Randomized Trial Research Articles

Respiratory complications of propofol, sevoflurane, and dexmedetomidine anesthesia for fiberoptic bronchoscopy in children aged 1 month to 3 years: a randomized trial

To evaluate the effect of propofol, sevoflurane, and dexmedetomidine on respiratory complications in children undergoing fiberoptic bronchoscopy (FOB). This double-blind randomized clinical trial was conducted among 120 children aged 1 month to 3 years undergoing FOB. The patients were randomized into 3 groups (n=40) for anesthesia induction with sevoflurane inhalation, 1 mg/kg propofol, or 1 μg/kg dexmedetomidine before bronchoscopy, and the changes in hemodynamic parameters, sedation level, and respiratory complications during and after the procedure were assessed. The patients' heart rate during bronchoscopy was significantly lower and the mean arterial blood pressure significantly higher in dexmedetomidine group than in sevoflurane and propofol groups (P < 0.05). Cough during bronchoscopy did not occur in any of the cases in propofol group, while the highest frequency of cough was recorded in dexmedetomidine group. The incidence of laryngospasm in the propofol group (12.5%) was significantly lower than those in sevoflurane and dexmedetomidine groups (30% and 32.5%, respectively) (P < 0.05). Sevoflurane and propofol are safe and suitable for anesthesia induction in children below 3 years of age undergoing diagnostic FOB and can achieve better sedative effect and lower the incidences of cough and respiratory complications as compared with dexmedetomidine.

The effect of Fenugreek seed dry extract supplement on glycemic indices, lipid profile, and prooxidant-antioxidant balance in patients with type 2 diabetes: A double-blind randomized clinical trial.

This study aims to determine the effects of fenugreek seed dry extract (FDE) on the glycemic indices, lipid profile, and prooxidant-antioxidant balance (PAB) in patients with type 2 diabetes (T2D). A double-blind randomized clinical trial was carried out on 54 individuals with T2D. Participants were randomly assigned to a FDE group (received 3 tablets containing 335 mg of FDE daily for 8 weeks) or a placebo group (received tablets containing microcrystalline cellulose). Anthropometric indices, physical activity, diet, fasting blood sugar (FBS), serum insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), triglyceride (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein (HDL-C), and PAB were assessed. An eight-week intake of 3 tablets containing 335 mg of FDE decreased serum insulin (P=0.016, P<0.001), HOMA-IR (P=0.009, P<0.001), TG (P<0.001, P=0.001), and PAB (P<0.001, P<0.001) compared to the baseline, in both placebo and intervention groups respectively. TC decreased significantly compared to the baseline in the placebo group (P=0.028), while HDL-C increased in the FDE group compared to the baseline (P<0.001) and placebo group (P=0.014). In the present study even though changes of parameters were more in intervention group compared to the control group, we did not observe any significant differences between studied groups except for HDL-C. However, the effects might become apparent with a higher dosage, longer study duration, or a larger sample size compared to the placebo group. Further clinical trials are needed in this regard.

A comparative Clinical Trial of Laparoscopic Appendectomy versus Open Appendectomy in uncomplicated Cases

Background: Appendicitis is one of the most frequent causes of acute abdominal pain and usually leads to the surgery called appendectomy. Various advantages can be associated with laparoscopic appendectomy but possible disadvantages include longer operative time and complications. Objectives: The purpose of this research was to find out the differences between laparoscopic appendectomy (LA) and open appendectomy (OP) in patients with uncomplicated acute appendicitis focusing on operative time, length of hospital stay, postoperative pain, postoperative complication rates, and patient satisfaction. Methods: The present study was a comparative randomized clinical trial performed in Farooq Teaching Hospital and Hameed Latif Teaching Hospital from January 2023 to January 2024. Two hundred patients with uncomplicated appendicitis were randomly chosen and divided into the laparoscopic appendectomy(n=100) and the open appendectomy(n=100). Primary outcomes were operative time, length of hospital stay, postoperative pain as assessed by the Visual Analog Scale, and complications. Secondary measures were time to resume normal activities, and patients’ satisfaction, measured on a Likert scale. Descriptive statistics, Student’s t-test and chi-square test were used for analysis and p≤0.05 was considered significant. Results: Laparoscopic appendectomy took a relatively longer mean operative time (54. 9 ± 14. 2 min) in comparison with open appendectomy (31. 4 ± 11. 1 min) with p&lt;0.001 but overall, the patients who underwent laparoscopic appendectomy had lesser hospital stay (1. 4 ± 0. 6 days) than those who underwent open appendectomy (2.7 ± 2.5 days, p&lt;0.01). Patients were able to get back to their normal activities sooner (11. 5 ± 3. 1 days; 16. 1 ± 3. 3 days; t = -3. 80; p&lt;0.01) and expressed higher level of satisfaction (4.7 ± 0.6 vs. 3.9 ± 0.7, p&lt;0.01). Conclusion: Compared to open appendectomy, laparoscopic appendectomy has a longer operative time, but the advantages include less postoperative recovery time, less postoperative pain and higher postoperative patient satisfaction.

