• Title/Summary/Keyword: Pilot trial

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Negligence theory of Aviation accident with reference to the japanese aviation accident precedent (항공 사고에서의 과실 이론 - 일본 항공 사고 판례를 중심으로 -)

  • Hwang, Ho-Won;Ham, Se-Hun
    • The Korean Journal of Air & Space Law and Policy
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    • v.23 no.2
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    • pp.115-136
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    • 2008
  • The development of the aviation technology is beyond the people's imagination. For example, with some exaggeration, If the autopilot engage upon take off, You will realize that you are on the centerline of the foggy JFK runway 13R after 15 hours with only once or twice of intervention. But the more aviation technology develops, the more responsible the pilot will be who has the final authority of the aviation safety. In the JAL 706 accident caused by unidentified reason, the pilot increased pitch abruptly and overrode the control from the autopilot. The result of this process made the death of a flight attendant and some injuries of a few passengers. The district court found the pilot not guilty at the first trial on the ground that the control override was not connected to the possibility of foresight and avoidance of the human death. The pilot was proved to be innocent through the analysis of the DFDR and ADAS that the override did not precede the unidentified pitch up motion. The judicial precedent related to aviation accidents in Korea requires pilots' absolute and extended care compared to the ordinarily prudent or reasonably careful behaviors in the vehicle and medical accidents. Although there is some controversy about the standard care, the care required in the actual operation of high tech aircraft by a pilot should include objective and standard care and be judged by analysis of the scientific data. Although the pilot maintained the unusual hi speed that doesn't have safety margin and descended under turbulence in case of the JAL 706 accident, the court negatived its relation to the cause of pitch up. Also, the override of the control after initial pitch up might have caused the possibility of the death and injury, but the court denied it. Because of this complex cause of the aviation accidents, it is important for a court to figure out the core reason of the event and casual relationship with the pilot Now, It is required that the judgement of negligence in the aviation accidents should include an objective care with scientific data from simulated circumstances(or a simulator) as the Japanese court not from the theory of vehicle's negligence.

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Effects of treadmill training with real optic flow scene on balance and balance self-efficacy in individuals following stroke: a pilot randomized controlled trial

  • Kang, Hyungkyu;Chung, Yijung
    • Physical Therapy Rehabilitation Science
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    • v.1 no.1
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    • pp.33-39
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    • 2012
  • Objective: The objective of this study is to investigate the effect of treadmill training with real optic flow scene on functional recovery of balance and balance self-efficacy in stroke patients. Design: Single blind, Randomized controlled trial. Methods: Nine patients following stroke were divided randomly into the treadmill with optic flow group (n=3), treadmill with virtual reality group (n=3), and control group (n=3). Subjects in the treadmill with optic flow group wore a head-mounted display in order to receive a speed modulated real optic flow scene during treadmill training for 30 minutes, while those in the treadmill with virtual reality group and control group received treadmill training with virtual reality and regular therapy for the same amount of time, five times per week for a period of three weeks. Timed up and go test (TUG) and activities-specific balance confidence scale (ABC scale) were evaluated before and after the intervention. Results: TUG in the treadmill training with optic flow group showed significantly greater improvement, compared with the treadmill training with virtual reality group and control group (p<0.05). Significantly greater improvement in the ABC scale was observed in the treadmill training with optic flow group and the tread mill training with virtual reality group, compared with the control group (p<0.05). Conclusions: Findings of this study demonstrate that treadmill training with real optic flow scene can be helpful in improving balance and balance self-efficacy of patients with chronic stroke and may be used as a practical adjunct to routine rehabilitation therapy.

