Controlled Clinical Trial Research Articles

Comprehensive clinical evaluation of indirect and direct bonding techniques in orthodontic treatment: a single-centre, open-label, quasi-randomized controlled clinical trial.

Few prospective investigations have compared direct and indirect techniques through comprehensive and detailed clinical evaluations, considering the impact of all factors. This study aimed to compare and evaluate direct and indirect bonding methods at a single institution and to clarify the selection criteria for the bonding method. This single-centre, quasi-randomized controlled clinical trial included 153 patients who required fixed orthodontic treatment. They were randomly divided into indirect and direct binding groups by the project lead (K.K.), who was blinded to all clinical data, and performed the allocation using medical record numbers. The chair time for bracket bonding, discomfort during bracket bonding, oral hygiene after bonding, number of bracket failures, number of intentional bracket reattachments, post-treatment occlusal index, and total treatment time were assessed. Outcomes were compared using a two-sample t-test or Mann-Whitney U test (P < .05). Fifty-eight patients were included in the indirect bonding group (20 male, 38 female; mean age: 20.63 ± 5.69 years) and 66 (14 male, 52 female; mean age: 23.17 ± 8.83 years) in the direct bonding group. Compared to the direct bonding group, the indirect bonding group had shorter chair time (P < .001), a shorter total treatment period (P < .01), and a better final occlusal relationship (P < .001). The number of bracket detachments was higher (P < .001) in the indirect bonding group, but the number of intentional reattachments was lower (P < .001). Indirect bonding may improve the efficiency of orthodontic treatment. No harm was observed during the study. This trial was approved by the Ethics Review Committee of Okayama University (approval number: d10001), UMIN registration number 000022182.

Effectiveness of low-intensity electrical current in accelerating the en-masse retraction of the upper anterior teeth following first-premolar extraction in young adult patients with Class II division 1 malocclusion: A randomized controlled clinical trial

Many efforts have been made to shorten fixed appliance orthodontic treatment time by accelerating the rate of tooth movement. Low-intensity electrical stimulation (LIES) is one of the proposed physical methods that has not yet been well studied in the medical literature. This study aimed to evaluate the effectiveness of LIES in accelerating orthodontic tooth movement in cases of en-mass retraction of the upper anterior teeth. Patients who attended the Department of Orthodontics at the Faculty of Dentistry, University of Damascus, between September 2019 and February 2021, for treatment were carefully checked. All patients who met the eligibility criteria were invited to participate in this RCT. Young adult patients having class II division I malocclusion were equally and randomly assigned into the low-intensity electrical stimulation group (LIES), and traditional en-masse retraction group (TRAD). The mini-implants assisted en-masse retraction technique was used to close the extracted upper first premolar spaces in both groups. NiTi closed coil springs (250g/side) were used. Electrical stimulation of 15-20μA for each tooth was applied on the upper anterior teeth using a recently developed intraorally removable device in the LIES group. The primary outcome was the en-masse retraction rate, the secondary outcomes were changes in the first molar position, intermolar width, and intercanine width. These outcomes were measured on the digital photographs of the maxilla cast using the Image J program. Two-sample t-test with Bonferroni's correction was utilized to explore any significant differences between the two groups in all studied variables. Of the 168 patients examined by the researcher, 38 patients with Class II division I malocclusion (30 females and 8 males; mean age: 21.1±2.31 years) were finally recruited in this RCT. The overall en-masse retraction rate was significantly greater in the LIES group compared to the TRAD group (1.02±0.08, 0.73±0.04mm/month respectively; P<0.001). In addition, the monthly rate of space closure was significantly greater in this group at all evaluation times (P<0.001). A small increase was noted in the intercanine width (1.60±0.27, and 1.65±0.33mm respectively). Negligible changes were noted in the first molar positions and intermolar width, with insignificant differences between the two groups. LIES according to the protocol applied in this trial accelerated the upper anterior teeth en-masse retraction rate by approximately 28% compared to the traditional en-masse retraction method. While this acceleration was statistically significant, may not have substantial clinical implications. This trial protocol was registered in the Clinical Trials database (ClinicalTrials.gov NCT05350280).

Effects of an Instability Training Program Using Global Versus Selective Instability Devices on Dynamic Balance and Ankle Stability in Young Amateur Soccer Players

Background/Objectives: Both Sides Utilized it is one of the most employed global instability devices (GID), but it is difficult to progress and select a particular foot structure. In this sense, the Blackboard has been created as selective instability device (SID). The aim of this study is to compare the effects of both devices on balance and ankle stability. Methods: The study was designed as a randomized controlled clinical trial. Twenty healthy amateur soccer players were divided into two groups: GID and SID. Both performed balance training (4-weeks, 3 days/week). Ankle balance and stability were assessed. Paired t-tests were used to analyze the pre-, post-, and between-groups differences. Results: No differences were found between the groups. Significant intra-group changes were found in both groups for posterolateral balance and summation. Moreover, posteromedial balance increased in the GID group. No changes were found in ankle stability results. Conclusions: A balance intervention using GID or SID is effective in improving general and posterolateral balance. Moreover, the GID intervention improved posteromedial balance.

