• Title/Summary/Keyword: random clinical trial

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Periotome versus piezotome as an aid for atraumatic extraction: a randomized controlled trial

  • Mohammed Abdullah, Alraqibah;Jingade Krishnojirao Dayashankara, Rao;Bader Massad, Alharbi
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.48 no.6
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    • pp.356-362
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    • 2022
  • Objectives: A single-blinded randomized controlled trial was designed to compare and evaluate the effectiveness of the periotome and piezotome as aids for atraumatic extraction and its sequalae. Materials and Methods: The study sample comprised 48 teeth, equally allotted to the piezotome or periotome groups by random allocation, in participants aged 19-62 years. All samples in both groups had either complete tooth structure or intact roots without crowns and had mobility ≤grade II. Clinical parameters of operative duration, presence or absence of gingival laceration, reported operative and postoperative pain, and intake of analgesics following extraction were recorded. IBM SPSS software package version 22 was used for data entry and analysis. Results: The mean operation time was significantly (P≤0.05) longer in the piezotome group than in the periotome group. However, fewer gingival lacerations were observed with use of a piezotome than with a periotome, although no significant difference was observed. The piezotome group reported significantly (P≤0.05) higher visual analog scale (VAS) pain scores during the procedure and non-significantly higher scores thereafter until the third postoperative day. In the piezotome group, the dosage of analgesic was higher, although the periotome group had a higher percentage of participants who used analgesics postoperatively; however, these differences were not statistically significant. Conclusion: The present clinical trial favors the use of periotome over piezotome for atraumatic extraction due to shorter operating time, lower postoperative VAS pain scores, and lower dosage of analgesics despite the superior ability of the piezotome to prevent gingival laceration.

Research Trends on Qigong in the Korean Journal (한국 저널에 게재된 기공관련 단일군 임상연구 동향 분석)

  • Park, Sun-Hee;Han, Chang-Hyun;Kim, Ki-Jin;Shin, Mi-Suk;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.14 no.2
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    • pp.75-80
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    • 2008
  • Background: Qigong is one energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although Qigong-neither itself nor its postulated mechanism of action-are within the paradigm of modern Western medical science. effects on the human body could be possible. Objectives: This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review grasp trends in this field of studies and direct further researches into the right direction. Method: The computerized Korean databases were searched from their respective inception up to January 2008. The search terms used were 'Qi', 'Qigong', 'Doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Result: Since the 1990s, Qigong papers in the Korean Literature have been increased. Clinical research studies are among the most control design study. Research subjects are less patient than the general public. The most common treatment disease was Musculo-skeletal disorder. Conclusions: The depth study for the each Qigong is needed. Specifically, I think it should be a clinical studies and qualified research methods for evaluation are needed.

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Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double-Blind Randomized Controlled Clinical Trial

  • Jafarpour-Sadegh, Farnaz;Montazeri, Vahid;Adili, Ali;Esfehani, Ali;Rashidi, Mohammad-Reza;Mesgari, Mehran;Pirouzpanah, Saeed
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7517-7522
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    • 2015
  • Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

A Systematic Review of Clinical Researches of Korean Medicine for Alopecia (탈모증의 한약제제 치료효과에 대한 체계적 문헌 고찰)

  • Ryu, Deok-Hyun;Roh, Seok-Sun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.30 no.2
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    • pp.1-18
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    • 2017
  • Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

Significance of the tethered maxillary frenulum: a questionnaire-based observational cohort study

