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 randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment. All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include different questionnaires and nasal endoscopy. This trial includes three treatment arms. 1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach. The presence of adverse effects will be assessed in each treatment arm.
This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-118 in healthy volunteers.This clinical phase I trial is divided in two stages and involves, first, a single ascending dose (SAD) study in healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young men and woman. MBF-118 is developed for the treatment of cancer.
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
PRONACERA THERAPEUTICS S.L. is a young biotechnological company focused on the development of genetic diagnostic tools and treatments for pathologies in different medical areas such as reproduction, fibromyalgia and rare diseases or with deficiencies in diagnosis, with the aim of helping to optimize health systems through improvement in terms and forms of diagnosis. Among the multiple lines of R+D+i that are currently being developed, the reproductive genomic line and endometrial functional molecular biology stand out. Specifically, it develops the design of markers and performs the genetic analysis of infertility focused on female endometrial tissue. Fibromyalgia is a complex and common chronic pain disorder that affects 12 million Europeans. Along with other symptoms, fibromyalgia causes pain and general tenderness to touch. Currently this disease is diagnosed following the criteria established by the American College of Rheumatology (ACR) of a combination of relevant symptoms and the description of how the person feels. In other words, in practice it is a diagnosis by elimination. A patient suffering from fibromyalgia usually takes between 2 to 3 years to obtain the correct diagnosis. Health experts consider that fibromyalgia is a disease that is difficult to diagnose and that is associated with an expensive use of health system services. With FIBROKIT, Pronacera aims to design and develop a new diagnostic and monitoring tool for fibromyalgia by designing a panel of specific plasma proteome and intestinal microbiome biomarkers and reducing the number of biological samples used. During the execution of this project, the company will have three leading research and innovation organizations in the sector (Helix BioS, CINUSA and CICbioGUNE) that will support Pronacera. FIBROKIT will have a cohort of 250 participants (206 patients and 44 healthy volunteers) to validate the diagnostic capacity of the tool and perform a robust biostatistical study.
Knee osteoarthritis pain is one of the conditions commonly seen in general and specialized medicine. Knee arthroplasty is one of the most successful orthopedic surgeries for the treatment of this disease, significantly improving pain, disability, and the overall quality of life for patients who undergo it. However, there is a subgroup of individuals in whom the pain persists or even worsens. Radiofrequency has been introduced over 10 years ago as a neuroablative technique targeting the genicular nerves, which innervate the sensory terminals of the knee joint, for the treatment of chronic pain in that region before or after arthroplasty. However, the results have not been entirely consistent. Recent anatomical studies have demonstrated the presence of other sensory terminal branches of the femoral nerve, such as the infrapatellar branch of the saphenous nerve, medial vastus nerve, intermediate vastus nerve, and lateral vastus nerve, which could be useful targets for the treatment of post-knee arthroplasty pain. To date, no studies have been conducted to address post-knee arthroplasty pain through the application of thermal radiofrequency on the sensory branches of the knee from the femoral nerve (infrapatellar branch of the saphenous nerve, medial vastus nerve, intermediate vastus nerve, lateral vastus nerve). Therefore, The investigators aim to conduct a randomized double-blind clinical trial where The investigators will apply thermal radiofrequency on the sensory terminal branches of the femoral nerve in the knee, based on recent anatomical studies. The objective of the study is to determine if radiofrequency ablation of sensory nerves in the knee improves pain and disability in patients with post-knee arthroplasty chronic pain at the L'Alt Penedés-Garraf Health Consortium. Method: This is a randomized double-blind clinical trial with two arms. Two groups will be used, where one group will receive thermal radiofrequency of sensory nerves in the knee, and the other group will receive a placebo treatment. The hypothesis The investigators propose is that radiofrequency ablation will alleviate at least 50% of baseline pain and disability in at least 50% of the patients.
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
This study explores the impact of high-intensity exercise during fasting on energy metabolism and cognitive function in healthy adults. Changes in respiratory exchange ratio, blood substances, and cognitive performance will be measured after 24 and 34 hours of fasting with and without exercise in a randomized crossover design.
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism < 1.50D, and anisometropia < 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. The available clinical evidence suggests that SBRT is highly effective in controlling localized prostate cancer (PCa) with acceptable side effects. On the other side, dose escalation is a commonly employed strategy in radiotherapy for prostate cancer. Recent studies have confirmed a dose-response relationship, demonstrating improved biochemical control with focal dose escalation to the identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) of the prostate. The hypothesis of this study is that the combination prostate SBRT with focal dose intensification on the DIL with preservation of the prostatic urethra, would lead to a higher probability of local control without a significant increase in toxicity compared to standard clinical practice. This is a prospective single-arm phase II study designed to evaluate the effectiveness, safety and impact on quality of life of focal dose intensification using SBRT technology and extreme hypofractionated radiotherapy.
Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance. According to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer >1:40) and/or anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and/or anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis). The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. However, up to 31% of patients with PBC are lost without follow-up. The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression. To date, two studies (one Spanish and one Portuguese) showed that 27% and 45.5% of the patients lost with PBC presented advanced fibrosis, respectively. The objective of this study is to identify, through computerized data, patients with PBC who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.