Randomized controlled clinical trial

随机对照临床试验
  • 文章类型: Journal Article
    背景:卒中后推进综合征(PS)患者出院后需要更长的康复时间和更多的补充护理。有效治疗PS仍然是一个挑战。尚未研究重复经颅磁刺激(rTMS)对PS的作用。
    目的:评估rTMS对卒中后PS患者推挤行为的疗效,增强运动恢复和提高机动性。
    方法:随机,我们进行了患者和评估者盲法假对照试验,并进行了意向治疗分析.34名符合卒中后PS的患者被随机分配接受rTMS或假rTMS2周。在Burke侧向撕脱量表和用于对比推的量表上的推行为,在基线测量Fugl-Meyer评估量表-运动域(FMA-m)上的运动功能和改良的Rivermead运动指数上的运动能力,干预后1周和2周。重复测量协方差分析用于数据分析。
    结果:在Burke侧向撕脱量表上,干预与时间之间没有显着交互作用(F=2.747,P=.076),反推刻度(F=1.583,P=.214),或改良Rivermead流动性指数的变化(F=1.183,P=0.297)。然而,FMA-m的干预和时间之间存在显著的交互作用(F=5.464,P=0.019).FMA-m的事后比较显示,rTMS组的改善更好,治疗后第1周和第2周的平均差异分别为12.7(95%CI-7.3至32.7)和15.7(95%CI-4.6至36.0)。
    结论:rTMS在改善PS患者的推动行为和活动能力方面没有显著疗效。然而,rTMS可能具有增强PS患者运动功能的潜在作用。
    该研究已在中国临床试验注册中心注册(注册号:ChiCTR2200058015在http://www。chictr.org.cn/searchprojen.aspx)于2022年3月26日。
    BACKGROUND: Patients with poststroke pusher syndrome (PS) require longer duration of rehabilitation and more supplemental care after discharge. Effective treatment of PS remains a challenge. The role of repetitive transcranial magnetic stimulation (rTMS) for PS has not been examined.
    OBJECTIVE: Assess the efficacy of rTMS for patients with poststroke PS in reducing pushing behavior, enhancing motor recovery and improving mobility.
    METHODS: A randomized, patient- and assessor-blinded sham-controlled trial with intention-to-treat analysis was conducted. Thirty-four eligible patients with poststroke PS were randomly allocated to receive either rTMS or sham rTMS for 2 weeks. Pushing behavior on the Burke lateropulsion scale and scale for contraversive pushing, motor function on Fugl-Meyer assessment scale-motor domain (FMA-m) and mobility on modified Rivermead mobility index were measured at baseline, 1 and 2 weeks after intervention. Repeated-measures analysis of covariance was used for data analysis.
    RESULTS: There was no significant interaction between intervention and time on Burke lateropulsion scale (F = 2.747, P = .076), scale for contraversive pushing (F = 1.583, P = .214), or change of modified Rivermead mobility index (F = 1.183, P = .297). However, a significant interaction between intervention and time was observed for FMA-m (F = 5.464, P = .019). Post hoc comparisons of FMA-m show better improvement in rTMS group with mean differences of 12.7 (95% CI -7.3 to 32.7) and 15.7 (95% CI -4.6 to 36.0) at post-treatment week 1 and week 2 respectively.
    CONCLUSIONS: rTMS did not demonstrate significant efficacy in improving pushing behavior and mobility in patients with PS. However, rTMS might have potential effect in enhancing motor function for patients with PS.
    UNASSIGNED: The study was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR2200058015 at http://www.chictr.org.cn/searchprojen.aspx) on March 26, 2022.
