Clinical trials

While body weight reduction can be achieved through various interventions in people living with obesity, most patients regain a substantial proportion of the lost weight within the following months. There is a lack of effective interventions to prevent this regain, making weight regain one of the most pressing challenges in obesity management. The goal of this clinical trial is to determine whether adhering to time-restricted eating (TRE; a form of intermittent fasting) during and after a dietary weight loss intervention, promotes weight maintenance to a greater extent than consuming all daily meals within 11 hours or more. Additionally, the study will address other questions, such as whether TRE improves body composition, insulin sensitivity, and cardiometabolic risk factors; whether the TRE intervention produces effects on different components of energy balance or related behaviors; and whether prior exposure to the TRE intervention influences eating window duration and weight change over the subsequent 24 months. The study will compare participants who concentrate all their food intake within 8 hours or less with those who consume all their daily meals within 11 hours or more. All participants will follow a calorie-restricted diet designed to induce an 8-10% weight loss over 12-16 weeks and will be followed for several months after the weight loss intervention.

The goal of this clinical trial is to evaluate whether a multimodal physiotherapy program and guided meditation using a mobile app can help reduce headache pain and improve quality of life in adults with frequent or chronic tension-type headache. The study analyzes the effects of physical and psychological interventions applied both separately and in combination, so that the combined treatment addresses tension-type headache as a multifactorial condition influenced by biopsychophysiological factors, integrating physical and psychological strategies to improve participants' overall well-being. The main questions it aims to answer are: * Does multimodal physiotherapy lower the intensity and frequency of headaches? * Does guided meditation through a mobile app help reduce stress and improve emotional well-being? * Are the combined effects of physiotherapy and meditation greater than either intervention alone? The study will compare: * A group receiving multimodal physiotherapy sessions once a week for four weeks, * A group practicing guided meditation with a mobile app for about 5 to 7 minutes daily, * A group combining both physiotherapy and meditation. Participants will: * Attend clinical sessions or use the meditation app depending on group assignment, * Complete short questionnaires about pain, stress, sleep, and daily functioning, * Record headache episodes in a structured diary during the study period.

ATOPE-PRO, was developed with the intention of consolidating the integration of an innovative system for the prevention of cancer therapy-related cardiovascular toxicity (CTR-CVT) in the continuum care of women with breast cancer in health services. It is a step further towards personalized medicine by optimizing the already available tools and integrating artificial intelligence. Breast cancer survival increases every year, a situation that poses new challenges for health professionals. The European Society for Medical Oncology, a reference in Europe, has just highlighted the need to anticipate to and prevent sequelae derived from the disease and its treatments. This, in addition to having a positive impact on improving the quality of life of people suffering from this disease, would mean a reduction in the risk of recurrence, the appearance of other tumors and other diseases, and death from cancer or other causes, which have a personal impact and represent an overload of the healthcare system. To this end, ATOPE- PRO aims to optimize and refine tools already developed in the previous project (ATOPE, Pl18/01840), integrating artificial intelligence to help identify CTR-CVT, risk profiles, and effective and safe doses (at a clinical level) early on, implementing the program in a longer term, and transferring the results to the social sector (social level). The project has 4 stages: Phase 0 or start-up (to make improvements and analyse usability); Phase 1 for piloting and optimization; Phase 2, to verify efficacy (randomized controlled clinical trial) and Phase 3, in which a deep analysis will be performed and future projects will be conceived.

Childhood cancer is a rare disease but a significant cause of death in children and adolescents. The incidence of childhood cancer is 1case per 300 cases of adult cancer, but surviving to it has important sequels. Endocrine dysfunction represents one of the most common issues in paediatric cancer survivors and impairs bone mineral density later in life. Some forms of exercise have been recommended to preserve bone health in healthy adults; however, its effect has not been properly studied yet in adult survivors of paediatric cancer using cutting-edge technologies, such as peripheral quantitative computed tomography (pQCT). As general aim, the 3D-BONE study will assess for the first time the effect of a live and online exercise programme on bone parameters and bone metabolism in adult survivors of paediatric cancer. This multicenter randomized controlled trial will be performed in three Andalusian provinces (Granada, Cordoba and Almeria). A minimum of 116 adult survivors of paediatric cancer aged 18 to 55 years will be recruited following the inclusion and exclusion criteria. They will be randomized (based on sex and age) into an INTERVENTION (n=58) or CONTROL group (n=58). The intervention group will receive a 6-month live and online exercise program based on progressive resistance and impact loading training that will be delivered by qualified professionals using a telehealth mobile app (3D-BONE app). Moreover, behaviour change techniques will be implemented in order to increase motivation and adherence to the program. This group will also receive diet counselling on calcium and vitamin so the difference between the groups is the exercise programme. Participants will be assessed before and after the intervention at the facilities of the Sport and Health University Research Institute (iMUDS) of the University of Granada. An in-depth analysis of bone parameters will be carried out using cutting-edge technologies, such as the pQCT (to analyse cortical and trabecular bone in 3 dimensions), dual-energy X-ray absorptiometry (DXA), hip and lumbar spine geometry outcomes. Moreover, a complete blood count will be obtained and markers of bone metabolism will be measured (B-CTX, PINP), including novel markers such as sclerostin and irisin which have recently been linked to human bone. Data will also be collected in anthropometry and body composition to obtain cardiovascular risk factors, sarcopenia and physiologic frailty risk factors, mental health, health-related quality of life and objective measures of physical activity and fitness. This will ensure obtaining novel, precise and strong data in this population.

