Single-center Trial Research Articles

Adjuvant Vitamin D Injection in Elderly Patients Before Intertrochanteric Fracture Surgery: A Randomised Controlled Trial.

There are multiple recommended protocols for Vitamin D (VitD) supplementation in elderly; however, only a few studies achieved to examine the role of VitD supplements before intertrochanteric fracture surgery on mortality and complications after surgery. This single-center block-randomized double-blinded trial was conducted on 80 patients with intertrochanteric fractures and a sufficient level of 25 (OH) VitD. The intervention group received an intramuscular 300,000IU VitD ampule before surgery. The primary outcome was a 6-month mortality rate, and the secondary outcomes were 1- and 2-year mortality rates and Harris Hip Score (HHS) in 6, 12, and 24months after surgery. Chi-square, t-test, repeated measure ANOVA, and Cox regression survival model was used for statistical analysis. 40 patients were allocated to each group. Demographic, clinical characteristics, and preoperative evaluations were not significantly different between the groups. Mortality rate 6-month after the surgery was 7.5% and 10% for the intervention and placebo groups respectively (P value = .71), 15% and 12.5% at 1-year (P value = .83), and 25% and 27.5% at 2-year (P value = .98). Based on the Cox regression model, only age was significantly associated with mortality (HR = 1.229, P value <.001). Significant HHS changes from baseline through 24 months after surgery were observed within both groups; however, mean differences were not significantly different between groups. A single preoperative 300,000IU VitD did not significantly impact 2-year survival and HHS in patients with intertrochanteric fractures and sufficient serum VitD level.

Influence of cardiorespiratory training program on the intercellular adhesion molecule level in patients with postmastectomy syndrome

To evaluate the influence of 12-week aerobic dynamic training program of moderate intensity on the endothelial dysfunction laboratory markers and life quality in patients with PMS. Single-center prospective randomized trial included 40 patients with PMS divided into study (20 patients) and comparative (20 patients) groups, as well as 20 healthy female volunteers. The expression level of soluble intercellular adhesion molecule-1 (ICAM-1) and platelet endothelial cell adhesion molecule-1 (PECAM-1) were evaluated in all participants at baseline by enzyme-linked immunosorbent assay method, and additionally psychological and physical component of health by SF-36 questionnaire were assessed in patients with PMS. The group of patients with PMS after BC treatment had increased level of ICAM-1 in long-term period, that may indicate endothelial dysfunction. Statistically significant decrease of endothelial dysfunction laboratory markers was revealed in patients with PMS, who underwent the course of cardiorespiratory training. In the same time, the dynamics of changes in ICAM-1 was higher in the study group than in comparative group. Further, improvement of physical and psychological components of health by SF-36 questionnaire was found. The program of cardiorespiratory trainings of moderate intensity in patients, who had BC treatment a year ago, decreases intercellular adhesion molecules level that may show an improvement of endothelial dysfunction.

Immunosuppressive therapy and COVID-19 infection in patients with NMOSD.

To evaluate whether treated with immunosuppressants in neuromyelitis optica spectrum disorder (NMOSD) shows an effect on the severity and outcomes of COVID-19 Omicron variant. This is a substudy of a single-center clinical trial involving human umbilical cord mesenchymal stem cells (hUC-MSCs) in NMOSD patients. NMOSD patients with hUC-MSCs treatment, NMOSD patients without hUC-MSCs treatment, and matched healthy controls (HC) were included. Demographic information, NMOSD-related clinical features, comorbidities, use of disease-modifying therapy, COVID-19 vaccination status, COVID-19 clinical features, COVID-19 clinical outcomes, and NMOSD-related disease activity were obtained through online questionnaires or phone calls. The majority of NMOSD patients received long-term treatment with mycophenolate mofetil (68.8%) or azathioprine (22.9%), and 50% received oral glucocorticoid. During the epidemic, 97.4% of NMOSD patients infected with COVID-19 had asymptomatic or mild forms, with only two patients (2.6%) requiring hospitalization. None of these patients required tracheal intubation or admission to the intensive care unit. Clinical symptoms were found to be more prevalent in HC groups. Additionally, the HC groups had higher fever-recorded temperatures. NMOSD patients who received hUC-MSCs treatment had shorter disease duration than patients who did not receive hUC-MSCs treatment. Immunosuppressant-treated patients with NMOSD have a similar risk of COVID-19 infection as the general population, but the disease duration is shorter and the clinical symptoms are less severe. Among our NMOSD patients who received hUC-MSCs treatment, COVID-19 outcomes were favorable, with no increased risk of severe COVID-19. Prospective studies on immunotherapies are needed to help determine best treatment practices.

Patient Satisfaction with Oral Testosterone Undecanoate in Men Who Received Prior Testosterone Therapy: An Open-Label, Single-Center Clinical Trial.

To evaluate patient satisfaction and symptom control in hypogonadal men transitioning from other testosterone therapies to oral testosterone undecanoate (TU). In this open-label clinical trial, men aged 18 to 75 years with hypogonadism were switched to oral TU after a sufficient washout of previous testosterone therapies. Treatment satisfaction and symptom control were primarily measured using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) and quantitative androgen deficiency in aging males (qADAM) questionnaires, respectively. Secondary outcomes included changes in serum testosterone (T), estradiol (E2), hematocrit (HCT), and prostate-specific antigen (PSA) levels. Forty-one men participated, with significant improvements in all TSQM-9 scores observed over 6 months. Symptom control as measured by qADAM remained consistent. There was a significant increase in serum T and E2 levels, but HCT and PSA levels remained stable. Switching to oral TU from other testosterone therapies is associated with increased patient satisfaction and stable hypogonadal symptom control.

Impact of TearCare on Reading Speed in Patients with Dry Eye Disease.

To evaluate the impact of TearCare (TC) treatment on clinical, quality of life, and functional visual outcome metrics in patients with dry eye disease (DED) and meibomian gland disease (MGD). This is a prospective, single-center clinical trial. Adults with MGD and a DED diagnosis and tear break-up time (TBUT) <10seconds were included. All subjects had at least 20/40 vision and no surgery or new treatment for DED within 60 days prior to enrollment. All patients had one baseline visit prior to undergoing TC and one follow-up visit 1 month after TC. At each visit, the meibomian gland secretion score (MGSS), TBUT, and corneal fluorescein staining (KFL) were assessed. DED symptoms were evaluated using the Ocular Surface Disease Index (OSDI) questionnaire, Visual Function Questionnaire 25 (VFQ-25), and the Fatigue Severity Scale. Reading speed was determined through the International Reading Speed Texts (IReST), Minnesota Low Vision Reading Test (MNREAD), and Wilkins Rate of Reading Test (WRRT). Thirty-two subjects were included. The average age was 55.9 years. Sixteen (52%) participants had a clinically significant improvement in reading speed after treatment with TC, defined as >10 words per minute increase in their IReST score. Improvement on the IReST and the MNREAD reached statistical significance (p = 0.012 and p = 0.028, respectively). OSDI scores significantly decreased and VFQ-25 scores significantly increased after TC treatment (p < 0.001). All of the clinical exam parameters showed statistically significant improvements after treatment (p < 0.001). TC is an effective treatment both clinically and with respect to visual function. Patients who had TC exhibited improvements in quality of life and improved reading speed after a single treatment. This treatment should be frequently considered and utilized to reduce the disease burden of DED related to MGD.

Effect of accelerated postoperative rehabilitation after tibial tubercle distalisation: A randomised controlled trial protocol.

