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NCT ID: NCT05943535 Recruiting - Clinical trials for Interstitial Lung Disease

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Start date: October 30, 2023
Phase: Phase 3
Study type: Interventional

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

NCT ID: NCT05942664 Completed - Sleep Clinical Trials

Sleeping Habits on Performance Following Sleep Deprivation

Start date: June 26, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized crossover clinical trial is to determine if habitual sleeping habits can predict endurance performance following a night of partial sleep deprivation in healthy untrained, recreationally trained, and trained cyclists (18-50 years, ~50% females). The main questions it aims to answer are: 1. Can habitual sleeping habits predict, or do different types of sleepers alter, performance outcomes following sleep deprivation? 2. Does sleep deprivation alter blood pressure, heart rate, or metabolic responses during a 20-minute time trial, and/or are these altered amongst different types of sleepers? 3. Can habitual sleeping habits predict, or do different types of sleepers alter, flow-mediated dilation following a night of normal sleep and/or sleep deprivation? - Participants will be asked to perform 4 performance tests (20-minute time trial), 2 for familiarization, and 2 testing visits (1 under normal sleep and 1 under partial sleep deprivation). - For 1 week prior to each testing visit, sleep will be tracked using an ActiGraph device. - During each testing visit, and prior to the performance test, the vascular function of the superficial femoral artery will be assessed using a flow-mediated dilation technique. The investigators hypothesize that habitual early sleepers, poor sleepers, those with greater variability in sleep duration, and females will show the greatest impairments in performance and flow-mediated dilation following partial sleep deprivation.

NCT ID: NCT05942534 Recruiting - Clinical trials for Respiratory Tract Infections

Pediatric Mask Fit Study

Start date: July 5, 2023
Phase:
Study type: Observational

This study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (FFE) and mask fit. It will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on FFE and mask fit, with the goal of determining how to optimize mask performance in children. It will also provide information on mask and respirator comfort and acceptability. This data will help inform public health messaging around mask choice for children and also modifications that can be made to improve fit for children who may not have access to various mask types.

NCT ID: NCT05941806 Not yet recruiting - Urinary Retention Clinical Trials

Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection

R-POUR
Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.

NCT ID: NCT05941507 Recruiting - Clinical trials for Advanced Solid Tumors

A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors

Start date: October 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.

NCT ID: NCT05941494 Recruiting - Anesthesia Clinical Trials

Cerebral Flow-metabolism Coupling During Adult Surgery

Start date: October 3, 2023
Phase: Phase 4
Study type: Interventional

The brain is a highly active organ that requires a large blood flow to function properly. Normally, blood flow is tightly linked to the brain's energy demands. However, during surgery, anesthesia can affect this relationship in different ways. Some types of anesthesia can decrease blood flow to the brain, while others can increase it. Anesthesiologists need to be careful to maintain adequate blood flow to the brain during surgery, especially when blood pressure drops. Drugs may be used to increase blood pressure, but some of these drugs can also affect blood flow to the brain. It is still unclear how to best maintain blood flow to the brain during surgery and how different types of anesthesia and drugs affect this process. The study aims to assess the clinical utility of a new technique that uses light-based neuromonitoring to measure changes in cerebral blood flow and metabolism. The investigators will recruit 80 adult patients undergoing surgery under general anesthesia and randomize them into one of four groups to evaluate the effects of different anesthetic agents and vasopressors on brain hemodynamics and metabolism. The study will include patients over 18 years of age with no history of neurological conditions, substance abuse, or contraindications to cerebral oximetry devices or specific anesthetic agents. The patients will receive standard anesthesia care and be monitored with our light-based neuromonitoring system. This study aims to demonstrate the device's ability to detect changes in cerebral hemodynamic parameters related to anesthesia induction and systemic hypotension. This study will also evaluate the effects of anesthetic maintenance agents and vasopressors on cerebral hemodynamics and neurovascular coupling.

