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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: NCT05968391 Recruiting - Clinical trials for Kidney Failure, Chronic

Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)

RENO-TEP
Start date: February 2, 2024
Phase:
Study type: Observational

The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.

NCT ID: NCT05968326 Recruiting - Clinical trials for Adenocarcinoma, Pancreatic Ductal

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma

IMCODE003
Start date: October 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.

NCT ID: NCT05968261 Recruiting - Anesthesia Clinical Trials

Near Remote Method to Guide Performance of Regional Anesthesia

Start date: January 2025
Phase:
Study type: Observational

Ultrasound-guided regional anesthesia/analgesia techniques (or simply, 'regional blocks') have gained popularity as they can reduce, and sometimes even eliminate, the need for opiate analgesics (and, consequently, their side effects), thereby improving patient safety, reducing length of hospital stay and medical costs, and improving patient satisfaction. However, a major barrier to mainstream uptake of such techniques relates to training. These techniques require the acquisition of new skills under expert guidance, which is often not possible given the daily demands placed upon anesthesiologists. As a result, many opportunities for providing regional blocks may be missed. The purpose of this study is to implement a new real-time 'near remote' guidance method in which trainees who are to perform regional blocks can do so via tele-mentoring under expert guidance. This will be done using a novel technology whereby the ultrasound image is concurrently displayed on an iPad screen (for the block operator/trainee) as well as on the (near remotely supervising) expert mentor's smartphone. Trainees and mentors will use this method to perform various standard of care regional blocks, either in the perioperative or emergency department settings. Participants' opinions of the novel teaching and learning method will be assessed.

NCT ID: NCT05967871 Recruiting - Clinical trials for Small Intestinal Bacterial Overgrowth

Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth

Start date: March 11, 2024
Phase: Phase 1
Study type: Interventional

The objective of the study is to assess feasibility, and clinical efficacy of a novel Fecal Microbiota Transplantation protocol for the treatment of pediatric small intestinal bacterial overgrowth (SIBO).

NCT ID: NCT05967806 Recruiting - Renal Disease Clinical Trials

A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria

Start date: July 31, 2023
Phase:
Study type: Observational

The purpose of the D4325C00007 study is to identify and characterise patients with known or newly diagnosed CKD for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions.

NCT ID: NCT05967689 Recruiting - Clinical trials for Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

REZILIENT2
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations.