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NCT ID: NCT02428452 Completed - Clinical trials for Autism Spectrum Disorder

Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: Trial of a Parent-Mediated Intervention

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

The Social ABCs is an innovative parent-mediated intervention for toddlers with confirmed or suspected Autism Spectrum Disorder (ASD). The intervention draws on what is known about core, early emerging impairments in ASD, and on evidence-based Pivotal Response Treatment (PRT) and associated parent training programs for enhancing development in children with ASD. Completion of a comprehensive pilot study set the stage for a randomized control trial (RCT) of the Social ABCs. The purpose of this RCT is to evaluate the efficacy of the Social ABCs intervention program on improving spoken language skills and positive parent-child emotion sharing in toddlers with signs of or a diagnosis of ASD.

NCT ID: NCT02428400 Completed - Chronic Hepatitis B Clinical Trials

Safety and Tolerability of TG1050: A Dose-finding Study

Start date: October 2015
Phase: Phase 1
Study type: Interventional

Methodology: This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled

NCT ID: NCT02428387 Completed - Dementia Clinical Trials

Evaluation of "My Tools 4 Care" for Family Caregivers of Persons With Dementia

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

With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing, supporting family care partners of persons with ADRD is critical. Family caregivers provide about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and multiple chronic conditions (MCC) experience significant, complex, distressing transitions such as changes to their environment, roles and relationships, physical and mental health, isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was developed for family caregivers of persons with ADRD and MCC living at home, to support caregivers through transitions and increase their self-efficacy, hope, and quality of life (QOL). Through this pragmatic mixed methods randomized controlled trial the investigators expect to find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater improvement in hope, self-efficacy and QOL, at no additional cost from a societal perspective, compared with those in an educational control group. Following baseline data collection 180 participants will be randomly assigned to one of the groups with repeated measures at one, three and six months.

NCT ID: NCT02428270 Completed - Pancreatic Cancer Clinical Trials

A Study of GSK2256098 and Trametinib in Advanced Pancreatic Cancer

Start date: April 2016
Phase: Phase 2
Study type: Interventional

This is a phase 2 study (the second phase in testing a new drug or combination to see how effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib. The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib in patients with advanced pancreatic cancer.

NCT ID: NCT02428140 Completed - Stroke Clinical Trials

Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

PERDIEM
Start date: July 2015
Phase: N/A
Study type: Interventional

The overall aim of this trial is to determine the most cost effective approach to diagnose paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke. A summary of the rationale for this study is as follows: 1. Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke. 2. The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed. 3. Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel atherosclerosis) is clinically important since appropriate anticoagulation for AF reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic strokes. 4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data 5. The rates of PAF in strokes with known causes (SKC) have not been well characterized. PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first-line investigations to detect PAF in patients with recent stroke and TIA. The study will also assess whether a pivotal trial is feasible and warranted. The principal research questions to be addressed in this study will be: 1. Whether implantable loop recorder (ILR) plus remote monitoring will diagnose more paroxysmal AF / atrial flutter and provide a better assessment of the total burden of AF resulting in a greater proportion of patients started on an OAC versus the external loop recorder (ELR) strategy. 2. What is the relative cost-effectiveness as a first-line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke. 2) What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.

NCT ID: NCT02428114 Completed - Clinical trials for Early Stage Breast Cancer

A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)

React-G
Start date: May 2015
Phase: N/A
Study type: Observational

In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of Neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of Neupogen daily injection. Neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost. This study will use an "integrated consent model" that involves an "oral consent" rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost. While determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.

NCT ID: NCT02427217 Completed - Clinical trials for Congenital Fibrinogen Deficiency

An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

Start date: May 7, 2015
Phase: N/A
Study type: Observational

This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.

NCT ID: NCT02426749 Completed - Clinical trials for Brain Injuries, Traumatic

Treatment and Recovery Monitoring of Post TBI Symptoms

Start date: September 2015
Phase: N/A
Study type: Interventional

This proposal aims to investigate the effect of a promising treatment for persistent post Traumatic Brain Injury (TBI) symptoms, and to monitor TBI patient's recovery by an objective technique along with standard clinical assessments. The treatment tool is the application of repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) of the brain. The treatment efficacy and monitoring TBI patients' recovery will be objectively assessed using Electrovestibulography (EVestGTM); this will be in parallel with clinical and standard assessments.

NCT ID: NCT02426736 Completed - Pain, Postoperative Clinical Trials

Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery

Start date: June 25, 2015
Phase: Phase 4
Study type: Interventional

In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the nerve block) route just prior to their surgery. The purpose of this study is to determine which dose and route of dexamethasone provides the longest duration of pain control and the fewest side effects after surgery. The investigators hypothesize that giving dexamethasone by the perineural route, and by higher doses, will result in the longer durations of pain control, without increased side effects.

NCT ID: NCT02426606 Completed - Healthy Clinical Trials

Effects of Lentil Consumption on Post-prandial Blood Glucose and Insulin

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

The purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.