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.
Background. Abdominal distention is produced by an abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of abdominal distension. Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal. Intervention. Patients will be randomized into biofeedback in placebo groups.Three sessions of either biofeedback or placebo intervention will be performed 30 min after ingestion of the offending meal during the first 3 weeks of the intervention period. Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth); patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. Primary Outcome Measure: Effect of the probe meal on the activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) measured by electromyography before and after the probe meal. The response to the probe meal will be measured before and after treatment. Secondary Outcome Measures: - Effect of the probe meal on sensation of abdominal distension measured by 0-6 scales after the probe meal. - Changes in girth produced by the probe meal measured using a non-stretch belt placed over the umbilicus before and after the probe meal. - Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
Background: Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance. Hypothesis: The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples. The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum. Objectives: Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories. Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods. Methods: Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.
This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.
HYPOTHESIS In older adults who receive a direct intervention from the perspective of occupational therapy with a "Training Program in Daily Cognition", there are greater benefits, both in the overall cognitive performance and in the levels of daily cognition, that in the older adults who receive an intervention based on a "Traditional Cognitive Stimulation Program", achieving not only an improvement or maintenance of cognitive functions, but a generalization and transfer of that improvement in their daily lives and occupational performance. OBJECTIVES: To evaluate the effectiveness of a "Training Program in Daily Cognition" in the elderly, to improve the levels of daily cognition and global cognitive performance. SPECIFIC OBJECTIVES: Compare the difference in levels of daily cognition between the participants of the control group who carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group who carry out a "Training Program in Daily Cognition". Analyze if there is a difference in the levels of global cognitive performance between the participants of the control group that carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group that carry out a "Training Program in Daily Cognition". To study the relationship between standard psychometric tests that measure cognitive performance and the ECB Daily Cognition Battery Recognition Test that measures daily cognition. Analyze if there is a relationship between age and cognitive performance and the daily cognition of the elderly. Describe the relationship between the educational level that the participants possess and the cognitive performance and their daily cognition Evaluate the impact of gender in the elderly with cognitive performance and daily cognition. Check whether or not physical activity influences the cognitive performance and daily cognition of study participants. STUDY DESIGN: Experimental, randomized, stratified, prospective, longitudinal study using a parallel scheme of fixed allocation experimental group and control group. The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible.
The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult participants with migraine and major depressive disorder (MDD) The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in adult participants with migraine and MDD on the reduction of MDD symptoms, responder rates in monthly migraine days, improving quality of life, improving disability, and the safety and tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab in adult participants with migraine and MDD. The total duration of participant participation in the study is planned to be approximately 28 weeks.
Objectives: To evaluate the effectiveness of a structured educational intervention in physical exercise "Active Legs" as an adjuvant treatment to improve the healing of chronic venous ulcers at 3 months of follow-up, compared with the usual practice in people treated in primary care. Secondary objectives: To evaluate if the intervention active legs as an adjuvant treatment produces better results than usual practice in: degree of healing, recurrence, complete healing at 6 months, pain and quality of life. Describe degree of adherence and satisfaction with the intervention. Design: Randomized, multicenter, pragmatic, open clinical trial of parallel groups with 6 months of follow-up. Setting: Primary Care Health Centers (Madrid). Subjects: Patients with venous ulcers, with treatment in the nursing consultation of the participating centers. Sample: 224 participants (112 in each group). Intervention: Both groups will receive the usual treatment of cleaning, debridement based on humid environment cure and multilayer compression therapy according to the recommendations of Community of Madrid. The intervention group will also receive the structured educational intervention of lower limbs physical exercise and daily walking patterns. Variables: Main: complete healing at 3 months follow-up. Secondary: Degree of healing; ulcer area; quality of life; pain, related to the healing process, prognosis and recurrences; Sociodemographic and related adherence and satisfaction. Data analysis: Main effectiveness: comparison of the incidence of ulcers with complete healing at 3 months of follow-up in both groups, time to complete healing (Kaplan-Meier and Log-rank test). Adjustment of prognostic factors (Cox regression).
This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treatment.
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
In functional environments, dual-tasks (DT) are common and require a correct motor and cognitive performance to be carried out successfully. In people with neurodegenerative diseases such as Parkinson's disease (PD), to walk with a secondary task affects gait. The inclusion of DT to the assessment and physical rehabilitation of patients allows to simulate day-to-day contexts in a controlled and safe environment and consequently, extrapolate more easily the advances of rehabilitation to daily life. This project studied the effects of a gait rehabilitation program with dual tasks (DUALGAIT) in patients with Parkinson's disease and compared the results with a control active group of patients who performed a general physical rehabilitation program (without dual-task and only motor exercise practice). The investigator's hypothesis is that gait training under dual conditions has a greater effect than traditional motor physiotherapy programs on the biomechanics of parkinsonian gait. The present study is a randomized controlled clinical trial, with evaluators blind to the allocation of participants in the different groups.