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The objective of this study is to investigate if the addition of a 12-week program of home-based high intensity interval training to a standard educational program aiming at preventing hypoglycemia episodes will restore hypoglycemia awareness in people living with type 1 diabetes and impaired awareness of hypoglycemia to a further extent than a standard educational program alone. Participants will be randomized for 12 weeks to the standard educational program with or without high intensity interval training. The Gold method will be used to identify people with impaired awareness of hypoglycemia. The educational program will consist of two education sessions on avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a CGM/Flash-GM and understand CGM/Flash-GM reports to adjust insulin doses. Participants randomized to the training program will be asked to train three times per week for 12 weeks following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week (ideally all 3 sessions) with the exercise specialist on a virtual platform.
Conditions:
Type 1 Diabetes | Hypoglycemia UnawarenessLocation:
- Institut de recherches cliniques de Montréal, Montreal, Quebec, Canada
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18 - 65This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.
Conditions:
Refractory Diffuse Large B-cell Lymphoma | Relapsed Diffuse Large B-cell LymphomaLocation:
- Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada
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Over 18Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. In the 2022-2023, influenza, RSV and SARS-CoV-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. Unfortunately, there continues to be limited data on duration of infectiousness and transmission risk of these viruses to inform public health decisions during times when there is significant circulation of these viruses.
Conditions:
Influenza | RSV Infection | SARS CoV 2 InfectionLocation:
- The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada
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Over 1The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric kidney transplant recipients who are trained to offer vital peer support and mentorship. Parents of children who received a kidney transplant at The Hospital for Sick Children will be invited to participate as mentors and mentees. The iP2P program can decrease feelings of isolation, improve mental health and have a long-term positive impact on patient health. This research will increase our understanding of one-to-one peer support and leverage eHealth technologies to improve the access to and acceptability of parent peer support interventions.
Conditions:
Kidney TransplantLocation:
- The Hospital for Sick Children, Toronto, Ontario, Canada
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18 - 75Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard care group to assess the feasibility and treatment effect of a multimodal integrative intervention for delirium prevention and associated detrimental effects. Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To assess feasibility and measures of effect of a multimodal intervention consisting of relaxation with guided imagery (RGI), and moderate pressure massage on physiological and psychological outcomes of critically ill patients. Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment, randomization, adherence, timing of intervention, workload), b) calculate estimates and variance of treatment effect across outcome measures, c) calculate confidence intervals (CI) of incidence proportions, means and standard deviation (SD) of outcome measures in study groups., d) explore underlying physiological mechanisms of efficacy Number of Subjects: 60 participants per arm. Total: 120 participants Diagnosis and Main Inclusion Criteria: Critical illness Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3. Exclusion Criteria: Patients: a) with expected ICU LOS\< 72 hours, b) with acute neurological illness/ trauma, persistent sedation or coma, c) with current history of severe mental health problems and dementia, as per history and psychiatrist assessment, c) with hearing impairment or conditions not permitting use of headphones, e) on neuro-muscular blockers, f) with substance/ alcohol withdrawal, g) enrolled in trials of sedatives, antipsychotics. Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a) relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured guided imagery script and c) music for 15 min (Mozart piano sonata KV283, G major (2 3) II Andante). Duration of administration: Up to 5 days while participants still in the ICU. Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology: Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on generalized estimating equations (GEE) with AR(1) correlation structure. Confidence intervals will be presented with estimated effects. Primary analysis will be based on all available data utilizing data from all assessments.
Conditions:
DeliriumLocation:
- Misreicordia Hospital, Edmonton, Alberta, Canada
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Over 18The aim of this randomized clinical trial is to verify the efficacy of VR immersion over a muted cartoon on a wall-mounted TV to decrease dental fear and anxiety of children undergoing dental procedures. The study also aims to gain insight on the satisfaction of parents and healthcare providers on the use of VR during dental appointments. Main research question: Does VR immersion compare to a cartoon on a wall-mounted TV is more efficacious to decrease dental fear and anxiety of children requiring dental procedures? Participants will be playing through a VR immersive game wearing a eye-tracking VR headset that requires no movement of the head to play, facilitating the dental procedure. The investigators will take measures of the stress levels of participants and their parents using a validated stress scale and also by taking salivary samples to verify the levels of a stress biomarker (alpha-amylase).
