• 제목/요약/키워드: randomized clinical trial

검색결과 875건 처리시간 0.031초

Assessment of Double-blindness at the Conclusion of the $\beta-Blocker$ Heart Attack Trial

  • Byington Robert P.;Curb J. David;Mattson Margaret E.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.293-296
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    • 1994
  • At the conclusion of a double-blinded, randomized clinical trial of propranolol hydrochloride, but before un blinding, the patients and clinic personnel were asked to guess the treatment group assignment of each patient. While 79.9% of the patients receiving propranolol correctly Identified their treatment group assignment, 57.2% of the patients receiving placebo incorrectly guessed that they were aiso in the propranolol group. No specific mechanism was identified to explain why more patients receiving propranolol were better able to guess' their group assignment. Clinic physicians correctly identified the group assignment of 69.9% of the patients receiving propranolol and 68.8% of the patients receiving placebo. Clinic coordinators correctly identified the group assignment of 67.1% of the patients receiving propranolol and 70.6% of the patients receiving placebo. For clinic personnel, heart rate level and heart rate change seem to be the mechanisms employed to Identify their patients' treatment assignment.

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임상판단모델에 근거한 디브리핑 적용이 임종간호 학습성과에 미치는 효과: 비무작위 대조시험설계 (Effect of Debriefing Based on the Clinical Judgment Model on Simulation Based Learning Outcomes of End-of-Life Care for Nursing Students: A Non-Randomized Controlled Trial)

  • 정경인;최자윤
    • 대한간호학회지
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    • 제47권6호
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    • pp.842-853
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    • 2017
  • Purpose: This study was conducted to identify effects of debriefing based on the clinical judgment model for nursing students on their knowledge, skill performance, clinical judgment, self-confidence and learner satisfaction during simulation based end-of-life care (ELC) education. Methods: Simulation based ELC education was developed in six steps as follows: selection of learning subjects and objects, development of learning tools, a trial run of simulation-based education, students' skill training, and evaluators' training. Forty-eight senior nursing students (25 in the experimental group and 23 in the control group) participated in the simulation-based ELC education using a high-fidelity simulator. Debriefing based on the clinical judgment was compared with the usual debriefing. Results: ANCOVA showed that there were differences in knowledge (F=4.81, p=.034), skill performance (F=68.33, p<.001), clinical judgment (F=18.33, p<.001) and self-confidence (F=4.85, p=.033), but no difference in satisfaction (t=-0.38, p=.704) between the experimental and control groups. Conclusion: This study found that debriefing based on the clinical judgement model is effective for supporting nursing students for reflecting on clinical judgment and improving their diverse competencies in complex clinical settings such as ELC.

신경근전기자극치료가 암 환자의 근육 손실에 미치는 영향: 체계적 문헌고찰 (Effects of Neuromuscular Electrical Stimulation on Muscle Wasting with Cancer Patient: A Systematic Review)

  • 박은수;김종희;김수담;김동현;이은정;오민석;유화승
    • 한방재활의학과학회지
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    • 제33권4호
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    • pp.15-29
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    • 2023
  • Objectives The purpose of this study is to systematically review the effects of Neuromuscular Electrical Stimulation treatment on muscle wasting in cancer patients. Methods Randomized controlled trials (RCTs) were searched from seven online databases (PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, Korean studies Information Service System, Research Information Sharing Service. The selected RCTs were evaluated for methodological quality through the Cochrane RoB. Results A total of 126 articles were identified, and 4 randomized controlled trials were selected for systematic review. In one study, it was found that there were statistically significant improvements in the Health-Related Quality of Life (FACTH&N total score, p<0.001). Additionally, significant effects were observed in measurements that represented the size of the quadriceps muscle (cross-sectional area of Vastus lateralis and Rectus femoris, p=0.004), maximum muscle strength, the twitch response of resistance muscles, and voluntary activation (p<0.001). However, no significant differences were observed between the intervention and control groups in terms of quadriceps muscle strength in two other studies (p>0.05). Lastly, while one study showed no significant differences in muscle fiber characteristics between the two groups, it did report significant improvements in measurements related to mitochondria within muscle tissue and muscle strength in the intervention group (p<0.05). Conclusions Neuromuscular electrical stimulation can be a method used to improve muscle strength in muscle wasting of cancer patients, but it is difficult to see its effects as significant compared to other treatments.

Conventional Versus Artificial Intelligence-Assisted Interpretation of Chest Radiographs in Patients With Acute Respiratory Symptoms in Emergency Department: A Pragmatic Randomized Clinical Trial

  • Eui Jin Hwang;Jin Mo Goo;Ju Gang Nam;Chang Min Park;Ki Jeong Hong;Ki Hong Kim
    • Korean Journal of Radiology
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    • 제24권3호
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    • pp.259-270
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    • 2023
  • Objective: It is unknown whether artificial intelligence-based computer-aided detection (AI-CAD) can enhance the accuracy of chest radiograph (CR) interpretation in real-world clinical practice. We aimed to compare the accuracy of CR interpretation assisted by AI-CAD to that of conventional interpretation in patients who presented to the emergency department (ED) with acute respiratory symptoms using a pragmatic randomized controlled trial. Materials and Methods: Patients who underwent CRs for acute respiratory symptoms at the ED of a tertiary referral institution were randomly assigned to intervention group (with assistance from an AI-CAD for CR interpretation) or control group (without AI assistance). Using a commercial AI-CAD system (Lunit INSIGHT CXR, version 2.0.2.0; Lunit Inc.). Other clinical practices were consistent with standard procedures. Sensitivity and false-positive rates of CR interpretation by duty trainee radiologists for identifying acute thoracic diseases were the primary and secondary outcomes, respectively. The reference standards for acute thoracic disease were established based on a review of the patient's medical record at least 30 days after the ED visit. Results: We randomly assigned 3576 participants to either the intervention group (1761 participants; mean age ± standard deviation, 65 ± 17 years; 978 males; acute thoracic disease in 472 participants) or the control group (1815 participants; 64 ± 17 years; 988 males; acute thoracic disease in 491 participants). The sensitivity (67.2% [317/472] in the intervention group vs. 66.0% [324/491] in the control group; odds ratio, 1.02 [95% confidence interval, 0.70-1.49]; P = 0.917) and false-positive rate (19.3% [249/1289] vs. 18.5% [245/1324]; odds ratio, 1.00 [95% confidence interval, 0.79-1.26]; P = 0.985) of CR interpretation by duty radiologists were not associated with the use of AI-CAD. Conclusion: AI-CAD did not improve the sensitivity and false-positive rate of CR interpretation for diagnosing acute thoracic disease in patients with acute respiratory symptoms who presented to the ED.

Effects of the Combination Herbal Extract on Working Memory and White Matter Integrity in Healthy Individuals with Subjective Memory Complaints : A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

  • Kwon, Oran;Lee, Sunho;Ban, Soonhyun;Im, Jooyeon J.;Lee, Doo Suk;Lee, Eun Hee;Kim, Joohee;Lim, Soo Mee;Lee, Sang Gon;Kang, Ilhyang;Kim, Kyung-Hee;Yoon, Sujung;Lee, Sun Hea
    • 생물정신의학
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    • 제22권2호
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    • pp.63-77
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    • 2015
  • Objectives The combination extract of four kinds of herbs, Gastrodia elata, Liriope platyphylla, Dimocarpus longan, and Salvia miltiorrhiza, has shown to have memory improving effects in mice. The aim of this study was to investigate the efficacy and safety of the herbal mixture for improving working memory as well as microstructural changes in white matter integrity in individuals with subjective memory complaints. Methods Seventy-five individuals with subjective memory complaints were assigned to receive either placebo (n = 15) or herbal mixture (low-dose group, n = 30 and high-dose group, n = 30) supplementation in an 8-week, randomized, double-blind, placebo-controlled clinical trial. Changes in working memory performance and fractional anisotropy (FA) values reflecting white matter integrity from baseline to 8-week endpoint were assessed. Results The herbal mixture group showed an increase in working memory performance compared to the placebo group (p for interaction = 0.001). In addition, the herbal mixture group showed an increase in FA values in the temporo-parietal regions (corrected p < 0.05), which are crucially involved in working memory function and are among the most affected regions in patients with cognitive impairments. Conclusions Findings from this study indicate that the herbal mixture may be a promising therapeutic option for individuals with subjective memory complaints.

신체화 장애에 대한 중의학 연구동향 (A Review on Treatment of Somatization Disorder in Traditional Chinese Medicine)

  • 김효섭;배진수;이승환;임정화;성우용
    • 동의신경정신과학회지
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    • 제28권3호
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    • pp.217-230
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    • 2017
  • Objectives: This study was conducted to review studies on somatization disorder in traditional Chinese medicine. Methods: We reviewed studies in the China National Knowledge Infrastructure (CNKI) to 2017. Keywords were 軀體化障碍, Somatization disorder, somatic symptom disorder. We included Randomized Controlled Trial (RCT), and excluded non-Randomized Controlled Trial (nRCT), non-related somatization disorder or traditional Chinese medicine, non-clinical trials, dissertations for degrees. Jadad scale and Cochrane Library's Risk of Bias (RoB) were used for assessment of the quality of studies. Results: Twelve studies were selected. The Chinese Classification of Mental Disorders-3 (CCMD-3) was most frequently used as diagnostic criteria for somatization disorder. As for outcome measurement, Hamilton Rating Scale for Depression (HAMD) was used most commonly. Meta-analysis of 10 studies revealed effective rate of Chinese Herbal Medicine groups (CHM) was significantly higher than Western Medicine groups (WM) (RR: 1.14, 95% CI: 1.02 to 1.27, p=0.02, $I^2=40%$). There was no significant difference in effective rate of CHM+WM and WM (RR: 1.12, 95% CI: 0.84 to 1.49, p=0.46, $I^2=83%$). And also, effective rate of Acupuncture group (Acu) revealed no significant difference compared to that of WM (RR: 1.17, 95% CI: 0.95 to 1.44, p=0.13, $I^2=84%$). For HAMD, there was significant difference in CHM vs, WM group and Acu vs. WM group. Quality of selected 12 RCTs was low. Conclusions: Therapies practiced in traditional Chinese medicine may be effective options for somatization disorder. treatment. For further clinical studies in Korean medicine, this study could be groundwork for development of diagnosis and treatment on somatization disorder.

비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험 (Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients)

  • 이지은;송윤경;임형호
    • 한방비만학회지
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    • 제10권1호
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

The effect of low glycemic index diet on body weight status and blood pressure in overweight adolescent girls: a randomized clinical trial

  • Rouhani, Mohammad Hossein;Kelishadi, Roya;Hashemipour, Mahin;Esmaillzadeh, Ahmad;Azadbakht, Leila
    • Nutrition Research and Practice
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    • 제7권5호
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    • pp.385-392
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    • 2013
  • Although several studies have assessed the influence of the glycemic index on body weight and blood pressure among adults, limited evidence exists for the pediatric age population. In the current study, we compared the effects of low glycemic index (LGI) diet to the healthy nutritional recommendation (HNR)-based diet on obesity and blood pressure among adolescent girls in pubertal ages. This 10-week parallel randomized clinical trial comprised of 50 overweight or obese and sexually mature girls less than 18 years of age years, who were randomly assigned to LGI or HNR-based diet. Macronutrient distribution was equivalently prescribed in both groups. Blood pressure, weight and waist circumference were measured at baseline and after intervention. Of the 50 participants, 41 subjects (include 82%) completed the study. The GI of the diet in the LGI group was $42.67{\pm}0.067$. A within-group analysis illustrated that in comparison to the baseline values, the body weight and body mass index (not waist circumference and blood pressure) decreased significantly after the intervention in both groups (P = 0.0001). The percent changes of the body weight status, waist circumference and blood pressure were compared between the two groups and the findings did not show any difference between the LGI diet consumers and those in the HNR group. In comparison to the HNR, LGI diet could not change the weight and blood pressure following a 10-week intervention. Further longitudinal studies with a long-term follow up should be conducted in this regard.

