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 TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.
Extrinsic or exogenous ageing is caused by repetitive exposure of the skin to harmful agents, while primary cause the exposure to ultraviolet (UV) radiation, known as photoageing, including solar effect. Chronic solar UV exposure has multiple damaging effects on skin, such as wrinkling, dryness, dyspigmentation, epidermal thinning and increasing fragility. In addition, solar exposure and age increase a subepidermal band. Fibrillar collagen, which is synthesized from fibroblasts, is the predominant extracellular matrix (ECM) component of the dermis. Collagen type I and III are considered to be the major interstitial, fiber forming collagen in normal human dermis. In addition, the dermis contains collagen types IV (gelatine), V and VI. Other important component of the EMC of the dermis are elastic fibers being elastin (ELN) their main component and play a critical role in skin elasticity and the reduction of elastic fiber production results in impaired elasticity. UV radiation induces ECM degeneration and consequently an increase in fragility and loss of elasticity of the skin. This process is mediated by an increase in matrix metalloproteinases (MMPs) expression in human skin which are responsible for degrading ECM proteins, such as collagen, fibronectin and elastin. The natural inhibitors of MMPs are tissue inhibitors of metalloproteinases (TIMPs), being TIMP-1 the most relevant TIMP affecting collagen metabolism.
Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and Commitment Therapy (ACT) or a behavioural activation program for depression (TACD) to the treatment as usual (TAU) for patients diagnosed of chronic pain and comorbid mild-moderate major depression; (2) To examine the cost-utility of these psychological treatments from healthcare and societal perspectives; (3) To measure a set of biomarkers alongside the RCT in order to know the physiological underpinnings of these psychological therapies and to identify potential predictors of treatment response. Methodology: 12-month multisite, randomised, controlled trial (RCT) Centres: Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat) and Hospital del Mar (Barcelona). Participants. 225 adult patients with chronic pain that meet the diagnostic criteria for mild-moderate major depression will be randomly assigned to one of the three study arms: TAU + ACT vs. TAU + TACD vs. TAU. Primary outcome: Quality of life. Secondary outcomes: pain intensity, depression severity, anxiety symptoms, pain catastrophising, and pain acceptance. Costs to the healthcare system and to society and quality adjusted life years (QALYs). In addition, the empirically validated app Multicenter Pain Monitor® will be used to monitor participants alongside the treatments (ecological momentary assessment). Biomarkers: hair cortisol and cortisone, corticosteroid-binding globulin (CBG), ACTH and cortisol in plasma, and genotyping of 5 polymorphisms in the FKBP5 gene involved in the regulation of the hypothalamic-pituitary-adrenal axis activity, cytokines, Th1: IL-6, IL-8, TNF-α; cytokines Th2: IL-10 + hsCRP test, and vitamin D levels. Main statistical analyses: Intention-to-Treat analyses that will include all participants who undergo random allocation, using multiple imputation to replace missing values. Linear mixed-effects models will be performed using Restricted Maximum Likelihood to estimate the parameters. Calculation of between-groups effect sizes using Cohen's d and of the number-needed-to-treat. Economic evaluation: cost-utility ratios evaluated by applying bootstrapping techniques, acceptability curves, and sensitivity analyses.
Objective of this study is to investigate the bystanders' exposure to e-cigarette emissions in controlled conditions in confined settings. Design: a cross-sectional experimental study developed in two settings: a car and a room. The experimental study will be replicated 5 times in each setting. Three volunteers will be enrolled: 2 non-users of e-cigarettes (and non-smokers of any tobacco or nicotine product) and 1 exclusive e-cigarette user (not using any other tobacco or nicotine product) to create aerosol. In brief, during the experimental session the e-cigarette user will be asked to use electronic cigarette during 30 minutes and two non-smokers will sit next to the user. Individual exposure will be measured through saliva sample collection and irritation symptoms questionnaire to be collected 4 times: before exposure, just after 30 minutes of exposure, 30 minutes after the end of exposure and 3 hours after the end of exposure. Moreover, environmental exposure will be measured prior (5 min), during (30 min) and after (5 min) the exposure; particulate matter and airborne nicotine concentrations will be measure for this purpose.