Patella alta is a clinical condition where the patella is positioned too proximal in relation to the femoral trochlea. Such an abnormality may cause patellar instability and predispose to recurrent patellofemoral dislocations and patellofemoral pain. There are no conclusive guidelines for determining a threshold for too high positioned patella, as several different methods have been described to measure patellar height. As a surgical solution, distalising tibial tubercle osteotomy has been described to correct excessive patellar height. In the early phase of the distalising tibial tubercle osteotomy postoperative protocol, weightbearing and knee flexion are limited with a brace commonly for 4-8 weeks to avoid potential implant failure leading to displacement of the osteotomy or non-union. The potential risks for adverse effects associated with the limitation rehabilitation protocol include a delay in regaining knee range of motion, stiffness and muscle weakness. As a result, recovery from surgery is delayed and may lead to additional procedures and long-term morbidity in knee function. This is a prospective, randomised, controlled, single-blinded, single centre trial comparing a novel accelerated rehabilitation protocol with the traditional, motion restricting rehabilitation protocol. All skeletally mature patients aged 35 years and younger, referred to as the distalising tibial tubercle osteotomy procedure group, are eligible for inclusion in the study. Patients will be randomised to either the fast rehabilitation group or the traditional rehabilitation group. Patients with patellar instability will be additionally treated with medial patellofemoral ligament reconstruction. The hypothesis of the trial is that the novel accelerated rehabilitation protocol will lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol. A secondary hypothesis is that the complication rate will be similar in both groups. The study will document short-term recovery and the planned follow-up will be 3 years. After the 1-year follow-up, the trial results will be disseminated in a major peer-reviewed orthopaedic publication. Protocol version 3.6, date 28/11/2023.

Feasibility of an artificial intelligence phone call for postoperative care following cataract surgery in a diverse population: two phase prospective study protocol

IntroductionArtificial intelligence (AI) development has led to improvements in many areas of medicine. Canada has workforce pressures in delivering cataract care. A potential solution is using AI technology that can...

Rifaximin Treatment of Collagenous Colitis: A Randomised, Double-Blind, Placebo-Controlled Trial

Introduction: Collagenous colitis (CC) is a disabling disease primarily affecting elderly women. Sparse, well-documented treatment modalities exist, except for budesonide. Long-term and repetitive treatment with budesonide is often necessary. Rifaximin is a poorly absorbed antibiotic with a positive modulatory effect on gut microbiota. In this randomised, double-blind, placebo-controlled single-centre trial, we test the effect of adding rifaximin in continuation to budesonide on relapse rates in CC. Methods: Eligible patients with active, biopsy-verified CC received oral budesonide during a 6-week open-label induction phase. Patients in clinical remission after 4 weeks of treatment were randomised to receive either rifaximin or placebo for 4 weeks. Results: Fifteen patients were randomised to receive either rifaximin (n = 7) or placebo (n = 8). At 12-week follow-up, 2 patients in the rifaximin group were still in remission and none in the placebo group (p = 0.2). The median number of days in remission in the rifaximin group was 42 (interquartile range [IQR] 33–126) compared to 18.5 (IQR 10.5–51.5) in the placebo group (p = 0.189). At 12-week follow-up, the relapse rate per 100 person-days in the placebo group was higher (3.25 [1.40–6.41]) than in the rifaximin group (1.33 [0.43–3.10]). Conclusion: Although not statistically significant (p = 0.0996), the study suggests a potential improvement in relapse rates within the rifaximin group compared to the placebo group. A major limitation in the study is the small sample size.

Comparison of Hemodynamic Changes and Their Management Following Subarachnoid Block Between Normotensive and Preeclamptic Women Undergoing Cesarean Section

Introduction. Spinal anesthesia (SA) is widely used for cesarean sections, yet its safety in preeclamptic patients remains uncertain. This study explores the use of subarachnoid block (SAB) in preeclamptic parturients during cesarean sections. Patients and Methods. This study was a single-center hospital-based controlled clinical trial. 30 normotensive and 30 preeclamptic women undergoing cesarean section were included in the study. Heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and SpO2 were evaluated at one, three, five, seven, nine, 11, 13, 15, 20, 25, 30, 40, 45, 50, 55 and 60 minutes intervals after giving the block. The independent samples t-test was used for statistical analysis. Results. In the normotensive (group N) vs. preeclamptic (group PE) comparison, significant differences in weight, SBP, DBP, and MAP were noted, with higher values in group PE (p&lt;0.05). Heart rates and oxygen saturation were comparable. Mephentermine consumption was notably higher in normotensive women compared to preeclamptic women (p&lt;0.001). Conclusion. Severe preeclamptic women exhibit significantly higher SBP, DBP, and MAP compared to normotensive women undergoing cesarean section following subarachnoid block. However, SAB does not impact heart rate and oxygen saturation. Importantly, hypotension following spinal anesthesia is less common in severe preeclamptic patients, indicating its potential safety in this group.

