Clinical Research Information Service Research Articles

The Impact of Membrane Stabilization for Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: A Non-Inferiority Randomized Controlled Trial.

The aim of this study was to investigate the non-inferiority of alveolar ridge preservation (ARP) with membrane stabilization compared with non-stabilization, focusing on changes of soft-tissue contour in periodontally compromised extraction sockets. Secondary outcomes included changes in hard-tissue contour, patient-reported outcomes and new bone formation. Twenty-four patients with periodontally compromised teeth were randomly assigned to ARP with (test group) or without (control group) membrane stabilization. To assess profilometric and hard-tissue dimensional changes, dental impressions and cone beam computed tomography scans were performed at baseline (T0), immediately after ARP (T1) and 4 months post surgery (T2). Soft-tissue healing in open healing sites was evaluated at T2, and wound closure was assessed 10 days post surgery. Patient-reported outcomes were documented, and core biopsies were obtained for histomorphometric analysis. The absolute profilometric horizontal width change at 3 mm below the crest in the test group was not inferior to that in the control group. For the relative values, horizontal width reduction (3 and 5 mm below the crest) and volumetric shrinkage (3-5 mm below the crest) were lower in the test group. No significant differences were observed in bone dimensional changes, wound healing, pain and swelling or histomorphometric outcomes. ARP with membrane stabilization in periodontally compromised extraction sockets is non-inferior in terms of soft-tissue contour changes to those without membrane fixation. Clinical Research Information Service (CRIS), KCT0005280. Registered 4 August 2020, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=19165&search_page=L.

Long-Term Effects of an Automated Personalized Self-Care Program for Patients With Type 2 Diabetes.

Elevated glycated hemoglobin (HbA1c) levels and longer disease duration increase the risk of complications in type 2 diabetes mellitus (T2DM), highlighting the need for continuous management. This study evaluated the 18-month effects of the Automated Personalized Self-Care (APSC) program on self-care self-efficacy, diabetes self-care, and complication risk indices in T2DM patients through a randomized controlled trial. Participants aged 40-69 years were assigned to either an intervention group using the APSC mobile app, which provided personalized goals, automated feedback, and monthly support, or a comparison group. The final analysis included 43 engaged participants from the intervention group and 78 from the comparison group. Data were collected at baseline, 6, 12, and 18 months using structured questionnaires and medical record reviews and analyzed using generalized estimating equations. Significant effects were observed for self-care self-efficacy, diabetes self-care activities, vegetable intake, HbA1c, and total cholesterol levels. The APSC program showed potential to improve long-term self-care and reduce complication risk in T2DM patients. Further research with a larger samples and strategies to promote long-term engagement is needed for its integration into routine diabetes care. Trial Registration: Clinical Research Information Service: KCT0007672.

Effectiveness of an e-book in enhancing knowledge, coping behaviors and preventive strategies for sexual harassment prevention among new nurses: A randomized controlled study

AimTo evaluate the effectiveness of an interactive e-book in improving new nurses' knowledge, coping behaviors and preventive strategies for sexual harassment prevention, while also assessing its impact on learning motivation. BackgroundSexual harassment has a detrimental effect on nurses' physical and mental well-being, as well as on patient safety, with new nurses being particularly vulnerable. DesignA single centre, randomized controlled study. MethodsThe study included 102 new nurses with less than 6 months of experience, recruited from a medical center in Taiwan. Participants were randomly assigned to the intervention group (e-book, n = 51) or the control group (video and manual, n = 51). Scales assessing sexual harassment prevention knowledge, coping behaviors, prevention strategies and learning motivation were used at baseline (T1), post-course (T2) and 2 weeks after the course (T3). ResultsBaseline measurements were similar between groups. The intervention group had significantly higher scores in prevention knowledge, strategies and learning motivation (p = 0.001; p = 0.05; p < 0.001) compared with the control group, though coping behavior scores were not statistically different (p = 0.228). Group and time effects were significant at T3 for prevention knowledge (p = 0.039), strategies (p = 0.042) and learning motivation (p < 0.001). ConclusionsThe e-book may enhance new nurses' knowledge and learning motivation for sexual harassment prevention, offering potential advantages over video/manual-based methods. Incorporating interactive e-books into nurse training programs could improve the effectiveness of sexual harassment prevention education. Trial registrationThis study was registered at the Clinical Research Information Service (NCT04139720.) on 30 January 2020 and the participant recruitment was initiated in 11 April 2020.