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  • 文章类型: Journal Article
    目标:尽管早期牙科护理对于预防儿童早期龋齿至关重要,并且有很多好处,这种护理的使用率在世界范围内仍然非常低,尤其是社会经济地位低下的家庭。这项研究的目的是系统地回顾有关干预措施对改善幼儿早期牙科护理利用率的有效性的科学证据。
    方法:我们回顾了与这些积极变化有关的科学证据,7项随机对照试验经过定性评价。评估的干预措施包括产前口腔健康促进,动机性面试,口内摄像机与社会工作咨询一起使用,以帮助减少护理障碍,刷牙的货币激励措施,氟化物清漆的应用,和益生菌的使用。
    结果:干预措施在降低儿童龋齿发生率方面显着有效,尤其是龋齿风险。当产前频繁提供口腔健康信息时,龋齿减少是显着的。当每天给药时引入益生菌时,龋齿的增加也减少了。试图通过增加动机和减少障碍来增加父母对口腔保健的参与的干预措施在研究组内没有定论。
    结论:考虑到高速率ECC,早期建立和保存牙科之家应成为公共卫生措施的重点。持续监测和父母参与是维持健康口腔状况的关键组成部分。未来的研究可以探索和测试各种创新策略,利用技术平台与父母互动,促进服务不足人群的早期牙科护理利用。
    OBJECTIVE: Although early-life dental care is crucial for preventing early childhood caries and has numerous benefits, the utilization rate of such care remains remarkably low worldwide, especially in families of low socioeconomic status. The aim of this study was to systematically review the scientific evidence relating to the effectiveness of interventions on improving early-life dental care utilization of very young children.
    METHODS: We reviewed scientific evidence relating to these positive changes, with 7 randomized controlled trials after qualitative evaluation. Interventions assessed included prenatal oral health promotion, motivational interviewing, intraoral camera use alongside social work consultations to aid in decreasing barriers to care, monetary incentives for tooth brushing, fluoride varnish applications, and probiotic usage.
    RESULTS: The intervention was significantly effective in reducing the incidence of dental caries among children, especially in caries risk. Caries reduction was significant when oral health information was provided at frequent intervals prenatally. Caries increment was also reduced when probiotics were introduced when administered daily. Interventions that attempted to increase parental involvement in oral health care by increasing motivation and decreasing barriers had inconclusive results within the study groups.
    CONCLUSIONS: Considering high rates ECC, early establishment and preservation of a dental home should be a focus in public health measures. Continuous monitoring and parental involvement are key components to maintaining healthy oral conditions. Future studies could explore and test various innovative strategies that utilize technological platforms to engage with parents and promote early-life dental care utilization among the underserved population.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    背景:关于老年人治疗的疗效数据很少,而溃疡性结肠炎(UC)患病率的增幅最大的是40~65岁和≥65岁的年龄组.
    目的:我们评估了接受美沙拉嗪治疗的UC成人(≤60岁)和老年人(>60岁)的临床和内镜反应和缓解率的差异。
    方法:我们在一项双盲和开放标签研究中,对817名接受美沙拉嗪治疗8周和另外26周的UC患者的3期非劣效性试验的数据进行了事后分析。分别。我们使用Wilcoxon秩和或卡方检验来分析组间差异,并使用多变量逻辑回归来确定内镜缓解作为结果(Mayo内镜子评分[MES]=0或≤1)与包括疾病持续时间在内的独立变量之间的关联。基线MES,年龄,性别,喜剧,和合并症。
    结果:老年人的病程较长,更多的合并症,合并用药,和较高的基线MES(2.38±0.486在老年人和2.26±0.439在成人;P=.008)相比成人。我们观察到临床和内镜联合缓解率没有差异,临床缓解和反应,以及治疗后第8周和第38周的内镜缓解和反应。除了其他众所周知的预后较差的预测因素外,在第8周和第38周时,有≥3项病因的患者MES=0,在第38周时MES≤1.
    结论:我们观察到美沙拉嗪在成人和老年UC患者中的疗效相似。增加的昏迷人数而不是年龄可能会降低UC药物的有效性,强调健康衰老的重要性。
    我们调查了口服美沙拉嗪治疗的成人(≤60岁)和老年人(>60岁)溃疡性结肠炎患者的临床和内镜反应率;我们的结果表明年龄不影响疗效和安全性。
    BACKGROUND: The efficacy data on treatment in older adults are scarce, while the greatest increase in ulcerative colitis (UC) prevalence is observed in age groups of individuals 40 to 65 years of age and ≥65 years of age.
