Clinical trials

Migraine is one of the most common and disabling neurological conditions worldwide, affecting approximately 1 billion people. Available pharmacological treatments have significant limitations (side effects, contraindications, medication overuse), highlighting the need for effective non-pharmacological alternatives. The HYlaMI program (Self-Hypnosis Training for Migraine Management) is an 8-session group-based telehealth intervention adapted from HYlaDO, a self-hypnosis program developed for chronic pain management at the Hôpital Maisonneuve-Rosemont Pain Clinic (Montréal, Canada). Building on a refinement study conducted in autumn 2025 (CER: 2026-4061), HYlaMI combines heterohypnosis (guided by a trained clinician) and self-hypnosis (practiced autonomously at home using audio recordings) through weekly one-hour video sessions (Zoom/CIUSSS EMTL platform). This study combines ORBIT Phase IIa (proof of concept) and Phase IIb (pilot study) objectives. The primary aims are to evaluate the feasibility of the HYlaMI program (retention and adherence rates) and to assess whether it can generate a clinically significant change in migraine-related disability compared to a waitlist control group. Secondary aims include evaluating effects on anxiety and depressive symptoms, pain self-efficacy, situational pain/anxiety/relaxation, migraine frequency, intensity and duration, medication intake, work absenteeism, quality of life, and the economic burden of migraine. A mixed-methods design will be used. Forty adults with a diagnosis of migraine for more than one year will be randomized to either the HYlaMI intervention group (n=20) or a waitlist control group (n=20). Participants will complete validated questionnaires at multiple time points (pre-intervention, mid-intervention, post-intervention, and 4-week follow-up), a weekly migraine diary, and self-hypnosis practice logs. Two semi-structured focus groups will be conducted with intervention group participants to inform program improvement. If successful, this study will provide the evidence base required to proceed to a larger randomized controlled trial (ORBIT Phase III).

The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms. The primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively. Participants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg/m2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg/m2) on postoperative days 1 and 2.

The present study aims to assess the feasibility of home-based tDCS in remote and urban areas (primary objective). The secondary aim is to obtain a preliminary assessment of the efficacy of 14 home-based tDCS sessions in reducing depressive symptoms in BPD patients with moderate to severe depressive episodes and BPD symptoms. Exploratory objectives include assessing the impact on neuropsychological and psychosocial functioning, anxiety, physical activity, sleep disorders, and addiction. Additionally, we aim to investigate the sociodemographic and clinical factors that are linked to the most favorable response to tDCS in addressing both depressive and BPD symptoms. We also aim to assess the feasibility of using a smartwatch as an outcome measure in this population. Finally, we intend to gather preliminary data on the effectiveness of an online psychoeducational program specifically designed for patients with BPD. Researchers will compare active tDCS to sham tDCS to see if active treatment is more effective in treating depression in this population. Participants will: * Receive 14 sessions of either active or sham tDCS over one week, delivered at home * Complete psychological and neurocognitive assessments at baseline, post-treatment, and at 6 weeks * Wear actigraphy monitors and complete questionnaires to assess sleep, physical activity, and other mental health outcomes This trial will also explore the feasibility of delivering tDCS in both urban and rural settings.

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.

The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.

Home dialysis is encouraged in Canada and peritoneal dialysis is the most common home dialysis method. However, many patients discontinue peritoneal dialysis, often transferring to hemodialysis. Despite the frequency of this transition, little is known about its impact on patients. Overall, the UPLIFT-PD program aims to fill this gap by studying the transition from peritoneal dialysis to hemodialysis. The specific goal of this mixed methods sub-study is to conduct a national survey to ask patients and caregivers about priorities and preferences when they anticipate a transfer from peritoneal dialysis to hemodialysis. This survey will be co-created by patient-partners and dialysis experts. Results from this survey will then be used in other phases of UPLIFT-PD program, detailed in other registrations, which will support people facing a transition from peritoneal dialysis to hemodialysis..

