• The Journal of Korean Medicine
• /
• v.28 no.3 s.71
• /
• pp.116-125
• /
• 2007

Objective : To overview the protocols of clinical acupuncture research on cancer in the USA. Methods : Using 'acupuncture' and 'cancer' as keyword search terms in Clinical Trials. gov, 28 clinical studies were found. Three studies by non-American institutions were excluded and 25 studies were analyzed. Analytic parameters were cancer condition, primary outcome, research institution, study design, and acupuncture intervention. Results : Breast cancer was the most frequent single condition in the searched protocols. Pain and quality of life were the primary outcomes in many studies. Memorial Sloan-Kettering Cancer Centerin New York has performed the largest number of acupuncture cancer studies. The majority of studies were randomized controlled trials with active controls or placebo/sham controls. Total enrollment varied between the range of 10 and 700 subjects and ages of these subjects were at least above 18 years old (except one protocol). Most protocols had strict exclusion criteria for acupuncture needling such as bleeding disorders, infection, heart disorder, and central nervous system disorder. Conclusions : Clinical acupuncture studies for cancer patients have focused on pain, quality of life, and side effects induced by anti-cancer therapies. Re-evaluation and cautions for strict exclusion criteria in foreign countries are required to perform multi-national acupuncture trials.

• Communications for Statistical Applications and Methods
• /
• v.25 no.3
• /
• pp.321-328
• /
• 2018

In clinical trials with repeated measurements, the time-averaged difference (TAD) may provide a more powerful evaluation of treatment efficacy than the rate of changes over time when the treatment effect has rapid onset and repeated measurements continue across an extended period after a maximum effect is achieved (Overall and Doyle, Controlled Clinical Trials, 15, 100-123, 1994). The sample size formula has been investigated by many researchers for the evaluation of TAD in two treatment groups. For the evaluation of TAD in multi-arm trials, Zhang and Ahn (Computational Statistics & Data Analysis, 58, 283-291, 2013) and Lou et al. (Communications in Statistics-Theory and Methods, 46, 11204-11213, 2017b) developed the sample size formulas for continuous outcomes and count outcomes, respectively. In this paper, we derive a sample size formula to evaluate the TAD of the repeated binary outcomes in multi-arm trials using the generalized estimating equation approach. This proposed sample size formula accounts for various correlation structures and missing patterns (including a mixture of independent missing and monotone missing patterns) that are frequently encountered by practitioners in clinical trials. We conduct simulation studies to assess the performance of the proposed sample size formula under a wide range of design parameters. The results show that the empirical powers and the empirical Type I errors are close to nominal levels. We illustrate our proposed method using a clinical trial example.

• The Journal of Internal Korean Medicine
• /
• v.40 no.3
• /
• pp.287-294
• /
• 2019

Objectives: This study aimed to investigate the clinical characteristics of patients with gastroesophageal reflux disease (GERD) according to globus sensation (GS). Methods: We reviewed the clinical records of 29 GERD patients who visited the Department of Digestive Diseases of Kyung Hee University Korean Medicine Hospital from March 1, 2018 to February 28, 2019. The subjects were classified according to the presence of globus sensation, and the two groups were compared in terms of heart rate variability (HRV) and the Ryodoraku results. Results: In comparing the GERD with GS group (GS group) and the GERD without GS group (non-GS group), a significant difference was found in the duration of symptom and several HRV parameters. The duration of the symptom in the GS group was significantly longer than that in the non-GS group. The non-GS group showed a significantly higher value of total power and high frequency than the GS group. Conclusions: The results suggest a significant difference in the stress level between patients with GERD with GS and those without GS. When approaching patients with GERD without GS, their stress status should be considered.

• Asian Pacific Journal of Cancer Prevention
• /
• v.14 no.10
• /
• pp.6019-6023
• /
• 2013

Lung cancer, one of the leading causes of cancer-related deaths, usually appears as solitary pulmonary nodules (SPNs) which are hard to diagnose using the naked eye. In this paper, curvelet-based textural features and clinical parameters are used with three prediction models [a multilevel model, a least absolute shrinkage and selection operator (LASSO) regression method, and a support vector machine (SVM)] to improve the diagnosis of benign and malignant SPNs. Dimensionality reduction of the original curvelet-based textural features was achieved using principal component analysis. In addition, non-conditional logistical regression was used to find clinical predictors among demographic parameters and morphological features. The results showed that, combined with 11 clinical predictors, the accuracy rates using 12 principal components were higher than those using the original curvelet-based textural features. To evaluate the models, 10-fold cross validation and back substitution were applied. The results obtained, respectively, were 0.8549 and 0.9221 for the LASSO method, 0.9443 and 0.9831 for SVM, and 0.8722 and 0.9722 for the multilevel model. All in all, it was found that using curvelet-based textural features after dimensionality reduction and using clinical predictors, the highest accuracy rate was achieved with SVM. The method may be used as an auxiliary tool to differentiate between benign and malignant SPNs in CT images.