Effectiveness of flaxseed consumption and fasting mimicking diet on anthropometric measures, biochemical parameters, and hepatic features in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): a randomized controlled clinical trial.

Although benefits of flaxseed and fasting mimicking diet (FMD), each alone, have been shown in the management of metabolic dysfunction-associated steatotic liver disease (MASLD), the benefit of combining the two is not clear. This study aimed to investigate the effect of the combination of FMD and flaxseed supplementation on surrogate measures of MASLD. The present study was conducted as a randomized, parallel, open-label controlled clinical trial on a hundred patients with MASLD for 12 weeks. Eligible participants were assigned to four groups including control group (lifestyle modification recommendations); flaxseed group (30 g/day of flaxseed powder consumption); FMD group (16 h of fasting per day), and combination of FMD with flaxseed. Changes in anthropometric parameters, serum levels of lipids, glycemic measures, High-sensitivity C-reactive protein (hs-CRP), and liver enzymes, and hepatic steatosis and fibrosis by transient elastography were assessed. Serum triglycerides, total cholesterol, fasting blood glucose and insulin, hs-CRP and liver enzymes decreased in all intervention groups. Hepatic steatosis score decreased in the intervention groups, but not significantly in comparison to the control group. Hepatic fibrosis score decreased significantly in the intervention groups compared to control. Our data indicate that the combination of FMD with flaxseed consumption is not superior to either of the interventions alone in the management of MASLD.

Effects of clindamycin and amoxycillin as prophylaxis against early implant failure: double-blinded randomized clinical trial.

The objective of this randomized controlled clinical trial (RCT) was to compare the frequency of early implant failure, postoperative infection, and pain/inflammation and the degree of implant stability between healthy non-penicillin-allergic individuals receiving a single prophylactic dose of 600mg clindamycin versus 2g amoxicillin at 1h before implant surgery. A single-center double-blinded RCT study with parallel groups was undertaken. Eighty-two patients fulfilled study inclusion criteria and were randomly assigned to the amoxicillin (n = 41) or clindamycin (n = 41) group. The primary outcome variable was early implant failure. The presence of infection was evaluated immediately after surgery and on days 7, 14, 30, and 90, and postoperative pain/inflammation was assessed daily on days 1 to 7 post-surgery. Resonance frequency analysis was used to measure primary and secondary implant stability. One early implant failure was observed (1/81), in a patient from the amoxicillin group. No statistically significant between-group differences were observed in early implant failure rate, postoperative infection rate up to 90 days, pain/inflammation scores during the first week post-surgery, or primary or secondary stability values. A single dose of 600mg clindamycin before implant surgery does not increase the risk of early implant failure or infection. These findings suggest that a single dose of 600mg clindamycin at 1h before implant surgery is a safe antibiotic prophylactic approach; however, when a more prolonged antibiotic therapy is required, it appears advisable to prescribe an alternative antibiotic to avoid adverse effects.

Abstract A045: Evaluating the potential of micronuclei DNA from erythrocytes for early detection of colorectal cancer

Abstract Background: Current development in stool- and cell-free DNA (cfDNA)-based technologies have demonstrated promising potentials in colorectal cancer (CRC) diagnosis. However, early detection of CRC and advanced adenoma (AA) remains challenging. Micronuclei (MN) are extranuclear bodies containing chromatin segments resulting from errors in DNA repair. Elevated levels of MN+ erythrocytes have been studied in genotoxicity testing and cancer diagnosis. We further performed whole-genome sequencing on purified and isolated micronuclei DNA (MN-DNA) from erythrocytes in peripheral blood using the approach (WO2021/228246 A1) we previously developed. By comparing MN-DNA from colorectal cancer (CRC) patients and healthy individuals, we identified a series of tumor-associated MN-DNA features (taMN- DNA) with significant differences in read counts and developed a classification model. Here, we established an independent cohort to clinically validate the CRC model and explore its application in early cancer diagnosis. Methods: We launched a prospective observational case- control clinical trial (NCT05875584), which was used as an independent cohort to validate taMN-DNA features in CRC and to perform a comparative analysis with quantitative fecal immunochemical test (qFIT). A total of 598 samples were enrolled in this study (585 was available, including 299 HDs, 206 AAs, and 80 CRCs). We gathered peripheral blood (1-2ml) from a training cohort of 1226 individuals, a test cohort of 309 individuals and this independent cohort of 598 individuals for the MN-DNA isolation from erythrocytes and whole-genome sequencing. Predictive models were developed using distinctive taMN-DNA features identified by genome-wide analysis from training cohort to differentiate between HD and AA or CRC. Results: The predictive CRC model built on taMN-DNA features achieved an AUC of 93% and the detection of AA achieved an AUC of 82% in this clinical validation cohort. Comparing MN-DNA with qFIT, the overall sensitivity was generally consistent (91.3% vs. 87.5%), with MN-DNA achieving 86.4% sensitivity in early-stage (stage I) CRC, significantly higher than 68.2% in qFIT. Additionally, MN-DNA showed superior sensitivity in detecting AA (71.4% vs. 18.4%), with comparable specificity (90.3% vs. 96.3%). Conclusions: Our results demonstrate that MN-DNA within erythrocytes from 1-2ml peripheral blood enable accurate detection of AA and early-stage CRC. Research sponsor: Timing Biotech. Citation Format: Yurong Jiao, Xingyun Yao, Haobo Sun, Chengcheng Liu, Xiangxing Kong, Honghao Liang, Fei Meng, Jun Li, Kefeng Ding, Xiaofei Gao. Evaluating the potential of micronuclei DNA from erythrocytes for early detection of colorectal cancer [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr A045.

Effectiveness and equity of mHealth apps for preeclampsia management in LMICs: A rapid review protocol.

Preeclampsia remains a formidable public health challenge, particularly in low- and middle-income countries (LMICs), where it significantly contributes to the high rates of maternal and neonatal morbidity and mortality. The advent of mobile health (mHealth) applications presents a promising avenue for enhancing the management of preeclampsia. This review protocol is designed to systematically assess the effectiveness and equity of mHealth apps in managing preeclampsia within LMICs, with a focus on clinical outcomes and the broader implications for accessibility, affordability, and cultural relevance. To achieve the objectives of this review, a rapid review methodology will be employed, encompassing a structured search strategy to identify pertinent studies from databases such as PubMed, Cochrane Library, and Google Scholar, as well as grey literature. The inclusion criteria are set to encompass randomized controlled trials (RCTs), controlled clinical trials (CCTs), observational studies, and qualitative studies that offer insights into the effectiveness and user experience of mHealth apps for preeclampsia management. Participants in these studies will include pregnant women at risk for or diagnosed with preeclampsia, healthcare providers, and app developers. The quality of the included studies will be critically appraised using standardized tools, and data extraction will focus on study characteristics, interventions, outcomes, and equity considerations. The implications of this review are far-reaching, offering the potential to inform stakeholders including policymakers, healthcare providers, and app developers about the deployment and development of mHealth solutions for preeclampsia management in LMICs. Ultimately, the anticipated findings of this review are expected to contribute significantly to the understanding of mHealth apps' role in improving preeclampsia management and addressing healthcare disparities, thereby guiding future strategies to enhance maternal and neonatal health outcomes in LMICs.

Comparative Efficacy of Intracanal Medicaments in Healing Apical Periodontitis: Insights from a Comprehensive Clinical Study

ABSTRACT Background: Apical periodontitis is a prevalent condition that necessitates effective intracanal medicaments for successful endodontic therapy. Materials and Methods: A randomized controlled clinical trial was conducted on 120 patients diagnosed with apical periodontitis. The patients were randomly assigned to three groups, Group A (calcium hydroxide), Group B (triple antibiotic paste), and Group C (chlorhexidine gel), with 40 patients in each group. Each medicament was placed in the root canal after standard endodontic procedures, and the patients were evaluated at 1, 3, and 6 months using radiographic assessment and clinical examination. The primary outcome measure was the reduction in lesion size, and secondary outcomes included pain relief and healing time. Results: After 6 months, Group B (triple antibiotic paste) showed the highest reduction in lesion size, with an average decrease of 75%, followed by Group C (chlorhexidine gel), with a 60% reduction, and Group A (calcium hydroxide), with a 50% reduction. Pain relief was observed in 85% of patients in Group B, 75% in Group C, and 65% in Group A. The average healing time was the shortest in Group B (4 months), compared to Group C (5 months) and Group A (6 months). Conclusion: Triple antibiotic paste demonstrated superior efficacy in healing apical periodontitis compared to calcium hydroxide and chlorhexidine gel.

Does adjunctive phototherapy have better outcomes than adjunctive antibiotic therapy for the management of peri-implantitis?

