• Title/Summary/Keyword: randomized controlled trial(RCT)

Search Result 138, Processing Time 0.022 seconds

A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan;Wang, Tao;Shi, Fan;Yang, Yun-Yi;Su, Jin;Chai, Yan-Lan;Liu, Zi
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.16 no.14
    • /
    • pp.5957-5961
    • /
    • 2015
  • Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.

Review of the Latest Oriental and Traditional Clinical Articles and Protocol about Male Sexual Dysfunction (남성 성기능장애 관련 한의학 및 전통의학 임상 연구 동향 분석과 프로토콜 분석)

  • Park, Dong-Su;Park, Sun Young;Shin, Seon Mi
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.27 no.5
    • /
    • pp.530-539
    • /
    • 2013
  • This study reviews the latest articles about oriental and traditional medicine treatment of male sexual dysfunction. We searched the article from 2000 to 2012 using 5 data bases. There were no restrictions on the type of publication, but articles not available in full text were excluded. The methological quality of RCT study was assessed according to Jadad scores and Cochrane's assessment of risk of bias. 18 articles were included in this study. 5 articles published in Korea, the rest were foreign articles. 9 articles were randomized controlled trial(RCT), Case-control studies were 3, case reports were 3, One group pre-post test were 3. In RCT studies, Jadad scores were generally low, and risk of selection bias and performance bias were generally high, risk of detection bias was unclear. Oriental and traditional medicine treatment is as effective as western medicine treatment for male sexual dysfunction, more rigorous oriental medicine treatment studies should be warranted.

Study Trends on Acupuncture Treatment of Cancer (암(癌)에 대한 침치료(鍼治療)의 연구(硏究) 동향(動向))

  • Nam, Dong-Woo;Lee, Jae-Dong;Choi, Do-Young
    • Journal of Acupuncture Research
    • /
    • v.24 no.1
    • /
    • pp.209-216
    • /
    • 2007
  • Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.

  • PDF

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial

  • Kim, Na Young;Park, Jae Hyeon;Park, Jimyung;Kwak, Nakwon;Choi, Sun Mi;Park, Young Sik;Lee, Chang-Hoon;Cho, Jaeyoung
    • Tuberculosis and Respiratory Diseases
    • /
    • v.84 no.4
    • /
    • pp.291-298
    • /
    • 2021
  • Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard diagnostic method for mediastinal and hilar lymphadenopathy. Although rare, fatal infectious complications can occur following EBUS-TBNA. However, to date, there is a lack of effective preventive strategies to reduce these complications. We started a trial to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Methods: This study is a single-center, parallel-group, assessor-blinded randomized controlled trial (RCT). We will enroll 112 adult participants undergoing EBUS-TBNA using a convex probe, and randomly assign them to two groups at a 1:1 ratio. The intervention group will gargle for 1 minute with 100 mL of 0.12% chlorhexidine gluconate before EBUS-TBNA, while the control group will have no mouthrinse before the procedure. Immediately after completion of EBUS-TBNA on all targeted lesions with an aspiration needle, a needle wash sample will be taken by instilling 5 mL of sterile saline into the used needle. The primary outcome is colony forming unit (CFU) counts in aerobic cultures of the needle wash samples. Secondary outcomes are CFU counts in anaerobic cultures, fever within 24 hours after EBUS-TBNA, and infectious complications within 4 weeks after EBUS-TBNA. Conclusion: This trial was designed as the first RCT to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Results from this trial can provide clinical evidence for a simple, safe, and cost-effective strategy to prevent infectious complications following EBUS-TBNA (ClinicalTrials.gov ID: NCT04718922, registered on 22 January 2021).

A Systematic Review of Randomized Controlled Trials With ICT-based Convergence Study for the Elderly (노인 대상 ICT 기반 융합연구: 무작위 대조군 실험연구의 체계적 고찰)

  • Lee, Hey-Sig;Park, Hae-Yean
    • Journal of the Korea Convergence Society
    • /
    • v.11 no.3
    • /
    • pp.85-93
    • /
    • 2020
  • This study is to examine the randomized controlled trials abroad studies on ICT-based convergence studies in the elderly, and to investigate the types and effects of ICT-based interventions. Eight studies that meet the selection criteria were selected from 326 studies identified by three databases and hand-searching. As a result of this study, the most commonly used ICT were the three internet, followed by two tablets and mobile phones, one twoway videoconferencing, one Kinect, one robot, and one Blood Glucose Monitoring System. These results could be used for ICT-based convergence studies in Korea, and further studies should be conducted with higher quality studies such as randomized controlled trials.

