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.
Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per year in Europe. Hypothermic treatment became the only established therapy to improve outcome after perinatal hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected children die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective interventions, beside hypothermia, are warranted to further improve their outcome. Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and brain damage in experimental, animal, and early human studies of ischemia and reperfusion. This project aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to near-term infants with HIE in addition to hypothermic treatment.
This is a first-in-human phase I/II randomized, double-blind, placebo (vehicle)-controlled, multicenter study to assess the Safety and Efficacy of AVX-012 Ophthalmic Solution in subjects with Mild-to-Moderate Dry Eye Syndrome. The study consists of two parts (part A and part B):
The aim of the study is to evaluate the effectiveness of an online intervention through a mobile application, specifically designed for adolescents with a First Psychotic Episode (FEP), as a complement to the pharmacological and therapeutic interventions they receive at their referral center (Treatment as usual). To do this, a longitudinal study will be carried out on patients with FEP and between the ages of 14 and 30, who come to the Child and Adolescent Psychiatry Service of the General Universitarian Hospital "Gregorio Marañón", Psychiatry Department of the Ramon y Cajal Hospital in Madrid and Psychiatry Department of San Joan de Déu in Catalonia. Adolescents and young will be randomly assigned to an experimental group, where they will receive standard treatment plus online intervention, or a control group, where they will receive standard treatment. This online intervention, the continuation of the work of this same team researcher in the "PIENSA program", aims to address little of the more traditional treatments and treatments such as community functioning, quality of life or affective symptoms. In addition, it will increase disease awareness, which will lead to greater adherence to treatment and fewer relapses and rehospitalizations.
The objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate depression: a global protocol composed of several therapeutic components (psychoeducation, cognitive restructuring, behavioral activation, positive psychology, and relapse prevention), a protocol just based on behavioral activation (BA), and a protocol just based on positive psychology (PP). The purpose is to know the specific contribution of each therapeutic components in the treatment of depression.
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.
Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs. Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year. Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.
Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.
Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it. The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are: 1. Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type). 2. Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy. They will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice.
The Essential oils (EO) are composed by a wide diversity of products. Therefore, their antimicrobial activity will be related to their composition, configuration, amount and their possible interaction. The traditional formulation containing EO (T-EO) is a complex mixture of phenolic compounds combined with determinate EO: 0.092% of eucalyptol, 0.064% of thymol, 0.06% of methyl-salicylate and y 0.042% of menthol. All of this solved in a hydroalcoholic vehicle containing from a 21.6% to a 26.9% of alcohol. Thus, T-EO contain ethanol, which is a chemical compound used in order to dissolve and stabilize the numerous substances present in the rinse. The concentration of ethanol present in the T-EO rinses, as previously said, is more than 20%. This concentration of ethanol, higher than 20%, is been found sufficient to dissolve the EO but insufficient to have a direct antibacterial effect. In fact, the manufacturer presents the alcohol contain (21.6%), among others, as an inactive ingredient in its formula. Over the years, the adequacy of the use of ethanol in mouthwashes, as well as their effects on the surfaces of composite restorations and their possible role in development of oropharyngeal cancer have been discussed. Although a direct cause-and-effect correlation between the development of oropharyngeal carcinoma and the use of alcohol-based rinses has not been demonstrated and probably it will never be (at least by epidemiological studies), it is considered desirable to eliminate ethanol from daily mouthwashes, especially for those patients at higher risk. Furthermore, the fact that the alcohol is present in its formula, have produced that some clinical practitioners do not prescribe the traditional formula due to the controversy of the issue. All this have lead to the development of new, alcohol free formulations of EO (Af-EO). The composition of the Af-EO is exactly the same in their active ingredients (Eucalyptol, Thymol, Methyl-salycilate and Menthol), but sodium fluoride has been added. Some differences are found in their inactive ingredients. These are based on the alcohol containing of the T-EO, without presence in the Af-EO and the presence of Propylene Glycol, sodium lauryl sulfate and sucralose in the Af-EO, without presence in the T-EO. In order to measure the efficacy of a mouthwash against the dental plaque two different concepts should be defined: the substantivity and antiplaque effect. The substantivity of an oral antiseptic is defined as the prolonged adherence to the oral surfaces and its slow release at effective doses which guarantee the persistence of the antimicrobial activity. The more substantivity an oral antiseptic has the better. For its study in vivo, the most popular models are those which analyze the effect that a single mouthwash has in a mature biofilm. The second aspect that should be studied from an oral antiseptic, the antiplaque effect, is defined as the capacity that an agent has to avoid the formation of bacterial aggregates (plaque) on the oral surfaces. For its study in vivo, models start from a baseline sample with levels of plaque near to 0 in order to assess the power of the antiseptic to reduce the formation of bacterial plaque (normally dental plaque) against the control. A clinical study of 6 months using a determinate antiplaque agent is necessary in order to tag an antiseptic as effective. However, in the literature, there is an established model of 4 days of plaque regrowing which can assess the inhibitory activity that the mouthwashes have per se; furthermore, it determines the relative efficacy of the different formulations being considered as predictable of the antiplaque effect of an antiseptic. In addition, another important factor in the study in vivo of an oral antiseptic is the necessity to conserve intact the oral biofilm at all stages: formation, recollection and analysis of the oral samples. This is in order not to interfere the delicate three dimensional structure of the oral biofilm which has been proven to be essential in the resistance to the effects of an external antiseptic agent. For these reasons, the study of the oral biofilm with the help of intraoral disks hold in specially designed apparatus combined with the application of the Confocal Laser Scanning Microscopy have proved to be very valuable at the study of the oral biofilm in its intact hydrated natural state. Since an alcohol free formulation of the EO have come up to the market, it seems convenient to compare its effects to the traditional one. Although some studies comparing the effects of T-EO and Af-EO have been found, none of them assessed and compared their substantivity and antiplaque effect in an in vivo model of structured oral biofilm. For this reason, the aim of the present study was to compare the in vivo antibacterial effect (immediate effect, substantivity and antiplaque effect) of the EO with and without alcohol in structured oral biofilm.
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.