Elsevier's Scopus, Web of Science and Pubmed through Medline identified 431 articles, which were reduced to 206 when duplicates were removed. 8 articles were screened, and 1 excluded after reading the full-text, leaving 7 studies. 6 of these were randomised controlled trials, and 1 a non-randomised controlled clinical trial. Studies selected were either blinded, double-blinded, split-mouth clinical studies, comparative or controlled clinical studies, or randomised controlled trials in humans. There were no limitations on year of publication or language of studies. Most studies had a control of mechanical debridement (MD) with adjuvant antibiotics; 1 was surgical therapy. The test group was MD with adjuvant phototherapy. Exclusions were in vitro reports, animal studies, treatment with sole laser therapy, treatment with no additional antimicrobial therapy alongside MD. Pre-prints, reviews, abstracts, opinion articles, editorials, case reports and case series were also excluded. Data were extracted electronically by a single author and a senior librarian from the 3 databases. Titles and abstracts of articles were screened by the author if they contained Medical Subject Headings either in free terms or with Boolean operators. Full text studies that met the inclusion criteria were included. Data were also searched manually in 6 journals. For missing or conflicting information, the author of the article was contacted for clarification. Data extracted were country of origin of article, study design, sample size, research groups, diagnostic criteria, frequency of intervention, follow-up visits, and outcome of parameters which included clinically: plaque index (PI), probing depth (PD), bleeding on probing (BOP) and radiographically: crestal bone loss (CBL). Additional data on lasers were also collected, although not all studies had complete data on this. RevMan was used for statistical analysis. Inconsistencies were evaluated using I2 value > 50% and Cochrane's Q test, with a P value < 0.05 considered. Standard Mean Differences (SMD) were calculated and Confidence Interval was set at 95%. A random effects model was used for each meta-analysis. PI had no statistical difference, with high heterogeneity. PD had no statistical difference, with no heterogeneity. BOP had a statistically significant difference and a high level of heterogeneity, favouring adjunctive phototherapy. MBL had statistically non-significant differences between control and test groups, and no heterogeneity. The findings from the systematic review differed from the meta-analysis, suggesting that application of adjuvant phototherapy was equally as effective as adjunctive antibiotic therapy in outcomes such as PI, PD, BOP and MBL. The meta-analysis found that implants treated with adjuvant phototherapy had superior outcomes in relation to BOP only.

Abstract 4138494: Remote Blood Pressure Monitoring and Intervention as a better and cost-effective method of Hypertension control compared to Usual care: A Systematic Review

Introduction/Background: Hypertension is a leading cause of morbidity and mortality. Despite treatment recommendations and encouragement of lifestyle changes, the actual rate of blood pressure control is still not at par. Remote intervention methods have been shown to achieve better rates of blood pressure control utilising lesser resources and lower healthcare costs. We conducted a systematic review by qualitatively evaluating the potential impact of remote monitoring and interventions compared to usual care in controlling Hypertension. Research Question: Are remote monitoring techniques and interventions better than usual in-person blood pressure checks for hypertension control? Methods: We did a comprehensive literature search of Pubmed/MEDLINE, Google scholar, Cochrane central Library, PLOS ONE, ScienceDirect and Clinicaltrials.gov to identify eligible randomised control trials and clinical trials published between July 2013 and May 2025. A Risk of Bias assessment was conducted using Cochrane Risk of Bias tools such as ROB-2 for randomised control trials and ROBINS-1 for cohort studies. This study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: Of the 5,185 records analysed, 10 randomised control trials, 1 cohort study and 1 implementation study satisfied our inclusion criteria. Compared to usual care, remote monitoring methods showed significant difference in systolic blood pressure control at 6-12 months in 9 out of 12 studies, while 3 studies did not show any significant difference. Quality of life, physical health, mental health and drug compliance have also shown a significant positive difference in patients. Remote self monitoring interventions were found to be more cost-effective than usual care. They also reduced the load of patients seeking appointments for hypertension control thereby improving the quality of patient care. Conclusion: The management of clinical hypertension is a challenging entity. Conventional methods of regular in-office blood pressure checks are both tedious and resource consuming. Using remote monitoring methods have shown to significantly improve blood pressure control compared to routine methods. It also eliminates white-coat hypertension during follow-up blood pressure checks which leads to more appropriate interventions. Remote monitoring and intervention for hypertension control is time-effective, cost-effective and improves quality of life.

Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials.

