Innovative Metaheuristic Optimization Approach with a Bi-Triad for Rehabilitation Exoskeletons.

The present work proposes a comprehensive metaheuristic methodology for the development of a medical robot for the upper limb rehabilitation, which includes the topological optimization of the device, kinematic models (5 DOF), human-robot interface, control and experimental tests. This methodology applies two cutting-edge triads: (1) the three points of view in engineering design (client, designer and community) and (2) the triad formed by three pillars of Industry 4.0 (autonomous machines and systems, additive manufacturing and simulation of virtual environments). By applying the proposed procedure, a robotic mechanism was obtained with a reduction of more than 40% of its initial weight and a human-robot interface with three modes of operation and a biomechanically viable kinematic model for humans. The digital twin instance and its evaluation through therapeutic routines with and without disturbances was assessed; the average RMSEs obtained were 0.08 rad and 0.11 rad, respectively. The proposed methodology is applicable to any medical robot, providing a versatile and effective solution for optimizing the design and development of healthcare devices. It adopts an innovative and scalable approach to enhance their processes.

Feasibility of three-dimensional nasal imaging and printing in producing customized nasal masks for non-invasive ventilation in extremely low birth weight infant: A pilot study.

72Several studies have been conducted to investigate the feasibility of customized nasal masks produced by three-dimensional (3D) facial imaging and printing for continuous positive airway pressure in adults and in premature mannequin. In addition to replicating the entire process, we applied the customized nasal mask to a premature patient who weighed less than 1,000 g. Facial scanning was performed. The study masks were manufactured using stereolithography with a 3D printer model Form3BL (FormLABS). Elastic 50 resin was used as the material. We verified the feasibility of the correct transmission of non-invasive ventilation and found that the mask improved the respiratory parameters and reduced the need for supplemental oxygen. The fraction of inspired oxygen (FiO2) was lowered from 45%, which was the requirement when the traditional mask is used, to almost 21% when the nasal mask was applied to the premature patient, who was either in incubator or in kangaroo position. In view of these results, a clinical trial is being launched to evaluate the safety and efficacy of 3D-printed masks in extremely low birth weight (ELBW) infants. 3D printing provides an alternative for obtaining customized masks that may be more suitable for non-invasive ventilation in ELBW infants than traditional masks.

Análisis y evaluación del riesgo cardiovascular y gastrointestinal de los antiinflamatorios no esteroideos inhibidores selectivos y no selectivos de ciclooxigenasa / Analysis and evaluation of cardiovascular and gastrointestinal risk of nonsteroidal anti-inflammatory drugs selective and non-selective cyclooxygenase inhibitors

Objetivos: revisar la evidencia publicada sobre el uso de AINE (coxibs y clásicos) y evaluar el riesgo cardiovascular (RCV) y gastrointestinal (RGI) asociado. Material y métodos: fueron seleccionados los estudios de cohorte y caso-control que mostraban el RCV o RGI de los AINE versus no expuestos. Se calculó el RR ponderado y el intervalo de confianza 95% para todos los AINE conjuntamente y de forma individual. Resultados: se observó un RCV significativo tanto con coxibs [RR= 1.24 (1.19-1.31)] como con AINE clásicos [RR= 1.18 (1.13-1.24)]. Para los coxibs sería elevado incluso a dosis bajas y en sujetos con RCV basal bajo. Por fármaco individual, rofecoxib [RR= 1.41 (1.33-1.50)] junto con diclofenaco [RR= 1.36 (1.27-1.47)] y etoricoxib [RR= 1.26 (1.08-1.48)] son los AINE con mayor RCV. El metaanálisis sobre el RGI mostró riesgo con los coxibs [RR 1.64 (95% CI 1.44-1.86)]. Por fármaco individual, etoricoxib [RR 4.48 (95% CI 2.98-6.75)] presentó mayor riesgo seguido de rofecoxib [RR 2.02 (95% CI 1.56-2.61)] y celecoxib [RR 1.62 (95% CI 1.46-1.78)]. El riesgo también fue elevado para dosis bajas y edad <65 años. Conclusión: según nuestro estudio, el uso de AINE (coxibs y clásicos) está relacionado con un incremento similar del RCV, incluso a dosis bajas y en pacientes con un RCV bajo-medio. Por otro lado, el uso de coxibs se relacionaría con un incremento del RGI, siendo elevado incluso para dosis bajas y edad <65 años. El riesgo para etoricoxib podría ser superior que para celecoxib y rofecoxib.(AU)

