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This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life

Conditions:
Melanoma
Location:
  • Sunnybrook Research Institute, Toronto, Ontario, Canada
Sex:
ALL
Ages:
Over 12

Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.

Conditions:
Sleep Disturbance | Perinatal Depression | Perinatal Anxiety
Location:
  • St. Joseph's Healthcare Hamilton, West 5th Campus, Hamilton, Ontario, Canada
Sex:
FEMALE
Ages:
18 - 45

To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)

Conditions:
DCIS
Location:
  • Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
  • BC Cancer - Fraser Valley Centre, Surrey, British Columbia, Canada
  • Cape Breton Cancer Centre, Sydney, Nova Scotia, Canada
  • Sunnybrook Health Science Centre -Odette Cancer Centre, Toronto, Ontario, Canada
  • Jewish General Hospital, Montréal, Quebec, Canada
  • BC Cancer - Centre for the North (Prince George), Prince George, British Columbia, Canada
  • QE II HSC - Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
  • Regional Cancer Care, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
  • CHUM - Centre Hospitalier de L'Université de Montréal, Montreal, Quebec, Canada
  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières, Trois-Rivières, Quebec, Canada
  • Cross Cancer Institute, Edmonton, Alberta, Canada
  • BC Cancer - Vancouver Centre, Vancouver, British Columbia, Canada
  • Juravinski Cancer Centre, Hamilton, Ontario, Canada
  • University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
  • McGill University Health Centre, Montréal, Quebec, Canada
  • BC Cancer - Abbotsford Centre, Abbotsford, British Columbia, Canada
  • BC Cancer - Victoria, Victoria, British Columbia, Canada
  • London Regional Cancer Program, London, Ontario, Canada
  • Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre), Greenfield Park, Quebec, Canada
  • Centre intégré de cancérologie du CHU de Québec - Université Laval, Québec City, Quebec, Canada
Sex:
FEMALE
Ages:
Over 46

Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.

Conditions:
Asthma | Cystic Fibrosis
Location:
  • The Hospital for Sick Children, Toronto, Ontario, Canada
Sex:
ALL
Ages:
Over 8

The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention. Participants will: will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program. A weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.

Conditions:
Concussion, Mild
Location:
  • McGill University Health Center, Montréal, Quebec, Canada
Sex:
ALL
Ages:
9 - 18

It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although the positive rate is low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging. A new tool (called Adjust-Unlikely) could safely reduce pulmonary embolism imaging in Canada. A research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results. The study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism.

Conditions:
Pulmonary Embolism | Diagnosis | D-dimer
Location:
  • Kingston Health Sciences Centre, Kingston, Ontario, Canada
Sex:
ALL
Ages:
Over 18

Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for an MRI. Objectives: The aims of this study are two-fold: 1- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 2- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to address the feasibility and acceptability of the use of virtual reality. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CHU Sainte-Justine's, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics, measures of anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological biomarkers of anxiety such as alpha-amylase and other markers such as heart rate and head deviation will also be measured. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Discussion: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. It will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI.

Conditions:
Anxiety | Magnetic Resonance Imaging | Pediatric | Virtual Reality
Location:
  • St. Justine's Hospital, Montréal, Quebec, Canada
Sex:
ALL
Ages:
7 - 17

This is a single centre study. The overarching hypothesis of this study is that MRI with inhaled tracer gases can provide high quality images of lung function to complement conventional 1H MRI. The study interventions do not affect the standard of care.

Conditions:
Healthy Volunteers
Location:
  • Hospital for Sick Children, Toronto, Ontario, Canada
Sex:
ALL
Ages:
6 - 75

This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.

Conditions:
Wounds | Wound of Skin
Location:
  • SHN Research Institute, Scarborough, Ontario, Canada
  • The Mayer Institute, Hamilton, Ontario, Canada
Sex:
ALL
Ages:
Over 22

The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).

Conditions:
Amyotrophic Lateral Sclerosis
Location:
  • Montreal Neurological Institute, Montreal, Quebec, Canada
Sex:
ALL
Ages:
Over 10