  • Naimer, Sody A.;Israel, Ariel;Gabbay, Aviezer
    • Clinical and Experimental Pediatrics
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    • v.64 no.3
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    • pp.130-135
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    • 2021
  • Background: The clinical significance of lip-tie, or a tethered maxillary frenulum, remains under debate. Clinicians and parents are often perplexed when deciding whether procedures available to relieve a seemingly tight or severe maxillary frenulum are needed. Purpose: No previous studies have assessed the consequences of not subjecting a tethered maxillary frenulum in newborns to surgical intervention. This study aimed to contribute the first prospective trial on this topic with a relatively extended follow-up of these newborn infants. Methods: This prospective observational questionnaire-based cohort trial was performed in a community setting and aimed to determine whether lip-tie is associated with an increased likelihood of eventual feeding or oral disorders. Results: The convenience sample comprised of 61 consecutively arriving infants with concomitant tethered frenula who were treated at the clinic for various reasons. This cohort was compared with a random sample of 66 age-matched children for a mean follow-up period of 6.42 years. Infants undergoing oropharyngeal procedures were excluded. Awareness of a deviation in oral structures was reported by 18% of the study group versus 0% of the controls. Mothers participating in the study group (24.6%) less frequently recalled painful nipples or discomfort during breastfeeding than those in the control group (47.0%) (P<0.01). There were no intergroup differences in other types of feeding difficulty, dental hygiene, pronunciation, or speech development. Conclusion: Our findings suggest that a tethered labial frenulum is not associated with an increase in breastfeeding disturbances or oral disorders. These data encourage clinicians to question the need to intervene in cases of tethered maxillary frenula.

Bootstrap Confidence Intervals for an Adjusted Survivor Function under the Dependent Censoring Model

  • Lee, Seung-Yeoun;Sok, Yong-U
    • Communications for Statistical Applications and Methods
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    • v.8 no.1
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    • pp.127-135
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    • 2001
  • In this paper, we consider a simple method for testing the assumption of independent censoring on the basis of a Cox proportional hazards regression model with a time-dependent covariate. This method involves a two-stage sampling in which a random subset of censored observations is selected and followed-up until their true survival times are observed. Lee and Wolfe(1998) proposed an adjusted estimate of the survivor function for the dependent censoring under a proportional hazards alternative. This paper extends their result to obtain a bootstrap confidence interval for the adjusted survivor function under the dependent censoring. The proposed procedure is illustrated with an example of a clinical trial for lung cancer analysed in Lee and Wolfe(1998).

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Meta Analysis of Symptom Improvement through Eradication of Helicobacter pylori in Patients with Non-ulcer Dyspepsia (비궤양성 소화불량에서 Helicobacter pylori 박멸치료후 증상개선에 대한 메타분석)

  • Ohm, Sang-Hwa;Jeong, Ki-Won;Shin, Won-Chang;Cho, Jong-Rae;Shon, Hye-Suk;Pae, Ki-Taek;Kim, Sung-Jun
    • Journal of Preventive Medicine and Public Health
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    • v.32 no.4
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    • pp.427-434
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    • 1999
  • Objectives: This study was conducted to determine, by reviewing the literature, whether treatment of Helicobacter pylori infection in patients with non-ulcer dyspepsia affects symptoms. Methods: We retrieved the literature using MEDLINE search, with nonulcer dyspepsia and Hericobacter pylori and treatment as key words, which were reported from 1984 to 1998, and manual literature search. The criteria for inclusion was as follows; 1) The paper should have confirmed nonulcer dyspepsia as case definition. 2) The paper should have peformed a randomized, blind trial. 3) Confirmation of Helicobacter pylori eradication should be done 4 weeks after treatment. 4) studies with no information on measurement of symptoms after treatment were not accepted. The percentage of patients with symptom improvement after eradication therapy for Helicobacter pylori infection was calculated. Cumulative odds ratio was compared by fixed effect model and random effect model as sensitivity and funnel plot was used to evaluate publication bias. Results: The overall effect size of symptom improvement was calculated by cumulative odds ratio. Cumulative odds ratio of random effect model was 4.16(95% CI: 1.55-11.19). Before integrating each effect sizes into common effect size, the homogeneity test was conducted and random effect model was selected(Cochran's Q=41.08 (d.f=10, p<0.001)). The heterogeneity across studies was evaluated and the different methodological aspects of studies led to differences between study results Conclusions: The results suggest that the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia results more symptom improvement. In studios that shows the opposite results there are methodological aspects explaining the heterogeneity.

