Tag: pubmed

BMC Gastroenterol. 2023 Nov 14;23(1):392. doi: 10.1186/s12876-023-03028-3.

ABSTRACT

INTRODUCTION: Endoscopic self-expandable metal stent (SEMS) placement is the key endoscopic treatment for unresectable malignant biliary obstruction. The benefit of covered SEMS over uncovered SEMS remains unknown as are risk factors for SEMS dysfunction. This study aimed to determine the factors associated with patency of SEMS.

METHODS: Patients with unresectable malignant biliary obstruction who underwent endoscopic SEMS placement at Ramathibodi Hospital, during January 2012 to March 2021 were included. Patient characteristics, clinical outcomes and patency of SEMS were collected. The primary outcome were stent patency and factors associated with patency of SEMS. The factors were analyzed by univariate and multivariate analyses. Median days of stent patency, median time of patient survival, rate of reintervention and complications after SEMS placement were collected.

RESULTS: One hundred and fourteen patients were included. SEMS dysfunction was found in 37 patients (32.5%). Size of cancer (Hazard ratio (HR), 1.20, (95% CI 1.02, 1.40), p 0.025), presence of stones or sludge during SEMS placement (Hazard ratio (HR), 3.91, (95% CI 1.74, 8.75), p 0.001), length of SEMS, 8 cm (HR 2.96, (95% CI 1.06, 8.3), p 0.039), and total bilirubin level above 2 mg/dL at one month after SEMS placement (HR 1.14, (95% CI 1.06, 1.22), p < 0.001) were associated with SEMS dysfunction. The median stent patency was 97 days. The median patient survival was 133 days, (95% CI 75-165). The rate of reintervention was 86% in patients with SEMS dysfunction.

CONCLUSION: The size of cancer, presence of stones or sludge during SEMS placement, the length of SEMS, and total bilirubin level above 2 mg/dL at 1 month after SEMS placement were associated with SEMS dysfunction. The median time of stent patency were not statistically different in each type of stent, covered stent, partially covered stent and uncovered stent. Median survival time of patients did not associate with SEMS patency or dysfunction.

PMID:37964198 | DOI:10.1186/s12876-023-03028-3

BMC Ophthalmol. 2023 Nov 14;23(1):456. doi: 10.1186/s12886-023-03192-w.

ABSTRACT

BACKGROUND: The aim was to study aqueous humour inflammatory mediators’ levels in a cohort of Egyptian patients with diabetic macular oedema (DMO).

METHODS: This was a case-control prospective study conducted on 2 groups: 25 eyes of 22 (11 females) patients seeking treatment for DMO as patients group, and 10 eyes of 10 (4 females) cataract patients as a control group. Aqueous humour was aspirated before intravitreal injection (patients’ group) or cataract surgery (control group). Inflammatory mediators in aqueous humour were measured using a multiplex bead immunoassay kit of 27 pre-mixed cytokines.

RESULTS: Eotaxin, interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein-1 (MCP-1/CCL2) and interleukin-8 (IL-8/CXCL8) were found significantly higher in patients’ group compared to control group (p = 0.043, 0.037, 0.001, 0.015 respectively). On the contrary, interferon-gamma (IFN-gamma) and granulocyte colony-stimulating factor (G-CSF) were found significantly higher in control group than patients’ group (p = 0.003, 0.019 respectively). Basic fibroblast growth factor (Basic-FGF/FGF-2) and interleukin-1 receptor antagonist (IL-1ra) were found higher (but not statistically significant) in controls (p = 0.100 and 0.070 respectively). Additionally, a negative and significant correlation was found between Eotaxin level in aqueous humour and central macular thickness.

CONCLUSIONS: Some mediators might be implicated in the pathogenesis of DMO either augmenting or suppressing role. Eotaxin, IP-10, MCP-1 and IL-8 might have a role in cases not responding to standard anti-vascular endothelial growth factor (VEGF) therapy. IL-1ra might have a protective role; therefore, the effectiveness of intravitreal injection of IL-1ra homologue needs to be studied in future clinical trials.

PMID:37964190 | DOI:10.1186/s12886-023-03192-w

Res Vet Sci. 2023 Nov 8;166:105079. doi: 10.1016/j.rvsc.2023.105079. Online ahead of print.

