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.
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
The project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care services; and, (iii) Population-based study on cost-effectiveness of integrated care services in the urban healthcare sector of Barcelona-Esquerra (540.000 inhabitants). The central hypothesis is that the approach will show safety and effectiveness with high level of user's acceptance and health value generation leading to sustainability of the service.The preliminary data indicate that HH/ED shows potential to strengthen care coordination between highly specialized hospital-based care and home-based services involving different levels of complexity. The need for appropriately designed transitional care services has been identified as the best option, not only for an efficient transference of patients from hospital to the community after hospital discharge, but as a way to overcome well identified limitations for generalization of community-based integrated care services. AISBE is a population-based health initiative aiming at deployment of integrated care in one urban healthcare sector (Barcelona-Esquerra, 540.000 inhabitants) in the city of Barcelona. Within this initiative, the HH/ED program carried out by Hospital Clinic provides home-based hospitalization. Moreover, the program aims to implement transitional care strategies for optimal discharge. The current document describes three studies: (Study 1) Analysis of the period 2006-2015; (Study 2) Program-based analysis of Home Hospitalization/Early Discharge (HH/ED) , and, (Study 3) Population-based analysis of cost-effectiveness of AISBE-based services. Study 2 is a program-based analysis of Home Hospitalization/Early Discharge (HH/ED). A quasi-experimental design. That is, a non-randomized intervention group (integrated care) will be compared with a control group (usual care) using propensity score matching wherein age, gender and health risk scoring will be main matching variables. The population-based evaluation will be done using registry data obtained from the Catalan Health Surveillance System (CHSS). The protocol evaluation follows a Triple Aim approach considering pre-defined outcome variables for: a) health and well-being, b) experience with care, and c) costs.
The aim of this study is to evaluate the effects of a psychoeducational multidisciplinary intervention focusing on improving coping skills, the psychosocial adaptation to Parkinson's disease and the quality of life in patents and family carers in a Primary Care setting. On the basis of previous research, the hypothesis we propose is that through the development of coping skills which will contribute to promoting a positive psychosocial adaptation to Parkinson' disease, the quality of life of the people with Parkinson's disease and their family carers will be improved. At the same time, it is predicted that, by incorporating this psychoeducational intervention into clinical practice, the patients and family caregivers will perceive a greater sense of normality in their lives, which will also promote compliance with drug treatments and promote healthy lifestyles. In the long-term, such an approach could have positive effects on the overall health of patients and their family carers. This quasi-experimental study with control group and mixed methods was designed to evaluate the ReNACE psychoeducational intervention (ReNACE is the spanish acronym for the Research Programme and means Recovery, Normalisation, Acceptance and Living with Chronic illness). Based on the relevant study power calculations, 100 people with Parkinson's disease and 100 family carers will be recruited. Participants will be assigned to two groups. The intervention group will receive the ReNACE psychoeducational intervention. The control group will be given a general educational program. The study will be carried out in community-based health centers. The results obtained from the two groups will be evaluated at three time points: at baseline, immediately after the intervention and at 6 months after the intervention. The results will be measured with the following instruments: the Quality of Life Scale PDQ-39 (The 39-item Parkinson's Disease Questionnaire) for patients and the Quality of Life Scale for caregivers SQLC (Scale of Quality of Life of Caregivers) for family carers, and for patients and family carers the Psychosocial Adjustment to Illness Scale Self-report (PAIS-SR) and the Brief Cope Inventory. To determine the acceptability of the intervention, focus groups will be organized with some patients and family carers who have received the ReNACE intervention and also with the healthcare professionals involved in its development.
The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
The NMB (Neuromuscular Blockade) is the most frequent complication in anesthesiology associated with an increase in adverse respiratory events in the postoperative period. Its appearance depends on multiple factors. The introduction of a comprehensive educational strategy aimed at promoting the proper management of NMB in the intraoperative period and a package of measures that must be performed (intraoperative neuromuscular monitoring and reversal of the effect of neuromuscular blockers) may contribute to a decrease in the incidence of NMB, Increase safety in the surgical patient and decrease associated costs.
The gut microbiota is a complex community comprising around 10^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. However, clinical evidence of the relationship between microbiota and mood disorders is lacking. The aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.
This study aims to analyze whether the course of infant massage serves as a tool to improve acceptance, commitment and awareness of influence of parents of babies with Down syndrome. These variables will be measure before and after the course of infant massage in the experimental group, investigators will make measurements with the same rate in the control group, but they will receive the course after the measurements.
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.