• Title/Summary/Keyword: Trials

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A DOUBLE BLIND CROSS-OVER COMPARISON OF ANTIDEPRESSANT AND ANTIANXIETY EFFECTS OF PAROXETINE AND PLACEBO IN CHILD-ADOLESCENT AND ADULT DEPRESSIVE NEUROSIS (소아 ${\cdot}$ 청소년 및 성인 우울신경증 환자에 대한 Paroxetine의 항우울 및 항불안 효과 검증 : 위약과의 이중맹 교차 비교실험)

  • Kim, S. Peter;Hong, Kyung-Sue
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.5 no.1
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    • pp.83-92
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    • 1994
  • Paroxetine is a potent and selective serotoin re-uptake inhibitor. It is well known as an effective and safe antidepressant and increasingly used for neurotic or non-psychotic depression with anxiety symptoms. The present study assessed antidepressant and antianxiety efficacy and tolerability of paroxetine against placebo in child-adolescent and adult depressive neurosis patients. 232 subjects aged 8-55 years and meeting DSM-III-R criteria for depressive neurosis or dysthymia were divided into 8 subgroups according to their sex and age(8-11 yeard old, 12-17 years old, 18-35 years old and 36-55 years old subgroup in each male and female group). In each subgroup, the randomly assigned half of the patients were treated with paroxetine(10-30mg/day) and the others with placebo for the first 2 weeks in double blind fashion. After 1 week of drug-washout period, paroxetine and placebo groups were crossed over. The depression and anxiety symptoms were assessed with Hamilton Depression Scale(HDS) and Hamilton Anxiety Scale(HAS) at baseline and every 1 week during the trial periods. The levels of reduction in HDS and HAS scores from baseline after 2-week trial were compared between paroxetine- and placebo- treated periods by paired t-test. In all the 8 subgroups, statistically significant differences between paroxetine and placebo were found on the antidepressant efficacy after 2-week treatment. The antidepressant efficacy of paroxetine compared to placebo was most prominent in child and adolescent female groups. On anxiety symptoms, paroxetine was also significantly more effective than placebo. The antianxiety efficacy of paroxetine compared to placebo was most prominent in male and female child groups and young adult female group aged 18-35 years. As for the adverse effects of paroxetine, 3 out of 232 subjects reported mild indigestion and abdominal pain. however, in all the 3 cases, the symptoms improved without reduction of dosage or discontinuation of the drug. In conclusion, paroxetine showed significantly higher antidepressant and antianxiety efficacy compared to placebo in child-adolescent and adult depressive neurosis patients after 2-week treatment. Further trials of paroxetine in depressive neurosis are warranted to elucidate the long-term antidepressant and antianxiety efficacy of paroxetine.

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The influence of magnet on tissue healing after immediate implantation in fresh extraction sites in dogs (성견에서 발치 후 즉시 식립 임플란트에 설치한 자석이 주위 조직에 미치는 영향)

  • Yu, Seok-Min;Cho, In-Ho;Shin, Soo-Yeon
    • The Journal of Korean Academy of Prosthodontics
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    • v.47 no.4
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    • pp.435-444
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    • 2009
  • Statement of problem: The clinical use of electric and electomagnetic fields for fracture healing applications began in the early 1970s. Since then, several technologies have been developed and shown to promote healing of fractures. Developments of these devices have been aided in recent years by basic research and several well controlled clinical trials not only in the medical field but in dentistry. Purpose: The purpose of this study was to compare alveolar bone reduction following immediate implantation using implants onto which magnets were attached in fresh extracted sockets. Material and methods: Four mongrel dogs were involved. Full buccal and lingual mucoperiosteal flaps were elevated and third and fourth premolars of the mandible were removed. Implants with magnets and implants without magnets were installed in the fresh extracted sockets and after 3 months of healing the animals were sacrificed. The mandibles were dissected and each implant sites were sampled and processed for histological examination. Results: The marginal gaps that were present between the implant and walls of the sockets at the implantation stage disappeared in both groups as a result of bone fill and resorption of the bone crest. The buccal bone crests were located apical of its lingual counterparts. At the 12 week interval the mean of marginal bone resorption in the control group was significantly higher than that of the magnet group. The majority of specimens in magnet group presented early bone formation and less resorption of the buccal marginal bone compared to the control group. Conclusion: Within the limitations of this study, it could be concluded that implants with magnets attached in the early stages of implantation may provide more favorable conditions for early bone formation and reduce resorption and remodeling of marginal bone.