    OBJECTIVE: We assessed the difference in rates of clinical and endoscopic response and remission in UC adults (≤60 years) and older adults (>60 years) treated with mesalazine.
    METHODS: We performed a post hoc analysis of data from a phase 3 noninferiority trial of 817 UC patients treated with mesalazine for 8 and additional 26 weeks in a double-blind and open-label study, respectively. We used Wilcoxon rank sum or chi-square test to analyze differences between groups and multivariable logistic regression to determine the associations between endoscopic remission as outcome (Mayo endoscopic subscore [MES] = 0 or ≤1) and independent variables including disease duration, baseline MES, age, sex, comedications, and comorbidities.
    RESULTS: Older adults had a longer disease duration, a higher number of comorbidities, concomitant medications, and higher baseline MES (2.38 ± 0.486 in older adults vs 2.26 ± 0.439 in adults; P = .008) compared with adults. We observed no difference in rates of combined clinical and endoscopic remission, clinical remission and response, and endoscopic remission and response at week 8 and 38 post-treatment. In addition to other well-known predictors of worse outcome, patients with ≥3 comedications were less likely to achieve an MES = 0 at week 8 and 38 and an MES ≤1 at week 38.
    CONCLUSIONS: We observed similar efficacy of mesalazine in adult and older adult UC patients. The increased comedication number rather than age may decrease effectiveness of UC medications, highlighting the importance of healthy aging.
    We investigated the rates of clinical and endoscopic response in adult (≤60 years) and older adult (>60 years) ulcerative colitis patients treated with oral mesalazine; our results demonstrated that age did not influence the efficacy and safety.
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  • 文章类型: Journal Article
    Sparsentan是一部小说,非免疫抑制,单分子,双重内皮素血管紧张素受体拮抗剂(DEARA)在正在进行的2期DUET治疗局灶性节段肾小球硬化(FSGS)试验中进行了检查。在DUET的8周双盲期,与厄贝沙坦相比,sparsentan导致更多的蛋白尿减少。我们报告了sparsentan在开放标签扩展超过4年的长期疗效和安全性。
    患者从第一次服用sparsentan(双盲期或开放标签延长)到4.6年进行检查。
    FSGS患者,不包括二级FSGS。
    Sparsentan(200、400和800mg/d)。
    尿蛋白-肌酐比值,FSGS部分缓解终点(尿蛋白-肌酐比值≤1.5g/g,比基线下降>40%),估计肾小球滤过率,和血压大约每12周。按年份和病例/100患者年划分的治疗紧急不良事件。
    109名患者入组;108名患者接受≥1次剂量的斯帕森坦;103名患者进入开放标签延伸(68斯帕森坦,35厄贝沙坦在双盲期)。45/108例患者(41.7%)接受Sparsentan治疗;治疗终止的中位时间为3.9年(95%CI,2.6-5.2)。通过随访维持从基线的平均蛋白尿减少百分比。在第一剂量的9个月内实现部分缓解(52.8%的患者)与未实现(47.2%)相比,在整个治疗期间(-2.70vs-6.56;P=0.03)和前2年(-1.69vs-6.46;P=0.03),肾小球滤过率下降速率显着降低。最常见的治疗引起的不良事件(>9例/100患者年)是头痛,外周水肿,上呼吸道感染,高钾血症,和低血压。外周水肿和低血压从第1年开始下降(13.9%和15.7%的患者,分别)在≥2年内≤4%。没有心力衰竭病例,也没有患者死亡。
    开放标签扩展不包括比较组。
    长期治疗显示持续的蛋白尿减少和一致的安全性。
    对于局灶性节段肾小球硬化(FSGS)的安全有效的治疗方法,临床上存在大量未满足的需求,有多种原因的肾脏病变。Sparsentan正在研究FSGS的治疗方法,并针对导致肾功能丧失的2个重要途径(内皮素-1和血管紧张素II)。在为期8周的随机研究中,FSGS患者的双盲DUET研究,sparsentan比厄贝沙坦(一种常用于治疗FSGS的降压药)更好地降低了尿液中的蛋白质含量。我们检查了在DUET开放标签扩展中使用sparsentan超过4年的长期治疗。我们发现,继续使用sparsentan治疗的患者的蛋白尿持续减少,并且安全性一致,没有新的或意外的不良反应。
    UNASSIGNED: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist (DEARA) examined in the ongoing phase 2 DUET trial for focal segmental glomerulosclerosis (FSGS). In the DUET 8-week double-blind period, sparsentan resulted in greater proteinuria reduction versus irbesartan. We report the long-term efficacy and safety of sparsentan during the open-label extension over more than 4 years.