The goal of this study is to evaluate quality of life (QoL) and frailty trajectories from advanced chronic kidney disease (CKD) to after dialysis initiation, specifically comparing patients choosing home dialysis and in-center hemodialysis. The main questions it aims to answer are: 1. What is the trajectory of QoL in patients transitioning from advanced CKD to dialysis (up to 12 months after initiation) and how does these changes differ for patients oriented towards home dialysis and in-center hemodialysis? 2. Is the development of frailty after dialysis initiation less likely in patient pursuing home dialysis? 3. What is the variation in other PROMs and health outcomes (fatigue, anxiety \& depression, general assessment, cognitive function) form advanced CKD to the first 12 months after dialysis initiation? 4. What are the predictors of severe decline in QoL, frailty and other important health outcomes (fatigue, cognition, anxiety \& depression) during CKD G5 follow-up and after 12 months post dialysis initiation? Participants will be ask to: * Answer some questions and complete questionnaires each 3 months; * Do a a grip test and a walking test each 6 months to evaluate their frailty;

The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults. The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by * Electroencephalographic (EEG) features available prior to induction of anesthesia * Cognitive performance * Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded.

This clinical study is testing a new way to improve stem cell transplants for adults with high-risk blood cancers, such as leukemia or myelodysplasia, who do not have a suitable donor. The transplant uses stem cells from umbilical cord blood that have been expanded in the lab using a molecule called UM171. Previous studies showed that UM171 helps these cells grow and work better, leading to faster blood count recovery and fewer complications. In this study, researchers are testing whether increasing the dose of UM171 during the lab expansion process can make the transplant less toxic. The hypothesis is that using a higher dose of UM171 to expand cord blood stem cells will help patients recover blood counts faster after transplant by improving the growth and function of the cells. This may lead to better immune recovery, fewer infections, shorter hospital stays, and improved overall outcomes. Only seven patients will be enrolled, and they will be followed for one year after their transplant.

Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions. To address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication. Only a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision. However, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia. Hence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups. The primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day. Secondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group.

The goal of this observational study is to find out how changes in body position during surgery might affect brain monitoring results in patients who are under general anesthesia.The main question it aims to answer is: \- Does patient positioning have an impact on Bispectral Index (BIS) and Nociception Level (NOL) index monitoring (which are values of awareness in anesthesized patients). Participants will undergo their surgery as planned, except for these extra features: * Extra monitors placed to check brain activity, pain response, and brain oxygen levels. * Before the surgery, while the patient is asleep, the patient's table will be moved into two different positions for 2 minutes each to see if the values on the monitor change. Participants will then have to answer a short questionnaire after surgery about their memories before and after the anesthesia.

The goal of this clinical trial is to demonstrate the importance of arterial pressure measurement sites during major abdominal surgeries. This randomized controlled trial will compare arterial pressure measurements obtained from radial artery catheterization (the current standard method of monitoring) with those obtained from brachial artery catheterization (a more accurate reflection of central arterial pressure). At the end of the study, we are looking to answer the following questions: 1. Does arterial pressure measurement sites influence the amount of vasopressors that is administered during major abdominal surgeries? 2. What are the instances where there is a difference between peripheral (radial catheter) and central (brachial catheter) monitoring and what are the risk factors leading to the appearance of this radial-brachial pressure gradient? 3. With the data collected, can artificial intelligence based analysis help predict the reliability of a radial monitoring and help guide clinicians on choosing a peripheral versus central arterial pressure monitoring site? All adult participants who are scheduled for elective major abdominal surgeries and meeting our inclusion criteria will be approached and included if they consent. Participants will be randomized 1:1 in the intervention group and the standard of care group. In the intervention group, the brachial arterial line will be used intraoperatively to guide vasopressor and fluid administration. A radial line will also be installed to measure the radial arterial pressure simultaneously, but will not be used to guide hemodynamic management. In the standard of care group, both lines will be installed just like in the intervention group, however, it is the radial arterial line that will guide fluid and vasopressor administration. In both groups, the anesthesia protocol will be standardized and the anesthesiologist will be blinded to the arterial pressure measurement site.