Deep Anterior Lamellar Keratoplasty Using Dehydrated versus Standard Organ Culture-Stored Donor Corneas: Prospective Randomized Trial

PurposeTo compare the outcomes of deep anterior lamellar keratoplasty (DALK) using dehydrated versus standard organ culture stored donor corneas for eyes with keratoconus. DesignProspective, randomized, single-center trial conducted in Italy ParticipantsAdult patients with keratoconus (≥ 18 years old) with keratoconus scheduled for an elective DALK MethodsCases with successful type 1 bubble pneumatic dissection using standard DALK technique were intraoperatively randomized to receive either dehydrated (n=30) or standard organ culture stored donor corneas (n=30). Main Outcome MeasuresThe primary study outcome was best spectacle-corrected visual acuity (BSCVA) 12 months after surgery. Secondary outcomes were refractive astigmatism (RA), endothelial cell density (ECD) and complication rates. ResultsPostoperative logMAR BSCVA did not significantly differ between groups at both time points (mean difference at 6 months = 0.030 [95%CI: -0.53-0.10] p = 0.471) and at 12 months = -0.013 [95%CI: -0.10-0.08] p = 0.764). No significant differences between groups were observed in terms of postoperative RA and ECD at all time points. In the first 3 days after DALK, an epithelial defect was present in 10 cases (33%) of the organ culture cornea group and in 29 cases (97%) of the dehydrated cornea group. Complete re-epithelialization was achieved by day 7 in all cases (100%) of both groups. ConclusionsThe study provides evidence that the use of dehydrated corneas is non-inferior to the use of standard organ culture donor corneas for DALK. Corneal tissue dehydration represents a viable solution that can allow long-term cornea preservation and avoid wastage of unused corneas.

Comparison between stapled hemorrhoidopexy and harmonic scalpel hemorrhoidectomy in the management of third- and fourth-degree piles: arandomized clinical trial.

This study compared the results of stapled hemorrhoidopexy (SH) and harmonic scalpel hemorrhoidectomy (HSH) in the management of gradeIII and gradeIV piles regarding the time of the procedure, postoperative pain, patient satisfaction, wound infection, bleeding, incontinence, and recurrence within 1year. This was asingle-blind, prospective, randomized, controlled, single-center trial conducted from January to December 2022 that included 50(68.75%) male and 20(31.25%) female patients with third- and fourth-degree piles. The patients were divided into two groups of 35patients each. GroupI underwent SH and groupII underwent HSH. The mean age of groupI was 42.94years and of groupII, 42.20years. The mean time of the procedure was 24.42 min ± 2.367 for SH and 31.48 min ± 2.21 for HSH. Postoperative pain in groupI was lower than in groupII during the first 2weeks, but there was persistent mild pain in most patients in groupI at the 2‑week follow-up. In groupII there was significant improvement in pain after 2weeks, with higher patient satisfaction. Wound infection was detected in 3(5%) patients in groupI and no patients in groupII (p = 0.077). Postoperative bleeding occurred in 4(11.4%) patients in groupI in the form of spotting after defecation only during the first postoperative month; no bleeding was detected in groupII (p = 0.039). There were 3(15%) cases of flatus incontinence but after taking a detailed history these were found to be cases of urgency to defecate rather than incontinence. There were 7(20%) cases of recurrence at the 1‑year follow-up in groupI and 1(2.9%) case in groupII (p = 0.024). Compared with SH, HSH was safer, easier, and associated with alower incidence of recurrence after 1year and with higher patient satisfaction.

New hope for esophageal stricture prevention: A prospective single-center trial on acellular dermal matrix.