    UNASSIGNED: Patients were examined from their first sparsentan dose (double-blind period or open-label extension) through 4.6 years.
    UNASSIGNED: Patients with FSGS, excluding secondary FSGS.
    UNASSIGNED: Sparsentan (200, 400, and 800 mg/d).
    UNASSIGNED: Urinary protein-creatinine ratio, FSGS partial remission endpoint (urinary protein-creatinine ratio ≤1.5 g/g and >40% reduction from baseline), estimated glomerular filtration rate, and blood pressure approximately every 12 weeks. Treatment-emergent adverse events by year and cases/100 patient-years.
    UNASSIGNED: 109 patients were enrolled; 108 received ≥1 sparsentan dose; 103 entered the open-label extension (68 sparsentan, 35 irbesartan during the double-blind period). Sparsentan was ongoing in 45/108 patients (41.7%); median time to treatment discontinuation was 3.9 years (95% CI, 2.6-5.2). Mean percent proteinuria reduction from baseline was sustained through follow-up. Achieving partial remission within 9 months of first sparsentan dose (52.8% of patients) versus not achieving (47.2%) was associated with significantly slower rate of estimated glomerular filtration rate decline over the entire treatment period (-2.70 vs -6.56; P = 0.03) and in the first 2 years (-1.69 vs -6.46; P = 0.03). The most common treatment-emergent adverse events (>9 cases/100 patient-years) were headache, peripheral edema, upper respiratory infection, hyperkalemia, and hypotension. Peripheral edema and hypotension declined from year 1 (13.9% and 15.7% of patients, respectively) to ≤4% in years ≥2. There were no cases of heart failure and no patient deaths.
    UNASSIGNED: The open-label extension does not include a comparison group.
    UNASSIGNED: Long-term sparsentan treatment showed sustained proteinuria reduction and a consistent safety profile.
    There is substantial unmet clinical need for safe and effective treatments for focal segmental glomerulosclerosis (FSGS), a kidney lesion with varied causes. Sparsentan is being studied for treatment of FSGS and targets 2 important pathways (endothelin-1 and angiotensin II) that lead to the loss of kidney function. In the 8-week randomized, double-blind DUET study in patients with FSGS, sparsentan reduced the amount of protein in the urine better than irbesartan (a blood pressure medicine often used to treat FSGS). We examined long-term treatment with sparsentan over >4 years in the DUET open-label extension. We found sustained proteinuria reduction in patients who continued treatment with sparsentan and a consistent safety profile with no new or unexpected adverse effects.
