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NCT ID: NCT03957304 Completed - Laceration Repair Clinical Trials

Intranasal Dexmedetomidine Dose-finding Study

Start date: February 20, 2020
Phase: Phase 2
Study type: Interventional

The most common injury prompting an emergency department (ED) visit in children is a cut (laceration) that requires repair using stitches or skin glue. Despite anesthetic (freezing), laceration repair is often very distressful because in young children, most occur on the face. There is currently no effective drug to relieve the distress of laceration repair in children. The goal is to find a safe and effective drug to reduce distress in children undergoing laceration repair. Dexmedetomidine is a new drug that safely provides mild sedation and can be given as a painless nasal spray. Intranasal dexmedetomidine (IND) has been shown to reduce distress in children undergoing painful procedures such as dental work and intravenous insertion. However, no large study has explored IND for laceration repair. In order for research to change the way we care for children, a large study that enrolls children across many paediatric EDs needs to be performed. The first step is to conduct a smaller study to identify the safest and most effective dose. The proposed study plans to enroll 55 children age 1-10 years who require laceration repair.

NCT ID: NCT03957200 Completed - Pregnancy Early Clinical Trials

Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound

Start date: June 18, 2019
Phase:
Study type: Observational

The objective of this study is to assess equivalency of the transabdominal Clarius handheld wifi C3 ultrasound (which uses Bluetooth to locate the ipad Mini 5 and then uses wifi direct to show the images) to the current standard of care in Women's Hospital outpatient department the portable Zonare ZS3 in patients presenting in the first trimester of pregnancy.

NCT ID: NCT03957083 Completed - Obesity Clinical Trials

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

Start date: June 26, 2019
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2. The investigators seek to find the best dose for patients with a BMI>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately.

NCT ID: NCT03957070 Completed - Liver Fibrosis Clinical Trials

The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.

NCT ID: NCT03956680 Completed - Clinical trials for Advanced Solid Cancers

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

Start date: March 26, 2019
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.

NCT ID: NCT03956355 Completed - Plaque Psoriasis Clinical Trials

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

Start date: May 21, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

NCT ID: NCT03955874 Completed - Critical Illness Clinical Trials

Mechanical Ventilation Discontinuation Practices

IOS
Start date: November 4, 2013
Phase:
Study type: Observational

Background: The requirement for ventilator support is a defining feature of critical illness. Weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the total time spent on ventilators is dedicated to weaning. The extent of practice variation in how this complex and expensive technology is discontinued from critically ill patients is unknown. Meanwhile, practice variation has been shown to adversely impact upon patient safety and clinical outcomes. Purpose: To characterize practice pattern variation in weaning and the consequences of weaning variation by implementing an international, prospective observational study in Canada, the United States, the United Kingdom, Europe, India and Australia/New Zealand. Primary Objectives: To describe 1. weaning practice variation among regions in 5 domains (the use of daily screening, preferred methods of support used before initial discontinuation attempts, use of written protocols, preferred methods of evaluating spontaneous breathing, and sedation and mobilization practices). 2. the assocation between selected discontinuation strategies and important clinical outcomes (length of stay, mortality, duration of ventilation). Methods: The investigators propose to conduct a large scale, observational study involving critically ill adults requiring ventilator support for at least 24 hours to evaluate practices in discontinuing ventilators in 150 centres. The investigators will classify each new admission over the observation period according to the initial strategy that precipitated or facilitated ventilator discontinuation. Relevance: This novel study will build collaborations with critical care investigators from around the world and industry

NCT ID: NCT03955523 Completed - Clinical trials for Spinal Cord Injuries

Single Exercise Session or Meal vs Control in SCI: Case Series

Start date: January 6, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the immediate effects of a single exercise session or a high fat/high carbohydrate meal on the physical and mental health of people with a spinal cord injury (SCI). Specifically, we want to better understand the responses in people with SCI when they conduct exercise or eat an unhealthy meal, when looking at inflammation levels, the number and function of immune cells, brain function, pain and how one feels (affect). If we can understand these responses, then clinicians, sports practitioners and dieticians can provide better advice to people with SCI.

NCT ID: NCT03954743 Completed - Clinical trials for Infections, Rotavirus

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: July 19, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.

NCT ID: NCT03954379 Completed - Clinical trials for Knee Replacement Arthroplasty

IPACK Study in Total Knee Arthroplasty Patients

Start date: October 24, 2019
Phase: Phase 4
Study type: Interventional

This study proposes to compare current multimodal analgesic treatment for TKA with a new multimodal analgesic regimen to demonstrate decreased opioid requirement, time to rehabilitation, and time to reach hospital discharge.