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.
In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.
This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
CORONA is a retrospective, observational, one center study to investigate the clinical evolution (in terms of survival and thromboembolic complications) of patients on chronic treatment with anticoagulants or antiplatelet agents who are admitted to the hospital for COVID-19 compared with patients who do not receive anticoagulants or antiplatelet agents.
A Phase 2b, study to measure the effect of Cotadutide at different doses versus placebo or comparator (semaglutide) in participants who have Chronic Kidney Disease with Type 2 Diabetes Mellitus.
There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx. There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM. This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.
Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice. Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.
RCC (Renal Cell Carcinoma) is the most common form of kidney cancer, accounting for 2-3% of all adult malignancies and for 90% of all kidney cancers. The incidence of RCC has steadily increased over the past two decades, showing a plateau in recent years. Many patients with RCC remain asymptomatic until late disease stages and other patients have disease at diagnosis (metastatic RCC or mRCC). Recently, the tyrosine kinase inhibitor (TKI) cabozantinib was approved as a first-line therapy for patients with advanced clear-cell RCC (ccRCC). Cabozantinib was initially approved for patients previously treated with antiangiogenic therapy based on the phase 3 METEOR study, which demonstrated a clinical benefit compared with everolimus. Immunotherapy has been also developed in ccRCC. The frontline treatment paradigm for ccRCC has evolved, particularly for intermediate-/poor-risk patients, with the recent addition of cabozantinib and nivolumab/ipilimumab (immunotherapy), but overall survival data are needed to understand their benefit-to-risk profiles compared with established therapies. In October 2016, the Spanish Agency of medicines (AEMPS) granted the temporary Authorization for special use to Cabometyx® 20/40/60 mg within a Managed Access Program (MAP) for the treatment of advanced RCC in adults following prior VEGF-targeted therapy (Vascular Endothelial Growth Factor targeted therapy). The MAP allows the possibility of using a medicinal product which is not yet commercially available or approved. By the end of the MAP period, on July 2017, 136 patients had been included by 61 centers who received at least one dose of Cabometyx® for the treatment of advanced RCC. Since then, Cabometyx® 20/40/60 mg was made commercially available for the treatment of advanced RCC in adults following prior VEGF-targeted therapy. After the commercialization of Cabometyx® in July 2017 in Spain, the inclusion of new patients in the MAP was closed but those patients that were already included continued receiving Cabometyx® free of charge until clinical decision. In July 2018, the European Commission approved a new indication for adult patients previously untreated with intermediate or poor risk. Based on this rationale, the aim of this study is to obtain safety and effectiveness information regarding the use of cabozantinib in a non-selected RCC population, both in patients that received this agent under the MAP or under routine clinical prescription (real-world [RW]).
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.