Thai Clinical Trials Registry Research Articles

A randomized single-blind non-inferiority trial of delayed start with drospirenone-only and ethinyl estradiol-gestodene pills for ovulation inhibition

We compared the efficacy of 4 mg drospirenone (DRSP) progestin-only pills (POPs) versus combined oral contraceptive pills (COCs) containing 0.02 mg of ethinyl estradiol (EE) and 0.075 mg of gestodene (GS) in ovulation inhibition and inducing unfavorable cervical mucus changes using a delayed-starting approach. This randomized controlled trial involved 36 participants aged 18–45 years. The major outcomes included ovulation inhibition assessed using the Hoogland and Skouby score, and cervical mucus permeability, assessed using the modified World Health Organization score. The results demonstrated ovulation inhibition rates of 77.8% for the EE/GS group and 88.9% for the DRSP group. The risk ratio and absolute risk reduction were 0.50 (95% confidence interval [CI]: 0.10, 2.40) and − 0.11 (95% CI: − 0.35, 0.13), respectively, satisfying the 20% non-inferiority margin threshold. The median time to achieve unfavorable cervical mucus changes was comparable between the DRSP (3 days, interquartile range [IQR]: 6 days) and EE/GS (3.5 days, IQR: 4 days) groups. However, the DRSP group had a higher incidence of unscheduled vaginal bleeding (55.56% vs. 11.11%; p = 0.005). DRSP-only pills, initiated on days 7–9 of the menstrual cycle, were non-inferior to EE/GS pills in ovulation inhibition. However, they exhibited delayed unfavorable cervical mucus changes compared to the standard two-day backup recommendation.Clinical trial registration: Thai Clinical Trials Registry (TCTR20220819001) https://www.thaiclinicaltrials.org/show/TCTR20220819001.

Tuberculosis Treatment Compliance Under Smartphone-Based Video-Observed Therapy Versus Community-Based Directly Observed Therapy: Cluster Randomized Controlled Trial.

There are no recent studies comparing the compliance rates of both patients and observers in tuberculosis treatment between the video-observed therapy (VOT) and directly observed therapy (DOT) programs. This study aims to compare the average number of days that patients with pulmonary tuberculosis and their observers were compliant under VOT and DOT. In addition, this study aims to compare the sputum conversion rate of patients under VOT with that of patients under DOT. Patient and observer compliance with tuberculosis treatment between the VOT and DOT programs were compared based on the average number of VOT and DOT compliance days and sputum conversion rates in a 60-day cluster randomized controlled trial with patients with pulmonary tuberculosis (VOT: n=63 and DOT: n=65) with positive sputum acid-fast bacilli smears and 38 observers equally randomized into the VOT and DOT groups (19 observers per group and n=1-5 patients per observer). The VOT group submitted videos to observers via smartphones; the DOT group followed standard procedures. An intention-to-treat analysis assessed the compliance of both the patients and the observers. The VOT group had higher average compliance than the DOT group (patients: mean difference 15.2 days, 95% CI 4.8-25.6; P=.005 and observers: mean difference 21.2 days, 95% CI 13.5-28.9; P<.001). The sputum conversion rates in the VOT and DOT groups were 73% and 61.5%, respectively (P=.17). Smartphone-based VOT significantly outperformed community-based DOT in ensuring compliance with tuberculosis treatment among observers. However, the study was underpowered to confirm improved compliance among patients with pulmonary tuberculosis and to detect differences in sputum conversion rates. Thai Clinical Trials Registry (TCTR) TCTR20210624002; https://tinyurl.com/3bc2ycrh. RR2-10.2196/38796.

Risk factors for postoperative urinary retention in fragility hip fracture patients: a prospective study

BackgroundPostoperative urinary retention (POUR) among older patients with hip fractures is common and may result in delayed ambulation, prolonged hospital stays, and urinary tract infections. Although preoperative urinary catheter indwelling and early postoperative removal can prevent perioperative urinary retention, this condition may occur in some patients after catheter removal, which requires urinary catheter re-indwelling or intermittent catheterization. Therefore, this study aims to identify risk factors and develop a screening tool for postoperative urinary retention in patients who have undergone operative treatment for fragility hip fractures subsequent to urinary catheter removal.MethodsA prospective cohort study of 145 fragility hip fracture in older patients who were operatively treated between September 2020 and May 2022 was conducted. All patients were evaluated for urine retention after urinary catheter removal using a bladder scan. In addition, factors related to urinary retention were collected and utilized for screening tool development.ResultsOf the included patients, 22 (15.2%) were diagnosed with POUR. A multivariable logistic regression model using a stepwise backward elimination algorithm identified the current use of drugs with anticholinergic effect (OR = 11.9, p = 0.012), international prostate symptom score (IPSS) ≥ 8 (OR = 9.3, p < 0.001), and inability to independently get out of bed within 24 h postoperatively (OR = 6.5, p = 0.051) as risk factors of POUR. The screening tool that has been developed revealed an excellent performance (AuROC = 0.85, 95%CI 0.75 to 0.91) with good calibration and minimal optimism.ConclusionsCurrent use of drugs with anticholinergic effects, IPSS ≥ 8, and inability to independently get out of bed within 24 h postoperatively are significant variables of POUR. For additional external validation, a proposed scoring system for POUR screening was developed.Trial registrationThe study protocol was retrospectively registered in The Thai Clinical Trials Registry (TCTR20220502001: 2 May 2022).