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  • 文章类型: Journal Article
    DUPLEX第3阶段试验正在评估Sparsentan,一本小说,非免疫抑制,单分子双内皮素血管紧张素受体拮抗剂,局灶节理性肾小球硬化(FSGS)患者。
    DUPLEX(NCT03493685)是一个全球性的,多中心,随机化,双盲,平行组,活性对照研究评估斯帕生坦800mg每天一次与厄贝沙坦300mg每天一次在8至75岁(美国/英国)和18至75岁(美国/英国除外)体重≥20kg的患者中的疗效和安全性。活检证实的FSGS或与FSGS相关的足细胞蛋白中的基因突变,尿蛋白肌酐比值(UP/C)≥1.5g/g。描述性报道了对治疗分配盲化的基线特征。
    主要分析人群包括371名患者(336名成人,35名儿科[<18岁])随机分组并接受研究药物(中位年龄,42年)。患者为白人(73.0%),亚洲(13.2%),黑人/非洲裔美国人(6.7%),或其他种族(7.0%);北美(38.8%),欧洲(36.1%),南美洲(12.7%),或亚太地区(12.4%)。基线中位数UP/C为3.0g/g;肾病范围为42.6%(UP/C>3.5g/g[成人];>2.0g/g[儿科])。患者均匀分布在估计的肾小球滤过率(eGFR)类别中,对应于慢性肾病(CKD)阶段1至3b。33例患者(352个可评估样本中的9.4%)具有足细胞结构完整性和功能必需基因的致病性或可能致病性(P/LP)变异,27例(7.7%)有P/LP胶原基因(COL4A3/4/5)变异,和14(4.0%)有高风险的APOL1基因型。
    DUPLEX患者登记,FSGS迄今为止最大的介入研究,将能够在地理上广泛和临床上多样化的FSGS人群中对sparsentan的治疗效果进行重要表征。
    UNASSIGNED: The phase 3 DUPLEX trial is evaluating sparsentan, a novel, nonimmunosuppressive, single-molecule dual endothelin angiotensin receptor antagonist, in patients with focal segmental glomerulosclerosis (FSGS).
    UNASSIGNED: DUPLEX (NCT03493685) is a global, multicenter, randomized, double-blind, parallel-group, active-controlled study evaluating the efficacy and safety of sparsentan 800 mg once daily versus irbesartan 300 mg once daily in patients aged 8 to 75 years (USA/UK) and 18 to 75 years (ex-USA/UK) weighing ≥20 kg with biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS, and urine protein-to-creatinine ratio (UP/C) ≥1.5 g/g. Baseline characteristics blinded to treatment allocation are reported descriptively.
    UNASSIGNED: The primary analysis population includes 371 patients (336 adult, 35 pediatric [<18 years]) who were randomized and received study drug (median age, 42 years). Patients were White (73.0%), Asian (13.2%), Black/African American (6.7%), or Other race (7.0%); and from North America (38.8%), Europe (36.1%), South America (12.7%), or Asia Pacific (12.4%). Baseline median UP/C was 3.0 g/g; 42.6% in nephrotic-range (UP/C >3.5 g/g [adults]; >2.0 g/g [pediatrics]). Patients were evenly distributed across estimated glomerular filtration rate (eGFR) categories corresponding to chronic kidney disease (CKD) stages 1 to 3b. Thirty-three patients (9.4% of 352 evaluable samples) had pathogenic or likely pathogenic (P/LP) variants of genes essential to podocyte structural integrity and function, 27 (7.7%) had P/LP collagen gene (COL4A3/4/5) variants, and 14 (4.0%) had high-risk APOL1 genotypes.
    UNASSIGNED: Patient enrollment in DUPLEX, the largest interventional study in FSGS to date, will enable important characterization of the treatment effect of sparsentan in a geographically broad and clinically diverse FSGS population.