Efficacy of combined administration of Baekhogainsam-Tang and low-dose pilocarpine on frequent intractable xerostomia: Study protocol for a randomized controlled trial.

Intractable xerostomia is defined as the subjective perception of dry mouth and persistent salivary gland hypofunction. Pilocarpine is an approved salivary sialagogue that is frequently prescribed for the treatment of intractable xerostomia; however, it often exhibits more side effects at high-doses and limited effectiveness at low-doses. Baekhogainsam-Tang (BIT) is a common herbal formula used by patients complaining of sore throats and thirst. It seems that BIT can compensate for the insufficient effect of low-dose pilocarpine. However, no clinical trials have studied the efficacy of combined administration of BIT and low-dose pilocarpine for intractable xerostomia. We aim to assess the non-inferior efficacy and fewer side effects of combined administration of BIT and low-dose pilocarpine compared with the administration of high-dose pilocarpine. A randomized, open-label, parallel-group, multi-center trial will be conducted. A total of 120 patients with Sjogren's syndrome having an unstimulated salivary flow rate (SFR) ≤0.1 mL/min or who have undergone radiotherapy to the head and neck with an unstimulated SFR ≤0.25 mL/min will be recruited competitively. They will be randomly allocated to either the experimental or control groups. The experimental group will receive BIT herbal granules three times and pilocarpine (2.5-mg) four times daily; meanwhile, the control group will receive only 5-mg pilocarpine four times daily for 12 weeks. The primary outcome is unstimulated SFR after 12 weeks of treatment. Secondary outcomes are stimulated SFR after 12 weeks of medication, as well as differences and mean percentage changes in unstimulated and stimulated SFR, visual analog scale, salivary scintigraphy, and questionnaires for both oral symptoms and quality of life during the clinical trial. An independent T test or Mann-Whitney U test will be performed to compare values between the two groups. The Paired T test or Wilcoxon signed-rank test will be performed to compare intragroup continuous values. This trial will be significant evidence on the efficacy and safety of combined use of BIT and low-dose pilocarpine to treat intractable xerostomia. The Clinical Research Information Service of the Republic of Korea (ISRCTN, KCT0005982). Registered on 10 February 2021.

Bacterial contamination of autologous blood salvaged during deceased donor liver transplantation: a prospective observational study.

Decompensated cirrhotic patients experience severely increased intestinal permeability and bacterial translocation. Thus, autologous blood salvaged during deceased donor liver transplantation (DDLT) may be contaminated with enteric bacteria. We aimed to evaluate bacterial contamination of autologous blood salvaged during DDLT and its association with post-transplant bacteremia. In 30 patients undergoing DDLT, bacterial culture was performed in salvaged autologous blood samples: one before graft reperfusion (non-leukoreduced) and two after graft reperfusion (non-leukoreduced and leukoreduced). The primary outcome was bacterial contamination of salvaged autologous blood. Seven of 30 patients (23.3%) were positive for bacteria (3 enteric/4 non-enteric) before graft reperfusion while 11 patients (36.7%) were positive (5 enteric/6 non-enteric) after graft reperfusion. Six of 7 patients who were positive for bacteria before graft reperfusion were positive after graft reperfusion with the same bacteria. Only 4 of 11 contaminated blood samples were converted to negative after leukoreduction. Post-transplant bacteremia risk was insignificantly greater in patients who received autologous blood with bacteria than in patients without bacteria (30.0% vs. 5.0%, P = 0.06). We found contamination of salvaged autologous blood with enteric bacteria throughout DDLT and incomplete performance of leukoreduction, indicating high bacterial load. The potential association between contaminated autotransfusion and post-transplant bacteremia warrants further validation in a larger prospective study.Clinical trial notation: This study was registered at the Clinical Research Information Service (CRiS; https://cris.nih.go.kr ; No. KCT0007223; principal registration investigator: Sangbin Han, date of registration: April 25, 2022).

