Validation of the portable virtual reality training system for robotic surgery (PoLaRS): a randomized controlled trial

Abstract Background As global use of surgical robotic systems is steadily increasing, surgical simulation can be an excellent way for robotic surgeons to acquire and retain their skills in a safe environment. To address the need for training in less wealthy parts of the world, an affordable surgical robot simulator (PoLaRS) was designed. Methods The aim of this pilot study is to compare learning curve data of the PoLaRS prototype with those of Intuitive Surgical’s da Vinci Skills Simulator (dVSS) and to establish face- and construct validity. Medical students were divided into two groups; the test group (n = 18) performing tasks on PoLaRS and dVSS, and the control group (n = 20) only performing tasks on the dVSS. The performance parameters were Time, Path length, and the number of collisions. Afterwards, the test group participants filled in a questionnaire regarding both systems. Results A total of 528 trials executed by 38 participants were measured and included for analyses. The test group significantly improved in Time, Path Length and Collisions during the PoLaRS test phase (P ≤ 0.028). No differences was found between the test group and the control group in the dVSS performances during the post-test phase. Learning curves showed similar shapes between both systems, and between both groups. Participants recognized the potential benefits of simulation training on the PoLaRS system. Conclusions Robotic surgical skills improved during training with PoLaRS. This shows the potential of PoLaRS to become an affordable alternative to current surgical robot simulators. Validation with similar tasks and different expert levels is needed before implementing the training system into robotic training curricula.

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Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial

BMC Health Services Research ◽

10.1186/s12913-021-06223-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Urška Nabergoj Makovec ◽

Igor Locatelli ◽

Mitja Kos

Keyword(s):

Medication Adherence ◽

Controlled Trial ◽

Test Group ◽

Multiple Linear Regression Model ◽

Relative Difference ◽

Control Group ◽

Adherence Support ◽

Medicines Use ◽

The Impact ◽

Medicines Use Review

Abstract Background Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. Methods A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. Results Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16–2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05–1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = − 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. Conclusion MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. Trial registration ClinicalTrials.gov - NCT04417400; 4th June 2020; retrospectively registered.

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The Effect of Oxymel Syrup on Some Cardiovascular Risk Factors in Overweight and Obese People: A Randomized Controlled Trial Study

Traditional and Integrative Medicine ◽

10.18502/tim.v6i3.7307 ◽

2021 ◽

Author(s):

Marjan Mahdavi Roshan ◽

Arsalan Salari ◽

Sogol Emaminejad ◽

Shirin Parvinroo ◽

Asieh Ashouri ◽

...

Keyword(s):

Risk Factors ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Controlled Trial ◽

Test Group ◽

The Body ◽

Risk Indicators ◽

Blood Cholesterol ◽

Control Group ◽

Obese People

High blood pressure, diabetes, hyperlipidemia and obesity are risk factors for cardiovascular diseases. With regard to the significant role of a healthy diet in the prevention and even treatment of diseases together with the high cost and side effects of drugs, finding foods effective in the treatment of metabolic disorders has been widely considered. This study aimed to evaluate the effect of oxymel – an Iranian traditional syrup with vinegar base – on cardiovascular risk indicators in obese and overweight people. Candidates were selected based on a set of inclusion criteria and were divided into two groups of control and test. The control group received 250 cc of water, while the test group received 250 cc water containing 30 cc of the oxymel for 30 days. Anthropometric and biochemical indicators were measured at the beginning and end of the study. The results showed that there were no significant changes in the body mass index, waist circumference, hip circumference, waist to hip ratio, HDL, LDL, Triglycerides, systolic and diastolic blood pressure, and blood glucose level. However, weight (P = 0.053) and cholesterol (P = 0.083) decreased relatively significantly in the test group compared to the control group. This study shows that consumption of oxymel has positive cardiovascular effects such as lowering the blood cholesterol level and can contribute to weight loss; however, studies with a larger sample size are recommended.

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Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial

BMC Oral Health ◽

10.1186/s12903-020-01265-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Pei Liu ◽

Weiye Wen ◽

Ka Fung Yu ◽

Xiaoli Gao ◽

Edward Chin Man Lo ◽

...

