632 results on '"Randomized controlled trial"'
Search Results
52. Herb-insulated moxibustion on the Governor Vessel in dog days of summer for postpartum pantalgia: a randomized controlled trial.
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Hai, Xia, Feng, Qian, Chen, Jialian, Wang, Xiaoxia, Liu, Xiaoyue, and Zhao, Zhongting
- Abstract
Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
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53. Observation on the therapeutic efficacy of warming needle therapy combined with Tuina in the treatment of cervical vertigo accompanied by anxiety state.
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Gu, You, Hu, Jiawei, Yan, Yuehua, Pan, Guoliang, Dong, Xiaowei, and Zeng, Liang
- Abstract
Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
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54. Effect of Remote Ischaemic Conditioning on the Inflammatory Cytokine Cascade of COVID-19 (RIC in COVID-19): a Randomized Controlled Trial.
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Lukhna, Kishal, do Carmo, Helison R. P., Castillo, Alejandro Rossell, Davidson, Sean M., Geffen, Hayli, Giesz, Sara, Golforoush, Pelin, Bovi, Ticiane Gonçalez, Gorag, Diana, Salama, Alan, Imamdin, Aqeela, Kalkhoran, Siavash, Lecour, Sandrine, Perroud Jr., Mauricio W., Ntsekhe, Mpiko, Sposito, Andrei C., and Yellon, Derek M.
- Abstract
Purpose : Patients hospitalized with COVID-19 may develop a hyperinflammatory, dysregulated cytokine "storm" that rapidly progresses to acute respiratory distress syndrome, multiple organ dysfunction, and even death. Remote ischaemic conditioning (RIC) has elicited anti-inflammatory and cytoprotective benefits by reducing cytokines following sepsis in animal studies. Therefore, we investigated whether RIC would mitigate the inflammatory cytokine cascade induced by COVID-19. Methods: We conducted a prospective, multicentre, randomized, sham-controlled, single-blind trial in Brazil and South Africa. Non-critically ill adult patients with COVID-19 pneumonia were randomly allocated (1:1) to receive either RIC (intermittent ischaemia/reperfusion applied through four 5-min cycles of inflation (20 mmHg above systolic blood pressure) and deflation of an automated blood-pressure cuff) or sham for approximately 15 days. Serum was collected following RIC/sham administration and analyzed for inflammatory cytokines using flow cytometry. The endpoint was the change in serum cytokine concentrations. Participants were followed for 30 days. Results: Eighty randomized participants (40 RIC and 40 sham) completed the trial. Baseline characteristics according to trial intervention were overall balanced. Despite downward trajectories of all cytokines across hospitalization, we observed no substantial changes in cytokine concentrations after successive days of RIC. Time to clinical improvement was similar in both groups (HR 1.66; 95% CI, 0.938–2.948, p 0.08). Overall RIC did not demonstrate a significant impact on the composite outcome of all-cause death or clinical deterioration (HR 1.19; 95% CI, 0.616–2.295, p = 0.61). Conclusion: RIC did not reduce the hypercytokinaemia induced by COVID-19 or prevent clinical deterioration to critical care. Trial Registration: ClinicalTrials.gov Identifier: NCT04699227. [ABSTRACT FROM AUTHOR]
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- 2024
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55. The effects of community-infused problem-oriented policing in crime hot spots based on police data: a randomized controlled trial.
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Taylor, Bruce G., Liu, Weiwei, Maitra, Poulami, Koper, Christopher S., Sheridan, Jackie, and Johnson, William
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VIOLENT crimes ,RANDOMIZED controlled trials ,CRIME ,POLICE ,OFFENSES against property ,POISSON regression - Abstract
Objectives: This randomized controlled trial (RCT) assessed the effectiveness of a community-infused problem-oriented policing (CPOP) intervention on reducing property/violent crime. Methods: In two mid-Atlantic cities, a total of 102 crime hot spots were randomly assigned to receive CPOP or standard patrol. Analyses examine changes in crime the year before, during, and one year after the intervention. We used hierarchical Poisson regression models. Results: We found no main effects for the CPOP intervention on property and violent crimes in either site. In site B, the violent crime count in low treatment hot spots was 200% higher than controls post-intervention but this likely reflected officers paying less attention to treatment locations with lower levels of crime. Conclusions: Our results suggest that CPOP was not effective in the unusual context of the COVID-19 pandemic and post-George Floyd killing. Given the challenges of implementing CPOP during this unique time, caution is needed in interpreting these findings. [ABSTRACT FROM AUTHOR]
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- 2024
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56. Fluid absorption during flexible ureteroscopy with intelligent control of renal pelvic pressure: a randomized controlled trial.
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Deng, Xiaolin, Chen, Yijian, Zhai, Qiliang, Song, Leming, Du, Chuance, and Tan, Wanlong
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URETEROSCOPY , *INTELLIGENT control systems , *RANDOMIZED controlled trials , *ABSORPTION , *URINARY calculi , *FLUIDS - Abstract
Purpose: To investigate fluid absorption and its influencing factors during flexible ureteroscopy with intelligent control of renal pelvic pressure (RPP). Methods: A total of 80 patients with upper urinary tract calculi underwent flexible ureteroscopy with intelligent control of RPP by pressure-measuring ureteral access sheath and were randomly divided into four groups. The RPP of Groups A, B, and C were set at – 5, 0 and 5 mmHg, respectively. Conventional flexible ureteroscopy with uncontrolled pressure served as control Group D. The perfusion flow rate was set at 100 ml/min in the four groups, with 20 patients in each group. The fluid absorption was measured by 1% ethanol every 10 min. Operation time, stone-free rate, and complications were recorded. Result: Seventy-three patients were finally included in the RCT. The general and preoperative data of the patients were comparable between the groups. The fluid absorption of Groups A, B, and C was significantly less than that of Group D (P < 0.01). Fluid absorption and operation time were positively correlated, and the correlation coefficients R were 0.864, 0.896, 0.918, and 0.947, respectively (P < 0.01). The fluid absorption of patients with vomiting, fever and ureteral injury was greater than that of patients without complications in the four groups (P < 0.01). In different groups, fluid absorption was greater in patients with ureteral injury Post-Ureteroscopic Lesion Scale (PULS) 1–3 than in noninjured patients (P < 0.01). Conclusion: Flexible ureteroscopy with intelligent control of RPP effectively reduces the absorption of perfusion fluid. Operation time and ureteral injury are also key factors affecting perfusion fluid absorption. Registration number and date: NCT05201599; August 11, 2021. [ABSTRACT FROM AUTHOR]
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- 2024
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57. Investigation of the probiotic supplement's effect on obese adults demonstrated a reduction in fasting insulin levels: a double-blind randomized clinical trial.
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Hasani-Ranjbar, Shirin, Hoseini Tavassol, Zahra, Malmir, Hanieh, Ejtahed, Hanieh-Sadat, Tajabadi Ebrahimi, Maryam, and Larijani, Bagher
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PROBIOTICS , *CLINICAL trials , *MEDICAL history taking , *LACTOBACILLUS casei , *LACTOBACILLUS rhamnosus , *LACTOBACILLUS plantarum - Abstract
Purpose: Regarding the importance of obesity concerns and trying to help obese individuals, we planned to develop an effective probiotic formula for weight control. So, this double-blind randomized clinical trial study investigated the impact of probiotics supplementation on anthropometric and biochemical parameters in obese adults. Methods: In this study, 66 obese patients with BMI in the range of 30–40 kg/m2, were enrolled and randomly assigned to either the probiotic or placebo group. They all received advice to maintain a reduction in daily caloric intake and for 3 months received two unlabeled placebo or probiotic (Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei and Bifidobacterium langum) capsules per day. For each participant demographic and medical history questionnaire, semi-quantitative food frequency questionnaire (FFQ), and modifiable activity questionnaire (MAQ) were completed at the beginning of the study and anthropometric and biochemical measurements were done before and after intervention. Results: At the end of the trial 25 subjects in the probiotic group and 26 subjects in the placebo group were analyzed. After the intervention, in the probiotic group, the level of fasting insulin was reduced significantly (P < 0.05). Weight, body mass index, waist circumference, and hip circumference decreased within both groups. This reduction amount's mean was higher in the probiotic group. Also, total cholesterol, triglycerides, and LDL levels were decreased, but not statistically significant. Conclusion: This study may suggest the potential of this combined probiotic supplement for treating obesity and related metabolic disorders. However, further researches are warranted for a definitive determination of its properties. [ABSTRACT FROM AUTHOR]
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- 2024
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58. Patient reported outcome measures (PROMs) as primary and secondary outcomes in total hip and knee arthroplasty randomized controlled trials: a systematic review.
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Reiter, Charles R., Abraham, Vivek M., Riddle, Daniel L., Patel, Nirav K., and Goldman, Ashton H.
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PATIENT reported outcome measures , *TOTAL knee replacement , *TOTAL hip replacement , *VISUAL analog scale - Abstract
Background: Significant heterogeneity exists regarding patient reported outcome measures (PROMs) used in total hip (THA) and knee (TKA) arthroplasty randomized controlled trials (RCTs). This study investigates the PROMs used as primary and secondary outcomes in contemporary arthroplasty RCTs. Methods: A literature search identified THA and TKA RCTs that were published in top ten impact factor orthopaedic journals from 2017 to 2021. Screening identified 241 trials: 76 THA, 157 TKA, and eight combined. Data were extracted to identify PROMs utilized as either primary or secondary outcomes and the time period of measurement. Results: Visual Analog Scale (VAS) Pain was the most reported primary PROM in THA (9.2%) and TKA (22.9%) trials. This was followed by Numeric Rating Scale (NRS) Pain (7.9%) and the Harris Hip score (6.6%) in THA trials and NRS Pain (4.5%) and the Knee Society score (4.5%) in TKA trials. Many THA (37.0%) and TKA (52.1%) trials did not clearly specify primary outcome time points. Only pain scales were reported at time points less than one week, while various joint-specific functional outcomes were reported at later time points. As secondary outcomes, the Harris Hip score (28.9%) was most common in THA trials and the Knee Society score (26.1%) was most common in TKA trials. Indeterminate primary or secondary outcomes were reported in 18.2% of studies. Conclusions: Contemporary THA and TKA trials exhibit heterogeneity of PROMs as study outcomes after the first postoperative week. Our findings highlight the need for consensus in PROM reporting and better methodological reporting to improve the interpretability of RCT outcomes. PROSPERO registration number: CRD42022337255. [ABSTRACT FROM AUTHOR]
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- 2024
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59. Inositol supplementation for the prevention and treatment of gestational diabetes mellitus: a meta-analysis of randomized controlled trials.
