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World Journal of Gastrointestinal... May 2024Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support...
BACKGROUND
Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD.
AIM
To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD.
METHODS
This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points.
RESULTS
In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores ( < 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group.
CONCLUSION
The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.
PubMed: 38813575
DOI: 10.4253/wjge.v16.i5.250 -
Journal of Inflammation Research 2024Effective biomarkers are needed to predict the efficacy of immune checkpoint inhibitors (ICIs) therapy in hepatocellular carcinoma (HCC). We evaluated the early changes...
BACKGROUND
Effective biomarkers are needed to predict the efficacy of immune checkpoint inhibitors (ICIs) therapy in hepatocellular carcinoma (HCC). We evaluated the early changes in serum interleukin-8 (IL-8) levels as a biomarker of response to ICIs in patients with unresectable HCC.
METHODS
Eighty patients who received ICIs therapy alone or in combination with other treatments for unresectable HCC were included. Serum was collected at baseline and 2-4 weeks after the first dose. Serum IL-8 levels were measured using by ELISA.
RESULTS
In the progressive disease (PD) group, serum IL-8 levels increased significantly before the second dose of ICIs therapy compared with baseline levels ( < 0.001). Early changes in serum IL-8 levels were significantly associated with the response to ICIs therapy ( < 0.001). A cutoff value of 8.1% increase over the baseline most effectively predicted the response to ICIs. Increases in serum IL-8 levels > 8.1% indicated the uselessness of ICIs immunotherapy in patients with unresectable HCC. Patients with increases in serum IL-8 levels > 8.1% had significantly shorter overall survival (OS) and progression-free survival (PFS) than those with increases in serum IL-8 levels ≤ 8.1% ( < 0.001). Increases in serum IL-8 levels > 8.1% were independent prognosticators of worse OS ( = 0.003) and PFS ( < 0.001).
CONCLUSION
Early changes in serum IL-8 levels, measured only 2-4 weeks after starting therapy, could predict the response to ICIs therapy, as well as OS and PFS of patients with unresectable HCC. Increases in serum IL-8 levels > 8.1% indicated the uselessness of ICIs immunotherapy and predicted worse OS and PFS.
PubMed: 38813541
DOI: 10.2147/JIR.S460931 -
The Lancet Regional Health. Europe Jul 2024[This corrects the article DOI: 10.1016/j.lanepe.2024.100912.].
Corrigendum to "Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study" [The Lancet Regional Health - Europe 41 (2024) 100912].
[This corrects the article DOI: 10.1016/j.lanepe.2024.100912.].
PubMed: 38813536
DOI: 10.1016/j.lanepe.2024.100940 -
Turkish Journal of Medical Sciences 2023Despite advancements in valve technology and increased clinical experience, complications related to conduction defects after transcatheter aortic valve implantation...
BACKGROUND/AIM
Despite advancements in valve technology and increased clinical experience, complications related to conduction defects after transcatheter aortic valve implantation (TAVR) have not improved as rapidly as expected. In this study, we aimed to predict the development of complete atrioventricular (AV) block and bundle branch block during and after the TAVR procedure and to investigate any changes in the cardiac conduction system before and after the procedure using electrophysiological study.
MATERIALS AND METHODS
A total of 30 patients who were scheduled for TAVR at our cardiovascular council were planned to be included in the study. TAVR was performed on patients at Erciyes University Medical Faculty Hospital as a single center between May 2019 and August 2020 Diagnostic electrophysiological study was performed before the TAVR procedure and after its completion. Changes in the cardiac conduction system during the preprocedure, intra-procedure, and postprocedure periods were recorded.
RESULTS
Significant increases in baseline cycle length, atrial-His (AH) interval, his-ventricular (HV) interval and atrioventricular (AV) distance were observed before and after the TAVR procedure (p = 0.039, p < 0.001, p = 0.018, p < 0.001, respectively). During the TAVR procedure, the preprocedural HV interval was longer in patients who developed AV block and bundle branch block compared to those who did not and this difference was statistically significant (p = 0.024). ROC curve analysis revealed that a TAVR preprocedure HV value >59.5 ms had 86% specificity and 75% sensitivity in detecting AV block and bundle branch block (AUC = 0.83, 95% CI: 0.664-0.996, p = 0.013). The preprocedure HV distance was 98 ± 10.55ms in the group with permanent pacemaker implantation and the mean value in the group without permanent pacemaker implantation was 66.27 ± 15.55 ms, showing a borderline significant difference (p = 0.049).
