Browsing by Subject "Clinical trial"
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- PublicationOpen AccessApical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial(Springer, 2021-11-17) Moreno Rodríguez, José Antonio; Ortiz Ruiz, Antonio José; Dermatología, Estomatología, Radiología y Medicina FísicaObjectives This parallel, randomized controlled clinical trial evaluated the influence of bone substitutes (BS) on the efficacy of the non-incised papillae surgical approach (NIPSA) with enamel matrix derivate (EMD) in resolving deep, isolated, combined non-contained intrabony and supra-alveolar periodontal defects, preserving the soft tissue. Material and methods Twenty-four patients were randomized to treatment with NIPSA and EMD or NIPSA plus EMD and BS. Bleeding on probing (BoP), interproximal clinical attachment level (CAL), interproximal probing depth (PD), recession (REC), location of the tip of the papilla (TP), and width of the keratinized tissue (KT) were evaluated before surgery and at 1 year post-surgery (primary outcomes). Wound closure was assessed at 1 week post‐surgery, and supra‐alveolar attachment gain (SUPRA-AG) was recorded at 1 year post‐surgery. Results At 1 week, 87.5% of cases registered complete wound closure and there were no cases of necrosis, without differences between groups (p > .05). At 1 year, all cases showed negative BoP. A significant PD reduction (NIPSA + EMD 8.25 ± 2.70 mm vs. NIPSA + EMD + BS 6.83 ± 0.81 mm) and CAL gain (NIPSA + EMD 8.33 ± 2.74 mm vs. NIPSA + EMD + BS 7.08 ± 2.68 mm) were observed (p < .001) in both groups, without significant between-group differences (p > .05). The residual PD was < 5 mm in all defects (NIPSA + EMD 2.50 ± 0.67 mm vs. NIPSA + EMD + BS 2.67 ± 0.78 mm). Soft tissues were preserved without significant between-group differences (REC: NIPSA + EMD 0.25 ± 0.45 mm vs. NIPSA + EMD + BS 0.17 ± 0.58 mm, p > .05; KT: 0.00 ± 0.43 mm vs. 0.08 ± 0.67 mm, p > .05). There were improvements in the papilla in both groups (TP: NIPSA + EMD 0.33 ± 0.49 mm vs. NIPSA + EMD + BS 0.45 ± 0.52 mm, p > .05), which was only significant in the NIPSA EMD + BS group (0.45 ± 0.52 mm; p < .05). In both groups, CAL gain was recorded in the supra-alveolar component, showing full resolution of the intrabony component of the defect in all cases (SUPRA-AG: NIPSA + EMD 1.83 ± 1.11 mm vs. NIPSA + EMD + BS 2.00 ± 1.76 mm, p > .05). Conclusions NIPSA and EMD with or without BS seem to be a valid surgical approach in the treatment of isolated, deep non-contained periodontal defects. In our study, both treatments resulted in significant PD reduction and CAL gain, that extended in the supra-alveolar component, without differences with the use of BS. Both treatments resulted in soft tissue preservation. However, the addition of BS may improve interdental papillary tissue. Clinical relevance NIPSA, with or without bone substitutes, resulted in significant periodontal improvement, with soft tissue preservation in isolated, deep non-contained periodontal defects. The application of bone substitutes may provide interproximal soft tissue gain.