MuSTARD is a singular project in the sense that investigators will develop a computational framework that is conceived as a common solution for disparate applications. This framework responds to a common need: the derivation of multi-scale spatio-temporal (ST) models equipped with statistical inference capabilities. Since the sequencing of the human genome, a significant portion of clinical research has shifted to the study of precision medicine (PM), resulting in numerous breakthroughs in both non-communicable and infectious diseases. PM refers to disease treatment and prevention that considers variability in genes, environment, and lifestyle for each person. Main drivers of PM are the omics technologies . Omics data is obtained from new high-throughput instruments that generate massive volumes of data. It is also notoriously complex data to analyze. In the last years, new separation technology has allowed us to measure omics data at single-cell resolution, creating a new (and even more complex) type of data generally referred to as single-cell omics. This allow us to study the spatial distribution of omics in a sample. Spatial and single cell omics represents one of the most powerful approaches today to understand cancer propagation in both time and space. Spatial omics. Unfortunately, there are no computational tools that can readily combine the nature of this new type of data with powerful statistical inference. Furthermore, spatially resolved omics experiments with repeated measures is another form of complex ST data. MuSTARD will provide a new computational framework that can handle ST omics to understand colorectal cancer propagation in both time and space, and leverage it in a new clinical study of reduced sample size (15 patients). The MuSTARD computational framework applied to ST omics will be made available for the general community in the form of open software.

This study will compare two ways of learning juggling in university students during a regular practical course: (A) juggling based on throwing the balls in the air and (B) juggling based on bouncing the balls off the floor. The study will also examine whether the order in which students learn these methods (A then B vs. B then A) influences how their performance improves over time. Students will follow two 4-week practice periods separated by a 1-week break, and juggling performance will be assessed at three time points (baseline, after period 1, and after period 2). Performance will be scored from video recordings using anonymized study identifiers. Questionnaires about mood and flow experience will be collected at each assessment, and handgrip strength and brief computerized cognitive tasks will be assessed at baseline and the final evaluation in an exploratory manner. The main comparison of training methods will focus on results after the first period to reduce the influence of prior practice, while results after the second period will be used to describe learning trajectories, order effects, and transfer to different execution conditions.

This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of daily saffron extract supplementation (30 mg/day) for six weeks on objective and subjective sleep quality in middle-aged adults with mild-to-moderate sleep disturbances. Secondary outcomes include heart rate variability, cognitive processing speed, emotional state, perceived health status, and biochemical stress markers.

The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are: * Does PT graft reduce donor site morbidity compared to the standard BPTB graft? * Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups. Patients will: * Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT) * Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.

The purpose of this study is to evaluate the effectiveness of a behavioural intervention designed to reduce exposure to environmental chemical pollutants among adults in Spain.

