Single-center Pilot Research Articles

Evaluation of myocardial work indexes in patients with cardiac sarcoidosis

Abstract Background Cardiac involvement is associated with worse prognosis and mortality in sarcoidosis. Diagnosis often requires expensive and less available tests. Purpose The aim of this study is to evaluate whether non-invasive measurement of myocardial work by transthoracic echocardiogram has incremental value in the diagnosis of cardiac involvement compared to left ventricular (LV) global longitudinal strain (GLS). Methods This is a cross-sectional, non-blinded, single-center pilot study. Patients of both genders > 18 years old, with confirmed diagnosis of cardiac sarcoidosis according to the Heart Rhythm Society criteria, and controls consisting of individuals diagnosed with systemic sarcoidosis without cardiac involvement, were included. Patients with obesity grade 2 or higher , moderate or severe primary heart valve disease, myocardial diseases of other etiologies, established coronary artery disease, and inadequate acoustic window were excluded. All patients underwent transthoracic echocardiography and non-invasive blood pressure measurement, followed by subsequent analysis involving the construction of a pression-strain curve. The following LV indexes were calculated: GLS, global work index, global constructive work, global wasted work, and global work efficiency. ROC curves were calculated for all variables using the EasyROC online tool (v 1.3.1), and these were later compared to GLS. Confidence intervals were established by the DeLong method, and curves were compared by the Bonferroni method. A two-tailed p value of 0.05 was considered significant. Results Twenty patients with cardiac involvement and twenty patients without cardiac involvement were evaluated. The results of the variables are presented in table 1. Conclusions With exception of wasted work, all other LV myocardial work variables showed statistical correlation with cardiac involvement in sarcoidosis patients. However, there was no incremental value of myocardial work indexes compared to the isolated use of GLS.

Влияние избыточной массы тела и ожирения на спирометрические, гематологические показатели, уровень общего иммуноглобулина Е и интерлейкина-6 в сыворотке крови у детей и подростков с бронхиальной астмой

There is undoubtedly insufficient number of studies dedicated to the interleukin-6 (IL-6) in blood serum of children and adolescents with bronchial asthma (BA) and those are contradictory. Connection between the IL-6 serum level and systemic markers of type 2 inflammation in BA in children and adolescents depending on the nutritional status remains a subject to discussion as well. The purpose of this research was to study the effect of excess body weight (BW) and obesity on spirometric, hematological parameters, total immunoglobulin E (IgE), IL-6 levels in blood serum of children and adolescents with BA. Materials and methods used: a single-center observational cross-sectional pilot study of 76 adolescents aged 6 to 17 y/o (75% (57) boys) with BA was conducted. All were measured for anthropometric and spirometric parameters, body composition, hematological parameters, total IgE and IL-6 levels in blood serum. Dysanapsis was diagnosed when three conditions were simultaneously met: 1. high or high-to-normal zFVC (above 0.674), 2. normal zFEV1 (above -1.645), and 3. low FEV1/FVC index (below 80%). Results: the number of monocytes (109/l) in peripheral blood and the serum IL-6 level (pg/ml) were statistically significantly higher in the group of patients with overweight and obesity compared to patients with underweight/normal BW (0.55 [0.49; 0.77] v 0.51 [0.42; 0.58], p=0.043 and 1.99 [1.20; 5.78] v 1.28 [0.31; 2.43], p=0.002, respectively). In patients with excess BW and obesity, an inverse statistically significant relationship was found between the serum IL-6 level, zFEV1/FVC and the dysanapsis ratio (R=-0.53, p=0.009, R=-0.61, p=0.002, respectively). Conclusion: formation of an obstructive pattern in children and adolescents with BA with excess BW and obesity may be associated with non-T2-dependent inflammatory mechanisms.

Взаимосвязь уровня неконьюгированного билирубина и спирометрических показателей у подростков с бронхиальной астмой

Either a high-to-normal or slightly elevated total bilirubin level may have external respiration protective effect in patients with bronchial asthma (BA). However, Authors have searched but not found any studies related to the connection between the unconjugated bilirubin level and spirometric parameters in adolescents. The purpose of this research was to study the connection between unconjugated bilirubin level and spirometric parameters in adolescents with BA. Materials and methods used: a single-center observational cross-sectional pilot study of 74 adolescents aged 10 to 17 y/o with BA was conducted. All participants had undergone measurements of anthropometric and spirometric parameters, hematological parameters, both total and unconjugated bilirubin level. Results: elevated total bilirubin (17.1 mmol/l and higher) occurred in 40.5% (30) being the highest in homozygous carriers of UGT1A1 gene polymorphisms with an increased number of TA repeats, the differences were statistically insignificant. The unconjugated bilirubin level and such spirometric indicators as z-ratio of forced expiratory volume in 1 s (FEV1)/forced vital capacity of the lungs (FVC) and z-criterion of the mean forced expiratory flow during the 25-75% of FVC (MEF25-75) had statistically significant direct correlation (R=0,42, p<0,001, R=0,37, p=0,001, respectively). Patients with obstructive lung ventilation disorders at the time of examination (zFEV1/FVC less than -1.645) had lower levels of both total and unconjugated bilirubin, the differences were statistically significant (p=0.002 and p=0.004, respectively). Conclusion: statistically significant correlations between unconjugated bilirubin level and such spirometric parameters as zFEV1/FVC and zMEF25-75 as well as unconjugated bilirubin low level identification in patients with spirometric indicators of bronchial obstruction suggest a protective effect of unconjugated bilirubin on the development of bronchial obstruction in adolescents with BA.

