• 제목/요약/키워드: Clinical Trial

검색결과 2,073건 처리시간 0.028초

집속형초음파자극시스템 카트리지의 동물실험을 통한 피부자극시험 및 피부 감작성시험 (Animal Skin Irritation and Skin Sensitization Tests of High Intensity Focused Ultrasound System Cartridges)

  • 김준태;김주희;주규태;김경아;최안렬;조재현;정진형
    • 한국정보전자통신기술학회논문지
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    • 제15권6호
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    • pp.477-484
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    • 2022
  • 본 연구는 집속형초음파자극시스템의 카트리지부를 시료로 사용하여 의료기기 안전성 평가 기준인 GLP(Good Laboratory Practice)에 관한 시험 중 동물실험을 통한 피부 자극 시험 및 피부 감작성시험을 진행하였다. New Zealand White Rabbit 암컷 6마리를 이용하여 IACUC 승인 후 시험을 진행하였으며, 실험기간 동안 사망한 개체 수는 없었으며, 실험동물에서 어떤 이상 증상도 관찰되지 않았다. 극성, 비극성 자극 지수는 모두 '0.0'으로 나타났다. 또한, 피부감작성 평가의 경우 IACUC 승인을 통한 기니피그 30마리를 통하여 대조군 및 실험군으로 나누어 시험검체 및 공시험액을 별도의 희석 없이 용출액 자체를 사용하여 모든 유도 및 유발단계를 적용하였다. 실험결과대조동물의 피부반응 등급은 0등급이었으며, 시험동물의 피부반응에서 1등급 이상을 나타내는 동물은 없었다. 두 시험 결과에서 피부의 이상 증상은 발견되지 않았으며, 인체에 적용하여 환자를 치료할 경우 시험에 사용된 시험재료로부터 피부의 이상 증상이 생기는 질환 등은 나타나지 않는지에 관하여 안정성을 알아 보고자 하였다.

Improved postoperative recovery profile in pediatric oral rehabilitation with low-dose dexmedetomidine as an opioid substitute for general anesthesia: a randomized double-blind clinical trial

  • Naveen, Naik B;Jaiswal, Manoj Kumar;Ganesh, Venkata;Singh, Ajay;Meena, Shyam Charan;Amburu, Vamsidhar;Soni, Shiv Lal
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권5호
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    • pp.357-367
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    • 2022
  • Background: Low-dose dexmedetomidine may be a suitable alternative to opioids for pediatric ambulatory procedures under general anesthesia (GA). However, the recovery profile remains unclear. Herein, we aimed to evaluate the effects of low-dose dexmedetomidine on the recovery profile of children. Methods: Seventy-two children undergoing ambulatory oral rehabilitation under GA were randomly and equally distributed into two groups (D and F). Group D received an infusion of dexmedetomidine 0.25 ㎍/kg for 4 min for induction, followed by maintenance of 0.4 ㎍/kg/h. Group F received an infusion of fentanyl 1 ㎍/kg over 4 min for induction, followed by maintenance at 1 ㎍/kg/h. The primary outcome was the extubation time. The secondary outcomes were awakening time, end-tidal sevoflurane (ET-Sevo) requirement, change in hemodynamic parameters, Richmond Agitation-Sedation Scale (RASS), Children's Hospital of Eastern Ontario pain scale (CHEOPS) score, length of PACU stay, and incidence of adverse events. Results: Statistically significant differences were observed in the recovery profile between the groups: the median time for extubation was 3.65 (3.44-6.2) vs. 6.25 (4.21-7) minutes in groups D vs. F (P=0.001), respectively, while the corresponding awakening times were 19 (18.75-21) and 22.5 (22-24) minutes, respectively (P < 0.001). The mean ET-Sevo was low in group D (1.1 vs. 1.2; P < 0.001). The heart rate was significantly low across all time points in group D, without resulting in bradycardia. The median RASS and CHEOPS scores were also significantly lower in group D. No significant differences were observed in the mean arterial pressure, incidence of adverse events, or length of PACU stay. Conclusion: Low-dose dexmedetomidine was more effective than fentanyl as an opioid substitute at providing a better recovery profile in pediatric ambulatory oral rehabilitation under GA. Dexmedetomidine also significantly reduced sevoflurane consumption without causing adverse events or prolonging hospital stay.

