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.
Experimental models have linked lipid lowering therapies with systemic inflammation; however, relatively little is known about this network in clinical populations and specifically how it changes with PCSK9 inhibition. The eligible subjects will have 6 visits in 13 to 16 weeks and will have Repatha/placebo 140mg subcutaneous every 4 weeks for 3 times since randomization visit, blood tests will be done in each visit to evaluate the effects of evolocumab upon biocellular markers potentially altered by PCSK9 inhibition in a population of type 2 diabetes patients with microvascular dysfunction. Primary Aims: Determine the ACUTE and SHORT-TERM effects of PCSK9 inhibition with evolocumab on biocellular markers of inflammation, immune mediated thrombosis and rheology. The data from this trial will be used to support a clinical trial to assess the role of PCSK9 inhibition in type 2 diabetes patients with cardiac microvascular dysfunction. Secondary Aims: 1. To define the association between PCSK 9 concentrations and immune-related phenotype. 2. To define the association between Lp(a) concentrations, oxidized phospholipids (OxPL), ApoB, biocellular markers of inflammation, tissue factor and immunothrombosis.
Cardiovascular diseases (CVD), primarily heart disease and stroke, are the leading causes of death and prescription drug use in Canada. Research on certain dietary supplements looks promising as a way to help reduce CVD risk factors. Studies show that supplementation of certain nutrients such as antioxidants, amino acids, electrolytes, vitamins and minerals may effectively reduce cardiovascular risk factors. The dietary supplement CardioFlex Q10, which is high in the aforementioned components, was developed to help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation. The overall objective of this study is to determine if 90 days of supplementing with CardioFlex Q10 can reduce CVD risk factors in adults, independent of other dietary or physical activity changes.
This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.
Cesarean section accounts for nearly 30% of births in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists. Cesarean scar isthmocele, meaning a defect in the uterine wall at the site of a previous uterine incision, is a common complication of this surgery. While most are likely asymptomatic, isthmoceles can lead to major complications in pregnancy (uterine rupture, invasive placentation, cesarean scar ectopic pregnancy) and outside of pregnancy (abnormal uterine bleeding, infertility and pain). Studies have shown that the method used to suture the uterus at the time of a cesarean section may have an impact on the incidence of post-operative isthmocele formation. Our study is a randomized control trial of the impact of locked vs unlocked uterine closure at cesarean section on the incidence of isthmocele formation. Women undergoing cesarean section will be randomized to have either a locked or unlocked uterine closure. They will then return 6 months after their surgery for a transvaginal ultrasound to evaluate the presence or absence of an isthmocele. This study is a pilot trial. The investigators hope to determine the feasibility of completing a large randomized control trial by recording: a) the number of patient who agree to participate in this study, b) the number of patients who receive the correct intervention and, c) the number of patients who return for their post operative ultrasound. The investigators also plan to assess multiple secondary outcomes. First, the goal is to determine the isthmocele incidence within the study subjects of the pilot trial in order to perform a power calculation for a subsequent larger trial in this area. Another goal is to determine if the uterine closure techniques in this study lead to differences in surgical time, blood loss or the need for intra- or post-operative blood transfusion. Last, the study will collect data on the suture material most commonly used in this study to determine if this requires standardization in the subsequent larger trial.
Hospitalized infants undergo multiple painful procedures daily. Despite generation of a significant amount of evidence, procedural pain assessment and management in infants continues to be suboptimal. Untreated pain at this vital developmental juncture is associated with negative behavioural and neurodevelopmental consequences. To address this knowledge to practice gap, the investigators developed the Implementation of Infant Pain Practice Change (ImPaC) Resource (Resource) to guide change in health care professionals' pain practice behaviour. The aim of this study is (i) to evaluate the clinical effectiveness of the Resource (primary), (ii) to evaluate the implementation effectiveness of the Resource (secondary), and (iii) to explore how organizational context influences clinical and implementation outcomes (other). Eighteen Level 2 or Level 3 Neonatal Intensive Care Units (NICUs) with a minimum of 15 beds across Canada will be included in a cluster randomized controlled trial (RCT). The NICUs will be randomized following baseline data collection using a computer-generated random allocation sequence (randomize.net) to either the intervention (INT) or standard practice (SP) arms. Those in INT arm will receive the Resource for a 6-month period. NICUs in the SP arm will continue as usual with their unit or institutional pain practices. They will be offered the Resource following outcomes assessment. Clinical outcomes will be assessed six months after randomization. Primary clinical outcomes include (1) the proportion of infants in the NICU who have procedural pain assessed with a valid pain measure, (2) the proportion of infants in the NICU who have procedural pain managed with an evidence-based pharmacological or physical intervention, and (3) the total number of painful procedures per infant in the NICU. Implementation outcomes will include feasibility, fidelity, cost, and reach. Organizational context will be assessed by using the Alberta Context Tool.
Fatigue is a common and problematic symptom of end-stage renal disease (ESRD). The investigators have developed a new program, called the Personal Energy Planning (PEP) program, that teaches people with ESRD to manage fatigue by using energy conservation strategies during everyday life (eg. organization, prioritization, using good body postures and assistive tools). A large study is needed to test whether the program is helpful for people with ESRD. First, the investigators need to do a smaller-scale pilot study to help plan the large study. The main purposes of this pilot study are to see how many people with ESRD are willing and able to complete the PEP program, and to explore whether the program helps people feel less fatigued. The investigators plan to invite 40 people with ESRD from 4 dialysis units in Calgary, Alberta to participate. People with ESRD who report feeling unusually tired a lot of the time (using a symptom assessment tool completed every 2 months) will be asked to take part. Study participants will either do the PEP program, or another program (the control) that gives them general information about kidney disease. Participants will also be asked to complete questionnaires about fatigue before and after the study. The investigators will compare fatigue scores between the PEP program group and the control group, and record how many agree to take part in the study and complete all study activities. This pilot study will help the investigators plan next steps for research into the PEP program.
Suicide is a significant public health concern and causes approximately 1.5 % of all deaths in the general population in Canada. Suicide is a multi-faceted issue that is often comorbid with psychiatric illness and associated with diverse sociodemographic risk factors. Consequently, there are several domains of suicide risk management. The proposed intervention, the brief intervention, and contact (BIC) model will be tested for feasibility using a pilot pragmatic randomized trial.
The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination stress and that reducing light stimulation with a phototherapy mask can make infants more comfortable. The objective of this study is to determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12 hour period following ROP screening.
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).