The current European Stroke Organisation expedited recommendation on tenecteplase (TNK) for acute ischemic stroke (AIS) advocates that TNK 0.25 mg/kg can be used alternatively to alteplase (tissue plasminogen activator [TPA]) for AIS of <4.5 hours duration, based on a meta-analytical approach establishing noninferiority. Since the publication of these guidelines, 4 additional randomized controlled clinical trials (RCTs) have provided further insight. We conducted an updated systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of TNK 0.25 mg/kg compared with TPA for the treatment of AIS within 4.5 hours of onset. The primary outcome was defined as the excellent functional outcome at 3 months (modified Rankin Scale [mRS] score 0-1), whereas good functional outcome (mRS score 0-2), reduced disability at 3 months (≥1-point reduction across all mRS scores), symptomatic intracranial hemorrhage (sICH), and 3-month mortality were evaluated as secondary outcomes. Pooled estimates were calculated with random-effects model. A prespecified subgroup analysis was performed stratifying for TNK formulation, that is, original TNK vs biocopy: recombinant human TNK tissue-type plasminogen activator that is available in China and has a different production process. Eleven RCTs were included comprising a total of 3,788 patients treated with TNK vs 3,757 patients treated with TPA. TNK was associated with higher likelihood of excellent functional outcome (risk ratio [RR] 1.05, 95% CI 1.01-1.10; p = 0.012; I2 = 0%; risk difference 2.95%; 95% CI 0.76%-5.14%; p = 0.008; I2 = 0%) and reduced disability at 3 months (common odds ratio 1.10, 95% CI 1.01-1.19; p = 0.034; I2 = 0%) compared with TPA while good functional outcome (RR 1.03, 95% CI 0.99-1.07; p = 0.142; I2 = 28%) was similar between the groups. Regarding safety outcomes, similar rates of sICH (RR 1.12, 95% CI 0.83-1.53; p = 0.456; I2 = 0%) and 3-month mortality (RR 0.97, 95% CI 0.82-1.15; p = 0.727; I2 = 12%) were observed. When stratified for TNK regimen (original vs biocopy), statistical significance in achieving an excellent functional outcome at 3 months was retained for the original TNK (RR 1.05, 95% CI 1.00-1.10; p = 0.044; I2 = 0%). The updated meta-analysis confirms similar safety between TNK 0.25 mg/kg and TPA, while showing that TNK is superior to TPA regarding excellent functional outcome and reduced disability at 3 months. These findings support transitioning to TNK in clinical practice.

Exploring optimal administration timing of pegylated recombinant human granulocyte colony-stimulating factor for chemotherapy-induced neutropenia in early breast cancer treated with pharmorubicin and endoxan: a prospective randomized controlled clinical trial.

Pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) is a treatment for preventing febrile neutropenia (FN) in patients with early breast cancer. However, the optimal injection timing of PEG-rhG-CSF after chemotherapy is obscure. The trial was designed to explore the best administration timing of PEG-rhG-CSF when breast cancer patients could benefit most. Patients with early breast cancer were randomly assigned to receive a preventive injection on the 7th or 3rd day following chemotherapy. The experimental group (n = 80) received PEG-rhG-CSF treatment on day 7 after chemotherapy, whereas the control group (n = 80) received it on day 3. The occurrence of grades 3-4 neutropenia and FN in the first cycle was the primary endpoint. The secondary endpoint was the frequency of PEG-rhG-CSF dose reduction. In comparison to the control group, the experimental group exhibited higher white blood cell count (WBC) and absolute neutrophil count (ANC) on the 9th and 13th days following chemotherapy (P < 0.05). Additionally, the incidence of grade 3-4 neutropenia was significantly lower in the experimental group (P = 0.038). Furthermore, a greater proportion of patients in the experimental group met the criteria for reducing the PEG-rhG-CSF dose compared to the control group (69.74% vs. 35.06%, P < 0.001). In comparison with PEG-rhG-CSF injection on day 3 after chemotherapy, the incidence of grade 3-4 myelosuppression is lower, and the safety is more manageable after the injection on day 7. This approach potentially allows for a wider adoption of PEG-rhG-CSF dose reduction, leading to a consequential decrease in overall medical costs for patients. Clinical Trials: NCT04477616. Registered July 16, 2020.

Effects of pericapsular nerve group block on early postoperative cognitive function in older people undergoing hip arthroplasty: a randomized controlled clinical trial.