Introduction: the aim of this study is to review the current evidence on the clinical use of NSAIDs, coxibs and nonselective, and to evaluate its cardiovascular (CVR) and gastrointestinal risk (GIR) by means of a meta-analytic procedure. Materials and methods: cohort and case-control studies showing CVR and GIR associated with NSAIDs versus no treatment were selected. We estimated the pooled RR and the 95% confidence interval (CI) for all NSAIDs as a whole and individually. Results: both coxibs (RR, 1.22 [95%CI, 1.17-1.28]) and nonselective NSAIDs (RR 1.18 [95%CI, 1.12-1.24]) were associated with an increased CVR. The coxibs CVR remained even for low-dose and low-baseline CVR subgroups. Analysis by drug disclosed that rofecoxib (RR 1.39 [95%CI, 1.31- 1.47]), along with diclofenac (RR, 1.34 [95%CI, 1.26-1.42]) and etoricoxib (RR 1.27 [95%CI, 1.12-1.43]) were the NSAIDs associated with the highest CVR. Gastrointestinal risk meta-analysis showed that coxibs were associated with a GIR increment [RR1.64 (95% CI 1.44-1.86)]. Analysis by drug disclosed that etoricoxib [RR 4.48 (95% CI 2.98-6.75)]presented the highest GIR followed by rofecoxib [RR 2.02 (95% CI 1.56-2.61)] and celecoxib [RR1.62 (95% CI 1.46-1.78)]. GIR was also high for <65 year-old and low-dose coxibs subgroups. Conclusion: according to our study the use of NSAIDs (coxibs and nonselective) are associated with a similar CVR increment, even for low-dose and low-baseline CVR subgroups. On the other hand, the use of coxibs is associated with a GIR increased, which would be high even for low-dose coxibs and <65-year-old subgroups. The risk would be higher for etoricoxib than for celecoxib and rofecoxib.

Cardiovascular Risk of Nonsteroidal Anti-inflammatory Drugs and Classical and Selective Cyclooxygenase-2 Inhibitors: A Meta-analysis of Observational Studies.

The purpose of this study was to review the published evidence on the clinical use of nonsteroidal anti-inflammatory drugs (NSAIDs) and to assess the cardiovascular risk (CVR) of cyclooxygenase-2 inhibitors (coxibs), excluding aspirin, by means of a meta-analytic procedure. A search was conducted on MEDLINE and EMBASE databases between October 1999 and June 2018. Cohort and case-control studies showing CVR as relative risk (RR), odds ratio, hazard ratio, or incidence rate ratio associated with NSAIDs versus no treatment were selected. We estimated the pooled RR and the 95% confidence interval (CI) for all NSAIDs as a whole and individually. Eighty-seven studies met the inclusion criteria. Overall, NSAIDs were found to be associated with a statistically significantly increased CVR (RR, 1.24 [95%CI, 1.19-1.28]). The risk was slightly higher for coxibs (RR, 1.22 [95%CI, 1.17-1.28]) as compared with nonselective NSAIDs (RR, 1.18 [95%CI, 1.12-1.24]). Data analysis by drug disclosed that rofecoxib (RR, 1.39 [95%CI, 1.31-1.47]), followed by diclofenac (RR, 1.34 [95%CI, 1.26-1.42]) and etoricoxib (RR, 1.27 [95%CI, 1.12-1.43]) were the NSAIDs associated with the highest CVR. Analysis by type of event showed that the highest risk corresponded to vascular events for both coxibs (RR, 2.18 [95%CI, 1.72-2.78]) and nonselective NSAIDs (RR, 2.46 [95%CI, 2.00-3.02]). The meta-analysis results suggest that the use of the marketed coxibs celecoxib and etoricoxib would be related to a statistically significant CVR increase. Etoricoxib CVR could be higher than that for celecoxib. This increment would be similar to classical NSAID CVR.

Gastrointestinal safety of coxibs: systematic review and meta-analysis of observational studies on selective inhibitors of cyclo-oxygenase 2.