Comparative Effects of Gaze Stabilization Exercises and Cawthorne-Cooksey Exercises on Craniovertebral Angle and Vestibulo-Ocular Reflex in IT Students

Background: Vestibular dysfunction affects balance and spatial orientation, leading to symptoms like dizziness and impaired gaze stability. Forward head posture (FHP) is common among IT students due to prolonged screen time, exacerbating vestibular and postural issues.Objective: To compare the effects of Gaze Stabilization Exercises (GSE) and Cawthorne-Cooksey Exercises (CCE) on craniovertebral angle (CVA) and vestibulo-ocular reflex (VOR) among IT students.Methods: A single-blinded randomized clinical trial was conducted on 50 IT students aged 19-25 years with FHP. Participants were randomly assigned to GSE (n=25) or CCE (n=25) groups. Interventions were performed thrice weekly for 3 weeks. CVA and VOR were assessed pre- and post-intervention using a goniometer and clinical scale, respectively. Data were analyzed using SPSS version 27 with Wilcoxon signed-rank and Mann-Whitney U tests.Results: Post-intervention, Group B (CCE) showed a significant increase in CVA (mean rank 26.80, U = 280.000, p = 0.527). Group A (GSE) demonstrated a significant reduction in VOR (mean rank 30.80, U = 180.00, p = 0.003).Conclusion: GSE effectively improved VOR, while CCE significantly enhanced CVA, indicating the potential for targeted rehabilitation in addressing vestibular and postural dysfunctions.

Comparing the effect of sedation with dexmedetomidine and propofol on sleep quality of patients after cardiac surgery: A randomized clinical trial.

Sleep quality is the main concern of patients after cardiac surgery. We compared the effect of two routinely used sedatives on the sleep quality of patients admitted to the intensive care unit (ICU) after cardiovascular surgery. It is a prospective, controlled, randomized clinical trial. A total of 120 patients, after cardiac surgery were enrolled. During extubating, patients were randomized into two groups: 60 patients received an infusion of dexmedetomidine (precede; 0.5 μg/kg/h), and 60 patients received 50 μg/kg/min propofol for 6 hours. Baseline characteristics were compared between the groups. The patients completed the St. Mary's Hospital Sleep Questionnaire, and the scores were compared between the groups. The groups were not different in terms of demographics, underlying diseases, smoking/drug abuse/alcohol, number of vessels involved, history of non-cardiac surgery, and mean levels of serum parameters (P>0.05). Most of the medications used were similar between the groups (P>0.05), except calcium channel blockers (more frequently used in the propofol group [P=0.027). The details of surgery were not statistically significant different (P>0.05); but, the mean volume of platelet received after the surgery was higher in propofol group (P=0.03). The propofol group had less problems with last night's sleep (0 vs 0.1±0.66), felt more clear-headed (4.9±0.6 vs 4.68±0.58, were more satisfied with their last night's sleep (52.1% vs 47.9%), but spent more time getting into sleep (0.38±1.67 vs 0 ) (P<0.5). The sleep quality of patients under the influence of propofol seemed to be better than dexmedetomidine after cardiac surgery.

