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NCT ID: NCT05363501 Completed - Opioid Overdose Clinical Trials

Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers

Start date: January 21, 2021
Phase: Phase 1
Study type: Interventional

The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1 until approximately 12 hours following the last study drug administration. Screening of alcohol and drugs of abuse will be performed before the first study drug administration. For female subjects, a pregnancy test will be performed before the first drug administration. Clinical nasal irritation rating and the Brief Smell Identification Test will be performed at screening.

NCT ID: NCT05363293 Completed - Alzheimer's Disease Clinical Trials

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

"MAD"
Start date: May 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001) or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a 42-day follow-up period.

NCT ID: NCT05362058 Completed - Diabetes Clinical Trials

A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

QWINT-2
Start date: June 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. Additional participants will continue to be enrolled in a maximum extended enrollment cohort.

NCT ID: NCT05361512 Completed - Labor Pain Clinical Trials

Characteristics of the Tsui Test and Pressure Waveform to Confirm Epidural Catheter Placement in Parturients With BMI ≥50 kg/m2

Start date: June 21, 2022
Phase:
Study type: Observational

The prevalence of obesity has increased worldwide, and the anesthetic care of patients with obesity remains a challenge for providers despite advances. Obesity during pregnancy is a risk factor for hypertensive disorders, gestational diabetes, emergency cesarean section and higher prevalence of difficult airway. Neuraxial techniques should always be preferred in women with obesity, particularly in those with body mass index (BMI) ≥50 kg/m2, where complications can be magnified. It is estimated an overall epidural failure rate of 4.3% in patients with obesity and an epidural failure rate of 13.7% in those with BMI ≥50 kg/m2. Hence, a confirmatory test of epidural catheter placement should prove useful in this patient population. The epidural electrical stimulation test (EEST) and the epidural waveform analysis are tests described in the literature as confirmatory methods for accuracy of placement of the epidural catheter. The Tsui test has been well studied in obstetric patients, including required threshold electric currents and muscle contraction patterns. However, these studies have been conducted in patients receiving lumbar epidural catheters. Furthermore, they have not specifically included women with obesity class 3, particularly those with BMI≥50 kg/m2. In a recent study conducted in our department, the investigators have observed that patients with BMI≥50 kg/m2 require placement of an epidural catheter at a low-thoracic or high lumbar interspace, to allow the provision of effective surgical anesthesia for cesarean delivery, which often requires a modified incision, either transverse supra-umbilical or infra-umbilical. There are only few studies with waveform confirmation in obstetric patients showing conflicting results and certainly no studies under the circumstances described above. Finally, the Tsui test and the epidural waveform analysis have never been compared in the obstetric population. The investigators aim to describe the characteristics of the Tsui test and of the epidural waveform analysis in parturients with BMI≥50 kg/m2 receiving epidural catheter placement at T12-L1 for both labor analgesia or anesthesia for cesarean delivery

NCT ID: NCT05359536 Completed - Physical Activity Clinical Trials

Training Early Childhood Educators to Increase Children's Physical Activity: The TEACH-Preschooler Study

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

This study aims to determine the effect of delivering a physical activity e-learning course to early childhood educators on young children's physical activity and sedentary behaviour while at childcare. It is hypothesized that levels of physical activity will increase and levels of sedentary behaviours will decrease during time spent in childcare in a sample of children who attend early childcare centres where early childhood educators have completed the physical activity e-learning course compared to children in centres where early childhood educators are randomized to not receive the intervention. Differences in changes in several secondary outcomes including fundamental movement skills, parent's perceptions of children's fundamental movement skills, children's cognitive development, emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviours will also be examined.

NCT ID: NCT05358990 Completed - COVID-19 Clinical Trials

Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol

eCOVID-PLR
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

Coronavirus Disease (COVID-19) recommendations are usually developed for healthcare professionals (for example Doctors, health organizations, etc.). It is important to make sure that these recommendations can be used and understood by everyone. This study aims to make COVID-19 recommendations more accessible and understandable for parents and caregivers, adults, and youth.

NCT ID: NCT05358613 Completed - Clinical trials for Alcohol Use, Unspecified

My Choices: Efficacy and Implementation Study

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to assess the efficacy of the My Choices - Alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months).

NCT ID: NCT05357755 Completed - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

SUMMIT
Start date: June 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT05357716 Completed - Atrial Fibrillation Clinical Trials

Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

PRE-ALERT
Start date: November 15, 2020
Phase:
Study type: Observational

The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.

NCT ID: NCT05356546 Completed - Cardiac Disease Clinical Trials

TYRX™ Pocket Health Study

Start date: May 31, 2022
Phase:
Study type: Observational

Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.