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NCT ID: NCT04163874 Completed - Type 1 Diabetes Clinical Trials

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

Start date: February 14, 2020
Phase: N/A
Study type: Interventional

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with the improved insulin aspart formulation - Fiasp, in an artificial pancreas system, will alleviate the need for carb counting by replacing it with a simple meal announcement, without degrading the quality of glycemic control in a closed-loop therapy.

NCT ID: NCT04163848 Completed - Anesthesia Clinical Trials

CARbon Impact of aNesthesic Gas

CARING
Start date: September 25, 2019
Phase:
Study type: Observational

Assessing the impact of anesthesia practice on global warming and carbon footprint becomes part of the standard of care and is growing concern within the anesthesia community. Global Warming Potential (GWP) is a measure of how much a given mass of greenhouse gas contributes to global warming over a specified time period. Inhaled anesthetics have various GWP20: 349 for sevoflurane and 3714 for desflurane. However, GWP20 and CDE20 alone are not sufficient to evaluate the environmental impact of anesthetic gases. Other parameters must be included in the analysis: fresh gas flow (FGF), carrier gas (air, O2, N2O) and potency of the anesthetic gas. Unfortunately, the majority of trials did not fully consider the FGF reduction and the fact that desflurane can be administered with new closed or very low-flow anesthesia circuits as opposed as the recommended 2L/min that must be used for sevoflurane according to its monography in Canada. Most of the calculations were made on a purely theoretical approach that could be different from actual measurements based on a strictly monitored anesthesia practice. When continuous and accurate gas monitoring and analysis is used as recommended nowadays, the use of closed or semi-closed-circuit anesthesia with very low FGF might allow for a reduction of more than 80% of the anesthetic gas administration and its consequent pollution. By properly monitoring the anesthesia depth and analgesia adequacy, the investigators can reduce the gas consumption. The proposed study will aim at determining whether with the help of high-quality monitoring (BIS and NOL) and high-end ventilators that allow minimal fresh gas flow, the use of desflurane remains more polluting than sevoflurane.

NCT ID: NCT04163289 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation

PERFORM
Start date: January 23, 2020
Phase: Phase 1
Study type: Interventional

Cancer immunotherapy has been largely adopted in oncology patient management in the last decade. The deep and long responses to immunotherapy have accelerated the approval of these drugs across multiple disease sites. However, these agents can also be toxic to patients, meaning, the patient will have to discontinue treatment and outcomes could be negatively affected. Recently, a combination of two immunotherapy drugs, ipilimumab and nivolumab (ipi/nivo), has been approved for the treatment of intermediate and poor-risk renal cell carcinoma (RCC) patients. This powerful combination provides survival benefit, however, it can also be highly toxic leading to discontinuation of this treatment. There has been some evidence that these otherwise toxic drugs can be better tolerated by altering the composition of the patients gut bacteria to create a more diverse and healthy microbiome. The current study will involve Fecal Microbiota Transplantation (FMT) before the start of the immunotherapy combination, and during the first two cycles of ipilimumab treatment (the more toxic agent) as supportive therapy to prevent toxicity associated with the ipi/nivo combination. The goal of this project is to study the safety of such FMT combination treatment and reduce occurrence of immune-related toxicities in patients, allowing them to continue their cancer treatments in the hopes of a better outcome. The investigators will also be looking at changes in the immune populations, microbiome profile of patients, response to treatment, and patient survival as secondary objectives.

NCT ID: NCT04163263 Completed - Clinical trials for Moderate to Severe Acne Vulgaris

Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris

Start date: November 4, 2019
Phase: Phase 1
Study type: Interventional

This study is being conducted to characterize the safety and tolerability of BOS-356 in adult participants with moderate to severe acne vulgaris following 14 days or 28 days of repeated topical application

NCT ID: NCT04163081 Active, not recruiting - Clinical trials for Nicotine Dependence, Cigarettes

The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments

INITIATE
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The INITIATE Study is a randomized controlled trial that is testing an intervention designed to increase long-term abstinence among tobacco smokers seen in emergency departments (ED). The intervention includes a behavioural incentive and tailored follow-up support on long-term smoking abstinence, health, healthcare utilization, and cost. Tobacco-related illnesses cost the healthcare system millions each year. Quitting smoking improves smoking-related outcomes, like the onset or management of heart disease, stroke, lung diseases, and several cancers. There are approximately 16 million visits to Canadian EDs each year; an estimated 3-4 million of these involve smokers. Effective quit smoking interventions exist, but are underutilized. Few hospital EDs in Canada offer tobacco-use interventions. In order for ED staff to offer quit smoking support, interventions need to be simple given the realities of the ED environment. Considering that stopping smoking improves health outcomes, that tobacco-use is an important cause of preventable ED use, and the volume of smokers, Canadian EDs are a missed opportunity in the initiation of quit smoking support. Our intervention has been designed to optimize uptake and smoking abstinence by including the most effective evidence-based behavioural and drug-related approaches, removing specific barriers and challenges that smokers face when trying to quit (e.g., affordability, low confidence and motivation), while packaging the intervention in a quick-to-initiate manner, making it ideal for fast-paced, complex ED environments.

