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NCT ID: NCT02560402 Completed - Sepsis Clinical Trials

The Relation Between the Renal Resistive Index and Glomerular Hyper Filtration

Start date: August 2015
Phase: N/A
Study type: Observational

Aim of the present study is to determine whether 1. RRI can predict glomerular hyperfiltration; 2. glomerular hyperfiltration is associated with low renal resistive index; 3. glomerular hyperfiltration/low RRI are associated with accelerated flow in the sublingual microcirculation; 4. glomerular hyperfiltration/low RRI are related to fluid status as quantified with bioimpedance analysis.

NCT ID: NCT02560207 Completed - Critically Ill Clinical Trials

Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.

Start date: November 2015
Phase: Phase 4
Study type: Interventional

This study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. Critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.

NCT ID: NCT02560142 Completed - Healthy Volunteer Clinical Trials

A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants

Start date: August 2015
Phase: N/A
Study type: Observational

This is a single center non-interventional study in healthy participants for behavioral assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5 participants and will study the implementation of the behavioral tests and identify potential issues. Part B will involve 30 participants and will study the test-retest reliability. Duration of participation for each participant will be 30 days for Part A (28 days screening period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2 study visits of 2 days each separated by a period of 14 days).

NCT ID: NCT02559908 Completed - Chin Retrusion Clinical Trials

A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw

Start date: February 26, 2015
Phase: N/A
Study type: Interventional

This study will evaluate the safety and performance of VYC-25L hyaluronic acid injectable gel for the restoration and creation of facial volume in participants seeking to increase projection of the chin and/or jaw.

NCT ID: NCT02559310 Completed - Clinical trials for Community Acquired Pneumonia

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

LEAP
Start date: September 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.

NCT ID: NCT02558894 Completed - Clinical trials for Metastatic Pancreatic Ductal Adenocarcinoma

Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

Start date: November 16, 2015
Phase: Phase 2
Study type: Interventional

A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

NCT ID: NCT02558556 Recruiting - Cholecystitis Clinical Trials

FALCON: a Multicenter Randomized Controlled Trial

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

Rationale: Several clinical feasibility studies have shown the potential benefit of near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) for enhanced and earlier biliary anatomy visualization during laparoscopic cholecystectomy with the aim to reduce the number of vascular and biliary injuries. Although the incidence of injuries is low (0.7%), the impact on patients in terms of morbidity, quality of life and costs are dramatic. The Critical View of Safety (CVS) technique is regarded as the safety valve in conventional laparoscopic cholecystectomy (CLC). It is hypothesized that standard application of near-infrared fluorescence imaging during laparoscopic cholecystectomy can be useful to obtain establishment of CVS (at least 5 minutes) earlier and with more certainty regarding visualization when compared to conventional laparoscopic imaging alone. Study design: A multicenter randomized controlled trial with two study arms. Patients scheduled for an elective laparoscopic cholecystectomy will be recruited and randomized at the outpatient clinic (n = 308 total). One group will undergo near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (NIRF-LC) and the other group will undergo conventional laparoscopic cholecystectomy (CLC). Compared with standard care, patients in the NIRF-LC group have to receive one preoperative intravenous injection of ICG. This is the only additional minimally invasive action for the patient. Initially, patients participating in this study will not benefit from the application of NIRFC during the surgical procedure. The administration of ICG and the modified laparoscope itself are not related with any kind of additional risk for the patient. Despite the encouraging results from several (pre)clinical feasibility studies, wide clinical acceptance of the routine use of ICG fluorescence laparoscopy is still lacking due to the absence of reliable and validated clinical data. A randomized clinical study is desirable to assess the potential added value of the NIRF imaging technique during laparoscopic cholecystectomy. Strong evidence in favor of routine implementation of this new imaging technique during laparoscopic cholecystectomy, will probably lead to worldwide routine application of the NIRF technique. Therewith long term sustainability of this research project is guaranteed.

NCT ID: NCT02558296 Completed - Clinical trials for Type 2 Diabetes Mellitus

Bexagliflozin Efficacy and Safety Trial

BEST
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

NCT ID: NCT02558231 Completed - Clinical trials for Pulmonary Arterial Hypertension

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

TRITON
Start date: May 1, 2016
Phase: Phase 3
Study type: Interventional

The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.

NCT ID: NCT02558166 Completed - Septic Shock Clinical Trials

Renal Resistive Index in Patients With Shock

Start date: August 2015
Phase: N/A
Study type: Observational

This study consists of two substudies. The first substudy: 'Renal resistive index in critically ill patients with cardiogenic and septic shock' Design: cross-sectional observational Aim of this project is: 1. to determine whether critically ill patients with cardiogenic and septic shock have an elevated Renal Resistive Index and 2. to determine whether Renal Resistive Index differs between cardiogenic/hypovolemic shock and shock due to sepsis/systemic inflammation (SIRS) 3. to determine the relation between the (change in) renal vascular resistance and - Markers of the systemic - and the microcirculation - Fluid status as quantified by bioimpedance analysis - Concomitant renal function The second substudy: 'Predictive value of the Renal Resistive Index on ICU admission and its course for the development of acute kidney injury in critically ill patients with cardiogenic and septic shock' Design: longitudinal observational The aim of this project is: 1. to determine whether the renal resistance index on admission to the intensive care unit can predict the development of acute kidney injury (AKI) in critically ill patients with shock 2. to investigate if the renal resistance index on admission to the intensive care unit is an independent predictor of the development of AKI or depends on the severity and duration of shock and other known risk factors of AKI such as comorbidity and use of nephrotoxic drugs Aim of the large research project is to determine whether the Renal Resistive Index could become a monitoring tool for intervention studies aiming to prevent acute kidney injury or protect the kidney.