Effects of cassava wax bath as a new therapeutic approach on patients with plantar fasciitis: a double-blind, randomised clinical trial

The aim of this study was to investigate the efficacy of a new therapeutic approach (cassava wax bath: CWB) compared with usual care (paraffin wax bath: PWB) in patients with plantar fasciitis (PF). Forty patients with PF were recruited into the study (CWB group, n = 20, PWB group, n = 20). Patients in the CWB group received cassava wax bath and patients in the PWB group received usual care (PWB). The primary outcome was pain intensity (PI). The secondary outcomes were the pressure pain threshold (PPT), pain frequency (PFr), foot and ankle ability measure (FAAM), and ankle dorsiflexion range of motion (ADROM). All outcomes were assessed before and after the five-week intervention, one month, and three months after the intervention period. After the intervention, statistically significant improvement was found in all outcomes after the intervention period and during the one month and three months follow-up study in both groups (P < 0.05). For all outcomes, no between-group differences were seen at any post-assessment time-point, except for PFr (P < 0.05). In conclusion, the findings of this study indicate that CWB was significantly superior to PWB in reducing PFr. For the other outcomes, CWB and PWB were both equally effective in reducing PI and increasing PPT, FAAM, and ADROM in patients with PF. Therefore, CWB might be considered as a novel useful therapeutic option for PF patients.Trial registration: Thai Clinical Trials Registry (TCTR) (Identification number: TCTR20220128002), First posted date: 28/01/2022.

Neonatal complications and risk factors associated with assisted vaginal delivery

To investigate neonatal injuries, morbidities and risk factors related to vaginal deliveries. This retrospective, descriptive study identified 3500 patients who underwent vaginal delivery between 2020 and 2022. Demographic data, neonatal injuries, complications arising from vaginal delivery and pertinent risk factors were documented. Neonatal injuries and morbidities were prevalent in cases of assisted vacuum delivery, gestational diabetes mellitus class A2 (GDMA2) and pre-eclampsia with severe features. Caput succedaneum and petechiae were observed in 291/3500 cases (8.31%) and 108/3500 cases (3.09%), respectively. Caput succedaneum was associated with multiparity (adjusted odds ratio [AOR] 0.36, 95% confidence interval [CI] 0.22–0.57, P < 0.001) and assisted vacuum delivery (AOR 5.18, 95% CI 2.60–10.3, P < 0.001). Cephalohaematoma was linked to GDMA2 (AOR 11.3, 95% CI 2.96–43.2, P < 0.001) and assisted vacuum delivery (AOR 16.5, 95% CI 6.71–40.5, P < 0.001). Scalp lacerations correlated with assisted vacuum and forceps deliveries (AOR 6.94, 95% CI 1.85–26.1, P < 0.004; and AOR 10.5, 95% CI 1.08–102.2, P < 0.042, respectively). Neonatal morbidities were associated with preterm delivery (AOR 3.49, 95% CI 1.39–8.72, P = 0.008), night-time delivery (AOR 1.32, 95% CI 1.07–1.63, P = 0.009) and low birth weight (AOR 7.52, 95% CI 3.79–14.9, P < 0.001). Neonatal injuries and morbidities were common in assisted vacuum delivery, maternal GDMA2, pre-eclampsia with severe features, preterm delivery and low birth weight. Cephalohaematoma and scalp lacerations were prevalent in assisted vaginal deliveries. Most morbidities occurred at night.Clinical trial registration: Thai Clinical Trials Registry 20220126004.

Influence of freeze-dried bone allograft on free gingival graft survival and alveolar ridge maintenance in socket seal procedures: a randomized controlled clinical trial.