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Li, Chaolin and Shi, Hao
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GESTATIONAL diabetes , *GLUCOSE tolerance tests , *INOSITOL , *RANDOMIZED controlled trials , *GLYCEMIC control , *PREMATURE labor - Abstract
Background: Inositol is a potential new therapeutic agent for gestational diabetes mellitus (GDM), but its effectiveness is still controversial. The aim of the report was to evaluate the effectiveness of inositol to preventing or reducing the severity of GDM. Methods: We searched PubMed, EmBase, Web of science, Cochrane library databases, Clinicaltrials.gov, and International Clinical Trials Registry Platform for randomized controlled trials (RCTs) assessing the effectiveness of inositol supplementation to prevent and treat GDM. This meta-analysis was performed using the random-effects model. Results: A total of 7 RCTs (1319 pregnant women at high risk of GDM) were included in the meta-analysis. The meta-analysis found that inositol supplementation resulted in a significantly lower incidence of GDM in the inositol versus the control group (odds ratio [OR] 0.40; 95% confidence interval [CI] 0.24–0.67; P = 0.0005). The inositol group had improved fasting glucose oral glucose tolerance test (FG OGTT; mean difference [MD] = − 3.20; 95% CI − 4.45 to − 1.95; P < 0.00001), 1-h OGTT (MD = − 7.24; 95% CI − 12.23 to − 2.25; P = 0.004), and 2-h OGTT (MD = − 7.15; 95% CI − 12.86 to − 1.44; P = 0.01) results. Inositol also reduced the risk of pregnancy-induced hypertension (OR 0.37; 95% CI 0.18–0.75; P = 0.006) and preterm birth (OR 0.35; 95% CI 0.18–0.69; P = 0.003). A meta-analysis of 4 RCTs including 320 GDM patients showed that the patients' insulin resistance (P < 0.05) and neonatal hypoglycemia risk (OR 0.10, 95% CI 0.01–0.88; P = 0.04) were lower in the inositol than in the control group. Conclusions: Inositol supplementation during pregnancy has the potential to prevent GDM, improve glycemic control, and reduce preterm birth rates. [ABSTRACT FROM AUTHOR]
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- 2024
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60. Minimal clinically important difference in the World Health Organization Quality of Life Brief (WHOQOL-BREF) for adults with neurofibromatosis.
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Pietrzykowski, Malvina O., Vranceanu, Ana-Maria, Macklin, Eric A., and Mace, Ryan A.
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QUALITY of life , *NEUROFIBROMATOSIS , *ADULTS , *GROUPOIDS , *CLINICAL trials - Abstract
Purpose: This study aimed to estimate minimal clinically important difference (MCID) values for the World Health Organization Quality of Life Brief version (WHOQOL-BREF) among adults with neurofibromatosis (NF). An MCID is needed to demonstrate clinical meaningfulness of interventions for NF. Methods: We estimated MCID for the WHOQOL-BREF: the quality of life (QoL) measure recommended by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration. We used data from 228 clinical trial participants with NF type 1, NF type 2-related schwannomatosis, or schwannomatosis (SCHWN) who completed 10 weeks of a virtual group mind–body program targeting resiliency or a time- and attention-matched control. Following established guidelines, we estimated MCIDs using both anchor-based and distribution-based methods for physical, psychological, social relationships, and environmental domains of the WHOQOL-BREF. Results: MCID results varied across method and QoL domain. Three anchor-based methods, average change (AC), change difference (CD), and regression (REG), yielded the most consistent and comparable MCID across QoL domains. Based on these methods, we recommend ranges for each QoL domain: Physical QoL (3.9–7.3), Psychological QoL (4.7–8.1), Social QoL (2.6–5.9), and Environmental QoL (4.1–6.6). Conclusion: Establishing a rigorous MCID for QoL in NF is a critical step toward evaluating meaningful change in response to psychosocial interventions. [ABSTRACT FROM AUTHOR]
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- 2024
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61. Evaluation of the internet-based intervention "Selfapy" in participants with unipolar depression and the impact on quality of life: a randomized, parallel group study.
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Schefft, Cora, Krämer, Rico, Haaf, Raoul, Jedeck, David, Schumacher, Anna, and Köhler, Stephan
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MENTAL depression , *QUALITY of life , *COGNITIVE therapy , *DEPRESSED persons , *DYSTHYMIC disorder - Abstract
Purpose: Depressive disorders cause a major burden of disease worldwide and often lead to a loss of social functioning. Patients suffering from depressive disorders report a lower quality of life (QOL) than people without a history of mental health issues. Internet-based interventions (IBIs) based on cognitive behavioral therapy (CBT) are effective in reducing symptom severity but data on their impact on quality of life in clinically depressed patients so far is scarce. Methods: Selfapy is a CBT-based IBI for depressive disorders. 401 participants (332 female, mean age 37 (SD = 11) with a diagnosis of major depressive disorder (MDD) or dysthymia were enrolled in a randomized, parallel, three-arm trial comparing a therapist-guided Selfapy intervention with an unguided Selfapy intervention and a waiting list control. QOL was measured using the WHOQOL-BREF at baseline, post-treatment (12 weeks) and at 24-week follow-up. The effects of the interventions on QOL were calculated using linear mixed effects models. Results: At post-treatment (12 weeks) the guided and unguided intervention groups reported an increase in QOL on physical and psychological health domains compared to controls (significant group*time interaction). The gain in QOL was maintained over the follow-up period only for psychological health. QOL decreased in the social relationships and environment domains over the course of treatment and during the follow-up treatment for all participants. There were no differences between the guided and the unguided intervention. Conclusion: Selfapy proved to positively affect psychological and physical QOL in a sample of participants suffering from depressive disorders and can therefore be considered an effective and highly scalable therapeutic tool. The pattern of results might partly be attributable to effects of the COVID-19 pandemic and public health measures that coincided with the trial. Trial registration: German Clinical Trials Register (DRKS): DRKS00017191. Registered June 14th, 2019, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017191. [ABSTRACT FROM AUTHOR]
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- 2024
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62. "All Children in Focus": Effects of a Universal Parenting Program at a 6-Month Follow-Up in a Randomized Controlled Trial in Sweden.
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Cinà, Isabella Victoria, Lindberg, Lene, and Enebrink, Pia
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RANDOMIZED controlled trials , *STRICT parenting , *PARENTS , *PARENTING , *CHILDREN with autism spectrum disorders , *EMOTION regulation , *MENTAL illness , *GIRLS - Abstract
Parenting programs have been shown to empower parents and prevent mental health problems in children. However, few programs are designed to promote wellbeing, which led to the development of the Swedish-promotive universal program, "All Children in Focus" (ACF). This study aimed to understand the effects of parents' participation in the ACF program on parents' emotion regulation and parenting practices over a 6-month follow-up and if intervention-produced changes predict child wellbeing (CW). Parental self-efficacy (PSE) was also included to assess the relation with parental outcomes and CW. This is an evaluation of a multicenter randomized waitlisted control trial conducted in Stockholm County, Sweden, with parents of children aged 3 to 12 years (n = 621) in 2012. Parents were randomized 1:1 to enter the program or to a waitlist. Questionnaires were completed by parents at baseline, post-intervention, and 6 months post-baseline. We used generalized mixed modeling to test effects on parental outcomes over time and regression analyses to study the predictive role of parental outcomes on CW. From baseline to the post- and to the 6-month follow-ups, parents in the intervention group reported greater levels of emotion regulation skills, cognitive reappraisal, and positive parenting than did parents in the control group. A decrease in negative and harsh parenting was evident in both groups, although it was greater in the intervention group. An increase in PSE was associated with high negative parenting at baseline in the intervention group. Child gender moderated positive parenting, suggesting that parents of girls in the intervention group had more favorable development of positive strategies. The findings indicate that a change in PSE predicts a change in CW at 6 months. The ACF program can be used to strengthen and develop parenting. This study advances our knowledge about the potential advantages of using a health-promoting approach to strengthen the wellbeing of families in the general population. Clinical trial registration: ISRCTN70202532 Current Controlled Trials [ABSTRACT FROM AUTHOR]
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- 2024
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63. The Saturation- and Dose-Dependent Effects of a Teen Sexual Harassment Prevention Program: Findings from a Randomized Controlled Trial.
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Liu, Lin, Taylor, Bruce G., Liu, Weiwei, and Stein, Nan D.
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SEXUAL assault , *SEXUAL harassment , *RANDOMIZED controlled trials , *MIDDLE school students , *TEENAGERS - Abstract
Using a randomized controlled trial, we investigated changes in both sexual harassment (SH) perpetration and victimization of 2104 middle school students in New York City who received divergent saturation and dosage levels of Shifting Boundaries, an SH prevention program, which was represented by the length of the program. We assessed the saturation effect of the program by comparing the outcomes across respondents from 26 schools in which there were varying percentages of students enrolled in the program. The data suggested that, overall, the program was effective in reducing sexual harassment victimization but achieved a null effect against respondents' SH perpetration and that neither the length nor the school-saturation level of the program exerted a significant effect on SH perpetration. Although the data indicated a significant difference in SH victimization between the treatment and control group, when comparing subgroups who received treatment with divergent saturation and dosage levels, no statistically significant difference was identified. Our results suggested that the program effect was not contingent on the portion of students in a school who enrolled in the program, nor was it contingent on the dosage. [ABSTRACT FROM AUTHOR]
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- 2024
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64. Therapeutic effects of repetitive transcranial magnetic stimulation in patients with cerebral palsy: a systematic review and network meta-analysis.