Sex-specific risk factors and clinical dementia outcomes for white matter hyperintensities in a large South Korean cohort

ObjectiveWhite matter hyperintensities (WMH) on brain MRI images are the most common feature of cerebral small vessel disease (CSVD). Studies have yielded divergent findings on the modifiable risk factors for WMH and WMH’s impact on cognitive decline. Mounting evidence suggests sex differences in WMH burden and subsequent effects on cognition. Thus, we aimed to identify sex-specific modifiable risk factors for WMH. We then explored whether there were sex-specific associations of WMH to longitudinal clinical dementia outcomes.MethodsParticipants aged 49–89 years were recruited at memory clinics and underwent a T2-weighted fluid-attenuated inversion recovery (FLAIR) 3T MRI scan to measure WMH volume. Participants were then recruited for two additional follow-up visits, 1–2 years apart, where clinical dementia rating sum of boxes (CDR-SB) scores were measured. We first explored which known modifiable risk factors for WMH were significant when tested for a sex-interaction effect. We additionally tested which risk factors were significant when stratified by sex. We then tested to see whether WMH is longitudinally associated with clinical dementia that is sex-specific.ResultsThe study utilized data from 713 participants (241 males, 472 females) with a mean age of 72.3 years and 72.8 years for males and females, respectively. 57.3% and 59.5% of participants were diagnosed with mild cognitive impairment (MCI) for males and females, respectively. 40.7% and 39.4% were diagnosed with dementia for males and females, respectively. Of the 713 participants, 181 participants had CDR-SB scores available for three longitudinal time points. Compared to males, females showed stronger association of age to WMH volume. Type 2 Diabetes was associated with greater WMH burden in females but not males. Finally, baseline WMH burden was associated with worse clinical dementia outcomes longitudinally in females but not in males.DiscussionOlder females have an accelerated increase in cerebrovascular burden as they age, and subsequently are more vulnerable to clinical dementia decline due to CSVD. Additionally, females are more susceptible to the cerebrovascular consequences of diabetes. These findings emphasize the importance of considering sex when examining the consequences of CSVD. Future research should explore the underlying mechanisms driving these sex differences and personalized prevention and treatment strategies.Clinical trial registrationThe BICWALZS is registered in the Korean National Clinical Trial Registry (Clinical Research Information Service; identifier, KCT0003391). Registration Date 2018/12/14.

Natural frequency tree- versus conditional probability formula-based training for medical students’ estimation of screening test predictive values: a randomized controlled trial

BackgroundMedical students and professionals often struggle to understand medical test results, which can lead to poor medical decisions. Natural frequency tree-based training (NF-TT) has been suggested to help people correctly estimate the predictive value of medical tests. We aimed to compare the effectiveness of NF-TT with conventional conditional probability formula-based training (CP-FT) and investigate student variables that may influence NF-TT’s effectiveness.MethodsWe conducted a parallel group randomized controlled trial of NF-TT vs. CP-FT in two medical schools in South Korea (a 1:1 allocation ratio). Participants were randomly assigned to watch either NF-TT or CP-FT video at individual computer stations. NF-TT video showed how to translate relevant probabilistic information into natural frequencies using a tree structure to estimate the predictive values of screening tests. CP-FT video showed how to plug the same information into a mathematical formula to calculate predictive values. Both videos were 15 min long. The primary outcome was the accuracy in estimating the predictive value of screening tests assessed using multiple-choice questions at baseline, post-intervention (i.e., immediately after training), and one-month follow-up. The secondary outcome was the accuracy of conditional probabilistic reasoning in non-medical contexts, also assessed using multiple-choice questions, but only at follow-up as a measure of transfer of learning. 231 medical students completed their participation.ResultsOverall, NF-TT was not more effective than CP-FT in improving the predictive value estimation accuracy at post-intervention (NF-TT: 87.13%, CP-FT: 86.03%, p = .86) and follow-up (NF-TT: 72.39%, CP-FT: 68.10%, p = .40) and facilitating transfer of training (NF-TT: 75.54%, CP-FT: 71.43%, p = .41). However, for participants without relevant prior training, NF-TT was more effective than CP-FT in improving estimation accuracy at follow-up (NF-TT: 74.86%, CP-FT: 58.71%, p = .02) and facilitating transfer of learning (NF-TT: 82.86%, CP-FT: 66.13%, p = .04).ConclusionsIntroducing NF-TT early in the medical school curriculum, before students are exposed to a pervasive conditional probability formula-based approach, would offer the greatest benefit.Trial registrationKorea Disease Control and Prevention Agency Clinical Research Information Service KCT0004246 (the date of first trial registration: 27/08/2019). The full trial protocol can be accessed at https://cris.nih.go.kr/cris/search/detailSearch.do?seq=15616&search_page=L.