The Effect of Rood's Ontogenic Motor Patterns on Trunk Control and Balance in Spastic Diplegic Cerebral Palsy Children

Background: Cerebral palsy (CP) is a non-progressive neuromotor disorder affecting movement, muscle tone, and posture due to brain injury during early development. Effective interventions are essential for improving functional outcomes in children with spastic diplegic CP.Objective: This study aimed to evaluate the effects of Rood's Ontogenic Motor Patterns (ROMP) on trunk control and balance in children with spastic diplegic cerebral palsy.Methods: A single-blinded randomized clinical trial was conducted with 22 children aged 3-10 years, diagnosed with spastic diplegic CP. Participants were randomly assigned to two groups: Group A received Functional Electrical Stimulation with ROMP, and Group B received conventional physical therapy. The intervention lasted five weeks, with three sessions per week. Outcomes were assessed using the Modified Ashworth Scale, Gross Motor Function Measurement Scale (GMFM-88), and Pediatric Berg Balance Scale. Data were analyzed using SPSS 27.Results: Group A showed significant improvement in balance (PBBS: pre 13.81 ± 1.64, post 24.18 ± 4.67; p=0.017) and GMFM-88 scores (pre 9.95 ± 109.50, post 15.73 ± 173.0; p&lt;0.001). Spasticity reduced significantly in the ROMP group (MAS: pre 11.50 ± 126.50, post 7.30 ± 73.00; p=0.010).Conclusion: ROMP significantly improved balance and reduced spasticity in children with spastic diplegic CP compared to conventional therapy, suggesting its potential integration into rehabilitation programs.

Infectious Diseases-Approved Virtual Reality Goggles for Common Procedures in Pediatric Surgical Patients.

Background/Objective: Virtual reality (VR) technology has been reported as effective in mitigating fear, anxiety, and pain in children undergoing various medical procedures. Our aim was to test the effectiveness of non-sponge-coated mobile phone-operated VR goggles approved by infectious diseases (ID) control in pediatric surgical patients. Methods: A prospective randomized trial in which pre-procedural and post-procedural heart rate, fear, and anxiety, and post-procedural pain were measured in pediatric surgical patients assigned to receive standard care versus standard care and VR goggles. The patients underwent line insertions, peripheral venipunctures for blood draws, drain removals, and wound care. Results: The control group and the intention-to-treat group were each randomly assigned twenty-four patients. Since eight patients who received VR goggles removed them prior to completion of the procedure, the study group included sixteen patients. In the study group, heart rate, fear, and anxiety scores were significantly lower after the procedure as compared to prior to the procedure. In the control group, these parameters were similar before and after the procedure. Post-procedural decrease in fear and anxiety was significant when comparing VR to control. However, despite better post-procedural physiological and emotional scores in the VR group as compared to control, the differences were not statistically significant. Pre-procedural anxiety was significantly higher in the study group. Conclusions: ID-approved VR goggles can reduce fear and anxiety associated with procedures commonly performed in pedicatric surgical patients. However, since increased baseline anxiety might be associated with VR, a higher benefit might be achieved if goggles were worn only by children who express a clear desire to use them.

Carpal tunnel release under local anesthesia with or without distal median nerve block: Double-blind randomized clinical trial

Background: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, and its surgical treatment is carpal tunnel release (CTR). It is mostly performed in local anesthesia. There are no clinical randomized controlled trials (RCTs) comparing local infiltration anesthesia with or without a distal median nerve block in CTR. The aim of the PERSONNEL trial (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is to assess whether a distal median nerve block reduces pain during and after the procedure in addition to local anesthesia. Methods: This is a single-center randomized clinical superiority trial comparing local anesthesia alone and local anesthesia with a distal median nerve block for CTR in patients with CTS. Adult patients will be randomized in one university hospital in Finland, and the intended sample size is 118. The primary outcome is the mean pain level after the procedure during 72 h using a visual analogue scale (VAS). The secondary outcomes include expected pain; pain during the injection of the anesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ); pain killer consumption;, patient satisfaction using Net Promoter Score (NPS); and complications. Discussion: Patient satisfaction is a crucial factor in modern healthcare. A distal median nerve block may reduce pain during and after CTR, potentially increasing patient satisfaction with the given treatment. It can also be hypothesized that better postoperative pain control may prevent complications, for example, complex regional pain syndrome. However, we lack adequate evidence to justify the use of distal median nerve block, which can itself predispose patients to complications, for example, median nerve injury. Therefore, there is a need for adequate RCTs to assess its efficacy. The results of this study can be used to optimize anesthesia for carpal tunnel surgery, improve patient satisfaction, and possibly prevent complications. Registration: ClinicalTrials.gov NCT05372393.