Observational, prospective, descriptive, open study on response predictors and tolerability of Candesartan in patients >18 years with episodic or chronic migraine with prior failure of three or more preventive drugs. Patients will receive Candesartan the same manner and intensity if they were not enrolled in the study. Vital signs, clinical variables and adverse events will be monitored. Primary endpoint will be to determine demographic and clinical factors associated with a 50% reduction in the frequency of headache days per month between weeks 20 and 24 compared with baseline.
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
Phase Ia - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)
In recent years, HIV care has been reframed by the concepts of the HIV care and prevention. The success of these strategies will depend on integrated prevention and care system and sustained behavioral modification. The HIV infection is a chronic disease and the improved survival in HIV patients favours the emergence of new long-term morbidities associated with treatment and/or the virus itself. In high-income countries, approximately 30% of all adults living with HIV are aged 50 years and over. In 2015, 50% of HIV-infected patients will be over 50 years of age. Health plans are a priority to prevent this accelerated and accentuated process. The development of mobile devices such as smartphones and tablet computers has spurred rapid growth in the field of mobile health, the use of mobile-enabled applications that collect or deliver health care information and data. These applications offer the potential for dynamic engagement of patients and providers in health care and a new means of improving health outcomes. This technology could have profound application in the prevention or in the treatment of patients with chronic disease such as diabetes, obesity, HIV, etc, since these diseases are generating more health spending worldwide. The rapid growth in health has outpaced the needed to validate the clinical effectiveness of these applications. For this reason, we propose a study to assess the benefit of a specific App on the management of HIV-infected population aged 60 years or older It is a Randomized clinical trial, including 2 groups: 1) an experimental group comprising patients using the app + routine medical care and 2) a control group. The usability of the app and patient satisfaction were evaluated in the app group at weeks 24 and 48. Quality of life, adherence to treatment, and clinical parameters were compared in both groups at 48 weeks.
To evaluate the efficacy and safety of eplontersen after administration for 65 weeks to patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as compared to the NEURO-TTR trial (NCT01737398). For more information, please visit http://www.neuro-ttransform.com/.
The primary care physiotherapy units of the Spanish health service in Castille and Leon (SACYL) are responsible for providing physiotherapy treatments to the general population. Being part of the primary health care system, the actions of these units are aimed at the treatment of common conditions that do not involve severity, frequently musculoskeletal disorders. The work of physiotherapists is closely related to the functionality of patients and, in this sense, the World Health Organization (WHO) has proposed the International Classification of Functioning, Disability and Health (ICF) as a conceptual framework to characterize the functional status of individuals. The use of ICF in the clinical setting is not sufficiently widespread due to the the difficulties that the use of such an exhaustive classification implies in practice. In an attempt to address this problem, the WHO has encouraged the development of reduced versions aimed at responding to specific conditions or care contexts. The idea behind the development of core sets is that it is possible to select a number of categories so as to capture the essence of a given clinical process, allowing an agile use of the ICF. However, in order to put these core sets into practice, it is necessary to check that the selected categories are valid from the perspective of the participants in the clinical processes. The purpose of this research project is to determine whether the musculoskeletal core sets of the ICF are applicable in SACYL primary care physiotherapy units. This implies knowing if the categories already selected in these sets are representative of the health aspects considered as most relevant in the clinical context of physiotherapy in primary care. To achieve this, four studies will be conducted to capture the perspective of patients, physiotherapists, researchers and clinical practice. This information will be translated into the language of the ICF to obtain comparable categories with those present in the core sets. In this way, this research project will make possible to validate or adapt the core sets of the ICF for musculoskeletal conditions, in a specific clinical context of physiotherapy in primary care.