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 a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Bipolar disorder is related to a high level of personal, familial, social and economic burden. There is a need for feasible adjunctive psychological interventions to use in clinical practice as a complement of pharmacotherapy to enhance aspects that medication cannot reach. This project aims at develop and evaluate the impact of an adjunctive brief integrative program for bipolar patients (euthymic or with subthreshold symptoms). The patients (N=124) will be randomly assigned to two different groups. The experimental group (62 patients) will take part on a group integrative program consisting of 12-sessions of 90 minutes (based on psychoeducation, mindfulness and functional remediation) whilst the control group (62 patients) will not receive any sort of add-on psychotherapy. All patients will mantain standard psychiatric treatment. Together with the baseline assessment, the whole sample will be assessed after the intervention and at 12 months from the baseline evaluation, regarding sociodemographic, clinical and neuropsychological variables. If the intervention is effective it will improve psychosocial functioning (main variable), wellbeing and quality of life, as well as improve clinical outcomes and neurocognitive functioning of those affected by the illness.
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.
The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.
Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence: - Group A: study product+wash out+control product - Group B: control product+wash out+study product
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.
Randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). The aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.
There are currently 50 million people in the world diagnosed with dementia. Due to the detrimental impact on the mental and physical health of family caregivers different online interventions have been developed in order to improve their well-being. In this paper, we describe the design of a randomized controlled trial aiming to study the impact of a multicomponent online program on primary and secondary caregivers of a person with dementia (PWD). The experimental group will receive the intervention which is a multicomponent program based on different components, among others; online psychoeducation, training on psychological skills, a forum with other caregivers and interaction with a psychologist. Caregivers in the control group will follow their lifestyle. More than 250 participants (primary and secondary caregivers) are expected to be recruited via several sources in the province of Guipuzcoa in Spain. The inclusion criteria for the primary caregiver are: a) being 18 years or older; b) being the primary caregiver of the PWD; c) more than 6 months caring; and d) give more than 1 hour of caregiving per day. The outcomes of this trial are caregiver burden (primary outcome), perceived health, depression and anxiety, social support, satisfaction with care and with the treatment and stress caused by the problem behaviour of the PWD (secondary outcomes).
Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial
This study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten. These are products adapted to infant feeding since 4 Months.