Conditions:
Dental Anxiety | Dental Diseases | Dental Trauma | Dental PhobiaLocation:
- St.Justine's Hospital, Montreal, Quebec, Canada
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6 - 17Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. The goal of our study is to test a newly developed app that focuses on providing stress management strategies for caregivers of people living with dementia.
Conditions:
Caregiver BurdenLocation:
- University of Regina, Regina, Saskatchewan, Canada
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Over 18Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.
Conditions:
Postural Orthostatic Tachycardia SyndromeLocation:
- University of Calgary, Calgary, Alberta, Canada
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18 - 60The aim of this study is to evaluate nedosiran in participants 11 years of age and younger who have Primary Hyperoxaluria with relatively intact renal function.
Conditions:
Primary Hyperoxaluria | Primary Hyperoxaluria Type 1 | Primary Hyperoxaluria Type 2 | Primary Hyperoxaluria Type 3Location:
- Clinical Research Site, Hamilton, Ontario, Canada
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Under 11Hospital Scene #1: A 6-year-old arrives in the Emergency Department at McMaster Children's Hospital (MCH) complaining of pain in his lower right side. His Dad explains the pain has been going on for a few hours and that Advil and Tyelnol haven't helped at all. He's anxious and concerned about his son because he never complains about pain - so this must be bad. After he has been seen by the doctor, the appendix appears to be the problem and the boy needs to have it removed. Dad wants his son's pain to go away but is worried because he once got a high dose of a medication and had some unwanted side effects. Hospital Scene #2: A 14-year-old girl has been experiencing migraine headaches for the past months and is awaiting an appointment with a specialist. Today, however, the pain is the worst it's been. Mom has picked her up from school and brought her to MCH not knowing what else to do to help her. The Advil and Tylenol have not improved her pain. She desperately wants the pain to go away but is worried because she read that some pain medicines are used without any studies done to see if they work and if they are safe. (https://www.ottawalife.com/article/most-medications-prescribed-to-children-have-not-been-adequately-studied?c=9). In both cases, these children need medicine to help their pain. The treating doctors want to give them pain medicine that will 1) be safe and 2) make the pain go away. This is what parents and the child/teenager, and the doctors want too. Some pain medicines like opioids are often used to help with pain in children. Unfortunately, opioids can have bad side effects and can, when used incorrectly or for a long time, be addictive and even dangerous. A better option would be a non-opioid, like Ketorolac, which also helps pain but is safer and has fewer side effects. The information doctors have about how much Ketorolac to give a child, though, is what has been learned from research in adults. Like with any medication, the smallest amount that a child can take while still getting pain relief is best and safest. Why give more medicine and have a higher risk of getting a side effect, if a lower dose will do the trick? This is what the researchers don't know about Ketorolac and what this study aims to find out. Children 6-17 years old who are reporting bad pain when they are in the Emergency Department or admitted in hospital and who will be getting an intravenous line in their arm will be included in the study. Those who want to participate will understand that the goal of the study is to find out if a smaller amount of medicine improves pain as much as a larger amount. By random chance, like flipping a coin, the child will be placed into a treatment group. The difference between these treatment groups is the amount of Ketorolac they will get. One treatment will be the normal dose that doctors use at MCH, and the other two doses will be smaller. Neither the patient, parent nor doctor will know how much Ketorolac they are getting. Over two hours, the research nurse or assistant will ask the child how much pain they are in. Our research team will also measure how much time it took for the pain to get better, and whether the child had to take any other medicine to help with pain. The research team will also ask families and patients some questions to understand their perceptions of pain control, pain medicines and side effects they know of. This research is important because it may change the way that doctors treat children with pain, not just at MCH but around the world. The results of this study will be shared with doctors through conferences and scientific papers. It's also important that clinicians share information with parents and children so that they can understand more about pain medicines and how these medicines can be used safely with the lowest chance of side effects.
Conditions:
Migraine | Acute Pain | Renal Colic | Abdominal Pain | Appendicitis Acute | Biliary ColicLocation:
- McMaster University Medical Centre, Hamilton, Ontario, Canada
- McMaster Children's Hospital, Hamilton, Ontario, Canada