두통에 대한 이혈 방혈요법의 유효성 분석: 체계적 문헌고찰 및 메타분석 (Effectiveness of Auricular Blood-letting Therapy for Headaches: A Systematic Review and Meta-Analysis)

  • 이경은;박민령;이지원;황인준;이보람;서종철;권찬영
    • 동의신경정신과학회지
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    • 제34권3호
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    • pp.259-274
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    • 2023
  • Objectives: The purpose of this study was to provide clinical evidence to support the use of auricular blood-letting therapy (ABT) for headaches. Methods: Studies were identified by a comprehensive search of five databases. Randomized controlled trials (RCTs) that investigated the effects of the ABT for headaches were included. Two authors independently extracted the data and assessed the methodological quality of the included studies using Cochrane's risk-of-bias tool. If two or more studies reported the same outcome, a meta-analysis was performed. Meta-analysis results for dichotomous variables are expressed as risk ratios (RRs) and 95% confidence intervals (CIs). Results: A total of eight RCTs were included in this review. The total effective rate (TER) was the most commonly used outcome measurement. Among the eight RCTs, five were included in the metaanalysis. The TER was not statistically significantly different in the ABT group compared to the medication group (two studies, n=55, RR=1.24, 95% CI: 0.78 to 1.96, p=0.36, I2 =86%). However, the TER of the combined ABT and medication group was significantly different compared to the medication alone group (four studies, n=159, RR=1.23, 95% CI: 1.12 to 1.35, p<0.0001, I2 = 0%). Pain and mental health-related outcomes in the combined ABT and medication group were significantly different from the control groups. The methodological quality of the included RCTs was generally low. Conclusions: ABT combined with medication may be effective for treating headaches. However, the number of studies included was small, so the results were insufficient, and statistically significant effects were not confirmed for a single implementation of ABT. Thus, well-designed further studies based on the findings of this study are recommended.

Effect of diabetes-specific oral nutritional supplements with allulose on weight and glycemic profiles in overweight or obese type 2 diabetic patients

  • Jihye Tak;Minkyung Bok;Hyunkyung Rho;Ju Hyun Park;Yunsook Lim;Suk Chon;Hyunjung Lim
    • Nutrition Research and Practice
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    • 제17권2호
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    • pp.241-256
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    • 2023
  • BACKGROUND/OBJECTIVES: Diabetes-specific oral nutritional supplements (ONS) have anti-hyperglycemic effects, while D-allulose exerts anti-diabetic and anti-obesity effects. In this study, we investigated the efficacy and safety of diabetes-specific ONS, including allulose, on glycemic and weight changes in overweight or obese patients with type 2 diabetes mellitus (T2DM). SUBJECTS/METHODS: A single-arm, historical-control pilot clinical trial was conducted on 26 overweight or obese patients with T2DM (age range: 30-70 yrs). The participants were administered 2 packs of diabetes-specific ONS, including allulose (200 kcal/200 mL), every morning for 8 weeks. The glycemic profiles, obesity-related parameters, and lipid profiles were assessed to evaluate the efficacy of ONS. RESULTS: After 8 weeks, fasting blood glucose (FBG) level significantly decreased from 139.00 ± 29.66 mg/dL to 126.08 ± 32.00 mg/dL (P = 0.007) and glycosylated hemoglobin (HbA1c) improved (7.23 ± 0.82% vs. 7.03 ± 0.69%, P = 0.041). Moreover, the fasting insulin (δ: -1.81 ± 3.61 μU/mL, P = 0.017) and homeostasis model assessment for insulin resistance (HOMA-IR) (δ: -0.87 ± 1.57, P = 0.009) levels decreased at 8 weeks, and body weight significantly decreased from 67.20 ± 8.29 kg to 66.43 ± 8.12 kg (P = 0.008). Body mass index (BMI) also decreased in accordance with this (from 25.59 ± 1.82 kg/m2 to 25.30 ± 1.86 kg/m2, P = 0.009), as did waist circumference (δ: -1.31 ± 2.04 cm, P = 0.003). CONCLUSIONS: The consumption of diabetes-specific ONS with allulose in overweight or obese patients with T2DM improved glycemic profiles, such as FBG, HbA1c, and HOMA-IR, and reduced body weight and BMI.

Comparison of ultrasound-guided subacromial corticosteroid and ozone (O2-O3) injections in the treatment of chronic rotator cuff tendinopathy: a randomized clinical trial

  • Merve Orucu Atar;Nurdan Korkmaz;Sefa Gumruk Aslan;Ozge Tezen;Sinem Uyar Koylu;Yasin Demir;Serdar Kesikburun
    • The Korean Journal of Pain
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    • 제36권1호
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    • pp.128-136
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    • 2023
  • Background: The authors aimed to compare the effects of a one-time ultrasound (US)-guided subacromial corticosteroid injection and three-time ozone (O2-O3) injection in patients with chronic supraspinatus tendinopathy. Methods: Participants were randomly assigned to the corticosteroid group (n = 22) or ozone group (n = 22). Injections in both groups were administered into subacromial bursa with an US-guided in-plane posterolateral approach. Primary outcome measure was the change in the Western Ontario Rotator Cuff Index (WORC) score between baseline and 12-weeks post-injection. Secondary outcome measures included visual analog scale and Shoulder Pain and Disability Index scores. Assessments were recorded at baseline, and 4-weeks and 12-weeks post-injection. Results: Forty participants completed this study. Based on repeated measurement analysis of variance, a significant effect of time was found for all outcome measures in both groups. Both the groups showed clinically significant improvements in shoulder pain, quality of life, and function. Baseline, 4-week post-injection, and 12-week post-injection WORC scores (mean ± standard deviation) were 57.91 ± 18.97, 39.10 ± 20.50 and 37.22 ± 27.31 in the corticosteroid group, respectively and 69.03 ± 15.89, 39.11 ± 24.36, and 32.26 ± 24.58 in the ozone group, respectively. However, no significant group × time interaction was identified regarding all outcome measures. Conclusions: Three-time ozone injection was not superior to a one-time corticosteroid injection in patients with chronic supraspinatus tendinopathy. It might be as effective as corticosteroid injection at 4-weeks and 12-weeks post-injection in terms of relieving pain and improving quality of life and function.

Efficacy of intraosseous saline injection for pain management during surgical removal of impacted mandibular third molars: a randomized double-blinded clinical trial