Prior meta-analyses have shown a higher gastrointestinal risk of nonselective NSAIDs versus placebo and a lower gastrointestinal risk of coxibs versus nonselective NSAIDs. However, the available data about gastrointestinal risk for coxibs versus placebo are scarce. The aim of this study was to review the current evidence on the use of coxibs and to evaluate the risk of gastrointestinal adverse outcomes (GAO) associated with coxibs versus nonexposed. Search was conducted on PubMed and Embase databases. We selected cohort observational, case-control, nested case-control and case-crossover studies that reported the risk of GAO associated with coxibs versus nonexposed as relative risk (RR), odds ratio (OR), hazard ratio (HR) or incidence rate ratio (IRR). It was estimated the pooled RR and the 95% confidence interval (CI) for coxibs both individually and as a whole by the DerSimonian and Laird method. Twenty-eight studies met inclusion criteria. Overall, coxibs were associated with a significant increment in the risk of GAO [RR 1.64 (95% CI 1.44-1.86)]. The analysis by individual drugs showed that etoricoxib [RR 4.85 (95% CI 2.64-8.93)] presented the highest gastrointestinal risk, followed by rofecoxib [RR 2.02 (95% CI 1.56-2.61)] and celecoxib [RR 1.53 (95% CI 1.19-1.97)]. Gastrointestinal risk was also high for the subgroups aged <65 years and low-dose coxibs. The use of coxibs is associated with a statistically significant increased risk of GAO, which would be high even for low-dose coxibs and <65-year-old subgroups. The risk would be higher for etoricoxib than for celecoxib and rofecoxib.

Cardiovascular and gastrointestinal safety of selective cyclooxygenase-2 inhibitors: a case/non-case study.

Background Coxibs cardiovascular (CV) safety continues being a current issue after rofecoxib worldwide withdrawal in 2004. Objective To evaluate the cardiovascular and gastrointestinal (GI) risk of coxibs through case/non-case study. Setting The Spanish Pharmacovigilance System for Human Use Drugs (FEDRA) and the Uppsala Monitoring Centre (VigiBase) databases. Method We identified adverse drug reactions (ADRs) cases reported under the MedDRA system organ classes of "cardiac disorders", "vascular disorders", "nervous system disorder" and "gastrointestinal disorders". Disproportionality was considered when the following criteria were met simultaneously: proportional reporting ratio (PRR) ≥ 2, 95% confidence interval lower limit of reporting odds ratio (ROR) > 1, Chi square test (χ2) ≥ 4; and number of ADR reports (n rep.) > 3. Main outcome measure Potential disproportionality between cardiovascular and GI ADRs as reported to FEDRA and VigiBase and the use of coxibs. Results We found association between coxibs and CV-ADRs in FEDRA [PRR 2.11 (95% CI 1.97-2.27); ROR 2.53 (95% CI 2.29-2.89); χ2 367.81; n rep., 561] and VigiBase [PRR 2.67 (95% CI 2.64-2.71); ROR 3.26 (95% CI 3.20-3.31); χ2 23,950.93; n rep., 21,047]; and between coxibs and GI-ADRs in VigiBase [PRR 2.91 (95% CI 2.84-2.97); ROR 3.08 (95% CI 3.01-3.16); χ2 8762.82; n rep. 6954]. No association was found between coxibs and GI-ADRs in FEDRA. Conclusion The association found support a potential coxibs class effect in terms of cardiovascular safety. Classical NSAIDs GI risk may be higher than that for coxibs.

Calidad de la prescripción para indicaciones no autorizadas en ficha técnica (off-label) en la enfermedad oncológica avanzada / Quality of off-label prescriptions in advanced oncologic diseases

