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NCT ID: NCT01876173 Completed - Clinical trials for Cardiovascular Disease

Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

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

Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the incidence of SCD by delivering an internal shock to restore a normal rhythm, if needed. Definitive evidence has established the effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary prevention indication). Approximately 3,700 new candidates accrue annually. Practice guidelines define the criteria to determine patient ICD candidacy for primary prevention. However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes, renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and risks of an ICD can become complex, particularly when competing mortality risks are present. Research has recognized human costs associated with device complications and shocks affecting psychological, health related quality of life (HRQL), and morbidity outcomes. The complexities surrounding the long-term benefits/risks, complications, replacements, and shocks, warrant decision support to prepare patients to make decisions. In Canada, there is no clear framework to support patients' decision-making in the context of ICD treatment options. Decision support, using a decision aid, could moderate treatment related uncertainty and prepare patients to make active, informed, quality decisions. Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to determine the feasibility of conducting a trial.

NCT ID: NCT01875991 Completed - Clinical trials for Rheumatoid Arthritis

Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

Start date: June 5, 2013
Phase: Phase 4
Study type: Interventional

The study will estimate the preference of rheumatoid arthritis (RA) and Plaque Psoriasis (PsO) patients who self inject etanercept for one of two experimental autoinjectors.

NCT ID: NCT01875679 Completed - Clinical trials for Technical Errors in Surgery

Comprehensive Surgical Coaching

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

Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training. The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.

NCT ID: NCT01875627 Completed - Obesity Clinical Trials

Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal

InGel
Start date: November 2010
Phase: Phase 1
Study type: Interventional

To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals.

NCT ID: NCT01875341 Completed - Hypertension Clinical Trials

Role of Sleep Apnea and Sympathetic Activity in Resistant Hypertensive Patients.

SAS
Start date: December 2004
Phase: Phase 3
Study type: Interventional

Hypertension is highly prevalent in type 2 diabetic patients (NIDDM) with nephropathy, and is the single most important determinant of the rate of renal function loss. In many of these patients, hypertension is resistant to therapy. Although increased sympathetic activity is also highly prevalent in NIDDM patients with nephropathy and chronic renal insufficiency, little attention has been paid to sleep apnea as the cause of both resistant hypertension and sympathetic hyperactivity in this population. Since the prevalence of sleep apnea is increased in patients with either NIDDM, or resistant hypertension, or chronic renal insufficiency, it is almost certain that sleep apnea has a high prevalence in patients in whom all three states co-exist, i.e. NIDDM patients with nephropathy and hypertension resistant to therapy. As a consequence of undetected and untreated sleep apnea, resistant hypertension, nocturnal hypertension, and sympathetic hyperactivity likely contribute to accelerated loss of renal function and increased cardiovascular morbidity and mortality in these patients. Hypothesis: A. Sleep apnea is highly prevalent in type 2 diabetic patients with diabetic nephropathy and hypertension resistant to therapy. Treatment with nasal continuous positive airway pressure (NCPAP) will result in a decrease in blood pressure and restore normal diurnal blood pressure pattern. B. Sleep apnea-caused hypertension is mediated by sympathetic hyperactivity and increased activity of the renin-angiotensin-aldosterone system (RAAS) in type 2 diabetic patients with nephropathy. A decrease in sympathetic hyperactivity in response to NCPAP therapy will result in a decrease in plasma renin activity and plasma aldosterone concomitant with decreases in blood pressure. Randomized, double blind, parallel comparative (two groups) one center trial. Therapeutic treatment with nasal continuous positive airway pressure (NCPAP) Sub-therapeutic treatment with nasal continuous positive airway pressure

NCT ID: NCT01875055 Completed - Cerebral Ischemia Clinical Trials

Reversing Cerebral Oxygen Desaturations Greater That 10% of Baseline Values Using NIRS in the ICU