- PublicationOpen AccessCognitive training therapy improves the effect of hypocaloric treatment on subjects with overweight/obesity: a randomised clinical trial(MDPI, 2019-04-24) Galindo Muñoz, Joaquín S.; Morillas Ruiz, Juana María; Díaz Soler, Inmaculada; Barberá Ortega, María del Carmen; Hernández Morante, Juan José; Martínez Cáceres, Carlos Manuel; Gómez Gallego, María; Atención SociosanitariaAbstract: Obesity has been associated with impaired cognitive performance. This study aimed to determine whether improvements in cognitive function may contribute to higher weight loss in patients with obesity. In this randomised, 12-week trial, participants with overweight/obesity were randomised into a cognitive training intervention (Cognitive) group or a cognitive-behavioural (Control) group. In addition, both groups followed a hypocaloric dietary treatment. Cognitive functioning measurements and anthropometrical parameters were evaluated. All cognitive measures improved in the intervention group (p < 0.005 in all contrasts). In controls, significant improvements in attention, flexibility and task planning were also observed. Regarding anthropometrical parameters, the effect of the intervention in the cognitive group was higher for the total percentage of weight loss, body mass index (BMI), body fat and waist circumference. Biochemical parameters improved in both groups. Attending to our data, cognitive training was more effective that the hypocaloric intervention alone, partly related to an improvement in the working memory. Despite the shortage of training interventions for executive functions in the context of weight control, this type of combined intervention could establish the first steps towards a more appropriate intervention for patients with obesity.
- PublicationOpen AccessEfecto del ejercicio cardiovascular sobre el autoconcepto en adultos mayores: ensayo clínico(Universidad de Murcia. Servicio de publicaciones, 2020) Landeros-Olvera, Erick; Gil-Benitez, Joaquín; Sosa-Rodríguez, Claudia; Galicia-Aguilar, Rosa María; Ramírez-Girón, NataliaObjetivo:Describir el efecto de una dosis de ejercicio gradual y progresiva de bajo impacto cardiovascular sobre el autoconcepto físico en un grupo de adultos mayores.Métodos: Ensayo Clínico Aleatorizado y Controlado con intervención simple ciego en dos grupos equivalentes (experimental y control), bajo un modelo de mediciones repetidas. La muestra estuvo compuesta por 20 sujetos por grupo. Se seleccionaron adultos mayores de 60 a 70 años, de ambos sexos, sin riesgo cardiaco; se excluyeronadultos mayores con patologías que pudieran causar limitaciones en la funcionalidad músculo-esquelética o cardiopulmonar. La intervención consistió en la realización de ejercicio de forma gradual y progresiva, 3 veces por semana durante 10 semanas. El indicador para evaluar el autoconcepto físico fue elInstrumento de Auto descripción (SDQ), con un patrón de respuesta tipo Likert.Resultados: Ingresaron 45 sujetos, grupo control 22 adultos (edad 66.6±6.14) y grupo experimental 23 adultos (edad 67.0±7.19); completaron el programa 38 adultos. En ambos grupos predominaron las mujeres (66.7%), nivel socioeconómico medio (73.3%) y escolaridad básica (44.6%). No existió diferencia significativa entre los grupos antes de la intervención, en contraste, después de la intervención existió diferencia significativa entre grupos, lo que resultó en un incremento del autoconcepto físico en el grupo experimental y un descenso del autoconcepto físico en el grupo control.Conclusión: La intervención de ejercicio controlado, gradual, progresivo y de bajo impacto cardiovascular, de tres sesiones por semana durante 10 semanas probó ser efectiva para aumentar el autoconcepto físico en el grupo experimental de adultos.