Keyword(s):

Oral Health ◽

Pregnant Women ◽

Oral Hygiene ◽

Controlled Trial ◽

Test Group ◽

Control Group ◽

Oral Health Promotion ◽

Periodontal Health ◽

The Mean ◽

Family Centered

Abstract Background Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum. Methods A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T0), in the 32nd gestational week (T1), and 12 months postpartum (T2). Results Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T0 was 0.19, which decreased to 0.14 at T1 and 0.15 at T2. In the control group, the mean VPI decreased from 0.19 at T0 to 0.16 at T1, but increased to 0.22 at T2. A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T1 and T2. The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T0:57%, T1:46%, T2:35%) than in the control group (T0:58%, T1:52%, T2:46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001). Conclusions Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone. Trial registration Clinicaltrials.gov, #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1

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Efficacy of a herbal toothpaste on patients with established gingivitis: a randomized controlled trial

Brazilian Oral Research ◽

10.1590/s1806-83242006000200015 ◽

2006 ◽

Vol 20 (2) ◽

pp. 172-177 ◽

Cited By ~ 26

Author(s):

Fabiana Ozaki ◽

Claudio Mendes Pannuti ◽

Ana Vitória Imbronito ◽

Wellington Pessotti ◽

Luciana Saraiva ◽

...

Keyword(s):

Adverse Reactions ◽

Controlled Trial ◽

Test Group ◽

Experimental Period ◽

Positive Control ◽

Control Group ◽

Control Groups ◽

Double Blind ◽

Significant Difference ◽

And Control

The aim of this randomised, double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis. Forty eight volunteers with established gingivitis were randomly assigned to either a test group (herbal dentifrice) or positive control group (dentifrice with triclosan and fluoride). The dentifrices were distributed in plain white tubes by an independent pharmacy, which revealed the contents of each tube only after the experimental period. Plaque and gingivitis assessments were carried out on baseline and after 28 days of product use. All examinations were conducted by the same calibrated investigator. Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days. There was a significant reduction in plaque levels in both the test and control groups. However, there was no significant difference between the groups. A significant reduction in gingivitis was observed in both groups, although there was no significant difference between them. No adverse reactions were reported. The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis.

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Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults

European Journal of Orthodontics ◽

10.1093/ejo/cjy082 ◽

2019 ◽

Vol 41 (5) ◽

pp. 495-501 ◽

Cited By ~ 11

Author(s):

Carole Charavet ◽

Geoffrey Lecloux ◽

Nastasia Jackers ◽

Adelin Albert ◽

France Lambert

Keyword(s):

Orthodontic Treatment ◽

Treatment Time ◽

Controlled Trial ◽

Test Group ◽

University Hospital ◽

Control Group ◽

Orthodontic Appliances ◽

Overall Treatment Time ◽

Randomized Controlled ◽

Cad Cam

Summary Objective The aim of this study was to investigate the effects of piezocision (surgical protocol with sutures) in orthodontic treatment using CAD/CAM (computer-aided design and computer-aided manufacturing) customized orthodontic appliances. Design The study is designed as a parallel group, randomized controlled trial (RCT). Setting University Hospital. Ethical approval The study was approved by the ethic committee of the University Hospital Liege, Belgium. Subjects and methods This RCT was conducted on 24 adult patients requiring orthodontic treatment to release mild overcrowding. Patients were all treated with a customized appliance and randomly assigned by means of sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment. A blinded orthodontist validated appliance removal or further adjustments based on the model study. Outcome measures The overall treatment time and the time between archwire changes were recorded. Moreover, clinical and radiological features such as tooth resorption, gingival recessions, and the presence of scars were evaluated. Results A total of 24 patients (12 control and 12 test) completed the study. The overall treatment time was significantly shorter in the test group than the control group. Likewise, the time difference between all arch changes was significantly lower when piezocision was performed, except for the first arch at the mandible and the last arches at both maxillae. During the fine-tuning phase, no significant difference was found between the two groups. All periodontal and radiographic parameters remained stable from the start to the end of treatment in both the groups. However, minor scars were found in 66 per cent cases. Limitations This trial was a single-centre trial. Conclusions Piezocision seems to be an effective method to accelerate orthodontic treatment in cases of mild overcrowding. However, the effect was only observed during the alignment phase and a greater efficiency was found in the maxilla. The technique may be contraindicated in patients with a high smile line since the risk of slight scarring exists. Registration ClinicalTrails.gov (Identifier: NCT03406130)

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Staphylococcal sepsis in mothers and newborn babies

Journal of Hygiene ◽

10.1017/s0022172400039358 ◽

1962 ◽

Vol 60 (1) ◽

pp. 105-112 ◽

Cited By ~ 2

Author(s):

M. S. Spink

Keyword(s):