This study aimed to investigate the viability of free gingival grafts (FGG) and assess clinical and radiographic changes in the alveolar ridge following socket seal surgery with or without freeze-dried bone allograft (FDBA). Twenty-eight anterior and premolar tooth extractions were randomly allocated to 2 groups: socket graft of FDBA sealed with FGG (n = 15) and control with empty sockets sealed solely with FGG (n = 13). Photographs taken at 3, 7, 14, and 30 days post-surgery assessed FGG viability. Alveolar ridge volume was clinically evaluated via intraoral scanners before surgery and at 1 and 3 months post-surgery. CBCT scans taken immediately post-surgery and 3 months later assessed alveolar ridge dimensions. FGG viability in both groups increased from day 3 and reached the maximum score on day 14. Alveolar ridge volume reduction at 3 months in the FDBA group was comparable to the control group. Buccal alveolar bone height reduction was significantly higher in the FDBA group than the control group, while palatal alveolar bone height was comparable. Alveolar bone width reduction was evident but not statistically significant between the groups. The FDBA group exhibited a significant alteration in bone volume compared to the control group. Viability of FGG was not affected by graft filling materials. Sealing the socket with FGG effectively preserved socket integrity and ridge volume in minor socket defects using either graft filling material or not. This study was registered on 4 January 2021 on Thai Clinical Trials Registry (TCTR20210104001).

A smartphone application to enhance bowel preparation for first-time colonoscopy: a randomized controlled study.

Colonoscopy is an essential cancer screening tool; however, bowel preparation is a multifaceted process that involves several steps. Proper preparation is crucial for a successful colonoscopy in terms of diagnostic accuracy and procedural safety. We evaluated the performance of a smartphone application with bowel preparation instructions on individuals undergoing their first colonoscopy. In this randomized, prospective, endoscopist-blinded study, participants were scheduled to undergo their first colonoscopy between January 2020 and January 2022. The study protocol was registered at Thai Clinical Trials Registry (TCTR20190928002). They were randomly assigned to the smartphone education application (APP) or the standard education (control) group. The Boston Bowel Preparation Scale (BBPS) score, polyp detection rate (PDR), and adenoma detection rate (ADR) were compared. Factors associated with excellent bowel preparation were also evaluated. In total, 119 patients (APP group, n = 57; control group, n = 62) underwent their first colonoscopy. The mean BBPS score and proportion of excellent bowel preparation (BBPS≥8) were significantly higher in the APP group than in the control group. Smartphone application-guided bowel preparation achieved a higher proportion of adequate and excellent bowel preparation scores, was associated with other quality indicators, and achieved the target ADR, cecal intubation rate, and adequate withdrawal time. This application may be a user-friendly option to improve the first-time colonoscopy experience, resulting in effective screening of colorectal cancer. The study protocol was registered at Thai Clinical Trials Registry (TCTR20190928002).

Comparison of the effects of core stability and whole-body electromyostimulation exercises on lumbar lordosis angle and dynamic balance of sedentary people with hyperlordosis: a randomized controlled trial

BackgroundHyperlordosis is an excessive inward curvature of the lumbar spine that affects spinal function. The aim of this study was to compare the effects of core stability exercises (CSE), Whole-Body Electromyostimulation (WB-EMS), and CSE Plus on the Lumbar lordosis angle and dynamic balance in sedentary people with hyperlordosis.MethodsIn a parallel randomized controlled trial study, seventy five untrained male adults with hyperlordosis, recruited from clinics of sports medicine and corrective exercise centers in Tehran, were randomly assigned to four groups: CSE (n = 19), WB-EMS (n = 18), CSE Plus (n = 18), and control Group (CG) (n = 20). The CSE group performed Core stability exercises, the WB-EMS group followed a Whole-body electromyostimulation combined training protocol, and the CSE Plus group engaged in a combined program protocol (CSE with the WB-EMS vest), and the control group only participated in activities of daily living. Anthropometric parameters and outcomes, including the lordosis angle and dynamic balance, were assessed before and after a six-week training program. A flexible ruler was used to measure the angle of lordosis, and the Y balance test was employed to evaluate the dynamic balance.ResultsThe results indicated that the lordosis angle improved in both the CSE and CSE Plus groups compared to the CG in the post-test (P = 0.017, P = 0.024). However, there were no significant differences observed between the other group pairs. Additionally, a significant difference in dynamic balance was found between the CSE Plus group and the CG in the post-test (P = 0.001), while no significant differences were observed between the other group pairs. Furthermore, within-group test results demonstrated that lumbar lordosis angle and dynamic balance variables significantly improved in the post-test compared to the pre-test stage (P < 0.05).ConclusionsThe two CSE and CSE Plus training protocols are effective as training methods for correcting certain parameters and physical deformities, including lumbar lordosis. Furthermore, the CSE Plus group demonstrated a positive impact on improving dynamic balance. Consequently, it is highly recommended that individuals with hyperlordosis can benefit from the exercises of the present study, especially CSE Plus exercises along with other rehabilitation exercises.Trial registrationThe trial was registered at Thai Clinical Trials Registry (TCTR20221004011, registration date: 04/10/2022).

New Proposed Classification of Difficulty in Laparoscopic Cholecystectomy.

Background: Difficult laparoscopic cholecystectomy (LC) has been challenging for surgeons. Randhawa's system used operative time, complications, and conversion to define three difficulty grades. However, using fixed numbers of operative time as dividers among three groups might not be applicable universally. This study aimed to propose new classification with more flexible parameters. Methods: This retrospective cohort study was conducted with patients who underwent LC because of gallstone-related diseases between January 2017 and December 2021 at Thammasat University Hospital. The exclusion criteria were (1) emergent LC for acute cholecystitis, (2) other procedures performed in the same setting of LC, (3) incomplete information, and (4) LC converted to open cholecystectomy. Patients were categorized into three groups using Randhawa's classification. Thereafter, new classification using mean and standard deviation was applied to reclassify patients into three new groups. The comparison between two grading results was performed to prove the advantage of new classification. Results: Total of 523 patients who underwent LC were included with median age 59.3 years old and 60.8% female. By Randhawa classification, proportions of easy, difficult, and very difficult groups were 39%, 53.7%, and 7.3%, respectively. Then, the new operative-time dividers among three groups were changed from 60 and 120 minutes to mean and mean + 2SD, respectively. Reclassified three difficult groups were 38.9%, 57.1%, and 4%. The comparison demonstrated new classification as more flexible and more compatible with each individual surgeon. Conclusions: New surgeon-referenced grading system of difficult LC included surgeon's factors, not only unfavorable operative findings. This classification should be more flexible than the previous criterion-referenced one. Thai Clinical Trials Registry at https://www.thaiclinicaltrials.org with Number TCTR20220426003.

Molnupiravir versus favipiravir in at-risk outpatients with COVID-19: A randomized controlled trial in Thailand

ObjectivesEvaluate and compare the efficacy and safety of molnupiravir and favipiravir in outpatients with mild to moderate COVID-19 and at risk of severe COVID-19. MethodsIn an open-label, parallel-group, multicenter trial in Thailand, participants with moderate COVID-19 and at least one factor associated with severe COVID-19 were randomly assigned 1:1 to receive oral molnupiravir or oral favipiravir (standard of care). Phone calls for remote symptom assessment were made on Days 6, 15, and 29. Participants with worsening symptoms were instructed to return to the hospital. The primary endpoint was pulmonary involvement by Day 29, as evidenced by ≥2 of the following: dyspnea, oxygen saturation <92% or imaging. ResultsNine hundred seventy-seven participants (487 molnupiravir, 490 favipiravir) were enrolled from 8 July 2022 to 19 January 2023. 98% had received ≥1 dose of COVID-19 vaccine and 83% ≥3 doses. By Day 29, pulmonary involvement occurred in 0% (0/483) in molnupiravir arm versus 1% (5/482) in favipiravir arm (−1.0%; Newcombe 95.2% CI: −2.4% to −0.0%; P = 0.021); all-cause death in 0% (0/483) and <1% (1/482); COVID-19 related hospitalization in <1% (1/483) and 1% (3/482); treatment-related adverse event in 1% (5/483) and 1% (4/486); and serious adverse event in 1% (4/483) and 1% (4/486). ConclusionsFavipiravir and molnupiravir had a similar efficacy and safety profile. Whether either of the two reduced the risk of complications during the omicron era in this population with a low risk of pulmonary involvement and a high vaccine coverage remains unclear. There were no differences in any of the safety endpoints. Thai Clinical Trials Registry IDTCTR20230111009.

Comparative-effectiveness study evaluating outcomes for transforaminal epidural steroid injections performed with 3% hypertonic saline or normal saline in lumbosacral radicular pain.

