• Title/Summary/Keyword: Randomized response

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Development and Clinical Evaluation of Dendritic Cell Vaccines for HPV Related Cervical Cancer - a Feasibility Study

  • Ramanathan, Priya;Ganeshrajah, Selvaluxmy;Raghanvan, Rajalekshmi Kamalalayam;Singh, Shirley Sundar;Thangarajan, Rajkumar
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5909-5916
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    • 2014
  • Human papillomavirus infection (HPV) and HPV related immune perturbation play important roles in the development of cervical cancer. Since mature dendritic cells (DCs) are potent antigen-presenting cells (APC), they could be primed by HPV antigens against cervical cancers. In this study we were able to generate, maintain and characterize, both phenotypically and functionally, patient specific dendritic cells in vitro. A randomized Phase I trial with three arms - saline control (arm I), unprimed mature DC (arm II) and autologous tumor lysate primed mature DC (arm III) and fourteen patients was conducted. According to WHO criteria, grade 0 or grade one toxicity was observed in three patients. One patient who received tumor lysate primed dendritic cells and later cis-platin chemotherapy showed a complete clinical response of her large metastatic disease and remained disease free for more than 72 months. Our findings indicate that DC vaccines hold promise as adjuvant sfor cervical cancer treatment and further studies to improve their efficacy need to be conducted.

A Study of Immunogenicity and Reactogenicity of Hepatitis B Vaccine Made by Recombinant DNA Techniques in Yeast (효모재조합 DNA B형 간염백신의 면역효과에 관한 연구)

  • Min, Chang-Hong;Kim, Kyo-Myung;Lee, Kyu-Man
    • The Journal of the Korean Society for Microbiology
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    • v.21 no.2
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    • pp.243-249
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    • 1986
  • A study of the immunogenicity and reactogenicity of two doses of lot H(10, 20 mcg), two doses of lot L (20, 40 mcg) of the Smith Kline-RIT recombinant DNA yeast-derived hepatitis B vaccine and a 20-mcg dose of the Merck Sharp and Dohme plasma-derived hepatitis B vaccine was conducted in young adults under randomized, double-blind conditions. Immunization was carried out according to a 0-, 1-, and 6-month vaccination schedule. Results indicated that the yeast-derived hepatitis B vaccine was well tolerated and immunogenic. Reactogenicity to both yeast- and plasma-derived vaccines was mild in severity and low in incidence with no significant differences appearing between the study groups. One month after the third dose, the yeast-derived vaccines induced a high degree of soroconversion ranging between 95.0% and 100%. The response was not lot or dose-dependent. The administration of the plasma-derived vaccine resulted in anti-HBs geometric mean titres statistically signifirantly higher than those elicited by the different yeast-derived hepatitis B vaccines one month after the third dose of vaccine but the difference was not large enough to be of great clinical significance.

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Interactive Effect of Nitrogen and Sulphur on Yield and Quality of Groundnut (Arachis hypogea L.)

  • Jamal Arshad;Fazli Inayat Saleem;Ahmad Saif;Abdin Malik Zainul
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.51 no.6
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    • pp.519-522
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    • 2006
  • Randomized field experiments were conducted to study the interactive effect of sulphur (S) and nitrogen (N) on seed, oil and protein yield of two cultivars of groundnut {Arachis hypogea: cv Amber $(V_{1})$: cv Kaushal, $(V_{2})$.} Two dosage levels of sulphur ($0\;and\;20kg\;ha^{-1}$) and two dosage levels of N ($23.5\;and\;43.5kg\;ha^{-1}$) in various combinations were tested as micronutrient treatments, $T_{1},\;T_{2},\;and\;T_{3}$. Results indicated significant enhancement of the yield components namely seed and oil yield as well as seed protein. Maximum response was observed with treatment $T_{3}$(having 20kg S and 43.5kg N $ha^{-1})$. Increase in seed and oil yields of 90% and 103% in $V_{1}$, and 79 and 90% in $V_{2}$, respectively were recorded as compared to the control treatment $T_{1}$(having 0kg S and 23.5kg N $ha^{-1}$). Effect of S and N interaction was observed on protein, N and S content in seeds. The results obtained by these experiments clearly suggest that judicious balanced application of N and S could improve the yield.