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Zhang, Qian and Qiu, Zhengang
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TRANSCRANIAL magnetic stimulation , *PEOPLE with cerebral palsy , *CHILDREN with cerebral palsy , *MAGNETOTHERAPY , *ELECTRONIC information resource searching - Abstract
The purpose of this study was to systematically evaluate the efficacy of repetitive transcranial magnetic stimulation in children with cerebral palsy and to compare the differences in efficacy of different treatment parameters. Computer searches of PubMed, Embase, Cochrane Library, Scopus, Web of Science, China Knowledge Network, Wanfang Data Knowledge Service Platform, Vipshop and China Biomedical Literature Database were conducted to collect randomized controlled trials (RCTs) of TMS to improve function in children with cerebral palsy. The search period was from the establishment of the database to April 2023. Two researchers independently screened the literature and extracted data information, and the risk of bias was assessed for the included studies using the Cochrane Systematic Evaluation Manual 5.1.0. Statistical analysis was performed using RevMan 5.4 and Stata software. A total of 18 studies containing 1675 patients with cerebral palsy were included, and r-TMS did not differ significantly from other treatments in improving language function [MD = 2.80, 95% CI (-1.51, 7.11), Z = 1.27, P = 0.20] after treatment. The results of the reticulated meta-analysis showed the best probability ranking of the effect of three different frequencies of r-TMS on motor function scores in children with cerebral palsy: combined LF-rTMS + HF-rTMS (49.8%) > LF-rTMS (45.6%) > HF-rTMS (4.6%) > conventional rehabilitation (0%). Publication bias showed no significant asymmetry in the inverted funnel plot, but the possibility of publication bias could not be excluded. The results of this study showed that r-TMS was not statistically significant in improving language function in children with cerebral palsy compared to conventional treatment. r-TMS was almost unanimously significantly effective in motor function in children with cerebral palsy according to current literature data, and the combined high- and low-frequency transcranial magnetic therapy was better than low-frequency transcranial magnetic therapy. [ABSTRACT FROM AUTHOR]
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- 2024
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65. Assessing the Immediate Effects of Detached Mindfulness on Repetitive Negative Thinking and Affect in Daily Life: A Randomized Controlled Trial.
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Bolzenkötter, Teresa, Bürkner, Paul-Christian, Zetsche, Ulrike, and Schulze, Lars
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Objectives: Repetitive negative thinking (RNT) is a problematic thinking style that is related to multiple mental disorders. Detached mindfulness is a technique of metacognitive therapy that aims to reduce RNT. Our study set out to investigate the immediate effects of detached mindfulness in daily life. Methods: Participants with elevated trait RNT (n = 50) were prompted to engage in detached mindfulness exercises three times a day for 5 consecutive days. Immediate effects on RNT and affect were assessed 15 and 30 min after each exercise using experience sampling methodology. We compared the effects of this exercise phase to (1) a 5-day non-exercise baseline phase and (2) a different group of participants that engaged in an active control exercise (n = 50). Results: Results of Bayesian multilevel models showed that, across groups, improvements in RNT, negative affect, and positive affect were stronger during the exercise phase than during the non-exercise baseline phase (RNT after 15 min: b = -0.26, 95% CI = [-0.38, -0.14]). However, the two exercise groups did not differ in these improvements (RNT after 15 min: b = 0.02, 95% CI = [-0.22, 0.27]). Thus, the detached mindfulness and the active control exercises resulted in similar effects on RNT and affect in daily life. Conclusions: Results of this study imply that there was no additional benefit of having participants observe their thoughts detached and non-judgmentally, compared to excluding these assumed mechanisms of action as done for the active control group. We discuss possible reasons for the non-difference between the groups. Preregistration: This study was preregistered at https://osf.io/rze64. [ABSTRACT FROM AUTHOR]
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- 2024
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66. Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study.
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Xie, Yun, Zhao, Hongyi, Wu, Wenyu, Xu, Jinhua, Li, Bi, Wu, Sufan, Chen, Kevin, Bromée, Torun, and Li, Qingfeng
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Background: Aesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin. Methods: A randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane
® DefyneTM (HADEF ), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HADEF or delayed-treatment controls, and those in the HADEF group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up). Results: HADEF was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HADEF group). All subjects reported satisfaction with results at 6 months after treatment with HADEF and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile. Conclusions: These results demonstrated HADEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population. Level of Evidence I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266. [ABSTRACT FROM AUTHOR]- Published
- 2024
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67. Efficacy of radiofrequency in lumbar facet joint pain: a systematic review and meta-analysis of placebo-controlled randomized controlled trials.
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Láinez Ramos-Bossini, Antonio Jesús, Jiménez Gutiérrez, Paula María, and Ruiz Santiago, Fernando
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Background: Lumbar facet joint pain (LFJP) is one of the main causes of chronic low back pain (LBP) and can be treated using radiofrequency (RF) sensory denervation. The aim of this work is to analyze the efficacy of RF in LFJP through a systematic review and meta-analysis of randomized controlled trials (RCTs) with placebo control. Materials and methods: A systematic search was conducted in the Medline (PubMed), Scopus, Web of Science databases, and the Cochrane Central Register of Controlled Trials (CENTRAL). The variables of interest were pain, functional status, quality of life (QoL), and global perceived effect (GPE) measured at different time intervals: short (< 3 months), medium (> 3 and < 12 months), and long term (> 12 months). Results: Eight RCTs with placebo control were included. RF showed significant benefits over placebo in pain relief in the short (MD − 1.01; 95% CI − 1.98 to -0.04; p = 0.04), medium (MD − 1.42; 95% CI − 2.41 to − 0.43; p = 0.005), and long term (MD − 1.12; 95% CI − 1.57 to − 0.68; p < 0.001), as well as improvement in functional disability in the short (SMD − 0.94; 95% CI − 1.73 to − 0.14; p = 0.02) and long term (SMD − 0.74; 95% CI − 1.09 to − 0.39; p < 0.001). No statistically significant differences were observed in QoL or quantitative GPE, but benefits for RF were observed in dichotomous GPE in the medium (OR 0.19; 95% CI 0.07–0.52; p = 0.001) and long term (OR 0.22; 95% CI 0.06–0.78; p = 0.02). Subgroup analyses showed more benefits for RF in LBP < 1 year in the short term and in RCTs that did not require performing an MRI for patient selection. Conclusions: RF demonstrated significant improvement in pain and functionality, but the benefits in terms of QoL and GPE are inconclusive. Future clinical trials should investigate the long-term effects of RF, its impact on quality of life, and define appropriate criteria for patient selection. [ABSTRACT FROM AUTHOR]
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- 2024
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68. Efficacy of electroacupuncture therapy in patients with functional anorectal pain: study protocol for a multicenter randomized controlled trial.
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Xue, Yahong, Zhou, Huifen, Zeng, Yusha, Wang, Chen, Yang, Yun, Wang, Xiaopeng, He, Zongqi, Yao, Yibo, Wang, Xiaofeng, and Fan, Zhimin
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ELECTROACUPUNCTURE , *RANDOMIZED controlled trials , *PELVIC pain , *RESEARCH protocols , *PATIENT satisfaction , *CHINESE people , *PELVIC floor - Abstract
Background: Some Chinese scholars have initially explored the efficacy of electroacupuncture at Baliao acupoint in patients with functional anorectal pain (FAP). However, their studies are performed in a single center, or the sample size is small. Therefore, we aim to further explore the efficacy of electroacupuncture at Baliao acupoint on the treatment of FAP. Methods: In this multicenter randomized controlled trial, 136 eligible FAP patients will be randomly allocated into an electroacupuncture group or sham electroacupuncture group at a 1:1 ratio. This trial will last for 34 weeks, with 2 weeks of baseline, 4 weeks and 8 weeks of treatment, and 1, 3, and 6 months of follow-up. Outcome assessors and statisticians will be blind. The primary outcome will be clinical treatment efficacy, and secondary outcomes will be pain days per month, quality of life, psychological state assessment, anorectal manometry, pelvic floor electromyography, and patient satisfaction. Discussion: Results of this trial will be contributed to further clarify the value of electroacupuncture at Baliao acupoint as a treatment for FAP in the clinic. Trial registration: This trial has been registered in Chinese Clinical Trial Registry https://www.chictr.org.cn/ (ChiCTR2300069757) on March 24, 2023. [ABSTRACT FROM AUTHOR]
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- 2024
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69. Restoration of constitutional alignment optimizes outcomes of computer navigated total knee arthroplasty: a prospective randomized controlled trial.
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Zheng, Kai, Wang, Yijun, Wang, Tianhao, Zhu, Feng, Zhang, Lianfang, Li, Rongqun, Zhou, Jun, Geng, Dechun, and Xu, Yaozeng
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TOTAL knee replacement , *RANDOMIZED controlled trials , *PATIENT reported outcome measures , *ANATOMICAL planes , *PATIENT positioning , *COMPUTERS - Abstract
Purpose: The value of computer navigation in total knee arthroplasty (TKA) for arthritic knees continues to be debated. The purpose of this study was to evaluate the value of navigated TKA associated with updated alignment philosophy. Methods: This prospective randomized controlled trial enrolled 38 consecutive patients (76 knees) and were randomly assigned to both groups. The demographic data and perioperative data were recorded. The coronal plane alignment of the knee (CPAK) classification was used to classify knee alignment phenotypes. Radiographic outcomes were measured and subgroup analysis was further performed. Clinical outcomes were evaluated using patient-reported outcome measures (PROMs). Surgery-related complications were recorded. Results: The distribution of CPAK phenotypes following constitutional aligned TKA was equivalent to the native cohort, whereas the mechanical aligned TKA dramatically altered the phenotype distribution from type I and type II to type V and type IV. Final implant positioning was different between groups, with constitutional aligned TKA having larger cTCA (P =.004), joint line obliquity (P =.006), joint line distance (P =.033) and smaller sFCA (P =.013). Subgroup analysis showed higher actual accuracy of component positioning was achieved in navigated TKA, especially in knees with deformity of > 10° (P <.05). Patients reported higher HSS score at three months postoperatively in constitutional aligned group (P =.002). One patient in navigated group suffered femoral pin site fracture caused by a minor trauma. Conclusion: Computer navigated TKA allows for restoration of constitutional alignment and minimizes soft tissue release, which when compared to mechanical alignment may be associated with superior early outcomes. [ABSTRACT FROM AUTHOR]
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- 2024
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70. A Randomized Controlled Pilot Study Exploring the Additive Clinical Effect of Cognitive Bias Modification-Memory in Depressed Inpatients.
