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.
Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.
Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study. Secondary outcome measures: 1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular: - Fistulas healing efficiency - Changes in quality of life in patients treated - Changes of systemic Crohn's disease after implant - Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success. 2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with: - Phenotype study - Suppressor capacity study. - Citoquines production analysis
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Positron emission tomography (PET) with [18F]fluorodeoxyglucose (FDG-PET) evaluates cancer cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this study is that early changes in FDG-PET signal can predict sorafenib response in hepatocellular carcinoma (HCC).
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR566658 Secondary Objectives: - To characterize the safety profile of SAR566658 - To evaluate the pharmacokinetic profile of SAR566658 - To assess the potential immunogenicity of SAR566658 - To assess preliminary antitumor activity - To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam - To assess safety in the alternative schedules of SAR566658 administration
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
Background: High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk (CVR) using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a CVR visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD. Design & Method: Cluster randomized controlled clinical trial. Location: 22 primary health care centres in Madrid. Participants: patients diagnosed as hypertensive (systolic >140 mmHg and/or diastolic >90 mmHg) at least a year before, uncontrolled. Age: 40-65 year-old patients who consent to take part. Sampling: randomized cluster assignment. Random allocation unit: health care centre. Analysis unit: patient who match criteria. Size: 736 patients (368 each arm. Measurements: Outcome variables: systolic and diastolic blood pressure (mmHg). Cardiovascular risk level: SCORE. Measure of Adherence to treatment (Morisky-Green questionnaire. Health related quality of life questionnaire MINICHAL. Smoking habits. Total Cholesterol. Other variables: Gender. Age. Educational level. Physical activity in metabolic equivalent (MET). Body mass index. Drug consume (cardiovascular line). Treatment changes and nature of the change. Intervention: EDUCORE group (direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients); Control Group: standard practice care.
The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.
Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with RAS/RAF mutations and on triple negative breast cancer. Both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days. Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's safety and pharmacokinetics or pharmacodynamics. Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination. - Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC - Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer - Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer