Clinical Trials Logo

Filter by:
NCT ID: NCT03997266 Recruiting - Clinical trials for Microbial Colonization

NICU Antibiotics and Outcomes Trial

NANO
Start date: August 5, 2020
Phase: Phase 4
Study type: Interventional

The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.

NCT ID: NCT03997123 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

CAPItello-290
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

NCT ID: NCT03996785 Completed - Experimental Clinical Trials

Effectiveness of Nature Walks in Depressed Adults

Start date: June 18, 2019
Phase: N/A
Study type: Interventional

Over the past few years, a growing number of campaigns from around the world, including Canada, are highlighting the positive impact of spending time in nature on well-¬being. Indeed, mounting evidence suggests that spending time with nature is associated with a myriad of affective and cognitive benefits. Surprisingly few studies to date have tested the assumption that walking in nature versus in urban settings could alleviate stress and depressive symptoms in clinically depressed adults. The main purpose of this study is to investigate the effectiveness of walking in nature versus in urban settings to improve depression related symptoms and reduce stress. The trial initially included 2 primary outcomes: patients stress levels (salivary cortisol) and depression-related symptoms (eg, affect, rumination, executive functioning). However, due to hygienic concerns in light of the COVID-19 pandemic in 2020, the collection of saliva samples (and in turn, the measurement of stress levels via salivary cortisol) was removed from the study's procedure. The main outcome was changed to effects on positive and negative affect.

NCT ID: NCT03996525 Terminated - Bell Palsy Clinical Trials

Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy. This study of ES in these patients will investigate: i) nerve regeneration over long distances; ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and iii) changes in functional outcomes in a patient population with much less variability. Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.

NCT ID: NCT03996369 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 12
Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03996291 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine the long-term safety and tolerability of SAR442168 in RMS participants Secondary Objective: To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

NCT ID: NCT03996109 Active, not recruiting - Adolescent Behavior Clinical Trials

Living Green and Healthy for Teens

LiGHT
Start date: December 11, 2021
Phase: N/A
Study type: Interventional

This is a two-group parallel randomized controlled trial testing whether a gamified healthy living smartphone app for youth aged 10-16 representative of the Canadian population and one of their parents is more effective at improving a composite of health behaviours (diet, physical activity, sleep and screen time) than a simple app providing links to healthy living websites.

NCT ID: NCT03995849 Completed - Observational Study Clinical Trials

Motion of Kids on Radiation Treatment

Start date: October 29, 2019
Phase:
Study type: Observational

At Princess Margaret Cancer Centre, a comprehensive approach to help children stay still during radiation treatment (RT) such as audio-visual distraction (television) is routinely used. These techniques help reduce the need for sedation or general anaesthesia to keep children still to avoid the chance of missing the tumour during RT. This approach has not been systematically evaluated to determine its effectiveness at reducing movement of children receiving RT. The purpose of the study is to measure the movement of children between the beginning and the end of RT to see how much they moved during treatment.

NCT ID: NCT03995693 Completed - Exercise Clinical Trials

Fuel Selection During Eccentric Cycling With Glucose Ingestion

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

This study compares fuel selection during eccentric and concentric cycling, with (placebo) or without glucose ingestion during exercise. After a 2-week familiarization and habituation with the ergometers, subjects will complete four experimental conditions in a randomized order: concentric with placebo, eccentric with placebo, concentric with glucose, eccentric with glucose.

NCT ID: NCT03995498 Completed - Type 1 Diabetes Clinical Trials

Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control

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

The objective of this study is to test whether an individualized carbohydrate intake based on weight and pre physical activity glucose level is more effective than usual camp care to improve glucose control in children and adolescents engaging in team sports (basketball, soccer, hockey) during a summer camp. At the enrollment interview, in addition to collecting patient's information (age, sex, diabetes duration, recent A1c, type of treatment, insulin doses body weight, concomitant diseases, diabetes complications and history of severe hypoglycemia), a continuous glucose monitoring system (FreeStyle Libre) will be installed by a nurse. At least, eight sports sessions per participant are planned for this study. In a randomized order, the individualized carbohydrate intake will be applied during at least 4 interventions sport sessions while at least 4 with matching types of sports will be used as control sessions. Two sport sessions are routinely scheduled at the camp each day; from 9h:30 to 10h:30 and from 11h:00 to 12h:00. For intervention sessions that involve individualized carbohydrate intake, the FreeStyle Libre will be scanned 0-10 minutes before the start of the team sport. Carbohydrates will then be given in the amount of 0.5g/kg for glucose levels between 4.5 to 7.0 mmol/L and 0.25g/kg for glucose levels between 7.1 to 10.0 mmol/L and none will be given if glucose levels are between 10.1 and 15.0 mmol/L. When glucose levels are below 4.5 mmol/L or above 15.0 mmol/L, the camp staff will take care of hypoglycemia/hyperglycemia treatment. During control sessions, as per camp routine care, there will be no measurement of glucose levels before the start of physical activity.