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NCT ID: NCT03681093 Completed - Nasal Polyps Clinical Trials

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

THUNDER
Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

NCT ID: NCT03680898 Active, not recruiting - Clinical trials for Carbapenem-Resistant Enterobacteriaceae

Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.

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

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase Producing Organisms (CPOs) in rectal swab samples.

NCT ID: NCT03680664 Completed - Anxiety Disorders Clinical Trials

Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS)

Start date: November 8, 2018
Phase: N/A
Study type: Interventional

Ideal interventions for the older aged population would be those that are easily accessible and associated with minimal burden on family members, the healthcare system and the individuals themselves. Mindfulness-Based Stress Reduction (MBSR) therapy and Transcranial Direct Current Stimulation (tDCS) are two interventions that may be effective in targeting cognitive deficits in individuals with anxiety, depression, and/or cognitive complaints. MBSR has been shown to decrease symptoms of depression and improve cognition and tDCS has been shown to improve cognition in the older aged population. The effectiveness of these two interventions combined to elicit changes in cognition has yet to be demonstrated. Therefore, the overall aim of the current research is to evaluate the efficacy of a combination of MBSR and tDCS to improve cognitive function in individuals with cognitive complaints and symptoms of anxiety and/or depression. This will be a randomized pilot study. Sixteen individuals (separated into 2 groups of 8) will be randomized to receive a combination MBSR + active tDCS or MBSR + sham tDCS over 8 weeks. Participants will visit the Centre for Addiction and Mental Health (CAMH) once per week for in-class group sessions and will complete the intervention daily at home for the duration of the study. Participants will be aged 60 and older with cognitive complaints, with symptoms of anxiety and/or depression. Participants will be trained to self-administer tDCS and given guidelines for the completion of daily MBSR activities at home. It is hypothesized that the combination of active tDCS + MBSR will enhance cognition compared to the combination of sham tDCS + MBSR.

NCT ID: NCT03680625 Completed - Pain Clinical Trials

Virtual Reality vs Passive Distraction for Pain Management

Start date: June 14, 2019
Phase: N/A
Study type: Interventional

Background: Outpatient pediatric orthopedic procedures such as percutaneous pins removal and sutures are considered painful and generate significant stress and anxiety in children. However, given their short duration and the need for a quick turnover in outpatient clinics, there are very few interventions aimed at relieving pain, stress and anxiety related to these procedures. Neither simple analgesia nor topical anesthetics proved effective for procedural pain reduction with this population. Moreover, narcotics and procedural sedation do not appear to be feasible alternatives as they require surveillance, prolonging visit to the outpatient clinic and generating several undesired side effects. Therefore, it would be imperative to explore non-pharmacological pain management methods as they require minimal preparation and do not usually generate any side effects. Aim: To examine the effect of virtual reality (VR) compared to passive distraction, on pain, stress, anxiety and memory of pain in children undergoing a percutaneous pin removal procedure or sutures in an outpatient orthopedic clinic. Hypothesis: VR distraction provides better pain relief during percutaneous pin removal procedures or sutures than passive distraction, in children from 7 to 21 years old. Methods: The study will be a prospective randomized controlled trial with parallel groups. Children from 7 to 21 years old, visiting the clinic for follow up and percutaneous pin removal procedure or sutures, accompanied by a parent or legal guardian will be recruited. The experimental group will receive a VR distraction through a head-mounted Oculus Quest® and the control group will receive passive distraction through watching a video on an iPad®. The primary outcome will be the mean pain score after the procedure (self-report of pain level during the procedure) measured by the Numerical Rating Scale (NRS). Anxiety will be measured by the Child Fear Scale (CFS) and stress will be measured using level of salivary Alpha-Amylase before and 10-min after the procedure. Memories of pain and anxiety will be measured one week after the procedure using the same scales (NRS and CFS). The investigators aim to recruit 188 children. Discussion: The investigators believe that results of this study will allow to improve pain, stress and anxiety management practices in this orthopedic clinic by showing that non-pharmacological interventions can be done, at very low cost, to improve the experience of the child undergoing these painful procedures through an innovative and more humanistic approach.

NCT ID: NCT03680274 Completed - COVID-19 Clinical Trials

Lessening Organ Dysfunction With VITamin C

LOVIT
Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.

NCT ID: NCT03680131 Active, not recruiting - Clinical trials for Allergic Contact Dermatitis

Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis

Start date: October 15, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of EB01 Cream (0.2%, 1.0%, 2.0%) applied twice per day (BID) for the treatment of moderate to severe chronic allergic contact dermatitis (ACD). The purpose of the open label extension is to assess the long-term safety, tolerability, and efficacy of EB01 2.0% cream in subjects with moderate to severe chronic allergic contact dermatitis.

NCT ID: NCT03679884 Completed - Insomnia Disorder Clinical Trials

Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

NCT ID: NCT03679715 Completed - Quality of Life Clinical Trials

A-Health RCT: Effects of Participatory Art-based Activity on Health of Older Community Dwellers

A-Health-RCT
Start date: January 5, 2019
Phase: N/A
Study type: Interventional

The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers. Aging is often associated with worsening health and withdrawal from social activities, both increasing the risk of a poor quality of life. It has been reported that the practice of art, especially participatory art-based activity enhances wellbeing, quality of life and health condition of patients and older adults. Since October 2015, the Montreal Museum of Fine Arts (MMFA; Quebec, Canada) has successfully initiated a participatory art-based activity known as "Les Beaux-Jeudis" for older community dwellers living in Montreal. Recently, the investigator demonstrated that the MMFA participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.

NCT ID: NCT03679611 Completed - Clinical trials for Obstructive Sleep Apnea

Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications

Sugammadex
Start date: January 14, 2019
Phase: Phase 4
Study type: Interventional

Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs. This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.

NCT ID: NCT03679507 Enrolling by invitation - Clinical trials for Osteoarthritis in the Knee

The Effect of Low Intensity Ultrasound Therapy on Chronic Pain Due to Osteoarthritis of the Knee.

Start date: June 15, 2019
Phase: N/A
Study type: Interventional

To evaluate a new, low intensity ultrasound device in the treatment of chronic pain due to osteoarthritis in the knee. Enhancing CBD oil penetration into joints by sonophoresis.