CONCLUSION
The prolongation of HV interval in patients with AV block and bundle branch block suggests that the block predominantly occurs at the infra-hisian level. Patients with longer preprocedural HV intervals should be closely monitored for the need for permanent pacemaker implantation after the TAVR procedure.
Topics: Humans; Transcatheter Aortic Valve Replacement; Male; Female; Pacemaker, Artificial; Aged; Aged, 80 and over; Atrioventricular Block; Bundle-Branch Block; Aortic Valve Stenosis; Electrocardiography; Postoperative Complications; Heart Conduction System
PubMed: 38813482
DOI: 10.55730/1300-0144.5750 -
EClinicalMedicine May 2024Hypochondroplasia is a rare autosomal dominant skeletal dysplasia due to activating variants in . It presents with disproportionate short stature with a wide range of...
BACKGROUND
Hypochondroplasia is a rare autosomal dominant skeletal dysplasia due to activating variants in . It presents with disproportionate short stature with a wide range of clinical severity. There are currently no approved medications to treat short stature in children with hypochondroplasia. Vosoritide is a C-type natriuretic peptide analog that was recently approved for improving growth in children with achondroplasia. We aimed to evaluate the safety and efficacy of vosoritide in children with hypochondroplasia.
METHODS
We conducted a single-arm, phase 2, open-label trial at a single centre in the USA and enrolled 26 children with hypochondroplasia. The trial consists of a 6-month observation period to establish a baseline annualized growth velocity followed by a 12-month intervention period during which vosoritide is administered daily via subcutaneous injection at a dose of 15 μg/kg/day. The trial's co-primary endpoints included the incidence of adverse events and the change from baseline in age-sex standardized annualized growth velocity and height standardized deviation score (SDS) after 12 months of treatment. This trial is registered with ClinicalTrials.gov (NCT04219007).
FINDINGS
Twenty-four participants with a mean age of 5.86 years received vosoritide therapy. The first participant was enrolled on August 4, 2020, and the final participant completed the 18-month trial on September 8, 2023. Vosoritide was well tolerated with no treatment-related serious adverse events. Injection site reactions occurred in 83.3% of participants. No participants discontinued therapy due to an adverse event. Annualized growth velocity increased by 2.26 standard deviations (SD) and height SDS increased by 0.36 SD during the treatment period versus the observation period. Hypochondroplasia specific height SDS increased by 0.38 SD. There was a 1.81 cm/year increase in absolute annualized growth velocity.
INTERPRETATION
Vosoritide was safe and effective in increasing growth velocity in children with hypochondroplasia. Efficacy was similar to what has been reported in children with achondroplasia.
FUNDING
This study was supported by an investigator-initiated grant from BioMarin Pharmaceutical.
PubMed: 38813446
DOI: 10.1016/j.eclinm.2024.102591 -
Frontiers in Public Health 2024Extreme heat events caused by occupational exposure and heat waves are becoming more common. However, the molecular changes underlying the response to heat exposure in...
INTRODUCTION
Extreme heat events caused by occupational exposure and heat waves are becoming more common. However, the molecular changes underlying the response to heat exposure in humans remain to be elucidated.
METHODS
This study used longitudinal multi-omics profiling to assess the impact of acute heat exposure (50°C for 30 min) in 24 subjects from a mine rescue team. Intravenous blood samples were collected before acute heat exposure (baseline) and at 5 min, 30 min, 1 h, and 24 h after acute heat exposure (recovery). In-depth multi-omics profiling was performed on each sample, including plasma proteomics (untargeted) and metabolomics (untargeted).
RESULTS
After data curation and annotation, the final dataset contained 2,473 analytes, including 478 proteins and 1995 metabolites. Time-series analysis unveiled an orchestrated molecular choreography of changes involving the immune response, coagulation, acid-base balance, oxidative stress, cytoskeleton, and energy metabolism. Further analysis through protein-protein interactions and network analysis revealed potential regulators of acute heat exposure. Moreover, novel blood-based analytes that predicted change in cardiopulmonary function after acute heat exposure were identified.
CONCLUSION
This study provided a comprehensive investigation of the dynamic molecular changes that underlie the complex physiological processes that occur in human males who undergo heat exposure. Our findings will help health impact assessment of extreme high temperature and inspire future mechanistic and clinical studies.
