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NCT ID: NCT02979613 Completed - Chronic Hepatitis B Clinical Trials

Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed

Start date: December 29, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.

NCT ID: NCT02979379 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Pain in Individuals With COPD During Pulmonary Rehabilitation

Start date: April 2016
Phase:
Study type: Observational

This study is aimed at determining the role of pain in individuals with chronic obstructive pulmonary disease (COPD) who are enrolled in a pulmonary rehabilitation (PR) program. It is not known whether pain interferes with an individuals performance in PR, or whether PR aggravates or relieves pain. Individuals with COPD who report chronic pain and those without pain will be enrolled in the study.

NCT ID: NCT02977923 Completed - Pain Clinical Trials

Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study

DREAM-P
Start date: July 10, 2017
Phase: N/A
Study type: Interventional

Children with injuries, including burns, experience severe pain intensity during medical procedures despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Virtual reality (VR) has gained growing consideration as a non-pharmacological method as it engages multiple senses and allows interactions with a virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness, at a relatively low cost, and could probably improve the management of pain and anxiety in wound care. Overall hypothesis: Distraction by VR via the OR, in combination with the standard pharmacological treatment, is a feasible, acceptable and satisfactory method for the management of pain and anxiety during wound-related treatments in children with injuries. Note that this pilot study will precede a larger trial aimed at assessing the effect of virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)

NCT ID: NCT02977299 Completed - Clinical trials for Treatment Resistant Major Depressive Disorder

Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD

ASCERTAINTRD
Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.

NCT ID: NCT02977026 Completed - Alcohol Consumption Clinical Trials

Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition

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

Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings. One promising strategy is Internet-based interventions for problem drinkers. Our recently completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help Centre; AHC) Internet intervention for problem drinkers found that, while there was a reduction in drinking across time for both interventions, there was no significant (p > .05) difference in reductions in drinking between the two interventions. Based on these results, it is not justifiable to say that either intervention 'worked' as there was no comparison condition of participants who received no active intervention. The current trial proposes to address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention control condition. Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who are interested will be randomized to receive access to the Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal will be used to send invitation emails that contain a link to the follow-up survey. The primary hypothesis to be tested is that participants receiving access to the AHC intervention will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week than participants in the CYD intervention. Further, participants in the CYD condition will report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the no intervention control condition.

NCT ID: NCT02976818 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Lp(a) and Aortic Valve Calcification

FHLPA
Start date: April 30, 2017
Phase:
Study type: Observational

Aortic valve stenosis (AVS), the most common form of valve disease in the western world, afflicts more than 1 million individuals in North America [1] and the burden of AVS is high and is expected to double within the next 50 years [2]. Medical therapy to prevent development or reduce progression of AVS is currently not available and the only effective treatment for AVS is aortic valve replacement, for which costs have been estimated up to 120,000$ [3,4]. Recently, we and others have identified rs10455872 at the LPA locus as a susceptibility single nucleotide polymorphism (SNP) for aortic valve calcification (AVC) and AVS [5,6] and rs10455872 is associated with elevated plasma lipoprotein (Lp)(a) levels [7]. Lp(a) is a LDL-like particle consisting of hepatically synthesized apolipoprotein B-100 that is noncovalently bound to the plasminogen-like glycoprotein apolipoprotein(a) [8]. Lp(a) promotes atherosclerotic stenosis, and possibly thrombosis, and has been hypothesized to contribute to wound healing, each of which could explain an association with AVS [9,10]. Lp(a) is relatively refractory to both lifestyle and drug intervention, with only nicotinic acid and monoclonal antibody inhibition of the proprotein convertase subtilisin/kexin type 9 that have showed reductions in Lp(a) levels [11,12]. However, the evidence that patients with AVS could be characterized by high Lp(a) levels is scarce. Glader et al. [13] showed that plasma levels of Lp(a) were almost 1.5-fold higher in 101 patients with AVS compared to matched controls, although this relationship did not reach statistical significance. Subsequent studies have also reported an association between elevated plasma Lp(a) levels and higher prevalence of AVS. More specifically, Kamstrup and colleagues [14] reported that elevated Lp(a) levels and corresponding genotypes were associated with increased risk of AVS in the general population with levels >90 mg/dL predicting a threefold increased risk. We have measured Lp(a) and oxidized phospholipids plasma levels in 220 patients with mild-to-moderate calcific AVS enrolled in the Aortic Stenosis Progression Observation: Measuring Effects of Rosuvastatin (ASTRONOMER) trial [15]. Results of this study suggest that high Lp(a) and oxidized phospholipids both predict calcific AVS progression, especially in younger patients with calcific AVS. We also found that statin therapy considerably increased both Lp(a) and oxidized phospholipids levels. Whether the fact that statins increase these risk factors for calcific AVS might explain at least to a certain extent why statins failed to promote calcific AVS regression or stabilization in at least four trials, including ASTRONOMER. Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by mutations in the LDL receptor gene that disrupt normal clearance of LDL. Phenotypic features characteristic of the disease's heterozygous form are 2- to 3-fold raise in plasma LDL-cholesterol concentrations, tendinous xanthomatosis and premature atherosclerotic coronary artery disease. High Lp(a) levels have been shown to explain residual cardiovascular disease risk in FH [16,17]. Recent studies have demonstrated that FH heterozygotes have elevated AVC compared with non-FH subjects [18] and that Lp(a) levels were positively correlated with AVC in asymptomatic FH heterozygotes [19]. Vongpromek et al. [19] demonstrated that plasma Lp(a) concentration is a independent risk factor for AVC in a cohort of 129 asymptomatic heterozygous FH patients aged between 40 and 69 years. In this study, AVC was significantly associated with plasma Lp(a) level, age, body mass index, blood pressure, duration of statin use, cholesterol-year score and coronary artery calcification (CAC) score.

NCT ID: NCT02976805 Completed - Colonoscopy Clinical Trials

Multi-centre Failed Bowel Prep RCT

B-CLEANR
Start date: February 13, 2017
Phase: Phase 3
Study type: Interventional

This is a multi-centre randomized clinical trial comparing the efficacy of two different bowel preparation regimens for patients who have already failed a bowel preparation for colonoscopy.

NCT ID: NCT02976428 Completed - Clinical trials for Total Knee Arthroplasty

Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning may result in knee stiffness, pain, instability and limited range of motion (ROM). This may result in implant failure and the need for revision surgery. As part of standard practice orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to achieve optimal knee balance. New sensor-assisted technology can provide surgeons with measurable information to help achieve soft tissue balancing, providing surgeons with immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the sensor, gives surgeons electronic information on soft tissue balance and implant position.The purpose of this study is to determine if a sensor guided soft tissue balancing device (Verasense) is more effective at balancing the knee during surgery as compared to standard soft tissue balancing performed with a manual balancer device.

NCT ID: NCT02976415 Completed - Critical Illness Clinical Trials

In-Bed Cycling in ICU Patients Post Cardiac Surgery

CardiO Cycle
Start date: August 28, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.

NCT ID: NCT02976129 Completed - Crohn's Disease Clinical Trials

A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease

HarbOR
Start date: December 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).