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Vrijsen, Janna N., Windbergs, Hanah, Becker, Eni S., Scherbaum, Norbert, Müller, Bernhard W., and Tendolkar, Indira
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COGNITIVE bias , *PSYCHOTHERAPY , *MEMORY bias , *RECOLLECTION (Psychology) , *MENTAL depression , *RUMINATION (Cognition) , *TRANSFER of training - Abstract
Background: Depression often leads to clinical admission. Stimulating positive memory bias through repeated retrieval can counteract a ruminative depressotypic processing style. Cognitive Bias Modification (CBM)-Memory is a psychological intervention, which was evaluated as possible adjunct treatment for depressed inpatients. Methods: A randomized controlled pilot study with a one-week follow-up was implemented to compare the effect of a four-session positive CBM-Memory intervention to a neutral CBM-Memory version. Training-congruent retrieval (as manipulation check), and transfer to rumination (as mechanistic target) and depressive symptoms (self-rated and clinician-rated; indication of clinical relevance) were assessed. Results: In the intention-to-treat sample (N = 81, Mage=35.6/SD = 11.9, 60% female), condition-congruent memory retrieval of previously presented target words was found after the training and at follow-up (large effect-sizes). Positive CBM-Memory intervention resulted in sustained recall bias and largest rumination reduction with a small-medium effect size. Additionally, the conditions did not differ significantly on the reduction in depressive symptoms. Conclusions: Positive CBM-Memory intervention yielded positive recall bias, which was still present one week later. Additionally, the positive condition did yield more decrease in trait (but not state) rumination, providing some support for rumination as mechanistic target of positive CBM-Memory. However, there was no evidence for transfer of the training effect to depressive symptoms, indicating no superiority on clinical recovery of the positive over the neutral condition. Future research should examine a higher dosage, integration of CBM in the treatment provision, and its long-term effects in a well-powered trial. [ABSTRACT FROM AUTHOR]
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- 2024
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71. Effect of Educational Intervention on Psychological Well-Being in CRS: A Randomized Controlled Trial.
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Kumar, Sanjay, Marlapudi, Sudheer Kumar, and Biradar, Kashiroygoud
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PSYCHOTHERAPY , *PSYCHOLOGICAL well-being , *RANDOMIZED controlled trials , *PATIENT education , *EDUCATIONAL standards - Abstract
Chronic Rhinosinusitis (CRS) affects nearly 10% of the global population, leading to substantial economic and quality-of-life burdens. While patient education has improved outcomes in other chronic conditions, its impact on CRS remains understudied. The study aims to evaluate the effectiveness of a structured patient education program on the psychological well-being and symptom severity of individuals diagnosed with CRS. This was a prospective, randomized controlled trial conducted in a tertiary care centre from January 2021 to December 2022. We enrolled 200 adult patients diagnosed with CRS based on the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines. Participants were randomized into two groups: the control group, receiving conventional CRS medical management, and the intervention group, receiving conventional treatment plus a structured patient education program. By the end of the study, 100 participants from each group completed the 2-year follow-up. The intervention group showed significant improvements in psychological well-being, with HADS scores decreasing from 10 ± 3.5 to 7 ± 3.0. CRS symptom severity, as measured by SNOT-22 scores, also significantly improved in the intervention group, dropping from 45 ± 10 to 35 ± 9. Additionally, the intervention group had fewer acute CRS flare-ups over two years compared to the control group. Adherence to nasal spray usage was higher in the intervention group, and feedback on the educational program was largely positive. A structured patient education program, when added to conventional CRS treatment, enhances psychological well-being, and reduces symptom severity. Given these promising results, there's need to integrate patient education into standard CRS management and explore its long-term benefits. [ABSTRACT FROM AUTHOR]
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- 2024
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72. Randomized Controlled Clinical Trial for Mastectomy Skin Flaps: Pre-Mammary Fascial Plane Versus a Thin Skin Flap Between Small and Large Fat Lobules and Flap Raised by Scalpel Versus Electrodiathermy.
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Patel, Swapnil, Kataria, Kamal, Ranjan, Piyush, Dhar, Anita, Seenu, Vuthaluru, Pandey, Ravindra Mohan, and Srivastava, Anurag
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RISK assessment , *RESEARCH funding , *HUMAN beings , *STATISTICAL sampling , *NECROSIS , *RANDOMIZED controlled trials , *DESCRIPTIVE statistics , *TREATMENT effectiveness , *SURGICAL flaps , *ELECTROCOAGULATION (Medicine) , *SURGICAL complications , *FASCIAE (Anatomy) , *MASTECTOMY , *SURGICAL site infections , *SURGICAL instruments , *COMPARATIVE studies , *BREAST , *DISEASE risk factors - Abstract
Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]
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- 2024
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73. Efficacy of cognitive behavioral therapy for insomnia in the perinatal period: a meta-analysis of randomized controlled trials.
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Feng, Shuya, Dai, Bingqin, Li, Huawei, Fu, Huili, and Zhou, Yunping
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COGNITIVE therapy , *PERINATAL period , *RANDOMIZED controlled trials , *EDINBURGH Postnatal Depression Scale , *SLEEP quality - Abstract
The meta-analysis aims to explore the effect of cognitive behavioral therapy for insomnia (CBT-I) in the perinatal period. Randomized controlled trials (RCTs) assessed the effects of CBT-I in perinatal women with insomnia, published in English, were eligible. Electronic searches were performed using PubMed, Embase (Elsevier), PsycINFO (Ebsco), and Web of Science (Clarivate Analytics). Insomnia Severity Index (ISI) as the primary outcome was used to estimate the pooled effects and durable efficacy of CBT-I. The secondary outcome measures were Edinburgh Postnatal Depression Scale (EPDS) and Pittsburgh Sleep Quality Index (PSQI). Of 46 studies reviewed, seven studies met the inclusion criteria. The meta-analysis indicated significant improvement in insomnia as measured with the ISI (standardized mean difference (SMD) = − 0.62, 95% confidence intervals (CI) − 0.77, − 0.47, I2 = 28%). At the follow-up time point, the meta-analysis indicated the durable efficacy of CBT-I (SMD = − 0.47, 95% CI − 0.90, − 0.03, I2 = 73%). Definite improvement of CBT-I on EPDS (SMD = -0.31, 95% CI − 0.55, − 0.06, I2 = 33%) and PSQI (SMD = − 0.82, 95% CI − 1.27, − 0.38, I2 = 68%) score change post-intervention were found. In sub-analyses, CBT-I had similar effect sizes, independent of possible modifiers (study population, comparison group, delivery format, etc.). This meta-analysis demonstrates that CBT-I is effective in alleviating insomnia, depression, and sleep quality among perinatal women. It is equally important to find that CBT-I has a durable efficacy on insomnia in the perinatal period. However, it is necessary to include larger samples and conduct rigorous RCTs to further explore this issue. [ABSTRACT FROM AUTHOR]
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- 2024
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74. Efficacy of an automatic electric toothbrush with nylon bristles in dental plaque removal: a cross-over randomized controlled trial.
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Statie, Maria Denisa, Lomonaco, Irene, Nieri, Michele, Giuntini, Veronica, Franceschi, Debora, and Franchi, Lorenzo
- Abstract
Objectives: The objective of this single-use, five-treatment, five-period, cross-over randomized controlled trial (RCT) was to compare the efficacy in dental plaque removal of a new Y-shaped automatic electric toothbrush (Y-brush) compared to a U-shaped automatic electric toothbrush (U-brush), a manual toothbrushing procedure (for 45 and 120 s), and no brushing (negative control). Materials and methods: Eligible participants were volunteer students randomized to the treatments in the five periods of the study. The primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing while the secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: After brushing procedures, manual toothbrushing (120 s) showed a statistically significant reduction in FMPS than Y-brush (difference 36.9; 95%CI 29.6 to 44.1, p < 0.0001), U-brush (difference 42.3; 95%CI 35.1 to 49.6, p < 0.0001), manual brushing (45 s) (difference 13.8; 95%CI 6.5 to 21.1, p < 0.0001), and No brushing (difference 46.6; 95%CI 39.3 to 53.9, p < 0.0001). Y-brush was significantly more effective than No brushing (difference 9.8; 95%CI 2.5 to 17.0, p = 0.0030), while there was no significant difference compared to U- brush. Similar results were obtained for the differences in the Clean Mouth VAS. Conclusions: Y-brush was significantly more effective than no brushing (negative control) in removing dental plaque. When compared to manual toothbrushing for both 45 and 120 s, however, Y-brush was less effective in dental plaque removal. Clinical relevance: Modified design of automatic toothbrushing devices could improve plaque reduction, especially in patients with intellectual disabilities or motor difficulties. [ABSTRACT FROM AUTHOR]
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- 2024
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75. Cash Transfers Improve Economic Conditions and Reduce Maternal Stress in Rural Côte d'Ivoire.
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Wolf, Sharon, Kembou, Samuel, Ogan, Amy, and Jasinska, Kaja
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POVERTY reduction , *WEST Africans , *ENDOWMENTS , *EDUCATION , *RESEARCH funding , *STATISTICAL sampling , *EVALUATION of human services programs , *RANDOMIZED controlled trials , *GOAL (Psychology) , *DESCRIPTIVE statistics , *GOVERNMENT aid , *FINANCIAL stress , *CACAO , *GOVERNMENT programs , *PSYCHOLOGY of mothers , *RURAL conditions , *COMPARATIVE studies , *MOTHER-child relationship , *AGRICULTURE , *PATIENT participation - Abstract
We report midline impacts of a community-randomized cash transfer intervention to 1857 vulnerable mothers in 140 rural cocoa-farming communities of Côte d'Ivoire. Compared to mothers in the comparison group who participated in village savings and loan associations (VSLAs), treatment mothers participated in VSLAs and received 8 € each week for up to one year with no conditions attached (the midway point of a two-year program). We find small- to moderate-sized treatment effects on four of six indicators of economic well-being (d = 0.23–0.75), as well as small reductions in maternal stress (d = −0.27). We find no statistically detectable impacts on educational engagement, educational aspirations, or educational expectations for children. Results suggest that cash transfer programs in rural West African communities can improve economic well-being and reduce maternal stress. Implications for children and families and for future cash transfer evaluations are discussed. [ABSTRACT FROM AUTHOR]
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- 2024
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76. Additional Effect of Extracorporeal Shockwave Therapy with Lidocaine Injection on Clinical and MRI Findings in Frozen Shoulder: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial.
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Nambi, Gopal, Alghadier, Mshari, Eltayeb, Mudathir Mohamedahmed, Aldhafian, Osama R., Saleh, Ayman K., Alsanousi, Nesreen, Ibrahim, Mohamed Nagah Ahmed, Attallah, Abdehamid A., Ismail, Mohammed Abdelgwad, Elfeshawy, Mohamed, Wahd, Yaser El Sayed Hasan, and Albarakati, Alaa Jameel A.
