Clinical Trials Registry Research Articles

Uptake of health economic evaluations alongside clinical trials in Australia: an observational study.

Australia's clinical trials sector is highly productive with continued sector investment needed to enhance research impact. Generating economic evidence alongside trials has the potential to facilitate the implementation of trial results into practice. Ascertaining the use of health economic evaluations alongside clinical trials can assist in determining whether clinical trials fully realize and operationalize their potential to change policy and practice. The aims of this study were to ascertain the uptake of health economic evaluations alongside Australian-led clinical trials and explore associations between uptake and trial characteristics. This observational study comprised a descriptive analysis of clinical trials registries, a cross-sectional survey of Australian Clinical Trials Alliance (ACTA) networks, and a subgroup analysis of completed acute care trials. Descriptive analyses of trial registrations were conducted, with logistic regressions used to identify predictors of proposing and subsequently publishing a health economic evaluation alongside acute care trials. Few randomized Australian-led clinical trials (11% of 9251) and ACTA network trials (43% of 227) proposed a health economic evaluation. In the subgroup analysis, 22% of the 324 acute care trials and 53% of the 38 ACTA network acute care trials proposed a health economic evaluation. Acute care trials funded by government bodies were significantly more likely to propose and publish a health economic evaluation than those funded by hospitals, universities, and other funders, after adjusting for phase, registration year, primary sponsor type, and comparator. Current uptake of health economic evaluations alongside Australian-led clinical trials is low, with uptake higher among the subset of ACTA network trials. This is despite economic evidence playing an increasingly prominent role in health system management, as well as rising health expenditure, limited budgets, and competing demands. There is significant opportunity to embed health economic evaluations alongside clinical trials, particularly phase 3 trials, to increase research outputs and optimize research translation. Investing in clinical trial networks that support funding for a health economist or a health economic evaluation may be an effective strategy to increase the uptake of health economic evaluations alongside trials.

Improvement in symptoms of anxiety and depression in individuals with type 2 diabetes: retrospective analysis of an intensive lifestyle modification program

BackgroundType 2 diabetes (T2D) is a chronic metabolic disorder that has a notable influence on mental well-being, contributing to elevated morbidity and mortality rates. Depression and anxiety disorders are the most common mental health concerns among patients with T2D worldwide. Therefore, the present study aimed to assess the impact of an online intensive lifestyle intervention (ILI) on mental health outcomes (depression and anxiety) in patients with T2D in India.Materials and methodsThis retrospective pre-post analysis included adult patients (aged > 18 years) diagnosed with T2D who were enrolled in a diabetes management program in India between June 2021 and June 2023. The intervention consisted of lifestyle modifications such as a customized plant-based diet, regular physical activity, psychological support through group and individual therapy, and medical management. Data were extracted from the electronic database of the clinic, including anthropometry, medical history, biochemical parameters, symptoms of depression, and anxiety (assessed using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorders-7 (GAD-7) scale) at the start and end of the six-month intervention period.ResultsOf the 1061 eligible patients (177 with prediabetes), 40.3% were female. The mean age, duration of diabetes, and HbA1c levels were 52 ± 10.4 years, 9.8 ± 7.8 years, and 8 ± 1.7%, respectively. The prevalence of symptoms of depression and anxiety (ranging from mild to severe) was 46% and 44.3%, respectively, which reduced to 28.7% and 29.2%, respectively, post-intervention.ConclusionIntegrated ILI successfully improved the symptoms of anxiety and depression, highlighting the importance of a multidisciplinary approach that includes diet, physical activity, psychological support, and medical management in enhancing mental health outcomes among patients with T2D. Future prospective studies are needed to explore the long-term effects of such interventions and develop effective strategies for promoting mental health in diverse populations.Trial registrationThe study was approved by the Freedom from Diabetes Research Foundation Institutional Ethics Committee (approval number FFDRF/IEC/2024/7) and registered in the Clinical Trials Registry of India (CTRI/2024/03/064596, registered on March 21, 2024).