Pericapsular nerve group (PENG) block has emerged as a reliable analgesia technique for hip arthroplasty (HA). However, the effects of PENG block on perioperative neurocognitive disorder (PND) after HA has not yet been assessed. The present study aimed to investigate the effects of PENG block on early postoperative cognitive function in older people undergoing hip arthroplasty. Sixty older patients undergoing HA under spinal anesthesia were randomly assigned to group P (n = 30) receiving PENG block with ropivacaine and patient-controlled intravenous analgesia (PCIA) pump with sufentanil after surgery or group C (n = 30) only receiving PCIA pump with sufentanil after surgery. The primary outcome was the Mini-Mental State Examination (MMSE) score at 7 days postoperatively. Secondary outcomes consisted of the incidence of PND 7 days postoperatively, the static VAS pain scores at 6, 12, 24, and 48h postoperatively; cumulative sufentanil consumption and the requirement of rescue analgesia during the 0-24h period after surgery; quality of recovery-15 (QoR-15) scale scores at 24h postoperatively; and the plasma levels of high mobility group box protein 1 (HMGB1) preoperatively and 1day after surgery, and adverse events. After surgery, the PENG block group had higher MMSE score than the control group at 7 days postoperatively (27.0 ± 1.8 vs. 26.1 ± 1.7, P = 0.048), with a mean difference of 0.9 (95%CI, 0.1-0.9). The incidence of PND at 7 days postoperatively was 6.7% in group P, lower than that of 30% in group C (P = 0.044). In group P, the static VAS scores at 6, 12, and 24h postoperatively were significantly lower than those in group C (all P < 0.05). Compared with group C, the cumulative sufentanil consumption and the number of patients required rescue analgesia during the 0-24h period after surgery were significantly lower in group P (all P < 0.05). The scores of QoR-15 scale were higher in group P at 24h postoperatively than those in group C (P < 0.05). Patients in group P showed lower plasma levels of HMGB1 than group C at 1day after surgery (P < 0.05), and the rate of complications didn't differ between both groups. Older people undergoing HA receiving a PENG block for perioperative analgesia experience improved early postoperative cognitive function, reduced postoperative pain, higher quality of recovery, and less postoperative inflammatory response. Chictr.org.cn identifier ChiCTR2200061055 (Date of registry: 15/06/2022, prospectively registered).

Ciprofol versus propofol for anesthesia induction in cardiac surgery: a randomized double-blind controlled clinical trial.

Ciprofol, a novel intravenous general anesthetic with a chemical structure similar to propofol, exhibits significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and has comparable effects on heart rate and blood pressure to propofol. However, clinical data on its use for anesthesia induction in cardiac surgery remain limited. Seventy-eight patients undergoing coronary artery bypass grafting or valve replacement surgery were randomly assigned to receive either ciprofol (N = 40) or propofol (N = 38) for anesthesia induction. Variables recorded included changes in mean arterial pressure and heart rate during anesthesia, alterations in the oxygenation index and lactic acid concentration before and 10min after anesthesia induction, and the incidence of adverse events such as bradycardia, hypotension, and injection pain. The incidence of anesthesia-induced injection pain was significantly lower in the ciprofol group compared to the propofol group (3% vs. 18%, P < 0.05). The incidence of other adverse events was similar between the groups. No significant differences in hemodynamics or oxygenation index were observed during anesthesia induction between ciprofol and propofol. Ciprofol demonstrated a significantly lower incidence of injection pain compared to propofol, potentially improving patient comfort during anesthesia induction. Additionally, ciprofol showed comparable circulatory stability to propofol during anesthesia induction in cardiac surgery, suggesting it may be a suitable alternative to propofol for this application. The trial was registered at the ClinicalTrials.gov on 03/10/2024 (NCT06312345).

Influence of an inspiratory muscle fatigue protocol on older adults on respiratory muscle strength and heart rate variability. A randomized controlled trial

IntroductionInspiratory muscle fatigue has been shown to have effects on the autonomic nervous system and physical condition. This study aimed to evaluate the influence of an inspiratory muscle fatigue protocol on respiratory muscle strength and heart rate variability in older adults.Materials and methodsA randomized controlled clinical trial with double-blinding was carried out involving 24 individuals over 60 years old who demonstrated physical independence in walking and movement. Participants were distributed randomly into three groups: Inspiratory muscle fatigue, activation and control. Measurements of heart rate variability, diaphragmatic ultrasound, and maximum inspiratory pressure were taken at two stages: prior to the intervention (T1) and directly after treatment (T2).ResultsThe inspiratory muscle fatigue group exhibited decrease scores in respiratory and heart rate variability subsequent to undergoing the diaphragmatic fatigue intervention compared to both the activation and control groups (p &amp;lt; 0.05). Conversely, the activation group demonstrated higher values in heart rate variability and respiratory capacity variables following the inspiratory muscle activation training (p &amp;lt; 0.05).ConclusionsFatigue of the inspiratory musculature appears to negatively impact heart rate variability and inspiratory muscle strength in older adults.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT06269042, identifier: NCT06269042.