Profiles of Local Fibrinolytic Activity before and after Urokinase Injection Into the Human Empyema Cavity (농흉환자에서의 늑막강내 유로키나제주입 전후의 섬유소 용해에 관한 연구)

  • Kim, Yong-Hoon;Kim, Jong-Bong;Moon, Jong-Ho;Song, Dong-Wha;Kim, Hyeon-Tae;Yang, Dong-Ho;Lee, Sang-Moo;Uh, Soo-Taek;Park, Choon-Sik
    • Tuberculosis and Respiratory Diseases
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    • v.40 no.4
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    • pp.378-383
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    • 1993
  • Background: In recent reports, it has been reported that increased coagulation and decreased fibrinolytic activity has been responsible for abnormal fibrin turnover in exudative pleural effusion. In the cases of empyema, the fibrinopurulent stage is characterized by the fibrin deposition resulting in formation of limiting membranes in the visceral and parietal pleura. Recently attention has been focused on intrapleural fibrinolytic therapy capable of removing intrapleural fibrin deposits by urokinase (UK) in the treatment of empyema. However, these clinical trials have provided the clinical evidences for resolution of pleural loculation after intrapleural urokinase injection (UK-injection), the profiles of fibrinolytic activity following the treatment were still not investigated. Therefore in order to demonstrate the fibrinolytic evidences behind the clinical efficacy of intracavitary UK-injection, we examined intrapleural plasminogen activator activity (PA-activity) and D-dimer (D-Di) concentrations before and after each repeated UK-injection into the pleura in subjects with loculated empyema cavity. Methods: In a group of 14 patients with multiple loculated empyema cavity, PA-activity and D-Di concentrations were measured before and after repeated UK-injection. One hundred thousand IU of UK was injected at each time and all sujects had at least two times of UK injection accoring to clinical decisions. Nine out of 14 sujects had three times of UK-injection. Results: The mean (${\pm}SE$) PA-activity prior to treatemnt was $10.5{\pm}7.0$ and it was increased to $91.9{\pm}27.0,\;432.3{\pm}177.1,\;170.0{\pm}85.3$ IU tPA/ml after first, second and third time of UK-injection respectively (p<0.01). D-Di concentrations were also increased from $4.16{\pm}1.06{\times}10^5$ to $9.62{\pm}1.54{\times}10^5,\;12.31{\pm}1.89{\times}10^5,\;8.54{\pm}1.56{\times}10^5$ ng/ml in the same order as above (p<0.05). Conclusion: The suppressed fibrinolytic activity in the empyema cavity get removed sinificantly after inrracavitary injection of urokinase by generation of additional intrapleural plasmin.

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Development of Health Promotion Program through IUHPE - Possibilities of collaboration in East Asia - (IUHPE를 통한 건강 증진 프로그램의 발달-동아시아권의 공동연구의 가능성-)

