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NCT ID: NCT05971459 Recruiting - Parkinson Disease Clinical Trials

A Study of the Efficacy of IAMT as an Assessment Tool for Prediction of Progression of Parkinson's Disease

Music Therapy
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The primary objective of this proposal is to examine the efficacy of Improvised Active Music Therapy (IAMT) sessions as an early novel tool for cognitive and motor assessment for individuals with Parkinson's Disease (PD) in neurological rehabilitation. This will be achieved by identifying subtle variations in how participants play music and correlating these data with mobility and cognitive parameters. The secondary objective is to examine and understand the participants' experience of playing improvised music through post-session interviews as a qualitative measure. We propose to conduct a mixed-method, single-blinded, age-matched group comparison of 25 older adults (= 50 years) with PD and 25 healthy older adults (= 50 years) at the Conrad Institute for Music Therapy Research (CIMTR), Faculty of Music, Wilfrid Laurier University. The CIMTR laboratory contains Musical Instrument Digital Interface (MIDI) equipment/instruments and MATLAB software, which will be used to collect and analyze the music data to compare the two groups. The long-term goal is to build a database of sessions to use Improvised Active Music Therapy (IAMT) as a complementary, reliable, and feasible assessment tool to predict whether older adults with PD will progress to Parkinson's Disease Dementia (PDD) or Dementia with Lewy Bodies (DLB) and distinguish the motor phenotype as Tremor Dominant (PDTD), Mixed (PDM), or Postural Instability and Gait Disturbances (PIGD). The purpose of this project is to understand the effect of music therapy sessions on cognition and motor skills within the reciprocal improvised music interactions between music therapist and clients. Therefore, the specific objectives are as follows: 1. To examine how physical characteristics of different neurological conditions influence music measures (note frequency, velocity of movement, synchronization, and acquisition of rhythmic complexity). 2. To examine how music measures contribute to cognitive and motor performance. 3. To assess the contributions of individual difference factors such as diagnoses, hand dominance, musical training, music preference, participant's personal experience, and cognitive abilities to music involvement.

NCT ID: NCT05971303 Recruiting - Gynecologic Cancer Clinical Trials

Impact of Cultural and Linguistic Backgrounds on Patient Care and Experience of Women With Gynecologic Malignancies

iCALD-2
Start date: March 15, 2022
Phase:
Study type: Observational

Purpose of this study to delineate the attitudes and experiences of patients, interpreters and cancer care professionals involved in the care of oncology patients with gynecologic malignancies with cultural and linguistic diversity backgrounds, in addition to highlighting any barriers to optimal patient care through questionnaires.

NCT ID: NCT05971147 Recruiting - Clinical trials for Skeletal Muscle Fatty Acid Metabolism

Time Course Change in Skeletal Muscle and Blood Phospholipid Composition With Omega-3 Fatty Acid Supplementation

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

Increased omega-3 fatty acid composition of human skeletal muscle phospholipids is linked to improved skeletal muscle strength and growth in women and men. However, what is unknown is if biological sex influences skeletal muscle phospholipid composition in response to omega-3 fatty acid supplementation. Moreover, whilst time course changes in skeletal muscle phospholipid composition with omega-3 fatty acid intake have been established, no study has characterized a washout of omega-3 fatty acids from skeletal muscle phospholipids following cessation of omega-3 fatty acid intake. Thus, the aim of the present investigation is to establish a time course change and washout of omega-3 fatty acids from skeletal muscle phospholipids in response to omega-3 fatty acid intake. The investigators also aim to establish if this washout is impacted by biological sex.

NCT ID: NCT05970588 Recruiting - Cognitive Function Clinical Trials

Standing Desk Converter & Habitual Posture

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

This project will determine the short-term impact of a standing desk converter on: 1) objectively measured physical activity and posture levels, and 2) brain (cognition) and heart (blood pressure regulation) function. The main outcome is habitual activity patterns, assessed by the thigh-worn inclinometer (activPAL). All participants will be equipped with an activPAL and have their cardiovascular and cognitive function assessed at baseline and 4 weeks. Participants in the intervention group will use a standing desk converter for 4 weeks, while the wait-list control group will be encouraged to maintain their regular activity patterns. Researchers will compare the intervention and control groups to see if using the standing desk converter will increase standing time and lower sedentary time, improve cognition, and improve blood pressure regulation.

NCT ID: NCT05970328 Recruiting - Clinical trials for Cardiac Rhythm Disturbance

Hexoskin Medical System - ECG Performance Testing

Start date: July 24, 2023
Phase:
Study type: Observational

The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

NCT ID: NCT05969977 Recruiting - Clinical trials for Rhizomelic Chondrodysplasia Punctata

A First-in-Human Phase 1 Study of Plasmalogen Precursor PPI-1011 in Healthy Adult Volunteers to Assess Safety, Tolerability, and Pharmacokinetics

Start date: May 29, 2023
Phase: Phase 1
Study type: Interventional

PPI-1011 is being developed as a docosahexaenoic acid (DHA) containing plasmalogen precursor with good long-term stability, specifically for the treatment of rhizomelic chondrodysplasia punctata (RCDP), which is an ultra rare type of peroxisomal biogenesis disorder (PBD). The goal of treatment with PPI-1011 is to increase the levels of plasmalogens within circulation and tissues, with the hope that this will normalize plasmalogen levels in the body and result in clinical improvement to patients. The present study is a first-in-human (FIH), phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of PPI-1011 administered orally to healthy subjects. The study consists of 5 planned single-dose cohorts (n = 8 per cohort, total randomized 6 active: 2 placebo) with sentinel design. Following a review of the safety and PK data by the safety review committee and submission to Health Canada the study will be expanded to include 2 planned multiple-dose cohorts (n = 8 per cohort, total randomized 6 active: 2 placebo).

NCT ID: NCT05969275 Recruiting - Sepsis Clinical Trials

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

UC-CISSII
Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).

NCT ID: NCT05968833 Recruiting - Kidney Transplant Clinical Trials

iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

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

The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric kidney transplant recipients who are trained to offer vital peer support and mentorship. Parents of children who received a kidney transplant at The Hospital for Sick Children will be invited to participate as mentors and mentees (randomized into the iP2P or control group). The iP2P program can decrease feelings of isolation, improve mental health and have a long-term positive impact on patient health. This research will increase our understanding of one-to-one peer support and leverage eHealth technologies to improve the access to and acceptability of parent peer support interventions.

NCT ID: NCT05968807 Recruiting - Clinical trials for Solid Organ Transplant

iParent2Parent Program for Parents of Pediatric Solid Organ Transplant Recipients

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

The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. Parents of children who received a SOT at The Hospital for Sick Children will be invited to participate as mentors and mentees (randomized into the iP2P or control group). The iP2P program can decrease feelings of isolation, improve mental health and have a long-term positive impact on patient health. This research will increase our understanding of one-to-one peer support and leverage eHealth technologies to improve the access to and acceptability of parent peer support interventions.

NCT ID: NCT05968612 Completed - Healthy Volunteer Clinical Trials

Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets

Start date: November 17, 2023
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product, Lumacaftor 200 mg /Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) in the fed state, and food-effect bioavailability of Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) in the fasted and fed state in healthy, non-smoking, male and non-pregnant female volunteers, 18 to 55 years of age, inclusive.