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The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

Conditions:
Pediatrics | Mental Health | Mental Disorders | Emergency Psychiatric
Location:
  • Janeway Children's Hospital, Saint John's, Newfoundland and Labrador, Canada
  • The Hospital for Sick Children, Toronto, Ontario, Canada
  • London Health Sciences Centre, London, Ontario, Canada
  • The Children's Hospital of Winnipeg, Winnipeg, Manitoba, Canada
  • IWK Health Centre, Halifax, Nova Scotia, Canada
  • Montreal Children's Hospital, Montréal, Quebec, Canada
  • McMaster Children's Hospital, Hamilton, Ontario, Canada
  • Jim Pattison Children's Hospital, Saskatoon, Saskatchewan, Canada
Sex:
ALL
Ages:
8 - 17

Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.

Conditions:
Cerebral Palsy
Location:
  • University of Alberta, Edmonton, Alberta, Canada
  • Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada
Sex:
ALL
Ages:
5 - 18

The goal of this trial is to test a debriefing protocol to improve non-technical skills (NTS) in medical students. The study aims to answer the following questions: * Does a debriefing intervention improve medical students' NTS? * Does the intervention have an impact on the students' performance in simulated scenarios? Participants in the study will be randomly assigned to one of the teams, each consisting of a trauma team leader and three assistants. The teams will rotate across four different scenarios, allowing participants to switch roles and act as team leaders. The intervention teams will be debriefed using the study protocol, while the control groups will receive standard technical feedback without focusing on NTS. The primary outcome measure will be the Non-Technical Skills for Surgeons (NOTSS) score, which is a validated assessment tool for NTS. Secondary outcome measures include the number of correct interventions performed in each scenario. The study will involve 40 medical students, and the sample size was determined based on previous studies and statistical considerations. A panel of health educators will define the debriefing protocol, and the trial has been approved by the McGill Research Ethics Board office. The study findings are expected to contribute significantly to the training of providers of trauma care for children worldwide. By exploring the impact of debriefing on NTS in pediatric trauma education, this project aims to fill a critical gap in current training models.

Conditions:
Injuries
Location:
  • McGill University, Montréal, Quebec, Canada
Sex:
ALL
Ages:
18 - 99

This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.

Conditions:
Cancer of Prostate | Sedentary Behavior
Location:
  • University of Toronto, Toronto, Ontario, Canada
Sex:
MALE
Ages:
Over 18

Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects

Conditions:
Overweight and Obesity
Location:
  • Syneos Clinical Research Unit, Quebec city, Quebec, Canada
Sex:
ALL
Ages:
Over 40

The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Conditions:
Prostate Cancer
Location:
  • CIUSSS du Saguenay-Lac-St-Jean/CSSS de Chicoutimi, Chicoutimi, Quebec, Canada
  • Jewish General Hospital, McGill University, Montreal, Quebec, Canada
  • CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada
  • CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières, Trois-Rivières, Quebec, Canada
  • CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne, Greenfield Park, Quebec, Canada
  • MUHC - Cedars Cancer Center, Montreal, Quebec, Canada
  • CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval, Laval, Quebec, Canada
  • CIUSSS de l'Estrie - Hôpital Fleurimont, Sherbrooke, Quebec, Canada
Sex:
MALE
Ages:
Over 18

This project is a clustered randomized controlled trial of a knowledge translation intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent is to reduce the rate of cesarean section (CS) in first time mothers at term (\>= 37 weeks), with a vertex presenting singleton fetus, without increasing maternal or neonatal morbidity. The guidelines were developed from data from the Consortium for Safe Labor. The unit of randomization will be sites in Alberta that deliver

Conditions:
Cesarean Section, Dystocia
Location:
  • University of Calgary, Calgary, Alberta, Canada
Sex:
FEMALE
Ages:
Any

Estrogen Receptor (ER) is a crucial prognostic factor and treatment target in breast cancer patients. Knowledge of its status greatly influences the choice of the optimal course of treatment. Pathological evaluations of primary tumor, axillary nodes, and metastases are the only confirmatory approach to ER status determination and are limited to known and accessible sites. However, it is known that many advanced breast cancer patients harbor diseases presenting inter-tumor or temporal ER heterogeneity, as ER expression can vary between tumor foci and can evolve during treatment and at time of recurrence, hence the need for whole-body, non-invasive assessment of ER status. In the last decades, 16α-\[18F\]fluoroestradiol (FES) was developed and evaluated as an ER-targeting positron emission tomography (PET) tracer. FES correlated with ER expression, and recently was shown to be able to predict hormone therapy response. Our Center designed and evaluated 4-fluoro-11β-methoxy-16α-\[18F\]fluoroestradiol (4FMFES), a successor PET tracer for ER imaging. Paired comparison during a phase II clinical trial showed that 4FMFES produced images of better quality, with less overall non-specific signal than FES. It resulted in a significantly improved tumor contrast and tumor detectability using 4FMFES-PET leading to increased diagnosis confidence in early-stage breast cancer compared to FES-PET. Those results demonstrated that, as of now, 4FMFES-PET is the best imaging modality worldwide for whole-body ER status determination, but further validations are necessary to position this method as a standard and essential tool for breast cancer management. Like what was observed for FES-PET, preliminary data suggest that 4FMFES-PET combined with FDG-PET will yield very high sensibility for breast tumor detection, each method being complementary. In continuity with previous work, we seek to expand our clinical knowledge of this high-potential diagnostic imaging through the following main objective: Launch a phase II clinical trial to explore the full potential and benefit of 4FMFES-PET in combination with FDG-PET for advanced ER+ breast cancer patients to demonstrate it is an essential tool for cancer management. This proposed project will focus on 3 specific aims: 1. Compare and complement 4FMFES-PET with FDG-PET and conventional imaging modalities, and evaluate how they improved prognosis and staging of ER+ advanced breast cancer patients; 2. Correlate 4FMFES/FDG uptake and staging with pathological data (histology, receptor status, grade), including distal biopsy metastases sampling; 3. Correlate 4FMFES/FDG uptake and staging with longitudinal outcomes (treatment response, progression-free survival, time-to-relapse) to determine which cohort of patient benefit most from 4FMFES.

Conditions:
ER+ Breast Cancer
Location:
  • Université deSherbrooke, Sherbrooke, Quebec, Canada
Sex:
ALL
Ages:
Over 18

This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. The investigators are carrying out this research study with the following goals: 1. Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction 2. Identify patient variables associated with positive response to balloon dilation of the eustachian tube 3. Re-demonstrate the safety of balloon dilation of the eustachian tube What does participation in this study involve? Participants in this study will: * Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks later * Agree to allowing the investigators access to their personal health information * Complete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure: * A questionnaire to assess your eustachian tube dysfunction * An assessment of the movement of your ear drum (tympanogram) * A hearing test (audiogram) * A questionnaire to assess the impact of eustachian tube dysfunction on work/activity * A questionnaire to assess overall health-related quality of life * An assessment of the ability to equalize middle ear pressure(s) * Visual examination of the ear drums * Repeat the above assessments and questionnaires over the course of four follow-up appointments at 6-, 12-, 24-, and 52-weeks after the procedure.

Conditions:
Eustachian Tube Dysfunction | Barotitis
Location:
  • Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
  • Otology Clinic, Clinic 7A, South Health Campus, Calgary, Alberta, Canada
Sex:
ALL
Ages:
Over 18

This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.

Conditions:
Obesity
Location:
  • Altasciences Clinical Company, Inc, Montreal, Quebec, Canada
Sex:
FEMALE
Ages:
18 - 65