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NCT ID: NCT01719003 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Start date: October 2012
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

NCT ID: NCT01718977 Completed - Spinal Cord Injury Clinical Trials

Cardiovascular Health/Outcomes: Improvements Created by Exercise and Education in SCI (CHOICES)

CHOICES
Start date: January 2013
Phase: N/A
Study type: Interventional

This study aims to determine whether body weight-supported treadmill training (BWSTT) has beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI). After SCI, the primary cause of illness and death is CVD. Currently, preventative measures focus around increasing physical activity- especially through the use of ACET. However, ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular health in individuals with SCI. The studies primary outcome measure is carotid-to-femoral pulse wave velocity (cfPWV) which has been shown to have prognostic value for CVD above and beyond that of other risk factors. It is hypothesised that through large muscle mass involvement and postural challenge, the physical stimuli of BWSTT will reduce cfPWV and lower CVD risk in individuals with SCI.

NCT ID: NCT01718574 Completed - Cancer Clinical Trials

Bibliotherapy for Patients With Cancer

Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.

NCT ID: NCT01718535 Completed - Clinical trials for Genotyping Techniques

Method Comparison Study of the Spartan FRX CYP2C19 Genotyping System Against Bi-directional Sequencing

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

The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and *17 genotypes from genomic DNA obtained from buccal swab samples. This study is purposed to demonstrate the concordance (positive and negative percent agreement) by comparing the Spartan FRX system against bi-directional DNA sequencing. The study will also evaluate the concordance between three different sample transport embodiments provided to laboratories for use in transporting the reagent tubes with collected buccal sample swab to the laboratory.

NCT ID: NCT01718353 Completed - Clinical trials for Prostate Cancer Metastatic

Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

TAXYNERGY
Start date: March 2013
Phase: Phase 2
Study type: Interventional

Docetaxel and cabazitaxel are cancer chemotherapy agents of the taxane drug class. The purpose of this study is to explore the benefit, for treatment of metastatic castration-resistant prostate cancer (mCRPC), of a regimen in which participants begin treatment with either of these two taxane drugs (docetaxel or cabazitaxel, in combination with prednisone) and are switched to the other taxane drug if prostate-specific antigen (PSA) value does not decrease ≥30% after 4 cycles. As defined in study protocol amendment 3, efficacy results are summarized for all participants combined, irrespective of which agent (docetaxel or cabazitaxel) was administered initially, rather than separately for the two groups based on taxane administered initially. One of the primary outcome measures is percentage of participants with a ≥50% sustained decrease from baseline in PSA at any time during the trial. By providing an opportunity for patients to switch taxane based on early PSA response, there may be a difference in result for this measure versus result in a study where it was not possible to switch. The other primary outcome measures are change from baseline in circulating tumor cells (CTCs) biomarkers percent androgen receptor nuclear localization (%ARNL) and microtubule bundling (MTB).

NCT ID: NCT01717742 Completed - Pleural Empyema Clinical Trials

Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)

Start date: December 2012
Phase: Phase 3
Study type: Interventional

Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. The incidence of pleural empyema in children has increased significantly in the last 10 years. Short term morbidity for this condition is substantial, but unlike in adults, the long term outcome of this condition for children in developed countries is favourable. Inserting a chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down organized pus has been shown to be an effective therapy for reducing the duration of illness. However, this treatment is still suboptimal and prolonged hospitalization is common. Recent data from adults suggests that adding an additional medicine (DNase) to decrease the viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes; however, there are no published studies on children. This is a multi-centre randomized controlled trial comparing the time to discharge from hospital after chest drain insertion in previously well children who present with pleural empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone. Other outcomes related to effectiveness, safety and cost will be assessed as well.

NCT ID: NCT01717716 Completed - Childhood Obesity Clinical Trials

Sugars-containing Beverage and Food Intake in Children

Start date: June 2011
Phase: N/A
Study type: Interventional

The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.

NCT ID: NCT01717703 Completed - Obesity Clinical Trials

Sugars-sweetened Commercial Beverages on Short-term Food Intake

Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.

NCT ID: NCT01717690 Completed - Clinical trials for Staph Aureus Methicillin Resistant Colonization

Study of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization in Complex Continuing Care

Start date: August 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether daily bathing with 2% chlorhexidine gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA). Investigators postulate that daily bathing with CHG significantly reduces incidence of colonization of hospitalized patients with MRSA.

NCT ID: NCT01717274 Completed - Sinusitis Clinical Trials

Hot Saline Irrigation Study

HSI
Start date: November 2012
Phase: N/A
Study type: Interventional

Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow for the best surgical view and to reduce risk while in surgery. Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body. The investigators would like to determine if hot saline irrigation (HSI) compared to room temperature saline irrigation (RTSI) can control bleeding during FESS. The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding during FESS.