NIRS-ICU
Start date: May 2013
Phase: N/A
Study type: Interventional

Study objectives: The main objective of this study is to determine the feasibility of implementing measures in the intensive care unit (ICU), based on a physiological algorithm, to reverse decreases in cerebral oxygen saturation using, near-infrared spectroscopy (NIRS). Methods: Randomization of 50 patients is balanced by experimental group; control and intervention, with an allocation sequence based on a block size of ten, generated with a computer random number generator. In the intervention group ICU Staff will use NIRS to follow a physiologically guided strategy to maintain regional oxygen saturation (rSO2) within 90% of baseline values. In the control group ICU Staff will provide standard of care without the use of NIRS.

NCT ID: NCT01875003 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: August 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

NCT ID: NCT01874782 Completed - Clinical trials for Orthostatic Hypotension

Transcranial Electrical Stimulation for Management of Orthostatic Instability in Acute Cervical Spinal Cord Injury

Start date: May 2013
Phase: Phase 2
Study type: Interventional

Individuals with acute cervical spinal cord injury (SCI) can suffer from an excessive and prolonged fall in blood pressure when assuming an upright position, such as transitioning from lying to sitting or standing, a condition also known as orthostatic hypotension (OH). Due to a decrease in cerebral oxygenation, affected individuals can develop debilitating symptoms including lightheadedness, blurred vision, fatigue and even loss of consciousness. Recent evidence suggests that OH has a negative impact on cognition in individuals with SCI. Clinical observations suggest that OH can lead to neurological deterioration in individuals who may otherwise have a stable SCI. The presence of symptomatic OH prevented participation in 43% of physical therapy treatment sessions in a study of individuals with acute SCI despite the use of current treatment options. OH is known to adversely affect health, delay rehabilitation and prolong hospitalization in the acute phase of management of individuals who display it. Our team found OH was present in 41 of 55 (75%) patients with acute cervical SCI at our center in 2004. We plan to research the efficacy of a low-cost, non-invasive device known as transcranial electrical stimulation (TES) to manage OH in individuals with acute cervical SCI. Previous studies have shown that this device is safe to use in individuals with SCI, and has improved blood pressure control in non-SCI individuals. We hypothesize that in individuals with acute cervical SCI and OH, TES intervention will elicit an attenuation of the drop in systolic BP (SBP)in response to orthostatic stress. TES-induced differences will be most pronounced in those individuals with sparing of spinal autonomic pathways

NCT ID: NCT01874509 Completed - Alcohol Consumption Clinical Trials

Randomized Controlled Trial of a Minimal Versus Extended Internet-based Intervention for Problem Drinkers

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

Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings. One promising strategy is Internet-based interventions for problem drinkers. The first randomized controlled trial found that the investigators could reduce alcohol consumption by about six drinks per week at a six-month follow-up using a minimal, personalized feedback Internet-based intervention. The investigators second randomized trial demonstrated that an extended Internet-based intervention that contained a range of cognitive-behavioural and relapse prevention tools could produce greater reductions in problem drinking compared to that provided by the same minimal intervention at a six-month follow-up. Building upon this research, the current project will assess whether this extended Internet-based intervention can have a sustained impact on problem drinking. Specifically, the major objective of this project is to conduct a randomized controlled trial comparing the impact of an extended Internet-based self-help intervention for problem drinkers to a minimal Internet-based intervention in the general population of problem drinkers over a two year period. Problem drinking participants will be recruited through media advertisements across Canada and will be randomly assigned to the minimal or extended Internet-based interventions. Six-month, twelve-month and two-year drinking outcomes will be compared between experimental conditions. It is predicted that participants receiving the extended Internet intervention will display sustained improved drinking outcomes compared to participants in the minimal Internet intervention condition. This programmatic line of research will advance the science of Internet-mediated intervention.

NCT ID: NCT01874431 Completed - Clinical trials for Diabetic Nephropathies

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

ARTS-DN
Start date: June 12, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.