Effectiveness of long-term low-dose aspirin in the prevention of gastric cancer after Helicobacter pylori eradication: study design and rationale of Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT)

BackgroundIn addition to Helicobacter pylori (H. pylori) infection eradication, some medications, including aspirin, metformin, and statins, have been suggested to have protective effects against gastric cancer (GC) development in observational studies. We launched the Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT) to evaluate the effectiveness of long-term low-dose aspirin use for the prevention of development and mortality of GC after H. pylori eradication.Methods/designAGCPT is a prospective population-based double-blind, randomized clinical trial. The study sample was targeted at 21,000 participants aged from 35 to 70 years old, both sexes, in Ardabil, a province in northwest Iran with relatively high rates of GC incidence and mortality. All eligible participants were initially tested for H. pylori infection using a H. pylori stool antigen test. Participants with positive tests undergo H. pylori eradication by standard treatment regimens. All participants with a negative test and those with a positive test with a subsequent confirmed H. pylori eradication test were entered into the intervention phase. In the intervention phase, participants were allocated randomly into either the treatment (daily oral consumption of 81 mg enteric-coated aspirin tablets) arm or the control (placebo) arm using permuted balanced blocks. Subjects will be followed for an average period of 10 years to evaluate the incidence and mortality rates of GC.DiscussionIn addition to preventing other diseases like cardiovascular events, aspirin may prevent GC incidence and mortality. AGCPT will investigate the difference between the two study arms in the proportion of the cumulative incidence and mortality rates of GC. The study’s results may help policymakers and researchers update the strategies for GC prevention.Trial registrationThis trial with the registry name of “The effect of Low-dose Aspirin in the Prevention of Gastric Cancer” was registered in the Iranian Registry of Clinical Trials, IRCT.ir, under the identifier IRCT201105082032N3. Registered on April 21, 2017.

Analysis of osseointegration of implants with macrogeometries with healing chambers: a randomized clinical trial

BackgroundTo verify the influence of macrogeometry with healing chambers on the osseointegration of dental implants by analyzing implant stability quotient (ISQ) and evaluate the correlation between insertion torque and ISQ insertion with different macrogeometries.MethodsIn total, 26 implants were installed in the posterior mandible of eight patients with sufficient bone height for the installation of implants measuring 3.5 mm in diameter and 9.0 mm in length. The implants were categorized according to two types of macrogeometry: a test group (GT) with 13 conical implants with healing chambers and a control group (GC) with 13 conical implants with conventional threads. To insert the implants, a bone drilling protocol was used up to a diameter of 3 mm with the last helical bur. The insertion torque of the implants was evaluated, followed by the measurement of ISQ at 0 (T-0), 7 (T-7), 14 (T-14), 21 (T-21), 28 (T-28), and 42 (T-42) days.ResultsThe mean insertion torque was 43 Ncm in both groups, without a significant difference. Moreover, no significant difference in the ISQ values was found between the groups at different time points (p > 0.05), except at T-7 (GT = 69.87±1.89 and GC = 66.48±4.49; p = 0.01). Although there was no significant difference, ISQ median values were higher in the GT group than GC group at 28 days (GT = 67.98 and GC = 63.46; p = 0.05) and 42 days (GT = 66.12 and GC = 60.33; p = 0.09). No correlation was found between the insertion torque and ISQ insertion (p > 0.05).ConclusionFurthermore, implants with a 3.5 mm diameter macrogeometry, with or without healing chambers, inserted with a drilling protocol up to 3 mm in diameter of the last helical bur, led to a similar secondary stability, with no difference in ISQ values. Although, implants with healing chamber demonstrates ascending values in the graph of ISQ, having a trend of faster osseointegration than implants without healing chambers. Both macrogeometries provide a similar primary stability to implants.Trial registrationThis study was registered retrospectively in ReBec (brazilian registry of clinical trials) under the number RBR-96n5×69, on the date of 19/06/2023.

The effectiveness of vedolizumab in advanced therapy-experienced ulcerative colitis patients: Real world data from the Inflammatory Bowel Disease of the Middle East (IBD-ME) Registry group.