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First Trial of Cervical Cytology in Healthy Women of Urban Laos using by Self-sampling Instrument

  • Nabandith, Viengvansay;Pholsena, Vatsana;Mounthisone, Phouthasone;Shimoe, Kyoko;Kato, Saiko;Aoki, Kunio;Noda, Sadamu;Takamatsu, Reika;Saio, Masanao;Yoshimi, Naoki
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4665-4667
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    • 2012
  • Cervical cancer is the most common cancer in Laos women and a screening programme, even with the PAP smear test (PAP test), has yet to be established for routine use. The Pap test is accepted as the most appropriate for cervical cancer screening in some settings but it is not commonly available in Laos hospitals, because there are few cytopathologists and gynecologists have little experience. As a pilot program, seminars for the PAP test were given in 2007 and 2008, and then PAP tests were carried out using self-sampling instrument (Kato's device) with 200 healthy volunteers in Setthathirath hospital, Laos, in 2008. The actual examination number was 196, divided into class I 104 (53.1%), class II 85 (43.3%), class IIIa 4 (2.0%), class IIIb 1 (0.5%), and class V 1 (0.5%) by modified Papanicolau classification. Four cases had menstruation. There were 6 cases with epithelial cell abnormalities including malignancy. There were 7 cases with fungus and 2 cases with trichomonas in Class II. More than 70% volunteers felt comfortable with the Kato's device and wanted to use it next time, because of the avoidance of the embarrassment and a low cost as compared with pelvic examination by gynecologists. This first trial for PAP test for healthy Laos women related to a hospital found three percent to have abnormal cervical epithelial cells. Therefore, this appraoch using a self-sampling device suggests that it should be planned for cervical cancer prevention in Laos.

Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: A Randomized Controlled Pilot Trial (폐경 후 고혈압 전단계 및 1기 고혈압에 대한 침 치료 효과: 무작위 대조 예비연구)

  • Kim, Jung-Eun;Choi, Sun-Mi;Choi, Jin-Bong;Kim, Hyeong-Jun;Kwon, Ojin;Kim, Jae-Hong;Park, Ji-Eun
    • Korean Journal of Acupuncture
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    • v.34 no.3
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    • pp.116-125
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    • 2017
  • Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study (급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검)

  • Song, Ho-Seub
    • Journal of Pharmacopuncture
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    • v.8 no.2
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    • pp.11-16
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    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

Diagnostic Values of Tongue Coating Thickness and Sterno-costal Angle in Functional Dyspepsia (기능성 소화불량 환자에서 설태후박 및 흉늑각 측정의 진단적 가치)

  • Son, Ji-Young;Kim, Jin-Sung
    • The Journal of Internal Korean Medicine
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    • v.35 no.2
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    • pp.157-174
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    • 2014
  • Objectives : The aims of this study were to evaluate the diagnostic values of tongue coating thickness and sterno-costal angle as the quantitative diagnostic indicators in functional dyspepsia. Methods : We surveyed 60 functional dyspepsia patients recruited by the clinical trial, 'Clinical Trial for Evaluation on Availability of tongue diagnosis system (CTS-1000) : a Pilot study'. The patients were classified into three groups according to Rome III criteria for functional dyspepsia, and categorized into five groups according to Instrument of pattern identification for functional dyspepsia. Nepean dyspepsia index-Korean version (NDI-K) score, tongue coating thickness (percentage of tongue coating by tongue diagnosis system (CTS-1000), and weight of tongue coating by microbalance), sterno-costal angle, duration of illness and body mass index (BMI) were investigated. Results : Among the 5 types by instrument of pattern identification for functional dyspepsia, a significant difference of percentage of tongue coating was found. Percentage of tongue coating and weight of tongue coating showed significant correlation with total NDI-K score. Sterno-costal angle showed strong positive correlation with BMI and also showed significant difference between the non-overweight (BMI<23, n=32) and overweight ($BMI{\geq}23$, n=28) groups. Conclusions : Tongue coating thickness showed its potential as a new quantitative diagnostic indicator of functional dyspepsia. Further studies on the sterno-costal angle are anticipated to evaluate its potential as a new quantitative diagnostic indicator.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.35 no.3
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

Cost Effective Analysis of Recall Methods for Cervical Cancer Screening in Selangor - Results from a Prospective Randomized Controlled Trial

