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Background: Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control. Objective: The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed. Methods Design: This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinical case management compared to HBPT with usual care. Setting: Peace River region in Northern Alberta Region, Canada. Patients: Primary care patients with CKD and hypertension. Measurements: Eligible patients will be randomized 1:1 to HBPT + BP case management versus HBPT + usual care. In the intervention arm, BP will be measured 4 times daily for 1 week, with medications titrated up or down by the study case manager until guideline targets (systolic BP \[SBP\]: \<130mmHg) are achieved. Once BP is controlled, (i.e., to guideline-concordant targets), this 1-week protocol will be repeated every 3 months for 1 year. Patients in the control arm will also follow the same BP measurement protocol, however, there will be no interactions with the case manager; they will share their BP readings with their primary care physicians or nurse practitioners at scheduled visits. Limitations: Potential limitations of this study include the relatively short duration of follow-up, possible technological pitfalls, and need for patients to own a smartphone and have access to the internet to participate. Conclusions: As this study will focus on a high-risk population that has been characterized by a large care gap, it will generate important evidence that would allow targeted and effective population-level strategies to be implemented to improve health outcomes for high-risk hypertensive CKD patients in Canada's remote communities.

Conditions:
Chronic Kidney Diseases
Location:
  • University of Alberta, Edmonton, Albert, Canada
Sex:
ALL
Ages:
Over 18

The aim of the study is to compare couple-based treatment to individual treatment (treatment as usual) for addiction (gambling or substance use disorder).

Conditions:
Substance Use Disorders | Gambling Disorder
Location:
  • Centre Intégré de Santé et de Services Sociaux des Laurentides, Saint-Jérôme, Quebec, Canada
  • Centre Intégré de Santé et de Services Sociaux de Lanaudière, Joliette, Quebec, Canada
  • Centre Universitaire Intégré de Santé et de Services Sociaux de l'Estrie, Sherbrooke, Quebec, Canada
  • Centre Universitaire Intégré de Santé et de Services Sociaux du Centre Sud de l'Ile de Montréal, Montréal, Quebec, Canada
  • Centre Universitaire Intégré de Santé et de Services Sociaux du Centre Sud de l'Ile de Montréal, Montreal, Quebec, Canada
  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Ouest, Saint-Hubert, Quebec, Canada
  • Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches (CISSS-CA), Lévis, Quebec, Canada
Sex:
ALL
Ages:
Over 18

The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.

Conditions:
Pulmonary Hypertension | Right Heart Failure | Right Ventricular Dysfunction
Location:
  • London Health Sciences Centre - University Hospital, London, Ontario, Canada
  • University of Alberta, Edmonton, Alberta, Canada
  • The University of British Columbia, Vancouver, British Columbia, Canada
  • University of Calgary, Calgary, Alberta, Canada
  • The Ottawa Hospital, Ottawa, Ontario, Canada
Sex:
ALL
Ages:
Over 18

Currently, the analgesic standard of care for patients undergoing total hip arthroplasty (THA) at our centre is intraoperative infiltration with a solution of local anesthetic, morphine (opioid), and ketorolac (nonsteroidal anti-inflammatory drug - NSAID). If a patient has a contraindication for the use of an opioid or NSAIDs, this infiltration is performed with a plain local anesthetic. No blocks (numbing of certain nerves to prevent pain from occurring in that area) are performed for postoperative pain in these patients. The pericapsular nerve group (PENG) block is a recently described technique with limited data in the literature that has assessed the benefits of using this nerve block for THA procedures. The purpose of this study is to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration (ILAI) with an associated cost benefit for patients undergoing THA.

Conditions:
Anesthesia
Location:
  • London Health Sciences Centre, London, Ontario, Canada
Sex:
ALL
Ages:
Over 19

Functional neurosurgery is dedicated to modulating aberrant neural circuits associated with a wide range of neurological conditions. Recently, technological advances in MRI have permitted marked improvements in the direct visualization of neural targets, which is necessary for the accurate targeting in functional neurosurgery procedures. This research study focuses on imaging patient brains before their scheduled procedures by using a 3 tesla (T) MRI to provide higher resolution and quality brain images. The reason for this study is to assess the image quality using different MRI sequences or settings to improve the image resolution of the most common functional neurosurgery targets (e.g., subthalamic nucleus, globus pallidus, and thalamus) and compare the image quality of the brains in patients with healthy controls. Performing a preoperative MRI is standard-of-care for patients indicated for deep brain stimulation (DBS), gamma knife radiosurgery (GKRS), radiofrequency ablation (RFA), magnetic resonance-guided focused ultrasound (MRgFUS). MRI sequence parameters shown to improve the image quality of different neural structures in a recent literature review (Boutet et al. 2021) will be reproduced on the 3T MRI at Toronto Western Hospital.