Nasal Mucosa ◽

Controlled Trial ◽

Bacterial Flora ◽

Phage Type ◽

Test Group ◽

Cross Infection ◽

Control Group ◽

Control Groups ◽

Peak Period ◽

And Control

A serious outbreak of staphylococcal infections in the maternity units in Blackburn was investigated. There were considerably more than one hundred cases of breast abscesses altogether, well over half of which occurred in primiparae. Staphylococcus aureus, phage type 80, was the predominating organism throughout the outbreak and at the peak period during the early part of the outbreak this type was responsible for nearly 80% of the infections.After the introduction of a number of procedures for the general reduction of cross-infection the incidence of breast abscess fell markedly and a controlled trial of an antibacterial cream, containing neomycin and hibitane, which was applied to the nasal mucosa of all infants and mothers in the test group of patients, was undertaken. The conditions obtaining in the test and control groups were identical in every way except that the control patients did not receive the neomycin-hibitane cream. There were about 1250 mothers and infants each in the test and control groups; the incidence of breast abscesses in the test group was 0·8% and in the control group it was 2·7%. The method adopted for the detection and treatment of carriers among the nursing staff broke down on two occasions; this fact and the emergence of an unforeseen source resulted in a larger number of infections than should have occurred. Had it not been for these incidents there is little doubt that the trial would have shown more conclusively the effectiveness of the neomycinhibitane cream, by the method laid down, in reducing cross-infection.Investigation of the bacterial flora on the nasal mucosa of over 1000 infants in the control group yielded results of considerable interest. Of 300 cases where there was early colonization by Staph. albus, this organism established its dominating position in 70% of the cases and it was not subsequently displaced by Staph. aureus. The significance of this observation and the evidence favouring nasal dissemination of Staph.aureus as the most important cause of hospital cross-infection are discussed.

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Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial

Journal of Oral Implantology ◽

10.1563/aaid-joi-d-17-00185 ◽

2018 ◽

Vol 44 (2) ◽

pp. 122-129

Author(s):

Arturo Sánchez-Pérez ◽

Jesús Muñoz-Peñalver ◽

María José Moya-Villaescusa ◽

Carmen Sánchez-Matás

Keyword(s):

Placebo Group ◽

Postoperative Pain ◽

Controlled Trial ◽

Test Group ◽

Control Group ◽

Double Blind ◽

Implant Surgery ◽

Lower Pain ◽

Dexketoprofen Trometamol ◽

Group A

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

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Effects of Probiotic Supplementation on Immune Response in Soldiers: A Randomized, Double-Blinded, Placebo-Controlled Trial

Annals of Military and Health Sciences Research ◽

10.5812/amh.100540 ◽

2020 ◽

Vol 18 (3) ◽

Author(s):

Mahtab Noorifard ◽

Elahe Ebrahimi ◽

Arasb Dabbagh Moghaddam ◽

Zatollah Asemi ◽

Ramin Hamidi Farahani ◽

...

Keyword(s):

Immune Response ◽

Immune System ◽

Controlled Trial ◽

Test Group ◽

Bacillus Coagulans ◽

Serum Lactate ◽

Control Group ◽

Probiotic Supplementation ◽

Double Blinded ◽

The Military

Background: Athletic soldiers undergo strenuous and high-endurance training to prepare for competition. Stress and deprivation of proper nutrition can weaken the immune system in athletic soldiers. Therefore, enhancing the immune system function in addition to enhancing the performance of athletic soldiers can lead to a reduction in health costs for the military. Objectives: In this study, the effects of probiotic supplementation on the immune response of soldiers were assessed. Methods: In a randomized, double-blinded, placebo-controlled trial, 42 athletic soldiers were randomly divided into two groups of 21 members. Participants in the probiotic group daily received one glass of fruit juice containing Bacillus coagulans (2 × 109 CFU/g). The control group consumed the placebo at the same time. At the beginning and end of the study, as well as at specific times, IgA, CD4, lactate, and urea were measured in blood samples of all participants. Results: Probiotic supplementation increased the concentration of IgA (+115.7 ± 28.3 vs. -108.3 ± 25.7 mg/dL, P < 0.001) and CD4 levels (+129.1 ± 42.6 vs. -54.5 ± 114.6 cells/µL, P < 0.001) after three months in the test group. In addition, a significant decrease was seen in serum lactate (-5.7 ± 10.1 vs. +10.1 ± 7.4. mg/L, P < 0.001) and urea (-9.9 ± 6.7 vs. +2.3 ± 5.6 mg/dL, P < 0.001) concentrations following probiotic supplementation compared to the placebo. Conclusions: Probiotic consumption for 12 weeks has a positive effect on the immune response of soldiers.