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EXTRACORPOREAL shock wave therapy , *SHOCK waves , *LIDOCAINE , *INTRA-articular injections , *SHOULDER , *MAGNETIC resonance imaging - Abstract
Introduction: Frozen shoulder is a very common musculoskeletal condition and the evidence related to the additional effects of extracorporeal shockwave therapy (ESWT) with intra-articular (IA) lidocaine injection in individuals with frozen shoulder is rare. Therefore, this study aims to compare and investigate the additional effects of extracorporeal shockwave therapy (ESWT) with intra-articular (IA) lidocaine injection in a frozen shoulder. Methods: Sixty eligible participants with frozen shoulder were included and the active group (n = 30, age 52.12 ± 5.2 years) received a lidocaine injection (1% lidocaine (Xylocaine) and 2cc (80 mg) methylprednisolone acetate) with active ESWT (3.5 bar air pressure and 2000 pulses with an energy flux density (EFD) ¼ 0.16 mJ/mm2) three sessions a week for 4 weeks. The placebo group (n = 30, age 53.56 ± 5.5 years) received lidocaine injection with placebo treatment (a special head that blocked the shock waves) three sessions a week for 4 weeks. Both groups received progressive resistance exercises (PRE) to the shoulder muscles. The primary outcome was pain intensity, measured with the visual analogue scale. The other outcome measures were the thickness of the coracohumeral ligament (CHL) measured by magnetic resonance imaging (MRI), abduction, and lateral rotation range of motion (ROM), functional disability, kinesiophobia, depression status, and quality of life. Participants were assessed at baseline, after 4 weeks, 8 weeks, and at 6-month follow-up. Results: The post-intervention at 4 weeks showed an improvement of 2.0 (CI 95% 1.71–2.28) in the active group compared to the placebo group. Similar effects were noted after 8 weeks (2.2) (CI 95% 1.91–2.48) and at the 6-month (1.9) (CI 95% 1.61–2.18) follow-up. Similar improvements were also found in the thickness of the CHL ligament (0.6) (CI 95% 0.46–0.73), abduction and lateral rotation (ROM) (– 23.6) (CI 95% – 27.47 to -19.72), (- 18.10) (CI 95% – 19.72 to – 16.47), functional disability (16.2) (CI 95% 14.85–17.54), kinesiophobia (11.0 (CI 95% 10.21–11.98), depression status (4.4) (CI 95% 4.03–4.76) and quality of life (0.9) (CI 95% 0.79–1.00) (p = 0.001) at the 6-month follow-up period, where mean estimates and their confidence intervals all included worthwhile effects. There were no adverse reactions or side effects noted in either the active or placebo groups during and after the treatment. Conclusions: The study concluded that the addition of extracorporeal shockwave therapy after intra-articular lidocaine injection improves pain, functional disability, range of motion, kinesiophobia, depression status, and quality of life in people with frozen shoulder. Trial Registration: https://ctri.nic.in, identifier; CTRI/2020/04/024834 prospectively registered on 24/04/2020. [ABSTRACT FROM AUTHOR]
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- 2024
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77. Effects of self-monitoring using an accelerometer on physical activity of older people with long-term care insurance in Japan: a randomized controlled trial.
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Kitamura, Masahiro, Izawa, Kazuhiro P., Nagasaki, Takayuki, Yoshizawa, Takashi, Okamura, Soichiro, Fujioka, Koji, Yamaguchi, Wataru, and Matsuda, Hiroaki
- Abstract
Key summary points: Aim: We investigated the effectiveness of a self-monitoring intervention to promote step count and reduce sedentary behavior in older people covered by the long-term care insurance system (LTCI) in Japan. Findings: Results from a randomized controlled trial of a self-monitoring intervention using accelerometers with a 5-week follow-up: improvement in a number of steps, light physical activity, and sedentary behavior in the intervention group compared to the control group. Message: Self-monitoring with an accelerometer may be effective in increasing the number of steps taken and amount of light physical activity per day and in reducing sedentary behavior in older people with LTCI. Purpose: This study aimed to investigate the effects of a self-monitoring intervention to promote an increase in physical activity, as measured by step count, and reduce sedentary behavior in older people covered by the long-term care insurance system (LTCI) in Japan. Methods: This was a randomized controlled trial conducted at a daycare center from October 2022 to January 2023. Fifty-two older adults with LTCI who were able to walk with or without aids were assigned to an intervention (n = 26) group and control (n = 26) group. During the 5-week follow-up period, the intervention group received education on physical activity and self-monitoring such as goal setting, self-management and feedback. The primary outcome was step count, and the secondary outcome was sedentary behavior. Results: Participants who completed the study to the end of the 5-week follow-up and drop-out participants for whom outcome data were available were included in the final analysis of 57 participants, n = 24 (79.8 ± 8.8 years, male 25.5%) in the intervention group and n = 23 (82.5 ± 8.5 years, male 39.1%) in the control group. Comparisons between the two groups at baseline showed no significant differences. In the results of a two-way mixed analysis of variance (ANOVA) including 2 (group: control, intervention) × 2 (term: baseline, 5-week follow-up) factors, an interaction was observed in the number of steps, sedentary behavior, and light physical activity (p < 0.05). Conclusion: Self-monitoring of physical activity using an accelerometer may be effective in increasing the number of steps and light physical activity and in reducing sedentary behavior in older people with LTCI. Clinical trial registration: UMIN000052044, registered on 2023/08/29. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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78. The Efficacy of a Group Program Integrating Compassionate Mind Training with Cognitive Behavioral Therapy for College Students With Test Anxiety in Mainland China.
- Author
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Guo, Mingchun, Liu, Aobo, Wang, Xinyi, and Liu, Yang
- Abstract
Objectives: Test anxiety has a negative impact on college students' academic performance and mental health. This study evaluated the effects of a group program integrating Compassionate Mind Training (CMT) with Cognitive Behavioral Therapy (CBT) on test anxiety and a range of secondary outcomes. It was hypothesized that a 6-week program would reduce test anxiety and improve a range of mental health outcomes, compared to a wait-list condition. Method: A total of 64 college students (M = 20.26, SD = 1.63 years) with test anxiety (Test Anxiety Index greater than 49) were randomly assigned to either a 6-week intervention or wait-list control group. Participants completed a series of self-reports questionnaires before the intervention, after the intervention, and at a 4-month post-intervention follow-up. Results: The intervention significantly reduced test anxiety and improved self-compassion, the perceived ability to manage negative emotions, and general anxiety levels, with these effects persisting at the follow-up assessment. Moreover, the intervention group of participants experienced a further significant reduction in test anxiety and a significant improvement in subjective well-being 4 months after intervention. Conclusions: This study provides preliminary evidence supporting the efficacy of an integrated CMT with CBT group program for alleviating test anxiety. Preregistration: This study is not preregistered. [ABSTRACT FROM AUTHOR]
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- 2024
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79. Immediate Effect of Electro-acupuncture on Endometrial Blood Flow in Patients with Recurrent Implantation Failure: A Randomized Controlled Trial.
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Lai, Yuan-yuan, Liu, Li-ying, Wu, Yong-na, Huang, Lei, Zheng, Xiao-yan, Gan, Di, Yu, Si-yi, Zhong, Ying, Liang, Fan-rong, Zhou, Ying, and Yang, Jie
- Subjects
ENDOMETRIUM ,RESEARCH funding ,EMBRYO transfer ,RANDOMIZED controlled trials ,FETAL ultrasonic imaging ,TREATMENT effectiveness ,ELECTROACUPUNCTURE ,TREATMENT failure ,COMPARATIVE studies ,EVALUATION - Abstract
Objective: To investigate the immediate effects of electro-acupuncture (EA) on endometrial blood flow among recurrent implantation failure (RIF) patients. Methods: Eighty RIF patients, enrolled from March 2022 to December 2022, were randomly allocated into either the EA group (40 cases) or the waiting-list (WL) group (40 cases) by using a random number table. The EA group underwent acupuncture at points of Shenting (GV 24), Baihui (GV 4), Benshen (GB 13), bilateral Zigong (EX-CA 1), Huangshu (KI 16), Sanyinjiao (SP 6) and Xuehai (SP10), and electric acupuncture apparatus was connected to EX-CA 1, KI 16, SP 6, and SP 10 with disperse-dense waves at 4/20 Hz frequencies for 30 min after transvaginal ultrasound, while the WL group received no intervention. The primary outcome measured was the endometrial volume blood flow. The secondary outcomes included the bilateral uterine artery index, endometrial volume, endometrial blood flow type, vascular distribution index (VI
MV ) for endometrial and ovary, clinical pregnancy rate, and embryo implantation rate. Results: In the EA group, there was a notable decrease in the bilateral pulsatility index and a significant improvement in the endometrial blood flow type post-EA (P<0.05). Both the endometrial blood flow type and VIMV for the endometrium and right ovary were markedly higher in the EA group compared to the WL group post-treatment (P<0.05). Conversely, no significant disparities were observed in vascular index, flow index, vascular blood flow index, uterine arterial blood flow indices, endometrial volume, clinical pregnancy rate and embryo implantation rate between the two groups after treatment (P>0.05). Besides, no adverse events related to EA were observed. Conclusions: EA can promptly ameliorate VIMV for the endometrial and right ovary, and endometrial blood flow type. Future randomized controlled trials are warranted to investigate the long-term effects of EA on blood flow of RIF patients and its implications for pregnancy outcomes. (Trial registration No. ChiCTR2200057377) [ABSTRACT FROM AUTHOR]- Published
- 2024
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80. Clinical study of electroacupuncture plus stuck-needle lifting method for intractable facial paralysis.
- Author
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Fan, Li, Yang, Qianyun, and Zhai, Wei
- Abstract
Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
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81. Clinical observation of electroacupuncture combined with training to improve motor function and serum brain injury markers in patients with ischemic stroke.
- Author
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Lan, Xie and Yang, Xiaobo
- Abstract
Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2024
- Full Text
- View/download PDF
82. Acupuncture plus tongue pressure resistance feedback training for post-stroke deglutition disorders: a randomized controlled trial.
- Author
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Yang, Jianfeng, Dang, Yulan, and Pang, Yiqiang
- Abstract
Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2024
- Full Text
- View/download PDF
83. Heterogeneous effects of information provision on fertilizer use in China's rice production.
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Zhang, Chao, Lin, Yang, Hu, Ruifa, Shi, Guanming, Xin, Jingshu, Chen, Kevin, and Meng, Yuanduo
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GREENHOUSE gases ,NONPOINT source pollution ,FERTILIZERS ,AGRICULTURAL extension work ,RICE farmers - Abstract
The inappropriate use, especially overuse, of fertilizers aggravates greenhouse gas emissions and non-point source pollution. China is the largest fertilizer user worldwide, and information provision is a determinant of farmers' fertilizer use. Using survey data of 1002 rice farmers from Hubei, Jiangsu and Jiangxi provinces in China, this study aims to analyze the heterogeneity in farmers' fertilizer use and evaluate the heterogeneous effects of various modes of information provision on fertilizer use among different groups of farmers. A group of extended difference-in-differences models are developed and estimated based on a two-year randomized controlled trial. Results show that while farmers as a whole overuse fertilizers, there is copresence of overusers, consistent users and underusers. Information provision induces a sizeable fertilizer reduction among the overusers and a moderate increase among the underusers. Moreover, the reduction is small among top overusers. Information provision by public agricultural extension agents exerts larger reduction effects among the overusers than that by fertilizer firms, while that by fertilizer firms exerts larger incremental effects among the underusers. These findings illustrate that information provision is effective in rationalizing farmers' fertilizer use in China and underscores the importance of reinforcing such a mechanism. This study provides fresh evidence for the copresence of fertilizer overuse and underuse in China and might be the first to investigate the heterogeneous effects of various modes of information provision on fertilizer use among the overusers, consistent users and underusers of fertilizers, which has crucial policy implications for rationalizing fertilizer use in China. [ABSTRACT FROM AUTHOR]
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- 2024
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84. Effectiveness of virtual reality compared to video training on acetabular cup and femoral stem implantation accuracy in total hip arthroplasty among medical students: a randomised controlled trial.
