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 study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.
Patients needing intensive care often require sedative drugs to reduce anxiety and agitation during ventilator care and invasive therapeutic and diagnostic procedures. At present there is no optimal sedative agent for these patients. The most commonly used sedative agents in intensive care units are midazolam and propofol. Both drugs have side effects of clinical importance. At present, a viable alternative to intravenous sedation is inhalatory sedation. Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. A new simplified method of administration of isoflurane or sevoflurane has been developed. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device. However, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12 hours, since the possible renal problems posed by inorganic fluoride in prolonged operations remain the subject of controversy. The primary aim (and primary hypothesis) of the current trial is to determine whether sevoflurane can be administered as a sedative drug for more than 48 hours without clinically relevant physiopathological effects on kidney and liver function. Other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in terms of sedation control, the rapidity and predictability of awakening, and the incidence of delirium in critical care patients.
Hypothesis: Both nifedipine or progesterone are widely used in clinical practice as maintenance tocolytic therapy after an episode of threatened preterm delivery. Nevertheless, there is insufficient evidence to justify its routine use. The present study aims to evaluate the efficacy and safety of these tocolytic drugs for maintenance tocolysis in the management of threatened preterm delivery. Materials and methods: Phase III clinical trial, which evaluates the efficacy and safety of nifedipine and progesterone as maintenance tocolytic therapy until the 34th week of pregnancy in randomized women after an episode of threatened preterm delivery. Pregnant women with singleton pregnancies are going to be evaluated, with intact membranes and cervical length less than or equal to 25 mm, which have received acute tocolysis with atosiban. They will be randomized to receive maintenance tocolysis with nifedipine (60 mg / day orally) or progesterone (200 mg / day vaginally) until week 34 of gestation. Therefore all included patients will receive treatment with proven but not agreed efficacy, to decrease the recurrence of threatened preterm delivery, prolongation of gestation and subsequent better perinatal outcome. During the course of pregnancy, patients will be monitored in outpatient obstetrics, thus checking an adequate compliance. Monitoring will continue until the end with the delivery and collection of newborn data. The study will be single-blind, since there will be a blind evaluator. The drugs or treatments not allowed before and / or during the clinical trial are those which are indicated in the data sheet for each drug. If the patient takes antihypertensive treatment and continues it during pregnancy, dose adjustment will be done if it is needed. Data will be collected in the case report data (CRD). The end of the test will be considered when the last recruited patient complete the gestation (delivered vaginally or cesarean), and all data from newborn are collected. If a serious adverse event occurs in a patient, the woman will immediately finish the clinical trial and will be followed until complete resolution of the episode. Treatment is going to be considered effective if the birth occurs after 37 weeks of pregnancy with satisfactory perinatal outcome. The drugs are going to be considered safe if they do not cause adverse events in pregnant women, or if they are not serious. Number of Subjects: 50 pregnant women Diagnosis and main criteria for inclusion and exclusion: Inclusion Criteria - Pregnant women with singleton pregnancies and intact membranes which have passed an episode of threatened preterm delivery (uterine contractions with cervical change) successfully treated with atosiban as acute tocolytic therapy. - Cervical length ≤ 25 mm. Exclusion Criteria - ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption, fetal abnormality incompatible with life, fetal death) . Investigational product, dose and mode of administration: After a successful treatment of acute preterm labor with atosiban, is will be compared the safety and efficacy of maintenance tocolytic therapy with nifedipine 60 mg / day orally or progesterone 200 mg / day vaginally. Therapeutic group: C08CA05 Nifedipine. G03DA04 micronized progesterone. Route of administration: nifedipine orally. Progesterone vaginally. Dose: Nifedipine 60 mg / day. Progesterone 200 mg / day. Duration of treatment: From the resolution of acute episode of threatened preterm labor until 34 weeks of gestation. Reference treatment, dose and mode of administration: Current evidence questions the utility of maintenance tocolytic therapy. No reference treatment is currently defined.
The main clinical study will be a randomized, double-blind, placebo-controlled, long term study involving a 100 week treatment period. The purpose of this study is to test for superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study is also to investigate the effect of initiating earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens. The study will also determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of action of Belimumab as well as effects on quality of life. All subjects (on either active treatment or placebo) will receive background supportive therapy throughout the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study treatment at any time during the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to week 104. A subject will be regarded as having completed the main clinical study if they complete all phases of the main clinical study (screening, treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects who complete the main clinical study will therefore participate in the main clinical study for approximately 28 months. After the main clinical study, there will be a 5 year (long term) follow-up phase to assess long term outcomes.
Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre, prospective, of cohort of patients who will receive different doses of allo-depleted lymphocytes . This project joins in this pioneering worldwide initiative with its own technology based on the use of proteasome inhibitors in vitro, which advantages are, over other methods described, the continuing viability of regulatory T cells and the use of a product to generate allo-depletion that, contrary to those reported by other research groups, it does not pose problems from the point of view of its use or toxicity as we employ a drug widely used clinically by intravenous administration.
