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NCT ID: NCT02094001 Completed - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH

Start date: May 2014
Phase: Phase 2
Study type: Interventional

Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive pulmonary hypertension (PH) and right ventricular failure- most common cause of death for patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved in Canada for the treatment of CTEPH. This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will show changes in glucose metabolism and improved resting myocardial blood flow using positron emission tomography ( PET ) imaging to measure myocardial function. The response between both treatment naive patients as well as patients on maximally tolerated dose of riociguat with tratment duration of at least 3 months will be included.

NCT ID: NCT02093780 Completed - Ulcerative Colitis Clinical Trials

Personalized "Alberta" Diet for Prevention of Relapse in Ulcerative Colitis

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

In the present study, ulcerative colitis (UC) patients in the remission stage of the disease will be randomized into two groups: Alberta anti-inflammatory diet and Canada's Food Guide diet. The elements of Alberta anti-inflammatory diet have previously been shown to have a role in decreasing the risk of UC development or management of UC-related symptoms or relapse. Since the primary outcome of interest is the relapse rate in two groups, disease status will be assessed monthly using appropriate tools. In order to find out the underlying mechanisms that will relate the proposed diet to decreased flare rate, some laboratory evaluations, which are mainly markers of inflammation or are related to gut microbiome will be conducted. In the present study, the investigators will also perform state-of-the art metabolomics tests, in order to study how the dietary changes will change the end metabolites. In addition, the investigators will be able to explore if metabolomic profile of participants can predict future UC relapse. This study will last for 6 months from baseline wherein all the study subjects will receive appropriate dietary instructions in addition to their stable doses of maintenance drug therapy.

NCT ID: NCT02093767 Completed - Ulcerative Colitis Clinical Trials

Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis

Start date: August 2007
Phase: N/A
Study type: Interventional

Based on the efficacy of inulin and oligofructose in treating experimental colitis and emerging evidence suggesting probiotics are efficacious in maintaining and inducing remission in human ulcerative colitis (UC), the investigators intend to conduct an open label study using Synergy-1, a 1:1 oligosaccharide/ inulin mixture, in patients with mild to moderately active left-sided UC. The investigators hypothesize that oligofructose-enriched inulin (Synergy-1) can be used safely in the treatment of mild to moderate UC, and daily oral administration of Synergy-1 will result in the clinical improvement and/ or remission of disease. Subjects will be randomized to either a 7.5g or 15g dose of Synergy-1 in order to investigate what amount of the prebiotic is efficacious and tolerable in patients with active UC. The clinical activity of disease will be evaluated using endoscopy and symptom scores. The investigators will also study the effect Synergy-1 on mucosal histology, intestinal microbiota composition and function and markers of inflammation (e.g. fecal calprotectin, cytokines). The study will be for 9 weeks from baseline wherein all subjects will receive Synergy-1 treatment. Half the subjects will receive a dose of 7.5g and half will receive 15g daily.

NCT ID: NCT02093663 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

PACE
Start date: December 12, 2014
Phase: Phase 3
Study type: Interventional

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

NCT ID: NCT02093117 Completed - Clinical trials for Subdural Pressure During Supratentorial Brain Tumour Resection