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  • 文章类型: Journal Article
    背景:阿尔茨海默病(AD),最常见的不可逆性痴呆类型,预计到2050年将影响1.52亿人。来自欧洲可修改风险变量的大规模预防性随机对照试验(RCT)的证据表明,针对痴呆症高危老年人的多领域生活方式治疗可能是实用且有效的。鉴于中国和欧洲人口在人口结构和生活条件方面存在巨大差异,在中国直接采用欧洲计划仍然不可行。尽管以前在中国进行了RCT,它的参与者主要来自中国北方的农村地区,因此,不能代表整个国家。迫切需要建立代表不同经济、文化,和地理情况,以便更全面和准确地探索实施策略和评估早期多领域干预的效果。
    我们开发了在城市社区环境中实施的综合干预程序,即中国多领域干预倡议(CHINA-IN-MUDI)。CHINA-IN-MUDI是一项为期2年的多中心开放标签集群随机对照试验,以中国式的多领域干预措施为中心,以防止认知能力下降。从一项具有全国代表性的研究中招募了60-80岁的参与者,即中国健康老龄化与痴呆研究队列。进行了外部协调过程,以保留原始的FINGER设计。随后,我们标准化了一系列中国式的干预计划,以符合文化和社会经济地位。此外,我们扩展了次要结局列表,包括基因组和蛋白质组分析.加强坚持和促进执行,我们利用了一个电子健康应用程序。
    结果:筛查于2022年7月开始。目前,1,965名参与者被随机分为生活方式干预组(n=772)和对照组(n=1,193)。干预组和对照组均表现出相似的基线特征。存在几种生活方式和血管危险因素,表明潜在的干预机会窗口。干预将于2025年完成。
    结论:该项目将有助于评估干预策略在控制AD风险和减少临床事件方面的有效性和安全性。为我国公共卫生决策提供依据。
    BACKGROUND: Alzheimer\'s disease (AD), the most common type of irreversible dementia, is predicted to affect 152 million people by 2050. Evidence from large-scale preventive randomized controlled trials (RCTs) on modifiable risk variables in Europe has shown that multi-domain lifestyle treatments for older persons at high risk of dementia may be practical and effective. Given the substantial differences between the Chinese and European populations in terms of demographics and living conditions, direct adoption of the European program in China remains unfeasible. Although a RCT has been conducted in China previously, its participants were mainly from rural areas in northern China and, thus, are not representative of the entire nation.There is an urgent need to establish cohorts that represent different economic, cultural, and geographical situations in order to explore implementation strategies and evaluate the effects of early multi-domain interventions more comprehensively and accurately.
    UNASSIGNED: We developed an integrated intervention procedure implemented in urban neighborhood settings, namely China Initiative for Multi-Domain Intervention (CHINA-IN-MUDI). CHINA-IN-MUDI is a 2-year multicenter open-label cluster-randomised controlled trial centered around a Chinese-style multi-domain intervention to prevent cognitive decline. Participants aged 60-80 years were recruited from a nationally representative study, i.e. China Healthy Aging and Dementia Study cohort. An external harmonization process was carried out to preserve the original FINGER design. Subsequently, we standardized a series of Chinese-style intervention programs to align with cultural and socioeconomic status. Additionally, we expanded the secondary outcome list to include genomic and proteomic analyses. To enhance adherence and facilitate implementation, we leveraged an e-health application.
    RESULTS: Screening commenced in July 2022. Currently, 1,965 participants have been randomized into lifestyle intervention (n = 772) and control groups (n = 1,193). Both the intervention and control groups exhibited similar baseline characteristics. Several lifestyle and vascular risk factors were present, indicating a potential window of opportunity for intervention. The intervention will be completed by 2025.
    CONCLUSIONS: This project will contribute to the evaluation of the effectiveness and safety of intervention strategies in controlling AD risk and reducing clinical events, providing a basis for public health decision-making in China.
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  • 文章类型: Journal Article
    许多行为管理技术被用来减少与儿童牙科手术相关的焦虑。最常用的方法之一包括使用虚拟现实(VR)眼镜的视听分心。在这项研究中,一个创新的设备,眶周眼部按摩器(PEM),与VR进行比较,以评估儿童的牙科焦虑。
    在这项研究中,22名儿童被分为两组,也就是说,由PEM组成的组I和由VR组成的组II。指示参与者佩戴该设备,然后进行牙科修复程序。程序完成后,儿童使用经过验证的问卷和第二名研究者使用改良的行为疼痛量表测量焦虑.此外,在牙科手术前后评估心率和氧饱和度等生理参数。
    当使用经过验证的问卷和改良的行为疼痛量表来测量儿童的牙科焦虑时,I组和II组的结果在统计学上无意义。此外,数据还显示,两组之间的心率和氧饱和度没有显着差异。
    创新的PEM还可以用作管理儿童牙科焦虑的有效行为管理工具,因为PEM和VR之间没有统计学上的显著差异。
    作为一名儿科牙医,因为行为管理因患者而异,所以用于给药患者的方法提出了新的挑战。因此,为儿科患者增加各种行为治疗技术的前景是无限的。
    加油,KalaskarR.对创新的眶周按摩器和虚拟现实眼镜在儿童牙科修复手术中减少牙科焦虑的有效性的比较评估。IntJClinPediatrDent2024;17(1):48-53。
    UNASSIGNED: Many behavior management techniques are employed to reduce the anxiety associated with dental procedures in children. One of the most commonly used methods comprises audiovisual distraction using virtual reality (VR) eyeglasses. In this study, an innovative device, a periorbital eye massager (PEM), is compared with VR to evaluate dental anxiety in children.