NCT ID: NCT04163042 Completed - Cancer Clinical Trials

Physical Activity Counselling for Young Adult Cancer Survivors

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Survival rates for cancer are increasing, resulting in more young adult cancer survivors living with lingering side effects. Physical activity has been shown to improve the quality and length of life in young adult cancer survivors; yet, few are active enough, and little is currently being done to promote physical activity in this population. The investigators developed a novel behaviour support intervention to promote physical activity in young adult cancer survivors. In this two-arm pilot randomized controlled trial, the investigators aim to: (1) assess trial and intervention feasibility, (2) assess trial and intervention acceptability, and (3) generate data on physical activity behaviour. Young adult cancer survivors will be randomized to receive either a 12-week behaviour support intervention delivered via videoconferencing or will be allocated to usual care.

NCT ID: NCT04162977 Completed - Clinical trials for Substance Use Disorders

Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services

Start date: October 2, 2019
Phase: N/A
Study type: Interventional

Substance use problems are major concern in adolescents involved in Youth Protection Services. However, there is an enormous gap between the needs and availability of interventions for youth with substance use problems in the system. The present study will examine the feasibility and proof-of-concept of implementing an evidence-based, personality-targeted drug and alcohol prevention programme for high-risk adolescents (i.e., Preventure programme) receiving services from Youth Protection Services. Our goal is to examine the effects of these interventions on reducing rates of substance use outcomes, depression symptoms, and self-reported anxiety sensitivity and impulsivity at 3- and 6-month post-intervention. These primary outcomes were selected based on previous Preventure trials with the community samples, that indicated these factors largely accounted for the long-term intervention effects on improving substance use outcomes. The study will be conducted at Batshaw Youth and Family Centres, which provide psychosocial, rehabilitation and social integration services and services related to child placement and adoption to English-speaking youth from all regions of Quebec. Adolescents receiving services from Batshaw centres (N = 100, aged 14 and above) will be invited to participate in the study. All interested adolescents will be invited to attend one assessment session with the research team. Participants who score high on one of subscales of Substance Use Risk Profile Scale (SURPS) (i.e., high-risk adolescents) will be invited to participate in two 90-minute group-based intervention sessions, which target their dominant personality profile. Sessions will be cognitive-behavioural in nature and are designed to help youth understand the target personality trait and develop adaptive coping strategies for managing that trait using motivational and cognitive restructuring techniques. The primary outcomes will be measured at baseline before receiving the interventions and then with 3-month and 6-month intervals after receiving the interventions to test whether these outcomes are significantly reduced after receiving the interventions. The results of this study will be used to plan the future directions of personality-targeted interventions for youth involved in Youth Protection Services.

NCT ID: NCT04162964 Suspended - Dementia Clinical Trials

Chair Yoga for Stress in Dementia

Start date: January 27, 2020
Phase: N/A
Study type: Interventional

Dementia is widely prevalent and results in high direct and indirect health costs. Dementia is associated with stress, anxiety, and depression in both patients and caregivers, and caregiver burden is extremely common. Treatment protocols for patients and caregivers are unclear and insufficient; drug treatments to manage behavioural and psychological symptoms of dementia can yield serious negative side effects, and caregivers may not have access to one-on-one psychotherapy due to high costs and long wait times. Yoga is an ancient Indian mind-body practice that uses physical postures, breathing exercises, and meditation. Yoga may be a viable therapeutic modality to address the psychological challenges associated with dementia in patients and caregivers, as it has been shown to decrease stress and improve anxiety and depressive symptoms in various populations. Recent research has suggested that patients with dementia and their caregivers may also experience positive effects on their mental health from practicing yoga. Furthermore, when yoga is taught in a gentle and mindful manner, it is generally not associated with any negative side effects. While there is preliminary data on dyadic exercise interventions for dementia patients and their caregivers, to date no research has examined the effectiveness of a dyadic yoga intervention on stress, anxiety, and depression. The investigators propose an 8-week study of a dyadic chair yoga program for patients with mild to moderate dementia and their caregivers (n = 30-40 participants). Our primary outcome of interest is changes in perceived stress, while secondary outcomes include changes in symptoms of depression and anxiety. The investigators will also look at the effects of the chair yoga program on caregiver burden, quality of interactions, well-being, mindfulness, and self-compassion. All outcomes will be assessed before the program starts and upon its termination. Participants will attend a 1-hour weekly group yoga class (4-10 participants per group) with their dyad for 8-weeks, and will also be given a video recording of a yoga class to practice together at home as often as possible. The investigators hypothesize that after the 8 week yoga program, patients and caregivers will report lower stress, as well as reduced symptoms of anxiety and depression. Results will be available mid-2020.

NCT ID: NCT04162769 Completed - Atopic Dermatitis Clinical Trials

A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis

ADVISE
Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT04162522 Completed - Clinical trials for Major Depressive Disorder

Canadian Biomarker Integration Network for Depression (CAN-BIND) - Validation Study

Start date: December 23, 2019
Phase: Phase 3
Study type: Interventional

This is a validation study that will replicate a completed study designed to assess biomarkers of treatment response to standard antidepressant treatment. The goal of this study is to integrate clinical, imaging, EEG, and molecular data across 8 sites to predict treatment outcome for patients experiencing a major depressive episode (MDE).