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NCT ID: NCT02049294 Completed - Clinical trials for Eosinophilic Bronchitis

Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Start date: March 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis. This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods. Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months). Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.

NCT ID: NCT02048865 Completed - Cancer Clinical Trials

Apixaban for the Prevention of Venous Thromboembolism in Cancer Patients

AVERT
Start date: March 24, 2014
Phase: Phase 2
Study type: Interventional

Cancer patients have an increased risk of developing blood clots in the veins compared to non-cancer patients. Cancer patients who develop blood clots can lead to reduced life expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most effective way to decrease the complications associated with blood clots in the veins. Although previous clinical trials have shown some benefit on the use of medication to prevent blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive in demonstrating that existing blood thinners significantly reduce the rate of blood clots in cancer patients. One possible explanation relates to the fact that these studies have included a large proportion of cancer patients who are a low risk of developing blood clots in the veins. We are proposing to identify cancer patients who are at a high risk of developing blood clots by using a validated tool at the time of their cancer diagnosis. The identified high risk cancer patients will be asked to participate in a trial to test the safety and efficacy of a new oral medication that has been used to prevent blood clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will receive the study drug and 287 will receive an inactive substance. Analysis will be performed to assess the safety and the superiority of the study drug.

NCT ID: NCT02048696 Completed - Clinical trials for Coronary Artery Disease

Effect of Exercise Training on Left Ventricular Function in Patients Post Myocardial Infarction

EXIT-V
Start date: February 2014
Phase: N/A
Study type: Interventional

Patients who have suffered a heart attack are at risk of developing worsening heart function and heart failure. Exercise training has a beneficial effect on heart function and prevents heart failure. The aim of the current study is to investigate the effect of exercise training on heart function in patients who have suffered a heart attack.

NCT ID: NCT02048124 Completed - Clinical trials for Solid Lesion Biopsies

Study Comparing 25d ProCor Needle Versus the Standard 25g Needle for Biopsies Performed by EUS-FNA

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a new needle named "ProCor" was developed in the hope of obtaining core samples and thus increase diagnostic yield. Objective: In this research project, we propose to conduct a prospective trial to compare the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor needle (25gP). EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P). The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive). Results for continuous variables will be summarized using mean ± SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.

NCT ID: NCT02047864 Completed - Osteoporosis Clinical Trials

Effect of Creatine Supplementation and Exercise on Bone Health

Start date: January 2014
Phase: N/A
Study type: Interventional

Osteoporosis is an important health problem, costing the Canadian health care system over $2 billion per year. Loss of bone mineral and bone fragility is especially prevalent in postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic. Creatine monohydrate is a nutritional supplement that is often combined with strength training to increase strength and muscle mass. The investigators recently completed a pilot study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate significantly improved hip bone mineral density during a 1-year resistance training program. In our current proposal the investigators want to determine whether creatine combined with strength training can have an even larger effect on bone mineral density at the hip if given over 2 years in a large group of postmenopausal women (n=240). The investigators also want to determine whether this leads to reduced fractures in these women for up to a year after completing the creatine and strength training program.

NCT ID: NCT02047734 Completed - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

RADIANCE
Start date: December 3, 2013
Phase: Phase 3
Study type: Interventional

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record. The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

NCT ID: NCT02047097 Completed - Multiple Sclerosis Clinical Trials

Dimethyl Fumarate (DMF) Observational Study

ESTEEM
Start date: November 19, 2013
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

NCT ID: NCT02046837 Completed - Prostate Cancer Clinical Trials

An Exercise Trial and Economic Analysis in Men With Prostate Cancer

ADT Ex RCT
Start date: November 2013
Phase: Phase 2
Study type: Interventional

Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective? In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based supported; and (c) 1:1 supervised in-centre exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective. The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program. Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.

NCT ID: NCT02045862 Completed - Overactive Bladder Clinical Trials

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

SYNERGY II
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

NCT ID: NCT02045836 Completed - Herpes Zoster Clinical Trials

Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older

Start date: March 5, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.