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10 result(s) for "Arias, Ainhoa"
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Fentanyl as pre-emptive treatment of pain associated with turning mechanically ventilated patients: a randomized controlled feasibility study
Purpose To compare pain incidence and changes in pain scores with fentanyl versus placebo as pre-emptive treatment during turning and 30 min post-turning in mechanically ventilated critically ill patients. Methods We performed a randomized, double-blind, parallel-group, placebo-controlled clinical trial in the intensive care unit of a university hospital. Seventy-five mechanically ventilated patients were randomized to an intervention group (fentanyl) or a control group (placebo). Patients in the intervention group received 1 µg/kg (medical patients) or 1.5 µg/kg (surgical patients) of fentanyl 10 min before turning. Pain indicators were assessed using the behavioral pain scale. Safety was assessed by determining the frequency and severity of pre-defined adverse events. Pain was evaluated at rest (T0), at turn start and end (T1 and T2) and at 5, 15 and 30 min post-turning (T3, T4 and T5). Results The two groups had similar baseline characteristics. The area under the curve for BPS values was significantly smaller in the fentanyl group than in the control group [median and interquartile range (IQR): 132 (108–150) vs. 147 (125–180); p  = 0.016, respectively]. Nineteen non-serious adverse events were recorded in 14 patients, with no significant between-group differences (23 % fentanyl group vs. 14 % control group; p  = 0.381). Conclusions These results suggest an intravenous bolus of fentanyl of 1 µg/kg for medical patients or 1.5 µg/kg for surgical patients reduces the incidence of turning-associated pain in critically ill patients on mechanical ventilation. ClinicalTrials.gov: NCT 01950000.
Design of a relative value unit-based tool for the measurement and reimbursement of pharmacy services for clinical trials
ObjectiveTo develop a relative value unit (RVU)-based tool for the measurement and reimbursement of pharmacy services for clinical trials.MethodsA portfolio of activities was agreed by consensus in four tertiary hospitals. Related activities were pooled into several categories or intermediate products. We recorded the duration of each activity by multiple determinations. We then calculated the average time of all determinations. The reference activity was assigned a value of 1. All other activities were compared to the reference activity to obtain the RVU. To establish which items should be invoiced to third parties for the activities performed, we defined the final products (different types of clinical trials according to their complexity).ResultsTen intermediate products and five final products were differentiated. Six intermediate products could be repeated over the course of a clinical trial and seven were performed whether or not the clinical trial had included patients. Each final product consisted of different categories. The total number of RVUs produced for a clinical trial was the sum of each constant category value plus the repetitive category values multiplied by the number of repetitions.ConclusionThe application of RVU methodology in investigational drug services allows a more precise quantification of services performed. After a prospective validation to confirm the applicability of this tool, it may contribute to more appropriate invoicing to third parties for these services.
Correlation between breast cancer subtypes determined by immunohistochemistry and n-COUNTER PAM50 assay: a real-world study
Purpose Molecular subtyping based on gene expression profiling (i.e., PAM50 assay) aids in determining the prognosis and treatment of breast cancer (BC), particularly in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative tumors, where luminal A and B subtypes have different prognoses and treatments. Several surrogate classifications have been proposed for distinguishing between the luminal A and B subtypes. This study determines the accuracy of local immunohistochemistry (IHC) techniques for classifying HR-positive/HER2-negative (HR+/HER2−) tumors according to intrinsic subtypes using the nCOUNTER PAM50 assay as reference and the HR status definition according the ASCO/CAP recommendations. Methods Molecular subtypes resulting from nCOUNTER PAM50 performed in our laboratory between 2014 and 2020 were correlated with three different proxy surrogates proposed in the literature based on ER, PR, HER2, and Ki67 expression with different cut-off values. Concordance was measured using the level of agreement and kappa statistics. Results From 1049 samples with the nCOUNTER test, 679 and 350 were luminal A and B subtypes, respectively. Only a poor-to-fair correlation was observed between the three proxy surrogates and real genomic subtypes as determined by nCOUNTER PAM50. Moreover, 5–11% and 18–36% of the nCOUNTER PAM50 luminal B and A tumors were classified as luminal A and B, respectively, by these surrogates. Conclusion The concordance between luminal subtypes determined by three different IHC-based classifiers and the nCOUNTER PAM50 assay was suboptimal. Thus, a significant proportion of luminal A and B tumors as determined by the surrogate classifiers could be undertreated or over-treated.
Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efficacy and safety of fibrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study)
IntroductionWe assessed the efficacy of fibrin sealant (FS) and tranexamic acid (TXA) administered topically in patients with a hip fracture treated with prosthetic replacement.Materials and methodsParallel, multicentre, open label, randomised, clinical trial. We compared three interventions to reduce blood loss: (1) 10 ml of FS, (2) 1 g of topical TXA, both administered at the end of the surgery, and (3) usual haemostasis (control group). The main outcome was blood loss collected in drains. Other secondary variables were total blood loss, hidden blood loss, transfusion rate, average hospital stay, complications, adverse events, and mortality.ResultsA total of 158 patients were included, 56 in the FS group, 52 in the TXA group, and 50 in the control group. The total amount of blood collected in drains was lower in the TXA group (148.6 ml, SD 122.7 in TXA; 168.2 ml, SD 137.4 in FS; and 201.5 ml, SD 166.5 in control group) without achieving statistical significance (p = 0.178). The transfusion rate was lower in the TXA group (32.7%), compared with FS group (42.9%) and control group (44.0%), without statistical significance (p = 0.341). There were no complications or adverse effects related to the evaluated interventions.ConclusionsThe use of TXA and FS administered topically prior to surgical closure in patients with a sub-capital femoral fracture undergoing arthroplasty did not significantly reduce either postoperative blood loss or transfusion rate, compared with a group that only received usual haemostasis.
Development of Molecular Tools to Identify the Avocado (Persea americana) West-Indian Horticultural Race and Its Hybrids
Avocado (Persea americana Mill.) is cultivated in a wide range of environments, from tropical and semitropical to subtropical regions. Its fruit, of high nutritional value, is increasingly demanded worldwide. Spain is the main European producer, but avocado cultivation in certain areas, such as the Canary Islands, requires the genetic identification of West-Indian rootstocks because they often show tolerance to low-quality water and soil salinization. In the present study, eight novel Retrotransposon-Based Insertion Polymorphism assays, derived from previously characterized inter-Primer Binding Site markers, have been developed and evaluated by multiplex PCR across 58 P. americana cultivars. The results showed 100% specificity and sensitivity in detecting the West-Indian genomic component, both in pure and hybrid avocado cultivars. This cost-effective and fast molecular tool provides a valuable resource for characterization and selection programs of avocado cultivars genetically related to the West-Indian horticultural race.
Mycorrhizal fungi volatiles: determining the fate of plants against stress?
Mycorrhizal fungi represent one of the oldest and most successful symbioses in plant evolution. Communication among mycorrhizal fungi and plants occurs prior to direct contact among them through different and variable biochemical signals, including microRNAs, hormones, small peptides and volatile organic and inorganic compounds. Volatile organic compounds (VOCs) emerge as key chemical signals that enable the transmission of chemical messages modulating plant and microorganism responses in both below- and above-ground ecosystems. The diversity and concentration of mycorrhizal VOCs will vary depending on the environment and the emitting organism and are usually related to changes in the conformation of root architecture and lateral root formation mediated by auxin and strigolactones. Moreover, the study of the effects of mycorrhizal VOCs in the tolerance to abiotic and biotic stress are still scarce although there are some promising results pointing out to the effect of these VOCs in plant development under osmotic stress conditions, and their properties as antifungal and antibacterial molecules. However, the information regarding the molecular mechanisms involved in mycorrhizal VOCs signaling and their effect on plants remains still elusive. The understanding of VOC-mediated plant-mycorrhizal interactions, together with the technical improvements for their detection and mode of application in the field, will open new avenues for biotechnological crop improvement and management that not only will reduce the dependence on agrochemicals but also fosters soil health and plant resilience.
Clinical Validation of a New Optical Biometer for Myopia Control in a Healthy Pediatric Population
To assess the clinical validation of the Myah device in a pediatric population by evaluating the repeatability of biometric evaluations and analyzing its agreement with the Myopia Master system. A total of 51 children (51 eyes) were enrolled. Repeated measurements of flat (K1) and steep (K2) corneal radius, white-to-white (WTW) distance and axial length (AL) were performed with the Myah device. The same parameters were obtained from a subgroup (30 eyes) with the Myopia Master for the agreement analysis. The repeatability was assessed using the intrasubject standard deviation (Sw) and the intraclass correlation coefficient (ICC). The agreement was analyzed using the Bland–Altman method and the paired Student t-test. The Sw was 0.018 D, 0.021 D, 0.071 mm and 0.017 mm for K1, K2, WTW and AL, respectively (ICC ≥ 0.971). The mean difference and limits of agreement when comparing instruments were −0.013 (−0.102/0.077) for K1 (p = 0.16), −0.058 (−0.127/0.012) for K2 (p < 0.001), 0.151 (−0.370/0.673) for WTW (p < 0.001) and 0.030 (−0.091/0.151) for AL (p = 0.009). In conclusion, the Myah device provides consistent measurements of corneal radius, WTW distance and AL in a healthy pediatric population, validating their usefulness in clinical practice. These measurements could be used interchangeably with those provided by the Myopia Master device, although with some caution.
