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.
Plant polyphenols have demonstrated the ability to ameliorate metabolic alterations induced by overweight and obesity, both in cellular and animal models, where most therapeutic approaches have failed. These have demonstrated the ability to improve appetite sensation, leading to improved body weight control, in addition to reducing fat accumulation and improving plasma glycemic and lipid profiles, as well as inflammatory process and vascular dysfunction. The plant polyphenols on which the extract to be studied will be based will be hibiscus and lemon verbena. A randomized controlled trial will be carried out in overweight or obese subjects from the province of Alicante. An electronic randomization will be carried out based on a two-branch design, therefore, there will be a control group (no intervention) and an experimental group (nutraceutical intake). Participants will have to ingest the nutraceutical for 3 months, as well as attend the agreed visits. Different satiety questionnaires, circulating parameters measured in capillaries (cholesterol, triglycerides and glucose), blood pressure and body composition measured by bone densitometry (DXA) will be collected. All variables will be measured at 4 different time points (baseline, 30 days, 60 days and 90 days). All these will be analyzed as a function of time; at the beginning and end of each intervention (intra-group analysis), as well as comparing the control group with the experimental group (inter-group analysis). A multidisciplinary team formed by physicians, nurses and nutritionists will be involved.
The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
The purpose of this study is to investigate the effectiveness of a programme based on inspiratory and expiratory muscle training to improve respiratory muscle strength, functional capacity and avoid pulmonary complications in adults with cervical or high dorsal spinal cord injury (C5-D5) in acute phase.
This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-30813 as monotherapy and in combination with tislelizumab in participants with advanced or metastatic solid tumors. The study will be conducted in 2 parts: Phase 1a dose escalation and Phase 1b dose expansion.
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: - medical problems (also called treatment-emergent adverse events (TEAEs)) - serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important - higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times. The study team will: - collect blood and urine samples - check the participants' vital signs such as blood pressure and heart rate - do a physical examination including height and weight - check the participants' heart health by using an electrocardiogram (ECG) - do pregnancy tests in women of childbearing potential
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).
IgG4-immunoglobulin-related disease (IgG4-IRD) is a relatively new pathology, characterized by intense inflammation, fibrosis, infiltration and elevated IgG4 levels in peripheral blood. Despite the interest in the disease, these diagnostic criteria are not without discrepancies and false negatives. In fact, despite the fact that elevated serum IgG4 concentrations can provide an important clue for the diagnosis of the disease,described that the specificity and positive predictive value of elevated serum IgG4 concentrations are 60 % and 34 % respectively. And, when they increased the cut-off values to double to improve specificity, the sensitivity of IgG4 levels drops to 35 %. In 2014, was described the presence of elevated concentrations of plasmablasts (CD19 low, CD20 -, CD38+ and CD27+) in the serum of patients with active ER-IgG4, even in patients with normal IgG4 levels, compared with healthy patients and with other autoimmune pathologies. Furthermore, several studies have shown that follicular T helper (Thf) cells are increased in both peripheral blood and affected tissue of patients with ER-IgG4. These cells appear responsible for the development of germinal centers in lymph nodes and for the production of interleukins that drive IgG4 class switching, and creation of IgG4-secreting plasmablasts and plasma cells. This suggests that interleukins IL4, IL5, IL 10, IL13 might also be relevant in discerning ER-IgG4 from other immune-mediated processes with similar symptoms. ACTION GOALS: 1. To evaluate the diagnostic validity of plasmablast count and other immunological markers (B lymphocyte differentiation stage, follicular T helper lymphocytes (Thf) and IL-4, IL5, IL-10 and IL-13) in peripheral blood for IgG4-Related Disease. 2. To evaluate the correlation of these biomarkers with inflammatory activity, clinical manifestation and diagnostic certainty (possible, probable or definite) of IgG4-Related Disease. 3. To evaluate whether high counts or concentrations of these biomarkers at diagnosis are prognostic factors for relapse during the first 12 months of follow-up in patients with IgG4-Related Disease.
The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. All patients will use a step counter in order to evaluate their activity during the study. Spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. Finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.