was significant factors of increasing TC, AST and ALT, and was significant factors of decreasing WBC. In conclusion, there was significant relations of BMI, smoking, and drinking with biomedical parameters such as Hb, TC, TG, and ALT in young-aged men. Therefore, practice of healthy lifestyle activities to include preventing obesity and heavy drinking, and quitting smoking needs to the 20s and 30s men for preventing lifestyle disease.

Open Clinical Trial of Morning Light Therapy in Sleep Disturbance of Alcohol Dependent Patients (알코올의존 환자에서의 수면장애에 대한 아침 광치료의 임상시도)

  • Ko, Young-Hoon;Joe, Sook-Haeng;Jeon, Seung-Kyu;Kim, Byoung-Kyu;Kwon, Sung-Min
    • Korean Journal of Psychosomatic Medicine
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    • v.11 no.2
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    • pp.196-204
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    • 2003
  • Objectives: It is known that sedative hypnotics would make cross tolerance with alcohol and deteriorate quality of sleep in alcoholics. Light therapy is effective non-pharmacological intervention for sleep disturbance in circadian phase disorders, jet-lag, shift-work and age-related sleep disorders. Authors would investigate the effects of morning light therapy on sleep of patients with alcohol dependence during recovery state without withdrawal symptoms. Methods: 13 patients with alcohol dependence who have not any alcohol withdrawal symptom were recruited. Light therapy during 1 hour in the morning had been administered by 2500 Lux light box through serial 3 days. Sleep state of subjects were assessed by sleep log and the subjective satisfaction at sleep was by 100 mm visual analogue scale. Sleepiness, depressive mood, anxiety were evaluated by 100mm visual analogue scale at 8 AM, 2 PM and 8 PM. For assessment of performance ability that would be associated with sleepiness and vigilance, trail making test A, B and digit symbol substitution test were performed by two times on base line and 4th day. Univariate repeated-measures ANOVAs were performed for each measures except performance tests which were analysed by paired t-test. Results: Sleep latency and sleep efficiency were significantly improved with light therapy and satisfaction at sleep was. There was no significant difference in sleepiness at 2 PM with light therapy but sleepiness at 8 AM significantly decreased and at 8 PM increased. The time to complete Trail making test and digit symbol substitution test were significantly shortened at 4th day compared with baseline. Fatigue at 8 AM were not significantly changed with light therapy but at 2 PM and 8 PM significantly decreased. Depressive mood and anxiety were not significantly changed with light therapy. Conclusion: Although this study had some limitations, it showed that light therapy would be effective modality on sleep disturbance of patients with alcohol dependence who have recovered from alcohol withdrawal symptoms. It is proposed that short term light therapy could be used clinically for alcoholics with insomnia. In the future, long term controlled studies using more objective tools for sleep are required to further investigate the effect of light therapy in alcoholics.

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Preliminary Result in Patients with Primary Hepatoma Treated by Stereotactic Radiotherapy (원발성 간암에 대한 정위방사선치료의 예비결과)

  • Kang Ki Mun;Choi Ihl Bohng;Kim In Ah;Choi Byung Ock;Kang Young Nam;Chai Gyu Young;Han Sung Tae;Chung Gyu Won
    • Radiation Oncology Journal
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    • v.19 no.1
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    • pp.34-39
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    • 2001
  • Purpose : It is not common to evaluate the response of the fractionated stereotactic radiotherapy (SRT) to primary hepatoma as compared with conventional radiotherapy. The purpose of the study was to take the preliminary result on the clinical trial of primary hepatoma by SRT. Materials and Methods : From July 1999 to March 2000, thirty three patients were hospitalized in the St. Mary's Hospital, and treated with SRT for extracranial tumors. Among them, 13 patients were diagnosed to primary hepatoma and then applied by frameless SRT using 6 MV linac accelerator. There were 12 male and 1 female patients. They had the age of $ 44\~66$ year old (median : 59) and the tumor size of $10\~825\;cc$ (median : 185 cc). SRT was given to them $3\~5$ fractions a week (5 Gy/fraction, $90\%$ isodose line) for $2\~3$ weeks. Median dose of SRT was 50 Gy and the range was $30\~50\;Gy$. Results : Follow-up period ranged from 3 months to 13 months with median of 8 months. After treating SRT to thirteen patients with primary hepatoma, the response of the tumor was examined by abdominal CT : they are classified by 1 complete regression $(7.7\%)$, 7 partial regression $(53.8\%)$, 4 minimal regression $(30.8\%)$, 1 stable disease $(7.7\%)$. The positive responses more than partial remission were 8 patients $(61.5\%)$ after the treatment. The level of serum alpha-fetoprotein (AFP) after the treatment as compared with pretreatment had been $92.3\%$ decreased. There was no severe complication except dyspepsia $84.6\%$, mild nausea $69.2\%$, transient decreased of hepatic function $15.4\%$ and fever $7.7\%$. Conclusion : SRT to the patients with primary hepatoma was potentially suggested to become the safe and more effective tool than the conventional radiotherapy even though there were relatively short duration of follow-up and small numbers to be tested.