No disponible

No disponible

Tumores del timo y cirugía / Tumors of thymus and surgery

Los tumores del timo constituyen menos del 1 por ciento de todas las neoplasias, y es la cirugía el tratamiento de elección. Objetivos: conocer el tipo de tratamiento quirúrgico y la magnitud de la resección, así como la relación con el tamaño del tumor, el sangrado, el tiempo quirúrgico, la morbilidad y la mortalidad. Métodos: se realizó un estudio prospectivo en 22 pacientes con tumor mediastinal, que tuvieron criterios de cirugía durante el ingreso en los servicios de neurología o cirugía general del hospital Hermanos Ameijeiras, desde enero de 2007 hasta febrero de 2009. Los resultados se presentan en por cientos y se empleó el chi cuadrado en la relación de variables. Resultados: 12 fueron del sexo femenino (54,5 por ciento ). El tratamiento más empleado fue la esternotomía total en 9 pacientes (40,9 por ciento ), el tiempo quirúrgico varió de 50 a 260 min con mediana de 127,5, mientras el sangrado por encima de 100 mL estuvo asociado a un tiempo quirúrgico de 61 a 180 min (p= 0,036). Se complicaron 11 pacientes (50 por ciento ) y hubo 1 fallecido (4,5 por ciento ). El tamaño del tumor varió de 3,5 a 20 cm. El paciente con tumor neuroendocrino recidivó a los 10 meses, mientras los pacientes con timomas no muestran hasta la fecha recidiva local ni se ha comprobado actividad metastásica. Conclusión: la cirugía constituye el paso más importante en el tratamiento de los tumores mediastinales, y se logra, en la gran mayoría, la resección completa, a pesar del tamaño y la relación con estructuras vecinas(AU)

Introduction: the tumors of thymus account for less than 1 percent of all neoplasms and the choice treatment is the surgery. Objectives: to know the type of surgical treatment and the magnitude of resection, as well as the relationship with the tumor size, bleeding, surgical time and morbidity and mortality. Methods: a prospective study was conducted in 20 patients presenting with mediastinum tumor with surgery criteria over the admission in the services of neurology or general surgery of the Hermanos Ameijeiras Clinical Surgical Hospital from January, 2007 to February, 2009. Results are showed in percentages and variables relation Chi2 was the test used. Results: twelve patients were of female sex (54.5 percent). The more applied treatment was the total sternotomy in 9 patients (40.9 percent), surgical time varied from 50 to 260 min with a mean of 127,5, whereas the bleeding over of 100 mL was associated with a surgical time from 61 to 180 min (p= 0.036). Eleven patients have complications (50 percent) with a death (4.5 percent). The tumor size varied from 3,5 to 20 cm. The patients with neuroendocrine tumor have a relapse at 10 months, whereas in patients with thymoma until now there was neither relapse nor metastatic activity. Conclusion: surgery is the more important step in the treatment of mediastinum tumors and in most of them it is possible a total resection despite its size and the relationship with neighbouring structures(AU)

Tumores del timo y cirugía / Tumors of thymus and surgery

Los tumores del timo constituyen menos del 1 por ciento de todas las neoplasias, y es la cirugía el tratamiento de elección. Objetivos: conocer el tipo de tratamiento quirúrgico y la magnitud de la resección, así como la relación con el tamaño del tumor, el sangrado, el tiempo quirúrgico, la morbilidad y la mortalidad. Métodos: se realizó un estudio prospectivo en 22 pacientes con tumor mediastinal, que tuvieron criterios de cirugía durante el ingreso en los servicios de neurología o cirugía general del hospital Hermanos Ameijeiras, desde enero de 2007 hasta febrero de 2009. Los resultados se presentan en por cientos y se empleó el chi cuadrado en la relación de variables. Resultados: 12 fueron del sexo femenino (54,5 por ciento ). El tratamiento más empleado fue la esternotomía total en 9 pacientes (40,9 por ciento ), el tiempo quirúrgico varió de 50 a 260 min con mediana de 127,5, mientras el sangrado por encima de 100 mL estuvo asociado a un tiempo quirúrgico de 61 a 180 min (p= 0,036). Se complicaron 11 pacientes (50 por ciento ) y hubo 1 fallecido (4,5 por ciento ). El tamaño del tumor varió de 3,5 a 20 cm. El paciente con tumor neuroendocrino recidivó a los 10 meses, mientras los pacientes con timomas no muestran hasta la fecha recidiva local ni se ha comprobado actividad metastásica. Conclusión: la cirugía constituye el paso más importante en el tratamiento de los tumores mediastinales, y se logra, en la gran mayoría, la resección completa, a pesar del tamaño y la relación con estructuras vecinas(AU)