Vedolizumab is an approved ulcerative colitis (UC) treatment. Multiple large randomized clinical trials have demonstrated the drug's efficacy and safety. However, real-world data from Middle Eastern countries are spare. The study aims to evaluate the clinical efficacy of vedolizumab (VDZ) therapy in advanced therapy experienced UC patients. A retrospective electronic chart review of a cohort study of 153 moderately to severely active UC patients who failed or were intolerant to TNF antagonists and received vedolizumab from two large tertiary care centers was performed. Rates of clinical response and remission were retrospectively evaluated at 3,6, and 12 months post VDZ therapy using Patient Simple Clinical Colitis Activity Index (P-SCCAI); clinical response was defined as a decrease in P-SCCAI ≥3, and clinical remission was defined as a P-SCCAI score of ≤3 points. Logistic regression analysis was used to identify predictors of response to vedolizumab. A total of 153 UC patients had sufficient data for analysis. Clinical remission rates were 61.9% for patients on vedolizumab every 8 weeks and 89.3% for those receiving every 4 (Q4) weeks dosing. A significant reduction in CRP and improvement of albumin post vedolizumab treatment were observed, and corticosteroids were stopped in most patients. In a multiple logistic regression analysis, several factors were found to influence the clinical effectiveness of VDZ in inducing remission. Female gender was associated with a higher likelihood of remission [OR =3.09, 95% CI = (1.05-9.13), P = 0.04]. Conversely, a greater number of biologics used prior to VDZ treatment was associated with a lower likelihood of remission [OR =0.418, 95% CI = (0.203-0.859), P = 0.017]. Patients with extensive disease (E3) had an increased likelihood of remission [OR =3.81, 95% CI = (1.32-10.97), P = 0.0129]. Additionally, a VDZ dosing frequency of Q4 weeks was associated with a significantly higher likelihood of remission [OR =6.08, 95% CI = (1.73-21.39), P = 0.0049]. No significant safety signals were reported. In this current real-world study, vedolizumab effectively achieved clinical response and remission in most advanced therapy experienced UC patients treated for up to 12 months. Future studies with larger sample sizes and more robust study designs should be conducted to further validate the results of this study.

Effects of Home-Based Daily Respiratory Muscle Training on Swallowing Outcomes in Patients with Chronic Stroke: Protocol for a Randomized Controlled Trial.

(1) Background: Swallowing disorders are common following a stroke. This study aims to evaluate the effects of a home-based daily intervention focused on inspiratory and expiratory muscle training on swallowing outcomes in patients with chronic stroke. (2) Methods: This manuscript presents the protocol of a single-blind randomized clinical trial. Patients with chronic stroke will be randomly assigned to either an experimental or a control group. The experimental group will undergo daily home-based respiratory muscle training in addition to standard speech and language therapy, while the control group will receive only the standard intervention. The main outcome measures will include the aspiration risk, the strength of respiratory muscles, and peak cough flow. (3) Results: It is hypothesized that patients receiving home-based respiratory training in addition to standard therapy will achieve significant improvements in aspiration risk, respiratory muscle strength, and cough efficacy in comparison with those included in the control group. The results will be published as a manuscript. (4) Conclusions: This study aims to provide evidence on the effectiveness of home-based respiratory muscle training in enhancing swallowing function and respiratory parameters in patients with chronic stroke.

Beyond T-Trials, T4DM and TRAVERSE: the next large testosterone randomized controlled trial.