Poor correlation of venous lactate with systemic oxygen saturation in the paediatric cardiac ICU: a pilot study.

Cardiac intensive care providers require a comprehensive understanding of cardiac output and oxygen delivery. The estimation of cardiac output in clinical practice often relies on thermodilution and the Fick principle. Central venous saturation and lactate levels are commonly used indicators for cardiac output assessment. However, the relationship between venous lactate levels and venous oxygen saturation in paediatric cardiac intensive care patients remains unclear. This is a single-centre retrospective pilot study aimed to investigate the correlation between venous lactate and venous oxygen saturation in paediatric patients. Data collected included venous saturation, heart rate, mean arterial blood pressure, arterial saturation by pulse oximetry, cerebral and renal near-infra-red spectroscopy values, and the presence of a functionally univentricular heart. Statistical analyses included Bayesian Pearson correlation and regression analyses. A total of 203 data points from 37 unique patients were included in the analysis. There was no significant correlation between serum lactate and venous saturation (correlation coefficient = -0.01; Bayes factor 10 = 0.06). Serum lactate also did not correlate with other haemodynamic metrics. Venous saturation showed correlations with arterial saturation and cerebral and renal near-infra-red spectroscopy. Regression analysis revealed that parallel circulation, arterial saturation, and cerebral near-infra-red spectroscopy were predictive of venous saturation. The following equation resulted from the regression analysis: 68.0 - (12.7 x parallel circulation) - (0.8 x arterial saturation) + (0.3 x cerebral near-infra-red spectroscopy). This model had a Bayes factor 10 of 0.03 and adjusted R-squared was 0.29. In paediatric cardiac intensive care patients, there is no significant correlation between venous lactate and venous saturation, suggesting that lactate may not be a reliable marker for assessing the adequacy of oxygen delivery in this population. Only a weak correlation could be identified once the venous saturation was 70% or lower. Additional research is needed to explore alternative markers for monitoring oxygen delivery in critically ill paediatric patients.

Safety and efficacy of fluoxetine in post-stroke anxiety-A pilot prospective randomized open blinded endpoint (PROBE) study.

The prevalence of post-stroke anxiety (PSA) is reported to be 20%-25%. There is insufficient evidence on the efficacy of antidepressants for treating anxiety in such patients. This Prospective Randomized Open Blinded Endpoint (PROBE) study was designed to assess the safety and efficacy of fluoxetine in PSA. In this single-center pilot study conducted in India, post-stroke patients (between 1 to 6months) were randomized to fluoxetine (intervention group: 20mg/day for 12weeks) or standard medical care (control group). The primary outcome was improvement in the Hamilton Anxiety Rating Scale (HAM-A) at 12weeks. The secondary outcomes were anxiety remission (>50% improvement in HAM-A), modified Rankin Scale (mRS), Barthel Index (BI), quality of life (SF-36), and Hamilton Depression Rating Scale (HAM-D). A linear regression analysis was done for determinants of HAM-A to account for baseline differences in the intervention and control groups. A total of 60 patients were randomized: (30: intervention, 30: control). The overall prevalence of post-stroke anxiety among participants in the study was 50.8%, and 31.5% experienced both anxiety and depression. The average HAM-A score at baseline was 11, and average follow-up score at study conclusion was 4. There was similar improvement in the HAM-A score at 12weeks post-randomization in the intervention and control groups [fluoxetine: -8.0 (95% CI = -11.0 to -4.0); control: -7.0 (95% CI = -9.5 to -4.0); P = 0.91]. Likewise, there was no significant difference between intervention and control groups at 12weeks post-randomization on the mRS, BI, SF-36, or HAM-D. There were no serious adverse events in either group during the study. Fluoxetine and standard medical care had comparable improvement in HAM-A in post-stroke patients with mild anxiety at 12weeks. Further study of the pharmacological treatment of post-stroke patients with more severe anxiety is needed. CTRI/2018/12/016568.

Artificial intelligence-driven skin aging simulation as a novel skin cancer prevention.

