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NCT ID: NCT04889352 Active, not recruiting - Colo-rectal Cancer Clinical Trials

Optimizing Timing of Follow-up Colonoscopy

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.

NCT ID: NCT04886596 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

NCT ID: NCT04886518 Active, not recruiting - Clinical trials for Myotonic Dystrophy 1

Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1

Start date: June 28, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years. The secondary objectives of this study are to assess the impact of pitolisant on fatigue, cognitive function and the burden of disease along with assessing the long-term safety and effectiveness of pitolisant in patients with Myotonic Dystrophy Type 1 ages 18 to 65 years.

NCT ID: NCT04885192 Active, not recruiting - Chronic Pain Clinical Trials

Implementation and Evaluation of a Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain

Start date: March 11, 2021
Phase:
Study type: Observational

Chronic pain affects nearly 20% of Canadians, and sixty percent or more of individuals with chronic pain are also struggling with mental health or substance use disorders (referred to as complex chronic pain, or CCP, patients). This is a major concern in the best of times and has become an emergency during the COVID-19 pandemic. Now individuals suffering from chronic pain are faced with the additional challenges of quarantine, including the stress of isolation, delays in much needed medical care, and anxiety of possible infection to self or loved ones. Prior to COVID-19, psychologists at The Transitional Pain Service and the GoodHope Ehlers-Danlos Syndrome Clinic at Toronto General Hospital have adapted gold standard treatments for mental health and substance use for the unique needs of individuals with CCP. The investigators propose to develop these treatments into a virtual intervention that will meet the needs of patients during and after the COVID-19 pandemic. The investigators will use a mobile health application (called Manage My Pain or MMP) already in use by our patients to identify patients with CCP currently struggling with mental health issues or at risk of opioid misuse. Patients identified at risk will be offered a single-session Acceptance and Commitment Therapy workshop and then reassessed one month after the workshop. Patients still reporting high levels of emotional distress or substance use risk at that time will be offered a six-week Dialectic Behavior Therapy-informed group and will be reassessed one month after conclusion of the group. The investigators propose to conduct prospective data collection during the implementation of this program to facilitate 1) evaluation of the impact of stepped-care program components on mental health and substance use concerns, 2) examination of current rates mental health and substance use concerns in patients, and 3) examination of uptake for virtual mental health care amongst patients with chronic pain.

NCT ID: NCT04884815 Active, not recruiting - Wilson Disease Clinical Trials

Study of UX701 Gene Transfer for the Treatment of Wilson Disease

Start date: September 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety of single IV doses of UX701 in patients with Wilson disease, to select the UX701 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the effect of UX701 on copper regulation.

NCT ID: NCT04881565 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

Falls are a health crisis that cost health care systems billions of dollars/year. This crisis is especially relevant for individuals living with incomplete spinal cord injury (iSCI); 78% fall at least once annually. In able-bodied individuals, falls are prevented by taking reactive steps; however, these reactions are impaired after iSCI. Research in stroke and geriatric rehabilitation showed that reactive balance training (RBT), which targets reactive stepping, prevents falls. We developed a modified version of RBT for the iSCI population. RBT resulted in fewer falls post-training compared to dose-matched, conventional balance training. However, only those who were able to take a step independently and without upper limb support were able to participate in RBT, limiting the applicability of this promising fall prevention method. To address this limitation, we will integrate functional electrical stimulation into RBT (RBT+FES). Our study aims to provide a preliminary evaluation of the efficacy of RBT+FES in participants with chronic, motor iSCI. We will complete a pilot randomized clinical trial (RCT) with 22 participants with iSCI. Participants will be randomly allocated to RBT+FES or to RBT alone (i.e. without FES). They will complete 18 training sessions over 6 weeks (3 sessions/week). Clinical and biomechanical assessments of balance, strength and proprioception will be completed before training, immediately after training, and six months post-training. Falls will be monitored for six months after training through an online survey and regular phone calls. Performance on clinical and biomechanical measures and fall data will be compared between groups. This research will inform the need for, and design of, a larger RCT, and has the potential to transform fall prevention after iSCI.

NCT ID: NCT04881084 Active, not recruiting - Mental Illness Clinical Trials

Exploring Empathy and Compassion Using Digital Narratives

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

Stories of suffering and struggle are shared continuously through digital formats such as internet videos, news stories, social marketing, and fundraising campaigns. Digital stories are often created and shared to generate awareness about a problem, impart knowledge on contemporary issues, or promote compassion. The practice of sharing critical life events and insights provided by these experiences are valuable for tellers and the listeners alike for catharsis, healing, reconciliation, and connectiveness. Portrayals of mental suffering are a matter of cultural and social interest as new media products become available to the public. Studies published since the 1990s overwhelmingly conclude that formal media depictions are biased, promoting the stereotype that people who suffer emotionally are mentally ill, dangerous, violent, or insane. Various agencies, organizations, and corporations are actively working to provide alternative stories/narratives to mainstream media by means of video testimonials in social marketing and fundraising campaigns and, ultimately, by taking advantage of the Internet. The impact of this work is under-researched. However, preliminary evaluations of social marketing campaigns report mixed results and raise questions about their effectiveness. As well, the first-person narrative prepared digitally and shared online is also providing alternative narratives to mainstream media stories. People are increasingly using digital videos to share their stories, viewing this as an opportunity to understand their emotions and thoughts, come to terms with disgrace around sensitive, personal issues and marginalization while providing hope and encouragement to others. This proposed study focuses on the process of creating digital narratives/stories, especially stories of mental and emotional suffering, and their impact in terms of inciting empathy, compassion, and good citizenship among viewers.

NCT ID: NCT04879732 Active, not recruiting - Hip Osteoarthritis Clinical Trials

RSA - ACTIS Hip Stem

Start date: October 5, 2021
Phase: N/A
Study type: Interventional

The principal objective of this study is to compare mean 2-year subsidence of the ACTIS femoral stem using model-based RSA against published migration patterns for hip stems of a similar design. Secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.

NCT ID: NCT04879628 Active, not recruiting - Multiple Sclerosis Clinical Trials

Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

Start date: June 7, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: - To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures - To evaluate the safety and tolerability of SAR441344 - To evaluate pharmacokinetics of SAR441344

NCT ID: NCT04878510 Active, not recruiting - Clinical trials for Respiratory Insufficiency

Non-invasive Ventilation and Dex in Critically Ill Adults

inDEX
Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Vanguard Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure. The results from this pilot trial, will subsequently inform a large, pragmatic, powered trial to definitively address the question.