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NCT ID: NCT05899816 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

ROCKET-VOYAGER
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to: - estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 - estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

NCT ID: NCT05899608 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients

Start date: October 26, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and key secondary endpoints include progression free survival. response and safety.

NCT ID: NCT05899452 Recruiting - Pain Clinical Trials

Bubble Blowing as an Effective Distraction During Pediatric IV Insertion

BubblesRCT
Start date: July 27, 2023
Phase: N/A
Study type: Interventional

Insertion of an IV cannula is a standard but potentially painful procedure. Distraction techniques are among the strategies used to alleviate this discomfort. The investigators are conducting a randomized controlled trial to assess whether bubble blowing is more effective than video distraction during IV insertions in young children in the medical imaging suite.

NCT ID: NCT05899231 Recruiting - Cirrhosis, Liver Clinical Trials

Online Prehabilitation for Patients Awaiting Liver Transplantation

OPAL
Start date: July 12, 2023
Phase: N/A
Study type: Interventional

Physical frailty is common in patients awaiting liver transplantation and has been associated with poor health outcomes. There is promising data from small studies showing that behavioural, nutrition and exercise therapy (prehabilitation) improves physical function in patients while they are waiting for a liver transplant. The proposed trial will assess if a 12-week online prehabilitation program improves physical function in patients listed for liver transplantation. Over 4 years, 221 patients will be recruited from 5 transplant centres across Canada and will be randomized to receive either the online prehabilitation program or usual care. The primary outcome will be the change in distance walked in 6 minutes between the beginning and end of the study. Secondary and exploratory outcomes include changes in the liver frailty intake, health-related quality of life, covert hepatic encephalopathy, and post-transplant health- related outcomes. Results will be compared between the intervention and usual care groups. If feasible, an economic evaluation will compare the costs and benefits of the prehabilitation program versus usual care.

NCT ID: NCT05899101 Recruiting - Pregnancy Related Clinical Trials

The Impact of Opioid and Cannabis Exposure on Fetal Growth

IMPACT
Start date: September 23, 2022
Phase:
Study type: Observational

Individually, both opioid and cannabis exposure during pregnancy are associated with changes in fetal growth. The extent to which opioid and cannabis exposure affect fetal growth is unknown. The Investigators hypothesize that the combination of both substances will impact placental function and subsequent fetal growth more severely than either substance alone. The primary objective is to determine the extent to which fetal growth profiles in opioid-exposed pregnancies are influenced by cannabis exposure. This prospective cohort study will consist of opioid-exposed pregnancies and pregnancies without opioid exposure recruited from 5 obstetrical clinics from across Ontario. A total of 546 participants will be recruited.

NCT ID: NCT05898789 Recruiting - Lymphoma Clinical Trials

Virtual Rehabilitation for Cancer Survivors

Start date: July 7, 2023
Phase: N/A
Study type: Interventional

Pragmatic hybrid type 1 effectiveness-implementation (E-I) trial of a virtual cancer rehabilitation program: The study team will conduct a multi-center hybrid type I effectiveness-implementation study to examine the clinical effectiveness and implementation potential of an 8-week multidimensional virtual cancer rehabilitation intervention (CaRE@Home) for cancer survivors with identified cancer-related impairments on level of overall disability (primary outcome) and patient reported physical and social functioning, anxiety, work status, quality of life, and physiologic changes (secondary outcomes). The study team will conduct a multi-centre pragmatic randomized controlled trial (RCT) (Vancouver, Toronto, Saint John and St. John's) to evaluate effectiveness and using the CIFR, the study team will identify potential factors that may affect successful implementation and integration of CaRE@Home in different cancer settings.