Transforaminal epidural steroid injections (TFESI) are commonly employed to treat lumbosacral radiculopathy. Despite anti-inflammatory properties, the addition of 3% hypertonic saline has not been studied. Compare the effectiveness of adding 0.9% NaCl (N-group) vs. 3% NaCl (H-group) in TFESI performed for lumbosacral radiculopathy. This retrospective study compared TFESI performed with lidocaine, triamcinolone and 0.9% NaCl vs. lidocaine, triamcinolone and 3% NaCl. The primary outcome was the proportion of patients who experienced a ≥ 30% reduction in pain on a verbal rating scale (VRS; 0-100) at 3 months. Secondary outcome measures included the proportion of patients who improved by at least 30% for pain at 1 and 6 months, and who experienced ≥15% from baseline on the Oswestry disability index (ODI) at follow-up. The H-group experienced more successful pain outcomes than the N-group at 3 months (59.09% vs. 41.51%; P = .002) but not at 1 month (67.53% vs. 64.78%; P = .61) or 6 months (27.13% vs 21.55%: P = .31). For functional outcome, there was a higher proportion of responders in the H-group than the N-group at 3 months (70.31% vs. 53.46%; P = .002). Female, age ≤ 60 years, and duration of pain ≤ 6 months were associated with superior outcomes at the 3-month endpoint. Although those with a herniated disc experienced better outcomes in general with TFESI, the only difference favoring the H-group was for spondylolisthesis patients. 3% hypertonic saline is a viable alternative to normal saline as an adjunct for TFESI, with randomized studies needed to compare its effectiveness to steroids as a possible alternative. Thai Clinical Trials Registry ID TCTR 20231110006.

Effect of online infographics for enhancing health literacy among patients with type 2 diabetes in primary care unit during the COVID-19 pandemic: a randomized controlled trial

BackgroundHealth literacy (HL) in patients with type 2 diabetes mellitus (DM) can help control disease and prevent complications. However, most patients with type 2 DM have inadequate HL; therefore, their HL must be further improved. This study aimed to determine the effects of online infographics on improving HL among patients with type 2 DM.MethodsThis randomized controlled trial was conducted from July 2022 to September 2022, at the primary care unit of Songklanagarind Hospital, Thailand; 30 patients with type 2 DM were randomly assigned to the experimental (n = 15; three types of infographics) and control (n = 15; three types of pamphlets) groups. Infographics and pamphlets were distributed weekly via social media platforms. The S-TOFHLA Thai version and Thai-FCCHL were used to evaluate HL. Chi-square, Fisher’s exact, Wilcoxon rank-sum, t-test, paired t-test, and McNemar’s chi-square tests were used.ResultsThe median age of 30 participants was 56 years. The mean duration of DM was 9.6 years, with a median HbA1c level of 7.5 mg%. Most participants (80%) had adequate HL in S-TOFHLA, whereas 63.3% had adequate HL in FCCHL. All participants in the infographic group who had inadequate HL in the S-TOFHLA pre-test achieved adequate HL. Meanwhile, only 50% of patients in the pamphlet group achieved adequate HL. Regarding FCCHL, 50% of patients in the infographic group and 60% in the pamphlet group who had inadequate HL in the pretest achieved adequate HL. However, no statistical significance in achieving adequate HL was found in either group. The mean differences (SD) in S-TOFHLA between before and after intervention were 12.53 (8.77; p = 0.0007) and 10.13 (9.88; p = 0.001) in the infographic and pamphlet groups, respectively. Regarding FCCHL, the mean differences (SD) were 3.47 (4.29) and 3.20 (2.91) in the infographic group (p = 0.003) and pamphlet (p = 0.002) groups, respectively. No statistical significance in the mean difference was found between both groups.ConclusionsNovel online infographics and pamphlets did not significantly differ in achieving adequate HL among patients with type 2 DM who should receive health education about disease control and complication prevention. However, both interventions can increase and maintain HL levels. Online educational media can be appropriate during the COVID-19 pandemic. Nevertheless, further larger-scale studies should be performed to examine the impact of other DM educational media on HL promotion.Trial registrationThe Thai Clinical Trials Registry (TCTR) with registry ID TCTR20230425001 (date of registration 25/04/2023).

Tremella fuciformis beverage improves glycated hemoglobin A1c and waist circumference in overweight/obese prediabetic subjects: a randomized controlled trial

BackgroundPrediabetes is increasing worldwide. Previous studies have demonstrated the potential of β-glucan derived from oat or barley to lower blood glucose, body weight, and plasma lipid levels. These findings offer a potentially attractive strategy for reducing the risk of diabetes in prediabetic individuals. However, the effects of β-glucan from Tremella fuciformis on glucose metabolism and anthropometric measurements in humans have yet to be studied. We hypothesized that β-glucan from Tremella fuciformis may improve metabolic parameters in subjects with prediabetes. This study aimed to investigate the effects of a once-daily beverage containing Tremella fuciformis (snow mushroom) on anthropometric measurements, metabolic biomarkers, and insulin sensitivity in overweight/obese subjects with prediabetes.MethodsIn this double-blind RCT, 56 participants were randomly assigned to receive either a Tremella fuciformis beverage or placebo daily for 12 weeks. All parameters were assessed at baseline and after the intervention.ResultsAfter 12 weeks, participants in the intervention group exhibited significant improvements in glycated hemoglobin A1c (HbA1C; 6.03 ± 0.26% at baseline vs. 5.96 ± 0.25% at 12 weeks, p = 0.047, Cohen’s d = 0.39) and waist circumference (95.2 ± 12.51 cm at baseline vs. 93.46 ± 11.48 cm at 12 weeks, p = 0.022, Cohen’s d = 0.45). There were no adverse events reported.ConclusionThis exploratory study demonstrated that Tremella fuciformis beverage consumption may improve HbA1C and waist circumference in overweight/obese prediabetic individuals. Further research, including larger-scale RCTs and mechanistic studies, is needed to confirm these findings and optimize the therapeutic potential of Tremella fuciformis derivatives in managing prediabetes and preventing type 2 diabetes.Trial registrationRegistered in Thai Clinical Trials Registry (14/07/2021, TCTR20210714004).