Topics: Humans; Male; Longitudinal Studies; Adult; Proteomics; Metabolomics; Hot Temperature; Multiomics
PubMed: 38813424
DOI: 10.3389/fpubh.2024.1384544 -
Frontiers in Public Health 2024Move for Life (MFL) is a theory-informed intervention that was developed to augment established physical activity (PA) programmes and enable inactive adults aged... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Move for Life (MFL) is a theory-informed intervention that was developed to augment established physical activity (PA) programmes and enable inactive adults aged 50 years and older to be more active. This study examined the feasibility of MFL and sought to provide evidence of its potential for improving PA and associated health outcomes.
METHODS
A 3-arm cluster randomised feasibility trial compared MFL intervention, usual provision (UP) and control (CON) groups at baseline (T0), post-intervention (T1, at 8, 10 or 12- weeks) and 6-month follow up (T2). We used purposive sampling strategies to recruit participants according to characteristics of interest. Feasibility outcomes assessed recruitment, fidelity, adherence, retention and data completion rates based on pre-set criteria. Primary outcomes were accelerometer-based moderate-to-vigorous intensity PA (MVPA) and self-reported compliance with physical activity guidelines (PAGL). Secondary outcomes included light intensity PA (LiPA), standing time, sedentary time, body composition (adiposity), physical function and psychological well-being. We used linear mixed models (continuous outcomes) or generalized estimated equations (categorical outcomes) to estimate group differences over time in the study outcomes.
RESULTS
Progression criteria for feasibility outcomes were met, and 733 individuals were recruited. Considering a 6-month period (T0-T2), while self-reported compliance with PAGL increased in MFL relative to UP and CON and in UP relative to CON, standing time decreased in MFL relative to CON and sedentary time increased in the latter compared to UP. Waist circumference decreased in MFL relative to UP and CON. MFL outperformed UP in the Timed Up and Go Test while MFL and UP increased the distance covered in the Six-Minute Walk Test compared to CON. Psychological well-being increased in MFL relative to CON (all < 0.05).
CONCLUSION
Findings show that MFL is feasible, while data are promising with regards to the potential of improving community PA programmes for adults aged 50 or more years.
CLINICAL TRIAL REGISTRATION
https://www.isrctn.com/Registration#ISRCTN11235176.
Topics: Humans; Male; Female; Feasibility Studies; Middle Aged; Exercise; Aged; Health Promotion; Sedentary Behavior; Accelerometry
PubMed: 38813401
DOI: 10.3389/fpubh.2024.1348110 -
Heliyon May 2024The erector spinae plane block (ESPB) was proposed as a part of the postoperative multimodal analgesic regimen to improve pain management after posterior spinal surgery....
BACKGROUND
The erector spinae plane block (ESPB) was proposed as a part of the postoperative multimodal analgesic regimen to improve pain management after posterior spinal surgery. However, ESPB might cause more surgical incisional wound exudate and poor wound healing, which might be improved after topical lyophilized thrombin application.
MATERIALS AND METHODS
We performed a retrospective study on patients who received posterior spinal surgery between January 2018 and December 2021. These patients were assigned into three groups: group A (general anesthesia), group B (general anesthesia with ESPB), and group C (general anesthesia with ESPB and topical 1000-unit thrombin application). Postoperative outcomes, including times of dressing changes, duration of suture removal, and incisional wound healing, were compared among these groups.
RESULTS
Our study included 89 patients, with 48, 20, and 21 patients in groups A, B, and C, respectively. Baseline demographics, height, weight, comorbidities, and operation duration were comparable among the three groups. Group B required statistically significantly more dressing changes and had a prolonged duration of suture removal than group A (9.4 ± 4.7 versus 6.5 ± 2.0 times, 16.2 ± 3.7 versus 14.2 ± 1.4 days, respectively), which could be statistically significantly improved after the thrombin application in group C. Group B also had more frequent poor wound healing (25.0 %), which could also be improved after the thrombin application (0.0 %).
CONCLUSIONS
ESPB could cause more dressing changes and poor surgical wound healing after posterior spinal surgery, which could be improved by topical lyophilized thrombin powder application.
PubMed: 38813190
DOI: 10.1016/j.heliyon.2024.e31335 -
Heliyon May 2024Management of peatlands with an integrated system of maize and cattle is an alternative to circular agriculture in peatland areas that can increase economic growth in...
Management of peatlands with an integrated system of maize and cattle is an alternative to circular agriculture in peatland areas that can increase economic growth in rural areas which is environmentally friendly and sustainable (green economy). This study aims to obtain a circular agriculture model with zero waste management based on the integration of maize and cattle which is environmentally friendly and sustainable in peatland areas, in addition to increasing the added value and farmers' income. This circular agriculture model utilizes site-specific technological innovations and local resources that can restore sustainability in the peatland. The analysis methods used were before-and-after study analysis, baseline surveys, field trials using an experimental design and analysis of variance, financial analysis, and institutional engineering. To achieve this goal, two sub-models were implemented, namely a rural agro-industrial approach based on local agricultural resources by managing appropriate site-specific technological innovations (on-farm) and a local human resource approach through rural institutional engineering, that is farmers' institutional initiation, development, empowerment, and institutional strengthening of agribusiness (off-farm). The results showed that the circular rural agricultural management model on integrating maize and cattle as a benchmark could increase farmers' income in the peatland areas by more than 208 % from IDR 4,760,000 to IDR 14,600,000 per month. The management of peatlands through circular agriculture can improve quality products and add value to the utilization of waste such as animal feed products (silage), organic fertilizers, and biourine. This rural circular agriculture model is carried out by social engineering, initiation, and strengthening of rural agribusiness institutions that are environmentally friendly so that they can be sustainable.
PubMed: 38813176
DOI: 10.1016/j.heliyon.2024.e31259 -
Heliyon May 2024The effects of vaccination are modified by hematological and autoimmune diseases and/or treatment. Anti-SARS-CoV-2 mRNA vaccine contains polyethylene glycol (PEG), it is...
Humoral immune response against SARS-CoV-2 and polyethylene glycol elicited by anti-SARS-CoV-2 mRNA vaccine, and effect of pre-existing anti-polyethylene glycol antibody in patients with hematological and autoimmune diseases.
BACKGROUND
The effects of vaccination are modified by hematological and autoimmune diseases and/or treatment. Anti-SARS-CoV-2 mRNA vaccine contains polyethylene glycol (PEG), it is largely unknown whether PEG influences the effects of vaccination or induces a humoral response. This study examined whether anti-PEG antibodies before vaccination (pre-existing) influenced the acquisition of SARS-CoV-2 antibodies and evaluated the relationship between the development of anti-SARS-CoV-2 antibodies and anti-PEG antibodies after SARS-CoV-2 vaccination in hematological and autoimmune diseases.
METHODS
Anti-SARS-CoV-2 antibody IgG, anti-PEG IgG, and IgM titers were evaluated in patients with hematological and autoimmune diseases after the second dose of BNT162B2. Anti-PEG IgG and IgM titers were also measured before vaccination to examine changes after vaccination and the relationship with vaccine efficacy.
RESULTS
In patients with hematological (n = 182) and autoimmune diseases (n = 96), anti-SARS-CoV-2 and anti-PEG antibody titers were evaluated after a median of 33 days from 2nd vaccination. The median anti-SARS-CoV-2 antibody titers were 1901 AU/mL and 3832 AU/mL in patients with hematological and autoimmune disease, respectively. Multiple regression analysis showed that age and days from 2nd vaccination were negatively associated with anti-SARS-CoV-2 antibody titers. Anti-CD20 antibody treatment was negatively correlated with anti-SARS-CoV-2 antibody titers in hematological disease, and C-reactive protein (CRP) was positively correlated with anti-SARS-CoV-2 antibody titers in autoimmune disease. Baseline anti-PEG antibody titers were significantly higher in patients with autoimmune disease but were not correlated with anti-SARS-CoV-2 antibody titers. Patients with increased anti-PEG IgG acquired higher anti-SARS-CoV-2 antibody titers in patients with autoimmune disease.
CONCLUSIONS
Anti-SARS-CoV-2 antibody acquisition was suboptimal in patients with hematological disease, but both anti-SARS-CoV-2 antibody and anti-PEG IgG were acquired in patients with autoimmune disease, reflecting robust humoral immune response. Pre-existing anti-PEG antibody titers did not affect anti-SARS-CoV-2 antibody acquisition.
PubMed: 38813140
DOI: 10.1016/j.heliyon.2024.e31489