Reproducibility of ultrasound-derived fat fraction in measuring hepatic steatosis

PurposeSteatotic liver disease (SLD) has become the most common cause of chronic liver disease. Nevertheless, the non-invasive quantitative diagnosis of steatosis is still lacking in clinical practice. This study aimed to evaluate the reproducibility of the new parameter for steatosis quantification named ultrasound-derived fat fraction (UDFF).Materials and methodsThe UDFF values were independently executed by two operators in two periods. In the process, repeated measurements of the same patient were performed by the same operator under different conditions (liver segments, respiration, positions, and dietary). Finally, the results of some subjects (28) were compared with the MRI-derived proton density fat fraction (PDFF). The concordance analysis was mainly achieved by the intraclass correlation coefficient (ICC) and Bland–Altman.ResultsOne hundred-five participants were included in the study. UDFF had good reliability in measuring the adult liver (ICCintra-observer = 0.96, ICCinter-observer = 0.94). Meanwhile, the ICC of the two operators increased over time. The variable measurement states did not influence the UDFF values on the surface, but they affected the coefficient of variation (Cov) of the results. Segment 8 (S8), end-expiratory, supine, and fasting images had the most minor variability. On the other hand, the UDFF value of S8 displayed satisfied consistency with PDFF (mean difference, −0.24 ± 1.44), and the results of both S5 (mean difference: −0.56 ± 3.95) and S8 (mean difference: 0.73 ± 1.87) agreed well with the whole-liver PDFF.ConclusionUDFF measurements had good reproducibility. Furthermore, the state of S8, end-expiration, supine, and fasting might be the more stable measurement approach.Critical relevance statementUDFF is the quantitative ultrasound parameter of hepatic steatosis and has good reproducibility. It can show more robust performance under specific measurement conditions (S8, end-expiratory, supine, and fasting).Trial registrationThe research protocol was registered at the Chinese Clinical Trial Registry on October 9, 2023 (http://www.chictr.org.cn/). The registration number is ChiCTR 2300076457.Key PointsThere is a lack of non-invasive quantitative measurement options for hepatic steatosis.UDFF demonstrated excellent reproducibility in measuring hepatic steatosis.S8, end-expiratory, supine, and fasting may be the more stable measuring condition.Training could improve the operators’ measurement stability.Variable measurement state affects the repeatability of the UDFF values (Cov).Graphical

Assessing the reach and engagement of three anti-vaping messages on Facebook Targeting Australian Youth: a protocol for a randomised trial

BackgroundVaping among 18-24-year-old Australians has increased from 5.8% in 2019 to 21% in 2023. This protocol describes a trial to investigate the dissemination and engagement achieved by three anti-vaping messages on Facebook.MethodsThis research employs a 3-arm randomised experimental design. Three distinct anti-vaping messages will be disseminated via Facebook using Meta Ads Manager. Each arm has a message that focuses on either health risks, environmental impact, or anti-vape industry sentiment. The campaign will run for three months. The primary outcome is the engagement rate as a measure of the effectiveness of anti-vaping message, and the secondary outcomes include network indicators: size, density, centralisation, and centrality to evaluate the extent to which the messages are disseminated. Participants will be randomly exposed to one of the three messages. Data on reach and engagement will be compared across the groups.DiscussionThis study will provide insights into the dissemination of social media-based anti-vaping campaigns. By evaluating engagement rates and network indicators, the research aims to identify which message themes engage most with young Australians. The findings will contribute to the development of more effective public health strategies for vaping cessation and prevention among youth.Trial RegistrationThe study was registered on July 19th 2024 with the Australian New Zealand Clinical Trials Registry (ACTRN12624000885594).

The effects of screen-based simulation on nursing students’ acquisition of medication administration and dosage calculation skills: a randomized controlled trial

BackgroundScreen-based simulation is a cost-effective educational modality that allows nursing students to comfortably acquire new skills as they become accustomed to digital environments. The aim of this study is to evaluate the effectiveness of a screen-based simulation tool in enhancing knowledge and skills related to medication administration and dosage calculation in nursing students.MethodsThis multicenter, single-blind, stratified, randomized controlled trial initially enrolled 480 nursing students. The 351 students eligibles were randomly allocated to two groups. Using a screen-based simulation tool (SIMDOSE®), the intervention group was trained in drug administration and dosage calculation through four perfusion clinical cases. The control group underwent the same training content using the paper-and-pencil method. knowledge and skills acquisition, Students’ satisfaction, self-confidence and anxiety were analyzed using Jamovi software (version 2.3.18).Results4 out of 5 main variables examined were significantly different, specifically in dosage calculation, where the simulation group excelled both in the knowledge post-test (post – pre = 1.00 (20%); p = 0.004) and in the objective structured clinical examination (p = 0.013). The intervention group reported higher levels of satisfaction and self-confidence than the control group (p < 0.001). Their moderate anxiety levels didn’t differ significantly (0.161).ConclusionThe SIMDOSE® platform can be used as a supplementary teaching method of dosage calculation for nursing students. Screen-based simulation has benefits that nurse educators should be aware of, such as being a key to more satisfied and confident students.Trial registrationThis Moroccan clinical trial was prospectively registered (16/05/2023) in the Pan African Clinical Trial Registry (pactr.samrc.ac.za) with trial registration number PACTR202305505743210.

The effect of coaching on health information literacy in patients with chronic kidney disease: a randomized controlled trial

BackgroundSince chronic kidney disease is highly insidious in the early stages, most diagnosed patients have already developed irreversible renal failure. There is a lack of effective implementation and standardization of health education management for patients with chronic kidney disease, and the impact of health education management on health information literacy is not yet known.MethodsThis randomized controlled clinical trial was conducted from March 2022 to March 2023. A total of 130 patients with chronic kidney disease stage 3–4 were selected from a tertiary hospital in Zhuhai via a convenience sampling method and were then randomly assigned to intervention and control groups. The Health Information Literacy Questionnaire for Chronic Kidney Disease was used to assess the health literacy of the patients at month 0 and month 12. In addition, the renal function-related indices of the patients were measured before and after the intervention. The study adhered to SPIRIT guidelines.ResultsThere was no significant difference between the two groups in health information literacy, platelet count, estimated glomerular filtration rate, or albumin level. However, the intervention group showed a significant improvement in health behavioral status such as information acquisition, checkups, and physical activity. Subgroup analysis revealed that hemoglobin was significantly higher in non-employed patients than in the intervention group. There was a significant improvement in hemoglobin level after receiving health guidance in patients with intermediate education, and acquisition capacity and estimated glomerular filtration rate in the intervention group were lower than in the control group for patients with elementary education.ConclusionReceiving health coaching helped to improve self-management behaviors and hemoglobin levels of patients with stage 3–4 chronic kidney disease. Education level is an important factor influencing the effectiveness of health coaching techniques.Trial registrationThis study was prospectively registered in the China Clinical Trial Registry on November 10, 2021, with registration number: ChiCTR2100053103.

Evaluation of efficacy and safety of low-intensity pulsed ultrasound in patients with concurrent erectile dysfunction and chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized controlled study

ObjectiveThe primary objective of this clinical trial is to investigate the effect of low-intensity pulsed ultrasound (LIPUS) on patients suffering from comorbid erectile dysfunction (ED) and chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS).MethodsThe clinical trial was conducted in the andrology outpatient treatment room of the Department of Urology, Xiangya Hospital, Central South University from August to November 2022 A total of 60 patients who met the research criteria for comorbid ED combined with CP/CPPS were recruited and randomly assigned to three treatment groups. They were treated with LIPUS (Group A), drug therapy(Group B), and LIPUS combined with drug therapy (Group C), respectively. Each group comprised 20 patients. Statistical analysis was performed on the five-item version of International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the nine-item Patient Health Questionnaire (PHQ-9), the seven-item Generalized Anxiety Disorder Scale (GAD-7), and the incidence of adverse events to comprehensively evaluate the efficacy and safety of LIPUS.ResultsThe positive response rate of ED and CP/CPPS treatment in Group A is 40%(8/20) and 45%(9/20), while those in Group B is 55%(11/20) and 60%(12/20), and those in Group C is 85%(17/20) and 85%(17/20). A notable increase in IIEF-5 scores was observed across the three groups post-treatment (10.45 ± 2.50 vs. 13.65 ± 3.03, P = 0.008; 11.80 ± 3.21 vs. 16.40 ± 3.20, P = 0.011; 12.90 ± 3.92 vs. 19.40 ± 2.35, P = 0.042) with a concomitant significant decrease in NIH-CPSI scores (16.75 ± 4.53 vs. 14.65 ± 4.51, P = 0.016; 16.35 ± 4.32 vs. 12.20 ± 4.74, P = 0.007; 16.00 ± 4.40 vs. 8.15 ± 4.28, P = 0.021). Notably, the most pronounced changes were seen in the group receiving LIPUS combined with tadalafil and doxazosin. Additionally, all groups exhibited marked improvements in anxiety and depression symptoms post-treatment. No adverse events were observed during treatment.ConclusionLIPUS can improve erectile function and CP/CPPS symptoms with good safety, and LIPUS combined with tadalafil and doxazosin is more effective during the treatment. However, its long-term efficacy remains to be seen.Trial RegistrationChinese Clinical Trial Registry; approval number: ChiCTR2200063038 (https://www.chictr.org.cn/) on August 29, 2022.

Diagnostic Accuracy of Toluidine Blue Electrospun in Detecting Oral Potentially Malignant Disorders.

