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 ARIES study is an observational study in which patients with a recent acute ischemic stroke of cryptogenic aetiology are consecutively enrolled in order to perform a extensive cardiologic work-up. The main objective is to study parameters that could predict arrythmias on prolonged monitoring and also echocardiographic parameters of left atrial disfunction that could predict the presence of a hidden atrial fibrilation and recurrent ischemic events in patients with cryptogenic stroke.
The main objective of the present study is to add knowledge of the potential health effects and mechanism of action by a dietary strategy based on a VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or combination with prebiotic supplementation based on fructooligosaccharides (FOS) and inulin to tackle sarcopenia by improving skeletal muscle mass and function and CVD risk factors in early elderly (60-80 years) home-dwelling sarcopenic subjects. The specific objectives: - To determine the compliance food intake biomarkers of VOO in 24h urine samples and prebiotic intake in faecal samples. - To evaluate the effect of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) on the improvement of muscle mass, muscle performance, gait performance, cardiovascular disease risk factors (inflammation, oxidation and endothelial function), and gut microbiota, in sarcopenic young-elderly subjects. - To assess the mechanisms of action of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) involved in the development of sarcopenia and cardiovascular disease in vivo and in vitro cellular models. - To determine if the effects achieved after the intervention (12 weeks of intervention) will be sustained 12 weeks after the FOOP-Sarc intervention cessation (12 weeks of intervention + 12 weeks of follow-up), by assessing the sarcopenia and CVD risk factors in sarcopenic early elderly subjects. - To co-create nutritional and physical activity recommendations of FOOP-Sarc study based on sarcopenia improvement by a sample of volunteers of the FOOP-Sarc study, and to assess the adherence and the effectivity of the recommendations, in comparison to standard recommendations created by researchers, the satisfaction and engagement experience in a co-creation process, and the usability of recommendations.
The HERCULES trial is a Randomized controlled clinical trial designed to prospectively compare endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) clinical outcomes in treatment of infrarenal abdominal aortic aneurysm (AAA) in subjects having wide proximal aortic neck diameters (≥ 28mm and ≤ 32mm).
Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care. The registry is a prospective observational real-world registry. It collects data from already available registries/database and/or directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https://euracan.eu/research/starter/rare-head-and-neck-cancer-registry/#codebook). The registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients' and cancers' variables; analytical analyses investigating the association of patients/disease and/or treatment characteristics and health outcomes. Fondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients' personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016/679 of the EU.
Life expectancy has dramatically increased in the last century, although this process has not been always accompanied by an equivalent increase in healthy life expectancy. However, extending longevity without decreasing the risk of age-associated pathologies would not be desirable since non-communicable diseases can diminish seniors' quality of life, raise health-care costs, and increase pressure on family members who are responsible for their care. Maintaining a good health would help to ensure independence, security, and continued productivity in the later years helping both health systems and pensions lower costs. Thus, many scientific studies have tried to delay the age of onset of major age-related chronic diseases. In other words, research has been more focused on extending healthspan rather than lifespan. Actually, numerous experimental studies have shown that the extension of lifespan by modifying risk factors is usually accompanied by delayed or reduced morbidity, including cardiovascular disease, neurodegeneration, and tumors. In the dietary context, modifications of the diet energy and/or macronutrient balance has shown to contribute to healthy aging, increasing healthspan and probably lifespan. Likewise, some foods would be able to supply a significant amount of compounds to the human diet, including non-nutrients which are thought to exert effects in the same sense. Thus, adequate nutritional intervention would be considered geroprotective interventions that would positively influence health by slowing basic biological processes of aging, such as cellular senescence, mitochondrial dysfunction, age-related decline of stress resistance, dysregulated cellular energy sensing/growth pathways, impaired proteostasis, deteriorated stem cell function/bioavailability, as well as inflammation/oxidative stress. The use of nutraceuticals and functional foods from olive products and by-products can be useful in the treatment of pathologies associated with aging, such as periodontitis, as well as from the point of view of a proper nutrition during aging. The study is a double-blind clinical trial of parallel design whose main objective is to evaluate the usefulness of a dietary supplement rich in oleuropein from the olive tree (leaf) in the adjuvant treatment of patients with age-related periodontitis. Efforts will be made to ensure that men and women be represented homogeneously in all study groups, although it is known that gender does not influence the appearance of periodontitis. The experimental design foresees the inclusion of 130 patients with chronic periodontitis aged 60 years or older, 65 for the control group and 65 for the treatment group. Volunteers will be recruited from new patients attending the Faculty of Odontology at the University of Sevilla, Sevilla (Spain) by one study team member. The investigational product will be provided by Natac Company (Madrid, Spain), a corporate group dedicated to researching, developing, manufacturing, and marketing natural ingredients to be used in food supplements, feed, pet food, as well as in functional foods, and as natural, active pharmaceutical ingredients. The planned schedule for the participating subjects is as follows: - Day 0: diagnosis of periodontitis, proposal to participate in the study, delivery of consent and information to the patient. - Day 15: oral exams, collection of sociodemographic data, study of anthropometric characteristics and blood pressure, evaluation of eating habits, urine and blood sampling, collection of samples for the study of the periodontal microbiota and data collection and calculation of the index of successful ageing. - Day 16 to 30 periodontal treatment. - Day 16 to 136: administration of treatment (oleuropein or placebo). - Day 136: oral exams, collection of sociodemographic data, study of anthropometric characteristics and blood pressure, evaluation of eating habits, urine and blood sampling, collection of samples for the study of the periodontal microbiota and data collection and calculation of the index of successful ageing. The analytical part of the of the clinical trial will be developed mostly in the Biomedical Research Center (CIBM) of the University of Granada. The field part of the clinical trial in patients with periodontitis will be carried out at the Faculty of Dentistry of the University of Seville. The design of the clinical trial provides for the participation of specialists from several disciplines, including specialists in Nutrition and Physiology, clinical specialists in Pathological Anatomy and Dentistry, technicians from the Center of Scientific Instrumentation of the University of Granada (specialists in various subjects such as microscopy, biochemical analysis, histology and veterinary) as well as technicians from the Marketing Unit of the OTRI of the University of Granada.
Neuropsychological tests currently considered to evaluate the cognitive performance of the oldest-old population (more than 80 years) are not adapted to this group population. This trial aims to determine the normal limits for this group population of a set of 18 neuropsychological test. Results may improve the diagnostic cognitive evaluation of this population.
The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.
This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.
The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.
The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.