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NCT ID: NCT03855488 Suspended - Excessive Worry Clinical Trials

Imagery Enhanced Cognitive Bias Modification for Chronic Worry

Start date: August 20, 2019
Phase: N/A
Study type: Interventional

People who experience high levels of worry often have mental habits that fuel their worry. One mental habit of interest to researchers is the tendency to assess situations and experiences in a very negative way even when it is possible the situation may turn out to be neutral or even positive. Cognitive bias modification of interpretations (CBM-I) is a training that is designed to target the tendency to catastrophize and jump to negative conclusions when faced with ambiguous information. CBM-I has been shown to improve this habit as well as anxiety and low mood. In this experiment, the investigators are looking to enhance CBM-I for pathological worry. Specifically, the investigators are testing the immediate and short-term effects of using imagery when completing CBM-I.

NCT ID: NCT03829631 Suspended - Pain Clinical Trials

Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain

Start date: June 12, 2019
Phase: N/A
Study type: Interventional

Low back pain accounts for billions of dollars in health care expenditures. Most cases of back pain do not have a clear cause. Thus, low back pain management methods usually rely on targeting people' pain and discomfort. Painkillers, including opioids, are usually prescribed in the emergency departments for people with low back pain. But, like all medications, painkillers can have side effects, and some of those can be serious. There are also serious concerns about the overuse of painkillers. Thus, newer pain management methods are needed to reduce the use of painkillers in people with low back pain. Lumbar braces are one of the underutilized low back pain management methods in the emergency departments. Like crutches for leg and ankle injuries, they can minimise movements of the spine. This may decrease people pain and improve their function. This may also reduce the use of painkillers. In support of this approach, two recent studies conducted in a primary-care setting observed a reduction in the use of painkillers in people with low back pain who wore lumbar braces. The investigators are conducting this study to determine if wearing a lumbar brace for 4 weeks following emergency department presentation will reduce people's pain and discomfort and increase spine function. This may decrease the use of painkiller and future use of healthcare resources. This research study may also assist emergency-department staff with offering new recommendations to improve the quality of clinical decisions.

NCT ID: NCT03802461 Suspended - Infection Clinical Trials

Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization

EFFECT-CPE
Start date: March 22, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in death in 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor to a recipient to alter the composition of gut microbes. Early studies support its use for eliminating CPE carriage but definitive studies are lacking. The investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial comparing the effectiveness of FMT with no intervention (standard of care) in eliminating intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and retain 40 patients over 12 months, and to provide FMT made at a central site to at least one off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6 and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and, intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes will be collected but not analyzed in this feasibility study.

NCT ID: NCT03751423 Suspended - Clinical trials for Abortion in First Trimester

Intravenous Ketamine for Pain Control During First Trimester Surgical Abortion

Start date: June 10, 2019
Phase: Phase 3
Study type: Interventional

A therapeutic abortion is one of the most common procedures performed in Canada, with approximately 100,000 occurring annually. 95% of induced abortions are done surgically, with just over two thirds of these procedures taking place in the first trimester. This study will be a randomized, controlled, double-blinded, single-centre superiority trial with three parallel groups; oral morphine vs intravenous fentanyl vs intravenous ketamine. The primary outcome will be immediate post-operative pain following a first trimester therapeutic abortion as assessed using the visual analogue scale. Randomization will be performed as block randomization with a 1:1:1 allocation ratio. In total, 123 participants will be recruited and randomized, with 41 being assigned to each treatment arm. This study will be conducted at the Women's Clinic at Kingston General Hospital in Kingston, Ontario, Canada. Women from Kingston and the surrounding areas are referred to this clinic and can self-refer for therapeutic abortion. The investogators hope that this research will move us towards a better form of pain control for our participants undergoing first trimester surgical abortion, without increasing length of stay, side effects, or adverse events. This, in turn, will hopefully improve access to optimal pain control to participants undergoing first trimester surgical abortion in an outpatient setting.

NCT ID: NCT03748654 Suspended - Glaucoma Clinical Trials

Feasibility of Visual Field Testing With a Virtual Reality Headset

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.

NCT ID: NCT03738384 Suspended - Arthroplasty Clinical Trials

Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty

Start date: March 9, 2020
Phase: N/A
Study type: Interventional

The main objective of this pilot study is to determine if using a portable, accelerometer based, visual feedback system improves exercise quality. The secondary objective of this study is to investigate the effect of motivational targets by testing the effects of increasing ROM targets. The results from this study will be used to improve the visual feedback system of the Knee Connect system and serve as starting point for a larger clinical study.

NCT ID: NCT03729401 Suspended - Clinical trials for Coronary Artery Disease

Personalization of Long-Term Antiplatelet Therapy - RAPID EXTEND

RAPID EXTEND
Start date: August 22, 2019
Phase: Phase 4
Study type: Interventional

In patients after myocardial infarction (MI) (heart attacks) and treated with percutaneous coronary intervention (PCI), the current standard is dual antiplatelet therapy (DAPT), with aspirin and a P2Y12 receptor inhibitor, for 1 year of treatment. At 1 year, there are several options including: i) Ongoing DAPT (with aspirin and ticagrelor), ii) Selective treatment use of a P2Y12 inhibitor based on risk profiles. This study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post MI and PCI at 1 year.