Lower testosterone concentrations have been associated with poorer health outcomes in ageing men, but proving causality and demonstrating potential for therapeutic benefit requires randomized clinical trials (RCTs). This review discusses recent observational findings and results of major testosterone RCTs, to explore the need for another, larger trial. Evidence of Leydig cell impairment emerges in men above the age of 70 years. Lower testosterone is associated with diabetes risk, and also risk of incident dementia. An individual participant data meta-analysis found that below thresholds of testosterone of 7.4 nmol/L and 5.3 nmol/l respectively, risks of all-cause mortality and cardiovascular deaths in men increased. Testosterone for the Prevention of Type 2 Diabetes Mellitus (T4DM), a multicentre RCT, showed that testosterone treatment prevented or reverted type 2 diabetes in men at high risk. Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE), a cardiovascular safety trial, demonstrated cardiovascular and prostate safety of testosterone treatment in men with or at risk of cardiovascular disease. T4DM confirmed findings from the Testosterone Trials (T-Trials) that testosterone improved sexual function, and bone microarchitecture and density. However, in TRAVERSE, testosterone-treated men had a higher risk of clinical bone fractures, but not major osteoporotic fractures. Men with disorders of the hypothalamic-pituitary-testicular (HPT) axis causing androgen deficiency warrant consideration for testosterone therapy. In men with an intact HPT axis, testosterone treatment is a pharmacological intervention which requires justification from high quality RCT data. Currently, there is insufficient evidence to justify wider use of testosterone for prevention of cardiometabolic disease. However, there is scope for another large testosterone RCT to investigate whether testosterone treatment might, in older men, extend disability-free survival.

Clinical Comparison of Stain Removal Efficacy between Glycine Powder Air Polishing System and Ultrasonic Scaling in Removing Dental Plaque and Stains: A Split-mouth Randomized Clinical Trial

Abstract Introduction: Glycine powder air polishing (GPAP) has emerged as a less invasive option for periodontal maintenance therapy. This study aims at comparing the efficacy of GPAP in removing plaque and stains as compared to conventional ultrasonic scaling (USS). Materials and Methods: The present split-mouth randomised clinical trial recruited 20 adults with healthy gingiva or mild gingivitis. Removal of plaque and stains was performed by USS in one maxillary quadrant and by GPAP in the other. Clinical parameters assessed included stain scores by Lobene Stain Index, plaque level by Silness-Loe plaque Index, and pain scores using the Visual Analog Scale. The assessments were performed before and after the treatment and at a 15-day follow-up visit. Results: Significantly lower (P &lt; 0.05) levels of plaque and stains were achieved by both interventions as compared to those before the treatment. While immediate postoperative plaque levels were significantly (P &lt; 0.05) lower following USS, the difference failed to reach statistical significance (P &gt; 0.05) 1 week after the treatment. On the contrary, the stain scores were significantly lower after treatment and at the 7th-day follow-up after GPAP as compared to USS. A significantly greater number of patients (P &lt; 0.05) reported pain to be absent or only mild following GPAP, while those treated with USS experienced pain of severe intensity. Conclusion: Both GPAP and USS are effective in stain and plaque removal. However, GPAP achieved superior stain removal outcomes and was associated with significantly lower pain scores, suggesting it was more comfortable for patients compared to USS.

Effectiveness and Safety of mRNA Vaccines in the Therapy of Glioblastoma.

Glioblastoma (GBM) is the most common and most malignant primary brain tumor, presenting significant treatment challenges due to its heterogeneity, invasiveness, and resistance to conventional therapies. Despite aggressive treatment protocols, the prognosis remains poor, with a median survival time of approximately 15 months. Recent advancements in mRNA vaccine technology, particularly the development of lipid nanoparticles (LNPs), have revitalized interest in mRNA-based therapies. These vaccines offer unique advantages, including rapid production, personalization based on tumor-specific mutations, and a strong induction of both humoral and cellular immune responses. mRNA vaccines have demonstrated potential in preclinical models, showing significant tumor regression and improved survival rates. Early-phase clinical trials have indicated that mRNA vaccines are safe and can induce robust immune responses in GBM patients. Combining mRNA vaccines with other immunotherapeutic approaches, such as checkpoint inhibitors, has shown synergistic effects, further enhancing their efficacy. However, challenges such as optimizing delivery systems and overcoming the immunosuppressive tumor microenvironment remain. Future research should focus on addressing these challenges and exploring combination therapies to maximize therapeutic benefits. Large-scale, randomized clinical trials are essential to validate the efficacy and safety of mRNA vaccines in GBM therapy. The potential to reshape the tumor microenvironment and establish long-term immunological memory underscores the transformative potential of mRNA vaccines in cancer immunotherapy.