The goal of this pilot randomized clinical trial is to test the efficacy of an intervention combining virtual reality and hypnosis on decreasing pain and improving quality of life in elderly patients with hand arthritis. The main questions it aims to answer are: * Does the intervention allow for an improvement of patient reported outcomes related to pain and quality of life? * Does the intervention allow for an improvement of physiological variables related to pain? Researchers will compare intervention group to a passive control group (i.e., waiting list with treatment as usual). Participants in the intervention group will be provided a virtual reality headset allowing them to beneficiate from the virtual reality and hypnosis modules.

For people with advanced kidney disease, deciding which type of dialysis is best can be challenging. Studies have shown that quality of life is very important to patients. It is thought that the quality of life of people receiving their dialysis at home may be better than the one of people receiving dialysis in a hospital. However, how the start of dialysis changes the quality of life of people who choose home dialysis in comparison to people choosing dialysis in a hospital is still unknown. TRANSIT-CARE is a prospective mixed methods study following adult with advanced kidney disease who progress to dialysis and receive home or hospital-based dialysis. This study aims to examine the trajectory and change in patients' quality of life and their frailty status (health, mobility and function) before start of dialysis and up to 12-month after start. Differences between people doing home dialysis and hospital-based dialysis will be assesses taking into account people's characteristics including their gender and socio-demographics characteristics. The study will include questionnaires to measure quality of life and tools to evaluate frailty. Additionally, semi-structured interviews will be done with a diverse group of patients and caregivers before and after the initiation of dialysis to better understand their experience of transitioning to dialysis.

Research into cancer patients has shown that quality of life is significantly altered by the disease and its associated treatments and is also reported to be a predictor of significant emotional distress. Blood cancer patients are among those most affected in terms of quality of life, facing stem cell transplantation after high-dose chemotherapy, a treatment that is recognized as one of the most stressful of cancer therapy, due to the many adverse effects, including pain, and the uncertainty linked to the fear of graft failure. Hypnosis interventions are proving effective in treating common side effects: nausea, pain, fatigue, anxiety, depressive symptoms and improving overall quality of life, and other interventions, based on virtual reality, have shown promising effects on patients' distress and acute pain. The aim of this study is to evaluate the effects of an intervention program combining hypnosis and virtual reality in assisting myeloma and lymphoma patients during stem cell transplantation, with a view to improving their quality of life during this period. The project aims to assess the validity of the intervention, and to evaluate the effects of the intervention on patients' anxiety, pain and fatigue during transplantation. The validity of the intervention will be measured by a questionnaire assessing the relevance and acceptability of the intervention, expected effects, and practical implementation. Socio-demographic and clinical data will be collected from patients, including axiety, pain, fatigue and quality of life, studied at pre (one week after transplantation) and post (one month after transplantation) intervnention, and at follow-up (three month after transplantation).

Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life. The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada. Adverse events: none expected.

Postoperative pain after VATS surgery is significant and associated with moderate to high post operative morphine requirements, which can cause opioid related side effects and delay postoperative recovery. To reduce this requirement, multimodal analgesia with non opioid medication such as dexmedetomidine and ketamine can be used. These drugs have demonstrated significant opioid-sparing properties after various types of surgeries. However, very little is known about their ability to do so in VATS surgery. Also, their relative opioid-sparing properties have not been compared, and it is not known whether their combined use can lead to an additional opioid-sparing effect. The primary goal of this study will be to determine the impact of a combined intra operative infusion of ketamine and dexmedetomidine on postoperative morphine requirements in patients undergoing elective VATS, compared to both these drugs infused separately. The hypothesis is that this combined infusion will lead to a 30% further reduction in morphine requirements, 24h after surgery, compared to both these drugs infused separately.

Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.

The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is: Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia? Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device. Participants will be randomly assigned to either a virtual reality (intervention) group or a control group. * The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice. * Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.

The goal of this clinical trial is to learn if smart pill bottles can be used as a tool to optimize data collection in clinical trials by increasing the quality of data collected and limiting the associated cost. The main questions it aims to answer are: Is the use of smart pill bottles a feasible method of data collection in clinical trials in terms of patient adherence. Is the data collected by the smart pill bottles of higher quality than that collected through human resources? What is the impact of the use of smart pill bottles on the costs involved in clinical trials ? Researchers will collect data on postoperative opioid medication consumption with the smart pill bottle and assess the adherence of patients to the device along with the quality of data collected and the costs involved in the process. Participants will: Use the smart pill bottle to consume opioid medication following surgery for 3 months At the end of the 3 month period, the group will have filled out surveys detailing their opioid consumption, surgical pain and other relevant information.

This observational study aims to identify the incidence and importance of discrepancies between measurements of intraoperative invasive and noninvasive blood pressure monitoring in patients undergoing non-cardiac surgeries under general anesthesia . The main questions it aims to answer are : * The importance of the differences, in mmHg, between the non-invasive and invasive blood pressure measurements (NIBP-IBP) on systolic, diastolic and mean arterial pressure. * Identify the predictive factors associated with these differences.

This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia.

This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit.

The objective of the study is to investigate, in patients aged 70 years and over undergoing major non-cardiac surgery, the effect of electroencephalic (EEG)-guided anesthesia on postoperative neurocognitive disorders when controlling for intraoperative nociception, personalized blood pressure targets and using full information provided by the processed EEG monitor (including burst suppression ratio, density spectral array and raw EEG waveform). This prospective, randomized, controlled trial will be conducted in a single Canadian university hospital. Patients aged 70 years and over, undergoing elective major non-cardiac surgery will be included. The administration of sevoflurane will be adjusted to maintain a BIS value between 40 and 60, a suppression Ratio at 0%, a direct EEG display without any suppression time and a spectrogram with most of the EEG wave frequency within the alpha, theta and delta frequencies in the EEG-guided group. In the control group sevoflurane will be administered to achieve an age-adjusted minimum alveolar concentration of \[0.8-1.2\]. A nociception monitor will guide intraoperative opioids' infusion and individual blood pressure targets will be personalized in both groups. The primary endpoint is the incidence of neurocognitive disorder (NCD) at postoperative day 1 evaluated by the Montréal Cognitive Assessment. Secondary endpoints include the incidence of postoperative neurocognitive disorder at different timepoints and the evaluation of cognitive trajectories among EEG-guided and control groups.

Obsessive-compulsive disorder (OCD) is a disabling psychiatric illness that is characterized by distressing obsessional thoughts and time-consuming compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice that requires patients to face their fears by being exposed to feared stimuli. This treatment has been shown to reduce symptoms in a significant proportion of patients. However, it is considered a difficult treatment and only a minority reach remission. Residual symptoms typically remain, or reappear after treatment, which is a risk for relapse. Inference-based Cognitive Behavioral Therapy (I-CBT) is a promising evidence-based treatment developed to overcome these limitations. I-CBT has already been found to be as effective as ERP and significantly more acceptable and easier to adhere to. There is also evidence that I-CBT is more effective for subgroups of patients. Consequently, the current research project is focused on improving treatments outcomes for those provide those who have previously unable to reach remission of their symptoms with ERP. Following an initial treatment with ERP, those that have been unable to reach remission, will be randomized to either I-CBT or more ERP. It is expected that I-CBT will be significantly more effective than providing patients with more of the same. In addition, the study aims to predict treatment outcome in order to be able to tell in advance which patients do not respond to ERP. The project is designed to maximize beneficial health outcomes with a stepped-care approach to treatment, but also to work towards a more personalized choice by being able to match patients in advance with the treatment that works best for them