NCT ID: NCT03718156 Suspended - Dementia Clinical Trials

The Prevention Program for Alzheimer's Related Delirium (PREPARED) Trial

PREPARED
Start date: June 23, 2018
Phase: N/A
Study type: Interventional

By the year 2038, over a million Canadians are expected to have Alzheimer's disease, a type of dementia. Dementia increases the risk of nursing home placement among the elderly more than fivefold. Given the exceptionally vulnerable nature of this patient population, there is a pressing need to ensure that the clinical care they receive is evidence-based, tailored specifically for them, and meeting the high standards of quality that would be expected in any other health-care setting. Delirium is a sudden and severe change in brain function that can cause a person to appear confused or disoriented, have memory loss, and have difficulties maintaining focus. It is an urgent care issue facing elderly patients residing in nursing homes, or long-term care (LTC) facilities. Delirium is a significant cause of illness and mortality, affecting between 10%-89% of LTC patients, but little research has focused on delirium prevention in the LTC setting. This study will assess the effectiveness of a LTC multicomponent delirium prevention program (PREPARED Trial intervention). The PREPARED Trial intervention is an intervention provided to nursing staff working in LTC facilities that consists of four components: a decision tree, an instruction manual, a training package, and a toolkit. The feasibility and acceptability of the PREPARED Trial intervention has already been successfully demonstrated; however, a thorough and well-designed large scale study is needed in order to confirm its ability to reduce delirium among LTC residents. In this study, approximately 40-50 LTC facilities will be randomized to either receive the PREPARED Trial intervention or to receive usual care. At the end of the 4-year study period, the investigators will be able to demonstrate the degree to which the PREPARED Trial intervention reduces: 1) the number of new cases of delirium; 2) delirium severity; and 3) the duration of delirium episodes. This study will provide the blueprint of a program that can be transferable to LTC facilities across Canada.

NCT ID: NCT03674671 Suspended - Clinical trials for Depressive Disorder, Major

Ketamine Versus Electroconvulsive Therapy in Depression

Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

While there are effective treatments for depression available, some patients do not see results with these options. Often, these patients are referred to electroconvulsive therapy (ECT) which has drawbacks such as adverse side effects, cost, and limited access. Recent research shows that intravenous ketamine may be an alternative option for these patients due to its rapid antidepressant effect sustained with multiple treatments. This study will recruit 240 participants from the ECT waiting list at the five participating hospitals, and randomize them to either the ketamine or ECT treatment arm. Participants in the ketamine treatment arm will receive 0.5mg/kg ketamine intravenously (IV) over 40 minutes as described in the study schedule. Participants in the ECT treatment arm will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted. The aim of this study is to show that compared to ECT, ketamine treatment produces faster results, has less side effects, requires less or shorter hospitalizations, and is less expensive. The measures collected throughout the study (clinician scales, self-reports, blood samples, and neuroimaging) may help with predicting if future patients will respond to ECT or ketamine. This could lead to faster, more effective treatment for patient with depression.

NCT ID: NCT03607708 Suspended - Clinical trials for Depression Anxiety Disorder

Alternative Treatments To Prevent Cognitive Decline in Older Adults With Depression and Anxiety

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

Major depression and anxiety disorders are leading causes of disability worldwide. These mental disorders deeply impact social functioning and physical health in more than 300,000-600,000 Canadians over the age of 60. Depressed and anxious older adults have a 2-3 times increased risk of developing dementia and cognitive decline. Mindfulness-based cognitive therapy (MBCT) is a group meditation intervention that has been beneficial in treating depression and anxiety in younger adults. Our research group has experience conducting clinical trials of MBCT in older adults with depression and anxiety. Meditation therapies may prevent cognitive decline, but no previous study has examined this with MBCT. In this 8-week clinical trial, Investigators are examining whether MBCT can strengthen the structural and functional integrity of brain networks and improve cognitive resilience in vulnerable depressed and anxious older adults. Investigators will also examine whether MBCT can improve depression, anxiety symptoms, disability, and quality of life in patients. Investigators will conduct a pilot randomized controlled trial (RCT), comparing Mindfulness-Based Cognitive Therapy (MBCT; n=15) versus a Health Enhancement Program (HEP; n=15) active control in 30 older patients (>60) with depression or anxiety. Participants will be blinded to the treatment hypothesis while investigators and raters will be additionally blinded to group assignment. Both MBCT and HEP will be taught in weekly sessions over 8 weeks in similar sized groups (4-10 participants). Investigators will measure the effect of these interventions on brain network function and structure using magnetic resonance imaging at baseline and 8-week timepoints. Investigators will also assess cognitive functioning and a range of clinical symptoms/quality of life measures at baseline, 8-week and 6-month follow-up. Investigators anticipate that this project will improve quality of life in depressed and anxious older adults by enhancing brain resilience, cognitive function, and general mental health. This project will provides essential pilot data for a longer-term definitive neuroimaging trial of MBCT to assess the potential of this intervention to prevent cognitive decline and dementia in older adults.