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NCT ID: NCT02431052 Completed - Acne Vulgaris Clinical Trials

A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

Start date: April 2015
Phase: Phase 2
Study type: Interventional

The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.

NCT ID: NCT02430935 Completed - Psychosis Clinical Trials

A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis

Start date: April 2015
Phase: N/A
Study type: Interventional

The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied.

NCT ID: NCT02429908 Completed - Clinical trials for Degenerative Disc Disease

Post-Market Surveillance Study of the TM Ardis Interbody Fusion System

Start date: March 2014
Phase: Phase 4
Study type: Interventional

This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability.

NCT ID: NCT02429856 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)

SCORPIO™
Start date: February 1999
Phase: Phase 4
Study type: Interventional

This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.

NCT ID: NCT02429791 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)

Start date: April 14, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

NCT ID: NCT02429765 Completed - COPD Clinical Trials

Effect of Aclidinium/Formoterol on Nighttime Lung Function and Morning Symptoms in Chronic Obstructive Pulmonary Disease

Start date: October 2015
Phase: Phase 4
Study type: Interventional

A number of studies have documented poor sleep quality and troublesome symptoms (breathlessness, cough and sputum production) upon awakening in patients with COPD. However, the investigators know very little about measurements of respiratory mechanics (i.e., lung volumes, respiratory pressures, diaphragm function, etc) during sleep in these patients. The investigators also know little about how modern bronchodilator therapies, or the timing of when they are taken, affect respiratory mechanics during sleep or the severity of early morning respiratory symptoms. COPD is often treated with inhaled bronchodilator medications which are used to open up airways and make it easier for air to get in and out of the lungs. The investigators are studying the effects of a new inhaler that contains two different types of long-acting bronchodilator: formoterol [a long-acting beta2-agonist (LABA)] and aclidinium bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]. Initial studies have shown that this combination therapy taken twice daily can improve some lung function measurements and respiratory symptoms in patients with moderate to severe COPD. There are also reports that evening administration of this medication may provide important advantages in patients with dominant nighttime and early morning symptoms. It is thought that sustained bronchodilation and lung deflation during the night may improve respiratory mechanics, diaphragmatic function, pulmonary gas exchange, sleep quality, and reduce severity of morning symptoms. This study will be the first to explore the effects of a nighttime dose of aclidinium/formoterol combination therapy on detailed measurements of respiratory mechanics and early morning symptoms in COPD. This study will also give us a better understanding of the mechanisms of early morning respiratory symptoms and their improvement with bronchodilators.

NCT ID: NCT02429206 Completed - Xerosis Clinical Trials

Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis

Start date: April 2015
Phase: Phase 2/Phase 3
Study type: Interventional

In the general population, xerosis is often caused by external factors such as seasonal changes. In that case, the best way to relieve dry skin is to use a standard moisturizer. However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems. This study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in patients suffering of paralysis.

NCT ID: NCT02429193 Completed - Clinical trials for Castration-resistant Prostate Cancer

Biomarkers of Androgen Response and Resistance In Evolution During a Rising PSA

BARRIER-P
Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is an open-label phase 2 multi-center study of abiraterone and enzalutamide in men with castration-resistant prostate cancer. Sixteen patients will be enrolled over 18 months.

NCT ID: NCT02429167 Completed - Clinical trials for Traumatic Brain Injury

Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)

Start date: August 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of the study device in conjunction with physical therapy will improve balance and gait in patients suffering from a TBI. The effects of using the device and undergoing therapy will be measured using standardized tests of movement control, gait, headache and other TBI symptoms.

NCT ID: NCT02428738 Completed - Pregnancy Clinical Trials

Text Message Reminders for Influenza Vaccine in Pregnancy

Start date: November 2013
Phase:
Study type: Observational

Influenza virus accounts for numerous cases (epidemics) of respiratory illnesses each year worldwide and affects people of all ages. These epidemics typically occur in the winter months, and can result in substantial morbidity and mortality in persons at risk. Pregnant women may be more susceptible to morbidity and mortality associated with influenza infection. This increased risk may result from several factors including increased heart rate, stroke volume, and oxygen consumption, decreased lung capacity, and changes in immunologic function. Immunization of women during pregnancy can help to prevent infection in the woman herself and may also offer protection to the infant in two ways: by the passage of antibodies from mother to the fetus during pregnancy, and by preventing infection in the mother and therefore decreasing the infant's exposure risk after birth. In Canada, the National Advisory Committee on Immunization (NACI) recommends the vaccine for pregnant women who are expected to deliver during influenza season because they will become household contacts of their newborn. Ideal timing of vaccination occurs in October or November since influenza outbreaks typically occur throughout the winter months. Despite the Canadian and American guidelines for influenza vaccination during pregnancy, it is unclear how many women are offered and/or actually receive the vaccine while pregnant. There is, however, evidence that women will accept the vaccine if offered. Specifically, in the Women's Health Care Centre at St. Michael's Hospital, it was found that 42% of women not only accepted but also received the influenza vaccination when offered. Innovative techniques will be required to continue to increase vaccination rates among vulnerable populations, including pregnant women. The purpose of the present study is to determine if the use of electronic reminders (text messages) increases the likelihood of receiving the influenza vaccine among pregnant women.