    UNASSIGNED: in this study, 22 children were divided into two groups, that is, group I consisting of PEM and group II consisting of VR. The participants were instructed to wear the device and then subjected to dental restorative procedures. After completion of the procedure, anxiety was measured using a validated questionnaire by the children and by using the modified behavior pain scale by the second investigator. Also, physiological parameters like heart rate and oxygen saturation were evaluated before and after a dental procedure.
    UNASSIGNED: The results were statistically insignificant for group I and group II when a validated questionnaire and modified behavior pain scale were used to measure the dental anxiety of children. Also, the data also shows no significant difference in heart rate and oxygen saturation between the two groups.
    UNASSIGNED: The innovative PEM can also be used as an effective behavior management tool in managing dental anxiety in children, as there was no statistically significant difference between PEM and VR.
    UNASSIGNED: As a pediatric dentist, the methods for administering a patient present a novel challenge because behavior management varies from patient to patient. As a result, the prospects for augmenting various techniques of behavior therapy for pediatric patients are limitless.
    UNASSIGNED: Gala UP, Kalaskar R. Comparative Evaluation of the Effectiveness of Innovative Periorbital Eye Massager and Virtual Reality Eyeglasses for Reducing Dental Anxiety during Dental Restorative Procedures in Children. Int J Clin Pediatr Dent 2024;17(1):48-53.
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  • 文章类型: Randomized Controlled Trial
    特发性耳鸣是一种常见且复杂的疾病,尚无治愈方法。CAABT(耳蜗交替声束治疗CAABT),是一种个性化的声音疗法,旨在针对特定的耳鸣频率,并根据临床耳鸣评估有效干预耳鸣。这项研究旨在比较CAABT和传统声音疗法(TST)在治疗慢性特发性耳鸣方面的有效性。这是一个随机的,双盲,平行组,单中心前瞻性研究。招募了60名成年耳鸣患者,并使用计算机生成的随机化以1:1的比例随机分配到CAABT或TST组。治疗持续12周,参与者使用耳鸣障碍清单(THI)进行评估,视觉模拟量表(VAS),耳鸣响度测量,和静息态功能磁共振成像(rs-fMRI)。两组均显示THI评分显着降低,VAS评分,治疗后耳鸣响度。然而,CAABT在THI功能方面优于TST(p=0.018),THIEmotional(p=0.015),THI灾难性的(p=0.022),THI总分(p=0.005)以及VAS评分(p=0.022)。更有趣,CAABT在THI分数的变化方面表现出优于TST的优势,和基线的VAS评分。rs-fMRI结果显示,两组治疗前后前肌均有明显变化。此外,与TST相比,CAABT组的脑区变化更多.没有观察到副作用。这些结果表明,CAABT可能是慢性特发性耳鸣的一种有希望的治疗选择,提供显著改善耳鸣相关症状和大脑活动。试用注册:ClinicalTrials.gov:NCT02774122。
    Idiopathic tinnitus is a common and complex disorder with no established cure. The CAABT (Cochleural Alternating Acoustic Beam Therapy CAABT), is a personalized sound therapy designed to target specific tinnitus frequencies and effectively intervene in tinnitus according to clinical tinnitus assessment. This study aimed to compare the effectiveness of the CAABT and Traditional Sound Therapy (TST) in managing chronic idiopathic tinnitus. This was a randomized, double-blind, parallel-group, single-center prospective study. Sixty adult patients with tinnitus were recruited and randomly assigned to the CAABT or TST group in a 1:1 ratio using a computer-generated randomization. The treatment lasted for 12 weeks, and participants underwent assessments using the tinnitus handicap inventory (THI), visual analog scale (VAS), tinnitus loudness measurements, and resting-state functional magnetic resonance imaging (rs-fMRI). Both groups showed significant reductions in THI scores, VAS scores, and tinnitus loudness after treatment. However, CAABT showed superiority to TST in THI Functional (p = 0.018), THI Emotional (p = 0.015), THI Catastrophic (p = 0.022), THI total score (p = 0.005) as well as VAS score (p = 0.022). More interesting, CAABT showed superiority to TST in the changes of THI scores, and VAS scores from baseline. The rs-fMRI results showed significant changes in the precuneus before and after treatment in both groups. Moreover, the CAABT group showed more changes in brain regions compared to the TST. No side effects were observed. These findings suggest that CAABT may be a promising treatment option for chronic idiopathic tinnitus, providing significant improvements in tinnitus-related symptoms and brain activity.Trial registration: ClinicalTrials.gov:NCT02774122.
