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The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is up to 6 years.
Conditions:
Rett SyndromeLocation:
- CHU Ste-Justine, Montréal, Quebec, Canada
Sex:
FEMALEAges:
5 - 8The study will examine the efficacy of an internet-based cognitive behavioural therapy (iCBT) for Inflammatory Bowel Disease (IBD) intervention to reduce stress, anxiety, and depression in individuals with IBD and comorbid clinically elevated t anxiety and/or depressive symptoms. The investigators will conduct a two-arm RCT comparing participants receiving the iCBT intervention (intervention group) and those receiving Treatment As Usual (TAU).
Conditions:
Anxiety | Inflammatory Bowel Diseases | Depression | StressLocation:
- University of Manitoba, Winnipeg, Manitoba, Canada
Sex:
ALLAges:
Over 18This study will include patients with invasive cervical cancer that wish to keep their fertility as much as possible in the future after treatment. Patients who receive surgery alone may experience long-term side effects including infertility. The purpose of this research study is to determine whether giving neo-adjuvant chemotherapy prior to surgery can maintain fertility in patients with invasive cervical cancer. The neo-adjuvant chemotherapy will consist of a platinum-based chemotherapy drug cisplatin or carboplatin, with a chemotherapy drug called paclitaxel. These are common chemotherapy drugs used in the treatment of women with cervical cancers.
Conditions:
Cervical CancerLocation:
- L'Hôtel-Dieu de Québec, Québec, Quebec, Canada
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Sex:
FEMALEAges:
18 - 40The genomic heterogeneity of cancers implies that to effectively use targeted therapies the investigators will need to assess each individual cancer and match it to a biologically relevant targeted therapy. The investigators will use full genome sequencing to try to identify cancer "drivers" and corresponding drugs that may inhibit these pathways.
Conditions:
Advanced Cancers | Metastatic Cancers | Cancers That Cannot be Treated With Curative IntentLocation:
- BC Cancer Agency, Vancouver, British Columbia, Canada
Sex:
ALLAges:
18 - 85The purpose of this study is to evaluate safety, tolerability, PK, and PD of SAD of FXI-GalNAc-siRNA administered SC to healthy subjects.
Conditions:
FXILocation:
- BioPharma, Toronto, Ontario, Canada
Sex:
ALLAges:
18 - 55Currently, several vaccines are available to combat the COVID-19 pandemic. The persistence of SARS-CoV-2 globally requires the development of additional vaccines to aid in preventing further SARS-CoV-2 infections. Covigenix VAX-002 is a vaccine based off its predecessors VAX-001 and VAX-001-1b. All three are plasmid DNA vaccines that express key antigenic determinants from SARS-CoV-2 and use the Entos Pharmaceuticals' Fusogenix proteo-lipid vehicle (PLV) platform. Currently, the safety and tolerability of VAX-001 and VAX-001-1b for primary vaccination following 1 or 2 doses are being investigated in a Phase 1/2 study (ENTVAX01-101). In Phase 1, VAX-001 was administered to healthy adults on Day 0 and Day 14, as either 2 low doses (100 μg/dose) or 2 high doses (250 μg/dose). Overall, data suggest that VAX-001 is safe at both the low and high dose levels. The Phase 2 part evaluates VAX-001-1b in adults at a 100 μg dose level on a 1-dose and a 2-dose schedule (Days 0 and 28). An interim analysis conducted on data from 18 participants in the sentinel group who had received their first dose of 100 μg showed that VAX-001-1b was overall safe with minor adverse events (AEs) registered. No serious adverse events (SAEs) were reported. After a review of the data, the Data Safety Monitoring Committee (DSMC) provided their recommendations for the participants in the 100 μg dose sentinel group to receive a second dose. The present study investigates the safety and immunogenicity of VAX-002 when given as a booster dose to generally healthy adults aged 18 years or older who have received a primary vaccination course or a booster dose of an authorized COVID-19 vaccine at least 3 months prior to Day 0. VAX-002 was specifically designed to address the new circulating omicron variants of SARS-CoV-2. The study consists of 2 parts: a dose-finding/safety evaluation part (Phase 1) to determine the dose of VAX-002 for booster vaccination (100 μg or 250 μg) followed by an adaptive Phase