• Journal of Periodontal and Implant Science
• /
• v.39 no.2
• /
• pp.157-166
• /
• 2009

Purpose: There are numerous reports about the usefulness of antibiotics such as doxycycline or metronidazole in the conventional treatment for the patients with chronic periodontal diseases. However, seldom are the reports about effects of vitamins or nutraceuticals. The purpose of this study was to evaluate the effects of nutrient supplement including multiple vitamins and neutraceuticals with PRF-K2 from plants and seaweed in treatment of the patients with chronic periodontitis which is needed a nonsurgical or a surgical treatment by evaluating the clinical parameters and the gingival crevicular fluid volume. Methods: The systemically healthy and nonsmoking patients diagnosed with chronic periodontitis were divided into a nonsurgical group and a surgical group. They were also divided into the test group with nutrient supplements and the control group without nutrient supplements. In the nonsurgical group, the clinical parameters (probing depth, clinical attachment level, sulcus bleeding index, and plaque index) and the gingival crevicular fluid volume were checked on baseline, at 1 week, at 3 week and at 9 week after a supplement treatment. In the surgical group, the clinical parameters and the gingival crevicular fluid volume were also checked at 15 week after a surgical treatment. Results: In both nonsurgical and surgical groups, reduction of pocket depth and increment of clinical attachment level were revealed in the test group compared with the control group, but there was not statistically significant difference (p>0.05), and sulcus bleeding index was decreased with statistically significant difference (p<0.05). In addition, plaque index was decreased with statistically significant difference (p<0.05) in the nonsurgical group. Gingival crevicular fluid volume was decreased with statistically significant difference (p<0.05) at week 9 in both non-surgical and surgical groups. Conclusions: In conclusion, our results demonstrate that providing nutrient supplement in both nonsurgical or surgical periodontal treatments may improve gingival inflammation and gingival crevicular fluid.

• YAKHAK HOEJI
• /
• v.43 no.2
• /
• pp.160-168
• /
• 1999

The purpose of this study was to determine pharmacokinetic parameters of vancomycin using peak and trough plasma level (PTL) and Bayesian analysis in 20 Korean normal volunteers, 16 gastric cancer and 12 lymphoma patients and also using the compartment model dependent (nonlinear least squares regression: NLSR) and compartment model independent (Lagrange) analysis in 10 ovarian cancer patients. Nonparametric expected maximum (NPEM) algorithm for calculation of the population pharmacokinetic parameters was used, and these parameters were applied for clinical pharmacokinetic parameters by Bayesian analysis. Vancomycin was administered as dose of 1.0 g every 12 hrs for 3 days by IV infusion over 60 minutes in normal volunteers, gastric cancer and lymphoma patients. Population pharmacokinetic parameters, K and Vd in gastric cancer and lymphoma patients using NPEM algorithm were $0.158{\pm}0.014{\;}hr^{-1},{\;}0.630{\pm}0.043{\;}L/kg{\;}and{\;}0.131{\pm}0.0261{\;}hr^{-1},{\;}0.631{\pm}0.089{\;}L/kg$ respectively. The K and Vd in gastric cancer and lymphoma patients using Bayesian analysis were $0.151{\pm}0.027,{\;}0.126{\pm}0.056{\;}hr^{-1}{\;}and{\;}0.62{\pm}0.105,{\;}0.63{\pm}0.095{\;}L/kg$. The K and Vd in ovarian cancer patient using the NLSR and Lagrange analysis were $0.109{\pm}0.008,{\;}0.126{\pm}0.012{\;}hr^{-1}{\;}and{\;} 0.76{\pm}0.08,{\;}0.69{\pm}0.19{\;}L/kg$, respectively. It is necessary for effective dosage regimen of vancomycin in cancer patients to use these population parameters.

• Journal of Dental Rehabilitation and Applied Science
• /
• v.28 no.1
• /
• pp.37-46
• /
• 2012

The ultimate goal of periodontal therapy is the regeneration of supporting tissues. It is recommended to avoid probing until 6~9 months following the regenerative therapy because the probing may jeopardize the newly formed tissues. We can measure tooth mobility objectively using Periotest. The purpose of this study is to investigate whether Periotest can be used to evaluate the treatment results alternatively, and whether there are the correlations between the changes of Periotest value (PTV) and other clinical parameters. Regenerative treatments have been performed on 29 teeth of twenty five patients, at Department of Periodontology, Pusan National University Hospital. We measured the tooth mobility by Periotest and other parameters at the baseline, 6 and 12 months after regenerative treatment. Compared to the baseline, there were the statistically significant improvements in all the parameters at 6 months and 12 months. There were statistically significant correlations among the probing depth, attachment level, gingival recession and PTV at baseline, 6 months, and 12 months. Also there was the correlation between changes in PTV and in the attachment level at each time of observation period. We may conclude that regenerative therapy would improve the clinical parameters and periodontal status and PTV would be an alternative index to evaluate the healing process after regenerative surgery.