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Kenanidis, Eustathios, Boutos, Panagiotis, Voulgaris, Grigorios, Zgouridou, Aikaterini, Gkoura, Eleni, Gamie, Zakareya, Papagiannakis, George, and Tsiridis, Eleftherios
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MEDICAL students , *TOTAL hip replacement , *RANDOMIZED controlled trials , *VIRTUAL reality , *VIRTUAL reality therapy , *RADIOSTEREOMETRY , *CLINICAL trials - Abstract
Purpose: Virtual reality (VR) training effectiveness in improving hip arthroplasty surgical skills requires further evaluation. We hypothesised VR training could improve accuracy and the time taken by medical students compared to a control group with only video teaching. Methods: This single-centre randomized controlled clinical trial collected data from March to June 2023. Surgically naïve volunteer undergraduate medical students performed three sessions on a VR training platform, either cup (VR-Cup=Control-Stem) or stem (VR-Stem=Control-Cup) implantation. The primary outcome was the mean difference between predefined cup inclination (60°) and stem anteversion (20°) compared to the actual implanted values in sawbones between VR and control groups. Secondary outcomes were task completion time and mistake number between the groups. Results: A total of 101 students participated (VR-Cup 47, VR-Stem 54). Groups did not significantly differ concerning age (p = 0.879), gender (p = 0.408), study year (p = 0.938), previous VR use (p = 0.269) and baseline medical and procedural knowledge. The VR-Cup implanted the cup closer to the intended target (p < 0.001) and faster than the Control-Cup group (p = 0.113). The VR-Stem implanted the stem closer to the intended target (p = 0.008) but not faster than the Control-Cup group (p = 0.661). Stem retroversion was commoner in the Control-Stem than in the VR-Stem group (p = 0.016). Conclusions: VR training resulted in higher rates of accurate procedure completion, reduced time and fewer errors compared to video teaching. VR training is an effective method for improving skill acquisition in THA. Trial registration: ClinicalTrials.gov Identifier: NCT05807828 [ABSTRACT FROM AUTHOR]
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- 2024
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85. Autologous Fascial Slings for Stress Urinary Incontinence: a 17-year Follow-up of a Randomised Controlled Study.
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Nair, Deepa B., Khan, Zainab, Mishra, Tapas, Chopra, Jagrati, Wareham, Kathie, and Emery, Simon J.
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MEDICAL slings , *PSYCHOLOGICAL distress , *PATIENT satisfaction , *QUANTILE regression , *RANDOMIZED controlled trials , *URINARY stress incontinence , *UROGYNECOLOGY , *LOGISTIC regression analysis ,VAGINAL surgery - Abstract
Introduction and hypothesis: Safety concerns with the use of mesh in vaginal surgery have been ongoing. Autologous fascial slings (AFS) avoid foreign body complications. We compared the long-term (17-year) outcomes of two AFS repair methods—the standard sling and short sling (sling-on-string), and assessed durability and patient satisfaction of these for the treatment of stress urinary incontinence (SUI). Methods: A total of 107 patients from three urogynaecology units who had participated in a randomised controlled trial assessing standard (n = 52) and short (n = 55) slings were followed up for a median period of 17 years. Primary outcomes were Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores to assess the impact on the quality of life and symptom distress. Logistic quantile regression was employed to compare the two methods. Secondary outcomes included long-term complications and patient satisfaction. Results: Mean scores showed no statistically significant difference between the standard and short slings at the 17-year follow-up relating to IIQ and UDI scores, leakage or urgency (p > 0.05). Improved bladder function was observed at 17 years compared with baseline (standard sling—IIQ scores mean difference [MD] 1.22 [CI: 0.69, 1.74], UDI scores MD 0.83 [CI: 0.70, 0.97]; short sling—IIQ score MD 1.14 [CI: 0.73, 1.54], UDI scores MD 0.54 [CI: 0.40, 0.67]) with age-related deterioration over time. Re-operation rates were low and patient satisfaction rates were high (67.2%) at follow-up. Conclusions: Autologous fascial slings are an effective and durable option for management of SUI and the short sling procedure can be recommended owing to plausible surgical advantages. [ABSTRACT FROM AUTHOR]
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- 2024
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86. Transcranial direct current stimulation for global cognition in Alzheimer's disease: a systemic review and meta-analysis.
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Wang, Xin and Tian, Lu
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TRANSCRANIAL direct current stimulation , *ALZHEIMER'S disease , *COGNITION , *MINI-Mental State Examination , *COGNITIVE training - Abstract
This meta-analysis was to investigate the efficacy of transcranial direct current stimulation (tDCS) for general cognitive function in Alzheimer's disease (AD) and to investigate the potential influential factors. A systematic literature retrieval until August 2023 was performed by searching the PubMed, Embase, Web of Science, and Cochrane Library. Therapeutic effects of tDCS were evaluated using standardized mean difference (SMD) and 95% confidence interval (CI). Pooled effects of tDCS on AD patients were calculated immediately after treatment and at follow-up periods. Subgroup analyses were conducted to identify the potential prognostic factors. Eleven studies with 12 trials including 451 cases were included in our systemic review, in which 9 studies with 10 trials using Mini-Mental State Examination (MMSE) scales were included in the meta-analysis. tDCS significantly improved global cognition in AD immediately after the treatment (SMD, 0.46; 95% CI, 0.25–0.66; P<0.0001), but not at the shorter or longer follow-up period. Subgroup analyses suggested significant global cognitive improvement in patients receiving stimulation on temporal lobes instead of left dorsolateral prefrontal cortex, and in cases receiving tDCS with current density ≥ 0.08 mA/cm2 rather than <0.08 mA/cm2. Compared with tDCS plus cognitive training (CT), tDCS without CT produced obvious cognitive enhancement. In addition, patients with lower education were more likely to benefit from tDCS. tDCS was effective in improving general cognition in AD after treatment. However, further randomized trials are warranted to validate its longer-term effects as well as our subgroup analyses results. [ABSTRACT FROM AUTHOR]
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- 2024
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87. Comparison of the clinical and radiographic outcomes of cortical bone trajectory and traditional trajectory pedicle screw fixation in transforaminal lumbar interbody fusion: a randomized controlled trial.
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Wu, Chenyu, Hu, Xinli, Liu, Rongjie, Xu, Cong, Jiang, Yi, Ge, Zhaohui, Zhou, Kailiang, Zhang, Di, Wu, Aimin, Dou, Haicheng, Xu, Hui, Tian, Naifeng, Hu, Zhichao, and Ni, Wenfei
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SPINAL fusion , *COMPACT bone , *LUMBAR vertebrae , *RANDOMIZED controlled trials , *CONTROLLED fusion , *CLINICAL trial registries , *SCREWS - Abstract
Purpose: To compare the clinical outcomes and radiographic outcomes of cortical bone trajectory (CBT) and traditional trajectory (TT) pedicle screw fixation in patients treated with single-level transforaminal lumbar interbody fusion (TLIF). Methods: This trial included a total of 224 patients with lumbar spine disease who required single-level TLIF surgery. Patients were randomly assigned to the CBT and TT groups at a 1:1 ratio. Demographics and clinical and radiographic data were collected to evaluate the efficacy and safety of CBT and TT screw fixation in TLIF. Results: The baseline characteristic data were similar between the CBT and TT groups. Back and leg pain for both the CBT and TT groups improved significantly from baseline to 24 months postoperatively. The CBT group experienced less pain than the TT group at one week postoperatively. The postoperative radiographic results showed that the accuracy of screw placement was significantly increased in the CBT group compared with the TT group (P < 0.05). The CBT group had a significantly lower rate of FJV than the TT group (P < 0.05). In addition, the rate of fusion and the rate of screw loosening were similar between the CBT and TT groups according to screw loosening criteria. Conclusion: This prospective, randomized controlled analysis suggests that clinical outcomes and radiographic characteristics, including fusion rates and caudal screw loosening rates, were comparable between CBT and TT screw fixation. Compared with the TT group, the CBT group showed advantages in the accuracy of screw placement and the FJV rate. Clinical Trials Registration: This trial has been registered at the US National Institutes of Health Clinical Trials Registry: NCT03105167. [ABSTRACT FROM AUTHOR]
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- 2024
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88. The outcome of combined use of iRoot BP Plus and iRoot SP for root-end filling in endodontic microsurgery: a randomized controlled trial.
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Dong, Xu, Su, Qin, Li, Wen, Yang, Jinbo, Song, Dongzhe, Yang, Jing, and Xu, Xin
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Objectives: Root-end filling is important for the clinical outcome of endodontic microsurgery. Our previous study showed that combined application of iRoot BP Plus Root Repair Material (BP-RRM) and iRoot SP Injectable Root Canal Sealer (SP-RCS) in root-end filling exhibited better apical sealing as compared to the application of BP-RRM alone. The aim of this randomized controlled clinical trial was to evaluate the effect of the combined use of BP-RRM and SP-RCS on the prognosis of teeth with refractory periapical diseases after endodontic microsurgery. Materials and methods: 240 teeth with refractory periapical diseases scheduled for endodontic microsurgery were randomly divided into BP-RRM/SP-RCS group (n = 120) and BP-RRM group (n = 120). The patients were followed up at 3 months, 6 months, and 12 months after endodontic microsurgery. Pre- and post-operative clinical and radiographic examinations were performed to evaluate the treatment outcome. The 1-year success rate of endodontic microsurgery in BP-RRM/SP-RCS and BP-RRM groups was compared by Chi-square test. Factors that might impact the prognosis were further analyzed using Chi-square test or Fisher's exact test. Results: A total of 221 teeth completed the 12-month follow-up. The 1-year success rates of the BP-RRM/SP-RCS and BP-RRM groups were 94.5% (104/110) and 92.8% (103/111), respectively. The combined use of BP-RRM and SP-RCS achieved a clinical outcome comparable to BP-RRM alone (P = 0.784). Tooth type (P = 0.002), through-and-through/apico-marginal lesion (P = 0.049), periodontal status (P < 0.0001), and Kim’s lesion classification (P < 0.0001) were critical factors associated with the 1-year success of endodontic microsurgery. Conclusions: The combined use of BP-RRM and SP-RCS is a practicable method for root-end filling in endodontic microsurgery with a satisfactory 1-year clinical outcome. Clinical relevance: The combined application of BP-RRM and SP-RCS in EMS is an effective root-end filling method with a satisfactory 1-year clinical outcome. Trial registration: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2100052174). [ABSTRACT FROM AUTHOR]
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- 2024
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89. Striving to thrive: a randomized controlled trial of educational support interventions for children in out-of-home care.