  • Moriyama, Masaki
    • Proceedings of The Korean Society of Health Promotion Conference
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    • 2004.10a
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    • pp.1-16
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    • 2004
  • This paper considers the possibilities of health promotion from the following perspectives; (1) IUHPE, (2) socio-cultural similarities, (3) action research, and (4) learning from our past. 1. The IUHPE values decentralized activities through regions, and countries such as Japan, Korea, Hong Kong, Taiwan and China belong to NPWP region. Since IUHPE World Conference was held in Japan in 1995, Japan used to occupy more than 60% of NPWP membership. After 2001, membership is increasing rapidly in Chinese speaking sub-region. The transnational collaboration is still in its beginning phase. 2. Confucianism is one of key points. Confucian tradition should not be seen only as obstacles but as advantages to seek a form of health promotion more acceptable in East Asia. 3. Within the new public health framework, people are expected to create and live their health. However, especially in Japan, the tendency of 'lacking of face-to-face explicit interactions' is still common at health-promotion settings as well as academic settings. Therefore, the author tried participatory approaches such as asking WlFY (interactive questions designed for subjects to review their daily life and environment) and as introducing round table interactions. So far, majority of participants welcome new trials. 4. The following social phenomena are comparatively discussed after Japanese invasion and occupation of Korea ended in 1945; ·status of oriental medicine, ·separation of dispensary services, and ·health promotion specialist as a national license. In contrast to Japanese' tendency of maintaining the status quo and postponing of substantial social change, trend toward rapid and dynamic social changes are more commonly observed in Korea. Although all of above possibilities are still in their beginning stages, they are going to offer interesting directions waiting for further challenges and accompanying researches.

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Establishment of the Text Method for Evaluating the Fideld Resistance of Rice Varieties to Rice leaf Blight (벼 흰잎마름병 포장저항성 검정방법 체계 확립+)

  • Lee, Du-Gu;Sim, Jae-Seong
    • The Journal of Natural Sciences
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    • v.7
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    • pp.91-101
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    • 1995
  • To establish the simple and practical test method of estimating resistance of rice varieties against rice leafblight, trials were made to correlate among the four test methods such as true resistance test,secondaryinfection test, secondary epidemic test and field test. The results obtained through the experiment on 25 ricevarieties and 3 pathogenic isolates designated to HB9O11, HB9022 and HB9033 can be summarized asfollows. 1 .Based on the results of true resistance test, 25 rice varieties can be classified into four groups:1 )Samgang variety group ;resistant to HB9011, 13 varieties, 2)Pungsan variety group ; resistant to HB9011 and HB9022, 5 varieties, 3)Samgang variety group ; resistant to all three isolates, 2 varieties, 4)Unbongvariety group: sensitive to all three isolates, 12 varieties. 2. The responses of rice varieties to isolates showed some discrepancies among on the test methods. These examples were found in 3 varieties including Yeongdeog varieties to HB9011, 3 varieties including Taebaeg variety to HB9022 and Taebaek vaieties to HB9033. 3. Correlation coefficiences between the secondary infection test and the secondary epidemic test for HB9011, HB9022 and HB9033 were 0.972, 0.894 and 0.919, respectively. It suggests that the two methods are not significantly different so that one of the two methods are not significantly different so that one of the two methods can be omitted from resistant test without affecting the result. 4. Between the true resistance test and the field test at the disease common area, there were no significant correlations. Unbong, Chucheong and Yeongdeog varieties are appeared as resistant varieties in the true resistant test, but their responses in the field test were different and appeared as sensitive varieties. 5. The disease index was used to express theresults from four test methods. The disease index was calculated as the sum of each numerical values of theresults from the four test methods by giving the same weights(0 to 25)to each test method. If the disease index for certain variety is less than 15, then the variety is considered to be resistant. 4 varieties such as Seohae, Hwajin, Yeongdeog and Pungsan varieties-disease indices were less than 15 were selected as field resistance varieties.

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A Review of Statistical Methods in the Korean Journal of Orthodontics and the American Journal of Orthodontics and Dentofacial Orthopedics (대한치과교정학회지(KJO)와 미국교정학회지(AJODO)에서 사용된 통계기법의 비교분석 및 고찰(1999-2003))