Given the high incidence of esophageal cancer in China, an increasing number of patients there are undergoing endoscopic mucosal dissection (ESD). Although the 5-year survival rate after ESD can exceed 95%, esophageal stricture, the most common and serious postoperative complication, affects the long-term prognosis of patients and the quality of life. Autologous mucosal grafts have proven to be successful in preventing stricture after ESD for early esophageal cancer. To examine the viability of acellular dermal matrix (ADM) as an alternative to autologous mucosa for the prevention of stricture after ESD. This is a prospective, single-center, controlled study. Consecutive patients who underwent ESD surgery and were willing to undergo autologous mucosal transplantation were recruited between January 1 and December 31, 2017. Consecutive patients who underwent ESD surgery and were willing to undergo ADM transplantation were recruited between January 1 to December 31, 2019. A final three-year follow-up of patients who received transplants was conducted. Based on the current incidence of esophageal stricture, the sample size required for both the autologous mucosal graft group and the ADM group was calculated to be 160 cases. Due to various factors, a total of 20 patients with autologous mucosal grafts and 25 with ADM grafts were recruited. Based on the inclusion exclusion and withdrawal criteria, 9 patients ultimately received autologous mucosal grafts and completed the follow-up, while 11 patients received ADM grafts and completed the follow-up. Finally, there were 2 cases of stenosis in the autologous mucosal transplantation group with a stenosis rate of 22.22% and 2 cases of stenosis in the ADM transplantation group with a stenosis rate of 18.18%, with no significant difference noted between the groups (P = 0.94). In this prospective, single-center, controlled trial, we compared the effectiveness of autologous mucosa transplantation and ADM for the prevention of esophageal stricture. Due to certain condition limitations, we were unable to recruit sufficient subjects meeting our target requirements. However, we implemented strict inclusion, exclusion, and withdrawal criteria and successfully completed three years of follow-up, resulting in valuable clinical insights. Based on our findings, we hypothesize that ADM may be similarly effective to autologous mucosal transplantation in the prevention of esophageal stricture, offering a comparable and alternative approach. This study provides a new therapeutic idea and direction for the prevention of esophageal stricture.

Fasting mimicking diet cycles versus a Mediterranean diet and cardiometabolic risk in overweight and obese hypertensive subjects: a randomized clinical trial

Abnormalities in the vascular endothelium such as impaired vasodilation can contribute to atherosclerosis and hypertension. Here we have performed a single-center randomized clinical trial to evaluate the efficacy of 4 months of a continuous Mediterranean diet (MD) regimen as compared to 4 cycles of fasting mimicking diet (FMD) administered for only 5 days/month on endothelial function, measured as reactive hyperemia index (RHI) and large/small-resistance artery compliance (AC1/AC2), and on other cardiometabolic risk factors, in hypertensive patients with obesity/excess weight [both sexes, body mass index (BMI) ≥ 28, RHI ≤ 2.0, and/or small-resistance artery compliance (AC2) ≤ 5.0]. At the end of the intervention period, FMD but not MD decreased RHI (p = 0.0023) compared to baseline with no increase in the portion of patients with abnormal RHI. Both FMD and MD improved PULS cardiac test score; evaluating the risk of cardiovascular events. FMD and MD did not show any significant change in either AC1 or AC2 compared to baseline. Both FMD and MD led to comparable decreases in weight, waist circumference, BMI, body fat mass and % body fat, total cholesterol, and leptin. FMD decreased HbA1c (p = 0.0059) and IGF-1 (p = 0.0427), while MD decreased glucose (p = 0.0488), HOMA-IR (p = 0.0476), and HDL-C (p = 0.0419). None of the parameters were significantly different between the FMD vs. MD group at the end of the intervention period. During the 3-month follow-up period, the FMD and MD groups continued to display weight and BMI reduction; however, the MD group also lost fat free mass (FMD vs. MD, p = 0.0498). In summary, both MD and FMD reduced a range of cardiometabolic risk factors, but FMD also decreased RHI, a change associated with either impaired functional integrity of vascular endothelial cells but also with vascular rejuvenation, with the latter being more likely considering the improved cardiometabolic profile, reduced PULS cardiac score and calculated heart age, and unaltered arterial compliance in the FMD group. MD but not FMD cycles caused loss of lean body mass.