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Effect of advanced periodontal self-care in patients with early-stage periodontal diseases on endothelial function: An open-label, randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0257247 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0257247

Author(s):

Ayako Okada ◽

Takatoshi Murata ◽

Khairul Matin ◽

Meu Ariyoshi ◽

Ryoko Otsuka ◽

...

Keyword(s):

Early Stage ◽

Periodontal Diseases ◽

Controlled Trial ◽

Self Care ◽

Test Group ◽

Control Group ◽

Atherosclerotic Cardiovascular Disease ◽

Adma Level ◽

Open Label ◽

Randomized Controlled

Although a significant association between periodontal disease and atherosclerotic cardiovascular disease has been reported, their cause-to-effect relationship remains controversial. This randomized controlled clinical trial aimed to investigate the effect of advanced self-care on atherosclerotic cardiovascular disease-related vascular function markers flow-mediated brachial artery dilatation (FMD) and serum asymmetric dimethylarginine (ADMA) level in patients with early-stage periodontal disease. The study was designed as a parallel group, 3-month follow-up, open-label, randomized controlled trial. The control group received standard care for periodontal diseases, whereas the test group additionally applied disinfectant using a custom-fabricated prescription tray for advanced self-care twice a day. Overall, 110 patients provided data for FMD and serum ADMA level. No significant improvements in FMD were observed in the control (mean increase, −0.1%; 95% confidence interval [CI], −1.0–0.8; P = 0.805) or test (mean increase, −0.3%; 95% CI, −1.1–0.4; P = 0.398) group. No significant changes in serum ADMA levels were observed (mean reduction, 0.01 μmol/L; 95% CI, −0.00–0.02; P = 0.366 and mean reduction, 0.00 μmol/L; 95% CI, −0.01–0.01; P = 0.349, respectively). No significant between-group differences were found in FMD (mean difference, −0.2%; 95% CI, −1.4–0.9; p = 0.708) or serum ADMA levels (mean difference, 0.01 nmol/L; 95% CI, −0.00–0.03; p = 0.122). Significant improvements in the average probing pocket depth were observed in the control and test groups. The bleeding on probing score in the test group was significantly reduced, while that in the control group was reduced, although not significantly. Periodontal care for a 3-month duration did not provide better endothelial function although improvements of periodontal status in patients with early-stage periodontal diseases. This trial is registered in UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/; ID: UMIN000023395).

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Clinical Evidence-Based Evaluation of ZFXNY in Treatment of Acute Cerebral Infarction

10.21203/rs.3.rs-689587/v1 ◽

2021 ◽

Author(s):

Wei Hu ◽

Chenhui Zhang ◽

Hong Zhang

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Cerebral Infarction ◽

Controlled Trial ◽

Case Fatality ◽

Test Group ◽

Acute Cerebral Infarction ◽

Control Group ◽

Chronic Obstructive ◽

Evidence Based

Abstract Background: Stroke is a severe and life-threatening disease, owns high rates of disability and mortality.[1] Stroke and ischemic heart disease, chronic obstructive pulmonary disease are the world’s three main killers.Ischemic strokes account for the vast majority of strokes.[2] Modern medicine has some advantages in treating ischemic stroke, but there are also limitations. Traditional Chinese medicine has thousands of years of experience in treating stroke, but there are few high quality clinical Randomized controlled trial.Methods: This is a multicenter, randomized, double-blind, placebo-controlled trial. 286 patients were randomly divided into test group and Control Group. Both groups received General Western medicine treatment, the test group combined with Chinese medicine treatment, the control group combined with placebo treatment. The duration of treatment was 30 days and the follow-up was 90 days. evaluation indicators include: Modified Rankin Scale, NIH stroke Scale, Glasgow Coma Scale, Barthel Index, Case fatality rate.Laboratory specifications and safety assessments will also be taken into account.Discussion: The aim of this study was to evaluate the safety and efficacy of ZFXNY in the treatment of acute cerebral infarction. Our research will provide a reliable evidence-based medicine basis for the treatment of acute cerebral infarction with traditional Chinese medicine, and provide another option for the treatment of acute cerebral infarction.Trial registration: ChiCTR2100043796, Registered February 28th, 2021.

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