  • Lim, Hoi-Jeong
    • The korean journal of orthodontics
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    • v.34 no.5 s.106
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    • pp.371-379
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    • 2004
  • The purpose of this study was to investigate the changes and types of statistical methods used in the Korean Journal of Orthodontics (KJO) and the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) from )999 to 2003. The frequency of use, transitions, assumption check of statistical methods and types of advanced statistical methods were examined from each journal. The study consisted of 247 articles published in the KJO and randomly chosen 50 articles per year which were original articles and used statistical methods T-test, analysis of variance(ANOVA), correlation analysis, nonparametric analysis. regression analysis chi-square test. factor analysis, were the order of statistical methods most frequently used in the KJO, while t-test. ANOVA, nonparametric analysis, correlation analysis, regression analysis, chi-square test. factor analysis. were the order of statistical methods used in the AJODO The changes of statistical methods observed in the KJO were not significant $(X^2=17.4\;p=0.5881)$ but the changes observed in the AJODO was seen to be significant $(x^2=42.4,\;p=0.0397)$ Some of the studies examined had overlooked the assumptions of the statistical methods employed. Data investigation such as outlier should be performed before analysis and alternative statistical approaches are applied for a small sample size. Types of advanced statistical methods were factor analysis and discriminant analysis in the KJO and Intention-To-Treat (ITT) analysis in clinical trials through multi-center, survival analysis and Generalized Estimating Equations (GEE) in the AJODO. Appropriate analysis approaches and interpretations should be applied for the correlated and repeated measurements of the orthodontic data set.

NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY (소아청소년정신과영역의 새로운 항우울제)

  • Lee, Soo-Jung
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.12-25
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    • 2003
  • Objectives:As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods:Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results:1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion:Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

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Investigation of aerodynamic evaluation in female patients undergoing thyroidectomy (갑상선절제술을 받은 여성 환자의 공기역학 검사변수 조사)

  • Kang, Young Ae;Kwon, In Sun;Won, Ho-Ryun;Chang, Jae Won;Koo, Bon Seok
    • Phonetics and Speech Sciences
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    • v.12 no.2
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    • pp.73-80
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    • 2020
  • Breathing is the voice's driving force and also acts as a regulator of larynx function and efficiency. Respiratory distress is a side effect of general anesthesia in thyroid surgery. Therefore, this study's objective was to provide practical and complementary information for voice recovery after thyroid surgery, based on aerodynamic evaluation pre- and post-thyroidectomy. From May 2014 to July 2015, aerodynamic evaluations were performed on 34 female patients diagnosed with thyroid papillary cancer one week before surgery (PRE), one month after surgery (P1), and three months after surgery (P3). The Phonatory Aerodynamic System (model 6600, KayPENTAX, USA) was employed for this purpose, and a total of 29 analysis parameters were selected. The results showed statistically significant differences in peak expiratory airflow (p=0.004), mean pitch (p<0.01), expiration airflow duration (p=0.001), and expiratory volume (p=0.018), based on time factors. In the comparison of time factors, peak expiratory airflow and mean pitch parameters were different in PRE-P1 and PRE-P3. Expiration airflow duration and expiratory volume parameters were different in PRE-P3 and P1-P3. The interaction effect of time and surgical range was significant only for expiratory volume (p=0.024). Female patients who undergo thyroidectomy require post-operative breathing training, and exhalation improvement is considered to reflect a positive lifestyle after surgery.

Comparison of Single vs Combined Modality Treatment in Locally Advanced Non-Small Cell Lung Cancer (국소 진행된 비소세포 폐암에서 복합요법과 단일요법의 비교)