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Eiberg, Misja and Scavenius, Christoffer
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EDUCATIONAL support , *FOSTER children , *CHILD care , *RANDOMIZED controlled trials , *COMPREHENSION in children , *PSYCHOSOCIAL functioning , *CHILD support - Abstract
Children in out-of-home care persistently show poorer educational and developmental outcomes than their peers. This study investigates the effect of the comprehensive educational intervention, "LUKoP," in a randomized controlled trial, compared to treatment-as-usual (TAU). Outcome measures included reading and math abilities, IQ and executive function, learning skills, and psychosocial functioning. One hundred foster children (66% female) aged 6–14 (M = 10.5, SD = 2.1) from 80 regular schools participated in the study. We applied a fixed-effects regression analysis. Regardless of group allocation, the children demonstrated significant progress in cognitive development, including IQ (ES = 0.40, p <.001), verbal comprehension (ES = 0.29, p =.02), and perceptual reasoning (ES = 0.60, p <.001) over time. The children who received the LUKoP intervention also had a significant increase in word-reading speed (ES = 0.21, p =.02) and a significant additional gain in IQ (ES = 0.34, p =.02) and verbal comprehension (ES = 0.41, p =.03), compared to TAU. No significant effect was found on the other outcome measures for either the TAU group (ES range = − 0.13 to 0.47, p >.05) or the LUKoP group (ES range = − 0.15 to 0.42, p >.05). We found no compelling evidence that the LUKoP intervention gives overall benefit to academic achievement; however, LUKoP demonstrated a greater effect on cognitive abilities than TAU. The findings and future directions for educational interventions for children in out-of-home care are discussed. [ABSTRACT FROM AUTHOR]
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- 2024
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90. How Exposure to Personal Distress With and Without Self-compassion Affects Distress Tolerance: Results from a Two-Sample Randomized Trial.
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Shaw, Jenessa L. and Kelly, Allison C.
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Objectives: Self-compassion is a caring way of relating to personal distress that has known soothing physiological effects characterized by feelings of safeness. Individuals low in distress tolerance feel threatened by negative emotions and believe that they are unable to tolerate them. We tested the theory that for this population, experiencing negative emotions with self-compassion, as compared to without self-compassion, would allow individuals to feel safer and more soothed, thereby increasing their distress tolerance, our primary outcome. Method: We tested this hypothesis in a randomized controlled trial involving Canadian undergraduate students (n = 150) and international community adults (n = 298) with below-average distress tolerance levels. In an online session, participants brought to mind a distressing situation and then completed one of three interventions: writing about their negative emotions (pure exposure); writing about their negative emotions from a compassionate perspective (self-compassionate exposure); writing about a neutral topic (placebo control). Results: In both samples, self-compassionate exposure yielded higher self-reported post-intervention distress tolerance than pure exposure (d = 0.37–0.55, p < 0.05) but not compared to placebo control (d = 0.10–0.34, p > 0.05). The relative effect of self-compassionate exposure over pure exposure occurred indirectly via greater levels of self-reported soothing affect during the intervention (proportion mediated, 0.53–0.67). Between-condition differences were absent at 1-week follow-up. Conclusions: Findings suggest that exposure to negative emotions with self-compassion, as compared to without, may be a more effective way to momentarily increase distress tolerance due to its effects on soothing affect. Preregistration: US Clinical Trials Registry #NCT05284578 [ABSTRACT FROM AUTHOR]
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- 2024
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91. A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial)
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Degiuli, Maurizio, Aguilar, Aridai H. Resendiz, Solej, Mario, Azzolina, Danila, Marchiori, Giulia, Corcione, Francesco, Bracale, Umberto, Peltrini, Roberto, Di Nuzzo, Maria M., Baldazzi, Gianandrea, Cassini, Diletta, Sica, Giuseppe S., Pirozzi, Brunella, Muratore, Andrea, Calabrò, Marcello, Jovine, Elio, Lombardi, Raffaele, Anania, Gabriele, Chiozza, Matteo, and Petz, Wanda
- Abstract
Background: Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials. Method: This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis. Results: Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available. Conclusions: Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison. Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial. [ABSTRACT FROM AUTHOR]
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- 2024
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92. Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy: A Multicenter Double-Blind Randomized Controlled Trial.
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Huang, Hao-yue, Lin, Yu-ping, Wei, Hua, Fu, Yu, Zhou, Yue-hong, Fang, Zhao-hui, Qiu, Xiao-tang, Wang, Mei, Li, Qing-bo, Li, Shan-shan, Wang, Shi-dong, Dai, Fang, Liu, Zhen-jie, Zhao, Ling, Wen, Jian-xuan, Wu, Li-yan, Zeng, Hui-yan, Zhang, Jin-ming, Lu, Qi-yun, and He, Liu
- Subjects
TREATMENT of diabetic neuropathies ,RESEARCH ,HERBAL medicine ,GLYCEMIC control ,FOOT care ,BATHS ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,NEURAL conduction ,BLIND experiment ,RESEARCH funding ,DESCRIPTIVE statistics ,STATISTICAL sampling ,CHINESE medicine ,MOTOR neurons ,PATIENT safety ,DRUG administration ,DRUG dosage ,THERAPEUTICS - Abstract
Objective: To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction (TW) in treating patients with diabetic peripheral neuropathy (DPN). Methods: It is a multicenter double-blinded randomized controlled trial. Participants with DPN were recruited between November 18, 2016 and May 30, 2018 from 8 hospitals in China. All patients received basic treatments for glycemic management. Patients received foot baths with TW herbal granules either 66.9 g (intervention group) or 6.69 g (control group) for 30 min once a day for 2 weeks and followed by a 2-week rest, as a therapeutic course. If the Toronto Clinical Scoring System total score (TCSS-TS) ⩾6 points, the patients received a total of 3 therapeutic courses (for 12 weeks) and were followed up for 12 weeks. The primary outcome was change in TCSS-TS score at 12 and 24 weeks. Secondary outcomes included changes in bilateral motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the median and common peroneal nerve. Safety was also assessed. Results: Totally 632 patients were enrolled, and 317 and 315 were randomized to the intervention and control groups, respectively. After the 12-week intervention, patients in both groups showed significant declines in TCSSTS scores, and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment (P<0.05). The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group (P<0.05). The number of adverse events did not differ significantly between groups (P>0.05), and no serious adverse event was related with treatment. Conclusion: Treatment of TW foot baths was safe and significantly benefitted patients with DPN. A low dose of TW appeared to be more effective than a high dose. (Registry No. ChiCTR-IOR-16009331). [ABSTRACT FROM AUTHOR]
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- 2024
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93. Factors and Their Impact on Treatment Effect of Acupuncture in Different Outcomes: A Meta-Regression of Acupuncture Randomized Controlled Trials.
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Xiu, Wen-cui, Gang, Wei-juan, Zhou, Qi, Shi, Lan-jun, Hu, Xiang-yu, Ming, Tian-yu, Luo, Zhen, Zhang, Yu-qing, and Jing, Xiang-hong
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ONLINE information services ,MEDICAL databases ,MEDICAL information storage & retrieval systems ,CONFIDENCE intervals ,ACUPUNCTURE ,SYSTEMATIC reviews ,TREATMENT effectiveness ,DESCRIPTIVE statistics ,MEDLINE ,EVALUATION - Abstract
Background: The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results. Objective: To identify factors and their impact on the treatment effect of acupuncture in different outcomes. Methods: Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2–0.4), or large (>0.4) effects. Results: The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01). Conclusions: High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes. [ABSTRACT FROM AUTHOR]
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- 2024
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94. Panacea or poison: Assessing how well basic propensity score modeling can replicate results from randomized controlled trials in criminal justice research.
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Campbell, Christopher M. and Labrecque, Ryan M.
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RANDOMIZED controlled trials ,CRIMINAL trials ,POISONS ,RESEARCH personnel ,TEST reliability - Abstract
As a substitute, randomized controlled trial (RCT) researchers increasingly rely on propensity score modeling (PSM) to estimate causal effects. However, some warn about the dangers of placing too much blind faith in the abilities of PSM. This study tests the reliability and validity of seven common PSM methods in their ability to remove an artificial selection bias and replicate results from several RCTs in criminal justice data. Findings suggest PSM can be an effective means for simulating RCT results. Meta-analyses reveal the average difference between PSM and RCT estimates were relatively small. Ultimately, our findings suggest that PSM can be an effective means for simulating an RCT while also harboring reason for concern. Researchers and policy-makers should approach the use and interpretation of PSM with cautious optimism as it appears to provide a reliable and valid estimate of the treatment effect most of the time. [ABSTRACT FROM AUTHOR]
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- 2024
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95. Efficacy of physical exercise on sleep quality in patients with chronic kidney disease: a systematic review and meta-analysis.