Conditions:
Neuro-Degenerative Disease
Location:
  • Toronto Western Hospital, Toronto, Ontario, Canada
Sex:
ALL
Ages:
18 - 85

Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal-setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. The investigators are also interested in service use and the cost vs. benefits of the ENGAGE approach compared to usual practice. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. The investigators will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. The investigators will also ask children, parents, therapists, and managers to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve the efficiency of paediatric rehabilitation services.

Conditions:
Neurodevelopmental Disorders
Location:
  • University of Alberta, Edmonton, Alberta, Canada
Sex:
ALL
Ages:
5 - 12

The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action. Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered. Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC). Putting together these data will allow to correlate clinical and radiological response to QOL and NC.

Conditions:
Relapse | Glioblastoma Multiforme
Location:
  • CHUS, Sherbrooke, Quebec, Canada
Sex:
ALL
Ages:
Over 18

Postpartum hemorrhage (PPH) continues to be an increasing problem globally. Uterotonics play an essential role in the pharmacological management of uterine atony. Carbetocin, a long acting analog of oxytocin has been recommended as a first line uterotonic for PPH prophylaxis at cesarean delivery. Considering many woman have associated comorbidities and are at high risk of PPH, finding alternative pharmacological agents is essential. Calcium is a key factor for myometrial contractions and calcium blood levels can be low at the end of pregnancy. Both hypocalcemia and hypercalcemia could lead to a decrease in myometrial contractions. It is already been demonstrated that in both desensitized and naïve myometrium, normocalcemia provides a better uterine tone compared to hypo and hypercalcemia when oxytocin is given as the first uterotonic drug. Currently, the role of extracelullar calcium in carbetocin- induced contractility is unknown. This will be the first ex vivo study to test the effects of extracellular calcium on oxytocin pretreated and naive myometrium. The results of this study will provide evidence on the use of this safe drug in clinical practice, particularly in women with labour arrest, and provide alternative pharmacological strategies to both prevention and treatment of PPH, thus improving our clinical practice. The investigators hypothesize that extracellular normocalcemia would provide superior carbetocin-mediated contractility in both naive and oxytocin-pretreated myometrium compared with hypercalcemia and hypocalcemia.

Conditions:
Postpartum Hemorrhage (Primary)
Location:
  • Mount Sinai Hospital, Toronto, Ontario, Canada
Sex:
FEMALE
Ages:
18 - 40

Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.

Conditions:
Cannabis
Location:
  • Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Sex:
ALL
Ages:
19 - 45

Older adults who live with multiple chronic conditions are more likely to experience frequent admissions and discharges from hospital. These transitions are often challenging and leave people at risk of readmission. Appropriate, timely and person-centred communication across all health care providers involved in transitions (in and out of hospital) as well as with patients and their families is critical to ensure a smooth and effective transition process. Digital health technologies can play an important role in improving person-centred communication across clinical settings and clinicians. This project will develop and test a Digital Bridge by connecting communication technologies already in use in hospital and primary care/community settings to improve communication between providers in hospital and in primary care, patients and family caregivers from admission to 6 months post-discharge. The investigators will engage with all the technology users to co-design the Digital Bridge, ensuring that how the investigators connect the existing technologies and adopt them into practice will meet the needs of providers, patients and their caregivers. Next hospital partners will adopt the technology into general medicine and rehabilitation services in hospital systems in Toronto (Sinai Health System) and Mississauga (Trillium Health Partners). The investigators will evaluate the Digital Bridge through a pre-post pragmatic trial, assessing impact on patient experience (quality of transition), patient outcomes (quality of life), transition processes (provider communication and teamwork), and system costs (economic evaluation). This project adopts an implementation science lens, allowing the investigators to collect qualitative data on enablers and barriers to adopting the Digital Bridge to help inform development of a scale and spread strategy.

Conditions:
Older Adults With Complex Care Needs
Location:
  • Sinai Health, Toronto, Ontario, Canada
Sex:
ALL
Ages:
Over 60