A Nonparametric Multivariate Test for a Monotone Trend among k Samples

  • Hyun, Noo-Rie;Song, Hae-Hiang
    • The Korean Journal of Applied Statistics
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    • v.22 no.5
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    • pp.1047-1057
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    • 2009
  • The nonparametric bivariate two-sample test of Bennett (1967) is extended to the multivariate k sample test. This test has been easily modified for a monotone trend among k samples. Often in applications it is important to consider a set of multivariate response variables simultaneously, rather than individually, and also important to consider testing k samples altogether. Different approaches of estimating the null covariance matrices of the test statistics resulted in the same limiting form. The multivariate k sample test is applied to the non-normal data of a randomized trial conducted for a period of four weeks in mental hospitals. The purpose of the trial is to compare the efficacy of three different interventions for a relief of the frequently occurring problems of constipation, caused as a side effect of antipsychotic drugs during hospitalization. The bowel movement status of patient for a week is summarized into a single severity score, and severity scores of four weeks comprise a four-dimensional multivariate variable. It is desirable with this trial data to consider a multivariate testing among k samples.

Meta-analysis on the Efficacy of Glutamate Receptor Antagonists for Acute Migraine Treatment (급성 편두통 치료를 위한 글루탐산 수용체 길항제의 임상적 유효성에 대한 메타분석)

  • Kim, Sunhee;Baek, In-hwan
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.4
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    • pp.247-253
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    • 2019
  • Background: Glutamate is implicated in the pathophysiology of migraine, a common neurological disorder. Therefore, glutamate receptor antagonists (GluRAs) have been suggested as a novel migraine treatment that are able to overcome the limitations of triptans. Objective: The aim of this study was to perform a meta-analysis to assess the efficacy of GluRAs for patients with migraine. Method: The PubMed, Cochrane Library, CINAHL, and Clinical Trial.gov databases were searched for randomized placebo-controlled trials of the efficacy of GluRAs for patients with migraine conducted up to August 2019. Two independent reviewers screened the literature according to inclusion and exclusion criteria and performed quality assessment and data extraction. Review Manager 5.3 software was used for the meta-analysis. Results: Three studies involving a total of 206 patients were included in the final analysis. Compared with placebo, GluRAs significantly improved the pain-free response at 2 hours (odds ratio [OR]=3.85, 95% confidence intervals [CIs]=1.63-9.09) and the 24-hour sustained pain freedom (OR=7.40; 95% CIs=2.36-23.20). The use of rescue medications with GluRAs was lower compared to that with placebo, but the difference was not significant (OR=0.39, 95% CI=0.10-1.47). Conclusion: Our meta-analysis showed that GluRAs were more effective than placebo for patients with migraine.

Deep Brain Stimulation for Controlling Refractory Epilepsy: a Clinical Perspective (난치성 뇌전증 치료를 위한 심부뇌자극술: 임상적 관점에서)

  • Kim, Woo Jun;Shon, Young-Min
    • Annals of Clinical Neurophysiology
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    • v.14 no.2
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    • pp.59-63
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    • 2012
  • Epilepsy has continued to provide challenges to epileptologists, as a significant proportion of patients continue to suffer from seizures despite medical and surgical treatments. Deep brain stimulation (DBS) has emerged as a new therapeutic modality that has the potential to improve quality of life and occasionally be curative for patients with medically refractory epilepsy who are not surgical candidates. Several groups have used DBS in drug-resistant epilepsy cases for which resective surgery cannot be applied. The promising subcortical brain structures are anterior and centromedian nucleus of the thalamus, subthalamic nucleus, and other nuclei to treat epilepsy in light of previous clinical and experimental data. Recently two randomized trials of neurostimulation for controlling refractory epilepsy employed the strategies to stimulate electrodes placed on both anterior thalamic nuclei or near seizure foci in response to electroencephalographically detected epileptiform activity. However, the more large-scale, long-term clinical trials which elucidates optimal stimulation parameters, ideal selection criteria for epilepsy DBS should be performed before long. In order to continue to advance the frontier of this field, it is imperative to have a good grasp of the current body of knowledge.

