There are about 28871 clinical studies being (or have been) conducted in Canada. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Introduction. Dental fear and anxiety (DFA) is a condition that affects approximately a quarter of children and adolescents. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely. Virtual reality use could improve DFA in children with special health care needs (SHCN) undergoing dental procedures. Aim. Assess the feasibility and acceptability of VR immersion as a tool to reduce dental fear and anxiety in pediatric special needs patients undergoing dental procedures and gain insight on parents and healthcare providers perspectives on the use of VR during dental appointments. Methods. This pilot randomized controlled trial study will follow a parallel design including two groups: A control group (clinic's standard care) and an experimental group (virtual reality). Twenty participants will be randomized to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care center that mostly serves pediatric patients with SHCN. The experimental group will receive the VR video game Dream designed specifically for this study. It aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. The VR headset offers children with the ability of viewing the game they are playing in real time while simultaneously obstructing the partial view they would normally have of the procedure. The primary outcome will be assessment of dental fear and anxiety in children using both observation-based proxy assessment with the Venham Anxiety and Behavior Rating Scale (VABRS) and a physiological biomarker such as the level of salivary alpha-amylase. Sociodemographic characteristics, measures of level of satisfaction of parents and healthcare professionals, occurrence of side effects and any deviation from normal procedure length will also be collected. Analysis will be carried out using statistical analysis software SAS (version 9.4; Cary, NC, USA). Descriptive statistics will be conducted for demographic and clinical variables and will be used to present parents and healthcare professionals' satisfaction levels, and also procedural time. Discussion. The investigators believe that the results of this pilot study will provide a better understanding of the feasibility and effect of VR on DFA in children with SHCN.
This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.
Factors related to successful rehabilitation in acquired brain injury (ABI) are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Regarding salience, patients may lose interest or find a traditional intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for patients but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Additionally, the same factors that are related to can impact adherence are also related to neuroplasticity. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes for those with ABI. The gamification of rehabilitation therapies using augmented reality (AR) may help promote adherence. Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the experience achieved through AR can further promote salience and be customizable to individual patient requirements. As AR systems are now highly portable, cost-effective, and relatively simple to utilize, they can provide an excellent opportunity to provide more engaging rehabilitation approaches compared to standard care alone. AR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose AR-delivered ABI program (developed by the Cognitive Projections Lab, University of Alberta) has been created in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with ABI rehabilitation therapy. The proposed studies are to investigate the feasibility of implementing this technology alongside routine clinical care, obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose AR ABI-therapies on patient adherence and clinical outcomes, compared to traditional clinical care alone.
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M [A2M]) study (NCT03299049).
This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis. This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.
This project will be a pilot study to test the feasibility of using Emotion Focused Therapy (EFT) among competitive athletes experiencing mild-to-moderate depression or anxiety. To test whether the intervention works, the researchers will assess athletes' emotion dysregulation, symptoms of mood disorders (anxiety and depression), sport-related distress, subjective performance satisfaction, and well-being. In addition to assessing athlete outcomes, key aspects to be examined in the pilot study include the recruitment and randomization procedures, informed consent procedures, data collection tools, implementation of the intervention, and retention of participants. Feasibility will be assessed by recruitment (willingness to be randomized, number of eligible participants in the recruitment process). Retention will be assessed by the number of athletes who continue or discontinue attendance. Participants' experiences in the intervention will be assessed via qualitative interviews to gain in-depth information about their perceptions of the intervention.
Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.
The goal of this clinical trial is to provide evidence, through an extreme exercise prescription (1,144 km of road cycling on seven consecutive days), that weight loss is not the appropriate outcome to evaluate the effects of exercise on abdominal adiposity and ectopic fat depots (e.g. liver fat and epi/pericardial fat) in eleven recreational middle-aged male cyclists (aged 50 to 66 years) without symptoms of cardiovascular disease. The main questions it aims to answer are: - If energy intake is substantially increased to compensate energy expenditure and prevent weight loss following an extreme exercise prescription, will significant changes in body composition and body fat distribution be observed? - Will these changes translate into improvements in the cardiometabolic health profile even in the absence of weight loss? Participants will be asked to partake in several evaluations: fasting plasma lipoprotein-lipid profile and inflammation markers, glycated hemoglobin, cardiorespiratory fitness, submaximal exercise test including measurement of energy expenditure, resting and exercise blood pressure and heart rate, evaluation of regional adiposity, liver fat content, epi/pericardial fat, nutritional quality, and level of physical activity. After baseline evaluations, participants will be asked to alternately bike 208 km and 104 km per day on a pre-specified course for seven consecutive days. They will be accompanied during each of the seven bike rides by research professionals in a recreational vehicle. Participants' weight, body composition and waist circumference will be measured under standardized conditions in the morning after an overnight fast and after the exercise. Their heart rate will be continuously monitored, and participants will wear accelerometers to estimate their daily exercise-related energy expenditure. Foods and fluids will be provided to participants and recorded. At the end of the 1,144 km/ 7-days bike ride, baseline evaluations will be repeated with the exception of the maximal exercise treadmill test, nutritional quality, and level of physical activity. To facilitate the conduct of the protocol, the eleven participants will be evaluated and followed in two distinct groups.