Clinical Trials Logo

Filter by:
NCT ID: NCT02211209 Completed - Clinical trials for Familial Chylomicronemia Syndrome

The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

NCT ID: NCT02211092 Completed - Family Caregivers Clinical Trials

Feasibility Study of a Home-based Physical Activity Intervention for Family Caregivers of People With Advanced Cancer

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

The purpose of this study is to develop an individually tailored home-based physical activity intervention for family caregivers of people with advanced cancer and assess the feasibility of a future randomized controlled trial (RCT) to test the effects of this intervention.

NCT ID: NCT02210715 Completed - HIV Clinical Trials

Raltegravir-based Antiretroviral Versus Maintaining Any Other Antiretroviral Therapy in HIV Mono-infected Patients

Start date: March 2015
Phase: Phase 4
Study type: Interventional

People infected with HIV are living longer thanks to the use of antiretroviral therapy (cART). In aging HIV persons, other factors are associated with early death. One of the major factors is liver disease, which can be due to liver infections or reasons such as fatty liver. Fatty liver in the general population is a serious problem, affecting 30% of Canadian population. A specific type of fatty liver characterized by much inflammation, named nonalcoholic steatohepatitis (NASH) can lead to cirrhosis and death. Persons living with HIV can be at increased risk of NASH because of toxic effect of certain types of cART on the liver, obesity and other metabolic factors (for example diabetes). Some scientific data suggest that newer cART are associated with less fatty liver and liver damage. However, NASH has not been studied in detail in persons living with HIV. One reason for the lack of research is one of the only ways to detect liver disease is to undergo liver biopsy which can be painful and has complications. Recently, a new non-invasive technology (Fibroscan) has been developed which can tell doctors how much a liver is damaged and how much fat it contains without pain or complications. Moreover, a simple test measuring a specific protein in the blood, the cytokeratin 18 (CK-18), can help the diagnosis of NASH. We will study the effect of switching cART to newer types of HIV medication in patients with a non-invasive diagnosis of NASH done by Fibroscan and cytokeratin 18. We expect that switching older cART to less hepatotoxic drugs will lead to improvement of liver damage, fatty liver and NASH diagnosed by Fibroscan and cytokeratin 18. To evaluate this approach we plan to recruit 58 consenting HIV mono infected patients with non-invasive diagnosis of NASH and/or fatty liver with liver damage. Participants will undergo Fibroscan, a blood test for cytokeratin 18, a complete physical examination and laboratory tests every 3 months for 12 months, then at 18 and 24 months. The effect of the switching of HIV medications will be recorded. We anticipate that the current study will provide evidence for reduction of inflammation and liver damage with newer cART for treatment of HIV infection.

NCT ID: NCT02210455 Completed - Clinical trials for Fetal Alcohol Spectrum Disorder

Parenting Training for Children With FASD

SF-FASD
Start date: July 2014
Phase: N/A
Study type: Interventional

Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum disorders (FASD) was established to encompass the full spectrum of teratogenic effects induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births, making this a public health problem of epidemic proportion. Even though considerable efforts have been aimed at identifying children with FASD, the need for access to services and supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is little empirical data available to influence policy change in how these services and supports are delivered. A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types of supports children with FASD and their families require and to develop appropriate mechanisms to provide these services at the community, provincial/territorial and federal levels. This identified need forms the basis of the current proposal. Although a variety of psychosocial interventions have been developed to treat neurobehavioural disorders, relatively little research has been conducted that is specifically aimed at improving the behavioral challenges identified in children with FASD. Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be developed using input from major stakeholders to meet the current limitations in access for families seeking services and supports; and (ii) this intervention and its evaluation will provide evidence for feasibility and efficacy to support changes in policy by key decision-makers and provide the basis for developing promising practices in the area of interventions for families affected by FASD. This grant will link academic teams with parents/guardians and decision makers to develop and evaluate a training program for the parents/guardians of children with FASD. Participants will be recruited from across Canada. The specific objectives of the proposed research program, which will be addressed in three inter-related studies, are to: 1. Develop an Internet-based intervention program for parents/guardians of children with FASD between the ages of 4-12 years, that is based on information collected from interviews completed by major stakeholders (e.g., parents/guardians, clinicians, decision-makers, community-based organizations); 2. Evaluate the feasibility (usability) of the intervention; and 3. Obtain data on outcomes from the randomized controlled trial This research will adopt an integrated knowledge translation and exchange approach where knowledge production, dissemination, uptake and usage will occur seamlessly throughout the project and researchers and knowledge users are engaged in the project right from its inception. The intervention will be based on the Strongest Families program that is designed to help families learn to deal with common childhood problems in the comfort and privacy of their home, and provide treatment and care via telephone contact with trained coaches, written manuals, videotapes, and audiotapes. This program has been successful in children neurodevelopmental disorders; and will be adapted for use in the FASD population, as children with FASD, share many of the same behavioral characteristics.

