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NCT ID: NCT05465083 Completed - Clinical trials for Acute Hypoxemic Respiratory Failure

Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure

STIMULUS
Start date: February 4, 2023
Phase: N/A
Study type: Interventional

This is a single-center proof-of-concept clinical trial designed to establish the feasibility of transvenous phrenic-nerve stimulation (PNS) to maintain diaphragm activation over the first 24 hours and for up to seven days of mechanical ventilation in patients who are likely to require more than 48 hours of invasive mechanical ventilation.

NCT ID: NCT05464420 Completed - Clinical trials for Pneumococcal Disease

A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Start date: August 12, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.

NCT ID: NCT05464316 Recruiting - Clinical trials for Urinary Incontinence

Prospective Pilot ATOMS vs AUS

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

Post-Prostatectomy Incontinence (PPI) is a common complication affecting 1% to 40% of patients after surgery. When conservative treatments fail, the installation of an artificial urinary sphincter (AUS) has been the treatment of choice for PPI since its introduction more than 50 years ago. Although small studies suggest inferior success rate of male slings compare to the AUS in moderate to severe male incontinence; recent studies, one prospective and one Canadian multicenter cohort study, have demonstrated adjustable transobturator male sling (ATOMS) as a safe and efficient alternative to treat PPI. Interestingly, the ATOMS does not required any operation manipulation from the user in order to void and it causes potentially less urethral erosion and less urethral atrophy than the AUS; although those findings were never compared head to head with the AUS. Therefore, we believe that a thorough prospective non-inferiority study comparing the outcomes and effectiveness of the ATOMS device versus the AUS in treating moderate to severe PPI could prove itself useful in guiding urologists and patients to choose their best treatment of male incontinence. The null hypothesis posed for the present study is that ATOMS is non inferior to AUS for the treatment of moderate to severe PPI using the non-inferiority margin of 15% to be of acceptable lower effectiveness. With regards to study methods, this will be a pilot prospective, randomized controlled trial, non-blinded with a non-inferiority design. This pilot study will take place at the CIUSSS de l'Estrie, in Sherbrooke, Quebec, Canada, with two surgeons. All male patients with moderate to severe incontinence after their prostate surgery, who are suitable for incontinence surgery will be screened for study eligibility respecting the exclusion and inclusion criteria. After written informed consent, enrolled patients will be randomized assigned (1:1) to one of the two interventions' arms (AUS or ATOMS). Sixty patients are estimated to be randomized in the two arms the day of their surgery with a computer-based algorithm sequence. By completing this pilot prospective study, we hope to provide concrete and scientifically significant evidence on the effectiveness of ATOMS in the treatment of moderate to severe PPI comparing with the AUS. Although both treatments are commonly used today, there has been little evidence comparing both devices side by side with more severe PPI. We therefore hope to make a global impact with said project.

NCT ID: NCT05464264 Recruiting - Clinical trials for Treatment-resistant Depression (TRD)

Auditory MMN EEG in TRD in Response to Ketamine

Start date: October 3, 2022
Phase:
Study type: Observational

To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.

NCT ID: NCT05463874 Active, not recruiting - Type 1 Diabetes Clinical Trials

Teaching Adolescents With Type 1 Diabetes Self-compassion

TADS
Start date: October 4, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to see if a mindful self-compassion program given virtually can improve emotional distress for youth with type 1 diabetes, compared to routine care as usual.

NCT ID: NCT05463302 Recruiting - Sleep Clinical Trials

Investigating the Efficacy of Sleepgift Blanket on Sleep Quality and Heart Health

