There are about 21071 clinical studies being (or have been) conducted in Spain. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.
This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.
The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy.
Drug use, substance use disorders (SUD) and other addictive behaviors are problems of enormous socio-health impact that still require a great research effort to improve the diagnostic and therapeutic procedures used in healthcare practice. Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions, it is necessary to be able to detect, evaluate and have specific therapies for these dysfunctions and investigate, among other issues, the role they play in the onset and course evolutionary. After implementing neuropsychological evaluation techniques for diagnostic improvement, addresses the search for procedures that allow working on cognitive and executive deficits, as a specific therapeutic target. To characterize the presence of alterations in the domains that make up social cognition (SC) in patients with SUD and test in our healthcare units the ET® program already tested both experimentally and at beta level. It is an online self-training program for CS rehabilitation that includes modules for emotion recognition (RE), Theory of Mind (ToM) and attributional style (AS). To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM, in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training, using advanced LC-ESI proteomics techniques. MS/MS in saliva since previous studies in a population with schizophrenia, subjected to different neurorehabilitation therapies. It is also intended to subsequently improve the instrument (ET®) through the implementation of big data analysis and machine learning and the introduction of automated user management. At this level, the objective is to determine, after the first games, the type of game and the intensity required to improve the user's performance until it reaches normality. From the perspective of the State Plan for Scientific and Technical Research and Innovation, this project combines CLINICAL AND TRANSLATIONAL RESEARCH, based on the evidence of scientific and technological knowledge, and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services. Health for people with SUD.
The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose. Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months? Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS.
This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes. Key objectives and related measured variables include: Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program. Participant Engagement and Program Adherence: Determined by participants' satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates. Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up. Healthcare Professionals' Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management. Participants will complete eight 90-minute sessions, engaging with VR to supplement the program's content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined. By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management.
Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults. Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults. Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire. All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them. An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet [Mediterranean Diet Adherence Questionnaire (MEDAS)], physical activity [Short physical performance battery (SPPB)], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire).
To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology. This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected. The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound.
Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.