Oral potentially malignant disorders (OPMDs) with epithelial dysplasia can progress to oral squamous cell carcinoma (OSCC). Toluidine blue (TB) has been used in oral screening with various methods. This study aimed to evaluate the sensitivity and specificity of TB-containing electrospun fibers in detecting OPMDs with epithelial dysplasia compared to histopathology. The concentrations of polyvinylpyrrolidone (PVP) and TB were optimized for fiber diameter and puncture strength using the design of experiments method with a central composite design. These optimized fibers were tested on 36 suspected OPMD lesions in 30 patients, followed by a biopsy for histopathological examination. The quadratic and two-factor interaction models described the relationship between TB and PVP concentrations and fiber characteristics. The TB-containing electrospun fibers had 77.3% sensitivity and 35.7% specificity in detecting OPMDs with epithelial dysplasia. The TB-containing electrospun fibers offer advantages such as easy application, cost-effectiveness, and enhanced sensitivity in identifying OPMDs with epithelial dysplasia. However, their diagnostic accuracy is insufficient as a standalone diagnostic method, and they should be considered an adjunctive tool for detecting dysplastic changes in the oral epithelium. Thailand Clinical Trials Registry: TCTR20240429002.

The effect of combined pudendal nerve and spermatic cord block or caudal epidural block on postoperative analgesia after posterior urethroplasty: a randomized trial

BackgroundPostoperative pain management remains a significant challenge for patients undergoing posterior urethroplasty (PU). In a previous study, we proposed a novel technique of combined pudendal nerve (PN) and spermatic cord (SC) block to manage pain after PU. The present trial was conducted to test the hypothesis that this technique is effective for pain control after PU and provides longer-lasting analgesia than caudal epidural block (CB).MethodsSixty patients undergoing PU were randomized into two groups: Group NB received combined PN and SC block, and Group CB received CB. General anesthesia with a laryngeal mask was performed. The primary outcome was the postoperative analgesic duration, and the secondary outcomes included the Numeric Rating Scale (NRS) scores for pain and the number of patients with different motor scores of the lower limb at 3, 6, 12, and 24 h postoperatively.ResultsTwo patients in Group CB were withdrawn due to block failure. The postoperative analgesic duration was statistically longer in Group NB compared with Group CB (mean difference [95% confidence interval], 115.78 min [17.80, 213.75]; P = 0.021). The NRS scores for pain at 12 and 24 h after surgery were statistically lower in Group NB compared with Group CB. Group NB had statistically more patients with motor score 0 at 3 h postoperatively than Group CB.ConclusionsPN combined with SC block is an effective technique for postoperative analgesia in PU. This technique can achieve a longer duration of analgesia and lower pain scores, especially 12 h after surgery, than a CB.Trial registrationThis study was registered in the Chinese Clinical Trial Register (registration no. ChiCTR2100042971, registration date on 2/2/2021).

Shuxuening injection for treating acute ischemic stroke: a PRISMA-compliant systematic review and meta-analysis of randomized controlled trials.

www.crd.york.ac.uk, identifier (CRD42023418565).

Effectiveness of Home-Based Self-monitoring of Blood Pressure in a Primary Care set-up of India (EASE-BP): Protocol for an Open-Label Randomized Controlled Trial.

Rising hypertension from inadequate detection, noncompliance with treatment, and poor control presents a major public health challenge. Previously, adopting the strategy of self-monitoring of blood pressure (SMBP) showed better hypertension detection, control, and medication adherence. However, evidence from India is scarce. Here, we present the trial protocol for the effectiveness of SMBP intervention in hypertension detection, blood pressure (BP) control, and medication adherence in a primary care set-up. EASE-BP is an open-label randomized trial in two distinct adult populations - part-A self-reported non-hypertensive population (total sample size: 400) and part-B known hypertensive population (total sample size: 332). The two populations will be sampled from two separate villages under the Ballabgarh Health and Demographic Surveillance System. In both the populations, participants randomized in the intervention arm will receive a validated electronic BP device and will be advised to self-monitor BP for at least twice a month (or more). Those in the control arm will be advised to monitor BP for at least twice a month (or more) at the nearby health center. Participants in both arms will receive education on hypertension and atherosclerotic disease. In addition, adult family members in the households of randomized participants will be encouraged to monitor their BP. All participants and family members will be instructed to maintain a log of BP recordings in a diary that will be provided to them. Data will be collected at baseline and then every month for three-months. The primary outcome in part-A will be the incidence of new cases of hypertension during 3 months follow-up and in part-B will be the difference in SBP and rate of medication adherence at 3 months follow-up. Secondary outcomes will include (1) uptake of the intervention, (2) any stroke, myocardial infarction, or death, (3) additional yield of new cases of hypertension among the family members, and (4) integrating the intervention into the national programs for long-term noncommunicable disease goals. EASE-BP will help understand if SMBP improves hypertension detection, BP control, and medication adherence. Consequently, this will appraise policymakers on whether provision of BP instruments may be added to the national program for hypertension prevention and control. This trial was registered under Clinical Trial Registry - India with reference number CTRI/2023/02/049949.

Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans.

Purpose: Cardiovascular health disparities are present in African Americans, but it remains unknown whether this phenomenon affect Somali Americans. Study of Somali Americans is warranted due to distinct genetic and cultural differences from African Americans of western African ancestry. Orthostatic hemodynamic responses have implications for cardiovascular risk, especially among African American females. We sought to examine race and sex differences in systolic (SAP) and diastolic (DAP) arterial pressure and heart rate (HR) responsiveness to standing. We hypothesized that SAP, DAP, and HR change from supine to standing position would be higher in Somali Americans. Methods: We studied blood pressure and HR responsiveness in 139 (70 Somali; age: 29±10 years, 69 White; age: 31±9 years) participants. Supine SAP, DAP, and HR were measured after at least five minutes of supine rest, and again after one minute of standing. SAP, DAP, and HR change was compared between groups. Results: ΔSAP and ΔDAP were similar between groups (race × sex: p>0.05). However, HR responsiveness to orthostasis varied between race and sex comparisons (race×sex: p=0.011). Somali females exhibited an augmented HR response to orthostasis compared to White females (Δ19±13 vs. 11±9 beats/min, p=0.005) and Somali males (Δ19±13 vs. 12±9 beats/min, p=0.020). Conclusion: ΔHR to standing is augmented in young female Somali Americans. These findings highlight an early potential impairment in hemodynamic regulation that may heighten future cardiovascular risk. Further work is warranted to identify the potential autonomic nervous system underpinnings that may contribute to potentiated orthostatic responses and cardiovascular risk in Somali American females. Clinical Trial Registration: www.clinicaltrials.gov; unique identifier, NCT04124848; NCT05411029; NCT03308578.

Pharmacokinetics and Bioequivalence of Two Powders of Azithromycin for Suspension: A Nonblinded, Single-Dose, Randomized, Three-Way Crossover Study in Fed and Fasting States Among Healthy Chinese Volunteers.

Azithromycin, a macrolide antibiotic, is commonly used to treat mild-to-moderate bacterial infections. This research aimed to evaluate the pharmacokinetics (PK) properties and bioequivalence (BE) of two azithromycin (EQ 100 mg base/packet) powders for suspension in Chinese healthy participants in fed and fasting conditions. A total of 90 Chinese healthy participants were enrolled in this nonblinded, single-dose, randomized, semireplicate, three-period, three-sequence, crossover study. Of them, 42 and 40 were categorized to the fed and fasting conditions, respectively. The washout period between doses was 21 days. Blood specimens were harvested prior to administering the drug and 194 h following administration. The plasma levels of azithromycin were analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) approach. PK parameters were measured using noncompartmental analysis. This research compared BE between the reference and test products using the average bioequivalence (ABE) or reference-scaled average bioequivalence (RSABE) method, considering the within-subject variability (SWR) of the reference preparation. Adverse events (AEs) were monitored to examine safety and tolerability. The RSABE method (SWR ≥ 0.294) was used to determine the BE of maximal plasma concentration (Cmax) in both fed and fasting conditions. In the ABE approach, (SWR < 0.294) was adopted to assess the BE of the area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t) and determine the area under the plasma concentration time curve from time zero to time infinity (AUC0-inf). In the fasting condition, the point estimate of the test/reference ratio for Cmax was 1.08, with a 95% upper confidence bound of - 0.05 < 0.00. The geometric mean ratio (GMRs) for AUC0-t and AUC0-inf was 115.21% [90% confidence interval (CI) 107.25-123.27%] and 113.07% (90% CI 105.14-121.61%), respectively. In the fed condition, the point estimate of the test/reference ratio for Cmax was 0.94, with a 95% upper confidence bound of - 0.10 < 0.00. The GMR for AUC0-t and AUC0-inf was 99.51% (90% CI of 91.03-108.78%) and 99.43% (90% CI 91.73-107.78%), respectively. These data all satisfied the BE criteria for drugs with high variability. All AEs were transient and mild, and no severe AEs were observed. Our study indicated that the test and reference products of azithromycin (EQ 100 mg base/packet) powder for suspension were bioequivalent and safe in healthy Chinese participants, irrespective of the feeding condition. CLINICAL TRIAL REGISTRATION (CHINADRUGTRIALS.ORG.CN): CTR20232646, registered on 25 August 2023.

Randomized phase III study comparing re-irradiation stereotactic body radiotherapy and conventional radiotherapy for painful spinal metastases: Japan Clinical Oncology Group study JCOG2211 (RESCORE study).