Conditions:
COVID-19Location:
- University of Alberta, Edmonton, Alberta, Canada
- Diex Recherche Quebec, Québec, Quebec, Canada
- Centricity Research, Toronto, Ontario, Canada
- Centricity Research, Burlington, Ontario, Canada
- Diex Recherche, Sherbrooke, Quebec, Canada
- Centricity Research, Toronto, Ontario, Canada
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ALLAges:
18 - 65This study aims to evaluate the feasibility, safety and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the time of colorectal surgery to prevent ovarian cancer. Ovarian cancer is the fifth cause of cancer-related mortality in females in Canada. OS can prevent the most common and lethal type of ovarian cancer, high grade serous carcinoma (HGSC). OS during gynecologic surgery (hysterectomy or instead of tubal ligation) is safe and effective. However, rates of hysterectomies and tubal sterilization are decreasing. This research team aims to extend the prevention of ovarian cancer by expanding to offer OS during other surgeries in the pelvis where fallopian tubes are accessible, beginning with colorectal surgery. This study will examine: 1) the feasibility of OS at the time of colorectal surgery; 2) the safety of OS at the time of colorectal surgery; 3) the cost-effectiveness of OS at the time of colorectal surgery. The hypothesis is that OS will be well accepted by individuals with fallopian tubes undergoing colorectal surgery, and that the vast majority (around 90 percent) of attempts to remove both fallopian tubes will be successful. It is expected that there will be 10-20 minutes additional operating room time for completing OS and that there will be no increased risk of complications when OS is included in a colorectal surgery. The researchers also hypothesize that OS at the time of colorectal surgery will be cost-effective because of the reduced number of ovarian cancer cases and associated treatment costs.
Conditions:
Colorectal Surgery | SalpingectomyLocation:
- St. Paul's Hospital, Vancouver, British Columbia, Canada
- Vancouver General Hospital, Vancouver, British Columbia, Canada
Sex:
FEMALEAges:
15 - 80Athletes in low energy availability (LEA) are at increased risk of developing the Relative Energy Deficiency in Sports (RED-S) syndrome (Mountjoy et al., 2018). LEA is a mismatch between dietary energy intake and exercise energy expenditure, leaving inadequate energy to support physiological functions, and the RED-S syndrome increases the risk of impaired health and performance (Drew et al., 2018, Sesbreno et al., 2022a, under review; Sesbreno et al., 2022b, in preparation; \& VanHeest et al., 2014). Although athletes with eating disorders are at high risk, many more may be vulnerable due to uninformed practices for weight loss and/or failure to match energy intake to energy demands for exercise (Wells et al., 2020). Despite efforts to better detect athletes in LEA/RED-S;there is no research on the effectiveness of dietary interventions to influence energy intake in international elite/world-class athletes tomitigate risk of LEA (De Souza et al., 2021; Elliott-Sale et al., 2018; Heikura et al., 2021; Melin et al., 2014; Stellingwerf et al., 2021;Stenqvist et al., 2021 \& Rogers et al., 2021). Therefore, it is important to investigate dietary interventions to influence eating habits to improve energy availability in elite athletes. Energy deficit associated with LEA in elite athletes may be accompanied by insufficient carbohydrate intake for training demands (Burke et al., 2011; Heikura et al., 2017; Sesbreno et al., 2021). Unfortunately, there is a paucity of information on the influence of sport nutrition education interventions on dietary intake in elite international (tier 4) and world-class (tier 5) athletes (McKay et al., 2022). However, recent findings suggest an association between nutrition knowledge and energy/carbohydrate availability in young female endurance athletes (Kettunen et al., 2021). This finding may offer a cost effective approach to lower the risk of LEA since education programs have shown to improve nutrition knowledge in athletes (Tam et al., 2019). However, an increase in nutrition knowledge may not always lead to a parallel increase in energy/carbohydrate intake (Heikkila et al., 2019). Indeed, the influence of nutrition education programs on improving dietary intake in athletes