  • Kim, Ae-Kyoung;Jeong, Seong-Su;Shin, Kyoung-Sang;Park, Sang-Gee;Jo, Hai-Jeong;Lee, Jong-Jin;Seo, Jee-Won;Kim, Ju-Ock;Kim, Sun-Young
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.4
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    • pp.502-512
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    • 1995
  • Background: One quarter to one third of patients with NSCLC present with primary tumors that although confined to the thorax are too extensive for surgical resection. Until resently standard treatment for these patients had been thoracic radiation, which produces tumor regression in most patients but few cures and dismal 5-year survival rate. The fact that death for most patients with stage III tumors is caused by distant metastases has promped a reevaluation of combined modality treatment approaches that include systemic chemotherapy. Therefore, we report the results observed in a study to evaluate the effect of multimodality treatment in locally advanced non-small cell lung cancer from 1/91 to 8/93 in CNUH. Method: We grouped the patients according to the treatment modalities and evaluated response rate, median survival and the effect of prognostic variables. Among 67 patients evaluated, twenty seven patients classified with group A, received cisplatin and etoposide containing combination chemotherapy alone, eighteen patients, classified with group B, received chemotherapy and radiotherapy, fifteen patients, group C, received neoadjuvant or adjuvant chemotherapy and surgery with/without radiation therapy, seven patients, group D, received only supportive care. Result: The major response rate for group A and B was 37% and 61% respectively. There was no statistically significant difference in response rate between A and B groups(p=0.97). The analysis of prognostic factors showed that differences of age, sex, pathology, blood type, smoking year, stage and ECOG performance did not related to improvement in survival. Median survival time was 8.6 months for group A, 13.4 months for group B, 19.2 months for group C, and 5.4 months for group D, respectively and there was statistically significant difference(p=0.003), suggesting that multimodality therapy was associated with signigicant improvement in survival. Subset survival analysis showed a significant therapeutic effect for earlier stage and good performance state(p=0.007, 0.009, respectively). A possible survival advantages were observed for major response groups. Conclusion: It was suggested that multimodality therapy for the management of patients who had stage III disease, has yielded good median survival and long survival for seleted patients. But, it is necessory to validate above result with further investigation in large scale and in prospective randomized trials.

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Comparison of Concurrent Chemoradiotherapy with Conventional Radiotherapy in Advanced Non-smal Cell Lung Cancer (진행된 비소세포 폐암 환자에서 Concurrent Chemoradiotherapy와 Conventional Radiotherapy의 비교)

  • Kim, Hui-Jung;Lee, Dong-Soo;Song, So-Hyang;Jung, Su-Mi;Kim, Young-Kyoon;Yoon, Se-Chul;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.3
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    • pp.493-504
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    • 1997
  • Background : Non-small cell lung cancer is one of the most frequent cause of death due to cancer in men, and its incidence among women is rapidly increasing. Although there has been a recent surge of interest in combined modality therapy for stageIII non-small cell lung cancer(NSCLC), the optimal treatment is still not well established. Thoracic irradiation has long been the gold standard for locally advanced unresectable NSCLC. However, although conventional radiotherapy(XRT) can palliate symptom and improve local control of disease, it has at most only a modest effect on survival. Recently, cisplatin(cis-diamminedichloroplatinum) has been reported to enhance the cell-killing effect of radiation For patients with unresectable NSCLC, cisplatin-based concurrent chemoradiotherapy(CCRT) had the advantage of therapeutic response over XRT alone and therapeutic side effect more commonly occurred in CCRT group in EORTC(European Organization for Research and Treatment of Cancer) and other trials. Objectives : We compared therapeutic response, compliance, and side effects between CCRT and XRT in patients with advanced NSCLC. Patients and Method : Thirty patients with biopsy-proven inoperable NSCLC were randomized to one of two treatment arms. Arm A consisted of XRT, radiotherapy for 4~6 weeks(1.8 Gy given 20~33 times, in five fractions a week), and arm B consisted of CCRT, radiotherapy for 2 weeks(3 Gy given to times, in five fractions a week), followed by 3 week rest period and then radiotherapy 2 more weeks(2.5 Gy given 10 times, in five fractions a week), combined with 6mg cisplatin per square meter, given daily before radiotherapy. We evaluate therapeutic response, compliance, change of performance status, side effects, and radiation pneumonitis by using the author's made scoring system. Results : There was no significant difference in therapeutic response and compliance. But there was a significantly lower laboratory complication and radiation pneumonitis in CCRT group (p < 0.05). There's significant negative correlation between stage and therapeutic response score in both groups(R=0.353, p < 0.05) In both groups, patients with squamous cell carcinoma had a tendency to higher therapeutic response score than those with adenocarcinoma. Conclusion : There was no difference between CCRT and XRT in respect to therapeutic response and compliance. But CCRT had a advantage of decreased side effects.

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