All Clinical Trials in Canada

Neonatal Abstinence Syndrome (NAS), is a common and costly problem in Alberta that affects approximately 250 babies per year exposed to drugs during pregnancy. Unfortunately, this has become more common in the last 10 years. Babies with NAS can be very difficult to care for with poor feeding, diarrhea, and extreme irritability. These babies often receive specialized care and medications in the Neonatal Intensive Care Unit (NICU), which leads to separation of mothers and babies at a time when it is most important that they be together. This separation is traumatic for families and expensive for the health and foster care systems, as babies often end up being cared for by governmental agencies. Recent research has shown that keeping mothers and babies together in a quiet, supportive environment in hospital, called 'rooming in', leads to a decreased need for NICU admission, decreased amount of time spent in the NICU, increased rates of breastfeeding, and an increase in babies going home with their mothers. This project will systematically introduce a program of 'rooming-in' to hospitals in Alberta to determine if the investigators can improve NAS care provided to babies and mothers. The goal is to decrease NICU admission and length of stay, increase the number of babies going home with mothers, increase breastfeeding rates, and increase the number of women enrolled in supportive programs for substance use. The investigators will also determine if this rooming-in model of care decreases health and societal costs associated with caring for babies with NAS. Read Less

The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer. Read Less

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established. The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial. Read Less

People who undergo allogeneic bone marrow transplant for blood cancers receive the highest chemotherapy doses possible that humans can receive and still survive. As a result, they have devastating side effects during the procedure and for many years afterwards. Damage to organs and muscles cause long-lasting physical weakness and the psychological experience is severe enough to be termed 'post traumatic stress disorder' that also lasts for many years. These effects are worsened by the fact that most Canadians live several hours away from treatment and transplant centers, leaving them entirely on their own to manage these difficult long term effects. The APOLLO team will perform a qualitative study to learn the experiences of people undergoing allogeneic bone marrow transplant while they receive access to a supportive care computer 'app' and telephone support from nursing, exercise and nutrition experts. In this way, the APOLLO team will learn the most helpful type and timing of supportive care from those who know best. Read Less

Stage 1 \[Enrolment closed\]: The goal of this open-label pilot clinical trial is to evaluate the safety and feasibility of accelerated, repetitive transcranial magnetic stimulation (rTMS) using continuous theta-burst stimulation (cTBS) in patients with ALS. Stage 2 \[CURRENTLY ENROLLING\]: The goal of this open-label pilot clinical trial is to evaluate the safety, tolerability and target engagement of accelerated, high dose cTBS using TMS in patients with ALS. Read Less

This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI). Read Less

In outpatient hand surgery, 40% of patients report moderate to severe pain within 24 hours of the operation. Effective pain management is therefore essential to ensure a comfortable and safe return home for the patient. Loco-regional anesthesia is the optimal method of analgesia for complex hand surgery. It involves the injection of a local anesthetic (LA) near the nerves responsible for the sensitivity of the arm. Following a single injection of long-acting local anesthetic, the maximum duration of analgesia is limited to approximately 13 hours, with great variability between individuals. In order to provide pain relief over a longer period of time, placing catheters near nerves has become a routine practice at the CHUM. Infraclavicular nerve block is one of the most widely used loco-regional anesthesia techniques for hand surgery. This block can be achieved either by paracoracoid (PC) or costoclavicular (CC) approach. Both approaches are currently used at the CHUM. The PC approach involves inserting a needle under the lower rim of the clavicle below the coracoid process. This approach makes it possible to reach the 3 different nerve bundles, located around the axillary artery, which are involved in the sensitivity of the hand. The CC approach, more recently described, proposes an insertion of the needle under the lower edge of the clavicle but in a lateral way to the axillary artery which makes it possible to reach the nerves at a place where the 3 main nerve bundles are still joined together. The clustering of nerve structures at the injection site may facilitate the spread of local anesthetics. Recent studies have demonstrated that the CC approach requires a smaller volume compared to the PC approach to achieve perineural blockade. The effective dose 90 (ED90) for the CC approach was 19 mL while it is 31 mL for the PC approach. This is explained by the greater proximity between the three nerve bundles targeted in the CC approach and a lower prevalence of anatomical variations at this level. However, studies on the subject are rare and do not allow conclusions to be drawn on the superiority of either approach. Read Less

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. Read Less

A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L 2. Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of \< 9 months 3. Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c 4. Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta) The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways: 1. The participant will be screened for adverse effects immediately post-injection 2. The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection) 3. The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection) The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows: 1. All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax \> 2.5 but no corresponding lesion on CT) will be recorded 2. The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant) 3. Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021) 4. Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy Read Less

Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo. Read Less

The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy. Read Less

Intracranial aneurysms located on the middle cerebral artery (MCA) are considered by many surgeons to represent a distinct subgroup of aneurysms for which clipping may still be the best management option. Most MCA aneurysms are accessible, proximal control can readily be secured in case of rupture, and clip application can typically proceed without requiring the dissection of perforating arteries. In comparison, certain anatomic features of MCA aneurysms such as a wide neck, often including a branch artery origin, frequently render endovascular management more difficult. New endovascular devices were and continue to be introduced to address these anatomic difficulties, including stents, flow diverters, and intra-saccular flow disruptors (ISFDs) such as the WEB. Thus, while most aneurysms are increasingly treated with endovascular methods, many MCA aneurysm patients are still managed surgically, but convincing evidence of which management paradigm is best is lacking. Read Less