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NCT ID: NCT01870401 Completed - Clinical trials for Critical Limb Ischemia

Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Start date: June 3, 2013
Phase: N/A
Study type: Interventional

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

NCT ID: NCT01870375 Completed - Clinical trials for Mucopolysaccharidosis Type II

Longitudinal Studies of Brain Structure and Function in MPS Disorders

Start date: September 2009
Phase:
Study type: Observational

Neurobehavioral function and quality of life are compromised in many patients with mucopolysaccharidosis (MPS) disorders. The long-term goals of this research are to: 1) more accurately inform patients/parents regarding potential neurobehavioral outcomes; 2) develop sensitive measures of disease progression and central nervous system (CNS) treatment outcome; and 3) help clinical researchers develop direct treatments for specific brain structures/functions. The investigators hypothesize that specific and localized neuroimaging and neuropsychological findings and their relationship will be distinct for each MPS disorder. It is further hypothesized that without treatment, functions will decline and structure will change over time in a predictable fashion, and will be related to locus of abnormality and stage of disease.

NCT ID: NCT01870336 Completed - Clinical trials for Osteoarthritis, Knee

Combination of Lateral Foot Orthoses and Knee Brace for Treatment of the Knee Osteoarthritis

Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of the combination is compared to the single use of these devices. The investigators recruited 22 knee osteoarthritis. They have to wear each of treatments (foot orthoses, knee brace and combination) during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (Knee Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC) and Medical Outcome Study Short Form-36( MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without treatment and ten with the treatment.

NCT ID: NCT01869972 Completed - Phenylketonuria Clinical Trials

Biological Variation of Phenylalanine in Patients With Hyperphenylalaninemia

Start date: May 2013
Phase: N/A
Study type: Observational

Phenylketonuria (PKU) is a rare disease where the level of phenylalanine (one of the amino acids) in the body is greatly increased. High levels can cause brain damage, especially in babies and children. This brain damage can be prevented if a special low phenylalanine diet is started soon after birth. A new drug, sapropterin, can also lower phenylalanine levels in some patients. PKU therapy is monitored by measuring the blood phenylalanine every week, with the goal to keep the level within a target range. Recently, studies have suggested that the variation in the blood phenylalanine may be just as important as the absolute blood phenylalanine level for brain outcome. The investigators will look at the variation in blood phenylalanine level over 24 hours to see how much the level changes. The investigators will measure this in patients with typical PKU who are compliant with the diet and in patients who are not compliant with the diet. The investigators will also measure this in patients with "mild" PKU who do not usually have as high levels of phenylalanine. Finally, the investigators will see if patients on sapropterin have lower variation.

NCT ID: NCT01869829 Completed - Clinical trials for Pediatric Invasive Candidiasis

PEACE: Pediatric Antifungal Comparative Effectiveness

PEACE
Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

The overarching objective is to develop new evidence-based treatment guidelines for invasive fungal diseases in children. To accomplish that, this protocol will focus on two specific aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for the subset of patients with invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive candidiasis per hospital admissions.

NCT ID: NCT01869608 Completed - Type 2 Diabetes Clinical Trials

Postpartum Screening of Type 2 Diabetes

Tot ou tard
Start date: April 2014
Phase: N/A
Study type: Interventional

Gestational diabetes mellitus (GDM) complicates 5 to 30 % of pregnancies. GDM is defined as hyperglycemia with onset or first recognition during pregnancy. Because it is a forerunner of type 2 diabetes mellitus (T2DM), professional associations recommend T2DM postpartum screening (T2DM-pPS) at 6 weeks/6 months post delivery, using a 75g oral glucose tolerance test (OGTT). However, less than a quarter of these women are screened. This recommendation has failed for multiple reasons; the most important being that busy new mothers must deal with the major inconveniences of returning to a sampling center for a 2h testing session, bringing baby along or paying for a sitter, transportation, parking… A mother-friendly solution is direly needed. The investigators hypothesize that, in these women, results of an OGTT performed after delivery on the last day of their hospital stay (OGTT-1) will predict results of the recommended OGTT (OGTT-2) at 6 weeks/6 months postpartum. The main aim of our project is to determine the optimal cut-off value for the 2h glucose result during OGTT-1 in order to predict abnormal glucose tolerance status at OGTT-2 (the gold standard), in the same woman.

NCT ID: NCT01869556 Completed - Clinical trials for Postpartum Hemorrhage

Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

Start date: June 4, 2013
Phase: N/A
Study type: Interventional

Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.

NCT ID: NCT01869413 Completed - Bladder Cancer Clinical Trials

Tranexamic Acid During Cystectomy Trial (TACT)

TACT
Start date: June 2013
Phase: Phase 2/Phase 3
Study type: Interventional

A cystectomy is the removal of the bladder and adjacent organs in patients with bladder cancer. This often results in significant blood loss, and about 60% of patients will require a blood transfusion during or up to 30 days after surgery. Significant blood loss may result in cardiovascular morbidity, and the use of blood products are expensive and expose patients to risk. Tranexamic acid reduces breakdown of hemostatic blood clots and it has therapeutic benefit when used in other surgical procedures to reduce blood loss and the need for transfusion. The current study will be the first to evaluate whether tranexamic acid is effective and safe to use during radical cystectomy. The results of the study will have an immediate impact on patient care.

NCT ID: NCT01869075 Completed - Clinical trials for Venous Thromboembolism

Toronto Thromboprophylaxis Patient Safety Initiative

TOPPS
Start date: July 2006
Phase: N/A
Study type: Interventional

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE, is one of the common and preventable complications of hospital stay. VTE prophylaxis through the use of evidence-based anticoagulant medication options or mechanical prophylaxis have been shown to reduce this risk and improve patient safety. Despite an abundance of evidence, use of VTE prophylaxis remains low. This study assesses the effectiveness of quality improvement strategies (use of pre-printed orders, audit and feedback, involvement of the pharmacist as project need and as a reminder to the physician, and education of staff) on use of appropriate VTE prophylaxis. The study aims to measure if the use of these strategies improves the use of VTE prophylaxis and therefore, improves patient safety and patient care by reducing the risk of developing DVT or PE.

NCT ID: NCT01869062 Completed - Heart Failure Clinical Trials

Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

SonR-ECHO
Start date: June 2013
Phase: N/A
Study type: Interventional

The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings. This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.