Skin cancer, a prevalent cancer type among fair-skinned patients globally, poses a relevant public health concern due to rising incidence rates. Ultraviolet (UV) radiation poses a major risk factor for skin cancer. However intentional tanning associated with sunburns remains a common practice, notably among female adults Appropriate prevention campaigns targeting children and adolescents are needed to improve sun-protection behavior particularly in these age groups. The aim of our study is to investigate if an AI-based simulation of facial skin aging can enhance sun-protection behavior in female adults. In this single-center prospective observational pilot study at Department of Dermatology at the University Hospital of Basel, we took photographs of healthy young females' faces with a VISIA-CR camera (Canfield Scientific Inc., Parsippany, New Jersey, Version 8.2) between February to March 2021. Digital images were performed in three angles (straight, left 45°, right 45°). All participants received an AI-based simulation of their facial skin with continuous aging to 80 years. A newly created anonymous questionnaire capturing participants' sociodemographic data and also tanning and sun-protection behavior was completed in pre- and post-aging simulation. To observe long-term effects, a 2-year follow-up was conducted between March to April 2023. The 60 participants (mean age 23.6±2.5 years) evaluated the importance of sun-protection significantly higher after skin aging simulation with VISIA-CR camera (p<0.0001; 95%-CI:8.2-8.8). Post-intervention, 91.7% (55/60) of the females were motivated to reduce UV exposure and to intensify UV protection in the future since the individual UV-dependent risk was perceived significantly higher (p<0.001; 95%-CI: 5.9-6.7). At two-year follow-up, 96% (24/25) indicated persistent effort reducing UV exposure. The preference for SPF50+ sunscreen increased to 46.7% (28/65) directly after the skin-aging simulation and continued to rise up to 60.0% (15/25) after two years. Our data emphasize the potential of AI-assisted photo-aging interventions to enhance motivation for UV protection in the short and the long term We encourage that different age and gender groups are addressed in a personalized, generation-specific manner with the appropriate media and by considering the Hawthorne effect. Campaigns with visual AI support can improve the intent of cancer-preventative behavior.

Traditional and non-traditional cardiovascular risk factor profiles in young patients with coronary artery disease

Study objectiveThere is an increasing trend in myocardial infarction (MI) hospitalizations in young individuals. The prevalence of modifiable cardiovascular risk factors is high in this population. This study aims to assess the prevalence of traditional and non-traditional cardiovascular risk factors among young patients with coronary artery disease (CAD) including novel lipid and dietary biomarkers with a focus on potential gender differences. DesignThe Young Heart study is a prospective, single-center pilot cohort study. Baseline data included medical history, medications, and lifestyle factors. We also collected blood samples for lipid profile, lipoprotein (a), high-sensitivity C-reactive protein (hsCRP), and trimethylamine N-oxide (TMAO). ParticipantsA total of 60 patients aged <60 years with CAD (on coronary CT or invasive angiogram) were included in the study. ResultsThe median age was 51 years and predominantly male (70 %). Baseline assessment revealed a high prevalence of hypertension (76.7 %), hyperlipidemia (91.7 %), and obstructive CAD (88.3 %). 36.7 % had diabetes, 28.3 % had prediabetes, and 38.3 % had prior MI. Uncontrolled risk factors were prevalent, including increased waist circumference (54.6 %), metabolic syndrome (60.0 %), and LDL ≥70 mg/dL (47.5 %), Lp(a) ≥75 nmol/L (47.5 %). Furthermore, 41.7 % had hsCRP ≥2 mg/L, and 28.3 % had suboptimal TMAO levels. 70.0 % of patients were on guideline-directed doses of statins. ConclusionYoung patients with CAD demonstrated a substantial burden of traditional and non-traditional cardiovascular risk factors. The study findings highlight the need for targeted interventions to improve risk factor control and optimize lifestyle behaviors. Further investigation is warranted to assess the impact of these interventions on cardiovascular outcomes.

Exploring the Potential Value of [68Ga]Ga-FAPI-46 PET/CT for Molecular Assessment of Fibroblast Activation in Interstitial Lung Disease: A Single-Center Pilot Study.