The Prevalence of Depression and Related Factors among Adults (제주지역 성인의 우울 유병률과 관련 요인)

  • Park, Eun-Ok;Kim, Moon-Doo;Son, Young-Ju;Song, Hyo-Jeong;Hong, Seong-Chul
    • Research in Community and Public Health Nursing
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    • v.20 no.3
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    • pp.277-284
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    • 2009
  • Purpose: This study was to investigate depression prevalence and related factors of depression in Jeju Province. Methods: The study sample selected using randomized cluster sampling method, and the unit of cluster was 25 households. Data were collected from 1275 adults in 723 households through home visit interview. The response rate was 89.4%. The instrument used for measuring depression was CES-D, the cut-off score was 21. Data were analyzed using Chi-square test and logistic regression. Results: The prevalence of depression in Jeju was 18.1%. The significant differences were found with depression prevalence rate by the group of gender, age, inhabited area, marital status, educational status, monthly household income, life satisfaction, socioeconomic status, perceived health status, morbidity during last 2 weeks, perceived stress, perceived fatigue, participation in social activities, and family life satisfaction. The most predictive factors among those variables were perceived fatigue with 17.93 of odds ratio, family life satisfaction with 9.86 odds ratio, and perceived stress with 9.66 of odds ratio. Conclusion: The prevention and management of depression program development was suggested and mental health promotion program for the prevention of depression was suggested.

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Placebo Control and Placebo Effect in Acupuncture Medicine (침구의학에서 플라시보 대조군과 플라시보 효과)

  • Chae, Younbyoung;Enck, Paul
    • Korean Journal of Acupuncture
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    • v.35 no.2
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    • pp.47-55
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    • 2018
  • Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

Brachytherapy in Coronary Artery Disease (관상동맥질환의 방사성동위원소 치료)

  • Song, Ho-Chun
    • Nuclear Medicine and Molecular Imaging
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    • v.40 no.2
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    • pp.113-119
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    • 2006
  • Coronary artery disease is a loading cause of morbidity and mortality across the world. Percutaneous coronary intervention has become the major technique of revascularization. However, restenosis remains a major limitation of this procedure. Recently the need for repeat intervention due to restenosis, the most vexing long-term failure of percutaneous coronary intervention, has been significantly reduced owing to the introduction of two major advances, intracoronary brachytherapy and the drug-eluting stents. Intracoronary brachytherapy has been employed in recent years to prevent restenosis lesions with effective results, principally in in-stent restenosis. Restenosis is generally considered as au excessive form of normal wound healing divided up in precesses: elastic recoil, neointimal hyperplasia, and negative vascular remodeling. Restenosis has previously been regarded as a proliferative process in which neointimal thickening, mediated by a cascade of inflammatory mediators and other factors, is the key factor. Ionizing radiation has been shown to decrease the proliferative response to injury in animal models of restenosis. Subsequently, several randomized, double blind trials have demonstrated that intracoronary brachytherapy can reduce the rates of both angiographic restenosis and clinical event rates in patients undergoing percutaneous coronary intervention for in stent restenosis. Some problems, such as late thrombosis and edge restenosis, have been identified as limiting factors of this technique. Brachytherapy is a promising method of preventing and treating coronary artery restenosis.

Evaluating the effects of probiotics in pediatrics with recurrent abdominal pain

  • Rahmani, Parisa;Ghouran-Orimi, Azin;Motamed, Farzaneh;Moradzadeh, Alireza
    • Clinical and Experimental Pediatrics
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    • v.63 no.12
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    • pp.485-490
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    • 2020
  • Background: Recurrent abdominal pain (RAP) is one of the frequent complaints in general practice, particularly in pediatrics and is among the common cause of referral to gastroenterology clinics. Purpose: This study is designed to investigate the effects of probiotics for the treatment of RAP and desired therapeutic outcomes. Methods: One hundred twenty-five children with the diagnosis of RAP according to Rome III criteria for irritable bowel syndrome (IBS), functional abdominal pain (FAP), functional dyspepsia (FD), and abdominal migraine (AM), were enrolled in this double-blind randomized controlled trial. Results: Sixty-five subjects received probiotics, and others received placebo treatment for 4 weeks. Lactobacillus reuteri was therapeutically effective in 32 patients compared to 8 patients, responding to the placebo treatment. Compared to baseline, all pain-related variables showed a significant reduction for the IBS and FD at the end of the 4th week. However, it did not respond well in FAP and AM groups. Pain-related outcomes such as, frequency of the pain, severity, and duration of the pain were decreased following the probiotic treatment. No therapeutic response was seen in AM group after the administration of probiotics. L. reuteri significantly led to pain relief in the overall population, and also in FAP, FD, and IBS subgroups. Conclusion: L. reuteri probiotics are likely to lead to RAP relief and can be recommended for the treatment of functional gastrointestinal disorders.