Effects of Smartphone Applications on Physical Activity in College Students: A Randomized Controlled Trial (스마트폰 걷기 어플리케이션 효과성 검증: 무선통제연구)

  • Kim, Yujin;Chung, Kyong-Mee
    • Journal of Convergence for Information Technology
    • /
    • v.10 no.2
    • /
    • pp.21-31
    • /
    • 2020
  • This study tested the effectiveness of commercialized smartphone apps in improving walking activities among college students. 66 participants were randomized into each of four groups that was used different behavior change strategies: monetary rewards app, goal setting and feedback app, gaming app, and self-monitoring control group. 45 participants who completed the experimentation was included in data analysis. Repeated measures ANOVA resulted in statistically significant time by groups interactions in recorded step counts, self-reported completed plans and self-reported walking activities scores. The Goal-setting and feedback group and the gaming group resulted in increase in both step counts and completed plans. The results were discussed in the framework of behaviorism.

Effects of garlic intake on cancer: a systematic review of randomized clinical trials and cohort studies

  • Lee, Jounghee;Zhao, Naisi;Fu, Zhuxuan;Choi, Jihee;Lee, Hae-Jeung;Chung, Mei
    • Nutrition Research and Practice
    • /
    • v.15 no.6
    • /
    • pp.773-788
    • /
    • 2021
  • BACKGROUND/OBJECTIVES: Due to the rapid increase of global cancer incidence and mortality and a high level of interest in cancer prevention, a systematic review of garlic intake and cancer risk is needed. SUBJECTS/METHODS: We implemented a systematic review to examine the effects of varying levels of garlic intake on cancer. We conducted comprehensive literature searches in three electronic databases (MEDLINE, Embase, and Web of Science) for studies published between database inception and July or September of 2018. Two investigators independently screened abstracts and full-texts, extracted data, and assessed risk of bias (RoB). A total of one medium-quality randomized controlled trial (RCT) and 13 cohort studies graded as high RoB were included. RESULTS: The 1-year follow-up results from a RCT showed that a significant decrease in the number and size of colorectal adenomas among participants with colorectal adenomas who received high-dose aged garlic extract (AGE) compared with those who received low-dose AGE (P < 0.05). The results of prospective observational studies provided inconsistent associations of colorectal cancer risk with garlic supplements and garlic intake as food. CONCLUSIONS: In summary, the AGE was effective in reducing the number and magnitude of colorectal adenomas in one RCT, but there were inconsistent associations between garlic intake and colorectal cancer in cohort studies. Therefore, we could not draw a firm conclusion regarding the effects of garlic on cancer, because the current strength of evidence is inadequate due to a lack of number of high-quality RCTs.

Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials (Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침)

  • Jung, Hoi-In;Kim, Hee-Eun
    • Journal of dental hygiene science
    • /
    • v.14 no.3
    • /
    • pp.269-275
    • /
    • 2014
  • Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

Review of Clinical Research for Herbal Medicine Treatment on Rhinosinusitis (비부비동염의 보완대체의학 약물치료에 대한 최신 임상 연구 동향 -RCT 연구를 중심으로 -)

  • Jang, Eun Ha;Min, Sang Yeon;Kim, Jang Hyun
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.32 no.3
    • /
    • pp.44-54
    • /
    • 2018
  • Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in rhinosinusitis. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on rhinosinusitis from the Pubmed in recent 10 years (from 2008 to 2018). Results 11 RCTs were reviewed. In 10 out of 11 studies showed that the herbal medicine may be effective in the treatment of chronic rhinosinusitis without nasal polyp and uncomplicated acute rhinosinusitis. However, inclusion and exclusion criteria, and outcome measures were varied among different studies. No serious adverse reactions were reported from the herbal medicine treatment. Conclusions The results of these trials showed that herbal medicine may be effective in the treatment of rhinosinusitis. Well-designed RCTs for domestic herbal medicine treatment on rhinosinusitis are needed to prove its efficacy clearly.

Recent Clinical Research on Effect of Acupuncture for Strabismus (사시의 침치료에 대한 최근 임상 연구 동향)

  • Lee, Ji Na;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.30 no.2
    • /
    • pp.23-30
    • /
    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for strabismus in Korea and other countries. We have analyzed 10 years (from 2006 to 2015) of case studies and randomized controlled trials (RCT) on effect of acupuncture for strabismus. Methods The search database includes Oasis, KTKP (Korean Traditional Knowledge Portal), Medline, Embase, and Cochrane library. To narrow the search, the following key search terms were used: 'strabismus, acupuncture'. The search was limited to the publication date from 2006 to 2015. 7 case studies and 5 control studies were selected for analysis. Results and Conclusions 1. The acupuncture treatment is effective for paralytic strabismus 2. The studies used BL1, GB1, ST2, TE23, GB15, EX-HN5, ST1, and LI4 acupoints and also an electroacupuncture treatment, which is 15 minutes of extraocular muscle stimulation, was used. 3. Degree of strasbismus was tested by Ocular motor range test, Corneal light reflex test, Ocular abducent scale test (Scott and Kraft, Diploptic range test).