Comparison of ropivacaine with ropivacaine–dexamethasone combination for postoperative analgesia in the pectoral nerve block for modified radical mastectomy: A randomized clinical trial

Abstract Background and Aims: The pectoral nerve block types I and II are novel techniques to provide analgesia for modified radical mastectomy (MRM) surgeries performed under general anesthesia. The primary objective of this study was to compare the duration of effective analgesia, and the secondary objectives were to evaluate the total amount of rescue analgesics in 24 h, hemodynamic changes, and postoperative adverse effects. Methods: This prospective, randomized, double-blind study was conducted on a total of 80 women with breast cancer belonging to American Society of Anesthesiologist class I and II scheduled for MRM, which were randomly allocated into two groups – Group R (n = 40) received 0.25% ropivacaine 29 ml + NS 1 ml and Group RD (n = 40) received 0.25% ropivacaine 29 ml + dexamethasone (4 mg) 1 ml. Ten milliliters of the study drug was used in Pecs I and the rest 20 ml in Pecs II block posttumor resection. Results: The duration of analgesia was statistically significantly longer in RD (778.75 ± 55.12 min) compared to Group R (412.63 ± 21.69 min) (P &lt; 0.05). Pain scores were significantly less in Group RD. The mean dose of acetaminophen required was significantly less in Group RD (2362.50 ± 375.32 mg) than in Group R (3525.00 ± 298.50 mg) (P &lt; 0.05). The incidence of adverse events was similar in both groups. Conclusion: The addition of dexamethasone with ropivacaine in the Pecs block can be used for prolonging the effective duration of analgesia and decreasing postoperative analgesic consumption with comparable hemodynamic and side effect profiles.

Red Blood Cell Transfusion in European Neonatal Intensive Care Units, 2022 to 2023

Red blood cell (RBC) transfusions are frequently administered to preterm infants born before 32 weeks of gestation in the neonatal intensive care unit (NICU). Two randomized clinical trials (Effects of Transfusion Thresholds on Neurocognitive Outcomes of Extremely Low-Birth-Weight Infants [ETTNO] and Transfusion of Prematures [TOP]) found that liberal RBC transfusion thresholds are nonsuperior to restrictive thresholds, but the extent to which these results have been integrated into clinical practice since publication in 2020 is unknown. To describe neonatal RBC transfusion practice in Europe. This international prospective observational cohort study collected data between September 1, 2022, and August 31, 2023, with a 6-week observation period per center, from 64 NICUs in 22 European countries. Participants included 1143 preterm infants born before 32 weeks of gestation. Admission to the NICU. Study outcome measures included RBC transfusion prevalence rates, cumulative incidence, indications, pretransfusion hemoglobin (Hb) levels, volumes, and transfusion rates, Hb increment, and adverse effects of RBC transfusion. A total of 1143 preterm infants were included (641 male [56.1%]; median gestational age at birth, 28 weeks plus 2 days [IQR, 26 weeks plus 2 days to 30 weeks plus 2 days]; median birth weight, 1030 [IQR, 780-1350] g), of whom 396 received 1 or more RBC transfusions, totaling 903 transfusions. Overall RBC transfusion prevalence rate during postnatal days 1 to 28 was 3.4 transfusion days per 100 admission days, with considerable variation across countries, only partly explained by patient mix. By day 28, 36.5% (95% CI, 31.6%-41.5%) of infants had received at least 1 transfusion. Most transfusions were given based on a defined Hb threshold (748 [82.8%]). Hemoglobin levels before transfusions indicated for threshold were below the restrictive thresholds set by ETTNO in 324 of 729 transfusions (44.4%) and TOP in 265 of 729 (36.4%). Conversely, they were between restrictive and liberal thresholds in 352 (48.3%) and 409 (56.1%) transfusions, respectively, and above liberal thresholds in 53 (7.3%) and 55 (7.5%) transfusions, respectively. Most transfusions given based on threshold had volumes of 15 mL/kg (470 of 738 [63.7%]) and were administered over 3 hours (400 of 738 [54.2%]), but there was substantial variation in dose and duration. In this cohort study of very preterm infants, most transfusions indicated for threshold were given for pretransfusion Hb levels above restrictive transfusion thresholds evaluated in recent trials. These results underline the need to optimize practices and for implementation research to support uptake of evidence.

Effect of Needle Insertion Angle on Pain During Labial Infiltration Anesthesia of the Anterior Maxilla: A Randomized Clinical Trial.