Neurosurgery Recruitment Maneuver Study

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

Background. Patients undergoing neurosurgical procedures experience higher rates of postoperative respiratory failure compared to the broader surgical population. Lung-protective ventilation strategies, including alveolar recruitment maneuvers may be beneficial. Despite this potential benefit, the effect of high levels of continuous airway pressure on intracranial pressure, brain swelling and cerebral perfusion must be defined prior to applying this intervention to the neurosurgical population. Objectives. The primary objective is to determine the effect of an alveolar recruitment maneuver on subdural pressure in patients undergoing supratentorial tumour resection. The secondary objectives are to determine the effect of an alveolar recruitment maneuver on 1) brain bulk score and 2) cerebral perfusion pressure in patients undergoing supratentorial tumour resection. Hypothesis. The investigators hypothesize that an alveolar recruitment maneuver of 30 cm of water over 30 seconds will not result in a clinically-important (>3 mmHg) increase in subdural pressure. Methods. This single center, randomized, cross-over study will enroll 30 American Society of Anesthesiologists Classification I-III patients scheduled to undergo supratentorial brain tumour resection at Vancouver General Hospital. All patients will receive a standardized general anesthetic including invasive blood pressure monitoring. After removal of the bone flap, subdural pressure will be measured using a sterile 22-gauge plastic cannula. Brain bulk will be assessed using a validated 4-point scale. After baseline arterial and subdural pressure determination and brain swelling assessments, patients will be randomized to receive either a recruitment maneuver of 30 cm of water for 30 seconds or a sham recruitment maneuver of 5 cm of water for 30 seconds. Maximal subdural pressure and minimum mean arterial pressure during the maneuver will be noted, and the neurosurgeon will be asked to score the brain bulk. After a 2-minute equilibration period, the protocol will be repeated with the alternate group allocation. Statistical Analysis. Our sample size calculation, based on our primary outcome (subdural pressure), determined that a sample size of 22 patients would allow us to detect a difference of 3.5 mmHg in subdural pressure assuming a type I error of 0.05, a type II error of 0.2 and two-sided significance testing. The subdural pressure during the recruitment maneuver as compared to the sham maneuver will be analyzed using a paired t-test. The brain bulk score will be compared using a Wilcoxon signed rank test. All data analysis will be performed with STATA 12.1 (StataCorp, College Station, TX).

NCT ID: NCT02093104 Completed - Clinical trials for Unresectable Hepatocellular Carcinoma

TACE Study-Liver Embolization Perfusion (VGH Radiology LIU)

TACE
Start date: February 2014
Phase: N/A
Study type: Observational

The purpose of this research study is to evaluate the quantitative information of utilizing C-arm systems in liver tumor care in hopes this potential clinical combination of imaging could aid in diagnosis and evaluation of tumor therapy.

NCT ID: NCT02093078 Completed - Clinical trials for Obstetrical Emergency Situations

Cognitive Aids With Roles Defined (CARD) for Obstetrical Crises: A Multisite Cohort Study

Start date: January 2014
Phase:
Study type: Observational

Crisis resource management represents the set of non technical skills, such as communication, leadership, delegation, and prioritization, that allow effective teamwork for optimal patient care during an urgent and critical situation. The Cognitive Aids with Roles Defined (CARD) is a new concept of cognitive aid addressing the well-documented issue of teamwork in crisis management. It relies on large identification cards specially designed for each team members profession and role. During a life threatening clinical situation, the CARD protocol focuses on clarification of individual roles and distribution of tasks for crisis management rather than creating an additional algorithm identifying either a list of actions to be taken or the dose of a medication. This study aims to evaluate the clinical impact of introducing the CARD protocol in obstetrical emergency situations ("code 333") in clinical practice at The Ottawa Hospital. Hypothesis: CARD protocol will: (i) decrease the total time taken to deliver the baby, and (ii) improve clinical outcome for the mother and baby compared to traditional management without the CARD protocol.

NCT ID: NCT02093026 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)

Start date: August 2002
Phase: Phase 2
Study type: Interventional

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

NCT ID: NCT02093013 Completed - Asthma Clinical Trials

Effectiveness of an Integrated Care Program on Asthma Control and Inhaled Corticosteroids Adherence

RESPIRE
Start date: May 2004
Phase: N/A
Study type: Interventional

The investigators propose to implement and evaluate an integrated care program for enhancing the care of patients with asthma in a region of Quebec province, Canada. The investigators will implement our intervention in a family medicine group practice setting and plan to deliver it to 150 experimental group subjects. The investigators will simultaneously study 300 control subjects who are receiving usual care in other regions of the province of Quebec. Our hypothesis is that the program will improve the quality of life of patients with asthma exposed to the program, asthma control, inhaled corticosteroid adherence, knowledge of asthma, and a number of variables that relate to the conceptual model selected as a framework for this study (the PRECEDE-PROCEED model of Green and Kreuter).

NCT ID: NCT02092935 Completed - Clinical trials for Clostridium Difficile Infection

A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Start date: April 2014
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).