Resultados de investigación

Deep brain stimulation (DBS) has emerged as an important therapeutic intervention for neurological and neuropsychiatric disorders. After initial programming, clinicians are tasked with fine-tuning DBS parameters through repeated in-person clinic visits. We aimed to evaluate whether DBS patients achieve clinical benefit more rapidly by incorporating remote internet-based adjustment (RIBA) of stimulation parameters into the continuum of care. We conducted a randomized controlled multicenter study (ClinicalTrails.gov NCT05269862) involving patients scheduled for de novo implantation with a DBS System to treat Parkinson's Disease. Eligibility criteria included the ability to incorporate RIBA as part of routine follow-up care. Ninety-six patients were randomly assigned in a 1:1 ratio using automated allocation, blocked into groups of 4, allocation concealed, and no stratification. After surgery and initial configuration of stimulation parameters, optimization of DBS settings occurred in the clinic alone (IC) or with additional access to RIBA. The primary outcome assessed differences in the average time to achieve a one-point improvement on the Patient Global Impression of Change score between groups. Patients, caregivers, and outcome assessors were not blinded to group assignment. Most of the data collection took place in the patient's home environment. Access to RIBA reduces the time to symptom improvement, with patients reporting 15.1 days faster clinical benefit (after 39.1 (SD 3.3) days in the RIBA group (n = 48) and after 54.2 (SD 3.7) days in the IC group (n = 48)). None of the reported adverse events are related to RIBA. This study demonstrates safety and efficacy of internet-based adjustment of DBS therapy, while providing clinical benefit earlier than in-clinic optimization of stimulation parameters by increasing patient access to therapy adjustment., Si

Exercise therapy is the first-line treatment in rotator cuff-related shoulder pain (RCRSP), and diverse types of exercise seem effective. However, it is not still clear if painful exercise should be allowed or avoided during exercises. The objective of this study was to investigate if exercise into pain is more effective than no pain in RCRSP. A randomized controlled trial was conducted in a physiotherapy clinic in Belgium. Forty-three participants with chronic RCRSP were randomly allocated to G1 (exercising into pain) or G2 (exercising without pain) in a 12-week intervention with 6-month follow-up. Primary outcome was the Shoulder Pain and Disability Index (SPADI); secondary outcomes were pain intensity, fear-avoidance beliefs, fear of pain, quality of life, strength, and range of motion. Outcomes were measured at baseline (T0), after 9 weeks (T1), 12 weeks (T2), and 6 months (T3) from the first session and analysed with linear mixed models. No between-group difference in SPADI (time-by-group interaction, p = 0.25) up to 6 months was found, with mean difference (G1-G2) at T1 = 5.78 (CI95%: -3.43,14.59; p = 0.33), at T2 = 0.93 (CI95%: -7.20,9.05; p = 0.82), at T3 = 4.15 (CI95%: -2.61,10.92; p = 0.33). No between-group differences were found for any other outcomes. Pain provocation seems not to be necessary in RCRSP for achieving successful treatment effect in pain and disability reduction, fear-related beliefs, and quality of life up to 6 months. ClinicalTrials.gov NCT04553289., Si

Objectives: The use of intraosseous (IO) access is recommended in cardiac arrest when peripheral venous access is not accessible. Various methodologies exist that are used for teaching and learning about cannulation of the IO route both in education and in research. The purpose of the present study was to compare self-efficacy in the cannulation technique for IO access through different techniques. Methods: A randomized comparative study was conducted. A total of 118 nursing students participated. The participants were randomly distributed into 2 intervention groups: chicken bone and egg. A checklist was used for data collection to evaluate the IO cannulation technique in nursing students and another to analyze self-efficacy. Results: The average total score of self-efficacy for all participants was 8.84 (standard deviation (SD) = 0.98). No statistically significant differences were found when comparing the total self-efficacy score and the intervention group ( U = 1604.500; z = -0.733; P = 0.463). No statistically significant differences were found between both groups for the average total score of the procedure ( U = 6916.500; z = -0.939; P = 0.348). The egg group carried out the IO cannulation procedure in a significantly less amount of time (M = 126.88, SD = 82.18) than the chicken bone group (M = 183.77, SD = 108.28), finding statistically significant differences ( U = 4983.500; z = -5.326; P < 0.001). Conclusions: Using an egg to teach and learn about IO access could be considered a methodology that is equally effective as using a chicken bone, with the advantage of achieving IO access in a lesser amount of time., Yes

