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NCT ID: NCT01676324 Completed - Ulcerative Colitis Clinical Trials

FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)

FOCUS
Start date: September 2012
Phase: N/A
Study type: Observational

Hypothesis: Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to colonoscopy in the management of patients with Inflammatory Bowel Disease. Objectives: By means of a survey from the ordering physician we would assess: Primary Endpoint 1. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient. Secondary Endpoints 1. To determine if the Fecal Calprotectin result influenced the number of endoscopies performed 2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed. 3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if endoscopy was performed).

NCT ID: NCT01676298 Completed - Clinical trials for Analytical Reproducibility of a Medical Device

Spartan FRX Project Reproducibility Study

Start date: August 2012
Phase: N/A
Study type: Observational

The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and *17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study is to evaluate the performance of the FRX System under multivariate conditions including different days, sites, operators and systems.

NCT ID: NCT01676220 Completed - Clinical trials for Type 2 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

EDITION III
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: - occurrence of nocturnal hypoglycemia

NCT ID: NCT01675882 Completed - Peanut Allergy Clinical Trials

Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy

VIPES
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The objectives of this dose-finding study for the treatment of peanut allergy are: - To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. - To evaluate the safety of a long-term treatment with Viaskin Peanut.

NCT ID: NCT01675817 Completed - Coagulation Delay Clinical Trials

Evaluation of Heparin Rebound in Cardiac Surgery

Start date: April 2011
Phase:
Study type: Observational

Recent work has shown that heparin rebound is common after cardiac surgery. The exact doze of protamine required to neutralize heparin at the end of CPB is unknown. Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also unknown if precise titration of protamine perioperatively in cardiac surgery can influence transfusion requirements after cardiac surgery.

NCT ID: NCT01675076 Completed - Hematoma Clinical Trials

Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

BRUISECONTROL2
Start date: January 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

NCT ID: NCT01674790 Completed - Stroke Clinical Trials

Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke

Start date: October 13, 2013
Phase: N/A
Study type: Interventional

The objective of the 'Exploring potential synergistic effects of aerobic exercise and cognitive training on cognition after stroke' pilot trial is to investigate the combined effects of aerobic and cognitive training on cognition after stroke. This is to lay the groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months post-stroke will be randomly assigned into one of four following treatment groups: (i) aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please see detailed description below). We hypothesize that the combination of aerobic exercise and cognitive training will be more effective in improving cognition after stroke than either treatment on its own.

NCT ID: NCT01674647 Completed - Atrial Fibrillation Clinical Trials

Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

X-VERT
Start date: October 2012
Phase: Phase 3
Study type: Interventional

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

NCT ID: NCT01674361 Completed - Clinical trials for Obsessive-Compulsive Disorder

A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)

Start date: December 31, 2012
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Participants will be allocated to one of two strata. Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2 visit. Participants in both strata will receive the study drug in addition to their background therapy with an SSRI until Week 16.

NCT ID: NCT01674335 Completed - Chronic Pain Clinical Trials

The Effectiveness of Operant Learning Versus Energy Conservation Activity Pacing Treatments in Fibromyalgia

Start date: September 2012
Phase: N/A
Study type: Interventional

Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people with pain try to continue their daily activities at the same level as they were able to manage before they had pain. This way of coping causes increases in their pain; they become discouraged and give up on their activities. AP treatments involve helping them regulate their activity level so that they can achieve important life goals. Although AP is widely used, its effectiveness is still unproven. There are two key approaches: The operant learning (OL) approach uses quotas related to time or goals the person sets. The energy conservation (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We will examine the effects of these treatments on pain, fatigue, quality of life, physical functioning and mental well-being. We will also investigate whether other factors influence treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care London. OL and EC treatment manuals will be developed by experts in the field and both interventions will be given by two occupational therapists over a 3 month period as "stand-alone" interventions (10 sessions of 120 min). All sessions will be recorded in order to assess intervention fidelity. This study will be the first to base AP interventions on a clearly delineated theoretical framework. It will clarify whether AP strategies benefit individuals with FMS and whether either of these two approaches is more effective. Our results will help to direct clinical resources and funding toward the most beneficial interventions.