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NCT ID: NCT01476540 Completed - Anorexia Nervosa Clinical Trials

Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

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

Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and neurobiology of AN has led to a greater understanding of its underlying pathophysiology, although few significant advances in treatment have been made in the last half-century. The central features of AN, which include an intense fear of gaining weight, a refusal to maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria surrounding food, have been linked to dysfunction in key brain structures and circuits. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the insertion of electrodes into structures believed to drive pathological behavior. The procedure is approved for the management of movement disorders, such as Parkinson's Disease, and has shown promising early results in the management of some psychiatric conditions, such as Major Depression. The purpose of this study is to explore the safety and initial efficacy of DBS, in patients with treatment resistant AN.

NCT ID: NCT01476527 Completed - Bipolar Disorder Clinical Trials

Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder

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

Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry. Although episodes of mania and hypomania define the different types of the disorder, the clinical picture is one dominated by depressed mood and agitation. The mainstay of BD treatment has thus far been pharmacologic, but many patients remain severely disabled by their condition, despite the best available medical treatment. The successful use of deep brain stimulation (DBS) in movement disorders, and its promising results in major depressive disorder (MDD), has led researchers to consider its use in highly selected refractory cases of BD. Evidence form the imaging and circuitry literature suggests that similar underlying dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose a phase I clinical trial to evaluate the safety of DBS in BD.

NCT ID: NCT01476501 Completed - Clinical trials for Diabetic Nephropathy

Vitamin D Supplementation in Diabetic Nephropathy

Start date: October 2011
Phase: Phase 2
Study type: Interventional

Diabetes is a life-long disease that is getting more common in Canada. One of the most common problems in people with kidney disease is diabetes and low bone mineral density (BMD). This can lead to a higher chance for broken bones, infection and life-long health problems. The most common reason for having low BMD is not getting enough vitamin D (Vit D) in your diet and not having enough sunlight. This is very common in Canada (especially in northern Alberta) because winter is very long. Most people also don't eat or drink enough foods that are high in Vit D (like milk) and so they don't have enough Vit D in their body to make healthy bones. This can mean the only way to get enough Vit D in your body for your bones when you have kidney disease is to take some extra vitamin D in a pill. Most people are not aware that they have poor bone health until they break a bone. Broken bones can really hurt and can prevent a person from being able to walk and take care of themselves. Right now, we are not sure exactly how much Vit D people with diabetes and kidney disease need to take to prevent them from having low BMD or how often they need to take it. Our plan is to study the effect of two ways to take Vit D pills (every day or once a month) on overall Vit D status and on bone health in adult patients with diabetes and chronic kidney disease and see how this influences their quality of life. Hypotheses: 1. Vitamin D supplementation (2,000 IU/day and 40,000 IU/month) for six months will result in significantly improved overall vitamin D status and improved markers of bone health in adult patients with diabetic nephropathy. 2. Monthly dosing of vitamin D (40,000 IU/month) over six months will result in improved patient adherence and satisfaction with vitamin D supplementation when compared to daily dosing of vitamin D (2000 IU/D). This will improve vitamin D status and bone health parameters, which will result in an increased quality of life and sense of well-being.

NCT ID: NCT01475838 Completed - HIV Infections Clinical Trials

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

NCT ID: NCT01475825 Completed - Clinical trials for Hypercholesterolemia

A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol

FOCUS FH
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus placebo, and SC mipomersen 70 mg thrice weekly versus placebo. Secondary Objectives: - Determine whether there are qualitative differences between the safety profiles of the 2 dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and the overall study population - Determine whether there are qualitative differences between the tolerability of the 2 dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population - Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1, Cohort 2, and the overall study population - Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic lipid levels in Cohort 2 compared to placebo - Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients with FH and inadequately controlled LDL-C who complete the primary efficacy assessment visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label Continuation Period

NCT ID: NCT01475721 Completed - Asthma Clinical Trials

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

AUSTRI
Start date: November 18, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

NCT ID: NCT01475669 Completed - Surgical Blood Loss Clinical Trials

Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery

REPLACE
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine. The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.

NCT ID: NCT01475201 Completed - Hypertension Clinical Trials

Step Monitoring to Improve ARTERial Health

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

Many people with diabetes and/or high blood pressure (hypertension) are not very active. When people are more active, they can reduce the chances of having a heart attack or stroke. Walking more is a cheap and effective way to be more active and to lower the risk of heart attacks and strokes. The problem is that many people do not walk enough! The investigators will study if people with diabetes and/or hypertension walk more when the doctor gives them a prescription with the number of steps they should be walking every day. The investigators will compare this group, called 'active', to another group, called 'control', in which doctors and their patients do what they usually do, over a period of one year. The investigators will measure the number of steps the investigators walk everyday with a step counter or pedometer. In the step count prescription group, the doctors will give to the 'active' group a pedometer, a step count record book, and step count prescriptions. The overall goal is to gradually increase daily steps. The speed of the increase in step count will be slower for less active people. At each visit the doctor will look at the step count record book. The doctor will then give a new step count prescription to the patients. Patients of the two groups will see their doctor about four times during the year, which is how often they usually see their doctor. At the end of one year, the investigators will see the difference in the hardness of the arteries between the 'active' and the 'control' groups, using simple and safe measurements, similar to ultrasound in pregnant ladies. People with hard arteries are more likely to have a heart attack or stroke. The investigators suspect that patients who get the step count prescriptions will walk more and their arteries will be less hard than the control group. Our study will help find out if this is true. In that case, doctors should take the time to prescribe steps for all their patients with diabetes and/or hypertension.

NCT ID: NCT01474928 Completed - Asthma Clinical Trials

Asthma and Health Literacy in Newcomer Communities in the Greater Vancouver Area

Start date: August 2009
Phase: N/A
Study type: Interventional

In this study, the investigators aim to develop and test the effectiveness of culturally appropriate asthma videos and other educational materials based on knowledge from this study and the investigators' previous studies. By culturally appropriate materials the investigators mean to develop health information (in the format of video and written materials) in the community own language and applied the most appealing cultural beliefs and practices in the Chinese and Punjabi communities. The investigators also aim to recommend a practical framework and to develop a measure of asthma knowledge and health literacy among immigrants from the Punjabi and Chinese communities in BC. The investigators' definition of health literacy in this study is the capability of a person to navigate and access to asthma-related information, as well as to understand, evaluate, and communicate the obtained information to improve his/her health status. The investigators' hypothesis is that audio-visual based asthma information in a subject's native language would improve a patient's knowledge and self-management of asthma in comparison to printed information.

NCT ID: NCT01474811 Completed - Hepatitis C Clinical Trials

HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network

Start date: November 2011
Phase:
Study type: Observational

The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.