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Combined Effects of Gamma-irradiation and Hyperthermia on the Human Cell Lines for Various Temperatures and Time Sequences (감마선과 온열치료 병용시 세포 치사 능력 증강에 관한 실험적 연구)

  • Koh Kyung Hwan;Cho Chul Koo;Park Woo Yoon;Yoo Seong Yul;Yun Hyong Geun;Shim Jae Won;Lee Mi Jung
    • Radiation Oncology Journal
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    • v.11 no.1
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    • pp.51-58
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    • 1993
  • We tried to establish the theoretical basis of clinical use of combined modality of hyperthermia and radiation therapy. For this purpose, we made an in vitro experiment in order to get the synergistic and/or additive effects on the cell killing of hyperthermia combined with radiation therapy by using the microwave-hyperthermia machine already installed at our department. In our experiment, we use two human cell lines: MKN-45 (adenocarcinoma of stomach) and K-562 (leukemia cell lines). In cases of combined treatments of hyperthermia and gamma-irradiation, the therapeutic effect was the highest in the simultaneous trial. Hyperthermia after gamma irradiation showed slightly higher therapeutic effect than that before irradiation without significant difference, but its effect was the same in the interval of 6 hours between hyperthermia and irradiation. The higher temperature and the longer treatment time were applied, the higher therapeutic effects were observed. We could observe the thermoresistance by time elapse at $43^{\circ}C$. When hyperthermia was done for 30 minutes at the same temperature, thermal enhancement ratio (TER) at DO. 01 (dose required surviving fraction of 0.01) were $2.5{\pm}0.08,\;3.75{\pm}0.18$, and $5.0{\pm}0.15\;at\;436{\circ}C,\;44^{\circ}C,\;and\;45^{\circ}C$ respectively in K-562 leukemia cell lines. Our experimental data showed that more cell killing effect can be obtained in the leukemia cell lines, although they usually are known to be radiosensitive, when treated with combined hyperthermia and radiation therapy. Furthermore, our data show that leukemia cell lines may have various intrinsic radiosensitivity, especially in vitro experiments. The magnitude of cell killing effect, however, will be less than that of MKN-45.

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Bladder And Rectum Dose Define 3D Treatment Planning for Cervix Cancer Brachtherapy Comparison of Dose-Volume Histograms for Organ Contour and Organ Wall Contour (자궁경부암의 고선량률 근접치료시 장기묘사 방법에 따른 직장과 방광의 선량비교 분석)

  • Kim, Jong-Won;Kim, Dae-Hyun;Choi, Joon-Yong;Won, Yeong-Jin
    • Journal of radiological science and technology
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    • v.35 no.4
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    • pp.327-333
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    • 2012
  • Purpose: To analyze the correlation between dose volume histograms(DVH) based on organ outer wall contour and organ wall delineation for bladder and rectum, and to compare the doses to these organs with the absorbed doses at the bladder and rectum. Material and methods: Individual CT based brachytherapy treatment planning was performed in 13 patients with cervical cancer as part of a prospective comparative trial. The external contours and the organ walls were delineated for the bladder and rectum in order to compute the corresponding dose volume histograms. The minimum dose in 0.1 $cm^3$, 1 $cm^3$, 2 $cm^3$, 5 $cm^3$, 10 $cm^3$ volumes receiving the highest dose were compared with the absorbed dose at the rectum and bladder reference point. Results: The bladder and rectal doses derived from organ outer wall contour and computed for volumes of 2 $cm^3$, provided a good estimate for the doses computed for the organ wall contour only. This correspondence was no longer true when large volumes were considered. Conclusion: For clinical applications, when volumes smaller than 5 $cm^2$ are considered, the dose-volume histograms computed from external organ contours for the bladder and rectum can be used instead of dose -volume histograms computed for the organ walls only. External organ contours are indeed easier to obtain. The dose at the ICRU rectum reference point provides a good estimate of the rectal dose computed for volumes smaller than 2 $cm^2$ only for a midline position of the rectum. The ICRU bladder reference point provides a good estimate of the dose computed for the bladder wall only in cases of appropriate balloon position.