Self-medication has traditionally been defined as the consumption of medicines, herbs, and home remedies on one's own initiative or on the advice of another person, without consulting a doctor. In Spain, the consumption of non-prescription drugs is quite widespread among young people, since more than half of them have used medications without a medical prescription in the last year. This high prevalence of self-medication among Spanish youth seems to be driven by various factors that encourage this practice. These include the increase in over-the-counter medications, delays in obtaining appointments at health centers, the influence of common family self-care practices, and the population's greater knowledge of and interest in health-related issues. Inappropriate use of medications constitutes a public health problem and can cause significant risks to users' health, such as adverse reactions, drug resistance, and complications in diagnosing diseases, since it can lead to the masking of symptoms, as well as an increase in morbidity. However, not all self-medication practices are harmful. Responsible self-medication refers to the use of over-the-counter medications (without a prescription) to treat common and mild symptoms (e.g., fever, mild pain, colds) for a reasonable period of time (two to three days, after which a doctor should be consulted if no improvement occurs). The benefits of responsible self-medication include convenience for the patient, reinforcement of personal autonomy through self-care, reduction of healthcare professionals' workload, and decreased costs to the healthcare system. In this regard, responsible self-medication not only provides individual and collective benefits but also promotes the development of personal autonomy, a key factor influencing young people's tendency to self-medicate. Attitudes toward autonomous medication use in young people are influenced by individual variables such as emotional regulation, family habits, peer influence, quality of life, and the use of other substances. Given that these factors-greater access to medications, delays in healthcare access, family self-care practices, and individual psychosocial characteristics-appear to drive self-medication behaviors among youth, it is hypothesized that an educational intervention developed with the support of artificial intelligence, and focused on the responsible and safe use of medications, will improve young people's knowledge and attitudes toward self-medication. By targeting both knowledge and attitudes, the intervention aims to strengthen responsible practices while fostering autonomy and informed decision-making in medication use.

The goal of this clinical trial is to learn whether diaphragmatic biofeedback added to respiratory muscle training improves clinical and functional outcomes in adults with chronic kidney disease. It will also evaluate the feasibility and acceptability of this intervention. The main questions it aims to answer are: Is diaphragmatic biofeedback added to respiratory muscle training acceptable and well tolerated in patients with chronic kidney disease? Does this intervention reduce respiratory symptoms and complications in this population? Does diaphragmatic biofeedback added to respiratory muscle training improve cardiorespiratory capacity and quality of life? Researchers will evaluate diaphragmatic biofeedback combined with respiratory muscle training and a placebo intervention based on conscious breathing to assess its effects. Participants will: * Perform the assigned intervention three times per day for 6 weeks * Follow a structured respiratory muscle training program with diaphragmatic biofeedback * Be monitored for symptoms, respiratory complications, and perceived quality of life throughout the study

The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.

The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.

The aim of this study is to investigate the effect of cronic GSE intake in crosstraining may have a favorable impact on biochemical markers, recovery, and performance.

The goal of this clinical trial is to evaluate the efficacy of topical application of simvastatin in bone regeneration in the maxillae, in the reduction of dimensional bone changes, using mandibular third molar surgery as a model and assessing bone healing at 12 weeks. We will also compare the two forms of intralveolar topical administration currently used to assess which is the best form of administration. The main questions it aims to answer are: * Can the topical application of simvastatin, used as a preservation material, improve the variations with respect to bone dimensions and density that occur after tooth extraction. * Can topical application of SM improve soft tissue healing. * Does the topical application of SM produce changes with respect to postoperative variables of pain, inflammation or trismus. * What is the best vehicle for topical SM administration? For this purpose, the investigators will randomly place 4 topical treatment options in the postextraction alveoli: * SM in gel form * collagen sponge impregnated with saline solution containing 10 mg of SM * collagen sponge with placebo gel. All patients will undergo postoperative CBCT, which will be repeated at 12 weeks. In addition, inflammation, trismus and pain variables will be measured preoperatively, at 24 hours, 3 and 7 days.