Comparar la calidad de vida en personas que viven con infección por el Virus de la Inmunodeficiencia Humana según el modelo de Atención Farmacéutica que reciben en los Servicios de Farmacia Hospitalaria: CMO (capacidad, motivación y oportunidad), versus seguimiento convencional. Método. Estudio longitudinal, prospectivo, multicéntrico, realizado entre octubre de 2019 y noviembre de 2021 en 14 Servicios de Farmacia Hospitalaria de España. Se incluyeron pacientes mayores de 18 años, que recibían tratamiento antirretroviral y acudían a las consultas de Atención Farmacéutica durante ≥1 año, excluyéndose aquellos sin autonomía para completar los cuestionarios previstos. Los centros fueron aleatorizados a seguir utilizando la misma sistemática de trabajo (seguimiento tradicional) o implementar el modelo CMO, utilizando la estratificación, el establecimiento de objetivos farmacoterapéuticos, el uso de entrevista motivacional y el seguimiento longitudinal con nuevas tecnologías. La variable principal fue la diferencia en el número de dimensiones afectadas negativamente, en cada rama, a las 24 semanas, según el cuestionario MOS-HIV. En el brazo CMO se registraron las intervenciones más frecuentemente realizadas. Resultados. Se incluyeron 151 pacientes, con una mediana de edad de 51,3 años. Se encontró una mejora significativa de la calidad de vida al final del seguimiento en el grupo CMO, reduciéndose el número de pacientes con dimensiones afectadas negativamente (2/11 vs 8/11). Las intervenciones más frecuentes llevadas a cabo, según la taxonomía, fueron motivación (51,7%) y revisión y validación del tratamiento antirretroviral (49,4%). Conclusiones. La calidad de vida de los pacientes es superior en aquellos centros que desarrollan Atención Farmacéutica basada en la metodología CMO en comparación con el seguimiento tradicional., To compare quality of life, in patients living with HIV infection with pharmaceutical care according to the CMO methodology: capacity, motivation and opportunity versus conventional follow-up. Longitudinal, prospective, multicenter, health intervention study, conducted between October 2019 and November 2021 in 14 centers throughout Spain. Patients over 18 years of age, receiving antiretroviral treatment and attending the consultations of the participating Pharmacy Services for 1 year were included. Patients who did not have the autonomy to complete the planned questionnaires were excluded. At baseline, participating centers were randomized to continue using the same systematics of work (traditional follow-up) or to implement the CMO model using patient stratification models, goal setting in relation to pharmacotherapy, use of motivational interviewing, as well as longitudinal follow-up enabled by new technologies. The main variable was the difference in the number of dimensions positively affected in each follow-up arm at 24 weeks of follow-up according to the MOS-HIV questionnaire. In the CMO group, the interventions performed the most frequently were recorded. 151 patients were included. The median age was 51.35 years. A significant improvement in quality of life was found at the end of follow-up in the CMO group, reducing the number of patients with negatively affected dimensions (2/11 vs 8/11). The most frequent interventions carried out in the CMO group, according to the taxonomy, were Motivation (51,7%) and review and validation (49,4%). The quality of life of patients is higher in those centers that develop Pharmaceutical Care based on the CMO methodology compared to traditional follow-up., Si

Several studies have evaluated the effect of intragastric injection of botulinum toxin A to treat obesity, achieving mixed results. Our objective is to determine the effect of intragastric botulinum toxin A on weight loss, satiety, biomarkers, and quality of life of obese patients prior bariatric surgery. Methods: Design: single-centre, randomised, double-blind, placebo-controlled clinical trial in 52 obese patients on bariatric surgery waiting lists. Two-arm parallel: the treatment group was administered intragastric botulinum toxin A by endoscopy, whereas the control group was administered physiological saline solution. Weight loss was evaluated at weeks 2, 4, 8, 16, and 24, as well as changes in body composition, satiety (Visual analogue scale (VAS) and GCSI questionnaire), quality of life (GIQLI questionnaire), and biomarkers of satiety and appetite. Results: Weight loss at weeks 2, 4, 8, 16, and 24 after the endoscopy, with respect to the basal visit, was 0.6 ± 2 kg, 0.4 ± 2.7 kg, 0.4 ± 3.1 kg, 0.2 ± 4.5 kg, and 0.6 ± 4.3 kg for the control group vs 1.9 ± 2.1 kg, 2 ± 2.6 kg, 2.8 ± 4.1 kg, 3.5 ± 5.3 kg, and 4.5 ± 7 kg for the treatment group, respectively, being differences between groups significant at all times (p = 0.016, 0.031, 0.014, 0.021, and 0.023, respectively). Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity. No significant differences were found regarding perception of satiety, or biomarkers of satiety and appetite. Conclusions: Intragastric injection of botulinum toxin A is an effective and safe procedure to achieve a moderate weight loss and improve quality of life., Yes

Background and aims: Parenteral nutrition (PN) composition could play a role in the management of systemic inflammatory response and intestinal barrier disruption. We aimed to evaluate changes in biomarkers of inflammation, oxidative status and intestinal permeability in patients with type 2 diabetes mellitus (T2DM) who received different PN lipid formulas. Methods: This was a prospective study, including 94 patients with T2DM who received omega (n)-3 polyunsaturated fatty acids (PUFA)-enriched PN, a mixture of medium and long chain triglycerides (MCT/LCT) PN, or an olive oil-based PN. Serum levels of biomarkers of oxidative status, intestinal permeability and inflammation biomarkers were determined at day 1 and day 5 after PN initiation. Registered under ClinicalTrials.gov Identifier no. NCT02706119. Results: At day 5 after the onset of PN, the MCT/LCT group had a significant reduction of 2 proinflammatory cytokines [interleukin (IL)-15, IL-17A], elevation of the anti-inflammatory cytokine IL-13 and increase of zonulin and indoxylsulfate. The olive oil group showed a statistically significant reduction of 5 proinflammatory cytokines [IL-1β, IL-17A, IL-6, cytokine-leukemia inhibitory factor (LIF) and tumor necrosis factor alpha (TNF-α)] and reduced concentrations of the anti-inflammatory cytokine IL-1RA, while the n-3 PUFA-enriched group presented a statistically significant reduction of 8 proinflammatory cytokines (interferon-gamma, IL-1β, IL-15, IL-17A, IL-6, LIF, monocyte chemoattractant protein 1, and TNF-α). In the between-group comparisons, indoxylsulfate significantly increased in the MCT/LCT group compared to the n-3 PUFA-enriched group, while 8-isoprostane and indoxylsulfate significantly increased in the MCT/LCT group compared to the other groups and superoxide dismutase significantly decreased in the MCT/LCT group compared to the other groups. Conclusion: In patients with T2DM, PN lipid composition exerts a profound impact on proinflammatory, prooxidative and intestinal permeability biomarkers., Yes

Carboplatin and paclitaxel (CP) have been the standard of care for advanced/recurrent endometrial cancer (EC) for many years. However, this chemotherapy combination shows limited efficacy and recurrences often occur in less than 12 months. ABTL0812 is a novel drug that selectively kill cancer cells by cytotoxic autophagy and has shown anticancer efficacy in preclinical models of EC in combination with CP. ENDOLUNG was an open-label, phase 1/2 clinical trial designed to determine the safety and efficacy of Ibrilatazar (ABTL0812) with CP in patients with advanced/recurrent EC and non-irradiable stage III and IV squamous non-small cell lung cancer (sq-NSCLC). The phase 1 part consisted of a 3 + 3 de-escalation design followed by an expansion cohort with 12 patients. The primary endpoint was safety. ABTL0812 starting dose was 1300 mg tid combined with carboplatin at area under the curve (AUC) 5 and paclitaxel at 175 mg/m2 both administered every 21 days for up to 8 cycles. The phase 2 part included a total of 51 patients. The primary endpoint was overall response rate (ORR) and the secondary endpoints included duration of response (DOR), progression-free survival (PFS) and overall survival (OS). During the phase 1 only one dose limiting toxicity (DLT), a grade 4 neutropenia, was observed in 1 out of 6 patients, thus no de-escalation was applied. One additional DLT, a grade 3 febrile neutropenia, was observed in the expansion cohort, thus the recommended phase 2 dose (RP2D) for ABTL0812 was established at 1300 mg tid. Most frequent hematological adverse events (AE) of the combination were neutropenia (52.9%), anemia (37.3%) and thrombocytopenia (19.6%). Nausea (66.7%), asthenia (66.7%), diarrhea (54.9%) and vomiting (54.9%) were the most frequent non-hematological adverse events (AEs). The combination of ABTL0812 plus CP showed an ORR of 65.8% (13.2% complete response and 52.6% partial response) with a median DOR of 7.4 months (95% CI: 6.3-10.8 months). Median PFS was 9.8 months (95% CI: 6.6-10.6) and median OS 23.6 months (95% CI 6.4-ND). Pharmacokinetic parameters were compatible with target engagement observed in preclinical studies, and blood pharmacodynamic biomarkers indicated sustained target regulation during, at least, 28 days after starting the treatment. This study suggests that the combination of ABTL0812 with CP is safe and feasible with an encouraging activity in patients with advanced/recurrent EC. Our data warrant further confirmation in prospective randomized trials. EU Clinical Trial Register, EudraCT number 2016-001352-21 and National Clinical Trials Number, NCT03366480. Registration on 19 September 2016., Si