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  • 文章类型: Randomized Controlled Trial
    背景:这是一个公认的事实,即卒中后抑郁(PSD)是一种普遍存在的疾病,会影响很大比例的中风患者。因此,我们的研究努力探索安全性,经皮耳迷走神经刺激(ta-VNS)治疗PSD抑郁症的疗效及潜在分子机制,假控制,随机试验。
    方法:经历过中风并表现出抑郁症状的患者,汉密尔顿抑郁量表(HAMD-17)评分≥8,符合DSM-IV标准,被诊断为PSD。志愿者样本(N=80)被随机分为ta-VNS组(除常规治疗外还接受ta-VNS)或对照组(仅接受常规治疗),以1:1的比例。使用17项汉密尔顿抑郁量表(HAMD-17)评估干预措施的有效性,Zung抑郁自评量表(SDS),和Barthel指数(BI)得分。此外,血浆BDNF,在治疗前后测量CREB1和5-HT水平。
    结果:同时应用ta-VNS显示HAMD-17和SDS评分显著降低,导致患者的日常功能显著增强,日常生活活动的改善证明了这一点,在所有评估的时间点,与对照组相比(p<0.0001)。值得注意的是,与对照组相比,ta-VNS组在调节测量的神经营养生物标志物方面表现出优异的效果(p<0.05)。
    结论:ta-VNS与常规治疗相结合的协同方法在治疗卒中后抑郁方面具有显著的疗效和耐受性。
    BACKGROUND: It is a well-established fact that post-stroke depression (PSD) is a prevalent condition that affects a significant proportion of individuals who have suffered a stroke. Hence, our research endeavors to explore the safety, efficacy and the potential molecular mechanism of transcutaneous auricular vagus nerve stimulation (ta-VNS) for the treatment of depression in PSD patients by conducting a double-blind, sham-controlled, randomized trial.
    METHODS: Patients who had experienced strokes and exhibited depressive symptoms, with a Hamilton Depression Scale (HAMD-17) score of ≥8 and met the DSM-IV criteria, were diagnosed with PSD. A volunteer sample of participants (N = 80) were randomly divided into either the ta-VNS group (which received ta-VNS in addition to conventional treatment) or the control group (which received conventional treatment only), in a 1:1 ratio. The effectiveness of the interventions was evaluated using the 17-item Hamilton Rating Scale for Depression (HAMD-17), Zung Self-Rating Depression Scale (SDS), and Barthel Index (BI) scores. Furthermore, Plasma BDNF, CREB1, and 5-HT levels were measured before and after treatment.
    RESULTS: The concomitant application of ta-VNS demonstrated a remarkable reduction in HAMD-17 and SDS scores, leading to noteworthy enhancements in patients\' daily functioning, as evidenced by improved activities of daily living, at all assessed time points, in contrast to the control group (p < 0.0001). Notably, the ta-VNS group exhibited superior effects in modulating the measured neurotrophic biomarkers when compared to the control group (p < 0.05).
    CONCLUSIONS: The synergistic approach of combining ta-VNS with conventional treatment has demonstrated remarkable efficacy and tolerability in managing depression following a stroke.
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