• Toxicological Research
• /
• v.16 no.2
• /
• pp.163-172
• /
• 2000

Recently, there is a worldwide concern that a great number of man-made chemicals have a hormone-like action both in humans and in animals. DECD is developing screening programs using validated test systems to determine whether certain substances may have an effect in humans. In the present study. the establishment oj repeated-dose toxicity test method was tried. Flutamide. an anti-androgenic agent. was administered by gavage to Sprague-Dawley rats for 28 days at dose levels of 0. 0.5. 3 and 18 mg/kg body weight (10-15 rats/sex/group) to examine the effects on general findings. especially reproductive and endocrine parameters. Clinical signs. body weights, food consumption, and sexual cycle were checked and measured. For the gross and microscopic examinations. 10 rats/sex/group were sacrificed at the end of dosing period and the remaining animals of control and high dose groups (5 each) were sacrificed after 14 days recovery. Examinations for hematology and clinical chemistry were carried out at necropsy. There were no treatment-related changes in clinical signs. body weights, food consumption. gross necropsy. hematology and clinical chemistry at all doses of both sexes. The period and regularity of sexual cycle were not adversely affected at all doses by the test agent. At 18 mg/kg. both decreased weights of prostate, seminal vesicle and epididymis in males and increased weights of spleen and thymus in females were observed. In addition, decreased number of spermatids and sperms. increased serum testosterone concentration and increased incidence (100%) of interstitial cell hyperplasia were seen in males. At 18 mg/kg of the recovery group. decreased prostate weight. reduced sperm count and increased incidence (20%) of interstitial cell hyperplasia in males and increased thymus weight in females were observed. At 3 mg/kg. reduced sperm count was found. There were no adverse effects on parameters examined at 0.5 mg/kg of both sexes. The results suggested that the potential target organs of flutamide may be accessory sexual glands including testes for males and spleen and thymus for females. Taken together. this test method was found to be a useful screening test system for endocrine disrupting chemicals.

• Tuberculosis and Respiratory Diseases
• /
• v.80 no.2
• /
• pp.179-186
• /
• 2017

Background: Although the World Health Organization (WHO) classification of lung squamous cell carcinoma (SCC) was revised in 2015, its clinical implications for lung SCC subsets remain unclear. We investigated whether the morphologic characteristics of lung SCC, including keratinization, were associated with clinical parameters and clinical outcome of patients. Methods: A total of 81 patients who underwent curative surgical resection of diagnosed lung SCC, were enrolled in this study. Attributes such as keratinization, tumor budding, single cell invasion, and nuclear size within the tumor, as well as immunohistochemistry of Bcl-xL and pS6 expressions, were evaluated. Results: The keratinizing and nonkeratinizing subtypes did not differ with respect to age, sex, TNM stage, and morphologic parameters such as nuclear diameter, tumor budding, and single cell invasion at the tumor edge. Most patients with the keratinizing subtype (98.0%) had a history of smoking, whereas the nonkeratinizing group had a relatively higher proportion of never-smokers relative to the keratinizing group (24.0% vs. 2.0%; p=0.008, chi-square test). Expression of pS6 (a surrogate marker of mammalian target of rapamycin complex 1 [mTORC1] signaling that regulates keratinocyte differentiation), and Bcl-xL (a key anti-apoptotic molecule that may inhibit keratinization), did not correlate significantly with the presence of keratinization. Patients with the keratinizing subtype had a significantly shorter overall survival (85.2 months vs. 135.7 months, p=0.010, log-rank test), and a multivariate analysis showed that keratinization was an independent, poor prognostic factor (hazard ratio, 2.389; 95% confidence interval, 1.090-5.233; p=0.030). Conclusion: In lung SCC, keratinization is associated with a poor prognosis, and might be associated with smoking.

• Annals of Clinical Neurophysiology
• /
• v.2 no.2
• /
• pp.89-94
• /
• 2000

Purpose : Carpal tunnel syndrome (CTS) is a disorder of median nerve at wrist. It is usually diagnosed through clinical manifestation and nerve conduction study (NCS). However, sometimes, NCS does not provide a reliable evidence to reach the diagnosis. Thus, authors performed this study to determine whether NCS was correlated with specific parameters measured on magnetic resonance imaging (MRI) which might become a potential complemental diagnostic tool. Methods : We performed MRI in 34 wrists of 18 patients with clinical manifestations of CTS and pathologic nerve conduction values and analyzed them at levels of the distal radioulnar joint, pisiform and hook of hamate, Results : Increase in the cross-sectional area of the median nerve at the pisiform level and flattening, increased signal intensity, and contrast enhancement of the median nerve at levels of the pisiform and hook of hamate were statistically significant. Change in cross sectional areas between the distal radioulnar joint and hamate and the signal intensities at levels of pisiform and hamate were well correlated with the median nerve conduction velocity. Conclusions : Characteristic MRI findings in CTS reported previously were well demonstrated and some of MRI parameters are well correlated with nerve conduction study. MRI, despite cost, may help in evaluating CTS.