The aim of the study was to evaluate the association of high-resolution computed tomography (HRCT) findings with pulmonary fibrotic activity in the corresponding regions using [68Ga]Ga-fibroblast activation fibroblast inhibitor (FAPI) PET/CT in patients with interstitial lung disease (ILD). Additionally, the potential of [68Ga]Ga-FAPI-46 PET/CT for evaluating the active fibrosis process and 99mTc-MIBI scintigraphy for assessing the inflammatory process in ILD patients was also assessed. In this pilot study, 20 ILD patients underwent [68Ga]Ga-FAPI-46 PET/CT and 99mTc-MIBI SPECT/CT. Additionally, 10 patients without lung or thoracic involvement who were undergoing [68Ga]Ga-FAPI PET/CT for cancer detection were enrolled in the control group. The images were evaluated both visually and semiquantitatively and also compared with HRCT and pulmonary function tests. Multiple quantitative parameters were derived from the lung segments in the PET scan, including SUVmax, SUVmean, maximum target-to-liver ratio, mean target-to-liver ratio (TLRmean), and total lesion FAPI expression for the entire lung, as well as its lobes and zones. Additionally, the maximum Hounsfield unit (HU) and mean HU in HRCT were calculated for the whole lung as well as its lobes and zones. Furthermore, an HRCT fibrosis score (HFS) was defined according to the HRCT findings. Twenty ILD patients with a mean age of 58.70 (SD, 11.09) years were enrolled. Additionally, 10 control patients were enrolled with a mean age of 57.70 (SD, 15.19) years. Based on visual assessment, the FAPI scan was positive in 12 (60%) patients. Similarly, the MIBI scan was positive in 12 (60%) patients. In the 20 ILD cases, both scans were positive in 6 cases, and both were negative in 2 cases. Six cases showed FAPI-negative and MIBI-positive results, whereas another 6 cases showed FAPI-positive and MIBI-negative results. Comparing the control and ILD patients, there was a significant difference in SUVmax, SUVmean, total lesion FAPI expression, TLRmean, maximum HU, and mean HU (P < 0.05). When comparing HFS with PET-derived parameters in zones, a significant positive correlation was found between HFS and SUVmean, SUVmax, maximum target-to-liver ratio, and TLRmean (P < 0.05). Additionally, a significant difference was noted between FAPI results and HFS (P = 0.003). An ancillary finding, 9 of 20 (45%) ILD patients showed intense FAPI uptakes in gallbladder, whereas none of the 10 in the control group showed such uptake. The present study may suggest that combining [68Ga]Ga-FAPI PET/CT and 99mTc-MIBI SPECT/CT yields an additive effect for evaluating ILD-related fibrosis and inflammatory processes over using either modality alone. Furthermore, it appears that [68Ga]Ga-FAPI PET/CT has the potential to ascertain levels of fibrotic activity from population of resident fibroblasts, active fibroblasts, and scar maturation among ILD patients based on their HRCT patterns.

4DryField vs. hyalobarrier gel for preventing the recurrence of intrauterine adhesions – a pilot study

Introduction This was a single-center pilot study that sought to describe an innovative use of 4DryField® PH (premix) for preventing the recurrence of intrauterine adhesions (IUAs) after hysteroscopic adhesiolysis in patients with Asherman’s syndrome (AS). Material and methods Twenty-three patients with AS were enrolled and 20 were randomized (1:1 ratio) to intrauterine application of 4DryField® PH (n = 10) or Hyalobarrier® gel (n = 10) in a single-blind manner. We evaluated IUAs (American Fertility Society [AFS] score) during initial hysteroscopy and second-look hysteroscopy one month later. Patients completed a follow-up symptoms questionnaire three and reproductive outcomes questionnaire six months later. Results The demographic and clinical characteristics, as well as severity of IUAs, were comparable in both groups. The mean initial AFS score was 9 and 8.5 in the 4DryField® PH and Hyalobarrier® gel groups, respectively (p = .476). There were no between-group differences in AFS progress (5.9 vs. 5.6, p = .675), need for secondary adhesiolysis (7 vs. 7 patients, p = 1), and the follow-up outcomes. Conclusion 4DryField® PH could be a promising antiadhesive agent for preventing the recurrence of IUAs, showing similar effectiveness and safety to Hyalobarrier® gel. Our findings warrant prospective validation in a larger clinical trial. Clinical trial registry number ISRCTN15630617

Impact of early continuous positive airway pressure in the delivery room (DR-CPAP) on neonates < 1500 g in a low-resource setting: a protocol for a pilot feasibility and acceptability randomized controlled trial

BackgroundPreterm birth is the leading cause of childhood mortality, and respiratory distress syndrome is the predominant cause of these deaths. Early continuous positive airway pressure is effective in high-resource settings, reducing the rate of continuous positive airway pressure failure, and the need for mechanical ventilation and surfactant. However, most deaths in preterm infants occur in low-resource settings without access to mechanical ventilation or surfactant. We hypothesize that in such settings, early continuous positive airway pressure will reduce the rate of failure and therefore preterm mortality.MethodsThis is a mixed methods feasibility and acceptability, single-center pilot randomized control trial of early continuous positive airway pressure among infants with birthweight 800–1500 g. There are two parallel arms: (i) application of continuous positive airway pressure; with optional oxygen when indicated; applied in the delivery room within 15 min of birth; transitioning to bubble continuous positive airway pressure after admission to the neonatal unit if Downes Score ≥ 4 (intervention), (ii) supplementary oxygen at delivery when indicated; transitioning to bubble continuous positive airways pressure after admission to the neonatal unit if Downes Score ≥ 4 (control). A two-stage consent process (verbal consent during labor, followed by full written consent within 24 h of birth) and a low-cost third-party allocation process for randomization will be piloted.We will use focus group discussions and key informant interviews to explore the acceptability of the intervention, two-stage consent process, and trial design. We will interview healthcare workers, mothers, and caregivers of preterm infants. Feasibility will be assessed by the proportion of infants randomized within 15 min of delivery; the proportion of infants in the intervention arm receiving CPAP within 15 min of delivery; and the proportion of infants with primary and secondary outcomes measured successfully.DiscussionThis pilot trial will enhance our understanding of methods and techniques that can enable emergency neonatal research to be carried out effectively, affordably, and acceptably in low-resource settings. This mixed-methods approach will allow a comprehensive exploration of parental and healthcare worker perceptions, experiences, and acceptance of the intervention and trial design.Trial registrationThe study is registered on the Pan African Clinical Trials Registry (PACTR) PACTR202208462613789. Registered 08 August 2022. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23888.