- PublicationRestrictedGene expression changes in colon tissues from colorectal cancer patients following the intake of an ellagitannin-containing pomegranate extract: a randomized clinical trial(Elsevier, 2017-01-27) Nuñez-Sánchez, María A.; González Sarrías, Antonio; García Villalba, Rocío; Monedero Saiz, Tamara; García Talavera, Noelia V.; Gómez Sánchez, María B.; Sánchez Álvarez, Carmen; García Albert, Ana M.; Rodríguez Gil, Francisco J.; Ruiz Marín, Miguel; Pastor Quirante, Francisco A.; Martínez Díaz, Francisco; Tomás Barberán, Francisco A.; Espín, Juan Carlos; García Conesa, María Teresa; Oftalmología, Optometría, Otorrinolaringología y Anatomía PatológicaThe clinical evidence of dietary polyphenols as colorectal cancer (CRC) chemopreventive compounds is very weak. Verification in humans of tissue-specific molecular regulation by the intake of polyphenols requires complex clinical trials that allow for the procurement of sufficient pre- and postsupplementation tissue samples. Ellagitannins (ETs), ellagic acid (EA) and their gut microbiota-derived metabolites, the urolithins, modify gene expression in colon normal and cancer cultured cells. We conducted here the first clinical trial with 35 CRC patients daily supplemented with 900 mg of an ET-containing pomegranate extract (PE) and evaluated the expression of various CRC-related genes in normal and cancerous colon tissues before (biopsies) and after (surgical specimens) 5–35 days of supplementation. Tissues were also obtained from 10 control patients (no supplementation) that confirmed a large, gene- and tissue-specific interindividual variability and impact of the experimental protocol on gene expression, with some genes induced (MYC, CD44, CDKN1A, CTNNB1), some repressed (CASP3) and others not affected (KRAS). Despite these issues, the consumption of the PE was significantly associated with a counterbalance effect in the expression of CD44, CTNNB1, CDKN1A, EGFR and TYMs, suggesting that the intake of this PE modulated the impact of the protocol on gene expression in a gene- and tissue-specific manner. These effects were not associated with the individuals' capacity to produce specific urolithins (i.e., metabotypes) or the levels of urolithins and EA in the colon tissues and did not reproduce in vitro effects evidencing the difficulty of demonstrating in vivo the in vitro results.
- PublicationOpen AccessIntervenciones enfermeras para disminuir la sobrecarga de cuidadores informales. Revisión sistemática de ensayos clínicos(Universidad de Murcia. Servicio de publicaciones, 2022) Tinoco Camarena, Jose Manuel; Hidalgo Blanco, Miguel Ángel; Daifuku Sansano, Nara; Lluch Canut, M ª Teresa; Puig LLobet, MontserratIntroducción: Los cuidadores informales suelen ser miembros de la familia de un paciente, que conducen a la dependencia del paciente del cuidador. Esto puede resultar en perturbaciones en la calidad de vida de los cuidadores. Para abordar los efectos negativos de la atención informal, existen varios tipos de intervenciones eficaces para reducir las visitas médicas tanto de los cuidadores informales como de los pacientes a su cargo. Objetivo: Examinar la eficacia de las intervenciones de enfermería existentes diseñadas para reducir la sobrecarga del cuidador informal de personas con enfermedad crónica. Metodología: Diseño: Revisión sistemática. Fuentes de datos: Bases de datos como Pubmed (MEDLINE), Embase, The Cochrane Library y CINAHL fueron buscadas usando palabras clave sobre intervenciones de enfermería en cuidadores familiares. Los artículos publicados entre 2014-2019 fueron recuperados y sometidos a análisis de datos y síntesis de conocimientos Método de revisión: Dos revisores seleccionados de forma independiente. La evaluación de la calidad se basó en la lista de verificación de evaluación de declaraciones prisma. La síntesis es narrativa. Resultados: Noventa y cinco estudios fueron examinados en su totalidad, y setenta y siete fueron descartados por no proporcionar resultados adecuados. El recuento final de artículos incluidos en esta revisión fue de dieciocho que fueron todos ensayos clínicos aleatorizados. Conclusiones: El análisis de los diferentes estudios muestra eficacia en la reducción de síntomas como estrés, ansiedad, depresión o incluso necesidades insatisfechas. Las intervenciones más eficaces para reducir la carga del cuidador fueron las visitas domiciliarias y las intervenciones psicoeducacionales, tanto individuales como grupales.