A qualitative study of pregnant women’s perceptions and decision-making regarding COVID-19 vaccination in Thailand

To identify pregnant women’s attitudes towards, and acceptance and rejection of, COVID-19 vaccination. This prospective, descriptive, implementation study was conducted in the Antenatal clinic of Siriraj Hospital, Bangkok, Thailand. In Phase I, 40 pregnant women were interviewed. Phase II consisted of questionnaire development and data validation. In Phase III, the questionnaire was administered to 400 participants. Pregnant women’s attitudes towards and acceptance and rejection of COVID-19 vaccination. Most pregnant women were uncertain about the potential harm of vaccination to themselves or their unborn child, including risks such as miscarriage or premature birth (59–66/101 [58.4%–65.3%]; OR 2.53–8.33; 95% CI 1.23–3.60, 5.17–19.30; P < 0.001) compared to those who disagreed with vaccination. Their vaccination decisions were significantly influenced by social media information regarding vaccination complications in pregnant women (74/101 [73.3%]; OR 15.95; 95% CI 2.15–118.55; P = 0.001) compared to those who disagreed with vaccination. Most pregnant women opined that they should not receive a COVID-19 vaccination during pregnancy (adjusted odds ratio [AOR] 6.57; 95% CI 2.44–17.70; P = 0.001). Most also rejected vaccination despite being aware of its benefits (AOR 17.14; 95% CI 6.89–42.62; P < 0.001). Social media messages and obligatory vaccination certifications influence maternal vaccination decisions. Pregnant women believe vaccination helps prevent COVID-19 infection and reduces its severity. Nevertheless, the primary reason for their refusal was concern about potential harm to their unborn child or themselves during pregnancy.The Thai clinical trials registry: TCTR20211126006.

Matrix Metalloproteinase-9 Testing of Golden Rice Cookies With Piper Crocatum Active Extract for Preventing Foot Ulcers in Patients With Diabetes: Protocol for a Randomized Controlled Trial.

Diabetic foot ulcers (DFUs) present a formidable challenge to both patients and health care systems. DFUs significantly reduce the quality of life for patients, prolong hospital stays, and are the cause of approximately 70,000 lower limb amputations across the globe annually. Prevention of DFUs primarily involves the optimization of blood sugar levels and the effective management of complications, particularly peripheral neuropathy. Golden Rice has been proven to lower blood sugar levels due to its beta-carotene content, and Piper crocatum (P. crocatum) has been found to be effective in reducing the risk factors of DFUs through biomolecular regulation because of its polyphenol content. The principal objective of this study is to identify the efficacy of P. crocatum-enriched cookies, with Golden Rice as their primary ingredient, in preventing DFUs. The evaluation will center on their impact on the expression of matrix metalloproteinase-9 (MMP-9), a pivotal factor in the development of DFUs. This study is an experimental clinical research that follows the randomized controlled trial method and uses a single-blind design. The participants in the study are outpatients from primary health centers in Makassar, Indonesia, who have been diagnosed with diabetes mellitus. The sample for the study will be randomly selected and subsequently categorized into 2 groups: the intervention group and the control group. The intervention group consumes P. crocatum-enriched Golden Rice cookies, while the control group receives cookies without these additives. The participants from both groups will consume their respective cookies (packaged identically) twice a day for 14 days. The cookies will be prepared according to a modified recipe with an emphasis on low glucose content, resulting in 51 calories per cookie, comprising 1% carbohydrates, 6% fat, 4% cholesterol, and 4% fiber, excluding gluten, sugar, and salt. They will be baked at 158°C for 20 minutes. The process involves the addition of 20% Golden Rice and 10% P. crocatum ethanol extract, both prepared via maceration with 96% ethanol. The dependent variable in this study is the expression of gelatinases matrix metalloproteinase, to be assessed at 2 distinct time points-preintervention (pretest) and postintervention (posttest)-with the evaluation conducted through the western blotting method. The recruitment and testing phase started in January 2024. The study is scheduled to be completed by the end of March 2024. Data analysis will commence in April 2024, and the publication of the results is anticipated in the same year (2024). The study will report on the changes in primary data, encompassing gelatinases matrix metalloproteinase, as well as secondary data, including the ankle-brachial index, neuropathy score, and random blood glucose level. The findings of this trial are expected to significantly impact the selection of strategies by health care practitioners to enhance diabetes self-management, particularly in the domain of therapeutic snacking, for patients diagnosed with diabetes mellitus. Thai Clinical Trials Registry TCTR20230502001; https://www.thaiclinicaltrials.org/show/TCTR20230502001. PRR1-10.2196/49940.