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Valera, Silvia, Diz, José Carlos, Rey-Fernández, Belén, González-Devesa, Daniel, García-Fresneda, Adrián, and Ayán, Carlos
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Background and objective: To revise and critically summarize the available scientific evidence regarding the effect of exercise on sleep quality in patients with chronic kidney disease (CKD). Methods: A systematic review of randomized controlled trials (RCTs) and comparative studies was conducted, searching MEDLINE/PubMed, SPORTDiscus, and Scopus using keywords "Exercise", "Physical Activity", "Chronic Kidney Disease," and "Sleep". The methodological quality of included studies was assessed using the PEDRo and MINORS scales. Results: A total of 8 RCTs and 3 comparative studies were included, showing a low (n = 1), fair (n = 7), and good (n = 3) methodological quality. Most of the studies included patients undergoing hemodialysis (HD) (n = 8). Self-reported sleep quality (n = 9), sleepiness (n = 2), and objective sleep status (n = 2) were the main outcomes analyzed. The most frequent exercise interventions included aerobic training (n = 7), resistance training (n = 2), or a combination of both (n = 4). Generally, exercise induced positive effects on the reported outcomes. Data synthesis indicated that participants who exercised obtained significant improvements on their self-reported sleep quality in comparison with those included in the control groups, with a mean difference in the Pittsburgh Sleep Quality Index of − 5.27 points (95% CI − 7.76, − 2.77; p < 0.001). Conclusion: Preliminary scientific evidence indicates that patients with CKD, especially those undergoing HD, report improvements in self-reported sleep quality after taking part in aerobic exercise programs, while combined training interventions yielded diverse findings. The effects of exercise on sleepiness and objective sleep status were backed by few studies with mixed results. [ABSTRACT FROM AUTHOR]
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- 2024
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96. Efficacy of a single Nd:YAG laser dose in reducing pain after mandibular third molar extraction: a prospective randomized controlled clinical trial.
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Meng, Tian, He, Linhai, Chen, Yuhuan, and Zhang, Zhiyong
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THIRD molars , *ND-YAG lasers , *CLINICAL trials , *RANDOMIZED controlled trials , *DENTAL extraction , *POWER density - Abstract
The purpose is to explore the analgesic effect of a single Nd:YAG laser dose after mandibular third molar extraction. This was a prospective randomized controlled clinical trial. Subjects were enrolled according to the inclusion and exclusion criteria and randomly divided into the experimental and control groups. In the experimental group, the wound was irradiated with the Nd:YAG laser (wavelength, 1064 nm; output power, 1.5 W; energy density, 45 J/cm2; and power density, 1.5/cm2, pulsed mode) immediately after mandibular third molar extraction for 120 s (30 s at each site). In the control group, the laser working tip was placed near the extraction site but not activated. The primary outcome was the visual analog scale (VAS) pain scores in both groups at 2, 4, 12, 24, 48, and 72 h and 7 days after surgery. Secondary outcomes included wound healing scores and adverse reactions. The VAS score was significantly lower in the experimental group than in the control group at 2 and 4 h after surgery, while there was no significant difference in the VAS score between the two groups at 12, 24, or 48 h or 7 days after surgery. There were no significant differences in the wound healing scores between the two groups on postoperative day 7. No adverse reactions were observed in any of the laser-irradiated areas. A single Nd:YAG laser dose was effective in reducing pain at 2 and 4 h after mandibular third molar extraction. China Clinical Trial Registry: ChiCTR2000033870 (Registration Date: 2020–6-15). [ABSTRACT FROM AUTHOR]
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- 2024
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97. Effect of cranial electrotherapy stimulation (CES) in treatment of premature ejaculation: a randomized clinical trial.
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Delpasand, Hadi, Mazaheri, Azadeh, Kheradmand, Ali, Ghorbani, Mahdi, Abedi, Amir Reza, and Khosroabadi, Mohsen
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PREMATURE ejaculation , *CLINICAL trials , *ELECTROTHERAPEUTICS , *SEXUAL dysfunction , *ELECTRIC stimulation - Abstract
Background: Premature ejaculation is one of the most common male sexual dysfunction, affecting approximately 30% of men. The aim of this study is to evaluate the efficacy and at the same time the safety of the cranial electrotherapy stimulation (CES) device in treatment of premature ejaculation disorder. Methods: Based on a randomized clinical trial, two groups were included in the study, so that the first group was treated with sertraline along with an ATANG (AT-9 model) CES, and the second group with sertraline and inactive the CES device (as the placebo group). The state of premature ejaculation after treatment (using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) was evaluated and compared for both groups. Results: In the intervention and placebo groups, the average score of the PEDT questionnaire before the intervention did not differ significantly between the two groups (p-value equal to 0.93). However, the average score of the PEDT questionnaire after the intervention for CES group and placebo group was 10.28 ± 1.93 and 13.23 ± 3.05, respectively, which demonstrated a significant decrease in the intervention group (p-value equal to 0.01). Conclusion: The use of CES device as a complementary treatment along with routine drug treatment (sertraline) is associated with a significant improvement in the condition of premature ejaculation of patients. Trial registration: Name of the registry: IRCT Iranian Registry of Clinical Trials. Trial registration number: IRCT20210621051657N1. Date of registration: December 11, 2022. URL of trial registry record: https://en.irct.ir/trial/57201. [ABSTRACT FROM AUTHOR]
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- 2024
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98. Effects of a 12-week exercise-based intervention on weight management in overweight or obese breast cancer survivors: a randomized controlled trial.
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Zhao, Fu-Yun, Liu, Jun-E, Fang, Xiao-Ming, Chen, Lu, Liang, Jia-Gui, Liu, Yu, Li, Ruo-Lin, and Chen, Hai-Rong
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Purpose: Breast cancer survivors face dual challenges: long-term sequelae of treatment and the risk of recurrent disease. Furthermore, obesity and a sedentary lifestyle can complicate both challenges. We aimed to assess the effect of a 12-week exercise-based weight-management program in overweight/obese breast cancer survivors. Methods: A two-arm, single-blinded, randomized controlled trial was conducted among 60 overweight/obese, stage 0–III breast cancer survivors. During the 12-week program, the intervention group received weekly information support, fortnightly exercise prescriptions, including aerobic and resistance exercises to perform at home, and one dietary instruction. The control group received information support about weight management and exercise. Weight, body composition, and physical fitness data were collected at baseline, postintervention, and the 3-month follow-up. Results: The intervention group showed significant improvements in body weight and all adiposity indices, including body mass index, waist circumference, and %body fat, in comparison with baseline (P < 0.001) and the control group (P < 0.05). Both groups showed no significant changes in fat-free mass during the 6-month period (P > 0.05). International Physical Activity Questionnaire scores and left grip strength increased significantly in the intervention group in comparison with the baseline (P < 0.01) and the control group (P < 0.05). Right grip strength, lower-body strength, and aerobic endurance showed no significant intergroup differences (P > 0.05). Conclusions: A combination of exercise prescription and weight-loss interventions yielded clinically meaningful weight loss in overweight/obese breast cancer survivors. These findings may facilitate the incorporation of home-based exercise and weight management into breast cancer treatment and survivorship care. [ABSTRACT FROM AUTHOR]
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- 2024
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99. Effect of a Randomized Controlled Trial of Housing Vouchers on Adolescent Risky Sexual Behavior Over a 15-Year Period.
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Gresham, Bria, Thyden, Naomi H., Gailey, Samantha, and Osypuk, Theresa L.
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HUMAN sexuality , *TEENAGERS' sexual behavior , *NEIGHBORHOODS , *ADOLESCENT health , *CLINICAL trials - Abstract
We examined whether a housing voucher intervention influenced adolescent risky sexual behavior (RSB) across 15 years in the Moving to Opportunity Study. Low-income families in public housing that resided in 5 cities were randomized to one of three treatment groups: a housing voucher to move to low-poverty neighborhoods (i.e., < 10% poverty rate), a Sect. 8 voucher but no housing relocation counseling, or a control group that could remain in public housing. Youth and their caregivers completed baseline surveys, as well as two uniform follow-ups: interim (2001–2002; 4–7 years after baseline) and final (2008–2010; 10–15 years after baseline). Approximately 4,600 adolescents (50.5% female) aged 13–20 years participated at the final timepoint. Adolescents reported on their RSB, including condom use, other contraceptive use, early sexual initiation (< 15 years old), and 2+ sexual partners in the past year. We modeled each indicator separately and as part of a composite index. We tested baseline health vulnerabilities as potential effect modifiers. The low-poverty voucher group and the Sect. 8 voucher group were combined due to homogeneity of their effects. Applying intent-to-treat (ITT) regression analyses, we found no significant main effects of voucher receipt (vs. control) on any RSB. However, we found protective effects of voucher receipt on RSB among youth with health problems that limited activity, and youth < 7 at baseline but adverse effects among females, youth > 7 at baseline, and youth who were suspended/expelled from school. Results highlight the importance of understanding how housing interventions differentially influence adolescent health and behaviors. [ABSTRACT FROM AUTHOR]
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- 2024
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100. Brain metabolite levels in remitted psychotic depression with consideration of effects of antipsychotic medication.
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Tani, Hideaki, Moxon-Emre, Iska, Forde, Natalie J., Neufeld, Nicholas H., Bingham, Kathleen S., Whyte, Ellen M., Meyers, Barnett S., Alexopoulos, George S., Hoptman, Matthew J., Rothschild, Anthony J., Uchida, Hiroyuki, Flint, Alastair J., Mulsant, Benoit H., and Voineskos, Aristotle N.
- Abstract
Background: The neurobiology of psychotic depression is not well understood and can be confounded by antipsychotics. Magnetic resonance spectroscopy (MRS) is an ideal tool to measure brain metabolites non-invasively. We cross-sectionally assessed brain metabolites in patients with remitted psychotic depression and controls. We also longitudinally assessed the effects of olanzapine versus placebo on brain metabolites. Methods: Following remission, patients with psychotic depression were randomized to continue sertraline + olanzapine (n = 15) or switched to sertraline + placebo (n = 18), at which point they completed an MRS scan. Patients completed a second scan either 36 weeks later, relapse, or discontinuation. Where water-scaled metabolite levels were obtained and a Point-RESolved Spectroscopy sequence was utilized, choline, myo-inositol, glutamate + glutamine (Glx), N-acetylaspartate, and creatine were measured in the left dorsolateral prefrontal cortex (L-DLPFC) and dorsal anterior cingulate cortex (dACC). An ANCOVA was used to compare metabolites between patients (n = 40) and controls (n = 46). A linear mixed-model was used to compare olanzapine versus placebo groups. Results: Cross-sectionally, patients (compared to controls) had higher myo-inositol (standardized mean difference [SMD] = 0.84; 95%CI = 0.25–1.44; p = 0.005) in the dACC but not different Glx, choline, N-acetylaspartate, and creatine. Longitudinally, patients randomized to placebo (compared to olanzapine) showed a significantly greater change with a reduction of creatine (SMD = 1.51; 95%CI = 0.71–2.31; p = 0.0002) in the dACC but not glutamate + glutamine, choline, myo-inositol, and N-acetylaspartate. Conclusions: Patients with remitted psychotic depression have higher myo-inositol than controls. Olanzapine may maintain creatine levels. Future studies are needed to further disentangle the mechanisms of action of olanzapine. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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