• Title/Summary/Keyword: Randomized Response

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Metformin Addition to Chemotherapy in Stage IV Non-Small Cell Lung Cancer: an Open Label Randomized Controlled Study

  • Sayed, Rana;Saad, Amr S;El Wakeel, Lamia;Elkholy, Engi;Badary, Osama
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6621-6626
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    • 2015
  • Purpose: To evaluate effects of metformin on clinical outcome of non-diabetic patients with stage IV NSCLC. Materials and Methods: A prospective, randomized, open-label, controlled pilot study was conducted on patients with stage IV NSCLC with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2, excluding patients with diabetes and lactic acidosis. Thirty chemo-$na\ddot{i}ve$, non-diabetic patients with stage IV NSCLC were enrolled. Fifteen patients received intravenous gemcitabine/cisplatin regimen alone (arm B) while fifteen patients received the same regimen plus daily oral metformin 500mg (arm A). The effect of metformin on chemotherapy-response rates, survival, and adverse events in these patients was evaluated. Results: Objective response rate (ORR) and median overall survival (OS) in arms A and B were 46.7% versus 13.3% respectively, p=0.109 and 12 months versus 6.5 months, respectively, p=0.119. Median progression free survival (PFS) in arms A and B was 5.5 months versus 5 months, p=0.062. No significant increase in toxicity was observed in arm A versus arm B. Percentage of patients who experienced nausea was significantly lower in arm A versus arm B, at 26.7% versus 66.7% respectively, p=0.028. Conclusions: Metformin administration reduced occurrence of chemotherapy induced-nausea. Non-statistically significant improvements in the ORR or OS were observed. Metformin had no effect on PFS.

Case Study on Local Differential Privacy in Practice : Privacy Preserving Survey (로컬 차분 프라이버시 실제 적용 사례연구 : 프라이버시 보존형 설문조사)

  • Jeong, Sooyong;Hong, Dowon;Seo, Changho
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.30 no.1
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    • pp.141-156
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    • 2020
  • Differential privacy, which used to collect and analysis data and preserve data privacy, has been applied widely in data privacy preserving data application. Local differential privacy algorithm which is the local model of differential privacy is used to user who add noise to his data himself with randomized response by self and release his own data. So, user can be preserved his data privacy and data analyst can make a statistical useful data by collected many data. Local differential privacy method has been used by global companies which are Google, Apple and Microsoft to collect and analyze data from users. In this paper, we compare and analyze the local differential privacy methods which used in practically. And then, we study applicability that applying the local differential privacy method in survey or opinion poll scenario in practically.

Effect of Korean Red Ginseng in individuals exposed to high stress levels: a 6-week, double-blind, randomized, placebo-controlled trial

  • Baek, Ji Hyun;Heo, Jung-Yoon;Fava, Maurizio;Mischoulon, David;Choi, Kwan Woo;Na, Eun Jin;Cho, Hana;Jeon, Hong Jin
    • Journal of Ginseng Research
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    • v.43 no.3
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    • pp.402-407
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    • 2019
  • Background: To investigate the neurobiological evidence supporting the adaptogenic effects of Korean Red Ginseng in reducing the harmful consequences of stress using a double-blind, placebo-controlled trial. Method: Sixty-three subjects with high stress levels were randomized to receive an orally administered, double-blind, 6-week treatment with Korean Red Ginseng (n = 32) or placebo (n = 31). All participants underwent a comprehensive psychological evaluation using Beck Depression Inventory and Stress Response Inventory, cognitive evaluation using the continuous performance test, biological evaluation by measuring blood levels of lipids, catecholamines, inflammation markers, and heart rate variability at baseline and after 6 weeks. Results: At baseline, both groups showed no significant differences in age, sex, years of education, Beck Depression Inventory, and Stress Response Inventory. After 6 weeks, triglyceride levels were significantly increased within the normal limit in the Korean Red Ginseng group (F = 4.11, p = 0.048), and the epinephrine level was decreased in this group (F = 4,35, p = 0.043). The triglyceride increase was significantly associated with epinephrine decrease (B = 0.087, p = 0.041), suggesting that Korean Red Ginseng may stabilize the sympathetic nervous system. In addition, we detected a significant group by time effect in the visually controlled continuous performance test, suggesting positive effects of Korean Red Ginseng on cognition. Conclusion: Korean Red Ginseng might help to stabilize the sympathetic nervous system and improve cognition in individuals with high stress.

