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.
Social anxiety represents one of the most prevalent comorbid conditions in schizophrenia and related psychosis. Schizophrenia patients with comorbid social anxiety often exhibit impaired social functioning, an increased risk for relapse, and higher rates of suicide. Social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. There is strong evidence that cognitive-behavioral therapy (CBT) for the treatment of social anxiety is very effective, whether it is delivered individually or in a group setting, and studies have shown that a group setting is more effective than individual therapy. Providing a CBT intervention for social anxiety represents an effective way to empower people with this illness. The investigators have conducted a preliminary study using an uncontrolled design to assess feasibility and initial benefits of a new manualized group CBT intervention for social anxiety specifically adapted for people with psychosis. The investigators observed a significant reduction in social anxiety symptoms across three groups of first episode psychosis (FEP) participants (n=29) following completion of this 13-week intervention, and observed large effect sizes confirming a significant positive influence of this intervention. The investigators now propose to conduct a randomized controlled trial to fully assess the efficacy of this intervention. The main objective of this research proposal is to contrast the impact of a CBT intervention for the treatment of social anxiety in first episode psychosis with another control condition involving computer assisted cognitive remediation therapy (CACRT). Both interventions will be offered in a group setting, and will therefore have the exact same parameters. A secondary objective of this study is to examine the impact of reduced social anxiety on measures of clinical and functional outcome. For this trial, 120 patients with recent onset psychotic disorder (defined as within 5 years from their first episode of psychosis) and with social anxiety will be clinically assessed. These participants will be recruited from five different first episode psychosis programs in the Montreal area and referred by their treatment team. They will then be randomly assigned to either the CBT or CACRT conditions. Both interventions will involve 13 weekly group sessions. At the end of group interventions and at two follow-ups (3-month & 6-month), the presence and severity of social anxiety symptoms will be assessed. It is hypothesized that compared to the CACRT group, individuals receiving the CBT intervention will show a reduction in symptoms associated with social anxiety (as determined with multiple self-report and clinician rated measures). This effect will be maintained at follow-ups. In addition, the investigators also hypothesize that the CBT group will show better clinical outcome, defined as the length of symptomatic remission at follow-ups. For functional outcome, they will show significant improvement on a self-report measure a clinician-rated measure of recovery. This study will be one of the first to specifically target social anxiety in people with psychosis using a psychosocial intervention. As such, it will tackle an important problem that is interfering with recovery and with the actualization of functional roles.
Lead survivability will be summarized.
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.
The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).
The purpose of this pilot study is to test the efficacy of the physical activity (PA) intervention protocol to increase preschoolers overall PA levels and time spent in moderate to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement based activities developed for preschoolers and successfully piloted for feasibility in 3 to 5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As well, the PA intervention includes educational workshops for the day care providers, ongoing biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment necessary to implement the program. The study is also evaluating the efficacy of the PA intervention to decrease the amount of time spent in sedentary behaviour at the day care setting. Secondary objectives include evaluating the effects of the PA intervention on preschool children's anthropometrics, and fundamental and gross motor skills. In addition, the intervention is also assessing the effects of the program on day care provider's attitudes, control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.
This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately two years after the start of treatment.
The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.