The long-chain polyunsaturated fatty acids (PUFA) of the n-3 or omega-3 series and, in particular, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both derived from the essential fatty acid alpha-linolenic acid, are part of all cell membranes and from them derive numerous compounds such as prostaglandins, thromboxanes, leukotrienes, resolvins, protectins and maresins that play numerous biological roles, most notably in the control of body homeostasis, blood coagulation and inflammation. The omega-3 index is a biomarker that reflects the nutritional status of n-3 PUFA, as well as cardiometabolic risk and cardiovascular health. This index is determined as the sum of the percentages in weight of EPA and DHA over the total of fatty acids present in the erythrocyte membranes. Previous studies carried out in Spain, such as ANIBES, indicate that in adults, and especially in those over 60 years of age, the intake of n-3 PUFA is well below the international recommendations, which is directly related to a low intake of fish, since both EPA and DHA are abundant in oily fish. However, in Spain, the nutritional status of omega-3 PUFA and their possible association with a higher prevalence of cardiometabolic risk is unknown, as well as the relationships with food intake and the cultural and socioeconomic status of the population. Therefore, the main objective of the present study is to evaluate the omega-3 index in the Spanish population over 60 years of age and to establish whether there are differences by sex, as well as in the different Spanish communities. In addition, we will study the possible associations between the omega-3 index and food intake, particularly of fish and omega-3 PUFA-rich supplements, as well as their possible associations with cardiometabolic risk indicators and cultural and socioeconomic conditions of the population. Determination of the omega-3 index usually requires an invasive venous blood collection followed by processing for separation of erythrocytes and extraction and methylation of their membrane lipids followed by chromatographic analysis. But fatty acids can also be determined on whole blood using less invasive methods, such as obtaining drops of blood with a lancet and depositing them on chromatographic paper impregnated with an antioxidant (dried spots). All this makes sampling much easier, although the result of the omega-3 index has to be corrected because it is affected by the lipid composition present in the plasma. For this reason, this project aims to carry out a validation study between the results of the fatty acid profile obtained in erythrocytes and in whole blood in the Spanish population (medamediantedried spots). In short, the results obtained will be used to calculate regression lines that allow us to evaluate the omega-3 index in erythrocytes in the adult Spanish population from different regions of Spain by means of a minimally invasive methodology. For this purpose, 800 participants aged 60 years or more will be recruited from different regions of Spain, randomized by age and sex for each region; at least 100 of the total number of participants should be frequent consumers of omega-3 supplements; if this figure is not obtained, an active search will be carried out until this number is reached (booster). All of them will be interviewed to complete different questionnaires on cultural and socioeconomic status, history of metabolic disease and cardiovascular health, and questionnaires on frequency of consumption and food intake reminders as established by the European Union. With the help of health personnel from different pharmacies and in mutual agreement with the General Council of Pharmaceutical Associations of Spain, a whole blood sample will be taken by lancet, which will be used to quantify the omega-3 index. For the validation study it will be necessary to obtain whole venous blood extracted by venipuncture from a subsample of 200 participants. This sample will be processed and will be used to determine the fatty acid profile in whole blood and in erythrocytes, which will be related by means of multiple linear and bivariate regression models with the fatty acid profile obtained in the dried spots. Cardiometabolic risk markers will also be determined in these 200 subjects, which will be used to establish relationships with the calculated omega-3 status.

Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).

The aims of this school-based cycling intervention called "ENERGY Commuting to school" (ENERGYCO) will be divided into two phases: Phase I will aim: 1) to design, test, and validate predictive equations for the objective quantification of the energy expenditure related to different modes of commuting to school (i.e., walking, cycling, motorized-vehicle); and 2) to quantify the energy expenditure of each mode of commuting to school using indirect calorimetry in adolescents; and Phase II will aim to evaluate the effect of a school-based cycling intervention on different health-related outcomes, such as energy expenditure, resting metabolic rate, basal metabolism, physical activity levels, body composition, muscle strength, cardiorespiratory fitness, blood pressure, physical literacy, motor competence, and psychosocial outcomes on Spanish adolescents.

This randomized clinical trial investigates the effects of a distance physical activity coaching program on the health of COVID-19 long-hauler. The study evaluates the impact of individualized coaching interventions to improve participants' physical activity and quality of life.

In view of the above and the possible improvements in terms of postoperative morbidity and tissue repair in oral surgery, this study is justified, the general objective of which would be: 'To evaluate the efficacy of perioperative oral administration of two nutritional supplements based on vitamins and antioxidants (Osteoimplant Complex® and Osteoimplant®), using mandibular third molar surgery as a study model, assessing postoperative symptomatology and bone density'. The null hypothesis of this study is: 1) the administration of the perioperative nutritional complex (Osteoimplant Complex® and Osteoimplant®) did not improve postoperative symptoms and 2) neither did it increase bone density after lower third molar extraction.

Based on the scientific evidence, the relevance of this subject, we consider this study to be justified, the general or specific objective of which is as follows: 'To evaluate the effect of the administration of Osteoimplant© and Osteoimplant Complex© as a food supplement in obtaining implant stability and in the healing of dental implant surgery'. As secondary objectives, we will also evaluate the effect of Osteoimplant© and Osteoimplant Complex© on pain, postoperative inflammation and soft tissue healing. The sample will consist of 60 patients. The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme. For blinding, neither the patient nor the operator shall be aware of the group to which each patient belongs. To ensure blinding, medication will be delivered in sealed, opaque envelopes. Patients shall be assigned to one of the following groups: * Group I: 30 patients prescribed to take Osteoimplant Complex© on the following schedule: 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant© for 2 months after implant placement. * Group II: 30 patients who were prescribed placebo with the following regimen: 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.

The objective is to analyze the short-term effect of a comprehensive HAMMAM experience combining therapeutic hydrotherapy, aromatherapy, music therapy, and Swedish massage on objective parameters and patient-reported outcomes related to well-being generation and pain reduction in women with endometriosis-related chronic pelvic pain.