Analysing literacy from non-dominant perspectives that consider multimodality, the non-human and the unplanned is a matter of justice, as posthuman scholars have recognised. In this research project (HAMLET), we explore which other literacies are valued when this approach is adopted. Our focus is on the relations that emerge and challenge the binaries that accompany education and literacy research (e.g. literacy/non-literacy, mind/body, adult/child). This shift enables us to consider approaches that are more inclusive, less verbocentric, and that de-centre the human. This dataset focuses from a group of young children and things (e.g. a notebook, a bench, and a cork floor) intra-acting, moving and playing as if they were in a football match. We observe how the bodies of children, ourselves, notebooks, spaces, and time become intertwined through this difficult-to-articulate practice. In the article that draws on this dataset, drawing on Mazzei’s (2017) methodology, we trace the contours of movement to further develop Erin Manning’s conceptualization of this phenomenon while challenging reductionist understandings of literacy. This anaysis helped us exploring how embodied, unintentional, and more-than-linguistic practices contribute to literacy. Furthermore, it encourages educators to embrace unexpected worldings, prioritize relationships, and reconsider the role of movement in the classroom and in reading practices., Analizar la alfabetización desde perspectivas no dominantes que consideran la multimodalidad, lo no humano y lo no planificado es una cuestión de justicia, como han reconocido los estudiosos posthumanos. En este proyecto de investigación (HAMLET), exploramos qué otras alfabetizaciones se valoran cuando se adopta este enfoque. Nuestro enfoque está en las relaciones que surgen y desafían las dicotomías que acompañan a la investigación educativa y literaz (por ejemplo, alfabetización/no alfabetización, mente/cuerpo, adulto/niño). Este cambio nos permite considerar enfoques más inclusivos, menos verbocéntricos y que descentran al ser humano. respuesta con el mundo en lugar de propósitos impulsados por adultos, y en las intensas relaciones entre niños y materiales, donde las palabras pierden prioridad cuando se valora lo que se crea. Este conjunto de datos se centra en un grupo de niños pequeños y objetos (un cuaderno, un banco y un suelo de corcho) que interactúan, se mueven y juegan como si estuvieran en un partido de fútbol. Observamos cómo los cuerpos de los niños, los nuestros propios, los cuadernos, los espacios y el tiempo se entrelazan a través de esta práctica difícil de articular. En el artículo que se basa en este conjunto de datos, partiendo de la metodología de Mazzei (2017), trazamos los contornos del movimiento para desarrollar aún más la conceptualización de Erin Manning sobre este fenómeno, al tiempo que cuestionamos las interpretaciones reduccionistas de la alfabetización. Este análisis nos ayudó a explorar cómo las prácticas corporales, no intencionadas y más allá de lo lingüístico contribuyen a la alfabetización. Además, anima a los educadores a acoger «mundos» inesperados, a dar prioridad a las relaciones y a reconsiderar el papel del movimiento en el aula y en las prácticas de lectura.

En este dataset se recogen imágenes de células de cáncer de mama de la línea MDA-MB-231 embebidas en hidrogeles de colágeno de diferente composición y concentración. Estas imágenes se tomaron mediante el uso de un microscopio confocal y el marcaje fluorescente de las células, además de utilizar beads o microesferas fluorescentes (rojo) como marcadores de posición, permitiendo calcular las fuerzas ejercidas por las células en cada una de las condiciones., Se incluye una imagen de una célula en cada tipo de hidrogel (colágeno bovino, de rata o mezcla de ambos) y cada concentración (0.8, 1.5 y 2.3 mg/ml).

En este dataset se recogen las figuras incluidas en el artículo “Quantitative atlas of collagen hydrogels reveals mesenchymal cancer cell traction adaptation to the matrix nanoarchitecture” (Acta Biomaterialia, 2024), así como las figuras del material suplementario. Este proyecto compara el comportamiento mecánico de células de cáncer de mama en diferentes hidrogeles de colágeno, según su composición (bovino, de rata o mezcla de ambos) o concentración (0.8, 1.5 y 2.3 mg/ml). Para ello se ha llevado a cabo la metodología Traction Force Microscopy, además de que se ha comparado con la microestructura de cada uno de los hidrogeles, reconstruida mediante la técnica FIB-SEM., Figuras 1-7 del artículo y Figuras 1-3 del material suplementario