NCT ID: NCT05940636 Not yet recruiting - Clinical trials for Spinal Cord Injuries

A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity

Start date: September 2023
Phase: N/A
Study type: Interventional

Many people with partial damages in their spinal cord (iSCI) have physical impairments such as muscle paralysis in legs which make standing balance difficult. Poor balance control often leads to falls, injuries, and hospitalization. Therefore, improvement of standing balance is an important therapeutic goal for these individuals. Our team has shown that a therapy called visual feedback training (VFT) can improve standing balance by allowing individuals with iSCI to actively participate and follow visual feedback of their body sway on a screen like a computer game. We have also found that the application of low-energy electrical pulses to weak muscles called functional electrical stimulation (FES) during VFT can enhance the training effects. Recently, transcutaneous spinal cord stimulation (TSCS) has been discussed as a promising technique to further promote the rehabilitation effects after SCI by enhancing the connectivity between the brain and spinal cord and within the spinal pathways. However, to date, the potential of combining the two techniques (TSCS+FES) to improve the standing balance remains unknown. In this study, through the completion of a clinical trial, we will investigate the effects of an intervention that combines lumbar TSCS with FES of ankle muscles during VFT on the functional and neurophysiological outcomes in individuals living with iSCI. Participants will be randomly allocated to receive combined TSCS with FES or FES alone during VFT for 12 training sessions over 4 weeks. We expect that the new therapy would further improve balance and strengthen the neural connections between the brain and muscles. The expected changes in the neural connections will be measured by recording electrical signals from the lower limb muscles following stimulation of the motor region of the brain. Results of this study will be used for a larger-scale study in people with iSCI to improve balance and reduce falls during their daily life activities.

NCT ID: NCT05939492 Recruiting - Chest Pain Clinical Trials

Mindfulness for Pediatric Chest Pain

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test mindfulness practices in children with idiopathic chest pain, which is chest pain that does not have a known cause. The main question this study aims to answer is whether children who experience idiopathic chest pain are able to follow a mindfulness program. This study also aims to determine whether mindfulness affects the way children with idiopathic chest pain cope, and if it affects their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity. Participants will: - Complete a survey at the beginning of the study that asks questions about their sex, ethnicity, and history of chest pain and other chronic pains. - Complete a short survey every day for the entirety of the study that asks about the number, intensity, and duration of chest pain episodes experienced that day. - Complete 4 surveys, 2 weeks after they have been enrolled in the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey. - Be randomly placed into either the control group or the mindfulness-based intervention group, 2 weeks after they have been enrolled in the study. - Receive the standard of care for children with idiopathic chest pain, if they are placed into the control group. - Use the mobile app Headspace to complete daily mindfulness sessions for the remaining 30 days of the study (starting after the initial 2 week period), if they are placed in the mindfulness-based intervention group. - Complete 4 surveys at the end of the study: pain coping survey, perceived stress survey, quality of life survey, and mindfulness survey. - Complete a mindfulness program evaluation survey at the end of the study, only if they are in the mindfulness-based intervention group. Researchers will collect information from Headspace to see how well participants in the mindfulness-based intervention group are able to follow the mindfulness program. This will help guide future, larger studies that look at the effects of mindfulness-based interventions in children with idiopathic chest pain. Researchers will also compare survey results between the control group and the mindfulness-based intervention group to see if the mindfulness program affects the way children with idiopathic chest pain cope, as well as their stress levels, quality of life, frequency of chest pain episodes, and chest pain intensity.

NCT ID: NCT05939427 Recruiting - Family Engagement Clinical Trials

Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial

NGAGE
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to assess if the NGAGE real-time feedback tool improves family engagement in family members of people admitted to an acute cardiac care unit The investigators will randomize 88 family members of people hospitalized in the acute cardiac ward in a 1:1 manner to either the NGAGE intervention or usual care. Family members will be eligible if the expected unit stay of their loved one is >48 hours and if they can communicate in English or French. A family member is considered anyone with a biological, emotional, or legal relationship with the patient whom the patient wishes to be involved in their care. The primary outcome of the study will be the FAMily Engagement (FAME) score at hospital discharge. Secondary outcomes will be family mental health (by HADS score) and family care satisfaction (by FS-ICU score).

NCT ID: NCT05939414 Recruiting - Clinical trials for Oligometastatic Prostate Cancer (OMPC)

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

PSMA-DC
Start date: March 12, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).