The Consumption of Lacticaseibacillus rhamnosus HDB1258 Changes Human Gut Microbiota and Induces Immune Enhancement Through NK Cell Activation.

The gut microbiota can play an important role in enhancing the host's complex immune system. In this regard, many studies indicate that probiotics consumption has a beneficial impact on alterations in the composition of the gut microbiota. Our previous study demonstrated that the oral administration of Lacticaseibacillus rhamnosus HDB1258 (HDB1258) enhances immune cell activity and alters the composition of gut microbiota in C57BL/6 mice, thereby showing its potential as a novel immunostimulatory ingredient. Therefore, this clinical trial assessed the effects of HDB1258 on human natural killer (NK) cell activity and changes in gut microbiota. It also investigated the correlation between gut microbiota and NK cell activity following HDB1258 supplementation. Participants (n = 71) were randomized into placebo and HDB1258 groups, and NK cell activity and gut microbiota were investigated at baseline (week 0) and endline (week 8). The present study showed that HDB1258 significantly increased NK cell activity and resulted in positive regulatory effects on the gut microbial balance in subjects compared to the placebo group. HDB1258 affected the gut microbial balance by inducing the growth of beneficial bacteria such as Lactococcus and Sutterella. Especially, the changes in Escherichia-Shigella composition were negatively correlated with the changes in NK cell activity after HDB1258 consumption. There was also a positive correlation between the NK cell activity in the HDB1258 group and the composition of Prevotella 9 and Adlercreutzia. These findings suggest that HDB1258 may improve the host's intestinal environment by regulating gut bacteria related to immune response and promote NK cell activation. This study was registered at clinical research information service (CRIS: KCT0008204).

The Reliability and Validity of the Korean Version of Autism Spectrum Quotient (AQ) Children's Version.

There is no validated screening measure for children with high-functioning autism spectrum disorder (ASD) in Korea. The purpose of the present study was (1) to examine the reliability and validity of the Korean version of the Autism Spectrum-Child (K-AQ-Child); (2) to find the optimal cut-off value of the K- AQ-Child in the Korean population. A total of 144 children aged 4-11 years (male 80.6%, mean age = 7.05 ± 1.75) were recruited in this study, with 72 in the high-functioning ASD group and 72 in the non-clinical Control group. The Cronbach's alpha coefficient of the K-AQ-child was 0.962, showing excellent internal consistency. For discriminant validity, the ASD group scored significantly higher than the Control group on the total score and all the scores of the subdomains of the K-AQ-Child after controlling for sex. Significant positive correlation between total scores of the K-AQ-Child and the K-SCQ was found. The optimal cut-off value of 58.5 yielded a sensitivity of 0.931 and specificity of 0.986. K-AQ-Child is a valid and reliable measure to quantify autistic traits and identify the high-risk individuals for further diagnostic evaluation in intellectually capable children aged 4-11 years. It would be useful for both clinical practice and research purposes. Clinical Trial Registration The trial was registered at the Clinical Research Information Service (CRIS) of Republic of Korea (Registration Number: KCT0008907).

Efficacy, Safety, and Economic Feasibility of Dokhwalgisaeng-Tang for Degenerative Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor Blinded, Controlled Trial.

Knee osteoarthritis (KOA) is one of the most prevalent degenerative joint diseases worldwide. The herbal decoction, Dokhwalgisaeng-tang (DHGST), has been commonly used in East Asia to treat osteoarthritis. However, there is insufficient evidence to draw clear conclusions concerning its effectiveness and safety for patients with KOA. We aim to determine the efficacy, safety, and economic feasibility of DHGST compared with Celecoxib, an oral COX-2 inhibitor, for patients with degenerative KOA. This multicenter, randomized, noninferiority trial, involving 160 participants who will be randomized using block randomization with 1:1 allocation, will compare DHGST and Celecoxib. The total trial period is 24weeks after random allocation, comprising 12weeks of treatment and 12weeks of follow-up. Participants with KOA will be administered 200 mg of DHGST (treatment group) or Celecoxib capsules (control group) for 12weeks. Efficacy and safety evaluations will be conducted at weeks 0, 4, 8, and 12, and 24. The primary outcome measurement is the Korean Western Ontario McMaster score at week 12. Changes in pain intensity using a 100 mm visual analog scale, changes in quality of life using a EuroQol 5-dimension 5-level self-report survey, and patient satisfaction will also be measured to evaluate effectiveness between the two groups. A trial-based economic feasibility evaluation will be conducted to analyze treatment cost-effectiveness from societal and healthcare system perspectives. Drug safety will be assessed through adverse reactions and laboratory test findings. This trial protocol has the following limitations. Applying a double-dummy design is not possible, as the tablet and granule forms can easily be distinguished visually, and achieving participant blinding is challenging. The trial findings are intended to inform participants, physicians, and other stakeholders in determining whether DHGST could be used as an alternative therapeutic option for KOA. KCT0008424 (Clinical Research Information Service of the Republic of Korea), registered on 12 May 2023.