NCT ID: NCT05898776 Recruiting - Lung Transplant Clinical Trials

10°C vs 4°C Lung Preservation RCT

Start date: June 9, 2023
Phase: N/A
Study type: Interventional

Despite lung transplantation (LTx) being the most effective treatment for end-stage lung disease, its success rate is lower than that of other solid organ transplantations. Primary graft dysfunction (PGD) is the most common post-operative complication and a major factor in early mortality and morbidity, affecting ~25% of lung transplant patients. Induced by ischemia reperfusion, PGD represents a severe and acute lung injury that occurs within the first 72 hours after transplantation, and has a significant impact on short- and long-term outcomes, and a significant increase in treatment costs. Any intervention that reduces the risk of PGD will lead to major improvements in short- and long-term transplant outcomes and health care systems. One of the main strategies to reduce the risk and severity of post-transplant PGD is to improve pre-transplant donor lung preservation methods. In current practice, lung preservation is typically performed by cold flushing the organ with a specialized preservation solution, followed by subsequent hypothermic storage on ice (~4°C). This method continues to be used and applied across different organ systems due to its simplicity and low cost. Using this method for the preservation of donor lungs, the current maximum accepted preservation times have been limited to approximately 6-8h. While the goal of hypothermic storage is to sustain cellular viability during ischemic time through reduced cellular metabolism, lower organ temperature has also been shown to progressively favor mitochondrial dysfunction. Therefore, the ideal temperature for donor organ preservation remains to be defined and should maintain a balance between avoidance of mitochondrial dysfunction and prevention of cellular exhaustion. In addition to that, safe and longer preservation times can lead to multiple advantages such as moving overnight transplants to daytime, more flexibility to transplant logistics, more time for proper donor to recipient matching etc. Building on pre-clinical research suggesting that 10°C may be the optimal lung storage temperature, a prospective, multi-center, non-randomized clinical trial was conducted at University Health Network, Medical University of Vienna and Puerta de Hierro Majadahonda University Hospital. Donor lungs meeting criteria for direct transplantation and with cross clamp times between 6:00pm - 4:00am were intentionally delayed to an earliest allowed start time of 6:00am and a maximum preservation time from donor cold flush to recipient anesthesia start time of 12 hours. Lungs were retrieved and transported in the usual fashion using a cooler with ice and transferred to a 10°C temperature-controlled cooler upon arrival to transplant hospital until implantation. The primary outcome of this study was incidence of Primary Graft Dysfunction (PGD) Grade 3 at 72h, with secondary endpoints including: recipient time on the ventilator, ICU Length of Stay (LOS), hospital LOS, 30-day survival and lung function at 1-year. Outcomes were compared to a contemporaneous conventionally transplanted recipient cohort using propensity score matching at a 1:2 ratio. 70 patients were included in the study arm. Post-transplant outcomes were comparable between the two groups for up to 1 year. Thus, intentional prolongation of donor lung preservation at 10°C was shown to be clinically safe and feasible. In the current study design, the investigators will conduct a multi-centre, non-inferiority, randomized, controlled trial of 300 participants to compare donor lung preservation from the time of explant to implant at ~10°C in X°Port Lung Transport Device (Traferox Technologies Inc.) vs a standard ice cooler. When eligible donor lungs become available for a consented recipient, the lungs will be randomized to undergo a preservation protocol using either 10°C (X°Port Lung Transport Device, Traferox Technologies Inc.) or standard of care. The primary outcome of the study is incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours. Post-transplant outcomes will be followed for one year.

NCT ID: NCT05898555 Recruiting - Healthy Clinical Trials

Validation of Smart Garments for Gait Classification

Start date: May 26, 2023
Phase:
Study type: Observational

The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig. 1). Participants will be asked to perform a number of scripted gait and balance tasks.

NCT ID: NCT05898529 Recruiting - COVID-19 Clinical Trials

COVID Infection in Pediatric Surgical Patient

Start date: July 1, 2023
Phase:
Study type: Observational

Children infected with COVID-19 are mostly asymptomatic. There is a dearth of data on the epidemiology of COVID-19 in the pediatric population. This is a prospective observational clinical study of pediatric surgical patients. COVID-19 rapid antigen testing will be performed on pediatric patients.

NCT ID: NCT05898516 Recruiting - Depression Clinical Trials

JoyPop Mobile Mental Health App With Indigenous Youth

Start date: May 26, 2023
Phase: N/A
Study type: Interventional

Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in other more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase risk for more serious outcomes. Novel, innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario. In partnership with Dilico Anishinabek Family Care, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for Indigenous youth who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a key difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while Indigenous youth are waiting for mental health services.