Bone metastases are often associated with pain and can occur in various types of cancer, significantly affecting patients' quality of life. Despite the high response rates to initial conventional radiotherapy in patients with painful spinal metastases, recurrence and inadequate response still occur. Thus, the development of a highly effective strategy for pain recurrence is crucial to improving the quality of life in patients with advanced metastatic cancer. This randomized phase III trial aims to confirm the superiority of re-irradiation with stereotactic body radiotherapy (24Gy in 2 fractions) over conventional radiotherapy (8Gy in a single fraction) in achieving a complete pain response at 12weeks in patients with previously irradiated painful spinal metastases. A total of 158 patients from 33 hospitals will be enrolled in Japan over 3.5years. This trial has been registered in the Japan Registry of Clinical Trials as jRCTs1030240172 (https://jrct.niph.go.jp/latest-detail/jRCT1030240172).

Peer support groups and care burden in hemodialysis caregivers: a RCT in an Iranian healthcare setting

BackgroundChronic renal failure poses a significant global health challenge, exerting a substantial burden on both patients and their caregivers. Hemodialysis, a common treatment for end-stage renal disease, imposes extensive physical, emotional, and financial pressures on caregivers, often leading to a high care burden. This study uniquely examines the impact of peer support groups on reducing the care burden among caregivers of patients receiving hemodialysis in an Iranian healthcare setting, an aspect that has not been extensively explored before.MethodsA parallel-controlled clinical trial was conducted involving 60 caregivers, divided into intervention and control groups. The intervention group participated in an 8-session peer support program tailored to their identified needs, including coping with stress, social isolation, and financial challenges. The Zarit Care Burden Interview Scale was used to measure care burden before and after the intervention.ResultsThe study revealed statistically significant reductions in care burden, particularly in physical, social, and emotional dimensions, among caregivers in the intervention group compared to the control group. The total care burden score showed a marked decrease, indicating the effectiveness of the peer support intervention. While economic challenges remained a concern, the intervention had a limited impact in this domain.ConclusionThis study demonstrates that peer support groups significantly alleviate the care burden experienced by caregivers of patients receiving hemodialysis, improving their well-being across several dimensions. The findings highlight the importance of integrating peer support strategies into healthcare programs for chronic disease management and underscore the need for supplementary economic support measures to comprehensively address caregivers’ needs. Future research should explore the scalability and long-term sustainability of such interventions and address the unique economic challenges faced by these caregivers.Trial registrationThis study was registered in the Iranian Registry of Clinical Trials (IRCT) under the registration number IRCT20220724055540N1 on 11/08/2022.

Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol

BackgroundBalance dysfunction affects 70% of stroke patients. Emerging neurophysiological approaches, such as virtual reality therapy (VRT) and repetitive transcranial magnetic stimulation (rTMS), have been proven by clinical studies that the balance function of stroke patients can be improved when applied alone, but there are relatively few studies on the combined treatment of balance dysfunction after stroke. This study aimed to evaluate the impact of a 4-week intensive intervention combining VRT and rTMS on both balance function and brain plasticity among stroke patients.MethodsThis single-blind, randomized controlled trial was conducted at the Rehabilitation Medical Center of the Rehabilitation General Hospital of Ningxia Medical University. A cohort of 136 stroke patients, with durations of 2 to 24 weeks post-stroke, were enrolled in the study. Participants were randomly allocated in a 1:1:1:1 ratio to four groups: the VR group (n = 34), the rTMS group (n = 34), the combined treatment group receiving both VR and rTMS (n = 34), and the control group undergoing traditional balance training (n = 34). All patients underwent a standardized inpatient rehabilitation program over 4 weeks. The VR group received daily 30-min sessions of VR therapy for 20 days. The rTMS group underwent daily sessions of rTMS stimulation for 20 min, targeting the motor imagery region in the affected hemisphere. The combination group received VR therapy after completing their rTMS treatment. The control group received conventional balance training, with each session lasting 30 min. Additionally, all patients received an extra 60 min of standard rehabilitation therapy twice daily. Assessments were conducted at baseline, 2 weeks, and 4 weeks post-treatment, using the Berg Balance Scale (BBS) as the primary measure, and secondary measures including the Timed Up-and-Go Test (TUGT), Fugl-Meyer Assessment-Lower Extremity (FMA-LE), and 6-m walking test (6MWT), as well as assessments for brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VGEF), tyrosine receptor kinase (TrκB), motor-evoked potential latency (PL), central motor conduction time (CMCT), and amplitude.DiscussionThe widespread application of VR technology and rTMS in clinical settings is well-established. However, the potential synergistic effects of combining these modalities on balance function and neuroplasticity in stroke patients remain uncertain. Our hypothesis suggests that the integration of VR with rTMS may result in more pronounced improvements in both balance function and neuroplasticity among stroke patients, surpassing the outcomes achievable with VR alone, rTMS alone, or traditional therapy. The possible mechanism is that VR-based training combined with rTMS plays a superimposed effect, promoting better repair of damaged neurons and ultimately improving balance function in stroke patients. The positive results anticipated from this trial could provide objective evidence advocating for the concurrent use of VR and rTMS in clinical interventions.Trial registrationThe study protocol underwent review and approval by the Medical Research Ethics Committee of the General Hospital of Ningxia Medical University on January 26, 2024 (No. KYLL-2024–0162). Subsequently, it was registered in the Chinese Clinical Trial Registry on March 11, 2024 (registration number: ChiCTR2400081775). Currently, the study is still ongoing.