Real-time machine learning-assisted sepsis alert enhances the timeliness of antibiotic administration and diagnostic accuracy in emergency department patients with sepsis: a cluster-randomized trial.

Machine learning (ML) has been applied in sepsis recognition across different healthcare settings with outstanding diagnostic accuracy. However, the advantage of ML-assisted sepsis alert in expediting clinical decisions leading to enhanced quality for emergency department (ED) patients remains unclear. A cluster-randomized trial was conducted in a tertiary-care hospital. Adult patient data were subjected to an ML model for sepsis alert. Patient visits were assigned into one of two groups. In the intervention cluster, staff received alerts on a display screen if patients met the ML threshold for sepsis diagnosis, while patients in the control cluster followed the regular alert process. The study compared triage-to-antibiotic (TTA) time, length of stay, and mortality rate between the two groups. Additionally, the diagnostic performance of the ML model was assessed. A total of 256 (intervention) and 318 (control) sepsis patients were analyzed. The proportions of patients who received antibiotics within 1 and 3h were higher in the intervention group than in the control group (in 1h; 68.4 vs. 60.1%, respectively; P = 0.04, in 3h; 94.5 vs. 89.0%, respectively; P = 0.02). The median TTA times were marginally shorter in the intervention group (46 vs. 50min). The area under the receiver operating characteristic curve (AUROC) of ML in early sepsis identification was significantly higher than qSOFA, SIRS, and MEWS. The ML-assisted sepsis alert system may help sepsis ED patients receive antibiotics more rapidly than with the conventional, human-dedicated alert process. The diagnostic performance of ML in prompt sepsis detection was superior to that of the rule-based system.Trial registration Thai Clinical Trials Registry TCTR20230120001. Registered 16 January 2023-Retrospectively registered, https://www.thaiclinicaltrials.org/show/TCTR20230120001 .

Effect of tobacco use on cadmium accumulation in the oral keratinized mucosa

BackgroundThis cross-sectional study aimed to evaluate the effect of tobacco use on the accumulation of cadmium (Cd), a carcinogenic element, in the oral keratinized mucosa (OKM).MethodsOKM samples were obtained by standard punch biopsy from nonsmokers (n = 19) and smokers (n = 21). Cd analysis was performed using inductively coupled plasma optical emission spectroscopy (ICP-OES). The calibration curve R2 values for three wavelengths (214,439, 226,502, and 228,802 nm) were at the level of 0.9999. The frequency of consumption of foods that are Cd sources, such as seafood, rice, and vegetables, was assessed in all patients. The age, sex, and nutritional habits of all patients and the frequency of tobacco consumption by smokers were recorded. The independent t-test, Mann–Whitney U test, Fisher’s exact test, and Spearman correlation test were used for the statistical analyses, and p < 0.05 was considered significant.ResultsAlthough the Cd levels in nonsmokers were higher than those in smokers, no statistically significant difference was found (p > 0.05). In smokers, a positive correlation was found between age and Cd level (r = 0.574, p = 0.006). No significant relationship was found between the groups in terms of nutrition or between the frequency of tobacco consumption and Cd accumulation.ConclusionThe OKM may not have the characteristic cumulative accumulation in terms of toxic elements. Changes in the turnover rate, keratinization, and apoptotic mechanisms in the OKM with the thermal/chemical effects of tobacco may be responsible for the difference in Cd accumulation.Trial registration numberTCTR20230206001/06 Feb 2023 (TCTR: Thai Clinical Trials Registry).

