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.
Randomised clinical trial, single-center, blinded assessment, controlled with standard practice with two-group parallel design. Eligible patients are those assisted and transferred suffering from ST-Elevation myocardial infarction in an Advanced Life Support ambulance from an public Emergency Medical Service in the Cadiz area (Spain). Experimental group will watch an ad hoc design multimedia content in a tablet (video with sound and subtitles) during the transfer and control group will be assisted as standard procedures. Main outcome variables will be conformed by patient reported outcomes (anxiety State, pain and comfort) and patient experience (transfer experience).
The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection
CONTEXT: Low back pain (LBP) is a common complaint in gymnasts. A deficit in the control of lumbopelvic movement has been related to low back pain. OBJECTIVE: This study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement control of elite gymnasts. DESIGN: single-group, pretest-posttest clinical trial. PARTICIPANTS: 70 Elite Rhythmic Gymnasts INTERVENTION: One standardized theoretical practical session of 15 Min that includes anatomical issues and one practical exercise in quadruped position for controlling the movement of lumbar spine during hip extension and flexion.
The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.
The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.
The main objective is to evaluate and quantify the manual gripping force caused by mental practice
The investigators will select two study groups from a population of patients with severe chronic low back pain (CLBP) of facet joint (FJ) origin already treated with conventional radiofrequency ablation (CRFA) of the medial branch of the dorsal ramus (MBDR) and that failed to obtain a 50% pain reduction measured through the numerical rate scale (NRS) for at least 3 months. Severe CLBP is considered a value of at least 7 by NRS pain assessment. The first group will be characterized by a nociceptive/mechanic type of back pain. The second group of study will be characterized by a neuropathic type of back pain. This difference will be established by a DN4 score of at least 4 points (Doleur Neurophatique 4). The patients in the group with nociceptive/mechanic back pain will be randomly assigned to conventional radiofrequency ablation or to water cooled radiofrequency (WCRF) of the MBDR. The patients in the group with neuropathic back pain will be randomly assigned CRFA of MBDR or to pulsed radiofrequency (PRF) of the dorsal root ganglia (DRG). The study will be carried on for an estimated time of 3 years. Primary outcomes will be: - at least 50% back pain reduction for at least 3 months evaluated through NRS, with a subcategorization of results that will consider a mean difference in effect (respect to the initial evaluation, with an initial NRS score of at least 7) of 1 point on NRS pain scale as small/modest, 2 points as moderate, more than 2 as large/substantial between the case/control study groups. - improvement of low back pain disability: 10 points increase on the Oswestry Low Back Pain Disability Questionnaire (ODI) have been proposed as minimal clinically important differences, between 10 and 20 as moderate, more than 20 as large/substantial clinical improvement at month 3 and 6. Secondary outcome will be evaluated by the 12-item short form survey SF12, accordingly with the clinical pre-interventional findings, analgesic intake at month 1-3-6 (if increased, unchanged, decreased, in dosages or number of pain killers' assumption). Groups sizes: will be calculated based on the disease's incidence and the outcome targets.
Methodology: This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection. Patients who give informed consent will be screened for enrolment in the study. Patients that meet the eligibility criteria will be enrolled and randomly allocated in the control arm (best standard of care) or the experimental arm (best standard of care plus IN01 vaccination). The patients enrolled in the control arm of the study will receive standard of care. The primary endpoint is safety, measured by the Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria. Biochemical and blood count alterations will be also monitored. Safety will be defined based on the frequency and severity of adverse events (AEs) throughout the patient's participation in the study comparing between control and experimental arms. Efficacy will be measured as function of the annual rate of decline in the Forced Vital Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52. High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12, 24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease. A translational substudy will be included. Objectives: Primary Objective ● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients that develop fibrotic lung syndrome after infection. Secondary Objectives - To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung disease after infection. - To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of action.
Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented. The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.
Music-Supported Therapy (MST) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. A modified version of the MST protocol has been created (hereafter, referred as enriched MST, eMST) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n=30) or a control GRASP intervention group (n=30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.