This study aimed to assess the effect of needle insertion angle on pain during labial infiltration anesthesia in the anterior maxillary region. In this parallel-design randomized clinical trial, participants were randomly assigned to four groups for labial infiltration anesthesia of the anterior maxilla. Local anesthesia was performed with needle orientation parallel to the longitudinal axis of the tooth using a conventional syringe (Syringe-0), needle at α angle with a conventional syringe (Syringe-α), computer-controlled local anesthetic delivery (CCLAD) device parallel to the longitudinal axis of the tooth (CCLAD-0), and CCLAD at α angle (CCLAD-α). The heart rate (HR), blood pressure (BP), and respiratory rate (RR) of participants were measured before needle insertion, immediately after needle insertion, and immediately after the injection by a vital signs monitor. The level of pain experienced by participants was quantified using a numerical rating scale (NRS). Data were analyzed by repeated-measures ANOVA and regression models (α = 0.05). Thirty-six participants aged from 21 to 60 years, with a mean age of 35.36 years were recruited. The mean pain scores were 7.44, 4.67, 2.89, and 0.67 in groups Syringe-0, Syringe-α, CCLAD-0, and CCLAD-α, respectively (p < 0.001). Age and sex had no significant effect on pain scores (p = 0.914 and p = 0.702, respectively). The four groups had no significant difference in vital signs (p > 0.05). Injection at an α angle and the application of CCLAD can be used in clinical practice to decrease the pain experienced by participants during labial infiltration anesthesia of the anterior maxilla. Iranian Registry of Clinical Trials: IRCT20230719058849N1.

Efficacy of subperiosteal drains in chronic subdural hematoma: a prospective randomized single-center study.

Background Chronic subdural hematomas (cSDH) are most frequently treated by evacuation via a burr-hole craniostomy procedure. Subperiosteal drains have been introduced as alternatives to subdural ones but only a few prospective studies have explored their efficacy. Thus, a prospective randomized trial was designed to assess their use. Methods The study enrolled patients with newly diagnosed surgically amenable cSDH. These patients were randomized into two groups. The first group underwent cSDH evacuation via a single burr-hole craniostomy procedure followed by placement of a subperiosteal drain; the second group underwent the identical procedure without drain placement. Patient demographics, drain volumes, duration of drainage, cSDH recurrence, and postoperative outcomes were recorded. Results Eighty-eight patients presenting with cSDH (12 with bilateral findings) from a total of 100 surgical cases were enrolled. Nine patients (1 bilateral) were lost to follow-up. Of all remaining 90 procedures, 37 were carried out with drain placement and the remaining 53 without. There were 5 recurrent cases (13,5%) in the drain group and 17 (32,1%) in the control group without drain placement. This resulted in a statistical significance (OR 0.33; p&lt;0.05) favoring the use of a drain. Conclusion Subperiosteal drain placement can be used safely and effectively to treat cSDH in conjunction with a burr-hole craniostomy procedure, significantly reducing the rate of recurrence without any additional disadvantages.

Effects of moderate physical activity on diabetic adhesive capsulitis: a randomized clinical trial.

Moderate physical activity (MPA) has proven advantages for glycemic control, cardiovascular health, and functional independence. However, physical activity is not part of routine conventional physical therapy (CPT) in managing diabetic adhesive capsulitis patients. To determine the effects of moderate MPA on diabetic adhesive capsulitis (AC). A randomized control trial was conducted at the Combined Military Hospital (CMH), Muzaffarabad, Pakistan from March 2022 to October 2022. A total of n = 44 patients with diabetic AC, aged 40 to 65 years, HbA1c > 6.5% were enrolled. Group A received MPA and CPT, while Group B only received CPT for six weeks. The upper extremity function, pain, and range of motion were assessed at baseline, third week, and sixth week through the disability of arm, shoulder, and hand (DASH) questionnaire, numeric pain rating scale (NPRSS), and goniometer respectively. The NPRS score and ROMs showed significant improvement (p < 0.05) in group A compared to group B with a large effect size. When comparing the mean difference of the DASH score (73 + 7.21 vs. 57.9 + 12.64, p < 0.001, Cohen's d = 1.46) was significantly improved with large effect size in group A as compared to group B. MPA along with CPT has positive effects on patient pain, range of motion, and disability in patients with diabetic adhesive capsulitis.