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 purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH). Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire. After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.
This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.
This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.
1. To demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of VAP regarding the final point of primary efficacy: mortality in the 28 subsequent days and clinical healing in patients clinically evaluated. 2. To compare the safety of treatment with colistin vs meropenem in VAP. 3. To compare microbiological efficacy of treatment with colistin vs meropenem in VAP
The purpose of this study is to demonstrate that an intervention based on the motivational interview directed to patients with polypharmacy to improve the Therapeutic Adherence and to reduce the errors of Medication in major measure that the habitual intervention.
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in predicting worsening kidney function in patients who present with acute heart failure (AHF) and who are treated with diuretics. It is believed that rising NGAL levels in the blood and/or urine can predict acute kidney injury. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.
Background Some patients complain of excessive evacuation, which may become socially disabling (Azpiroz F & Malagelada J-R, 2005). However, there no systematic investigation on the range of gas evacuation in healthy subjects and in subjects complaining of flatulence under basal conditions and in response to a high-flatulogenic diet (Azpiroz F & Levitt DG, 2009). Hypothesis Patients complaining of excessive passage of gas per anus have more intestinal gas production and more anal gas evacuation during basal conditions and in response to a high flatulogenic diet than healthy subjects. This abnormality is related to the differences in colonic microflora. Objectives - To determine the normal range of intestinal gas evacuation under basal conditions and in response to a high flatulogenic diet. - In patients complaining of flatulence, to determine whether intestinal gas evacuation under basal conditions and in response to a high flatulogenic diet is increased. - To identify differences in the microbiota pattern in subjects with normal and excessive anal gas evacuation. - In patients complaining of flatulence, to determine the segmental distribution of intestinal gas after a diet challenge. Methods Healthy subjects (n=20) and patients complaining of flatulence (n=30) will undergo a 3-day basal phase on their current diet and a 3-day challenge phase on a high-flatulogenic diet; patients will be followed-up for 7 days on a low-flatulogenic diet. The following g measurements will be performed: daily measurement of the number of anal gas passages with an event marker, continuous recording of anal gas evacuation in the laboratory using an electronic leakage-free gas collection system, colonic flora analysis by fecal sampling, and segmental gas distribution in the gut by abdominal computer tomography (CT) imaging. Relevance These studies will allow to develop the normal range of anal gas evacuation during basal conditions. Furthermore, a provocative test will be developed for the diagnosis of excessive gas production in patients complaining of flatulence. This data will allow a proper diagnosis of these patients and will pave the path for a rational management and for the development of evidence-based treatment strategies. This pilot study will allow a proper design with adequate sample size calculation in future interventional studies.