This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.
Study objectives: The primary objective is to determine the efficacy of BEZ235 on Objective Response Rate (best response on study) according to RECIST 1.1 criteria The secondary objectives are: - To determine the progression free survival rate at 32 weeks in the included population - To assess the duration of response among responders - To evaluate time to response - To evaluate the time to progression - To assess the overall survival - To evaluate safety and tolerability of BEZ235 The exploratory objectives are: - To identify molecular and genomic profiles of PEComas and their potential relationship to clinical outcome by analyzing PIK3CA, Ras, Raf, TSC, AKT and PTEN alteration in tumor samples (archival or fresh pre-treatment tumor biopsy) and PIK3CA in circulating DNA. - To determine biomarkers relevant to BEZ235 activity by analyzing the expression of phosphoproteins p-AKT, p-S6, p-4EBP1 at screening and during treatment as well as biomarkers for the proliferation (Ki-67) and apoptosis (PARP) (only if fresh tissue (optional) is available). Study population: The patient population consists of patients 18 years old or older with progressive unresectable/advanced or metastatic malignant PEComas previously treated for unresectable/advanced/metastatic disease with 1 to 2 prior lines of chemotherapy. Patients must have adequate hematologic, renal, cardiac and hepatic functions and not be previously treated with a mTOR inhibitor. Number of patients: 16 to 33 patients Overview of study design: This is a prospective, multicenter, open-label, single arm, two-stage phase II study to investigate the efficacy and tolerability of BEZ235 in patients with progressive metastatic or unresectable/advanced malignant PEComas. The patient should have received 1 or 2 prior lines of chemotherapy. BEZ235 will be administered until disease progression. Sixteen patients will be enrolled into Stage 1 and observed for at least 32 weeks at which time an interim analysis will be performed (plus eventually 4-5 weeks for confirmation of responses occurring on or closely before this cut-off date). If the number of patients with a response (CR or PR) is 2 or less, the trial will be stopped for futility. If 3 or more patients experience a response enrollment will continue up to 33 patients (Stage 2). An Independent Data Monitoring Committee (IDMC) will be constituted for reviewing the interim analysis.
The process of atherosclerosis is multifactorial and involves many mechanisms. The majority of published works have identified endothelial dysfunction as the first step in a cascade of events that culminates in plaque formation. Among the various mechanisms that occur following the attack on the vessel wall, it is thought that stem cells in the form of endothelial progenitor cells (EPCs) are the endothelial protection mechanism. Factors identified as cardiovascular risk factors, or rather those conditions which suppose a threat to the vessel wall, should therefore be associated with low levels of EPCs. To date this link has been shown in hypertension, diabetes, hyperlipidaemia, and smoking. Furthermore, the lack of wall protection in situations of low levels of EPCs is clearly a biomarker of cardiovascular morbidity and mortality. On the other hand, the correction of a risk factor allows recuperation of EPCs and is therefore showing itself to be a promising tool for measuring therapeutic efficacy. The tools for correcting EPC levels are not clearly defined. The effect of statins on levels of EPC has been shown, and the low levels of EPCs in diabetes seem to be susceptible to treatment with statins. The role of glucagon-like peptide (GLP-1) is slowly being elucidated but the actual mechanism of its potential endothelial protection is unknown, and its effect on EPCs has not been studied. Liraglutide, a long-acting GLP-1 analogue, could also be an interesting option for long-term vessel wall protection, but to date its ability to correct cardiovascular biomarkers such as EPCs has not been studied.
The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).
A natural sweetener (Stevia Rebaudina Bertoni) reduces blood glucose levels and blood pressure according to various preclinical and clinical studies conducted worldwide. Since it is not found many studies in the literature wich compares Stevia Rebaudiana with saccharin, we've proposed a randomized crossover clinical trial comparing the effects on postprandial capillary blood glucose and blood pressure in healthy adults. Sample: healthy professionals from two health centers in Alava (Kakuabizkarra primary care center and Txagorritxu hospital). Inclusion criteria: Professionals of two health centers of Álava (Lakuabizkarra and Txagorritxu) and active employment status at the beginning of the trial, weighing more than 50kg and age over 18 years. Intervention: 200mg capsules of Stevia or 250mgcapsules of saccharin. Measurements: Capillary blood glucose and blood pressure, fasting and after eating. Evaluation of satiety, hunger and fullness by questionnaire after intake, and at the end of the day. Statistical analysis: Compare the postprandial capillary glucose levels between 8 am and 1 st hour, 2nd hour 3rd hour after intake between treatments by ANCOVA. We will also compare blood pressure before and after intake between treatments. We will also compare by t test or paired Wilcoxom (depending on the nature of the variable) the results of the questionnaire after intake between treatments.