Clinical evaluation of efficacy of transcortical anesthesia for the extraction of impacted mandibular third molars: a randomized controlled trial

  • Demir, Esin;Ataoglu, Hanife
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권1호
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    • pp.9-17
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    • 2020
  • Background: This study aimed to compare the pain levels during anesthesia and the efficacy of the QuickSleeper intraosseous (IO) injection system and conventional inferior alveolar nerve block (IANB) in impacted mandibular third molar surgery. Methods: This prospective randomized clinical trial included 30 patients (16 women, 14 men) with bilateral symmetrical impacted mandibular third molars. Thirty subjects randomly received either the IO injection or conventional IANB at two successive appointments. A split-mouth design was used in which each patient underwent treatment of a tooth with one of the techniques and treatment of the homologous contralateral tooth with the other technique. The subjects received 1.8 mL of 2% articaine. Subjects' demographic data, pain levels during anesthesia induction, tooth extractions, and mouth opening on postoperative first, third, and seventh days were recorded. Pain assessment ratings were recorded using the 100-mm visual analog scale. The latency and duration of the anesthetic effect, complications, and operation duration were also analyzed in this study. The duration of anesthetic effect was considered using an electric pulp test and by probing the soft tissue with an explorer. Results: Thirty patients aged between 18 and 47 years (mean age, 25 years) were included in this study. The IO injection was significantly less painful with lesser soft tissue numbness and quicker onset of anesthesia and lingual mucosa anesthesia with single needle penetration than conventional IANB. Moreover, 19 out of 30 patients (63%) preferred transcortical anesthesia. Mouth opening on postoperative first day was significantly better with intraosseous injection than with conventional IANB (P = 0.013). Conclusion: The IO anesthetic system is a good alternative to IANB for extraction of the third molar with less pain during anesthesia induction and sufficient depth of anesthesia for the surgical procedure.

Comparison of lidocaine with articaine buccal injection in reducing complications following impacted mandibular third molar surgery: a split-mouth randomized clinical trial

  • Naghipour, Amin;Esmaeelinejad, Mohammad;Dehnad, Seyed Vahid;Shahi, Anahita;Jarrahi, Alireza
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권4호
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    • pp.213-221
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    • 2020
  • Background: Complications following impacted third molar surgery significantly affect patients' quality of life during the immediate postoperative period. This study aimed to achieve the proper anesthesia method by comparing the effect of the application of lidocaine alone with the application of lidocaine and articaine simultaneously in reducing the complications during and following impacted mandibular third molar surgery. Methods: The study design was a split-mouth double-blind randomized clinical trial. The study was conducted on 13 patients (26 samples) referred for elective surgical removal of bilateral impacted mandibular third molar with similar difficulty on both sides. Each patient underwent similar surgical procedures on two separate appointments. Each patient randomly received 2% lidocaine for conventional inferior alveolar nerve block and 4% articaine for local infiltration before the surgery on one side (group A) and 2% lidocaine alone (for both block anesthesia and infiltration) before the surgery on the other side (group B). Intraoperative and postoperative variables for both groups were established and statistically analyzed. Results: The findings showed that pain on the first day after surgery in group A was significantly lower than that in group B. The patients in group A mentioned experiencing less discomfort following the surgery. The increased horizontal swelling on the first and third days following surgery and oblique swelling on the seventh day in patients in group B were statistically significant. Conclusion: Choosing an appropriate anesthetic drug for oral surgery, specifically impacted third molar surgery, is dependent on the clinician's opinion, however; it seems that the combination of lidocaine and articaine may control the patient's pain significantly better than lidocaine alone.