Association between advanced glycation end products and uveitis/scleritis activity in patients with active immune-mediated ocular inflammatory diseases

PurposeTo investigate for association between skin autofluorescence (SAF) advanced glycation end products (AGEs) and uveitis/scleritis activity in systemic inflammatory disease-related active non-infectious uveitis/scleritis patients.MethodsThis cross-sectional study was conducted at Siriraj Hospital during October 2019 to March 2020. AGEs were measured by SAF method in systemic immune-related disease patients with active uveitis/scleritis, and those results were compared with those of healthy age-matched controls.ResultsThirty-one active non-infectious uveitis/scleritis patients and 31 age-matched controls were enrolled. The mean age of patients was 40.0 ± 12.8 years, and most were female (55.0%). The most common associated systemic immune-related disease was Vogt–Koyanagi–Harada disease (n = 14). Mean SAF AGE level in the study group compared to the control group was 2.38 ± 0.66 arbitrary units (AU) versus 2.58 ± 0.56 AU, respectively (p = 0.20). Multivariate analysis showed decreased SAF AGE level to be significantly associated with active ocular inflammation, (odds ratio: 0.01, 95% confidence interval: 0.00004–0.81; p = 0.04).ConclusionsSAF AGE level was not so far found to be a reliable biomarker for indicating uveitis/scleritis activity in systemic immune-related disease patients with active ocular inflammation.Clinical trial registrationThai Clinical Trials Registry, https://www.thaiclinicaltrials.org/. (Reg. No. TCTR20200114004, registered date 01/01/2020, beginning date of the trial 10/01/2019).

Early postoperative neurocognitive complications in elderly patients: comparing those with and without preexisting mild cognitive impairment- a prospective study.

As societies age, increasing numbers of older adults undergo surgeries with anesthesia. Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) frequently occur in older surgical patients. Most of these patients already have preoperative mild cognitive impairment (MCI). However, the correlation between MCI and POD remains unclear. This study aimed to determine the incidence of POD in elderly patients with and without preexisting MCI. A prospective study enrolled patients aged 60 years and above scheduled for major surgeries between December 2017 and April 2022. Preoperative MCI was determined by a Montreal Cognitive Assessment (MoCA) score between 18 and 24. POD was diagnosed using criteria from the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). POCD was characterized by a MoCA score reduction of 2 or more points from the preoperative score. The primary outcome was the incidence of POD within the first 72h postoperatively. Secondary outcomes encompassed other postoperative complications, including POCD. The study comprised 223 elderly patients with MCI and 56 without MCI. The incidence of POD was 16.6% in the MCI group and 14.3% in the non-MCI group (P = 0.839). POCD occurred in 24.3% of MCI patients and 50% of non-MCI patients (P = 0.001). There were no significant differences in other postoperative complications between the groups. Postoperatively, the MCI group notably declined in visuospatial, attention, and orientation domains, while the non-MCI group declined in all domains except delayed recall. The incidence of POD was similar in the MCI and non-MCI groups. However, the non-MCI group demonstrated a higher incidence of POCD than the MCI group. This was identified by a reduction in postoperative MoCA scores for the visuospatial, naming, attention, language, abstraction, and orientation domains. These findings underscore the importance of postoperative cognitive assessments for both elderly patients with preexisting MCI and those with previously intact cognitive functions. This trial was retrospectively registered in the Thai Clinical Trials Registry on 15/01/2019 (registration number: TCTR20190115001).

Effect of Transdermal Microneedle Patch Plus Nonsteroidal Anti-Inflammatory Drug in Knee Osteoarthritis: A Randomized, Double-Blind Study

Purpose: No recent clinical study has shown the efficacy of transdermal microneedle patch (TDM) plus nonsteroidal antiinflammatory drug (NSAID) in early knee osteoarthritis (OA). This study aimed to determine the effect of TDM plus NSAID on synovial hypertrophy, knee pain, and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score in osteoarthritic knees. Methods: A randomized, controlled, double-blind trial was conducted. One hundred participants, aged 40–70 years, with painful knee OA and radiographic nonstructural changes were randomly assigned into two groups to undergo TDM plus NSAID (ketorolac 30 mg) or TDM (placebo) at the medial joint line of the knee twice (once weekly). The synovial thickness was measured using ultrasonography at pretreatment, weeks 1, 2, and 4. The visual analog scale (VAS) for pain, WOMAC score, and adverse events (AEs) were also recorded. Results: The TDM plus NSAID group demonstrated a significant reduction in synovial thickness and VAS at weeks 2 and 4 compared with the placebo group (P&lt;0.05). At week 4, the mean synovial thickness reduction was 1.1 and 0.3 mm, and the mean VAS reduction was 3.2 and 1.7 for the TDM plus NSAID and placebo groups, respectively. The mean WOMAC scores at week 4 were significantly reduced (5.7 and 0.9 for the TDM plus NSAID and placebo groups, respectively). No complication and treatment-related AEs occurred. Conclusions: TDM plus NSAID significantly reduced synovitis and improved the pain score in knee OA after 2 weeks. The WOMAC score improved at week 4 without any AEs. Thai Clinical Trials Registry (TCTR), TCTR identification number is TCTR20200613001.