ABSTRACT

The computing environment has revolutionized the management and analysis of data in sciences during the last decades. This study aimed to evaluate the use of R software in research articles addressing the study of wildlife worldwide, particularly focusing on the research area “Veterinary Sciences”. For this purpose, a systematic review mainly performed in the Web of Science database was conducted. Out of a total of 509 articles reviewed, our results show an increasing trend of the number of publications using the R software over time, as well as a wide geographical distribution at a global scale, particularly in North America, Europe, Australia and China. Most publications were categorized in research areas related to “Biological Sciences”, while a minority of them was included in “Veterinary Sciences” (5.9%; 30/509). About the species groups assessed, many articles evaluated a single species group (96.5%), being mammals (50.7%) and birds (14.8%) the most studied ones. The present study showed a high variety of R-packages used in the publications reviewed, all of them related to data analysis, the study of genetic/phylogenetic information and graphical representation. Interestingly, the common use of packages between different research areas is indicative of the high interest of using R software in scientific articles. Our study points the R software as an open-source programming language that allows to support research addressing the study of wildlife, becoming a key software for many research areas, including “Veterinary Sciences”. However, an in-depth methodological description about the use of R software in publications to improve the tracking, reproducibility and transparency is encouraged.

PMID:37963421 | DOI:10.1016/j.rvsc.2023.105079

J Chromatogr Sci. 2023 Nov 15:bmad084. doi: 10.1093/chromsci/bmad084. Online ahead of print.

ABSTRACT

Herbal medicine is widely used for the treatment and prevention of various ailments, highlighting the importance of ensuring its consistency and quality. This research focuses on the simultaneous detection of Gymnemic acid (GYM) and Resveratrol (RES) in an antidiabetic polyherbal formulation as no reported method exists for their simultaneously detection. The objective of this study is to develop and validate novel derivatization-based spectrometric and HPTLC methods for the simultaneous determination of GYM and RES. The spectrophotometric method involved derivatization of GYM with benzoyl chloride, followed by measurement of absorbance at 349 nm an isoabsorptive point. The HPTLC method utilized post derivatization with vanillin-sulfuric acid, and its separation was achieved on pre-coated silica gel 60GF254 using chloroform:methanol:glacial acetic acid (13:4:0.1, v/v/v) as mobile phase and estimated at 575 nm. The developed method exhibits linearity, accuracy, precision, LOD, LOQ, specificity and robustness in accordance with the ICH Q2 (R1) guideline. The percent assay of GYM and RES in the marketed capsule formulation was statistically compared using an unpaired t-test, resulting in a range of 99.51-102.65%. These indicate no significant difference between the proposed method and the marketed formulation. Therefore, both novel methods can be interchangeably used for quality control of GYM and RES in polyherbal formulations.

PMID:37963414 | DOI:10.1093/chromsci/bmad084

Rep Prog Phys. 2023 Nov 14. doi: 10.1088/1361-6633/ad0c5c. Online ahead of print.

ABSTRACT

Majorana excitations are the quasiparticle analog of Majorana fermions in solid materials. Typical examples are the Majorana zero modes (MZMs) and the dispersing Majorana modes. When probed by scanning tunneling spectroscopy, the former manifest as a pronounced conductance peak locating precisely at zero-energy, while the latter behaves as constant or slowly varying density of states. The MZMs obey non-Abelian statistics and are believed to be building blocks for topological quantum computing, which is highly immune to the environmental noise. Existing MZM platforms include hybrid structures such as topological insulator, semiconducting nanowire or 1D atomic chains on top of a conventional superconductor, and single materials such as the iron-based superconductors (IBSs) and 4Hb-TaS2. Very recently, ordered and tunable MZM lattice has also been realized in iron-based superconductor LiFeAs, providing a scalable and applicable platform for future topological quantum computation. In this review, we present an overview of the recent local probe studies on MZMs. Classified by the material platforms, we start with the MZMs in the iron-chalcogenide superconductors where FeTe0.55Se0.45 and (Li0.84Fe0.16)OHFeSe will be discussed. We then review the Majorana research in the iron-pnictide superconductors as well as other platforms beyond the IBSs. We further review recent works on ordered and tunable MZM lattice, showing that strain is a feasible tool to tune the topological superconductivity. Finally, we give our summary and perspective on future Majorana research.

PMID:37963402 | DOI:10.1088/1361-6633/ad0c5c

Global Spine J. 2023 Nov 14:21925682231216082. doi: 10.1177/21925682231216082. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective database analysis.