Comparative analysis of salivary microbiota in diabetic and non-diabetic individuals of North India using metagenomics

BackgroundSaliva, an oral secretion is considered an essential biological modulator involved in maintaining oral homeostasis. Increased glucose levels in diabetic patients' saliva may have an impact on diversity of microbes. Comparing the salivary microflora of diabetic and non-diabetic cohorts will help in diagnosis and risk assessment of oral health complications. This will provide greater knowledge about the contribution of oral microbes to the development of oral illnesses. The association between salivary microbiota and diabetic state is less explored in the North Indian population, hence current observational study was performed to analyze the salivary microflora of diabetic and non-diabetic individuals using metagenomic analysis. Materials and methodsThis single-center non-randomized observational trial was conducted in Uttar Pradesh, India. Participants were enrolled into either diabetic (n = 68) or non-diabetic groups (n = 68) based on their diabetes status. Following saliva collection, DNA was extracted and metagenomic sequencing was performed. ResultsPhylum Bacteroidetes and Fusobacteria were significantly abundant in diabetic individuals (p < 0.0001), while Proteobacteria was significantly higher among non-diabetic individuals (p < 0.0001). No statistical difference in phylum Actinobacteria and Firmicutes among diabetics and non-diabetics. Veillonella, Prevotella, Porphyromonas, Leptotrichia, Lactobacillus, and Streptococcus were greater in diabetics whereas the abundance of Capnocytophaga and Neisseria was more among non-diabetics (p < 0.05). ConclusionsThe genera Veillonella, Prevotella, Porphyromonas, Leptotrichia, Lactobacillus, and Streptococcus were comparatively over the odds with the diabetics in India. The association between microbiota in diabetic population and risk related to increase in occurrence of caries, gingivitis, and periodontitis in diabetic population prevalence should be investigated.

Feasibility and Safety of the Routine Distal Transradial Approach in the Anatomical Snuffbox for Coronary Procedures: The ANTARES Randomized Trial.

The distal transradial approach (dTRA) through the anatomical snuffbox is hypothesized to offer greater benefits than the conventional transradial access (cTRA) for patients undergoing coronary procedures. Our goal was to assess the safety and efficacy of dTRA. Out of 465 consecutive Caucasian patients, 400 were randomized (1:1) to dTRA or cTRA in a prospective single-center trial. Clinical and ultrasound follow-ups were obtained at 24 h and 60 days post-procedure. The primary combined endpoint consisted of access crossover, access-related complications, and major adverse cardiovascular events (MACE). Secondary endpoints included clinical success endpoints (puncture success, crossover, and access time), access-site complications endpoints, and MACE at 60 days. The primary endpoint was significantly higher in the dTRA [odds ratio (OR): 2.31, 95% confidence interval (CI): 1.38-3.86, p = 0.001]. Clinical success endpoints, namely crossover (10% vs. 3.5%, p < 0.05) and access-time [median: 140s (85-322) vs. 80s (58-127), p < 0.001], did not favor the dTRA, despite a similar success rate in radial artery puncture between the dTRA and cTRA (99.5% vs. 99%). Radial artery spasm (19% vs. 4.5%, p < 0.0001), physical discomfort during access, and transient thumb numbness after the procedure occurred more frequently with the dTRA. However, early (2.5% vs. 4.5%, p = 0.41) and mid-term (2.5% vs. 3%, p = 0.98) forearm radial artery occlusion rates were comparable between the dTRA and cTRA. Randomization to the dTRA, lower forearm radial pulse volume, higher body mass index, and lower body surface area independently predicted the primary endpoint in multivariate analysis. In the interaction effect analysis, only diabetes increased the incidence of the primary endpoint with the dTRA (OR: 18.67, 95% CI: 3.96-88.07). The dTRA was a less favorable strategy than cTRA during routine coronary procedures due to a higher incidence of arterial spasm and the necessity for access crossover. The majority of local complications following the dTRA were clinically minor complications. Individuals with diabetes were particularly susceptible to complications associated with the dTRA.

