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NCT ID: NCT03464760 Completed - Elderly Clinical Trials

Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly

ANGIO SPIRUL
Start date: January 22, 2020
Phase: N/A
Study type: Interventional

The investigators hypothesize that spirulina-silicon supplementation will lead to an improvement in vasomotor endothelial function, followed by decreased arterial wave velocity on the aorta and central arterial pressure compared to placebo subjects.

NCT ID: NCT03464747 Completed - Shock Clinical Trials

Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.

Start date: February 17, 2017
Phase:
Study type: Observational

During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation. The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter. However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.

NCT ID: NCT03464721 Completed - Surgery Clinical Trials

Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery

SMART ANGEL 1
Start date: May 14, 2018
Phase:
Study type: Observational

This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient

NCT ID: NCT03464565 Completed - Stroke, Ischemic Clinical Trials

COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

Start date: July 2, 2018
Phase:
Study type: Observational

The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

NCT ID: NCT03464136 Completed - Crohn Disease Clinical Trials

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

SEAVUE
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

NCT ID: NCT03464019 Completed - Clinical trials for Paroxysmal Supraventricular Tachycardia

Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]

Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting. Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1. The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. The study will continue for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID will be conducted). The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.

NCT ID: NCT03463798 Completed - Healthy Volunteers Clinical Trials

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

DYSDIA
Start date: June 11, 2018
Phase:
Study type: Observational

this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.

NCT ID: NCT03462849 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Expiratory Flow Limitation Assessment

FLAIR
Start date: February 5, 2018
Phase: N/A
Study type: Interventional

This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.

NCT ID: NCT03462238 Completed - Clinical trials for Chronic Kidney Diseases

Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation

PyroCal-greffe
Start date: September 10, 2018
Phase: N/A
Study type: Interventional

Arterial calcifications (AC) are constant lesions in patients with Chronic Kidney Diseases (CKD). Renal transplantation would reduce their progression compared to dialysis. AC pathophysiology is a complex and finely regulated process that involves many local and systemic factors, both pro- and anti-calcification. The progression of the CKD is accompanied by an increase in phosphate levels as the renal excretion capacity of inorganic phosphates (Pi) decreases while their digestive absorption remains unchanged. Hyperphosphatremia is a well-identified calcifying factor contributing to ACs in the CKD. On the other hand, pyrophosphate (PPi) is an anti-calcifying factor from the hydrolysis of extracellular ATP by ectonucleotidases. While there are many factors that may contribute to a protective effect against AC progression of renal transplantation, no study has been yet analysed the role of PPi. Plasma concentration of PPi is decreased in dialysis patients compared to non-kidney failure patients. The main objective of this monocentric, prospective and interventional pilot study will be to compare the progression of CA and [PPi]pl between a group of renal transplant patients over the past 24 months and a group of dialysis patients over the same period of time. The secondary objectives will be to compare the progression of ACs and the ratio[PPi]pl/[Pi]pl between transplanted and dialysis patients. Transplanted patients will be included within 24 (±3) months of transplant. Dialysis patients will be included at 24 (±3) months of the CT scan performed during the pre-transplant check-up. At inclusion, all patients will benefit from a CT scan without injection and a plasma dose of PPi, Pi and other factors involved in controlling calcification.

NCT ID: NCT03461900 Completed - Septic Shock Clinical Trials

Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock

GOAL
Start date: June 4, 2019
Phase: N/A
Study type: Interventional

Many observational studies have highlighted an independent association between fluid overload and clinical outcomes during septic shock. To optimize fluid balance, clinician has several options to consider carefully fluid administration and avoid fluid overload. More than a general restrictive approach, a pragmatic, individual tailored approach should be considered to optimize patients' hemodynamics during acute circulatory failure. Many advances in hemodynamic monitoring were described. Mini-fluid challenge appears to be a sensible method to use for bedside assessment to optimize fluid infusion. The next step for hemodynamic management in the ICU should be to test a hemodynamic goal-directed approach to better control fluid management and eventually improve patient's outcome. The main objective of the GOAL study is to evaluate a pragmatic optimization fluid management protocol tailored to each patient's hemodynamic status based on mini-fluid challenges. This intervention will be compared to usual management based on the latest guidelines. This intervention aims to decrease organ dysfunction during septic shock. This is the first large clinical trial designed to test this hypothesis.