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NCT ID: NCT01897532 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Start date: July 10, 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.

NCT ID: NCT01896713 Completed - Prostate Cancer Clinical Trials

The Value of MultiSpectral 3 Tesla MRI in Active Surveillance of Prostate Cancer

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

MultiSpectral 3 Tesla MRI (MS3TMRI) can increase the yield of Trans Rectal Ultrasound Biopsy (TRUSBx) to improve identification of patients on active surveillance requiring treatment.

NCT ID: NCT01896505 Completed - Sarcoma Clinical Trials

A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma

Start date: July 30, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.

NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01896037 Completed - Spinal Cord Injury Clinical Trials

Omega-3 Supplementation for Tetraplegics With Poor Cholesterol Levels

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

People with a spinal cord injury (SCI) characteristically have low levels of high-density lipoprotein-cholesterol (HDL-c; "good cholesterol") and high levels of low-density lipoprotein-cholesterol (LDL-c; "bad cholesterol"), and are at a higher risk of developing cardiovascular health problems, such as heart disease, heart attack and stroke, than the able-bodied population. A common way for able-bodied people to improve their lipid profile is through exercise; however, SCI people, especially tetraplegics, are often unable to achieve and maintain a level of exercise needed to obtain these benefits. It is therefore clinically important to find an effective, safe and inexpensive method of increasing HDL-c levels in people with chronic tetraplegia. This study will investigate the effects of omega-3 fatty acid supplementation on the lipid profile of people with tetraplegia. The investigators hypothesize that 5 months of daily consumption of high doses of omega-3 fatty acids will increase plasma levels of HDL-c in those with tetraplegia, leading to decreased risk of cardiovascular health issues.

NCT ID: NCT01896011 Completed - Clinical trials for Non Displaced Atypical Femoral Fractures

Effect of Teriparatide on Fracture Healing in Patients With Incomplete Atypical Femur Fractures

Start date: July 2013
Phase: Phase 3
Study type: Interventional

Atypical femur (thigh bone) fractures (AFFs) are uncommon low-trauma fractures which often occur without warning, are highly debilitating, and are slow to heal. As physicians learn more about them, AFFs are increasingly being identified prior to a total break. However, there's no evidence on the best way to treat these non-displaced AFFs. One option is teriparatide, an osteoporosis medication that can build new bone. Investigators will conduct a double blind randomized placebo controlled trial to examine whether teriparatide use in AFF patients with an incomplete break will help accelerate fracture healing and prevent surgical intervention. Co-primary outcomes include change in WOMAC scores from baseline to 12 months and number of participants requiring surgical intervention at 12 months. Investigators will recruit 60 women and men over the age of 30 who have experienced an incomplete AFF. Participants will be randomly assigned to either teriparatide (20 mcg/day) or placebo (using an identical injection pen) for up to 2 years. As AFFs are highly debilitating, a trial examining the use of Teriparatide in this population is urgently needed.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895738 Completed - Trauma Clinical Trials

WrapAround Care for Youth Injured by Violence

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

Youth injured by violence is a major public health concern in Canada. It is the fourth cause of death and the leading reason for a youth to visit an emergency department (ED). In Winnipeg, 20% of youth who visit an emergency department with an injury due to violence have a second visit for a subsequent violent injury within the following year. This is consistent with studies in other jurisdictions that demonstrate that violent injury is a chronic condition. Youth injured by violence are in a reflective and receptive state of mind, rendering the emergency department setting appropriate for intervention. The investigators propose a WrapAround Care model delivered by a support worker with lived experience with violence, supported by a social worker, an addictions and mental health counsellor, a family counsellor and links to multiple community partners. Support workers will be on call 24 hours a day, 7 days a week in order to start the intervention in the ED and take advantage of the "teachable moment". The proposed study is a pilot randomized control trial to assess the feasibility of a randomized control trial designed to assess efficacy. For the pilot trial the investigators will assess recruitment, treatment fidelity, participant adherence and safety. The intervention arm will receive wraparound care initiated at the time of their visit for injury due to violence. The control arm will receive standard of care (usually a list of community contacts). The investigators will use an adapted pre-consent randomization methodology. This intervention has been developed using a community based participatory research approach. Our team includes clinicians, nurses, social workers, community youth workers, ex-gang members, elders and researchers.

NCT ID: NCT01895543 Completed - Clinical trials for Chronic Idiopathic Constipation

Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Echo 3
Start date: September 2013
Phase: Phase 3
Study type: Interventional

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation

NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.