• Journal of Trauma and Injury
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• v.31 no.3
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• pp.143-150
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• 2018

Purpose: We have implemented a multi-disciplinary Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol to prevent individuals who sustained alcohol-related traumatic injuries. We therefore conducted this single-center, prospective, randomized, controlled trial (RCT) to assess its efficacy. Methods: All the enrolled patients (n=30) were randomized to either the SBIRT group or the control group. In the current RCT, the proportion of the patients who reduced the amount of alcohol consumption and those who received a specialized treatment served as primary outcome measures. Moreover, changes in a 3-item version of the Alcohol Use Disorders Identification Test Consumption (AUDIT-C), Severity of Dependence Scale (SDS) and Kessler Psychological Distress Scale (K-6) scores at 3 months from baseline served as secondary outcome measures. Results: At 3 months, the proportion of the patients who reduced the amount of alcohol consumption was significantly higher in the SBIRT group as compared with the control group (86.7% vs. 57.1%, p=0.02). Moreover, the proportion of the patients who received a specialized treatment was also significantly higher as compared with the control group (26.7% vs. 1.4%, p=0.01). Furthermore, there were significant differences in changes in the AUDIT, SDS and K-6 scores at 3 months from baseline between the two groups (p<0.05). Conclusions: In conclusion, our results indicate that the SBIRT is effective in reducing hazardous and harmful levels of drinking, the degree of alcohol dependence and that of psychological distress in at-risk drinkers.

• Sleep Medicine and Psychophysiology
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• v.23 no.2
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• pp.84-92
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• 2016

Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), 'Bioguard,' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose 'Bioguard' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD 'Bioguard' should be considered as an alternative treatment option for OSA patients.

• Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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• v.9 no.2
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• pp.115-127
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• 1998

Laryngopharyngeal reflux(LPR) is one firm of the gastroesophageal reflux diseases(GERD). It is known to cause various kinds of otolaryngologic symptoms such as hoarseness, foreign body sensation in throat, chronic throat clearing, chronic cough, etc. Disease entities diagnosed by otolaryngologists as posterior laryngitis, globus pharyngeus should be suspected as LPR-related diseases. In this multi-center trial, we tried to evaluate the effect of cisapride(10mg tid) on LPR-related symptoms as the part I study(CIS-KOR-051) in 19 centers, and as the part II study(CIS-KOR-052) comparative evaluation of effect between cisapride(10mg tid) and ranitidine(150mg bid) on LPR-related symptoms in 4 centers. In part I study, efficacy of cisapride on LPR-related symptoms after 4 weeks was 53.5% and that of after 8weeks was 77.9% in per protocol(PPA) analysis group. In part II study, efficacy of the cisapride was much better than that of ranitidine not only from 8 weeks trial(p<0.001) but also from 4 weeks trial(p<0.021) in PPA group. In the multiple logistic regression analysis among the parameters which affect the efficacy of the treatment, cisapride prescribed group showed 10 times greater than that of ranitidine prescribed group(p<0.0001, Odds ratio : 10) in PPA group. LPR was proved by 24Hr double probe pHmetry in 13 patients out of 19 patients tested(68.4%). Thus these results indicated that inducing the improvement of motility functions could affect the amelioration of the LPR-related symptoms much better than reducing acid secretion from the stomach. And maybe it suggests that LPR-related symptoms mainly developed by the reduced motility functions of the esophagus and/or delayed gastric emptying.

• Journal of Gastric Cancer
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• v.13 no.3
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• pp.164-171
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• 2013

Purpose: Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. Materials and Methods: Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopyassisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. Discussion: Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).

• Journal of Institute of Control, Robotics and Systems
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• v.22 no.2
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• pp.133-138
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• 2016

This paper describes the track initiation and target-tracking filter for ship tracking in a marine environment by using Light Detection And Ranging (LiDAR). LiDAR with three-dimensional scanning capability is more useful for target tracking in the short to medium range compared to RADAR. LiDAR has rotating multi-beams that return point clouds reflected from targets. Through preprocessing the cluster of the point cloud, the center point can be obtained from the cloud. Target tracking is carried out by using the center points of targets. The track of the target is initiated by investigating the normalized distance between the center points and connecting the points. The regular track obtained from the track initiation can be maintained by the target-tracking filter, which is commonly used in radar target tracking. The target-tracking filter is constructed to track a maneuvering target in a cluttered environment. The target-tracking algorithm including track initiation is experimentally evaluated in a sea-trial test with several boats.

• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.11-24
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• 2007

Objectives : Hemiplegic shoulder pain is one of the common sequelae of stroke. Although many different methods of treatment are applied, none have yet been proved to be effective. In this study we assessed the effectiveness of bee venom in patients with shoulder pain after stroke. Methods : This study was a double blinded, randomized, placebo-controlled clinical trial. All subjects received either 0.6 ml bee venom injection (venom:saline = 1:10000) or 0.6ml physiological saline solution (placebo) at three acupoints. The effectiveness was assessed by visual analogue scale, pain rating score, Fugl-Meyer assessment and passive external rotation. Results : There were 24 patients in the venom group and 22 patients in the placebo group. The venom group5,hewed more effectiveness in VAS and PRS than the placebo group. Conclusions : This study suggests that bee venom injection has significant analgesic effect on hemiplegic shoulder pain. Further study based on multi-centers, larger population, and long term 1311ow-up is needed to confirm this suggestion.

