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NCT ID: NCT02804685 Completed - Knee Injuries Clinical Trials

Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players

Start date: June 2016
Phase: N/A
Study type: Interventional

This research presents a randomized clinical trial which evaluates the effectiveness of an exercise protocol on the knee-joint repositioning in futsal players related to a post-match muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position before and after the match when performing our exercise program.

NCT ID: NCT02804672 Completed - Physical Disability Clinical Trials

Study on Cardiovascular Health, Nutrition and Frailty in Older Adults in Spain

Seniors-ENRICA
Start date: March 2008
Phase:
Study type: Observational

The purpose of this study is to examine the association between ideal cardiovascular health, diet and other lifestyles, biological risk factors, either well-established or emergent, and the risk of frailty in older adults, throughout different waves (2008-10, 2012 and 2015 -16).

NCT ID: NCT02803918 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

Start date: May 17, 2017
Phase: Phase 1
Study type: Interventional

Primary Objective: To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM. Secondary Objectives: - To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM. - To evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.

NCT ID: NCT02803814 Completed - Clinical trials for Pancreatic and Periampullary Tumors

Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

DUOPAN-EPAM
Start date: February 2016
Phase: N/A
Study type: Interventional

Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated. Aims: To compare the rate of free resection margin (R0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery. Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (R0) or infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.

NCT ID: NCT02802748 Completed - Breast Cancer Clinical Trials

Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

Start date: July 2016
Phase: Early Phase 1
Study type: Interventional

VENTANA is a "window-of-opportunity" trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone.

NCT ID: NCT02802345 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment

Start date: June 30, 2016
Phase: Phase 3
Study type: Interventional

To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.

NCT ID: NCT02802098 Completed - Clinical trials for Metastatic Breast Cancer

Abrogation of Chronic Monoclonal Antibody Treatment-induced T-cell Exhaustion With DURVALUMAB in Advanced HER-2 Negative Breast Cancer

Start date: May 2016
Phase: Early Phase 1
Study type: Interventional

This is a single-arm pilot proof of concept, open-label clinical trial. Twenty-five subjects will be enrolled in 6 sites. Metastatic breast cancer patients with disease progression to bevacizumab maintenance treatment will be potential candidates. Bevacizumab maintenance will be considered as six weeks of bevacizumab treatment in monotherapy, with hormonal treatment or combined with chemotherapy in the context of previous bevacizumab plus chemotherapy regimens. When progression to bevacizumab maintenance treatment occurs, patients will enter the trial and will start receiving DURVALUMAB 10 mg/kg Q2W IV infusion plus bevacizumab 10mg/kg IV infusion every 2 weeks. The patients will undergo a tumor biopsy before the first dose of DURVALUMAB, and after one month of combined treatment - the blood sampling will continue on a monthly basis. The treatment will continue until disease progression.

NCT ID: NCT02801045 Completed - Clinical trials for Psychological Stress

Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient

Start date: October 20, 2016
Phase: N/A
Study type: Interventional

This study evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience.

NCT ID: NCT02800642 Completed - Clinical trials for Central Retinal Vein Occlusion

Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO

CENTERA
Start date: June 10, 2016
Phase: Phase 4
Study type: Interventional

Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries. The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.

NCT ID: NCT02800161 Completed - Bipolar Disorder Clinical Trials

Trehalose as add-on Therapy in Bipolar Depression

Start date: June 2016
Phase: Phase 3
Study type: Interventional

The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating nature, characterized by lifelong recurrent episodes and residual intraepisodic symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have reported dramatic illness-associated morbidity and premature mortality in bipolar patients. The efficacy and safety of antidepressant drug treatment in BD is the subject of long-standing debate based on a scientific literature that is limited and inconsistent. The evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is insufficient evidence for treatment benefits with antidepressants combined with mood stabilizers. The need to develop new agents for the treatment of depression, and in particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In the past years there has been increasing interest in the health benefits of supplemental and/or dietary substances in the treatment and prevention of depression. The disaccharide trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation. In vivo studies with trehalose show cellular and behavioural beneficial effects in animal models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a process that had been recently suggested to be involved in the therapeutic action of antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like properties and that the trehalose induced behavioral changes are possibly related to trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that trehalose also augments lithium effects in animal models (mice). Based on this hypothesis, this project aims to conduct a study to assess the efficacy and tolerability of trehalose as adjunctive treatment to lithium in bipolar depression.