- PublicationOpen AccessProgress of research on engineered extracellular vesicles from different sources for disease treatment(Universidad de Murcia, Departamento de Histología e Histopatología, 2025) Kang Jinhui; Wen Jun; Chen Huifang; Zhu Cui; Bai Yinshan; Biología Celular e HistologíaExtracellular vesicles (EVs) are lipid bilayer nanoparticles that encapsulate proteins, lipids, nucleic acids, and small molecules and display low immunogenicity, high stability, and cross-species transmission. By applying engineering technologies, the surface of EVs can be modified and loaded with cargo with therapeutic properties. Thus, engineered EVs can play important roles in preventing and treating various diseases. However, many challenges and uncertainties are faced in the clinical translation of EVs. In this review, we comprehensively analyzed the types of EVs derived from animal cells, plant cells, and microorganisms and summarized their biological properties and potential for engineering modifications. Furthermore, we also explored their therapeutic potential and discussed recent advancements in relevant clinical trials, aiming to provide scientific guidance for future research on the engineering of EVs and precision treatment of clinical diseases
- PublicationRestrictedTargeted metabolic profiling of pomegranate polyphenols and urolithins in plasma, urine and colon tissues from colorectal cancer patients(Wiley, Wiley-VCH Verlag, 2014-02-16) Núñez Sánchez, María Angeles; García-Villalba, Rocío; Monedero Saiz, Tamara; García-Talavera, Noelia V.; Gómez Sánchez, María B.; Sánchez-Álvarez, Carmen; García-Albert, Ana M.; Rodríguez-Gil, Francisco J.; Ruiz-Marín, Miguel; Pastor Quirante, Francisco A.; Martínez Díaz, Francisco; Yáñez-Gascón, María J.; González-Sarrías, Antonio; Tomás-Barberán, Francisco A.; Espín, Juan C.; Oftalmología, Optometría, Otorrinolaringología y Anatomía PatológicaScope: Urolithins are bioactive metabolites produced by the gut microbiota from ellagitannins (ETs) and ellagic acid (EA). We investigated whether urolithins could be detected in colon tissues from colorectal cancer (CRC) patients after pomegranate extract (PE) intake. Methods and results: CRC patients (n = 52) were divided into controls and PEs consumers (900 mg/day for 15 days) before surgical resection. PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio were administered. Twenty-three metabolites, but no ellagitannins, were detected in urine, plasma, normal (NT) or malignant (MT) colon tissues using UPLC-ESI-QTOF-MS/MS (UPLC, ultra performance liquid chromatography; QTOF, quadrupole TOF). Free EA, five EA conjugates, gallic acid and 12 urolithin derivatives were found in colon tissues. Individual and total metabolites levels were higher in NT than in MT, independently of the PE consumed. The maximal mean concentration (1671 ± 367 ng/g) was found in NT after consumption of PE-1 and the lowest concentration (42.4 ± 10.2 ng/g) in MT with PE-2. Urolithin A or isourolithin A were the main urolithins produced (54 and 46% patients with urolithin A or isourolithin A phenotype, respectively). High punicalagin content (PE-2) hampered urolithins formation. Conclusion: Significant levels of EA derivatives and urolithins are found in human colon tissues from CRC patients after consumption of pomegranate. Further studies are warranted to elucidate their biological activity.
- PublicationOpen AccessThe function and significance of SERA2a in congestive heart failure: an analysis of gene therapy trials(Universidad de Murcia. Departamento de Biología Celular e Histología, 2017) Wu, Pei; Zhai, Yuting; Li, DongyeCongestive heart failure (CHF) is a widespread disease that has a negative impact on health, worldwide. Despite advances in therapies, morbidity, mortality and hospital discharges due to CHF remain high. Advances in the understanding of the pathophysiological mechanisms of CHF and the development of gene transfer technology have made gene therapy a realistic potential therapeutic method for CHF. Among the various potential targets, sarco-endoplasmic reticulum Ca2+-ATPase 2a (SERCA2a), which is an important protein in the regulation of Ca2+ cycling, has piqued the interest of many researchers. Restoring decreased SERCA2a activity in CHF could improve cardiac contractions and energetics, as well as reducing myocardial fibrosis and ventricular arrhythmias, and these benefits have been confirmed by studies using both in vivo and in vitro models. Following these promising preclinical results, SERCA2a gene therapy advanced to clinical trials. However, results of the clinical trials were controversial, leading some to question whether SERCA2a is the right target for CHF treatment. In this review, we illustrate the function and significance of SERCA2a in CHF, and more importantly, analyze possible causes of the controversial clinical trials results, with the aim of stimulating future research on the relationship between SERCA2a and CHF.