NCT ID: NCT02210182 Completed - Clinical trials for Hepatocellular Carcinoma

A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects Undergoing Thermal Ablation

NCT ID: NCT02209532 Completed - Cervical Cancer Clinical Trials

A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

FILM
Start date: December 2015
Phase: N/A
Study type: Interventional

This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.

NCT ID: NCT02209363 Completed - Parkinson's Disease Clinical Trials

Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy

COPE-PAP
Start date: April 2015
Phase: N/A
Study type: Interventional

Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's disease (PD), often progresses to dementia, and profoundly affects quality of life. Obstructive sleep apnea (OSA) is a common disorder in the general population that is treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive function, but whether treatment improves cognitive function is less clear. When already affected by a degenerative process like PD, the brain might be more vulnerable to the effects of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized as a significant factor in PD. In preliminary work in PD patients, the investigators have found an association between OSA and poor cognition, and cognitive improvement with PAP therapy. The investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive function in PD in a randomized controlled trial. The investigators primary objective is to assess, in PD patients with OSA and cognitive deficit, the effect of OSA treatment on global cognitive function. The investigators will also assess other non-motor symptoms of PD, quality of life, and specific domains of neurocognitive function. PD patients will be recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network Centres. Participants will need to have evidence of cognitive deficit and presence of OSA on screening diagnostic polysomnography (sleep study). Ninety subjects will be randomly assigned to PAP or nasal dilator strips. Detailed neuropsychological testing and other measurements (including quality of life) will be done at baseline, 3 months and 6 months. At the end of the study period, subjects will have polysomnography on their respective treatment to assess efficacy with respect to OSA treatment. This study may demonstrate that a non-pharmacologic intervention has the potential to have a marked beneficial impact on cognitive function and quality of life in a significant proportion of PD patients.

NCT ID: NCT02209285 Completed - Multimorbidity Clinical Trials

Self-Management Program for Older Adults With Multimorbidity

Start date: January 2016
Phase: N/A
Study type: Interventional

Patients with multimorbidity move between multiple care settings, and so they are at high risk of receiving fragmented care leading to increased risk for avoidable illness, death, and health care costs. Recent Canadian studies and reports identify significant gaps in the delivery of effective care to patients with multiple chronic conditions in community-based settings. The overall goal of the intervention is to promote successful management of chronic conditions, enhance quality of life, reduce the on-demand use of expensive health services and support primary caregivers (i.e. family or friends) who provide physical, emotional or financial care to an older adult with multimorbidity. This research program will leverage the tremendous potential to reduce the burden of multimorbidity by enhancing community-based prevention and chronic disease management. This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of an interprofessional team-based self-management intervention on health-related quality of life (HRQOL), depression, anxiety, self-efficacy, and the costs of use of health services for older adults with multimorbidity receiving home care and their family caregivers. The results will inform: (1) the development of national standards for community-based care for patients with multimorbidity and (2) the development of a new and innovative community-based model for the management of multimorbidity that can be scaled up and spread across Canada.

NCT ID: NCT02209220 Completed - Clinical trials for Obstructive Sleep Apnea

Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery

APAP-CPAP
Start date: September 2014
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation and sleep micro-arousals. In surgical patients, OSA is a well-known risk factor for perioperative complications. At Institut Universitaire de cardiologie et de Pneumologie de Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year. Consequently, the identification and management of OSA in this high-risk surgical population is an essential part of practice. Actual guidelines recommend that treatment for OSA be initiated before the surgical procedure. Presently, the first line treatment for OSA is continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously to maintain the patency of the upper airways. However the compliance to this therapy is poor. An available alternative is automatic positive airway pressure (APAP) which delivers a variable amount of pressure to prevent reduction in airflow that accompanies upper airway obstruction. The APAP delivers the lowest pressure needed to prevent upper airways collapse. APAP significantly reduces the mean level of pressure delivered in comparison to conventional treatment. Theoretically, it seems logical that applying the lowest pressure necessary would allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling obstructive events. APAP would be a valuable alternative if it was not for its excess cost. However, APAP improves compliance to treatment in two types of population: poor compliant subjects and those needing high pressure levels. The investigators know that compliance to positive pressure is poor in patients without excessive daytime sleepiness, which represents the majority of patient waiting bariatric surgery. Moreover, in patients needing levels of pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects and improves quality of life. The review of 180 files of OSA patients treated by CPAP who had bariatric surgery in our center in 2012 demonstrated that the majority of patients needed high level pressure. These values suggest that APAP could improve treatment compliance in apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and they generally require high positive pressure level.

NCT ID: NCT02209077 Completed - Glaucoma Clinical Trials

Spectralis OCT Repeatability and Reproducibility Study

S-2013-1
Start date: June 2013
Phase: N/A
Study type: Interventional

This single-center, prospective, interventional clinical study is conducted to evaluate the repeatability and reproducibility of structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study are compared to those from a previous, larger healthy volunteer study that was conducted in the United States and Europe (S-2012-1), and data from glaucoma patients are compared to those from the healthy volunteers.