Effect of lower-limb isokinetic muscle strengthening on knee function and joint contact force in knee osteoarthritis patients awaiting total knee arthroplasty: study protocol for a randomized controlled trial.

Knee osteoarthritis (OA) is a common and serious joint disease and patients mainly suffer from knee pain and dysfunction, significantly impacting their quality of life and daily activities. Non-pharmacological treatments and total knee arthroplasty (TKA) are the two major treatments for knee OA. TKA is the primary treatment for severe knee OA patients, however, the postoperative rehabilitation results are not entirely satisfactory. To enhance postoperative rehabilitation outcomes, preoperative lower-limb muscle strengthening has aroused attention and demonstrated significant results on functional recovery after TKA. Specifically, isokinetic muscle strengthening (IMS) has been highly anticipated as an efficient training method. Nevertheless, its effects in perioperative and long-term periods of TKA require further investigation. This study aims to evaluate the impact of preoperative lower-limb IMS during the 4weeks before TKA on the perioperative and postoperative outcomes, with particular attention on knee function, pain, and inflammatory response. In this study, 104 patients awaiting TKA will be randomized to 2 groups: the IMS and health education groups. All patients will be evaluated at baseline, post-intervention, discharge day, and postoperative day 14, with follow-up assessments at 6weeks, 3, 6, and 12months after discharge. The primary outcome will be the Knee Injury and Osteoarthritis Outcome Score 3months after TKA and the medial-to-lateral knee contact force ratio. The secondary outcomes will be changes in lower-limb muscle strength, knee pain, inflammation response, active range of motion, performance-based function (5-times Sit-to-Stand Test, Time Up-and-Go Test, 3m walking speed), Berg Balance Scale, and surgical need. Lower-limb IMS can improve muscle strength, pain, and function for early knee OA patients. However, the effects of different doses of IMS on perioperative and postoperative knee pain, inflammation response, and function after TKA are inconclusive. This study will provide high-quality evidence to assess the efficacy of IMS in end-stage patients who will undergo TKA. Understanding IMS in end-stage knee OA patients will help guide future surgical management for this population. Trial Registration Chinese Clinical Trial Registry ChiCTR2400088136.

Efficacy of vital pulp therapy for carious pulp injury in permanent teeth: a study protocol for an open-label randomized controlled noninferiority trial.

Vital pulp therapy (VPT) has recently been reported as an effective approach for preventing and treating carious pulp injury in permanent teeth. Compared with root canal treatment (RCT), which involves complete removal of the pulp tissue, VPT effectively maintains pulp vitality and retains the physiological functions of the pulp. In the research pool, large-scale randomized controlled trials evaluating the treatment outcome of VPT using calcium silicate cements and RCT in cariously exposed permanent teeth are lacking. Here, we present a monocentric clinical protocol to compare the effects of VPT using iRoot BP Plus (Innovative Bioceramix, Vancouver, BC, Canada) as a pulp-capping material with RCT. The proposed trial is an open-label, single-centre, randomized, controlled, noninferiority trial. In total, 462 patients will be included in this trial according to the following criteria: adult patients (18-50years old), pulp exposure during the treatment of deep caries in mature permanent teeth, a diagnosis of reversible or partially irreversible pulpitis without apical translucency on X-ray, without periodontitis or systemic disease. Patients with signed informed consent forms will be enrolled and randomly divided into two groups (VPT and RCT) with a balanced treatment allocation (1:1). Clinical evaluations will be conducted at baseline and at 3, 6, 12, and 24months after treatment, with the potential for extension. The primary outcome measure will be the duration of success. The secondary outcomes will include the success rate at the 1-year follow-up and any adverse reactions. The Kaplan‒Meier method and log-rank test will be used to compare the duration of success of both treatments. For other outcomes, the χ2 test or Fisher's exact test will be used for categorical variables, and the t test or Mann‒Whitney U test will be used for continuous variables to assess the differences between groups. The results of this trial will provide a clinical reference for selecting treatments for carious pulp injuries in permanent teeth. ClinicalTrials.gov ChiCTR2100051369. The study has been registered in the Chinese Clinical Trial Registry (ChiCTR) ( www.chictr.org.cn ). Registered on 21 September 2021.

Reducing rehospitalization in cardiac patients: a randomized, controlled trial of a cardiac care management program (“Cardiolotse”) in Germany

BackgroundWe conducted a prospective, randomized, controlled, two-group parallel trial investigating the effectiveness of a care management program employing cardiac care navigators providing post-discharge support to patients compared to standard care.MethodsThe intervention commenced in 2019/2020 for 2862 patients hospitalized with heart failure, coronary heart disease, or cardiac arrhythmias in departments of cardiology across eight participating sites of a hospital group in Berlin, Germany. We analyzed the results using an intention-to-treat approach. The primary outcome was the all-cause rehospitalization rate after 12 months. Secondary outcomes included rehospitalizations due to one of the qualifying cardiac diagnoses, duration of rehospitalization, mortality, health-related quality of life, and several process indicators.Trial data were collected from a combination of face-to-face and phone interviews conducted by hospital staff throughout the 12-month follow-up period using standardized questionnaires. Administrative claims data were provided by a large statutory health insurer. Outcomes for the intervention and control groups were compared using logistic regression, generalized linear models (GLMs) with a negative binomial distribution, ordinary least squares, and Cox proportional hazards regression.ResultsCompared to the control group (N = 1294), the intervention group (N = 1256) had a lower rate of all-cause rehospitalizations (62.6% vs. 66.4%, p = 0.05) and shorter lengths of stay (14.49 vs. 16.89 days, p = 0.02) during the 12-month follow-up period. These differences were also present for rehospitalizations due to the cardiac diseases qualifying for study recruitment, with rehospitalization rates for the intervention and control groups being 58.0% vs. 61.4% (p = 0.08) and particularly pronounced for lengths of rehospitalization stay of 12.97 vs. 15.40 days (p = 0.01), respectively. Subgroup analyses indicated positive effects of the intervention for patients 70 years and older (p = 0.05), females (p = 0.06), and those with little or no German language proficiency (p = 0.03). Furthermore, we found positive effects on patients’ adherence to health-related behavioral recommendations (81.91% vs. 73.95%, p = 0.000).ConclusionsThis study adds to the body of evidence indicating that care management interventions supporting patients as they transition from the inpatient to the outpatient sector can lower rehospitalizations, decrease length of rehospitalization stays, and improve adherence to post-discharge recommendations.Trial registrationGerman Clinical Trial Register, DRKS00020424. Registered 2020-06-18. (retrospectively registered).

Association of SIRT1 (rs7069102) Gene polymorphism with premature myocardial infarction in young Egyptian patients

Abstract Background Premature myocardial infarction (PMI) is one of the most pressing global issues in modern cardiology. Recently, the incidence of PMI has gradually increased. Researches found that genetics is a major contributor in its development. SIRT1, an extremely conserved class III NAD-dependent deacetylase, has been linked to numerous cardiovascular disorders and engaged in a number of cellular functions. This work investigated the association between SIRT1 SNP rs7069102 in Egyptian patients ≤ 40 years old with premature ST-elevation Myocardial infarction (STEMI). Methods This cross sectional, single-center study included patients younger than 40 with STEMI (PMI group, n = 140) and a control group (n = 140) of healthy subjects of comparable age. In addition to clinical examination and standard tests, all participants underwent echocardiography, coronary angiography, SIRT1 (rs7069102) genotyping, and nitric oxide assay. Results The risk for PMI was increased in CG or CC genotype carriers of SIRT1 gene rs7069102 (OR: 3.93, 95% Cl: 2.25–6.86), as did carriers of the C allele (OR: 2.26, 95% Cl: 1.65–3.86). In the PMI group, endothelial nitric oxide synthase (eNOS) was significantly decreased; whereas, neuronal nitric oxide synthase (nNOS) was significantly increased. Conclusions SIRT1 single-nucleotide polymorphism (rs7069102) may confer an increased risk for PMI in young Egyptian patients with affecting endothelial nitric oxide synthase protein expressions. Traditional cardiovascular risk factors are prevalent in patients with PMI, with dietary behaviors, obesity, diabetes and dyslipidemia serving as independent risk factors for PMI. Clinical trial registration number: NCT05160844.