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NCT ID: NCT02562781 Completed - Vascular Disease Clinical Trials

Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications?

HYPEROXIA
Start date: November 2014
Phase: Phase 3
Study type: Interventional

Patients undergoing vascular surgery are at a significantly high risk of perioperative cardiovascular, cerebral and renal events compared to those undergoing non-vascular surgery. This could be because of co-morbidities that are common in this patient group. Additionally, smoking, which is common in this population, may be a contributing factor. Oxygen therapy has been used for decades in order to reduce the risk of myocardial infarction and stroke in patients undergoing vascular surgery and pre-existing co-morbidities in the belief that increased inspired oxygen increases oxygen delivery to tissues, thereby reducing the risk for hypoxia and cell death. However, several studies published recently have questioned the routine use of high inspired oxygen concentration (hyperoxia) to improve oxygen delivery, specifically in the neonatal period but possibly even following myocardial infarction. This could be explained by the fact that increasing inspired concentrations of oxygen cause vasoconstriction in cerebral and coronary arteries, thereby reducing blood flow. Additionally, increased oxygen causes excessive production of reactive oxygen species (ROS), and repercussion injury from oxidative stress. The latter can lead to apoptosis (cell death) in myocardial or cerebral neurons. Despite the high risks of administering oxygen when not needed, it is routinely used in hospitals all over the world without a doctors prescription. This study aims to assess peri-operative complications up to 1 year following vascular surgery in patients randomised to receive high inspired oxygen concentration (endpoint: SpO2 98 - 100%) or minimal inspired O2 concentration (endpoint: SpO2 > 90%).

NCT ID: NCT02562443 Terminated - Clinical trials for Myelodysplastic Syndrome

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA

INSPIRE
Start date: December 2, 2015
Phase: Phase 3
Study type: Interventional

The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

NCT ID: NCT02561806 Completed - Plaque Psoriasis Clinical Trials

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

IXORA-S
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

NCT ID: NCT02560662 Completed - Breast Cancer Clinical Trials

PhysSurg-B : Physical Activity in Relation to Surgical Operations - Breast Cancer

PhysSurg-B
Start date: January 27, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery.

NCT ID: NCT02558530 Completed - NAFLD Clinical Trials

Resolution of Liver Fat in Non-alcoholic Fatty Liver Disease

Start date: January 2015
Phase: N/A
Study type: Interventional

The major adverse health consequences of obesity occur only when non-alcoholic fatty liver disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of triglycerides and other lipids. The first-line approach to NAFLD management is caloric restriction and weight loss, but these remain difficult to achieve. Little attention has been given to dietary carbohydrate restriction, despite recent reports showing that hepatic de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the postprandial state, accounts for approximately 25% of liver triglyceride content in hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized 30% fat diet for four days before being assessed.

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: NCT02557776 Completed - Clinical trials for Hereditary Breast Cancer

Written Genetic Counseling and Mutation Analysis of BRCA1 and BRCA2 to Patients With Breast Cancer

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

The overall purpose of the study is to evaluate a method for offering mutation analysis of BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at diagnosis and family history. Information about the study as well as pre-test genetic counseling will primarily be given in a written way. In addition to that, if a study participant wishes to, she can also receive pre-test telephone genetic counseling.

NCT ID: NCT02556580 Recruiting - Inflammation Clinical Trials

Volume Kinetics for 20% Albumin in Different Clinical Situations

Albumin
Start date: February 2016
Phase: Phase 4
Study type: Interventional

The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.

NCT ID: NCT02556203 Terminated - Clinical trials for Transcatheter Aortic Valve Replacement

Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes

GALILEO
Start date: December 16, 2015
Phase: Phase 3
Study type: Interventional

To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.

NCT ID: NCT02551874 Completed - Clinical trials for Type 2 Diabetes Mellitus

A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Start date: October 20, 2015
Phase: Phase 3
Study type: Interventional

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.