Characterization of Dysfunctional Lens Index and Opacity Grade in a Healthy Population
This study enrolled 61 volunteers (102 eyes) classified into subjects < 50 years (group 1) and subjects ≥ 50 years (group 2). Dysfunctional Lens Index (DLI); opacity grade; pupil diameter; and corneal, internal, and ocular higher order aberrations (HOAs) were measured with the i-Trace system (Tracey Technologies). Mean DLI was 8.89 ± 2.00 and 6.71 ± 2.97 in groups 1 and 2, respectively, being significantly higher in group 1 in all and right eyes (both p < 0.001). DLI correlated significantly with age (Rho = −0.41, p < 0.001) and pupil diameter (Rho = 0.20, p = 0.043) for all eyes, and numerous internal and ocular root-mean square HOAs for right, left, and all eyes (Rho ≤ −0.25, p ≤ 0.001). Mean opacity grade was 1.21 ± 0.63 and 1.48 ± 1.15 in groups 1 and 2, respectively, with no significant differences between groups (p ≥ 0.29). Opacity grade significantly correlated with pupil diameter for right and all eyes (Rho ≤ 0.33, p ≤ 0.013), and with some ocular root-mean square HOAs for right and all eyes (Rho ≥ 0.23, p ≤ 0.020). DLI correlates with age and might be used complementary to other diagnostic measurements for assessing the dysfunctional lens syndrome. Both DLI and opacity grade maintain a relationship with pupil diameter and internal and ocular HOAs, supporting that the algorithms used by the device may be based, in part, on these parameters.
Treatments for intracranial hypertension in acute brain-injured patients: grading, timing, and association with outcome. Data from the SYNAPSE-ICU study
PurposeUncertainties remain about the safety and efficacy of therapies for managing intracranial hypertension in acute brain injured (ABI) patients. This study aims to describe the therapeutical approaches used in ABI, with/without intracranial pressure (ICP) monitoring, among different pathologies and across different countries, and their association with six months mortality and neurological outcome.MethodsA preplanned subanalysis of the SYNAPSE-ICU study, a multicentre, prospective, international, observational cohort study, describing the ICP treatment, graded according to Therapy Intensity Level (TIL) scale, in patients with ABI during the first week of intensive care unit (ICU) admission.Results2320 patients were included in the analysis. The median age was 55 (I-III quartiles = 39–69) years, and 800 (34.5%) were female. During the first week from ICU admission, no-basic TIL was used in 382 (16.5%) patients, mild-moderate in 1643 (70.8%), and extreme in 295 cases (eTIL, 12.7%). Patients who received eTIL were younger (median age 49 (I–III quartiles = 35–62) vs 56 (40–69) years, p < 0.001), with less cardiovascular pre-injury comorbidities (859 (44%) vs 90 (31.4%), p < 0.001), with more episodes of neuroworsening (160 (56.1%) vs 653 (33.3%), p < 0.001), and were more frequently monitored with an ICP device (221 (74.9%) vs 1037 (51.2%), p < 0.001). Considerable variability in the frequency of use and type of eTIL adopted was observed between centres and countries. At six months, patients who received no-basic TIL had an increased risk of mortality (Hazard ratio, HR = 1.612, 95% Confidence Interval, CI = 1.243–2.091, p < 0.001) compared to patients who received eTIL. No difference was observed when comparing mild-moderate TIL with eTIL (HR = 1.017, 95% CI = 0.823–1.257, p = 0.873). No significant association between the use of TIL and neurological outcome was observed.ConclusionsDuring the first week of ICU admission, therapies to control high ICP are frequently used, especially mild-moderate TIL. In selected patients, the use of aggressive strategies can have a beneficial effect on six months mortality but not on neurological outcome.
In vitro antiviral properties of two recombinant sendai virus vectors encoding ORFV 011 and ORFV 059 genes
This research was funded by the Gobierno de Navarra, grant number PC080-081 ECTICONA and PC24-ECTIVAC-002-017-018