Abstract 4117365: Effect Of Renal Denervation In Combination With Cardiac Ablation On The Recurrence Of Atrial Fibrillation: A Systematic Review and Meta-Analysis

Background: Atrial fibrillation(AF) is the most common cardiac arrhythmia, affecting millions globally. Despite various treatments, recurrence remains high, especially among those with drug-resistant hypertension. Aim: To evaluate the efficacy of combining Renal Denervation and Cardiac Ablation compared to Cardiac Ablation Alone in reducing AF recurrence. Methods: A systematic review and meta-analysis were conducted following the PRISMA-2020 guidelines, A search for randomized controlled clinical trials was carried out in PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and ScienceDirect until March 2024. Specifically, about adult patients aged 18 years and above diagnosed with AF and drug-resistant hypertension undergoing renal denervation and or cardiac ablation. The primary outcome was the recurrence of AF. The secondary outcomes were effects on systolic blood pressure, diastolic blood pressure, cardiovascular structural changes, glomerular filtration rate (eGFR). In addition, periprocedural events and major complication events. Dichotomous outcomes were calculated using relative risk (RR) with 95% confidence interval (CI). For continuous variables, the results were shown considering the mean difference (MD) and standard deviation with 95% CI. Results: From 409 studies identified, 8 studies and 695 patients were included. Meta-analysis showed a significant reduction in atrial fibrillation recurrence with the combination therapy (HR 0.66 [95% CI=0.55 – 0.79], p=0.00001). Blood pressure outcomes were superior in the combination group, with reductions in both systolic (MD = -9.66 mmHg [95% CI: -13.89, -5.42], p=0.00001) and diastolic pressures (MD = -7.09 mmHg [95% CI: -13.67, -0.50], p=0.003). Cardiovascular structural changes, such as left atrial size (RR 2.85 [95% CI: 2.13, 3.81], p=0.00001) and interventricular septal thickness (MD = -1.15 [95% CI: -1.85, -0.44], p=0.003), also favored the combination therapy. Kidney function, measured by eGFR was better preserved (MD = -10.34 [95% CI: -13.39, -7.28], p&lt;0.00001). Conclusion: The combination of RDN and CA is more effective than CA alone in reducing the recurrence of AF, with additional benefits in blood pressure control, cardiovascular structural improvements, and renal function preservation.

Pooled safety analysis from the VOLTAIRE clinical trials of adalimumab-adbm and adalimumab reference product in patients with rheumatoid arthritis, Crohn’s disease, and chronic plaque psoriasis

ABSTRACT Objectives This analysis reported the incidence of safety endpoints across five phase 3 randomized controlled clinical trials in patients with rheumatoid arthritis (RA), Crohn’s disease (CD), and chronic plaque psoriasis (PsO) who received ≥ 1 dose of adalimumab-adbm or adalimumab reference product (RP). Methods Exposure-adjusted incidence rates for safety endpoints were calculated per 100 patient-years and reported by disease indication and treatment arm. Subgroup analyses by patient age and sex were also conducted. Results The mean length of follow-up was 62 weeks, 48 weeks, and 32 weeks for patients with RA, CD, and PsO, respectively. Rates of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) were similar among patients with RA and PsO, but slightly higher among those with CD. Incidence rates of all safety endpoints were consistent between the adalimumab-adbm and adalimumab RP treatment arms within each indication Subgroup analyses of patients with RA, CD, and PsO showed no between-group differences by age and sex. Conclusions In patients with RA, CD, and PsO, there were no differences between biosimilar adalimumab-adbm or the adalimumab RP regarding the rate of AEs, SAEs, discontinuations due to AEs, deaths, or any AEs of special interest.

CTNI-31. AI-GUIDED PERSONALIZED PRECISION RADIATION THERAPY WITH TARGETED DOSE ESCALATION FOR NEWLY DIAGNOSED GLIOBLASTOMA: A MATCHED-CONTROL STUDY

Abstract BACKGROUND The purpose of this study was to assess the feasibility and effectiveness of AI-guided personalized precision radiation therapy (PPRT) with targeted dose escalation in enhancing outcomes for patients with newly diagnosed glioblastoma. METHODS An open-label trial was conducted at the University of Pennsylvania (NCT03477513) from August 2018 to April 2023, enrolling 20 patients with IDH-wildtype glioblastoma who underwent maximal safe resection. They were matched with a contemporaneous cohort of glioblastoma patients based on age, sex, extent of resection (EOR), O6-methylguanine-DNA methyltransferase promoter (MGMTp) methylation status, and IDH status. Propensity score matching (PSM) was employed to select the control group, utilizing one-to-four nearest neighbor matching. One patient was excluded due to concurrent treatment with tumor treating fields (TTFields). The PPRT group received personalized radiation dose escalation to 75 Gy in 30 fractions guided by AI-based predictive modeling of recurrence, along with temozolomide chemotherapy. The control group received standard-of-care chemoradiotherapy, 60 Gy in 30 fractions. A previously published and evaluated (retrospectively and prospectively) predictive AI model, which has demonstrated high predictive value for neoplastic cell infiltration and future tumor recurrence using preoperative, multi-parametric MRIs, was utilized. RESULTS Median overall survival was 24.3 months in the PPRT-temozolomide group compared to 17.5 months in the standard-of-care treatment group (hazard ratio [HR]=0.30; 95% CI: 0.16-0.57; p&amp;lt;0.001). Excluding two patients with leptomeningeal disease and bone marrow metastasis, the median survival was 35.4 months (HR=0.25; 95% CI: 0.12-0.51; p&amp;lt;0.001). CONCLUSION AI-guided PPRT for newly diagnosed glioblastoma patients demonstrated feasibility in routine clinical practice and significantly improved overall survival compared to matched controls receiving standard-of-care treatment. These findings underscore the potential of personalized precision radiation therapy, with focused dose escalation, in improving outcomes for glioblastoma patients and emphasize the need for prospective validation in a randomized controlled clinical trial.