Artificial intelligence-based CT-free quantitative thyroid SPECT for thyrotoxicosis: study protocol of a multicentre, prospective, non-inferiority study

IntroductionTechnetium thyroid uptake (TcTU) measured by single-photon emission CT/CT (SPECT/CT) is an important diagnostic tool for the differential diagnosis of Graves’ disease and destructive thyroiditis. Artificial intelligence (AI) may reduce...

Prediction of immediate bleeding after cold snare polypectomy: A prospective observational study.

The risk factors for immediate post-polypectomy bleeding (IPPB) after cold snare polypectomy (CSP) are not well-known. We sought to define such risk factors and develop a predictive risk-scoring model. This prospective observational study included 161 polyps (4-9 mm in diameter) that were removed via CSP from 118 patients during the period from June to September 2019 in 2 tertiary hospitals. IPPB was defined as post-polypectomy bleeding within 24 hours or grade 3 or 4 intraprocedural bleeding requiring endoscopic hemostasis. IPPB incidences according to grade were 13.0% (21/161) (grade 3) and 0% (grade 4). Univariate analysis showed that the polyp size and morphology, as well as iatrogenic ulcer size and shape, were significantly associated with IPPB. Multivariate analysis showed that polyp size [6-9 mm vs 4-5 mm, odds ratio (OR) 3.72, 95% confidence interval (CI) 1.28-10.79], polyp morphology (polypoid vs non-polypoid, OR: 3.93, 95% CI: 1.22-12.64), and iatrogenic ulcer size (≥10 vs ≤ 9 mm, OR: 3.12, 95% CI: 1.04-9.38) were significantly associated with IPPB. We created a four-marker risk-scoring model to predict IPPB after CSP; we summed the points assigned for the 4 factors. At a cutoff of 2, the sensitivity was 85.7% and the specificity was 65.0%; at a cutoff of 3, the sensitivity was 65% and the specificity was 90.0%. Polyp size and morphology, as well as iatrogenic ulcer size and shape, were associated with IPPB after CSP. The four-marker risk-scoring model appears to effectively predict IPPB after CSP (Clinical Research Information Service: KCT0004375).

Prospective comparative analysis of three types of decompressive surgery for lumbar central stenosis: conventional, full-endoscopic, and biportal endoscopic laminectomy

Conventional open laminectomy has long been considered one of the important surgical options for lumbar central stenosis owing to its positive outcomes. However, newer approaches have emerged as alternatives, including full-endoscopic and biportal endoscopic laminectomy. Therefore, a comparison of the outcomes that are associated with each of these surgical methods is warranted. This prospective multicenter trial, initiated in February 2019, compared the outcomes of three lumbar central stenosis surgical approaches: open laminectomy (OPEN), uniportal endoscopy (UNIPORT), and biportal endoscopy (BIPORT). Among 115 participants from seven centers, one-year follow-ups assessed laboratory, radiological, and clinical outcomes. Despite all groups showing adequate decompression and clinical improvement, the OPEN group exhibited less improvement in Visual analog scale (VAS) for back pain scores (p < 0.05) and significant postoperative increases in most laboratory markers. Furthermore, the OPEN group experienced a significant decrease in multifidus muscle cross-sectional area compared to endoscopic groups (p < 0.001). Each surgical techniques produced similar clinical outcomes and dural space expansion. However, endoscopic surgery was associated with better muscle preservation and better relief of back pain. Endoscopic surgery is a reasonable alternative to conventional laminectomy for treating lumbar central stenosis.This trial was registered on CRIS (Clinical Research Information Service, KCT0004355).

