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.
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D intake presently recommended for healthy children, and also given to children with CHD, is inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been no studies investigating any other vitamin D dose in children with heart disease. Recently, a higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health Canada) and recent work on healthy children has shown it to be safe. The objective of this study is to determine whether this recently approved higher dose of vitamin D can safely reduce the number of children who are vitamin D deficient following surgery. This dose evaluation study will also evaluate whether it is possible to perform a large study (across Canada) to determine whether vitamin D supplementation can improve outcomes following surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce vitamin D deficiency following CHD surgery, when compared with usual intake.
Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use, confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in older adults compared to group-based information sessions; and 3. the study design is appropriate. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.
Obstructive Sleep Apnea is a serious medical condition affecting an estimated 1-5% of children. The disease is believed to have several overlapping causes including large tonsils and small or narrow jaws. This prospective, randomized cross-over study will evaluate the effectiveness of orthodontic treatment of narrow upper teeth and jaws compared to the current standard of care which is surgical removal of the adenoids and tonsils. Patients will be evaluated by both an orthodontist and ENT physician, complete a series of questionnaires and undergo an overnight sleep study, both initially and after undergoing the randomized treatment. Patients who on reassessment have residual symptoms of sleep apnea will then be crossed over and receive the other form of treatment. The levels of improvement to both subjective (questionnaire) and objective (overnight sleep study) measures of sleep apnea will then be compared. The null hypothesis is there is no significant difference in improvement between maxillary expansion and adenotonsillectomy in the objective and subjective outcome measures in children with mild to moderate obstructive sleep apnea.
Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if: 1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate; and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.
The process of enhancing the functional capacity of an individual before an operation to enable him or her to withstand the stress of surgery has been termed prehabilitation. It has been shown that poor baseline capacity for physical performance and poor nutritional status increase the risk of complications after major non cardiac surgery and prolong recovery. A controlled randomized study in patients undergoing radical cystectomy for cancer is therefore proposed to determine the impact of multimodal prehabilitation on functional exercise capacity and functional recovery. Patients who accept to be enrolled in the study will be randomized to either a group receiving a multimodal intervention which includes nutritional supplementation (Immunocal® whey protein) combined with a physical exercise program and stress reduction strategies before and after surgery, or a control group who will receive standard preoperative treatment as per our institution.
This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.
Hypothesis: The investigators propose that obese parturients will have an increased inflammatory response and a decreased anti-inflammatory response to the surgical and anesthetic insult of caesarean section and that this will be associated with a higher rate of perioperative complications, as compared to non-obese parturients.2 Background: Obese patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore, obese patients have a higher incidence of perioperative complications, especially wound infections, and this is well documented in the caesarean section population. The pregnant population is unique as a result of the immunologic changes that occur at baseline, and an increase in pro-inflammatory markers is seen in serum and in placental tissue of obese subjects, and has been demonstrated to correlate with adverse fetal outcomes. Specific Objectives: To determine the baseline levels of three established markers of inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35 kg/M2 respectively), and examine how they change in response to the stress of surgery/anesthesia. The investigators will correlate the inflammatory response with the incidence of postoperative wound infections. Methods: Patients will be recruited to the study prior to the planned caesarean section. Blood samples for inflammatory marker levels will be performed preoperatively, immediately postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3 (a relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory marker). Plasma will be analyzed by ELISA to determine levels of each biomarker. Patient charts will be reviewed to determine which patients have experienced surgical complications in the 30 days postoperatively. Surgical complications will then be correlated with the measured levels of inflammatory markers. Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the investigators would need to study 18 patients per group to prove our hypothesis that inflammatory cytokine levels are correlated with postoperative infections. The investigators plan to study 20 patients per group to account for a potential patient attrition rate of 10% during the study. Significance/Importance: The connection between obesity and dysregulation of the perioperative inflammatory response has not been well established nor has perioperative inflammation in the obese population been linked to the observed increased in perioperative morbidity. The investigators hope to demonstrate these connections and hopefully will be able to identify at risk patients earlier, and in a subsequent study intervene to reduce the risk of postoperative wound infections with pharmacokinetically targeted antimicrobial prophylaxis.
Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is associated with high rates of delirium. The aim of this pilot study is two fold. First, to determine the feasibility and potential challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.
Background: There are no published studies regarding the use of wound protectors in the context of surgical site infection (SSI) rates among patients receiving a pancreatoduodenectomy (Whipple) with preoperatively placed intrabiliary stents. In high volume experiences, the SSI rate is 40-50% within this cohort. In Calgary, preoperative biliary stent placement for bile duct decompression represents the norm given typical surgical wait times. In addition to having higher associated lengths of hospital stay, ICU admissions, hospital re-admissions, and overall mortality, patients with SSI are also delayed, and often omitted, in their progression to critical oncologic adjuvant chemotherapy. As a result, SSI remain crucial and devastating complications for pancreas surgeons and their patients alike. Methods: The investigators will complete a randomized controlled trial evaluating the rate of SSI in adult patients who undergo a pancreatoduodenectomy following biliary stent placement when wound protectors are employed versus no wound protector use. This trial will employ block randomization. All four University of Calgary Heapato-Pancreatico-Biliary (HPB) surgeons will participate with a planned inclusion of all patients scheduled to undergo a pancreatoduodenectomy. Analysis: The investigators will use an intention to treat approach to the analysis. Categorical baseline data will be analyzed using the Fisher exact probability test. Non-categorical baseline data will be analyzed using the Student t test. SSI rates will be determined using the Fisher exact probability test. Hypothesis: Wound protectors will reduce the SSI rate in patients undergoing a pancreatoduodenectomy with preoperatively placed intrabiliary stents. Potential Impact: Given the tremendous oncologic, economic, and psychological impact of SSI following pancreatoduodenectomy, the epidemic incidence of this complication must be reduced. The additional crippling effect of refusing (Medicare) payment for any patient who receives a SSI in the United States has launched all techniques and analyses that can potentially reduce this complication into the National health care agenda. In Canada, health care utilization and economics are always a relevant and ever expanding area of importance. It is crucial that the investigators reduce complications such as SSI, regardless of individual payer sources.
A pilot randomized, two parallel group study comparing an iPad software game application versus standard care in post-stroke patients. Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially efficacious tool which has the potential to promote fine motor recovery of the upper extremity after stroke.