OBJECTIVE: Polytraumatized patients with spinal injuries require tailor-made treatment plans. Severity of both spinal and concomitant injuries determine timing of spinal surgery. Aim of this study was to evaluate the role of spinal injury localization, severity and concurrent injury patterns on timing of surgery and subsequent outcome.

METHODS: The TraumaRegister DGU^® was utilized and patients, aged ≥16 years, with an Injury Severity Score (ISS) ≥16 and diagnosed with relevant spinal injuries (abbreviated injury scale, AIS ≥ 3) were selected. Concurrent spinal and non-spinal injuries were analysed and the relation between injury severity, concurrent injury patterns and timing of spinal surgery was determined.

RESULTS: 12.596 patients with a mean age of 50.8 years were included. 7.2% of patients had relevant multisegmental spinal injuries. Furthermore, 50% of patients with spine injuries AIS ≥3 had a more severe non-spinal injury to another body part. ICU and hospital stay were superior in patients treated within 48 hrs for lumbar and thoracic spinal injuries. In cervical injuries early intervention (<48 hrs) was associated with increased mortality rates (9.7 vs 6.3%).

CONCLUSIONS: The current multicentre study demonstrates that polytrauma patients frequently sustain multiple spinal injuries, and those with an index spine injury may therefore benefit from standardized whole-spine imaging. Moreover, timing of surgical spinal surgery and outcome appear to depend on the severity of concomitant injuries and spinal injury localization. Future prospective studies are needed to identify trauma characteristics that are associated with improved outcome upon early or late spinal surgery.

PMID:37963389 | DOI:10.1177/21925682231216082

Epidemiology. 2023 Nov 14. doi: 10.1097/EDE.0000000000001690. Online ahead of print.

ABSTRACT

BACKGROUND: When a randomized controlled trial fails to demonstrate statistically significant efficacy against the primary endpoint, a potentially costly new trial would need to be conducted to receive licensure. Incorporating data from previous trials might allow for more efficient follow-up trials to demonstrate efficacy, speeding availability of effective vaccines.

METHODS: Based on the outcomes from a failed trial of a maternal vaccine against respiratory syncytial virus (RSV), we simulated data for a new Bayesian group-sequential trial. We analyzed the data either ignoring data from the previous trial (i.e., weakly informative prior distributions) or using prior distributions incorporating the historical data into the analysis. We evaluated scenarios where efficacy in the new trial was the same, greater than, or less than that in the original trial. For each scenario, we evaluated the statistical power and type I error rate for estimating the vaccine effect following interim analyses.

RESULTS: When we used a stringent threshold to control the type I error rate, analyses incorporating historical data had a small advantage over trials that did not. If control of type I error is less important (e.g., in a post-licensure evaluation), the incorporation of historical data can provide a substantial boost in efficiency.

CONCLUSIONS: Due to the need to control the type I error rate in trials used to license a vaccine, incorporating historical data provides little additional benefit in terms of stopping the trial early. However, these statistical approaches could be promising in evaluations that use real-world evidence following licensure.

PMID:37963353 | DOI:10.1097/EDE.0000000000001690

J Acquir Immune Defic Syndr. 2023 Nov 10. doi: 10.1097/QAI.0000000000003337. Online ahead of print.

ABSTRACT

BACKGROUND: Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with demonstrated efficacy as a third agent in treatment-naive and treatment-experienced people living with HIV (PLWH) in registration studies. However, limited real-world data are available.

METHODS: By searching electronic healthcare records, PLWH using doravirine-based regimens were selected with at least one year of follow-up after their first prescription. All stable PLWH who were switched to a doravirine-based regimen were included in the analysis. The primary outcome was the durability of a doravirine-based regimen one year after prescription. Reasons for stopping were also collected. Secondary outcomes for PLWH continuing a doravirine-based regimen after one year were routine laboratory assessment, BMI, and differences in medication costs compared with their prior cART.

RESULTS: A total of 689 patients (92% men) were included from September 2019 to August 2022: 97.7% switched to doravirine/tenofovir/lamivudine (DOR/TDF/3TC). After one year 94/689 (13.6%) PLWH stopped this therapy. The main reason for discontinuation was patient-reported adverse events in 70/689 (10.2%). Medical reasons for discontinuation included increased ALT levels in 6/689 (0.9%), decreased eGFR in 3/684 (0.4%), and precautions after diagnosis of osteoporosis in 2/689 (0.3%) patients. Virologic failure occurred in 4/689 cases (0.6%), and one case demonstrated resistance mutations. The secondary outcomes demonstrated a statistically significant increase in ALT levels and decrease in LDL-C levels. The switch to a doravirine-based regimen in the Netherlands reduced medication costs by 27%.

