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NCT ID: NCT01563458 Completed - Clinical trials for Acquired Bleeding Disorder

Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

Start date: August 2001
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

NCT ID: NCT01562912 Completed - Atrial Fibrillation Clinical Trials

Efficiency Study Evaluating the Use of PVAC Catheter Technology for Performing Ablation in Pts With Atrial Fibrillation

CAPCOST
Start date: February 2012
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF is associated with increased risk of stroke,HF, and even mortality. AF can cause debilitating symptoms, adversely affect patient's (pt's) quality of life and functional status. Hence a strategy of sinus rhythm (SR) may be pursued over a strategy of allowing AF to persist. Percutaneous catheter ablation is an effective alternative to antiarrhythmic drugs (AAD) for maintaining SR. The success rate of PV isolation off AAD is about 80-90% in pt's with PAF, but repeat procedures are required in up to 40% of pt's. After one ablation, the success rate may only be 50-70% off drugs.Current standard ablation procedures for PV antral isolation employ mapping systems which reconstructions of the LA and PV anatomy are created. Visualization may be supplemented by integration of CT/ MRI images and/or intracardiac echocardiography. Robotic navigation has been employed to assist in ablation. Based on single point unipolar radiofrequency (RF) ablation catheter where lesions are created point-by-point around the PVs to obtain electrical isolation.This results in lengthy complex, costly procedures,often more than 4 hours, which requires high degree of operator skill.Creation of contiguous, transmural lesions is challenging with standard single-point RF. A novel multipolar catheter ablation system has been evaluated for achieving PV isolation (PVAC catheter, Medtronic Inc.) An over-the-wire circular mapping/ablation catheter can be advanced into the PV antrum, and multiple lesions around the circumference of the catheter can be delivered simultaneously using duty-cycled unipolar and bipolar RF energy. Early reports, the system can achieve complete PV isolation with reduced fluoroscopy and procedural times using lower powers to achieve more reliable lesion sets.Long-term efficacy also seems comparable to standard RF ablation.This novel technology has potential to broaden the application of AF ablation, making procedures less time-consuming, less complex without compromising procedural efficacy. Published data PVAC technology outcomes are limited to studies with small sample sizes of 12-102 pt's. Data has been restricted to a small number of European centers performing moderate numbers of PVAC procedures. There is no prospective, multicenter data. Little is known about the efficiency of PVAC procedures, allowing for an assessment of cost-effectiveness in using this technology.

NCT ID: NCT01562470 Completed - Thigh Cellulite Clinical Trials

Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream

Start date: June 2011
Phase: Phase 1
Study type: Interventional

Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo. This will be a double-blind, placebo-controlled study involving subjects with distinctive cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo to the other, by random allocation, and cellulite appearance will be measured at week 0, 8 and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.

NCT ID: NCT01562171 Completed - Obesity Clinical Trials

Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk

LEN-0-2012
Start date: March 2012
Phase: N/A
Study type: Interventional

Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with high cholesterol and obesity.

NCT ID: NCT01562015 Completed - Clinical trials for Non Small Cell Lung Cancer

A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC)

CHIARA
Start date: April 2012
Phase: Phase 2
Study type: Interventional

Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers. Subjects will be enrolled to receive ganetespib one time per week for three weeks followed by a rest week; and will repeat this schedule until the cancer gets worse or the subject is unable to tolerate ganetespib. The primary goal of the study is to determine how ganetespib is tolerated and how active it is in ALK positive NSCLC.

NCT ID: NCT01561651 Completed - Atrial Fibrillation Clinical Trials

Left Atrial Appendage Occlusion Study III

LAAOS III
Start date: July 2012
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works. The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.

NCT ID: NCT01561625 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Signaling Pathway Activation After Exercise in Patients With Chronic Obstructive Pulmonary Disease

SIM
Start date: October 2009
Phase: N/A
Study type: Interventional

Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD). Although resistance exercises increase strength and muscle mass in patients with COPD, the response to training appears to be suboptimal in these individuals. A dysregulation in the signaling pathways involved in the regulation of muscle mass could play an important role in this phenomenon. Hypothesis: Proteins involved in muscle mass regulation will be less activated in the quadriceps of patients with COPD following the acute bout of resistance training exercise compared to healthy age-matched controls.

NCT ID: NCT01561547 Completed - Pain Clinical Trials

Trial of Repeated Analgesia With Kangaroo Care

TRAKC
Start date: June 2012
Phase: Phase 3
Study type: Interventional

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied. AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.

NCT ID: NCT01561274 Completed - Hypotension Clinical Trials

ET 50 for Post Caesarean Section Spinal Hypotension

ET-50
Start date: March 2012
Phase: Phase 2
Study type: Interventional

Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery. Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is one cause of this hypotension. The higher the spread of the blockade will result in a higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread within the intrathecal space before it will be taken up by the nerve roots. The time that a patient remains in one position after medication injection will affect the spread of the resultant anesthetic block. A patient who is left sitting for a longer period of time after injection of hyperbaric medication will have a lower level of block than someone who is placed supine immediately. In this study, the investigators wish to use up down sequential analysis to determine the time period a patient should remain seated after intrathecal injection of hyperbaric bupivacaine that will result in a 50% rate of hypotension.

NCT ID: NCT01560637 Completed - Clinical trials for Pulmonary Arterial Hypertension

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

Start date: September 11, 2013
Phase: Phase 3
Study type: Interventional

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.