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 phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy.
The main objective of the study is to establish if patients with advanced bile duct cancer, who have already received a line of treatment for their disease, will receive any associated benefits from the combination of mFOLFOX6, bevacizumab and atezolizumab as a second-line therapy All patients who meet the criteria to participate in the study shall receive the following drugs intravenously every 14 days: mFOLFOX6 combined with Atezolizumab 840 mg and Bevacizumab 10 mg/kg. These drugs will be administered until one of the following situations arises: disease progress, intolerable side effects, pregnancy or if the patient or the doctor decide to stop the treatment. Atezolizumab is an antibody that operates on an important receptor of the immune system (PD1/PD-L1 axis). Atezolizumab (Tecentriq®) has already been approved in a number of countries to treat a range of tumours, although it has not yet been approved for bile duct tumours. Bevacizumab is an antibody that is joined to the vascular endothelial growth factor (VEGF). Bevacizumab was approved for the first time in the USA in 2004 and is now approved in over 100 countries around the world for a variety of conditions. However, it has not yet been approved for treating bile duct cancers. mFOLFOX6 is a chemotherapy regime used to treat many kinds of gastrointestinal tumours, including bile duct cancer, since it is a treatment approved for this type of tumour. The combination of mFOLFOX6 with atezolizumab and bevacizumab (trial drugs), may bring more information about an anti-tumour immune response that could improve the results of mFOLFOX6, which backs up the research on this treatment combination with cancer patients.
Rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature B leukemia/lymphoma. However, the toxicity of this therapy is high. The purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. With this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification. Gold standard will be mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs). Participants will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases. Secondary objectives are: - To assess whether age, sex and PPIs, have an influence on the results of RAC. - To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC. - To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence. Primary and secondary variables The primary study variable is: - Endoscopic detection of RAC. Secondary variables will be considered: - Sex - Age - PPI intake in the last two weeks - Centre - Country - Hp prevalence - Endoscopist - Type of endoscope - Significant findings (need of histological confirmation) - Atrophic gastritis - Intestinal metaplasia - Erosive gastritis - Benign gastric ulcer - Gastric adenoma - Gastric cancer
The lack of ADAMTS13 is the only biological marker that is specific for aTTP diagnosis8 and the assessment of ADAMTS13 is of clinical importance because it is essential for the rapid differential diagnosis between aTTP and other TMA. Furthermore, monitoring of ADAMTS13 activity is useful to ensure biological remission (ADAMTS13 levels > 10%) as well as predicting relapses. Due to the high mortality rate of aTTP, treatment should be started as soon as the disease is suspected, sometimes even before confirmation with the ADAMTS13 test results. This situation may lead to misdiagnose some patients and leave them without the appropriate treatment. In conclusion, ADAMTS13 activity assay is crucial for an early diagnosis and optimal management of acute aTTP and any delay in ADAMTS13 results will have a negative impact on the diagnosis, treatment and prognosis of the patient. There are currently 2 techniques available for the ADAMTS13 activity determination, the fluorescence resonance energy transfer (FRET) and the Technozym chromogenic enzyme-linked immunosorbent assay (ELISA). Both are considered reference methods but they require considerable skill because they are highly manual and this increases the risk of error. Furthermore, these methods are time-consuming, not widely available and, in case of the ELISA method, it requires a new calibration at each run. The inter-laboratory variability is also a challenge and therefore a validation and/or interpretation method could be needed. Recently, a new and first fully automated HemosIL AcuStar ADAMTS13 Activity assay (Instrumentation Laboratory, Bedford, Massachusetts, United States) has been developed. HemosIL AcuStar ADAMTS13 Activity assay is a two steps chemiluminescent immunoassay (CLIA) with an analytical time of 33 minutes for the quantitative measurement of ADAMTS13 activity in human-citrated plasma on the ACL AcuStar analyser. The immunoassay uses the GST-VWF73 substrate in combination with magnetic particles for rapid separation and chemiluminescence technology detection. The ADAMTS13 present in the plasma sample cleavages the GST-VWF73 substrate and the detection of the generated fragments is based upon an isoluminol-labelled monoclonal antibody that specifically reacts with the cleaved peptide. The emitted light is proportional to the ADAMTS13 activity in the sample. This new ADAMTS13 assay method has been compared with the other two available techniques in two different studies. First, Favresse et al. published the results of the comparison between Technozym activity ELISA assay and the new HemosIL AcuStar chemiluminescent assay. On the other hand, Valsecchi et al. have recently published the results of validation of this new technique in comparison with ELISA and FRETS in 176 samples. Both studies conclude that the new chemiluminescent ADAMTS13 activity assay showed a good correlation and excellent clinical performance for the diagnosis of severe ADAMTS13 deficiency with the FRETS-VWF73 assay and a commercial ELISA when considering only ADAMTS13 activity values below 10% (the internationally accepted cut-off for a diagnosis of severe ADAMTS13 deficiency typical of aTTP). Finally, Stratmann et al. have just published another study comparing the HemosIL AcuStar chemiluminescent assay with two commercially available ADAMTS13 assay kits using 24 paired test samples derived from 10 consecutively recruited patients13 and their results corroborate the previously published data suggesting that the AcuStar assay could be a valuable and accurate tool for ADAMTS13 activity testing and aTTP diagnostic. In this context, a unique opportunity to validate this new technique is generated, both retrospectively with our already available data from frozen samples and also in the context of a large prospective study. This will be the first study worldwide testing HemosIL AcuStar method in real clinical practice aTTP population (Spanish and Portuguese aTTP populations) with the aim to standardize the diagnosis and follow-up methodology for the disease.
Background: Nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. Every year, more than 8 million people die from tobacco use. Smoking-related mortality is significantly higher in people with serious mental illness. Is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. People with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. While significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. Smoking cessation often requires numerous attempts by these people. Thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit. Smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. Available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health. The investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.
The ANRS HB07 IP-cure-B study is a proof of concept Phase II clinical trial in HBeAg negative virally suppressed non-cirrhotic CHB patients. It will explore whether stopping NUC or stopping NUC after SLGN administration can increase the rate of HBsAg decline compared to standard of care CHB treatment.
Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology. The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.
The evidence base relating to the use of SCAP and HIFU is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when the few studies reported are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority of studies refer only to BCR-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting. Another important hot issue in this scenario is the potential benefit that new imaging and diagnosis techniques (MRI, targeted biopsy, PSMA) may add for a more accurate indication. This could provide the possibility of better results for SCAP. The clinical value of this new diagnostic tools is unknown in this scenario and needs to be explored.