Retrospective Review of the Image Quality of Monoplane Transesophageal Echocardiography in Prehospital Out-Of-Hospital Cardiac Arrest: A Single Center Pilot Study

ABSTRACT OBJECTIVES Out of Hospital Cardiac Arrest (OHCA) is a frequently encountered pathology with resultant poor outcomes in the majority of patients. Echocardiography has been utilized to help guide clinical decision making and monitor effectiveness of resuscitative efforts. Transthoracic echocardiography (TTE) the mainstay of point-of-care ultrasound (POCUS) real time resuscitative imaging has limitations, most notably is the disruption of closed chest compressions. Trans-esophageal echocardiography (TEE) is an emerging technology in emergency care and can potentially overcome these limitations but image quality and accuracy of use in the prehospital environment remains unknown. Our primary objective is to identify the accuracy of Emergency Medical Services (EMS) fellow physicians in performing TEE via the identification of key cardiac structures. Secondarily we assess image quality as well as accuracy on cardiac activity interpretation as compared to TEE-experienced cardiologists. METHODS A pilot study using descriptive analysis of a retrospective case-series with specific focus on inter-rater reliability as well as pragmatic management alterations based on real-time image interpretation by EMS physicians. After focused education, 13 patients were eligible for prehospital TEE who suffering OHCA from July 2022-June 2023. Ultrasound (US) images were interpreted by EMS fellow physicians and over-read by cardiologists with specific focus on inter-rater reliability. After collection of patients presenting data and US images, analysis was performed. RESULTS Of 13 patients initially screened, 10 patients were included in a study with a median age of 50 years old (41-70). Three patients were excluded due to equipment malfunction or insufficient image capture. An interrater reliability identified a kappa of 0.96 with respect to identification of cardiac structures and a kappa of 0.65 for identification of cardiac activity. CONCLUSIONS In this small study of prehospital TEE, EMS fellow physicians had high inter-rater reliability in image interpretation pertaining to anatomy and cardiac activity when compared with cardiologists. Further research is needed to determine its efficacy, safety, and widespread application in the prehospital setting.

Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study

Background and AimsBiliary drainage by endoscopic retrograde cholangiography (ERCP) in patients with malignant distal bile duct obstruction (MBO) is frequently associated with complications, such as pancreatitis, hampering patient outcome. EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is a promising alternative in patients with MBO but is associated with a worrisome risk of stent dysfunction. Placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage towards the descending duodenum, may decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates. MethodsProspective single center pilot study in patients with a pathology confirmed MBO without gastric-outlet obstruction. Primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent bile duct dilatation, or cholangitis. The study was registered in clinicaltrials.gov (registry number NCT05595122). ResultsOverall, 27 consecutive patients eligible for EUS-CDS were enrolled. The placement of a LAMS was successful in 24/27 patients (89%), and placement of FCSEMS through the LAMS was successful in 20/24 (83%), in the remaining 4 patients a coaxial double-pigtail plastic stent was placed. In 2 of these 20 patients there was persistent jaundice requiring stent revision (10%), leading to a clinical success rate of 90%. No patients developed stent dysfunction after initial clinical success. ConclusionsThis study showed a stent dysfunction rate of 10% following technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the design of LAMS may further reduce the rate of stent dysfunction.

Safety of acamprosate for alcohol use disorder Post-Liver transplant: a pilot randomized controlled trial.

