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NCT ID: NCT03239509 Completed - Surgery Clinical Trials

15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years

ANDALVALVE
Start date: January 2017
Phase:
Study type: Observational

Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B. Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 5 Cardiovascular Surgery Centers in Andalousia (south Spain)

NCT ID: NCT03239340 Completed - Clinical trials for EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

ELIOS
Start date: May 30, 2018
Phase: Phase 2
Study type: Interventional

A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.

NCT ID: NCT03238963 Completed - Clinical trials for Diabetic Retinopathy

A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.

ROBIN
Start date: September 19, 2017
Phase: Phase 2
Study type: Interventional

The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME)

NCT ID: NCT03237325 Completed - Oral Mucositis Clinical Trials

DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

Start date: December 4, 2017
Phase: Phase 3
Study type: Interventional

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

NCT ID: NCT03236363 Completed - Obesity Clinical Trials

Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!

MOVI-da10!
Start date: September 19, 2017
Phase: N/A
Study type: Interventional

Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.

NCT ID: NCT03236337 Completed - Obesity Clinical Trials

Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!

Start date: September 19, 2017
Phase: N/A
Study type: Interventional

Project which objective is to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance.

NCT ID: NCT03236038 Completed - Clinical trials for Exocrine Pancreatic Insufficiency

Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis

(EPIIHC)
Start date: October 1, 2017
Phase:
Study type: Observational [Patient Registry]

Exocrine pancreatic insufficiency (EPI) is the inability of the pancreas to perform a normal digestive function. The prevalence of IPE in patients with decompensated hepatic cirrhosis (HC) is unknown and most published series are short, old and use a single diagnostic technique with potential risk of false positives and negatives. Demonstrating IPE in a patient with HC can change their vital prognosis with the indication of pancreatic enzymes that can improve their nutritional status and help control their decompensations. Objectives: To assess the prevalence of IPE in patients with decompensated CH. To establish correlation between fecal elastase and 13C triolein breath test. Methodology: Unicentric, transversal study that will be carried out during hospitalization. Patients with HC who enter for decompensation and requiere hospitalization will be included consecutively. Exclusion criteria will include prior diagnosis of IPE, suspicion of biliary obstruction, more than 5 dep / d induced by laxatives or liquid stools. The diagnosis of IPE will be made with the combination of two techniques (13C triolein breath test and fecal elastase). Demographic, epidemiological data, clinical data as well as anthropometric parameters will be collected. A blood test will also be done to assess nutritional status and associated deficits. A multivariate analysis will be performed to assess the predictive factors of IPE

NCT ID: NCT03234348 Completed - Clinical trials for Acute Coronary Syndrome

MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

MAGSTEMI
Start date: July 1, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years. All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to - Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or - Biotronik ORSIRO Sirolimus Eluting Coronary Stent System Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months angiographic follow-up (Primary endpoint). In a subgroup of 40 patients Optical Coherence Tomography will be performed after the procedure and at 12 months follow-up. Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months follow-up) will be analyzed off-line by an independent core lab.

NCT ID: NCT03234023 Completed - Physical Activity Clinical Trials

Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)

SPRING
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric. CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored outhospital not inhospital supervised. MAIN OBJECTIVE: To determine the incidence of major adverse events (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.

NCT ID: NCT03232944 Completed - Heart Failure Clinical Trials

Personalized CRT - MPP Post Approval Study

Start date: July 5, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).