Introduction: the tumors of thymus account for less than 1 percent of all neoplasms and the choice treatment is the surgery. Objectives: to know the type of surgical treatment and the magnitude of resection, as well as the relationship with the tumor size, bleeding, surgical time and morbidity and mortality. Methods: a prospective study was conducted in 20 patients presenting with mediastinum tumor with surgery criteria over the admission in the services of neurology or general surgery of the Hermanos Ameijeiras Clinical Surgical Hospital from January, 2007 to February, 2009. Results are showed in percentages and variables relation Chi2 was the test used. Results: twelve patients were of female sex (54.5 percent). The more applied treatment was the total sternotomy in 9 patients (40.9 percent), surgical time varied from 50 to 260 min with a mean of 127,5, whereas the bleeding over of 100 mL was associated with a surgical time from 61 to 180 min (p= 0.036). Eleven patients have complications (50 percent) with a death (4.5 percent). The tumor size varied from 3,5 to 20 cm. The patients with neuroendocrine tumor have a relapse at 10 months, whereas in patients with thymoma until now there was neither relapse nor metastatic activity. Conclusion: surgery is the more important step in the treatment of mediastinum tumors and in most of them it is possible a total resection despite its size and the relationship with neighbouring structures(AU)

Tumor del estroma gastrointestinal y cirugía / Tumor of the gastrointestinal stroma and surgery

Los tumores del estroma gastrointestinal son los tumores mesenquimales más frecuentes del tubo digestivo. Se estudiaron 4 pacientes operados en el Hospital ®Hermanos Ameijeiras¼ entre junio de 2004 y marzo de 2007. En un caso de localización gástrica se realizó la resección primaria del tumor y en los restantes la cirugía se realizó después de una respuesta parcial con Imatinib Mesylateâ. Para la resección total del tumor fue necesaria una gastrectomía total con esofagogastrectomía en Y de Roux y una proctosigmoidectomía con conservación del esfínter anal y colostomía terminal transitoria. Los de localización gástrica tuvieron una evolución satisfactoria, y uno de ellos con recurrencia de la enfermedad. El paciente con tumor de localización rectal falleció después de un shock séptico. La cirugía constituye para estos enfermos la única posibilidad de curación, incluso en casos de tumores inicialmente irresecables(AU)

The tumors of the gastrointestinal stroma are the most common mesenchimal tumors of the digestive tube. Four patients operated on at ®Hermanos Ameijeiras¼ Hospital from June 2004 to March 2007 were studied. Primary resection of the tumor was performed in a case of gastric localization, whereas in the rest surgery was carried out after a partial response with Imatinib Mesylateâ. A total gastrectomy with Roux en-Y esophageal gastrectomy and a proctosigmoidectomy with conservation of the anal sphincter and transient terminal colostomy were necessary for the total resection of the tumor. Those of gastric localization had a satisfactory evolution, and one of them with recurrence of the disease. The patient with tumor of rectal localization died alter a septic shock. Surgery is the only possibility of cure for these patients, even in the cases of initially unresectable tumors(AU)

Tumor del estroma gastrointestinal y cirugía / Tumor of the gastrointestinal stroma and surgery

Los tumores del estroma gastrointestinal son los tumores mesenquimales más frecuentes del tubo digestivo. Se estudiaron 4 pacientes operados en el Hospital ®Hermanos Ameijeiras¼ entre junio de 2004 y marzo de 2007. En un caso de localización gástrica se realizó la resección primaria del tumor y en los restantes la cirugía se realizó después de una respuesta parcial con Imatinib Mesylateâ. Para la resección total del tumor fue necesaria una gastrectomía total con esofagogastrectomía en Y de Roux y una proctosigmoidectomía con conservación del esfínter anal y colostomía terminal transitoria. Los de localización gástrica tuvieron una evolución satisfactoria, y uno de ellos con recurrencia de la enfermedad. El paciente con tumor de localización rectal falleció después de un shock séptico. La cirugía constituye para estos enfermos la única posibilidad de curación, incluso en casos de tumores inicialmente irresecables.

The tumors of the gastrointestinal stroma are the most common mesenchimal tumors of the digestive tube. Four patients operated on at ®Hermanos Ameijeiras¼ Hospital from June 2004 to March 2007 were studied. Primary resection of the tumor was performed in a case of gastric localization, whereas in the rest surgery was carried out after a partial response with Imatinib Mesylateâ. A total gastrectomy with Roux en-Y esophageal gastrectomy and a proctosigmoidectomy with conservation of the anal sphincter and transient terminal colostomy were necessary for the total resection of the tumor. Those of gastric localization had a satisfactory evolution, and one of them with recurrence of the disease. The patient with tumor of rectal localization died alter a septic shock. Surgery is the only possibility of cure for these patients, even in the cases of initially unresectable tumors.