Jibaekjihwang-hwan and Daeboeum-hwan Combination Therapy on Precocious Puberty: a Systematic Review and Meta-Analysis (지백지황환·대보음환 병용투여를 통한 성조숙증 치료에 대한 체계적 문헌고찰 및 메타분석)

  • Kang, So-Hyeon;Seo, Ji-Hye;Hur, Da-Hee;Lee, Dong-Nyung;Kim, Hyeong-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.2
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    • pp.124-141
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    • 2021
  • Objectives: The purpose of this study is to assess the efficacy of Jibaekjihwang-hwan and Daeboeum-hwan combination therapy for the treatment of precocious puberty. Methods: 6 databases were searched from the date of inception until April 2021 for relevant studies. We included randomized controlled trials (RCTs) and non-randomized controlled trials (nRCTs) which focused on effects of Jibaekjihwang-hwan and Daeboeum-hwan on precocious puberty. Results: Total 8 literatures were included in qualitative analysis and meta analysis on results was conducted on 4 synthesizable studies. The response rate was significantly higher in Jibaekjihwang-hwan and Daeboeum-hwan combination group than in conventional therapy group. Also, serum estradiol and follicle stimulating hormone (FSH) level were significantly lower in Jibaekjihwang-hwan and Daeboeum-hwan combination group than in conventional therapy group. Conclusions: It seems that combination therapy of Jibaekjihwang-hwan and Daeboeum-hwan can effectively reduce serum estradiol and FSH level while increasing response rate significantly. Further high quality studies are needed to supplement the efficacy and safety of combination therapy of Jibaekjihwang-hwan and Daeboeum-hwan on precocious puberty.

The effects of Korean Red Ginseng on stress-related neurotransmitters and gene expression: A randomized, double-blind, placebo-controlled trial

  • Jihyun Yoon;Byoungjin Park;Kyung-Won Hong;Dong-Hyuk Jung
    • Journal of Ginseng Research
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    • v.47 no.6
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    • pp.766-772
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    • 2023
  • Background: Korean Red Ginseng (KRG) is an effective anti-stress treatment. In this study, we investigated the therapeutic potential effects of KRG on relieving stress in a general population using transcriptome analysis. Methods: We conducted an 8-week clinical pilot study on 90 healthy men who reported stress. The study was completed by 43 participants in the KRG group and 44 participants in the placebo group. Participants were randomized 1:1 to the KRG and placebo groups. We evaluated the stress by stress response inventory (SRI) at baseline and 8 weeks. The main outcomes were changes in the levels of neurotransmitters (NTs) and NT-related gene expression. NTs were analyzed using automated (GC) content, and levels of gene expression were measured by reads per kilobase of transcript per million mapped reads (RPKM). Results: The KRG group showed significantly preserved epinephrine decrease compared with placebo group at 8 weeks (changes in epinephrine, KRG vs. placebo; -1623.2 ± 46101.5 vs. -35116.3 ± 86288.2, p = 0012). Among subjects who higher SRI score, meaning stress increased compared to baseline, the KRG group showed a smaller decrease in serotonin than the placebo group (changes in serotonin, KRG vs. placebo; -2627.5 ± 5859.1 vs, -8087.4 ± 7162.4, p = 0.005) and a smaller increase in cortisol than the placebo group (changes in cortisol, KRG vs. placebo; 1912.7 ± 10097.75 vs. 8046.2 ± 8050.6 , p = 0.019) in subgroup analysis. Transcriptome findings indicated that KRG intake affects gene expression related with metabolism of choline, adrenalin, and monoamine. Conclusion: These findings suggest that KRG has beneficial effects on the amelioration of stress response in NTs, and this effect is more prominent in stressful situations. Further clinical studies are required to confirm the anti-stress effect of KRG.

The effects of child abuse prevention education on parents' response to positive emotion, parenting stress, and child abuse potential: A randomized controlled pretest posttest design (아동학대 예방교육이 부모의 긍정정서 반응, 양육 스트레스, 아동학대 잠재성에 미치는 영향: 무작위 대조군 사전·사후 연구)

  • Kim, Mi Hyun;Park, Bu Kyung
    • The Journal of Korean Academic Society of Nursing Education
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    • v.30 no.1
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    • pp.19-28
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    • 2024
  • Purpose: The purpose of this study was to develop a child abuse prevention education program for parents. Furthermore, the aim was to investigate the impact of child abuse prevention education on parents' response to positive emotion, parenting stress, and potential for child abuse. Methods: A randomized controlled pretest posttest design was used. A total of 60 participants, who were parents with children aged 1~5 and attending 8 nurseries and kindergartens located in Daegu, were recruited. They were randomly assigned to an experimental group (n=30) and a control group (n=30). The collected data were analyzed by an independent t-test, paired t-test, and χ2-test along with descriptive statistics using IBM SPSS Statistics 25.0. Child abuse prevention education for the experimental group included four modules on child rights, understanding child abuse, proper child discipline, and positive parenting attitudes. Results: The experimental group showed a significant difference in positive rumination from the control group (t=2.15, p=.036). The experimental group reported a significant difference in dampening from the control group (t=-2.49, p=.016). Additionally, the experimental group reported a significant difference in parenting stress from the control group (t=-2.12, p=.038) and also reported significant differences in child abuse potential from the control group (t=-2.26, p=.028). Conclusion: The results of this study indicate that child abuse prevention education for parents can improve positive rumination, reduce dampening, and reduce parenting stress and child abuse potential. Therefore, this study is useful in demonstrating how parental susceptibility to child abuse can be decreased. Future studies should pursue long-term programs and counseling programs.