The influence of sex on the dosage of remimazolam co-administered with remifentanil for loss of consciousness in adult patients: an up-and-down sequential allocation trial

BackgroundThis study aimed to determine the 50% effective dose of remimazolam co-administered with remifentanil for loss of consciousness in men and women as well as to investigate whether there are between-sex differences.MethodsUsing a modified Dixon’s up-and-down allocation approach, we sequentially enrolled male and female patients aged 19–60 years with American Society of Anesthesiologists class I or II who were scheduled for robotic surgery. For both sexes, the starting remimazolam dose was 0.15 mg/kg, with a step size of 0.05 mg/kg. After achievement of a target effect-site concentration 2.0 ng/ml of remifentanil, and administration of a bolus dose of remimazolam, we assessed whether adequate loss of consciousness (defined as a Modified Observer’s Assessment of Alertness/Sedation scale score < 2 within 2 min) was achieved.ResultsWe included 22 male and 22 female patients. Based on Dixon’s up-and-down method, the 50% effective dose of remimazolam (mean ± standard error) was 0.13 ± 0.01 mg/kg and 0.17 ± 0.01 mg/kg in the male and female groups, respectively (P = 0.34). Isotonic regression analysis revealed that the 95% effective dose (95% confidence interval) was 0.19 (0.18–0.20) mg/kg in the male group and 0.29 (0.29–0.30) mg/kg in the female group.ConclusionsThere was no between-sex difference in the 50% effective dose of remimazolam for loss of consciousness; however, the 95% effective dose was significantly higher in female patients than in male patients.Trial registrationThis study protocol was registered at Clinical Research Information Service (CRIS No. KCT0007951, 02/12/2022).

Transcutaneous electrical nerve stimulation and catheter-related bladder discomfort following transurethral resection of bladder tumour: A randomised controlled trial.

Catheter-related bladder discomfort (CRBD) is problematic in patients with a urinary catheter. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive analgesic modality used to relieve various types of pain. We evaluated the effect of TENS on CRBD after transurethral resection of bladder tumours (TURBT). A randomised controlled trial. A large university tertiary hospital, from October 2022 to March 2023. Patients requiring urinary catheterisation after TURBT. In this randomised controlled trial, patients were randomly allocated to the TENS ( n = 56) or control ( n = 56) groups. CRBD manifests as a burning sensation with an urge to void or discomfort in the suprapubic area. Moderate to severe CRBD was defined as patients self-reporting CRBD symptoms with or without behavioural response, including attempts to remove the urinary catheter, intense verbal reactions, and flailing limbs. TENS was performed from the end of surgery to 1 h postoperatively. The primary endpoint was considered moderate to severe CRBD immediately postoperatively. Secondary endpoints included moderate to severe CRBD at 1, 2 and 6 h postoperatively. Additionally, postoperative pain, patient satisfaction, and TENS-related adverse effects were evaluated. Moderate to severe CRBD immediately postoperatively was significantly less frequent in the TENS group than in the control group: 10 (17.9%) vs. 34 (60.7%); P < 0.001; relative risk (95% CI) = 0.294 (0.161 to 0.536); absolute risk reduction = 0.43; number needed to treat = 2.3. Moderate to severe CRBD differed between the two groups at 1 h postoperatively: 1 (1.8%) vs. 16 (28.6%); P < 0.001; relative risk = 0.06 (95% CI 0.01 to 0.46); absolute risk reduction = 0.27; number needed to treat = 3.7. The TENS group exhibited a significantly lower score for postoperative pain at 1 h (1.8 ± 0.6 vs. 2.2 ± 0.4; P < 0.001, mean difference (95% CI) = 0.4 (0.2 to 0.6) and a higher score for patient satisfaction, 5.0 (4.0 to 6.0) vs. 3.0 (3.0 to 4.0); P < 0.001; median difference (95% CI) = 2.0 (1.0 to 2.0). TENS reduced moderate to severe CRBD, decreased postoperative pain, and increased patient satisfaction after TURBT. Clinical Research Information Service (KCT0007450).

