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The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent

Digibug. Repositorio Institucional de la Universidad de Granada
oai:digibug.ugr.es:10481/66329
Digibug. Repositorio Institucional de la Universidad de Granada
This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33)., Ministry of Health of Government of Andalusia PI-057/2012
 
DOI: http://hdl.handle.net/10481/66329
Digibug. Repositorio Institucional de la Universidad de Granada
oai:digibug.ugr.es:10481/66329

HANDLE: http://hdl.handle.net/10481/66329
Digibug. Repositorio Institucional de la Universidad de Granada
oai:digibug.ugr.es:10481/66329
 
Ver en: http://hdl.handle.net/10481/66329
Digibug. Repositorio Institucional de la Universidad de Granada
oai:digibug.ugr.es:10481/66329

Digibug. Repositorio Institucional de la Universidad de Granada
oai:digibug.ugr.es:10481/76560
. 2022

A PROGRAM FOR THE COMPREHENSIVE COGNITIVE TRAINING OF EXCESS WEIGHT (TRAINEP): THE STUDY PROTOCOL FOR A RANDOMIZED, CONTROLLED TRIAL

Digibug. Repositorio Institucional de la Universidad de Granada
Background: The available treatments for people with excess weight have shown small effects. Cognitive training has shown promising results, but most of the research focused on normalweight university students and reported immediate results after a single training session. This parallel group, randomized, controlled trial aims to study the efficacy of a program for the comprehensive cognitive treatment of excess weight. Methods and Analysis: Participants will be 150 people with excess weight recruited through social media, who will be randomized into three groups: cognitive intervention, sham cognitive intervention, and treatment as usual. All assessment and intervention sessions will be online in groups of 5–6 participants. The three groups will attend a motivational interviewing session, and they will receive individualized diet and physical exercise guidelines throughout the program. The cognitive training will consist of four weekly sessions of approximately 60–90 min, each based on approach–avoidance bias training, inhibitory control training, implementation of intentions, and episodic future thinking, respectively. The main outcome measure will be a change in Body Mass Index (kg/m2). Secondary outcomes include changes in cognitive measures, eating and physical exercise behaviors, and anthropometric measures. Assessments will be conducted up to 6 months after the end of the program. In addition, data on the use of the health system will be collected to analyze the cost-effectiveness and the cost-utility of training. Linear mixed models will be used for statistical analysis. Findings of this study will expand the available evidence on cognitive interventions to reduce excess weight., Spanish Ministry of Science, Innovation, and Universities MCIN/AEI, European Regional Development Fund "ERDF A way of making Europe" RTI2018-098771-B-I00




Digibug. Repositorio Institucional de la Universidad de Granada
oai:digibug.ugr.es:10481/66329
. 2016

THE STUDY PROTOCOL FOR A NON-RANDOMIZED CONTROLLED CLINICAL TRIAL USING A GENOTYPE-GUIDED STRATEGY IN A DATASET OF PATIENTS WHO UNDERGONE PERCUTANEOUS CORONARY INTERVENTION WITH STENT

Digibug. Repositorio Institucional de la Universidad de Granada
This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33)., Ministry of Health of Government of Andalusia PI-057/2012




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