CONCLUSION: This study demonstrated that switching to a doravirine-based regimen, mostly DOR/TDF/3TC, was highly effective and generally well tolerated, with substantial cost savings.

PMID:37963350 | DOI:10.1097/QAI.0000000000003337

Menopause. 2023 Nov 14. doi: 10.1097/GME.0000000000002274. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to compare the efficacy of CO2 laser, radiofrequency, and promestriene in treating genitourinary syndrome of menopause in women with breast cancer receiving adjuvant therapy and to analyze the clinical and histological findings of the vulvar vestibule.

METHODS: Women with moderate-to-severe symptoms of vulvar atrophy were enrolled. The participants were evaluated according to pretreatment and posttreatment protocols using the visual analog scale and clinical assessments, which included a gynecological examination and vestibular biopsy. Participants were randomly assigned into the laser, radiofrequency, or promestriene groups. Participants in the energy treatment groups underwent three consecutive monthly outpatient vulvovaginal treatment sessions, whereas those in the control group were administered promestriene for 4 months. During a follow-up visit 30 days posttreatment, the participant global posttreatment impression of improvement was evaluated using a Likert scale.

RESULTS: Seventy women completed treatment. Histological vulvar atrophy was identified in four (5.7%) of the pretreatment vulvar samples. Postintervention, all histological parameters were normalized. Significant improvements in symptoms were observed, as all three groups showed a reduction in the visual analog scale score, with no statistically significant differences among them. A high level of satisfaction was reported posttreatment in all groups. No damage to the histological structure of the vulvar vestibule or relevant clinical adverse events were identified posttreatment.

CONCLUSIONS: Laser, radiofrequency, and promestriene delivered comparable, significant symptom improvements among women with breast cancer receiving adjuvant therapy. These treatments did not cause structural tissue damage or other clinical complications.

PMID:37963315 | DOI:10.1097/GME.0000000000002274

J Clin Oncol. 2023 Nov 14:JCO2202668. doi: 10.1200/JCO.22.02668. Online ahead of print.

ABSTRACT

PURPOSE: GemPred, a transcriptomic signature predictive of the efficacy of adjuvant gemcitabine (GEM), was developed from cell lines and organoids and validated retrospectively. The phase III PRODIGE-24/CCTG PA6 trial has demonstrated the superiority of modified folinic acid, fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) over GEM as adjuvant therapy in patients with resected pancreatic ductal adenocarcinoma at the expense of higher toxicity. We evaluated the potential predictive value of GemPred in this population.

PATIENTS AND METHODS: Routine formalin-fixed paraffin-embedded surgical specimens of 350 patients were retrieved for RNA sequencing and GemPred prediction (167 in the GEM arm and 183 in the mFOLFIRINOX [mFFX] arm). Survival analyses were stratified by resection margins, lymph node status, and cancer antigen 19-9 level.

RESULTS: Eighty-nine patients’ tumors (25.5%) were GemPred+ and were thus predicted to be gemcitabine-sensitive. In the GEM arm, GemPred+ patients (n = 50, 30%) had a significantly longer disease-free survival (DFS) than GemPred- patients (n = 117, 70%; median 27.3 v 10.2 months, hazard ratio [HR], 0.43 [95% CI, 0.29 to 0.65]; P < .001) and cancer-specific survival (CSS; median 68.4 v 28.6 months, HR, 0.42 [95% CI, 0.27 to 0.66]; P < .001). GemPred had no prognostic value in the mFFX arm. DFS and CSS were similar in GemPred+ patients who received adjuvant GEM and mFFX (median 27.3 v 24.0 months, and 68.4 v 51.4 months, respectively). The statistical interaction between GEM and GemPred+ status was significant for DFS (P = .008) and CSS (P = .004). GemPred+ patients had significantly more adverse events of grade ≥3 in the mFFX arm (76%) compared with those in the GEM arm (40%; P = .001).

CONCLUSION: This ancillary study of a phase III randomized trial demonstrates that among the quarter of patients with a GemPred-positive transcriptomic signature, survival was comparable with that of mFOLFIRINOX, whereas those receiving adjuvant gemcitabine had fewer adverse events.

PMID:37963313 | DOI:10.1200/JCO.22.02668