Effectiveness of mixed reality-based rehabilitation on hands and fingers by individual finger-movement tracking in patients with stroke

BackgroundMixed reality (MR) is helpful in hand training for patients with stroke, allowing them to fully submerge in a virtual space while interacting with real objects. The recognition of individual finger movements is required for MR rehabilitation. This study aimed to assess the effectiveness of updated MR-board 2, adding finger training for patients with stroke.MethodsTwenty-one participants with hemiplegic stroke (10 with left hemiplegia and 11 with right hemiplegia; nine female patients; 56.7 ± 14.2 years of age; and onset of stroke 32.7 ± 34.8 months) participated in this study. MR-board 2 comprised a board plate, a depth camera, plastic-shaped objects, a monitor, a palm-worn camera, and seven gamified training programs. All participants performed 20 self-training sessions involving 30-min training using MR-board 2. The outcome measurements for upper extremity function were the Fugl–Meyer assessment (FMA) upper extremity score, repeated number of finger flexion and extension (Repeat-FE), the thumb opposition test (TOT), Box and Block Test score (BBT), Wolf Motor Function Test score (WMFT), and Stroke Impact Scale (SIS). One-way repeated measures analysis of variance and the post hoc test were applied for the measurements. MR-board 2 recorded the fingers’ active range of motion (AROM) and Dunnett’s test was used for pairwise comparisons.ResultsExcept for the FMA-proximal score (p = 0.617) and TOT (p = 0.005), other FMA scores, BBT score, Repeat-FE, WMFT score, and SIS stroke recovery improved significantly (p < 0.001) during MR-board 2 training and were maintained until follow-up. All AROM values of the finger joints changed significantly during training (p < 0.001).ConclusionsMR-board 2 self-training, which includes natural interactions between humans and computers using a tangible user interface and real-time tracking of the fingers, improved upper limb function across impairment, activity, and participation. MR-board 2 could be used as a self-training tool for patients with stroke, improving their quality of life.Trial registration number: This study was registered with the Clinical Research Information Service (CRIS: KCT0004167).

Magnesium from Deep Seawater as a Potentially Effective Natural Product against Insulin Resistance: A Randomized Trial.

Background and Objectives: Deep seawater has been shown to restore pancreatic function in obese diabetic mice and considerably improve the homeostatic model assessment for insulin resistance, total cholesterol, and low-density lipoprotein cholesterol concentrations in patients with impaired fasting glucose or glucose tolerance. In this study, the effect of 12-week daily consumption of magnesium (Mg2+)-containing deep seawater mineral extracts on blood glucose concentration and insulin metabolism-associated indicators was investigated in patients with impaired glucose tolerance. Materials and methods: In this 12-week randomized, double-blind trial, patients (n = 37) with impaired glucose tolerance consumed deep seawater mineral extracts. Changes in blood glucose concentration and related indicators were compared between the treatment group and placebo group (n = 38). Results: The fasting insulin, C-peptide, homeostatic model assessment for insulin resistance, quantitative insulin sensitivity check index, homeostatic model assessment of beta-cell function, and Stumvoll insulin sensitivity index values in the deep seawater mineral extract group showed improvements compared with the placebo group. However, no significant differences between groups were observed in fasting blood glucose, postprandial blood glucose, glycated hemoglobin, or incremental area under the curve values. Conclusions: Oral supplementation with deep seawater mineral extracts enriched in Mg2+ markedly improves insulin sensitivity in patients with pre-diabetes. This study illustrates the potential clinical application of natural Mg2+ from deep seawater to alleviate insulin resistance in patients with pre-diabetes. Trial registration: This trial was retrospectively registered with Clinical Research information Service (CRIS), No. KCT0008695, on 8 August 2023.

One-Year Results of Ear Reconstruction with 3D Printed Implants.