  • Jawahar Babu. S;Naveen Kumar Jayakumar;Pearlcid Siroraj
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제23권3호
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    • pp.163-171
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    • 2023
  • Background: Surgical extraction of impacted mandibular third molars is the most common procedure performed by oral surgeons. The procedure cannot be performed effectively without achieving profound anesthesia. During this procedure, patients may feel pain during surgical bone removal (at the cancellous level) or during splitting and luxation of the tooth, despite administration of routine nerve blocks. Administration of intraosseous (IO) lignocaine injections during third molar surgeries to provide effective anesthesia for pain alleviation has been documented. However, whether the anesthetic effect of lignocaine is the only reason for pain alleviation when administered intraosseously remains unclear. This conundrum motivated us to assess the efficacy of IO normal saline versus lignocaine injections during surgical removal of impacted mandibular third molars. The aim of this study was to assess the efficacy of IO normal saline as a viable alternative or adjunct to lignocaine for alleviation of intraoperative pain during surgical removal of impacted mandibular third molars. Methods: This randomized, double-blind, interventional study included 160 patients who underwent surgical extraction of impacted mandibular third molars and experienced pain during surgical removal of the buccal bone or sectioning and luxation of the tooth. The participants were divided into two groups: the study group, which included patients who would receive IO saline injections, and the control group, which included patients who would receive IO lignocaine injections. Patients were asked to complete a visual analog pain scale (VAPS) at baseline and after receiving the IO injections. Results: Of the 160 patients included in this study, 80 received IO lignocaine (control group), whereas 80 received IO saline (study group) following randomization. The baseline VAPS score of the patients and controls was 5.71 ± 1.33 and 5.68 ± 1.21, respectively. The difference between the baseline VAPS scores of the two groups was not statistically significant (P > 0.05). The difference between the numbers of patients who experienced pain relief following administration of IO lignocaine (n=74) versus saline (n=69) was not statistically significant (P > 0.05). The difference between VAPS scores measured after IO injection in both groups was not statistically significant (P >0.05) (1.05 ± 1.20 for the control group vs. 1.72 ± 1.56 for the study group) Conclusion: The study demonstrates that IO injection of normal saline is as effective as lignocaine in alleviating pain during surgical removal of impacted mandibular third molars and can be used as an effective adjunct to conventional lignocaine injection.

Incidence of postoperative pain after using single continuous, single reciprocating, and full sequence continuous rotary file system: a prospective randomized clinical trial

  • Umesh Kumar;Pragnesh Parmar;Ruchi Vashisht;Namita Tandon;Charan Kamal Kaur
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제23권2호
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    • pp.91-99
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    • 2023
  • Background: Extrusion of debris is a major factor that results in postoperative pain during root canal treatment with various instruments and instrumentation techniques. Therefore, instrumentation techniques that extrude minimal debris into the periapical area while reducing pain are desirable. This study aimed to compare the incidence of postoperative pain and intake of analgesic medication (frequency and quantity) after endodontic treatment of mandibular posterior teeth using two single files and full-sequence continuous rotary systems with different kinematic motions. Methods: Thirty-five of 105 patients were assigned equally to three groups according to the instrumentation system used: ProTaper Next (PN) X2, 25/06 (Dentsply, Maillefer, Ballaigues, Switzerland), One Shape (OS), #0.25/06 (Micro Mega, Besancon, France), and Wave One Gold (WG), Red - #0.25, 0.07 (Dentsply, Maillefer, Ballaigues, Switzerland). Five specialists were included in this study design; each professional prepared 21 teeth, and randomly selected 7 per instrument system. The VAS sheet ranging from 0 to 10 was used to record the initial and postoperative pains at 24, 48, and 72 h, and 7th day after single visit endodontic treatment in mandibular premolars and molars with a diagnosis of asymptomatic irreversible pulpitis with or without apical periodontitis. Postoperatively, an analgesic, ibuprofen 400 mg was administered for intolerable pain at a dose of 1 tablet for 6 h. The patients were asked over the telephone regarding postoperative pain at intervals of 24, 48, and 72 h, and 7th day using a visual analogue scale. Result: There were no statistically significant differences among the PN, OS, and WG systems (P > 0.05) with regard to the incidence of postoperative pain at any of the four time points assessed. Conclusion: The intensity of postoperative pain, frequency, and analgesic intake were similar across all three types of instrument systems; however, the reciprocating single file (WG) was associated with less postoperative pain than the full sequence continuous rotary file.

