Estabilidad en el tiempo de relajación magnética de la solución CM-95 / Stability in the magnetic relaxation time of the CM-95 solution

INTRODUCCIÓN: la solución CM-95 constituye un candidato a medicamento inmunomodulador en la terapia de pacientes con cáncer, el que debe cumplir las Buenas Prácticas de Producción con el correspondiente control de calidad y estabilidad, según las regulaciones vigentes. Se determinó la estabilidad de la solución CM-95 y el conteo de leucocitos en ratones Balb/c en el tiempo de relajación magnética. MÉTODO: se elaboraron tres lotes pilotos, los que fueron sometidos a estudios de estabilidad de vida de estante y acelerado. Los índices de calidad determinados antes y después del tratamiento magnético fueron: características organolépticas, pH, conductividad eléctrica, valoración del cloruro de sodio, concentración del preservo y control microbiológico. Se determinó el conteo de leucocitos totales en ratones Balb/C antes y después del tratamiento. RESULTADOS: se demostró el cumplimiento de los parámetros establecidos en condiciones aceleradas y vida útil de la solución, sin y con tratamiento magnético. Se demostró la utilidad del sistema envase - cierre seleccionado durante el estudio. El conteo total de leucocitos mostró variaciones con respecto al control hasta los dos meses como efecto del tratamiento magnético. CONCLUSIONES: se demostró el cumplimiento de los índices de calidad establecidos de la solución CM-95 tratada magnéticamente, en las condiciones aceleradas y de vida útil empleando ambos tipos de envase. Se evidenció la activación de la respuesta inmune a partir del tratamiento hasta los dos meses. Se comprobó que el tiempo de relajación magnética de la solución fue de dos meses

INTRODUCTION: the CM-95 solution constitutes a candidate for immunomodulatory medication in the therapy of cancer patients, who must comply with Good Production Practices with the corresponding quality and stability control, according to current regulations. It was determined the stability of the CM-95 solution and the leukocyte count in Balb / c mice at the time of magnetic relaxation. METHODS: three pilot lots were prepared, which were subjected to shelf stability and accelerated life studies. The quality indices determined before and after the magnetic treatment were: organoleptic characteristics, pH, electrical conductivity, sodium chloride titration, preservation concentration and microbiological control. Total white blood cell count in Balb / C mice was determined before and after treatment. RESULTS: compliance with the parameters established in accelerated conditions and solution life, without and with magnetic treatment, was demonstrated. The utility of the container-closure system selected during the study was demonstrated. The total white blood cell count showed variations with respect to the control up to two months as an effect of the magnetic treatment. CONCLUSIONS: compliance with the established quality indices of the magnetically treated CM-95 solution was demonstrated, under accelerated conditions and useful life using both types of packaging. The activation of the immune response was evident from the treatment up to two months. It was found that the magnetic relaxation time of the solution was two months

Heart beat characterization from ballistocardiogram signals using extended functions of multiple instances.

A multiple instance learning (MIL) method, extended Function of Multiple Instances (eFUMI), is applied to ballistocardiogram (BCG) signals produced by a hydraulic bed sensor. The goal of this approach is to learn a personalized heartbeat "concept" for an individual. This heartbeat concept is a prototype (or "signature") that characterizes the heartbeat pattern for an individual in ballistocardiogram data. The eFUMI method models the problem of learning a heartbeat concept from a BCG signal as a MIL problem. This approach elegantly addresses the uncertainty inherent in a BCG signal (e. g., misalignment between training data and ground truth, mis-collection of heartbeat by some transducers, etc.). Given a BCG training signal coupled with a ground truth signal (e.g., a pulse finger sensor), training "bags" labeled with only binary labels denoting if a training bag contains a heartbeat signal or not can be generated. Then, using these bags, eFUMI learns a personalized concept of heartbeat for a subject as well as several non-heartbeat background concepts. After learning the heartbeat concept, heartbeat detection and heart rate estimation can be applied to test data. Experimental results show that the estimated heartbeat concept found by eFUMI is more representative and a more discriminative prototype of the heartbeat signals than those found by comparison MIL methods in the literature.

Robust heartbeat detection from in-home ballistocardiogram signals of older adults using a bed sensor.

We propose a simple and robust method to detect heartbeats using the ballistocardiogram (BCG) signal that is produced by a hydraulic bed sensor placed under the mattress. The proposed method is found beneficial especially when the BCG signal does not display consistent J-peaks, which can often be the case for overnight, in-home monitoring, especially with frail seniors. Heartbeat detection is based on the short-time energy of the BCG signal. Compared with previous methods that rely on the J-peaks observed from the BCG amplitude, we are able to achieve considerable improvement even when significant distortions are present. Test results are included for different BCG waveform patterns from older adults.

Heartbeat detection from a hydraulic bed sensor using a clustering approach.

Encouraged by previous performance of a hydraulic bed sensor, this work presents a new hydraulic transducer configuration which improves the system's ability to capture a heartbeat signal from four subjects with different body weight and height, gender, age and cardiac history. It also proposes a new approach for detecting the occurrence of heartbeats from ballistocardiogram (BCG) signals through the use of the k-means clustering algorithm, based on finding the location of the J-peaks. Preliminary testing showed that the new transducer arrangement was able to capture the occurrence of heartbeats for all the participants, and the clustering approach achieved correct heartbeat detection ranging from 98.6 to 100% for three of them. Some considerations are discussed regarding adjustments that can be done in order to increase the correct detection of heartbeats for the participant whose percentage of correct detection ranged from 71.0 to 92.5%.

Refinement and evaluation of a hydraulic bed sensor.

Research indicates that long-term monitoring of vital signs and activity in elderly adults may provide opportunities for maintaining quality-of-life and extending independence into later years. Such a strategy requires development of a system to collect this data while imposing minimal intrusion into the lives of those being monitored. To further this goal, we have developed a hydraulic bed sensor to non-invasively monitor heartbeat and respiration during sleep. This paper describes the refinement of our developed prototype and signal processing methods, along with an evaluation of the robustness of our algorithms and results from testing. An evaluation of our sensor on a group of five diverse subjects (ranging in age from 24 to 67, two with cardiac history), in three different positions, demonstrates accuracy within 8 beats per minute up to 97.5% of the time.