  • Abdul Rashid, Rima Marhayu;Ramli, Sophia;John, Jennifer;Dahlui, Maznah
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.13
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    • pp.5143-5147
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    • 2014
  • Cervical cancer screening in Malaysia is by opportunistic Pap smear which contributes to the low uptake rate. To overcome this, a pilot project called the SIPPS program (translated as information system of Pap smear program) had been introduced whereby women aged 20-65 years old are invited for Pap smear and receive recall to repeat the test. This study aimed at determining which recall method is most cost-effective in getting women to repeat Pap smear. A randomised control trial was conducted where one thousand women were recalled for repeat smear either by registered letter, phone messages, phone call or the usual postal letter. The total cost applied for cost-effectiveness analysis includes the cost of sending letter for first invitation, cost of the recall method and cost of two Pap smears. Cost-effective analysis (CEA) of Pap smear uptake by each recall method was then performed. The uptake of Pap smear by postal letter, registered letters, SMS and phone calls were 18.8%, 20.0%, 21.6% and 34.4%, respectively (p<0.05). The CER for the recall method was lowest by phone call compared to other interventions; RM 69.18 (SD RM 0.14) compared to RM 106.53 (SD RM 0.13), RM 134.02 (SD RM 0.15) and RM 136.38 (SD RM 0.11) for SMS, registered letter and letter, respectively. ICER showed that it is most cost saving if the usual method of recall by postal letter be changed to recall by phone call. The possibility of letter as a recall for repeat Pap smear to reach the women is higher compared to sending SMS or making phone call. However, getting women to do repeat Pap smear is better with phone call which allows direct communication. Despite the high cost of the phone call as a recall method for repeat Pap smear, it is the most cost-effective method compared to others.

Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial

  • Juthong, Siwasak;Panyarath, Pattaraporn
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.67-73
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    • 2022
  • Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough, sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George's Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 ㎍ of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV1 increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended to improve more in the roflumilast group than in the placebo group.

Efficacy and Safety of Miniscalpel Acupuncture, Non-Steroidal Anti-Inflammatory Drugs or Combined Treatment for Chronic Neck Pain: An Assessor-Blinded Randomized Controlled Pilot Study (만성 경항통(목부위 통증)의 도침요법, 진통제, 복합치료의 효능 및 안전성 연구)

  • Gong, Han Mi;Jun, Seungah;Chung, Yeon-Joong;Kim, Ju-Ran;Lee, Jung Hee;Lee, Hyun-Jong;Park, Chung A;Kim, Jae Soo
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.14-23
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    • 2020
  • Objectives : We investigated the efficacy and safety of miniscalpel acupuncture (MA) treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain (CNP) in an assessor-blinded randomized controlled pilot trial to establish a basis for larger-scale randomized controlled studies on this subject. Methods : Participants (n=36) were recruited and randomly allocated to the MA group, NSAIDs and combined treatment group. The MA group received MA three times over three weeks. The NSAIDs group was administered orally with zaltoprofen 80mg t.i.d. over three weeks. The combined treatment group received MA and zaltoprofen in the same manner as MA and NSAIDs groups. The primary outcome was pain as assessed by a visual analogue scale (VAS) and the secondary outcomes were assessed using the Neck Disability index (NDI), EuroQol 5-dimension questionnaire (EQ-5D), and Patients' Global Impression of Change scale (PGIC). Assessments were made at week 0 (baseline), 1, 2, 3 (primary end point) during treatment and at week 7 (4 weeks after the end of treatment). Results : 35 participants completed the study. No serious adverse event occurred and blood test results were within normal limits. The improvement of VAS and NDI was significantly greater in combined and MA group than that in NSAIDs group (p<0.017). The combined group showed better outcomes in EQ-5D at visit 2 and 5, in PGIC at visit 4 than the NSAIDs group (p<0.017). No significant differences were found between combined and MA group. Conclusions : Our results suggest that both combined and MA group can be more effective in improving pain control than NSAIDs group. A large-scale clinical study is warranted to further clarify these findings.