Dynamic profiling of immune microenvironment during anti-PD-1 immunotherapy for head and neck squamous cell carcinoma: the IPRICE study

BackgroundImmune checkpoint inhibitors of programmed cell death protein 1 (PD-1) represent a significant breakthrough in treating head and neck squamous cell carcinoma (HNSCC), with long-lasting responses and prolonged survival observed in first- and second-line therapy. However, this is observed in < 20% of patients and high primary/secondary resistance may occur. The primary objective of the identification of predictive factors for the response to anti-PD-1 immunotherapy in head and neck squamous cell carcinoma (IPRICE) study is to identify predictive factors of response to anti-PD-1 immunotherapy.MethodsThe IPRICE study is a single-center, prospective, non-randomized, open-label, and interventional clinical trial. Liquid and tumor biopsies will be performed in 54 patients with recurrent/metastatic (R/M) HNSCC undergoing anti-PD-1 immunotherapy alone to compare the evolution of gene expression and immunological profile between responders and non-responders. We will use a multidisciplinary approach including spatial transcriptomics, single seq-RNA analysis, clinical data, and medical images. Genes, pathways, and transcription factors potentially involved in the immune response will also be analyzed, including genes involved in the interferon-gamma (IFN-γ) pathway, immunogenic cell death and mitophagy, hypoxia, circulating miRNA-mediated immunomodulation, cytokines, and immune repertoire within the tumor microenvironment (TME). With a follow-up period of 3-years, these data will help generate effective biomarkers to define optimal therapeutic strategy and new immunomodulatory agents based on a better understanding of primary/secondary resistance mechanisms. Tumor biopsy will be performed initially before the start of immunotherapy at the first tumor assessment and is only proposed at tumor progression. Clinical data will be collected using a dedicated Case Report Form (CRF).DiscussionIdentifying predictive factors of the response to anti-PD-1 immunotherapy and optimizing long-term immune response require a thorough understanding of the intrinsic and acquired resistance to immunotherapy. To achieve this, dynamic profiling of TME during anti-PD-1 immunotherapy based on analysis of tumor biopsy samples is critical. This will be accomplished through the anatomical localization of HNSCC, which will allow for the analysis of multiple biopsies during treatment and the emergence of breakthrough technologies including single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics.Trial registrationClinicaltrial.gov. Registered April 14, 2022, https://www.clinicaltrials.gov/study/NCT05328024.

Clinician-Created Video Education for Patients With AF

Patient education is a critical aspect of atrial fibrillation (AF) management. However, there is limited time to provide effective patient education during routine care, and resources available online are of variable quality. To determine whether clinician-led creation of video-based AF education is feasible and improves knowledge of AF. This single-center randomized clinical trial was conducted between 2020 and 2022. Outcomes were assessed prior to their clinic visit and 2 and 90 days after the visit by blinded assessors. Participants included adults with AF and congestive heart failure, hypertension, age at least 75 years (doubled), diabetes, prior stroke or transient ischemic attack or thromboembolism (doubled), vascular disease, age 65 to 74 years, and sex category scores of 1 or greater presenting for routine care at publicly funded outpatient cardiology clinics within a tertiary teaching hospital. Individuals too unwell to participate or with limited English were excluded. Data were assessed as intention to treat and analyzed from December 2022 to October 2023. Intervention participants viewed a series of 4 videos designed and narrated by clinicians that aimed to improve understanding of AF pathophysiology, clinical presentation, diagnosis, and management. After viewing the videos, participants received weekly email links to review the videos. The control group received usual care. The prospectively selected primary outcome was AF knowledge at 90 days, measured by the validated Jessa Atrial Fibrillation Knowledge Questionnaire (JAFKQ). Among 657 individuals screened, 208 adults with AF were randomized (mean [SD] age, 65.0 [12.2] years; 133 [65.2%] male) and included in analysis. Participants were randomized 1-to-1, with 104 participants in the control group and 104 participants in the video intervention group. At 90 days after the baseline clinic visit, intervention participants were more likely to correctly answer JAFKQ questions than control participants (odds ratio [OR], 1.23 [95% CI, 1.01-1.49]). The difference was greater in participants who remotely accessed videos on 3 or more occasions during the study (OR, 1.46 [95% CI, 1.14-1.88]). In this randomized clinical trial of patients with AF, remotely delivered, clinician-created video education improved medium-term AF knowledge beyond usual care of standard in-clinic education. The improvement demonstrated in this study provides support for the implementation of clinician-created educational resources across the care continuum. Further work is needed to assess for impact on clinical outcomes. anzctr.org.au Identifier: ANZCTRN12620000729921.