Start date: January 1, 2023
Phase: Early Phase 1
Study type: Interventional

Exposure to electromagnetic field (EMF) emitted by mobile phones and devices with WIFI is on the rise and so is the EMF effects on sleep quality and well-being of individuals with high exposures to EMF. Some studies have shown poor sleep quality among individuals with long-term occupational exposure to EMF, and some have shown association between EMF long-term exposure and neuropsychiatric disorders including depression. This study aims to investigate a commercially available EMF- blocker blanket, called Sleepgift, that claims helping people to have a better sleep and improved health. We will investigate the Sleepgift efficacy on adults' quality of sleep and their vital signals as a measure of their well-being in a placebo-controlled single- blind cross-over designed study. Participants will sleep in our sleep lab at baseline and then 10 days later with the Sleepgift blanket after using it every night for the past 10 consecutive days. Participants will be given two blankets for each cycle of the study as it is a cross-over designed study: one Sleepgift and one regular blanket; they will not know which one is real or sham. There will be one-month washout period between the two cycles of the cross-over study. We aim to enroll 30 adults for the study. Participants' sleep quality will be measured by the established device called Prodogy; their vital signals will also be measured and monitored through the night. The collected data will be analyzed statistically for any significant effect of the Sleepgift blanket on sleep quality and vital signals such as heart's rhythm and heart rate variability.

NCT ID: NCT05463211 Enrolling by invitation - Cerebral Palsy Clinical Trials

Exoskeleton-assisted Physiotherapy for Children With Mobility Impairments

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

Non-ambulatory children with cerebral palsy (CP) and similar childhood-onset neuromotor conditions face many challenges to fulsome participation in everyday life. Recent initial phase research suggests that physiotherapy paired with use of robotic exoskeletons, such as the Trexo exoskeleton ("The Trexo"; Trexo Robotics, Canada) provides a novel opportunity for children with severe mobility challenges to experience active walking that is individualized to their movement potential (guiding and powering leg movements) and upright support needs. This before-and-after study will assess the first-time experience of 10 non-ambulatory children (ages 4-7) using the Trexo for 6 weeks of twice weekly physiotherapy sessions, and evaluate associated brain, muscle and functional outcomes including accomplishment of individualized goals. To study clinical utility, we will simultaneously capture physiotherapists' (PTs) and PT assistants' (PTAs) training/learning/user experiences with the Trexo's first time use within our center's out-patient program and on-site affiliated school. This project will contribute evidence-based knowledge to guide clinical decisions about introduction of the Trexo within pediatric rehabilitation settings (target demographic, potential goals, integration into physiotherapy) and be a foundation for a progressive program of multi-centre research. Overall, we hope that this research will lead to better opportunities for children's meaningful participation within the community, including family and peers.

NCT ID: NCT05462925 Active, not recruiting - Clinical trials for Spinal Cord Injury Cervical

Prediction of Muscle Responsiveness to FES Therapy

Start date: July 20, 2022
Phase: N/A
Study type: Interventional

Reduced arm and hand function has a significant impact on independence and quality of life after spinal cord injury. Functional electrical stimulation therapy (FES-T) is a treatment that can produce improvements in reaching and grasping function after neurological injuries. However, not all paralyzed muscles respond equally well to the therapy. Currently, therapists cannot predict which muscles will respond, limiting their ability to create a personalized therapy plan that can maximize outcomes while making the best use of the limited treatment time available. The objective of this study is to develop a diagnostic method that will allow therapists to quickly and easily screen muscles in the clinic, in order to predict how they will respond to FES-T. Participants with cervical spinal cord injury will receive FES-T through the Rocket Family Upper Extremity Clinic at the Toronto Rehabilitation Institute - University Health Network. Muscles receiving training will undergo a electrophysiological examination before the start of therapy, and will then be tracked for strength recovery over the course of 30 sessions. Lastly, signal processing and machine learning techniques will be applied to the electrophysiological data to predict the recovery profile of each muscle. The significance of this work will be to provide personalized therapy planning in FES-T, leading to more effective use of healthcare resource as well as improved outcomes.

NCT ID: NCT05462899 Not yet recruiting - Goals Clinical Trials

Purpose in Life, Goals, and Expectations

Start date: September 1, 2024
Phase:
Study type: Observational

Study investigators are inviting participants to participate in a study to describe older adults' and family caregivers' purpose in life, goals, and expectations for recovery after hospitalization. Study investigators will ask older adults and caregivers to take part in a telephone or online interview to ask questions and answer questionnaires related to their experience with the hospitalization.

NCT ID: NCT05462639 Available - Multiple Myeloma Clinical Trials

Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma

MAGNETISMM17
Start date: n/a
Phase:
Study type: Expanded Access

Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity. This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.