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NCT ID: NCT02649218 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Start date: May 24, 2016
Phase: Phase 2
Study type: Interventional

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

NCT ID: NCT02648308 Completed - Obesity Clinical Trials

Extension of the 5As Team Study for Improved Provider Obesity Management to Physicians and Medical Trainees (Part 2)

5AsT-MD2
Start date: October 8, 2015
Phase: N/A
Study type: Observational

Results from the 5As Team (5AsT) Study have identified critical gaps in medical school curricula on obesity, leading to a wave of new family physicians who lack confidence and are poorly equipped to manage obesity with their patients. In an effort to address this gap, all first year medical residents training in family medicine at the University of Alberta during the 2015/2016 year will be required to take a 2 day workshop in Obesity Management as part of the Doctor-Patient Relationship Course. The comprehensive workshop provides medical residents with knowledge and training in obesity prevention and management through didactic lectures, experiential learning, and clinical practice. Participants were asked to complete and submit pre- and post- workshop assessment measuring self-reported confidence on aspects of weight management counselling, narrative reflections regarding the experiential components of the course, and measures to assess beliefs and attitudes towards people living with obesity. The purpose of our program evaluation was to assess the program's impact on residents' knowledge of obesity and attitude towards counselling patients with obesity, as well as to refine and further develop the course. Evaluation of the 5AsT-MD pilot project shows increases of residents' understanding of the complexity and chronicity of obesity, and an uptake of the 5As framework and tools by residents to improve confidence and success of their weight management practice.

NCT ID: NCT02647359 Completed - Aniridia Clinical Trials

Study of Ataluren in Participants With Nonsense Mutation Aniridia

STAR
Start date: January 31, 2016
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the effect of ataluren on Maximum Reading Speed as measured using the Minnesota Low Vision Reading Test (MNREAD) Acuity Charts in participants with nonsense mutation aniridia. This study involves a 4-week screening period, a 144-week treatment period (Stage 1: Weeks 1 to 48 [double-masked treatment] and Stage 2: Weeks 49 to 144 [open label treatment]), an optional 96-week open label extension sub-study, and a 4-week post-treatment follow-up period (either study completion or early termination). Participants that choose not to participate in the sub-study will be required to complete the post-treatment follow-up visit at the end of the Stage 2 open-label extension.

NCT ID: NCT02647320 Completed - Clinical trials for Type 2 Diabetes Mellitus

12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

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

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

NCT ID: NCT02647268 Completed - Clinical trials for Postpartum Hemorrhage

Effect of Magnesium Sulphate Pre-exposure on Oxytocin-induced Contractility in Desensitized Human Myometrium - an in Vitro Study

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

Postpartum hemorrhage (PPH) is the loss of more than 500ml of blood within 24 hours after delivery. It is a major cause of maternal morbidity and mortality across the globe. Oxytocin is a naturally-occurring hormone that causes the uterus to contract, thereby causing labor. A synthetic form of oxytocin is used in obstetric medicine in the same way. It causes the uterus to contract by acting at the oxytocin receptor (OTR). It is used for both the prevention and the treatment of PPH. By causing the uterus to contract, it constricts the blood vessels within it, thus reducing bleeding. Oxytocin is also used to augment labor in women with slow labor progression. Desensitization of the OTR after prolonged exposure to oxytocin occurs, leading to reduced contractions of the uterus with the same doses of oxytocin. This has been demonstrated in previous studies done by the investigators. The resultant need for a higher oxytocin dose to cause adequate uterine contraction has also been demonstrated in laboring women having received oxytocin for labor augmentation. Magnesium sulphate (MgSO4) is widely used within obstetric medicine. It is used for seizure prevention and treatment in preeclampsia and eclampsia, and is used for fetal neuroprotection in preterm labor, to reduce the risk of cerebral palsy. It is well-known to have a relaxant effect on uterine muscle, and as such, has been used as a tocolytic agent in preterm labour to prevent premature contractions and premature delivery. The effect of MgSO4 on contractions in oxytocin pre-treated myometrium has not been fully elucidated with human lab studies. There are suggestions it may lead to increased oxytocin requirements or increased postpartum hemorrhage (PPH) in preeclamptic patients. This bears significance in the preeclamptic and eclamptic populations who are likely to be receiving MgSO4 in combination with oxytocin. The investigators hypothesize that MgSO4 will reduce uterine contractions in oxytocin pre-treated myometrium, as well as untreated myometrium, and higher oxytocin doses will be needed to produce equivalent contractions. This will help us to better understand the implications of the use of these drugs together in the clinical setting.

NCT ID: NCT02647021 Completed - Fatigue Clinical Trials

Therapeutic Resistance Group Exercise Training for Head & Neck Cancer Survivors

TARGET
Start date: March 31, 2016
Phase: N/A
Study type: Interventional

The investigators will conduct a randomized controlled trial examining 12-week, 24-week and one year outcomes from a combined therapeutic and physical exercise program that aims to bridge head-and-neck cancer survivors from acute care rehabilitation services to community-based exercise programming.

NCT ID: NCT02644824 Completed - Clinical trials for Congenital Heart Disease (CHD)

Biventricular Pacing in Children With Congenital Heart Disease

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

Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery compared to standard care alone.

NCT ID: NCT02644668 Completed - Clinical trials for Spinal Muscular Atrophy

A Study of CK-2127107 in Patients With Spinal Muscular Atrophy

Start date: January 14, 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate the pharmacodynamic (PD) effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on measures of skeletal muscle function or fatigability in patients with Type II, III, or IV spinal muscular atrophy (SMA).

NCT ID: NCT02643563 Completed - Clinical trials for Brachial Plexus Block

Analgesic Duration of Long Acting Local Anesthetics for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block

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

Severe pain following shoulder surgery is common and remains a major challenge. The interscalene nerve block is well suited for operations on the shoulder or upper arm, for providing surgical anesthesia as well as prolonged effective postoperative analgesia. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic. The current trend is to lower the volume of local anesthetic for ultrasound-guided interscalene block in order to reduce potential complications such as phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic duration of the block could be compromised. Studies to elucidate the best local anesthetic agent, concentration and adjuncts to prolong analgesia at low volumes are needed. Ropivacaine and Bupivacaine are long acting local anesthetics commonly used for peripheral nerve blocks, however, there are no studies comparing their analgesic duration in the setting of low volume interscalene block to date. This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5% Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB. This study aims to conduct a comparison of the duration of post operative analgesia achieved by these agents, hence allowing the appropriate local anesthetic agent and concentration selection in low-volume techniques.

NCT ID: NCT02643420 Completed - Breast Cancer Clinical Trials

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)

ADVANCE
Start date: January 19, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.