Effect of intravenous low-dose norepinephrine on blood loss in non-tourniquet total knee arthroplasty under general anesthesia: a randomized, double-blind, controlled, single-center trial

ObjectiveThis prospective trial aimed to evaluate the effects of low-dose intravenous norepinephrine (NE) on intraoperative blood loss and bleeding from osteotomy sites during non-tourniquet total knee arthroplasty (TKA) under general anesthesia.MethodsA total of 120 patients who underwent TKA between December 2020 and May 2022 were enrolled and randomly assigned to the intravenous low-dose NE Group (NE Group) or the control group (C Group). During surgery, NE Group received 0.05–0.1 μg/(kg min) of NE intravenously to raise and maintain the patient's mean arterial pressure (MAP). C Group received the same dose of saline as placebo. Intraoperative blood loss, bleeding score at osteotomy sites, Δlactate levels (Lac), postoperative complications, and transfusion rate during hospitalization were compared between groups.ResultsIntraoperative and osteotomy blood loss was significantly lower in the NE Group than in the C Group (P < 0.001). No significant difference was observed in ΔLac between groups (P > 0.05). There was no significant difference in complications between the groups 3 days after surgery (P > 0.05). In addition, there was no significant difference in blood transfusion rates between the two groups during hospitalization (P > 0.05).ConclusionIn non-tourniquet TKA under general anesthesia, low-dose intravenous NE safely and effectively reduced intraoperative blood loss and provided a satisfactory osteotomy site while maintaining a higher MAP.

Bojungikgi-tang for Anorexia in Lung Cancer Patients with Treated with Chemotherapy: A Single-arm, Open-label, Single-center Trial

Objectives: This study was to evaluate the effectiveness and safety of Bojungikgi-tang for lung cancer patients with anorexia.Methods: This was a single-arm, open-label, and single-center trial, and suitable participants took Bojungikgi-tang (Buzhongyiqi-tang in Chinese, Hochuekki-to in Japanese) three times a day before or between meals for six weeks (42 days). After registration of clinical trials (visit 2), they visited the hospital every three weeks (visits 3 and 4) and measured or tested the effectiveness or safety evaluation variables to analyze the results. The primary outcome was the anorexia/cachexia subscale (A/CS) of functional assessment of anorexia/cachexia therapy (FAACT) score.Results: Seventeen lung cancer patients were included in the intention-to-treat (ITT) analysis. Lung cancer patients had higher A/CS of FAACT scores after six weeks of Bojungikgi-tang administration compared to that at the baseline. This was not significant four lung cancer (p=0.1668). In the secondary outcomes, the visual analog scale (VAS) score of anorexia decreased significantly (p=0.0009), and the CD4/CD8 ratio (p=0.0396) and CD4 levels (p=0.0345) significantly increased after six weeks of treatment. No serious adverse events were reported with Bojungikgi-tang in lung cancer patients.Conclusions: Bojungikgi-tang can be an effective and safe treatment for anorexia in lung cancer patients undergoing chemotherapy.

Shared decision-making improving efficacy in diarrhoea-dominant irritable bowel syndrome in Chinese outpatient setting: protocol of a prospective, randomised controlled trial

IntroductionDiarrhoea-dominant irritable bowel syndrome (IBS-D) is a disorder with multiple pathogenesis; many people with IBS-D may have psychosocial issues which can make assessment and treatment more difficult. Routine treatment procedure...