External ear reconstruction has been a challenging subject for plastic surgeons for decades. Popular methods using autologous costal cartilage or polyethylene still have their drawbacks. With the advance of three-dimensional (3D) printing technique, bioscaffold engineering using synthetic polymer draws attention as an alternative. This is a clinical trial of ear reconstruction using 3D printed scaffold, presented with clinical results after 1 year. From 2021 to 2022, five adult patients with unilateral microtia underwent two-staged total ear reconstruction using 3D printed implants. For each patient, a patient-specific 3D printed scaffold was designed and produced with polycaprolactone (PCL) based on computed tomography images, using fused deposition modeling. Computed tomography scan was obtained preoperatively, within 2 weeks following the surgery and after 1 year, to compare the volume of the normal side and the reconstructed ear. At 1-year visit, clinical photo was taken for scoring by two surgeons and patients themselves. All five patients had completely healed reconstructed ear at 1-year follow-up. On average, the volume of reconstructed ear was 161.54% of that of the normal side ear. In a range of 0 to 10, objective assessors gave scores 3 to 6, whereas patients gave scores 8 to 10. External ear reconstruction using 3D printed PCL implant showed durable, safe results reflected by excellent volume restoration and patient satisfaction at 1 year postoperatively. Further clinical follow-up with more cases and refinement of scaffold with advancing bioprinting technique is anticipated. The study's plan and results have been registered with the Clinical Research Information Service (CRIS No. 3-2019-0306) and the Ministry of Food and Drug Safety (MFDS No. 1182).

Evaluation of the suitability of using ArtiSential in various renal surgery: IDEAL stage 1 study

BackgroundArtiSential, a new articulating laparoscopic instruments, addresses the limited movement associated with conventional laparoscopic instruments. This study was conducted to assess the clinical effectiveness of ArtiSential in detailed steps of various renal surgery.MethodsThis study was approved by the Institutional Review Board of our institution and registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency. Participants meeting all inclusion and exclusion criteria were included in the clinical trial and underwent renal surgery. The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters across 9 detailed steps.ResultsOf the 15 potential candidates enrolled from October 2021 to November 2021, 1 patient dropped out due to anaphylaxis from an anesthetic agent, and 14 patients underwent laparoscopic surgery using ArtiSential. Of the 14 patients, 2 patients were converted to laparoscopic surgery using straight-shaped instruments due to the ischemia time exceeding 30 min, and 1 patient due to excessive bleeding. The feasibility for most steps was more than 90%, except the renorrhaphy step. The median total operation time and ischemia time were 161 and 23 min, respectively. The median estimated blood loss was 58.5 mL. Two cases of venous injury occurred during renal pedicle dissection step. The accuracy of the procedure judged by reviewers and usability judged by the operator were acceptable in all steps. The surgeon’s quantitatively measured stress score was the highest during renorrhaphy step.ConclusionsLaparoscopic surgery using ArtiSential is feasible for most steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, which could be addressed by overcoming the learning curve.Trial registrationClinical Research Information Service site of the Korea Disease Control and Prevention Agency, KCT0006532. Registered 03/09/2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24071.

Effectiveness and satisfaction with virtual and donor dissections: A randomized controlled trial

In recent years, human anatomy education has faced challenges with traditional donor dissection, leading to the emergence of virtual dissection as an alternative. This study aims to investigate the academic performance and satisfaction of medical students by comparing the virtual and donor dissections. An open-labeled crossover randomized controlled trial was conducted with 154 first-year medical students in Human Anatomy and Neuroanatomy laboratories, which were divided into three classes. Students were randomly assigned to either the virtual (virtual dissection followed by donor dissection) or donor (donor dissection followed by virtual dissection) groups in each class. A curriculum, incorporating head-mounted displays (HMDs), a life-sized touchscreen, and tablets, was developed. Data was evaluated through quizzes and surveys. In the Human Anatomy laboratory, each class of the donor group conducted heart extraction, dissection and observation. In observation class, the virtual group had a significantly higher mean quiz score than the donor group (p < 0.05). Compared to the donor, satisfaction was significantly higher for the HMD (understanding of concept and immersion), life-size touchscreen (esthetics, understanding of the concept, and spatial ability), and tablet (esthetics, understanding of the concept, spatial ability, and continuous use intention). In the Neuroanatomy laboratory, the virtual group showed significantly higher mean quiz scores than the donor group (p < 0.05), and tablet showed a significantly higher satisfaction than donor in terms of esthetics, understanding of the concept, and spatial ability. These results suggest that virtual dissection has the potential to supplement or replace donor dissection in anatomy education. This study is innovative in that it successfully delivered scenario-based virtual content and validated the efficacy in academic performance and satisfaction when using virtual devices compared to donor.Trial registration: This research has been registered in the Clinical Research Information Service (CRIS, https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=L&pageSize=10&page=undefined&seq=26002&status=5&seq_group=26002) with registration number "KCT0009075" and registration date "27/12/2023".