Acamprosate is a therapy for alcohol use disorder but data on feasibility and safety in liver transplant (LT) recipients are lacking. This was a single-center unblinded prospective pilot randomized controlled trial of adults (≥18 years) with LT for ALD enrolled between 2021-2023 who were randomized 2:1 to the intervention of acamprosate (666mg dose three times daily) or standard of care (SOC) over 14 weeks. Outcomes included safety [prevalence of adverse events (AE)], feasibility (weekly survey response rate >60%), adherence (self-reported acamprosate use>60%), and efficacy (reduction in Penn Alcohol Craving Scale [PACS]) and relapse-blood phosphatidylethanol≥20ng/mL/reported alcohol use) evaluated by standardized weekly surveys. The efficacy analysis was done in both the intention to treat (ITT) (excluding withdrawals before medication administration) and per-protocol (PP) population (excluding withdrawals/<4 weeks participation). Of 78 participants approached, 30 enrolled (19 acamprosate, 11 SOC) with similar baseline characteristics. Eight participants withdrew (6 acamprosate prior to medication administration and 2 SOC). AEs were similar between acamprosate and SOC groups (92.3% vs. 90.0%, p>0.99), including Grade 3 AEs (53.9% vs. 60.0%, p>0.99) with no reported grade 4/5 AEs. Survey response rates were similar in acamprosate vs SOC groups (61.0% vs. 76.0%, p=0.19), and 69.0% were acamprosate adherent. Baseline PACS values were low with no difference by group in median absolute change in PACS for ITT (0, IQR:-4-0 vs. 0, IQR:0-0, p=0.32) and PP analyses (-1, IQR:-6-0 vs. 0, IQR:0-0, p=0.36). There were no reported or biochemical evidence of alcohol relapse. In this pilot study, preliminary data suggests that acamprosate may be safe and feasible. These data can inform larger studies and clinician efforts to address alcohol use disorder in post-LT care. (ClinicalTrials.gov, Number: NCT06471686).

Pharmacist E-script transcription service initiated nicotine replacement therapy uptake in pre-admission clinic: A pilot study.

Pharmacist-led smoking cessation programs in pre-admission clinics (PAC) have shown to increase quit attempts and achieve abstinence by the day of surgery (DOS). To evaluate the feasibility of Pharmacist E-script Transcription Service (PETS) initiated nicotine replacement therapy (NRT) in PAC, including smoking cessation on DOS. A single centre, pre and post-intervention pilot study conducted at an Australian public hospital PAC. In a two-month intervention period, PAC nursing staff invited smokers (≥1 cigarette/day) to see a smoking cessation PET pharmacist. Pharmacist-initiated NRT and Quitline© referrals were offered. Cessation outcomes were compared with the preceding two-month control period. feasibility of intervention. DOS smoking abstinence rates and three-months post-surgery. PAC nurses identified 112 smokers over 4 months; 53 during pre-intervention period, and 59 during intervention period. Twenty-two intervention patients (37%) accepted seeing the pharmacist, with 16 subsequent Quitline© referrals (73%) and 11 NRT prescriptions (50%) written. The median nursing smoking status documentation time increased in the intervention period (1 min vs. 4, p < .001). The intervention did not impact pharmacist's workload. Verified abstinence increased from 8.5% (4/47) pre-intervention to 9.4% (5/53) post-intervention, p =1.00. Relapse rates in the intervention period increased (20% vs. 50%) at three-months post-surgery. A PETS-initiated NRT program in PAC is feasible and increased preoperative use of NRT and Quitline© with minimal impact on smoking cessation. SO WHAT?: This study has highlighted the importance of implementing a multidisciplinary smoking cessation program in PAC however, larger studies are needed to determine the true impact of the program on smoking cessations.

Pentoxifylline ameliorates subclinical atherosclerosis progression in patients with type 2 diabetes and chronic kidney disease: a randomized pilot trial

BackgroundDiabetic kidney disease (DKD) is associated with a higher risk of cardiovascular disease (CVD). Pentoxifylline (PTF), a nonselective phosphodiesterase inhibitor with anti-inflammatory, antiproliferative, and antifibrotic actions, has demonstrated renal benefits in both clinical trials and meta-analyses. The present work aimed to study the effects of PTF on the progression of subclinical atherosclerosis (SA) in a population of patients with diabetes and moderate to severe chronic kidney disease (CKD).MethodsIn this open-label, randomized controlled, prospective single-center pilot study the evolution of carotid intima-media thickness (CIMT) and ankle-brachial index (ABI) were determined in 102 patients with type 2 diabetes mellitus and CKD assigned to PTF, aspirin or control groups during 18 months. We also determined the variations in the levels of inflammatory markers and Klotho (KL), a protein involved in maintaining cardiovascular health, and their relationship with the progression of SA.ResultsPatients treated with PTF presented a better evolution of CIMT, increased KL mRNA levels in peripheral blood cells (PBCs) and reduced the inflammatory state. The progression of CIMT values was inversely related to variations in KL both in serum and mRNA expression levels in PBCs. Multiple regression analysis demonstrated that PTF treatment and variations in mRNA KL expression in PBCs, together with changes in HDL, were significant determinants for the progression of CIMT (adjusted R2 = 0.24, P < 0.001) independently of traditional risk factors. Moreover, both variables constituted protective factors against a worst progression of CIMT [OR: 0.103 (P = 0.001) and 0.001 (P = 0.005), respectively].ConclusionsPTF reduced SA progression assessed by CIMT variation, a beneficial effect related to KL gene expression in PBCs.Trial registrationThe study protocol code is PTF-AA-TR-2009 and the trial was registered on the European Union Drug Regulating Authorities Clinical Trials (EudraCT #2009–016595–77). The validation date was 2010-03-09.

Evaluation of the Predictive Character of the Expiratory Inferior Vena Cava/Abdominal Aorta (eIVC/Ao) Index for Minimum Blood Pressure Following Spinal Anesthesia With 0.5% Hyperbaric Bupivacaine.

Spinal anesthesia has many side effects, one of them being a drop in blood pressure (BP). Identifying predictive factors for this drop is a clear matter of concern. In this regard, the expiratory inferior vena cava/abdominal aorta (eIVC/Ao) index has already been spotted as such for doses of 0.5% hyperbaric bupivacaine greater than 12mg. Departing from the demonstrated correlation between this index and hypotension post-spinal anesthesia, our study aimed to (1) evaluate whether an eIVC/Ao index greater than 0.7, thus defining non-hypovolemic patients, can also predict minimal BP for doses inferior to 12mgand (2) identify other predictive factors for minimal BP post-spinal anesthesia. Lastly, we verified whether preoperative fasting induces hypovolemia. This single-center prospective observational pilot study included 20 patients. The baseline measurements of BP, eIVC/Ao index, and fasting time were recorded at time T0'. Then spinal anesthesia was administered with 0.5% hyperbaric bupivacaine in doses inferior to 12 mg. The patients' systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and metameric levels were each recorded at times T5', T10', T15', and T20'. The results indicated that baseline DBP was predictive of low DBP and minimum MAP, which reflect myocardial perfusion and systemic pressures, respectively. Therefore, it should trigger prophylaxis (spinal-lateralized, continuous, or lower dose) in patients with a low DBP baseline. Additionally, baseline SBP was predictive of minimumSBP, an independent risk factor for post-anesthetic hypotension if its baseline is lessthan 120 mmHg. Although female gender was linked to minimum SBP, other confounding factors (size, dose administered, and type of surgery related to gender) must also be considered. Moreover, a correlation was established between height and MAP in parturients. Hypotension was not recorded at local anesthetic (LA) doses between 8 and 12 mg and the doses administered were sufficient to achieve the metameric levels required for surgery (ether tests). Since 8 mg of 0.5% hyperbaric bupivacaine achieved the same level as 12 mg, lower doses of LA might prevent a significant drop in BP and its deleterious effects. Therefore, in the current cohort, the eIVC/Ao index was not predictive of minimum BP during spinal anesthesia with doses less than 12 mg of 0.5% hyperbaric bupivacaine. However, predictive factors for minimum BP included gender and baseline SBP (for minimum SBP), height and baseline DBP (for minimum MAP), and baseline DBP (for minimum DBP). Lastly, preoperative fasting did not cause hypovolemia.

Feasibility of Simultaneous Anodal Transcranial Direct Current Stimulation During Gait Training in Chronic Stroke Patients: A Randomized Double-Blind Pilot Clinical Trial.

Transcranial direct current stimulation (tDCS) is a therapeutic tool for improving post-stroke gait disturbances, with ongoing research focusing on specific protocols for its application. We evaluated the feasibility of a rehabilitation protocol that combines tDCS with conventional gait training. This was a randomized, double-blind, single-center pilot clinical trial. Patients with unilateral hemiplegia due to ischemic stroke were randomly assigned to either the tDCS with gait training group or the sham stimulation group. The anodal tDCS electrode was placed on the tibialis anterior area of the precentral gyrus while gait training proceeded. Interventions were administered 3 times weekly for 4 weeks. Outcome assessments, using the 10-meter walk test, Timed Up and Go test, Berg Balance Scale, Functional Ambulatory Scale, Modified Barthel Index, and European Quality of Life 5 Dimensions 3 Level Version, were conducted before and after the intervention and again at the 8-week mark following its completion. Repeated-measures analysis of variance (ANOVA) was used for comparisons between and within groups. Twenty-six patients were assessed for eligibility, and 20 were enrolled and randomized. No significant differences were observed between the tDCS with gait training group and the sham stimulation group in gait speed after the intervention. However, the tDCS with gait training group showed significant improvement in balance performance in both within-group and between-group comparisons. In the subgroup analysis of patients with elicited motor-evoked potentials, comfortable pace gait speed improved in the tDCS with gait training group. No serious adverse events occurred throughout the study. Simultaneous anodal tDCS during gait training is a feasible rehabilitation protocol for chronic stroke patients with gait disturbances. URL: https://cris.nih.go.kr; Registration number: KCT0007601; Date of registration: 11 July 2022.

Outcomes of pediatric endoscopic ultrasound-guided celiac plexus block: A single center pilot study.

