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.
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
Randomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal age, of both sexes, recruited in the mental health clinics of the Salamanca University Assistance Complex and who will be randomly distributed into two groups (intervention and control). The main objective of the study is to determine the effect of physical exercise on telomere size in patients diagnosed with schizophrenia. As secondary objectives in this group of patients we will try to: Evaluate the influence of strength training on cognition and negative symptoms of schizophrenia. To quantify the impact of strength training on frailty. To determine the effect of strength training on quality of life. To study the possible correlation between physical parameters (frailty) and telomere length. To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the maintenance of telomere length.
Diabetes generates a great impact on society, as well as a concern for health professionals due to its high and increasing prevalence; there are more and more studies that demonstrate the effectiveness of vibration platforms and their benefits at a physiological level. The objective is to analyze the decrease in glycosylated hemoglobin and glycemia levels after the use of whole body vibration platforms and the possible inclusion of this therapeutic option within the usual treatments.The sample will be composed of people diagnosed with Type 2 Diabetes Mellitus in the Plasencia area (Cáceres, Extremadura). Participants will be randomly assigned to the intervention or control group using a randomization list and will follow the inclusion criteria: healthy type 2 diabetics between 50 and 60 years of age and not taking diabetes medication. All participants will undergo a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight and height, and different functional tests such as TUG, 10MMT, 5STS. The experimental group will perform a full body vibration intervention on an oscillating platform for 12 weeks with a weekly frequency of 3 non-consecutive days and a duration of 12 minutes. The exercises will consist of 60 seconds of work and 60 seconds with rest. The control group will carry out their normal life insisting on the importance of glycemic controls before and after their daily physical exercise.
Mental health, understood as the individual or group well-being at an emotional, psychological, and/or social level, affects up to 35% of university students, of whom only 16.4% seek or receive help from healthcare professionals. Despite this prevalence and its impact on academic performance and the challenges faced by universities in terms of limited resources to address this situation, most research tends to focus on primary and/or secondary education stages. Consequently, there is limited research on the reasons why university students experience mental health problems and why they do not seek help. Physical activity and reducing sedentary behaviour could be protective factors for mental health in both children and adolescents. In this regard, according to data from the DESK-Uni at UVic-UCC, university students report engaging in low levels of physical activity, with female students reporting lower levels than male students. Additionally, adolescent girls report more mental health problems than boys. Therefore, there is a need for research and projects that consider the gender bias in health that exists in our society, including universities. This bias could explain why girls engage in less physical activity or claim to do so and why they experience more mental health problems. Thus, the purpose of the project is to improve or reduce gender inequalities within the university community and their impact on health behaviour (physical activity/sedentary behaviour) and mental health of both students and staff members. Overall, the project aims to decrease the risks of experiencing mental health problems in the university environment by enhancing identification and promoting health-related behaviours that act as protective factors (e.g., physical activity). This will be done by considering the intersectionality of inequality axes present in our society and reproduced within the university setting. To do it, the Sustainable Development Goals (SDG; 3-4-5) will be taken in consideration.
Introduction: Fibromyalgia (FM) is a prevalent syndrome that lacks curative treatment, imposing high healthcare and societal costs. The SMART-FM-Spain study investigates the effectiveness, physiological effects, and cost-utility of a self-guided digital intervention (STANZA-Spain) based on Acceptance and Commitment Therapy (ACT) for patients with FM. Methodology: Six-month, 3-arm randomized controlled trial (RCT) A total of 360 adult individuals meeting the 2016 American College of Rheumatology (ACR) criteria for FM will be recruited mainly at Vall d'Hebron University Hospital (Barcelona, Spain), and will be randomly allocated to one of the three study arms: Treatment as usual (TAU) plus STANZA-Spain, TAU plus digital symptom tracking (FibroST), or TAU. Participants will be assessed at baseline, post-treatment, and 6 month-follow-up. The primary outcome will be functional impairment and secondary outcomes will include patient impression of change, depression-anxiety-stress, and pain catastrophizing, among others constructs relevant to FM. Effectiveness and cost-utility analysis from a societal perspective will be computed, whereas ACT-related constructs, such as psychological flexibility, will be assessed to identify processes of change that will be analyzed with path analyses. Biomarkers will be assessed at baseline and post-treatment including hair cortisol, cortisone, corticosteroid binding globulin (CBG), adrenocorticotropic hormone (ACTH), cortisol in plasma, genotyping of FKBP5 gene polymorphisms, immune-inflammatory markers, and vitamin D levels. Discussion: This study might represent a significant advancement in the management of FM in Spanish-speaking patients with FM, by examining the effectiveness, physiological effects, and cost-utility of a smartphone-based digital therapeutic with demonstrated empirical support in the United States of America.
In recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (OD). The investigators have demonstrated the acute and sub-acute therapeutic effect of TRP agonists on mechanical and neural swallow responses in patients with OD. The present hypothesis is that 6-months treatment with TRPV1 (capsaicin) or TRPA1 (piperine) agonists will improve the biomechanics and neurophysiology of the swallow response without inducing desensitization. The aim of this study is to evaluate the effect on biomechanics assessed by videofluoroscopy (VFS), neurophysiology (pharyngeal evoked sensory potentials -pSEP- and motor evoked potentials -pMEP-), and clinical outcomes during a 6-month treatment with TRP agonists added to the alimentary bolus 3 times a day in older patients with OD. Design: 150 older patients (>70y) with OD will be included in a randomized clinical trial with three treatment arms, in which the effect of oral administration of 1) capsaicin 10µM (TRPV1 agonist), 2) piperine 150µM (TRPA1), and 3) placebo (Control), will be evaluated. Measurements: 1) VFS signs of swallowing safety and efficacy and timing of swallow response ; 2) Spontaneous swallowing frequency; 3) Latency, amplitude and cortical representation of pSEP and pMEP; 4) Concentration of substance P and CGRP in saliva, 5) Clinical outcomes (respiratory and nutritional complications). The results of this study will increase evidence for a new generation of pharmacological treatments for older patients with OD, moving from compensation to rehabilitation of the swallowing function.
Aims: To evaluate the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission, and; to explore the factors that may affect its implementation. Design: 24-month, parallel, open-label, multicentre, pragmatic, hybrid type 1 randomized clinical trial. Setting, sample, and randomization: 118 primary healthcare centers from multiple regions in Spain will be randomly assigned (ratio 1:1) to two groups (control and intervention). The intervention group will receive two audits (baseline and intermediate at 12 months). The audits will consist of the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a sample of around 100 patients per center. The intervention group will receive reports on the results of both audits, along with resources aimed at facilitating the design and implementation of safety improvement plans. The intervention will be deployed through the SinergiAPS web tool, developed and validated in previous projects. The control group will have access to the intervention after the end of the clinical trial (waitlist). Outcomes: Primary outcome: rate of avoidable hospitalizations (electronic health records). Secondary outcomes: patient-reported patient safety (PREOS-PC questionnaire); patient safety culture perceived by professionals (MOSPC questionnaire); adverse events experienced by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions (ad hoc questionnaire). Outcome data will be collected at baseline and at 24 months follow-up. Implementation evaluation: Drawing on the CFIR model, we will collect and analyze qualitative (30 individual interviews, implementation logbooks) and quantitative (questionnaires for professionals from intervention centers, level of use of the SinergiAPS web tool) data to examine the implementation of the intervention in the Spanish primary healthcare centers.
Sarcopenia (SAR) is the loss of strength and muscle mass caused by aging. It is accompanied by a progressive loss of physical and cognitive abilities, increasing the risk of falls. This loss of muscle mass leads to pathophysiological changes at the neuromuscular and tendon level as a consequence of, among others, alterations in the protein synthesis/degradation balance, inflammation (INF), or alterations in the anabolic/catabolic state (EAC). These alterations are caused by oxidative stress (OS), when reactive O2 species, toxic metabolites produced by cells using O2, exceed the defense capacity of the antioxidant mechanism. Therapeutic strategies to modulate SAR are based on exercise and nutrition programs. Multicomponent physical exercise program has shown improvements in sarcopenia-related parameters. Likewise, the use of nutritional supplements such as creatine (CRE) has shown improvements in muscle function in the elderly. CRE could reduce INF and EO in the general population. Guanidinoacetate (GAA, also known as guanidinoacetate acid or glucosamine) is a naturally occurring creatine precursor with advanced transportability and an innovative dietary supplement that may increase the rate of creatine turnover. The CRE-GAA mixture outperforms creatine in increasing brain and muscle performance in adult men and women, but whether this mixture improves muscle function and quality in people with sarcopenia has not been addressed so far. Similarly, whether this mixture may promote oxidative stress and inflammation in adults with sarcopenia has not been studied. Similarly, beta-hydroxy-beta-methylbutyrate (HMB) also appears to improve muscle function in older people by enhancing myogenesis. However, the effects of these supplements on the elderly have only been shown to be seen when used in isolation. In this regard, our research team observed that a 10-week combination of 3 g/day of CRE+3 g/day of HMB (CRE-HMB) improved muscle recovery (better EAC) and physical performance in athletes exposed to heavy muscle wasting. However, not aware that it has been addressed whether this mixture improves muscle function, EO, INF, and EAC in women with SAR. Therefore, the hypothesize would be that the CRE-HMB combination could improve muscle function and physical performance, as well as OE, INF, and EAC in people with high muscle wasting such as those with SAR. Therefore, a randomized double-blind study is proposed to analyze the effect of 12 weeks of co-supplementation of 3 g/day of CRE + 3 g/day of HMB (CRE-HMB) and 3 g/day of CRE and 3 g/day of GAA (CRE-GAA) with 3 sessions/week of multicomponent physical exercise on muscle function, EO, INF, and EAC in 81 women with SAR over 70 years of age. These 81 women will be divided into 3 groups of 27 (27 placebo group, 27 CRE-HMB group, and 27 CRE-GAA group). At the control points (at baseline and after 12 weeks) participants will have their body composition, nutritional intake, strength, and performance tests analyzed. Blood will also be drawn to determine biochemical values of EO, INF, and EAC. The expected results are that co-supplementation with CRE-HMB and CRE-GAA for 12 weeks together with multicomponent physical exercise in individuals diagnosed with SAR will improve muscle strength, muscle quantity, and performance. In addition, improved EO, INF, and EAC levels are expected.
The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the static and dynamic versions against each other, and to provide estimates of QoL across European countries. The EUonQoL-Kit will be administered to a sample of patients from 45 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,500 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity. - Live-CAT version, to validate the static and dynamic versions against each other. - EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.
The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.