Evaluation of patient satisfaction and maximum biting force of three differently constructed bars on two implants retaining mandibular overdenture - one year follow-up (a randomized controlled clinical trial)

BackgroundDifferent bar construction techniques will affect the bar passive fitness, which may induce stresses or strain on the implant and/or tightening screw and sequentially may affect the biting force and patient satisfaction.Aim of the studyThis clinical investigation assessed patient satisfaction and maximum biting force (MBF) using three differently constructed (conventional casting, milling, and 3D printing CAD/CAM techniques) cobalt-chromium (Co-Cr) bar-retained implants mandibular overdentures over a one-year period of follow-up.Materials and methodsThirty edentulous patients seeking for two implants bar-retained mandibular overdentures were randomly assigned into three groups as the following: Group I: 10 patients received a Co-Cr conventional casting bar, Group II: 10 patients received a Co-Cr CAD/CAM milled bar, and Group III: 10 patients received a Co-Cr CAD/CAM 3D-printed bar. All the bar groups were connected to two implants in the canine area bilaterally. Within the first two weeks following implant placement, patients received the definitive prosthesis. Patient satisfaction was evaluated by using the (OHIP-EDENT-19) questionnaire form after 6, and 12 months. Additionally, the maximum biting force was tested at after delivery, 3, 6, and 12 months for each group. The results were collected, tabulated, and statistically analyzed. Trial registration: This study was recorded on ClinicalTrials.gov retrospectively registered (ID: NCT06401187) on 30/04/2024.ResultsAfter one year follow up, regrading patient satisfaction the three groups showed no statistically significant difference. Although, the functional limitation domain was in favor of the milled bar. Regarding the maximum biting force, no statistically significant difference was found among three groups. However, at 12 mouths follow-up the milled bar showed statistically value.ConclusionWithin the limitations of this study, the conventional, milled and 3D printed bar overdentures groups can be used as a satisfactory treatment modality for edentulous mandible in terms of patient satisfaction and maximum biting force.

Effect of dural puncture epidural technique combined with programmed intermittent epidural bolus on labor analgesia: A randomized, double-blind, parallel-group, controlled clinical trial.

Labor analgesia can be achieved by different approaches. The efficacy and safety of combined dural puncture epidural (DPE) with program intermittent epidural bolus (PIEB) are not well characterized. This study aimed to compare the efficacy and safety of DPE combined with PIEB vs epidural (EP) combined with PIEB for labor analgesia. We performed a prospective, randomized, double-blind, parallel-group, controlled clinical trial. Eligible pregnant nulliparous women received either DPE combined with PIEB (group D) or epidural combined with PIEB (group E) for labor analgesia. Analgesia was initiated with 0.1% ropivacaine + 0.3 µg/mL sufentanil and maintained with PIEB at 12 mL/h. Primary outcome was the proportion of women with adequate analgesia within 10 minutes after the initiation of analgesics. Secondary outcomes (time to achieve analgesia, time to first request for additional analgesic, proportion of women required additional analgesic or epidural catheter adjustment and resetting, total labor duration, total analgesic consumption, level of anesthesia, and motor block), side effects, and patient satisfaction were also documented. Out of 174 enrolled women, 160 were included in the analysis. Baseline characteristics were comparable. The proportion of women who achieved adequate analgesia in group D was significantly greater than that in group E (38.8% vs 20.0%, P < .05). Compared with group E, group D also showed advantages in faster adequate analgesic achievement, more likely to reach adequate analgesia, a longer time to maintain analgesia, lesser requirements for additional analgesic, and better sensory blocks. There were no significant inter-group differences in other outcome measures. Compared with epidural and PIEB mode, DPE and PIEB mode achieved better analgesia without increasing maternal or neonatal side-effects during labor.