The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial

  • Hawal Lateef Fateh;Goran Kareem;Shahab Rezaeian;Jalal Moludi;Negin Kamari
    • 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.

A randomized, open labeled study comparing the serum levels of cobalamin after three doses of 500 mcg vs. a single dose methylcobalamin of 1500 mcg in patients with peripheral neuropathy

  • Sil, Amrita;Kumar, Hrishikesh;Mondal, Rahul Deb;Anand, Sidharth Sankar;Ghosal, Anirban;Datta, Ashis;Sawant, Sandesh V;Kapatkar, Vaibhavi;Kadhe, Ganesh;Rao, Sameer
    • The Korean Journal of Pain
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    • v.31 no.3
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    • pp.183-190
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    • 2018
  • Background: Vitamin B12 deficiency has been associated with peripheral neuropathy, loss of sensation in the peripheral nerves, and weakness in the lower extremities. Methylcobalamin is the most effective analogue of vitamin B12 used to treat or prevent the complications associated with vitamin B12 deficiency. The current study aimed to compare the serum cobalamin levels after administration of two different regimes of methylcobalamin in peripheral neuropathy patients. Methods: The present study was a prospective, randomized, comparative study. The study consisted of two parallel groups, group A (methylcobalamin $500{\mu}g$ injection intramuscularly three times a week) and group B (methylcobalamin $1500{\mu}g$ injection intramuscularly once a week). A control group of healthy volunteers was also included. Results: A total of 24 patients (12 in each group) were included in the study. Five healthy volunteers were also included as a control in each group. At the end of treatment, serum cobalamin levels were significantly (P = 0.028) higher in group A ($1892.08{\pm}234.50$) as compared with group B ($1438.5{\pm}460.32$). The serum cobalamin levels in Group A healthy volunteers were also two times higher than that of group B (P = 0.056). Both the LANSS scale and DN4 questionnaire reported similar results at end of treatment. Conclusions: The $500{\mu}g$ methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the $1500{\mu}g$ methylcobalamin once weekly regime.

Review of Randomized Controlled Trials of Oriental Medicine for Recurrent Vulvovaginal Candidiasis (재발성 칸디다성 외음질염의 한약치료 효과에 관한 무작위 대조 연구 문헌고찰)

  • Chae, Min-Soo;Park, Seung-Hyeok;Hwang, Deok-Sang;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.2
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    • pp.29-43
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    • 2020
  • Objectives: The purpose of this study is to review and evaluate the effectiveness of oriental medicine per oral for recurrent vulvovaginal candidiasis (RVVC). Methods: We searched articles from Korean journal databases including Journal of Korean Obstetrics and Gynecology, Korean studies Information Service Studies, and Chinese National Knowledge Infrastructure, Cochrane Library, PubMed. Searched keywords were "재발성 칸디다성 외음질염", "recurrent vulvovaginal candidiasis", "㚆发性外阴阴道假丝酵母菌病", "中藥". Results: 10 randomized controlled trials with 700 patients were identified and reviewed. 8 studies compared combination of oriental medicine and anti-fungal agent with anti-fungal agent, and 6 of them reported that treatment group (TG) showed statistically higher total effective rate or cure rate and lower recurrence rate. One study compared oriental medicine and anti-fungal agent and TG showed statistically higher total effective rate and lower recurrence rate after 1 month. One study compared combination of oriental medicine and lacto bacillus capsule with lacto bacillus capsule, and TG showed statistically higher total effective rate and lower positive fungul test rate after 6 months. No severe adverse response was reported. Conclusions: Our review found that oriental medicine per oral is effective for alleviating symptoms, lowering recurrence rate and positive fungal test in RVVC patients. We recommend standardized randomized controlled trial guideline should be made to obtain stronger evidence and well designed trials with larger sample sizes are needed.

The Clinical Effect of Bosingunyang-tang on Chronic Non-bacterial Prostatitis/Chronic Pelvic Pain Syndrome : Randomized Double-blind, Placebo-controlled Clinical Trial

  • Song, Moon-Koo;Kang, Ji-Suck;Kang, Cheol-Ho;Ahn, Young-Min;Ahn, Se-Young;Doo, Ho-Kyung;Lee, Byung-Cheol
    • The Journal of Internal Korean Medicine
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    • v.29 no.3
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    • pp.800-809
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    • 2008
  • Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.

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