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.
An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study including HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
This study investigates the effect of two different techniques (deep dry needling and superficial dry needling) on the latent myofascial trigger point in the upper trapezius. Subjects with latent Myofascial trigger point in this location of the muscle will be identified and will be randomly assigned to one out of the three groups: deep dry needling, superficial dry needling or sham dry needling in gastrocnemius muscle. cervical range of motion and pain pressure threshold in the upper trapezius will be registered before, immediately after the intervention, at 24 hours after the intervention, at 72 hours after the intervention and a week after the intervention
Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.
The objective of the present study is to evaluate the effect of a 20-week group intervention program based on acceptance and mindfulness in emotional eating, weight loss, physiological parameters and the level of physical exercise, as well as in the quality-of-life and weight self-stigma of overweight and obese people on the short- and medium-term. Design, participants, and method: A randomized clinical trial comprising a total of 110 overweight or obese (BMI ≥ 25) participants that are receiving medical treatment at Primary Care Centers, 20-65 years, will be included and randomly assigned to standard program (N=55) or standard + intervention program (N=55). The standard program group will receive the treatment as usual (TAU) that comprises 5 sessions (on a monthly basis) that will include a personalized diet and physical exercise recommendations, while the standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program. At baseline prior to randomization, after the intervention, and seven months after the program has finished anthropometric and body composition data, biochemical data in blood, waist circumference, blood pressure, eating habits, level of physical exercise, general health, emotional eating, quality-of-life, weight self-stigma, experiential avoidance, self-compassion level and mindfulness abilities will be evaluated. It is hypothesized that the integrated treatment of obesity implementing a group intervention program based on acceptance and mindfulness could help to reduce the emotional eating, enhance weight loss, improve physiological parameters, increase the level of physical exercise, improve the quality of life and reduce the weight self-stigma of overweight and obese individuals.
The BRAKE-AF Study is a phase III, randomised, controlled, multicentric, open-label clinical trial to prove the noninferiority of ivabradine versus digoxin in the treatment of permanent atrial fibrillation. The total duration of the study is 3 years, with 24 months of enrolment, treatment and follow-up.
The primary prevention of cardiovascular disease is an unresolved health problem. A sedentary lifestyle and a low cardiorespiratory condition both increase the risk of cardiovascular disease, at a similar extent as that promoted by traditional risk factors, such as smoking, high blood pressure or dyslipidemia. The scientific evidence regarding the effect of the promotion of an active lifestyle on primary cardiovascular prevention is limited. Several studies have shown that structured training programs (TP) are effective at short term, but at the medium or long term their efficacy is still unknown. There are very few randomized controlled trials, and there are almost no studies conducted in the primary care setting which analyze the long-term effects of this type of program on primary cardiovascular prevention. The investigators performed in primary care a previous quasi-experimental study without control group demonstrating the short-term effectiveness in the improvements of both physical condition and in the practice of physical exercise of this TP, the shortest so far analyzed in primary care. With the current study the investigators also want to demonstrate its short-term efficacy in the promotion of moderate-high physical activity and in the practice of physical exercise, through a high-evidence design such as a randomized clinical trial with a control group, also the extension of such efficacy in the medium and long term. Objective: To determine the efficacy of a supervised 2 month TP on short-term (1 month post-TP), medium-term (6 months post-TP) and long-term (12 months post-TP) promotion of moderate-high physical activity and practice of physical exercise, in a sedentary population with high cardiovascular risk, attending primary care centres. Methodology: A parallel, randomized, intervention study, with a control group. Inclusion criteria: Men and women of an age between 35 and 70 years, attending a primary care center in hospital reference area, with high cardiovascular risk. Sedentary lifestyle defined by a score <2 in the brief Physical Activity Questionnaire for care consultations primary adapted to measure the frequency of physical exercise and with a total result in the International Physical Activity Questionnaire (IPAQ)-long version ≤1500 METs x minutes/week, who agree to participate and commit to compliance with the program. Participants were randomized (automated list generation) to a control group, consisting in conventional management or to an intervention group (TP 2 months, 3 times / week). Both groups received an educational talk about cardiovascular risk, healthy diet habits and cardio-healthy exercise at the beginning of TP. Assessments were performed at baseline, and at 3, 8 and 14 months. OUTCOMES: 1. Main outcome measure: differences between groups in the proportion of participants with an "Effective response in Physical Activity ". This effective response was considered if there was an increase ≥ 240 METs x minutes / week in the moderate-high physical activity (measured by IPAQ-long version) in the final evaluation. 2. Secondary outcome variables: differences between groups in the change in: 1. Physical exercise: quantitatively (measured by the sum of the results obtained in items 22-25 of the IPAQ-long version), frequency (Physical Activity Questionnaire for care consultations primary adapted to measure the frequency of physical exercise), and intention (Questionnaire of Stages of Change of Exercise (QSCE)-Short Form). 2. Global physical activity (measured with the total result in the IPAQ-long version). 3. Physical condition: ergometric variables (Peak Oxygen Consumption, exercise duration, anaerobic threshold moment)) and 6 Minute Walk Test. 3. Other efficacy and safety variables: differences between groups in the changes in: 1. Anthropometric variables. 2. Blood pressure. 3. Biochemical parameters. 4. Mediterranean diet (simplified version of the questionnaire ¨Adherence to the Mediterranean Diet¨). 5. Quality of life (questionnaire SF36-long version). 6. Mood (Beck depression index).
The main purpose of the study was to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous non-small-cell lung cancer (NSCLC).
This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.
This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.