• The korean journal of orthodontics
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• v.46 no.2
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• pp.104-110
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• 2016

Objective: Traditional retainers (both metal and fiber-reinforced composite [FRC]) have limitations, and a retainer made from more flexible ligature wires might be advantageous. We aimed to compare an experimental design with two traditional retainers. Methods: In this prospective preliminary clinical trial, 150 post-treatment patients were enrolled and randomly divided into three groups of 50 patients each to receive mandibular canine-to-canine retainers made of FRC, flexible spiral wire (FSW), and twisted wire (TW). The patients were monitored monthly. The time at which the first signs of breakage/debonding were detected was recorded. The success rates of the retainers were compared using chi-squared, Kaplan-Meier, and Cox proportional-hazard regression analyses (${\alpha}=0.05$). Results: In total, 42 patients in the FRC group, 41 in the FSW group, and 45 in the TW group completed the study. The 2-year failure rates were 35.7% in the FRC group, 26.8% in the FSW group, and 17.8% in the TW group. These rates differed insignificantly (chi-squared p = 0.167). According to the Kaplan-Meier analysis, failure occurred at 19.95 months in the FRC group, 21.37 months in the FSW group, and 22.36 months in the TW group. The differences between the survival rates in the three groups were not significant (Cox regression p = 0.146). Conclusions: Although the failure rate of the experimental retainer was two times lower than that of the FRC retainer, the difference was not statistically significant. The experimental TW retainer was successful, and larger studies are warranted to verify these results.

• Journal of Genetic Medicine
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• v.20 no.1
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• pp.6-14
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• 2023

Fabry disease (FD), a rare X-linked lysosomal storage disorder, is caused by mutations in the α-galactosidase A gene gene encoding α-galactosidase A (α-Gal A). The functional deficiency of α-Gal A results in progressive accumulation of neutral glycosphingolipids, causing multi-organ damages including cardiac, renal, cerebrovascular systems. The current treatment is comprised of enzyme replacement therapy (ERT), oral pharmacological chaperone therapy and adjunctive supportive therapy. ERT has been introduced 20 years ago, changing the outcome of FD patients with proven effectiveness. However, FD patients have many unmet needs. ERT needs a life-long intravenous therapy, inefficient bio-distribution, and generation of anti-drug antibodies. Migalastat, a pharmacological chaperone, augmenting α-Gal A enzyme activity only in patients with mutations amenable to the therapy, is now available for clinical practice. Furthermore, these therapies should be initiated before the organ damage becomes irreversible. Development of novel drugs aim at improving the clinical effectiveness and convenience of therapy. Clinical trial of next generation ERT is underway. Polyethylene glycolylated enzyme has a longer half-life and potentially reduced antigenicity, compared with standard preparations with longer dosing interval. Moss-derived enzyme has a higher affinity for mannose receptors, and seems to have more efficient access to podocytes of kidney which is relatively resistant to reach by conventional ERT. Substrate reduction therapy is currently under clinical trial. Gene therapy has now been started in several clinical trials using in vivo and ex vivo technologies. Early results are emerging. Other strategic approaches at preclinical research level are stem cell-based therapy with genome editing and systemic mRNA therapy.

• Clinical Nutrition Research
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• v.12 no.4
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• pp.269-282
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• 2023

Vitamin D participates in the biological function of the innate and adaptive immune system and inflammation. We aim to specify the effectiveness of the vitamin D supplementation on the side effects BioNTech, Pfizer vaccination, and immunoglobulin G response against severe acute respiratory syndrome coronavirus 2 in subjects tested positive for coronavirus disease 2019 (COVID-19). In this multi-center randomized clinical trial, 498 people tested positive for COVID-19 were divided into 2 groups, receiving vitamin D capsules or a placebo (1 capsule daily, each containing 600 IU of vitamin D) over 14-16 weeks. Anthropometric indices and biochemical parameters were measured before and after the second dose of vaccination. Fourteen to 16 weeks after supplementation, the intervention group had an immunoglobulin G (IgG) increase of 10.89 ± 1.2 g/L, while the control group had 8.89 ± 1.3 g/L, and the difference was significant between both groups (p = 0.001). After the second dose of vaccination, the supplement group significantly increased their 25-hydroxy vitamin D from initially 28.73 ± 15.6 ng/mL and increased to 46.48 ± 27.2 ng/mL, and the difference between them was significant. Those with a higher body mass index (BMI) had the most of symptoms, and the difference of side effects according to BMI level was significantly different. In 8 weeks after supplementation obese participants had the lowest IgG levels than overweight or normal subjects. The proportion of all types of side effects on the second dose was significantly diminished compared with the first dose in the intervention group. Supplementation of 600 IU of vitamin D3 can reduce post-vaccination side effects and increase IgG levels in participants who received BioNTech, Pfizer vaccine.

• The Korean Journal of Applied Statistics
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• v.28 no.6
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• pp.1209-1216
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• 2015

Competing-risks events are often observed in a clustered clinical study such as a multi-center clinical trial. We propose a joint modelling approach via a shared frailty term for competing risks survival data from a cluster. For the inference we use the hierarchical likelihood (or h-likelihood), which avoids an intractable integration. We derive the corresponding h-likelihood procedure. The proposed method is illustrated via the analysis of a practical data set.