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NCT ID: NCT03954743 Not yet recruiting - Clinical trials for Infections, Rotavirus

A Safety Study of 2 Formulations of GlaxoSmithKline Biologicals' (GSK's) Human Rotavirus (HRV) Vaccine in Healthy Infants of 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 (ROTARIX) across the Porcine circovirus (PCV)-free development plan. This study will use 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 will be stored frozen in order to keep the titre stable until administration during the study. As the liquid formulation of ROTARIX is not licensed in the US, the lyophilized formulation of the vaccine will be used as a control in all phase III studies as part of the PCV-free development plan.

NCT ID: NCT03954665 Not yet recruiting - Clinical trials for Exercise Performance

Ketone Supplementation and Exercise Performance

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

The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age).

NCT ID: NCT03954483 Not yet recruiting - Anxiety Clinical Trials

Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

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

New technologies are needed to help diagnose anxiety disorders. EVestG has facilitated the identification of numerous possible biomarkers of several psychiatric disorders. Some EVestG features seem to be caused by differences in low-frequency modulation that is consistent (both in frequency and behaviour) with the hippocampal rhythm (theta), which is known to play a role in anxiety. Critically, there is ample support in the literature for an anatomical and functional basis for the modulation of vestibular signals via theta. If anxiety could be measured continuously, perhaps throughout a patient's day, or throughout a task, it might be able to confirm an anxiety disorder. However, current techniques for measuring theta are highly invasive, performed rarely, and only in epilepsy patients. EVestG technology, however, is non-invasive, and could potentially record anxiety levels in any subject for extended periods of time. The proposed study will attempt to identify hippocampal theta in vestibular signals in healthy participants through a double-blind administration of two different drugs that are dissimilar both pharmacologically and in acute clinical effects but which are known to reduce the theta rhythm.

NCT ID: NCT03954379 Not yet recruiting - Clinical trials for Knee Replacement Arthroplasty

IPACK Study in Total Knee Arthroplasty Patients

Start date: June 1, 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.

NCT ID: NCT03954327 Not yet recruiting - Clinical trials for Primary Biliary Cholangitis

Combination Antiretroviral Therapy (cART) for PBC

Start date: May 2019
Phase: Phase 2
Study type: Interventional

Placebo Controlled, double-blind RCT with 12 months Tenofovir Disoproxil and Raltegravir for patients unresponsive to Ursodeoxycholic Acid (UDCA). Placebo patients will be offered 12 months open label therapy at unblinding. All patients will be offered an additional 12 months open label therapy. Observational, open label study will be performed in parallel using Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) & Raltegravir in liver transplant recipients meeting all entry criteria except for use of immunosuppression.

NCT ID: NCT03953534 Recruiting - Acute Pain Clinical Trials

Quantity of Opioids for Acute Pain and Limit Unused Medication

Start date: May 6, 2019
Study type: Observational

Opioids (morphine and morphine-like substances) are often prescribed to patients to manage pain after an emergency department visit. In the past 20 years, opioid prescriptions have risen sharply, accompanied by a significant rise in opioid misuse (e.g., recreational or non-medical use, potentially leading to addiction or overdose). One explanation for this crisis is the availability and easy access of leftover opioid pills in Canadian homes, allowing family members (including children) and friends to take them for reasons other than pain relief. Canada has no recommendations for the dosage, duration, or quantity of opioids that physicians should prescribe to manage acute pain at home. Physicians are therefore left guessing as to how much to prescribe when a patient with a condition like a fracture or renal colic is discharged from the emergency department. Our preliminary study showed that two-thirds of the pills from the initial opioid prescription to treat acute pain actually remained unused and were therefore available for potential misuse. The investigators propose to determine how many opioid pills are consumed by patients who suffer from acute pain as they recover at home. The investigators will ask 2,580 patients (from 6 Canadian hospitals) to record their pain medication consumption in a 14-day diary. The investigators will also determine, their pain intensity level, whether or not they had new opioid prescriptions, and health services revisits. In case of missing information, patients will be contacted by phone at 2 weeks. The overall aim is to help emergency department physicians prescribe the right number of pills in order to manage patients' pain and at the same time reduce substantially leftovers available for potential misuse.

NCT ID: NCT03953144 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

Visible Patientâ„¢ With Intravascular Indocyanine Green

Start date: August 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

With the advent of CT screening for lung cancer, an increasing number of NSCLCs are being detected at very early stages, and the demand for pulmonary segmentectomy is rising rapidly. As such, there is a need to develop new surgical techniques to facilitate minimally invasive pulmonary segmentectomy, as segmentectomy may provide a number of significant advantages over lobectomy for patients presenting with early-stage lung cancer, or for patients unable to undergo a full lobectomy due to existing comorbidities. This study will provide the first case series using preoperative 3D anatomical planning (Visible Patientâ„¢) added to ICG and NIF-guided robotic segmentectomy to date and will be the first reported use of Visible Patientâ„¢-guided targeted pulmonary segmental resection in Canada. As lung cancer is the most frequently fatal cancer in North America, many thousands of patients will be able to benefit from this operation every year.

NCT ID: NCT03953014 Recruiting - Clinical trials for Major Depressive Disorder

Pharmacogenetics of Antidepressant-Induced Disinhibition

Start date: January 2, 2019
Study type: Observational

The purpose of this study is to identify pharmacogenetic profiles associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioral disinhibition in children with Major depressive disorder (MDD), anxiety disorders and/or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.

NCT ID: NCT03952338 Not yet recruiting - Clinical trials for Health Risk Behaviors

Impact of BC Farmers' Market Nutrition Coupon Program on Diet Quality and Psychosocial Well-being of Low-income Adults

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

The British Columbia (BC) Farmers' Market Nutrition Coupon Program (FMNCP) provides low-income households with $21/week in coupons to purchase healthy foods at farmers' markets and supportive nutrition skill-building activities. This randomized controlled trial will assess the impact of the BC FMNCP on the overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, experiences of food insecurity, risk of malnutrition (secondary outcomes) and subjective social status (exploratory outcome) of low-income adults immediately post-intervention and 16 weeks post-intervention.

NCT ID: NCT03951051 Recruiting - Bioequivalence Clinical Trials

The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions.

Start date: May 6, 2019
Phase: Phase 1
Study type: Interventional

This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject will receive each study treatment in a crossover fashion, a control group is not included. Within the clinical portion of the study each subject will receive a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints are the pharmacokinetic (PK) parameters Cmax and AUC0-t of olmesartan.