Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods: study protocol

Introduction In recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson's disease patients (Parkinson's Holter). The effectiveness of these monitoring devices for improving clinical control is not known. Methods and analysis This is a single-blind, cluster-randomised controlled clinical trial. Neurologists from Spanish health centres will be randomly assigned to one of three study arms (1:1:1): (a) therapeutic adjustment using information from a Parkinson?s Holter that will be worn by their patients for 7 days, (b) therapeutic adjustment using information from a diary of motor fluctuations that will be completed by their patients for 7 days and (c) therapeutic adjustment using clinical information collected during consultation. It is expected that 162 consecutive patients will be included over a period of 6 months. The primary outcome is the efficiency of the Parkinson?s Holter compared with traditional clinical practice in terms of Off time reduction with respect to the baseline (recorded through a diary of motor fluctuations, which will be completed by all patients). As secondary outcomes, changes in variables related to other motor complications (dyskinesia and freezing of gait), quality of life, autonomy in activities of daily living, adherence to the monitoring system and number of doctor?patient contacts will be analysed. The noninferiority of the Parkinson's Holter against the diary of motor fluctuations in terms of Off time reduction will be studied as the exploratory objective. Ethics and dissemination approval for this study has been obtained from the Hospital Universitari de Bellvitge Ethics Committee. The results of this study will inform the practical utility of the objective information provided by a Parkinson's Holter and, therefore, the convenience of adopting this technology in clinical practice and in future clinical trials. We expect public dissemination of the results in 2022.Funding This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195] and the European Fund for Regional Development, 'A way to make Europe'

A crowdsourcing database for the copy-number variation of the Spanish population

Background: Despite being a very common type of genetic variation, the distribution of copy-number variations (CNVs) in the population is still poorly understood. The knowledge of the genetic variability, especially at the level of the local population, is a critical factor for distinguishing pathogenic from non-pathogenic variation in the discovery of new disease variants. Results: Here, we present the SPAnish Copy Number Alterations Collaborative Server (SPACNACS), which currently contains copy number variation profiles obtained from more than 400 genomes and exomes of unrelated Spanish individuals. By means of a collaborative crowdsourcing effort whole genome and whole exome sequencing data, produced by local genomic projects and for other purposes, is continuously collected. Once checked both, the Spanish ancestry and the lack of kinship with other individuals in the SPACNACS, the CNVs are inferred for these sequences and they are used to populate the database. A web interface allows querying the database with different filters that include ICD10 upper categories. This allows discarding samples from the disease under study and obtaining pseudo-control CNV profiles from the local population. We also show here additional studies on the local impact of CNVs in some phenotypes and on pharmacogenomic variants. SPACNACS can be accessed at: http://csvs.clinbioinfosspa.es/spacnacs/. Conclusion: SPACNACS facilitates disease gene discovery by providing detailed information of the local variability of the population and exemplifies how to reuse genomic data produced for other purposes to build a local reference database

Valoración de la información recibida por mujeres con cáncer de cérvix en remisión tras tratamiento con radioterapia

El cáncer de cérvix es la segunda causa de muerte por cáncer en mujeres, además su incidencia en los últimos años está aumentando de forma gradual, y cada vez se presenta en mujeres más jóvenes, debido principalmente a los cambios en el estilo de vida, especialmente al cambio en el patrón sexual. El diagnóstico y detección precoz son fundamentales para prevenir la mayoría de los cánceres cervicales invasivos. Los tratamientos para cáncer cervicouterino dependerán de la etapa en que se encuentra la enfermedad, el tamaño del tumor, la edad y estado de salud general, así como el deseo de tener hijos, así las opciones terapéuticas son múltiples: cirugía, radioterapia, terapia biológica y quimioterapia. En las mujeres con cáncer de cérvix se presentan numerosas alteraciones que afectan a su vida sexual, entre ellos encontramos la falta de excitación sexual y de placer. En ocasiones está ligado a problemas físicos tales como: disminución de expansión vaginal y disminución de la lubricación de la vagina y también pueden ser consecuencia de factores psicológicos. Los objetivos de este proyecto consisten en describir y valorar la información sobre los cambios en la sexualidad que refieren las mujeres con cáncer de cérvix en remisión post-radioterapia así como identificar las principales causas que producen los cambios en el patrón sexual de la mujer post-radioterapia, para lo cual realizaremos un estudio descriptivo transversal. Abstract: Cervical cancer is the second cause of death due to cancer on women, and its incidence is increasing gradually on the latest years. It is occurring on women who are younger each time due to changes on the way of life, and specially changes on the sexual pattern. The diagnosis and early detection are essential to prevent most of the invasive cervical cancer. The treatment for cervical cancer will depend on the stage where the illness is, the size of the tumor, the age and general health state of the woman, and also whether she wishes or not to have children, so the therapeutic options are multiple: surgery, radiotherapy, biological therapy and chemotherapy. Women with cancer of the cervix have many alterations which affect their sexual life, among them there are the lack of sexual excitation and pleasure. Sometimes it is caused by physical problems such as: decrease of the vagina expansion and decrease of the vagina lubrication, but also it may be a consequence of psychological factors. The objectives of this study are to describe and evaluate the information about the changes on their sexuality that women with cervical cancer in remission after radiotherapy have received, as well as to identify the main causes that produce the changes on the women sexual pattern after being treated with radiotherapy, so a transversal descriptive study will be performed. Centro de Trabajo: (1, 2) Hospital Universitario 12 de Octubre. (Madrid), (3) Centro de Transfusiones Cruz Roja. (Madrid), (4) Hospital Universitario Infantil del Niño Jesús. (Madrid), (5) Hospital General Universitario Gregorio Marañón (Madrid) Fecha del Trabajo: 30/05/2006 Palabra Clave: de cérvix, radioterapia, sexualidad, estudio descriptivo Key Words: Cervical cancer, radiotherapy, sexuality, descriptive stud

Estrategia GRUSE. Guía para el desarrollo de grupos con hombres

Guía y AnexosYesEsta estrategia comenzó a funcionar en el año 2011, en el marco del Plan Integral de Salud Mental 2008-2012, con el objetivo de mejorar las capacidades de las personas para afrontar las dificultades de la vida cotidiana. La Guía que hoy presentamos es un paso más en esta Estrategia, y su objetivo es facilitar el desarrollo de estos grupos socioeducativos con hombres (GRUSE-H), de manera que los contenidos y las dinámicas se adapten a su problemática más frecuente, que es la relacionada con la pérdida del “rol productivo” socialmente impuesto