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Systematic review on the Randomized Controlled Clinical Trials of Qigong in the Korean Journals (국내 기공관련 무작위 임상연구에 대한 현황 검토)

  • Han, Chang-Hyun;Lee, Sang-Nam;Park, Ji-Ha;Ahn, Sang-Woo
    • Korean Journal of Acupuncture
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    • v.26 no.1
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    • pp.27-40
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    • 2009
  • Background : Qigong is an energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although qigong-neither itself nor its postulated mechanism of action-are within the paradigm of modern Western medical science, its effects on the human body could be possible. Objectives : This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Method : The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'qi', 'qigong', 'doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Result : Since the 1990s, Qigong papers in the Korean Literature are increased. The articles on Korean traditional medicine had been published more than those on physical education or nursing etc. However, since the majority of the trials determine questionnaire, it was difficult to determine the efficacy of a specific intervention. The methodological quality of the trials was generally low (Jadad score: mean, 1.3; range, 1 to 4), questioning their reliability. Conclusions : More profound studies for Qigong are needed. Further rigorous clinical trials with more objective outcome measures that include sham procedures should be performed. Specifically, we think it should be clinical studies and qualitative research methods for evaluation are needed.

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Research clinical trends on Gigong(氣功, Qigong) in the Korean Journal (한국(韓國) 저널에 게재(揭載)된 기공관련(氣功關聯) 임상(臨床) 연구(硏究) 동향(動向) 분석(分析) )

  • Han, Chang-Hyun;Lee, Sang-Nam;Kwon, Young-Kyu;Ahn, Sang-Woo;Choi, Sun-Mi
    • Journal of Korean Medical classics
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    • v.21 no.3
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    • pp.297-306
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    • 2008
  • Background : Gigong(氣功, Qigong) is one energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although Gigong(氣功, Qigong) - neither itself nor its postulated mechanism of action - are within the paradigm of modern Western medical science, effects on the human body could be possible. Objectives : This study aims to review the bibliography, biological responses and therapeutic effects of Gigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Method : The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'Gi(氣, Qi)', 'Gigong(氣功, Qigong)', 'Doin(導引)', 'Training', 'Bioenergy', 'life nurturing' and random or Korean language terms related to Gigong. Several specialized journals were also manually searched for relevant articles. Result : Since the 1990's, Gigong papers in the Korean Literature is increased. Clinical research studies are among the most control design study. Research subjects are less patient than the general public. The most common treatment disease was Musculo-skeletal disorder Conclusions : The depth study for the each Gigong(氣功, Qigong) is needed. Specifically, I think it should be a clinical studies and qualitative research methods for evaluation are needed.

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Research Trends on the Clinical Studies of Qigong in the Korean Journal (한국 저널에 게재된 기공관련 대조군 임상연구 현황 분석)

  • Han, Chang-Hyun;Kwon, Young-Kyu;Lee, Sang-Nam;Park, Ji-Ha;Ahn, Sang-Woo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.23 no.2
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    • pp.319-324
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    • 2009
  • Qigong is one energy-healing intervention used to prevent and cure ailments and to improve health through regular practice. Although qigong -neither itself nor its postulated mechanism of action- are within the paradigm of modern Western medical science, effects on the human body could be possible. This study aims to review the bibliography, biological responses and therapeutic effects of Qigong. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. The computerized Korean databases were searched from their respective inceptions up to January 2008. The search terms used were 'qi', 'qigong', 'doin', 'training', 'bioenergy', 'life nurturing' and random or Korean language terms related to qigong. Several specialized journals were also manually searched for relevant articles. Since the 1990s, Qigong papers in the Korean Literature is increased. Clinical research studies are among the most control design study. Research subjects are less patient than the general public. The most common treatment disease was hypertension. The depth study for the each Qigong is needed. Specifically, I think it should be a clinical studies and qualitative research methods for evaluation are needed.