is reportedly equivocal (Boidin et al., 2021). However, the differences in intervention design with lack of guidelines on standardized and/or validated methods to assess sport nutrition knowledge and eating habits in elite athletes have made comparisons difficult for generalized interpretation. Fortunately, the new arrival of the Platform to Evaluate Athlete Knowledge of Sports Nutrition Questionnaire (PEAK-NQ) and the Athlete Diet Index (ADI) offer validated methods for assessing sport nutrition knowledge and eating habits in elite athletes (Capling et al., 2021 and Tam et al., 2021). Nevertheless, it is also important to appreciate that nutrition knowledge is not the sole influencing factors to athletes' dietary habits; and recognizing additional factors affecting athletes' decisions around nutrition is critical. A multitude of factors influence food choices in elite athletes (Thurecht et al., 2019). It ranges from sensory appeal, emotional influences, influence of others, weight control, performance among others (Thurecht et al, 2020). Interestingly, a moderate intercorrelation between nutritional attributes of the food and weight control, performance as well as food values and beliefs were reported (Thurecht et al., 2021). In fact, restraint eating behaviour have been associated with LEA, body weight and physique morphology (Jurov et al., 2021; Sesbreno et al., 2021; Sesbreno et al., 2022c in preparation; Sesbreno et al., 2022d, in preparation \& Viner et al., 2015). Clearly, multiple factors influence dietary habits, and therefore, it is important to consider how education interventions are developed to influence dietary outcomes in elite athletes. The Capability, Opportunity, Motivation - Behaviour (COM-B) model describes the importance of influencing 3-sources of behaviour to consistently alter habits (Michie et al., 2011). This was reiterated by sport nutritionists who characterized enablers and barriers to nutrition adherence in high performance sports (Bentley et al., 2019). In a case study, dietary interventions that targeted all 3-source behaviours was associated with improvements in dietary intake, including energy availability as an elite rugby player prepared for his 1st professional season (Costello et al., 2018). Therefore, a sport nutrition education program that accounts for all source behaviours may be necessary to improve eating habits intake to lower the risk of LEA/RED-S in elite international and world-class athletes during the competitive season. Overall Aim: Investigate whether elite athletes' nutrition knowledge and dietary intake can improve through an education intervention to lower the risk of low energy availability.
Conditions:
Eating BehaviorLocation:
- McGill University, Montréal, Quebec, Canada
Sex:
ALLAges:
18 - 40Type 2 diabetes (T2D) prevalence has steadily been rising in the past decades and its complications, including cardiovascular diseases (CVD), are a major public health concern. To lower CVD risk and to maintain an adequate glycemic control, Diabetes Canada recommends aerobic exercise of high-intensity interval training (HIIT). The leading hypothesis of this study is that longer intervals will favor an anti-inflammatory immune state, and that and that it will be correlated with reduced arterial stiffness and blood pressure.
Conditions:
Diabetes Mellitus, Type 2Location:
- Centre de recherche sur le vieillissement, Sherbrooke, Quebec, Canada
Sex:
FEMALEAges:
60 - 80The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD). The main questions it aims to answer are: * Does group WET lead to a reduction in symptoms of PTSD? * Is group WET better at reducing the number of patients that drop out of treatment in comparison to group Cognitive Processing Therapy (CPT)? Participants will: * Attend 6 weekly sessions of group WET that will be delivered online by two therapists (psychologist and social worker) * Complete questionnaires relating to their symptoms at different points throughout the treatment Researchers will evaluate change in PTSD symptoms over time for people who participate in group WET. They will also compare the results of group WET to the results of group CPT to see if group WET shows a similar reduction in symptoms of PTSD and fewer treatment drop-outs.
Conditions:
Posttraumatic Stress DisorderLocation:
- Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada