Clinical Trials Logo

Filter by:
NCT ID: NCT02847884 Completed - Crohn's Disease Clinical Trials

IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study

IDeaL
Start date: October 2015
Phase:
Study type: Observational

Crohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness, stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss, skin rashes, arthritis and inflammation of the eye. Infliximab-IFX (Remicade®) is a medication that is used to treat CD in adults and children. In adults it has been shown that the amount of this drug a person has in their blood can show how well it is working for them. Health Canada has approved Infliximab -IFX for the treatment of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to younger children when other therapies do not resolve their disease symptoms. This is called "off-label" use of Infliximab. IFX levels in the body and consequently its efficacy can be influenced by many biological characteristics within the patient's body. In about 17% of those treated with IFX, the patient's immune response against IFX may lead to a three to fivefold increased risk of loss of response. This immune response to the medication often occurs when drug levels are undetectable in the body. Thus it is in order to achieve best results with this treatment, physicians need to be able to adjust dosing specific to each patient. A recent study has shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next infusion. In order to minimize the loss of response, we hope to conduct an observational cohort study of pediatric patients treated with IFX. This open label, cohort study aims to: 1. Determine the pharmacokinetics of IFX in children with CD and the factors that affect IFX levels during the first three loading infusions 2. Obtain data to create a model that can guide and adjust the IFX dose and frequency to achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.

NCT ID: NCT02847572 Completed - Cataract Clinical Trials

Assessment of Visual Performance Combining a Symfony IOL and a +3.25 Tecnis Multifocal IOL

Start date: January 2016
Phase: N/A
Study type: Interventional

This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.

NCT ID: NCT02846831 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings. The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.

NCT ID: NCT02846532 Completed - Thrombosis Clinical Trials

Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure

UNIVERSE
Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

NCT ID: NCT02845479 Completed - Lung Neoplasms Clinical Trials

The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I

POISE
Start date: December 7, 2018
Phase: Phase 3
Study type: Interventional

Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.

NCT ID: NCT02843100 Completed - Crohn's Disease Clinical Trials

Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease

DIETOMICS-CD
Start date: April 10, 2018
Phase: N/A
Study type: Interventional

The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.

NCT ID: NCT02842905 Completed - Hearing Loss Clinical Trials

Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention

Start date: July 2016
Phase: N/A
Study type: Interventional

Most of us will experience some degree of hearing loss as we get older. It can affect one or both ears and without treatment causes difficulty with following conversations in the home or workplace. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly, however they diagnose hearing loss and can recommend hearing aids amongst other treatments for hearing loss. It is undecided whether consulting with a physician in addition to an audiologist will improve user's satisfaction with hearing aids, compared to consulting with an audiologist alone. The purpose of this study is to determine whether physician involvement (in addition to an audiologist) in the hearing aid fitting process improves users' satisfaction with hearing aids. The study utilizes questionnaires to assess satisfaction with hearing aids. Furthermore, participants decision to keep the purchased hearing aids will be recorded. The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and audiologists. A hearing aid suitable for the needs of the participant will be fitted by an audiologist. In the first 21days after the fitting, participants will attend follow-up visits with the audiologists for adjustments to the hearing aids to best meet their specific listening needs. After 21 days, eligible participants will be allocated to either the Control or Test groups. Participants in both groups will be asked to describe the change in their hearing performance related to the use of hearing aids to their audiologist(Control) or Physician (Test) at a follow-up visit. At the study's final visit, participants will be asked to complete a satisfaction-based questionnaire. The time taken to fit a hearing aid varies depending on the individual needs of the patient. It is estimated that at most 10 visits will be required over 90 days to complete the hearing aid fitting and study processes. These visits will be of 30 minutes duration on average, except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of this time will be specifically related to the study. The study is intended to determine the satisfaction with hearing aids and consultations with health professionals.

NCT ID: NCT02842736 Completed - Menorrhagia Clinical Trials

A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding

CLARITY
Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.

NCT ID: NCT02842593 Completed - Clinical trials for Weight-Lifting Exercise Program

Vascular Responses to High vs Low Repetition Resistance Exercise Training in Young Men

Start date: September 2014
Phase: N/A
Study type: Interventional

This study evaluates the effects of two types of resistance exercise training (higher-repetition, lower load vs lower-repetition, higher load vs control) on regional and local measures of arterial stiffness in trained young men.

NCT ID: NCT02841137 Completed - Menopause Clinical Trials

Efficacy Study of Progesterone Tablet in Post-menopausal Women

Start date: June 2016
Phase: Phase 2
Study type: Interventional

This is a phase II study intended to determine the effect of progesterone 5, 10 and 20 mg tablets compared to progesterone 100 mg capsules on the endometrial thickness of post-menopausal women under hormone therapy with estradiol.