Celiac plexus blocks (CPB) using endoscopic ultrasound (EUS) guidance provide significant pain relief in adults with chronic pancreatitis. We present on EUS-guided CPB for pediatric patients with abdominal pain from chronic pancreatitis or severe functional dyspepsia necessitating clinically assisted nutrition and hydration. Patients who underwent EUS-CPB were included and followed prospectively at 2-, 4-, and 8-weeks postprocedure about pain, enteral tolerance, and school/activity attendance. Thirteen patients underwent EUS-guided CPB with a total of 21 procedures. In the pancreatitis cohort, mean pain relief was 11.7 weeks for those who responded. In the functional dyspepsia cohort, mean improvement (in either pain or enteral tolerance) was 4.8 weeks. Symptom improvement varied between the two cohorts. Acute recurrent/chronic pancreatitis patients demonstrated more sustained relief than the functional dyspepsia cohort. This study adds to the limited data investigating the utility of EUS-CPB as part of a multimodal treatment plan in pediatrics.

Validation of a checklist to facilitate serious illness conversations in adult emergency in China: a single-centre pilot study

BackgroundAdvances in emergency and critical care have improved outcomes, but gaps in communication and decision-making persist, especially in the emergency department (ED), prompting the development of a checklist to aid in serious illness conversations (SIC) in China.MethodsThis was a single-centre prospective interventional study on the quality improvement of SIC for life-sustaining treatment (LST). The study recruited patients consecutively for both its observational baseline and interventional stages until its conclusion. Eligible participants were adults over 18 years old admitted to the Emergency Intensive Care Unit (EICU) of a tertiary teaching hospital, possessing full decisional capacity or having a legal proxy. Exclusions were made for pregnant women, patients deceased upon arrival, those who refused participation, and individuals with incomplete data for analysis. First, a two-round Delphi process was organized to identify major elements and generate a standard process through a checklist. Subsequently, the efficacy of SIC in adult patients admitted to the EICU was compared using the Decisional Conflict Scale (DCS) score before (baseline group) and after (intervention group) implementing the checklist.ResultsThe study participants presented with the most common comorbidities, such as diabetes, myocardial infarction, cerebrovascular disease, moderate-to-severe renal disease, congestive heart failure, and chronic pulmonary disease. The median Charlson Index did not differ between the baseline and intervention cohorts. The median length of hospital stay was 11.0 days, and 82.9% of patients survived until hospital discharge. The total DCS score was lower in the intervention group than in the baseline group. Three subscales, including the informed, values clarity, and support subscales, demonstrated significant differences between the intervention and baseline groups. Fewer intervention group patients agreed with and changed their minds about cardiopulmonary resuscitation (CPR) compared to the baseline group.ConclusionThe use of a SIC checklist in the EICU reduced the DCS score by increasing medical information disclosure, patient value awareness, and decision-making support.

Hybrid FDG-PET/MRI for Diagnosis and Clinical Management of Patients with Suspected Perihilar Cholangiocarcinoma: A Feasibility Pilot Study

PurposeRecently introduced hybrid 2-[18 F]-fluoro-2-deoxy-D-glucose (18 F-FDG) Positron Emission Tomography (PET) combined with Magnetic Resonance Imaging (MRI) may aid in proper diagnosis and staging of perihilar cholangiocarcinoma (pCCA). The aim of this study is to assess the effect of 18 F-FDG PET/MRI on diagnosis and clinical decision making in the pre-operative work up of pCCA.MethodsIn this single-centre pilot study patients with presumed resectable pCCA underwent state-of-the-art 18 F-FDG hybrid PET/MRI using digital silicone photomultiplier detectors integrated within a 3-Tesla bore. Data were collected on several baseline and imaging characteristics. The primary outcome measure was the added diagnostic information and the effect on clinical decision making. Secondary aim was to correlate quantitative PET signal intensity to patient- and tumour characteristics. High and low SUVmax subgroups related to the mean value were made. Significance of lesion- and patient characteristics with the high and low SUVmax subgroups, as well as TLR and TBR, was evaluated with Fisher’s exact test or Mann-Whitney-U test.ResultsIn total 14 patients were included (mean age 62.4 years, 64% male). Final diagnosis was pCCA in 10 patients (71.4%), follicular lymphoma in one patient (7.1%) and benign disease in the remaining three patients. FDG-PET/MRI added valuable diagnostic information in six (43%) patients and affected clinical decision making in two of these patients (14%) by increasing confidence for malignancy which lead to the decision for surgery on short term. High SUVmax values were seen in half of cases with pCCA and half of cases with non-cancerous lesions. In addition, high SUVmax values were directly associated with primary sclerosing cholangitis when present (p = 0.03).ConclusionSimultaneous 18 F-FDG-PET/MRI added diagnostic information in six of fourteen patients and influenced clinical decision making in two patients (14%) with presumed resectable pCCA.