Orthodontic pain control following arch wire placement; a comparison between pre-emptive tenoxicam and chewing gum: a randomized clinical trial

  • Basam, Lakshman Chowdary;Singaraju, Gowri Sankar;Obili, Sobitha;Keerthipati, Thejasree;Basam, Ram Chowdary;Prasad, Mandava
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권2호
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    • pp.107-116
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    • 2022
  • Background: Pain during fixed orthodontic treatment can have a detrimental effect on patient treatment compliance. To overcome this, there is a definite need to establish the best pain-relieving methods suitable for orthodontic patients in terms of efficacy and use. The objective of this study was to compare the effect of chewing gum and pre-emptive tenoxicam on pain after initial archwire placement and to evaluate the pain perceptions of orthodontic patients in the two groups while performing various functions at specific time intervals. Methods: Forty-two patients were selected and randomly divided into two groups: group A (chewing gum) and group B (pre-emptive tenoxicam). Pain perception was documented by patients immediately; at 4 h; at bedtime on the day of archwire placement; the next morning; at 24 h; and at bedtime on the 2nd, 3rd, and 7th day after the initial archwire placement. Pain scores were noted during fitting of the posterior teeth, biting, and chewing using a visual analog scale. The data obtained were subjected to statistical analysis. Results: Group A showed a significant increase in pain until the next morning while fitting the posterior teeth, biting, and chewing [36.2, 52.0, 33.4, respectively]], followed by a gradual decrease by the 7th day. Group B showed a significant increase in pain at bedtime on biting, with a peak value of 47.5. Pain on chewing, fitting posterior teeth, peaked the morning of the next day (100.0, 45.0). The Freidman test showed a statistically significant difference with a p-value of < 0.01. Higher pain scores were observed while chewing and biting compared with that while fitting the posterior teeth in both groups. The overall comparison of pain control between the two groups was not statistically significant [P > 0.05] between the two groups. Conclusions: Chewing gum was not inferior to pre-emptive tenoxicam. Thus, chewing gum is a non-pharmacological alternative to analgesics for orthodontic pain control that eliminates the chance of adverse reactions and can be used in the absence of adult observation.

심혈관질환 고위험군에 대한 통심락(通心絡)의 유효성 및 안전성 평가를 위한 임상시험 (Clinical trial to evaluate the efficacy and safety of Tongxinluo in high risk group of cardiovascular diseases)

  • 박성욱;정우상;문상관;고창남;조기호;김영석;배형섭
    • 대한중풍순환신경학회지
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    • 제6권1호
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    • pp.25-32
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    • 2005
  • Background and purpose: Arterial stiffness is an important, independent determinant of cardiovascular risk. Pulse wave velocity (PWV) has been used as a valuable index of arterial stiffness and as a surrogate marker for atherosclerosis. The Framingham risk score was developed using categorized risk factors to predict the 10 year absolute risk of developing coronary heart disease (CHD). This algorithm is established using recommended guidelines for blood pressure, total cholesterol, and high density lipoprotein cholesterol in addition to age, smoking history and history of diabetes. Tongxinluo(TXL) has been shown to have anti hyperlipidemic activity and anti atherogenic effects. To determine its efficacy and safety, we examined whether TXL improves PWV, ABI, Framingham score, blood pressure, and lipid profile in high risk group of cardiovascular diseases. Subjects and methods: 49 subjects with the high risk of cardiovascular diseases were recruited. Subjects were administered TXL with the dose of 1110mg three times a day for 8 weeks. baPWV, ABI, Framingham risk score, Blood pressure and serum lipid profile were assessed at baseline and after 4 and 8weeks. Results: Total cholesterol, LDL cholesterol, triglyceride, total lipid and phospolipid significantly decreased after 4 weeks of medication. Total cholesterol, total lipid and phospolipid significantly decreased after 8 weeks of medication. There were no significant changes in Framingham risk scores, ABI, PWV and blood pressure. On safety assessment, there were no adverse effects, hepatic or renal toxicity. Conclusion: We suggest that TXL is a safe and useful herbal medicine for hyperlipidemia and as for anti-atherognic effects, further research would be necessary.

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Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • 제27권2호
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)