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NCT ID: NCT02056795 Completed - Ankle Sprain Clinical Trials

Study of Effects of Electroacupuncture on Balance in Subjects With Chronic Functional Ankle Instability

Start date: January 2013
Phase: N/A
Study type: Interventional

Introduction: Ankle sprains, the most common sports-related musculoskeletal injury, account for approximately 25% of sports injuries. An estimated 40% of these individuals will progress to develop chronic functional ankle instability (CFAI), which can significantly affect athletic performance and activities of daily life. Stresses from the injury can damage the ligaments, muscles, nerves and mechanoreceptors. It is widely accepted that ankle proprioception is critical for balance and that individuals with CFAI demonstrate decreased proprioception and altered muscular function, which impairs postural stability. The goal of this study is to determine if a single application of electroacupuncture can have an immediate positive outcome related to balance in individuals with CFAI. Methods: This single blinded randomized trial will include 12 subjects receiving a single application of electroacupuncture and 12 subjects in the placebo group receiving sham electroacupuncture. Subjects aged 18-50 with a history of unilateral inversion ankle sprain(s) and chronic symptoms of instability will be selected. Balance will be assessed pre- and post-treatment using force plate data during a single-leg stance and via the Star Excursion Balance Test (SEBT). GB-34 and GB-40 will be used for the experimental group and non-traditional points on the medial aspect of the leg will be used for the sham electroacupuncture group. Both will be connected to the electrical stimulation unit for 10 minutes. Results from this study may inform future research investigating the ability of EA at decreasing the risk of ankle sprains, improving perceived stability, and reducing the risk of subsequent degenerative changes.

NCT ID: NCT02056444 Completed - Osteoarthritis Clinical Trials

Efficacy of Intravenous Versus Topical Tranexamic Acid in Primary Total Hip Arthroplasty

TeACH-R
Start date: February 2014
Phase: N/A
Study type: Interventional

Bleeding during and after total hip replacement surgery is a primary concern to the surgical and anaesthetic team. Tranexamic acid is a commonly-used drug that helps blood clotting and decreases surgical bleeding. The investigators commonly administer the drug intravenously prior to the procedure. Some patients are unable to receive the drug in this form, because of risks related to blood clotting. The investigators know, from studies in total knee replacement surgery, that the investigators can deliver tranexamic acid directly to the surgical site (topically), with similar benefits and less of the drug absorbed into the bloodstream, resulting in less risk to the patient. The investigators seek to find if similar benefit in terms of reducing blood loss is seen using topical tranexamic acid in hip replacement surgery. The investigators' hypothesis is that the topical form will be equivalent, but not better than the intravenous form for reducing intra- and postoperative bleeding. The investigators also expect to see decreased levels of tranexamic acid in the bloodstream when it is administered topically.

NCT ID: NCT02056314 Completed - Problem Gambling Clinical Trials

Developing and Evaluating Effectiveness of a Reinstatement Tutorial

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

This study will compare a computerized tutorial to a brochure in terms of their education impact of people who wish to end voluntary self-exclusion. Voluntary self-exclusion is a program used by people who seek to bar themselves from further access to the casino or other gambling venue. The Centre for Addiction and Mental Health (CAMH), in cooperation with Ontario Lottery and Gaming (OLG), is developing a tutorial designed to provide practical information to players who choose to reinstate and return to gambling. The goal of this study is to determine if this new computerized tutorial decreases the harm of gambling experienced by gamblers who are reinstated. For example, are they less likely to relapsing to problematic levels of gambling.

NCT ID: NCT02055872 Completed - Edema Clinical Trials

Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial

FADE
Start date: September 2014
Phase: Phase 3
Study type: Interventional

Critically ill patients usually require intravenous fluids to correct low blood pressure and improve blood flow to vital organs. However, once the patient's blood pressure has improved, these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess fluid in these tissues, called edema, has been associated with longer ICU stays and higher mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema is to use diuretics, such as furosemide, which increase urine output. To further improve urine output, patients are sometimes given albumin, a protein which helps to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered in the kidney and removed in the urine. Although albumin is often used for this purpose, there is little evidence to support it. A large randomized controlled trial is needed to determine if albumin plus furosemide is truly more effective than furosemide alone in critically ill patients with low levels of blood albumin. We will perform a pilot study to assess the feasibility of such a trial.

NCT ID: NCT02055820 Completed - Clinical trials for Lymphoma, Non-Hodgkin

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

Start date: November 17, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.

NCT ID: NCT02055807 Completed - Atelectasis Clinical Trials

Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy

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

The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during laparotomy will limit the development of atelectasis and therefore improve the aeration score.

NCT ID: NCT02055339 Completed - Feeding Behavior Clinical Trials

Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants

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

Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not started due to concerns for choking. This may cause them to miss their window of learning and may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of ventilators, but no studies have been done in older babies. We plan to compare the feeding of babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time to full oral feeds.

NCT ID: NCT02055118 Completed - Hunter Syndrome Clinical Trials

Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment

AIM-IT
Start date: March 24, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase.

NCT ID: NCT02054897 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

SUSTAIN™1
Start date: February 3, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).

NCT ID: NCT02054832 Completed - Clinical trials for Glycogen Storage Disease Type IA

Sleep and Quality of Life in Patients With Glycogen Storage Disease on Standard Versus Modified Uncooked Cornstarch

Start date: November 2013
Phase: N/A
Study type: Observational

The aim of the present study is to determine if there is a change in quality and quantity of sleep perceived by adults and children with GSD and their parents while starting a modified UCCS (Glycosade) to prevent nocturnal hypoglycemia. The investigators also aim to evaluate if there is a change in quality of life perceived by adults and children and their parents with Glycosade.