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NCT ID: NCT03518281 Completed - Symptoms Flu Clinical Trials

Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function

Start date: March 28, 2018
Phase: N/A
Study type: Interventional

Upper respiratory tract infections cause cold and flu-like symptoms and are the most common form of acute illness. Certain populations are at increased risk of upper respiratory tract infections including athletes who train at a high level of intensity for prolonged periods of time. Consequently, some athletes experience higher rates of cold and flu-like symptoms than the general population. Euglena gracilis is a micro-algae which can synthesize many nutrients necessary for human health, including insoluble beta glucan. Thus, intake of whole cell Euglena may be beneficial to athletes by providing essential vitamins to optimize immune function.

NCT ID: NCT03518073 Completed - Clinical trials for Alzheimer Disease (AD)

A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).

NCT ID: NCT03517774 Completed - Amputation Clinical Trials

Improving Prosthetic Care for Patients With a Lower Limb Amputation

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Adults with lower limb amputation undergo rehabilitation in order to learn how to effectively use a lower limb prosthesis. Unfortunately, the process of being fitted a prosthesis can be delayed due to resource constraints and manufacturing times, which delays the rehabilitation process and puts patients at higher risk for functional decline. Preliminary work by our team have shown that our 3D printing system, 3DPrintAbility Devices by NIA (http://niatech.org/), perform at the same level of efficacy as traditionally manufactured prosthetics, which suggests that a digital manufacturing tool-chain is a viable alternative and may be desirable given the time savings involved. In order to lead to improved processes related to prosthesis fitting for adult transtibial amputees, we want to assess the feasibility and acceptability of using 3DPrintAbility sockets in this population. Specifically, we want to determine if: 1) the 3D printing of transtibial prosthetic sockets can provide better quality prosthetic care in regards to cost, timeliness, and accessibility; 2) 3D printed sockets are equivalent in quality to standard thermoplastic preparatory sockets in regards to safety, fit, durability and comfort; and 3) whether a 3D scanning, design and printing process can be integrated into the workflow of current rehab centres. If successful, the findings from this work can provide an innovative approach for facilitating the fitting of a socket for adults with amputation might provide significant savings to the healthcare system by making the process more efficient while optimizing clinical outcomes by allowing patients to begin their rehabilitation sooner

NCT ID: NCT03517540 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

TANDEM
Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT03517423 Completed - Epilepsy Clinical Trials

Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study

Start date: October 4, 2018
Phase:
Study type: Observational

Brivaracetam (BRV) is a new antiepileptic drug approved in March 2016 by Health Canada for the adjunctive treatment of focal epilepsy in adults. While randomized controlled trials represent the gold standard in measuring intervention efficacy, the generalizability of these findings to usual clinical practice remains uncertain. The primary objective of this study is to evaluate the effectiveness of BRV as an adjunctive treatment in epilepsy. The secondary objective of this study is to evaluate the tolerability of BRV as an adjunctive treatment in epilepsy. This is a prospective and multicentre post-marketing observational study. All consecutive adult patients (i.e. aged at least 18 years) in whom BRV is introduced in participating medical centres, ambulatory or hospitalized, will be approached to participate in the study. The investigators will exclude individuals with generalized epilepsy as those aged less than 18 years, in order to respect current Health Canada indications. The investigators will exclude individuals cognitively or physically unable to complete the study questionnaires. The investigators will collect data from participants during three clinical visits with their regular treating physician. These will be the baseline visit, the 3-month visit (three months following the initiation of BRV), and the 6-month visit. At each visit, the investigators will collect data on seizure type(s) and frequency. Study participants will also complete four questionnaires to measure irritability, anxiety, depression, and quality of life. There will be two primary study outcomes. These are: a) mean percent change in monthly seizure frequency; and b) proportion with at least a 50% decrease in seizure frequency. There will be several secondary study endpoints: a) mean change in irritability [measured using the Brief Irritability Test (BITe)]; b) mean change in generalised anxiety [measured using the Generalized Anxiety Disorder - 7 (GAD-7) scale]; c) mean change in depression [measured using the Neurological Disorders Depression Inventory (NDDI-E) scale]; d) mean change in quality of life [measured using the 7-item Quality of Life Inventory in Epilepsy-10 (QOLIE-10) scale]; e) the proportion of individuals that are seizure free, and f) change in distribution of seizure types (e.g. focal with motor seizures, generalized absence). The investigators will query for all adverse effects the participant may experience.

NCT ID: NCT03517085 Completed - GSD1 Clinical Trials

Safety and Dose-Finding Study of DTX401 (AAV8G6PC) in Adults With Glycogen Storage Disease Type Ia (GSDIa)

Start date: May 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study is to determine the safety of single doses of DTX401, including the incidence of dose-limiting toxicities (DLTs) at each dose level.

NCT ID: NCT03516240 Completed - Fatigue Clinical Trials

The Effect of Fatigue and Biofreeze® on the Biomechanics of Running

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Delayed onset muscle soreness (DOMS) can be identified as the muscular pain that occurs due to intense use of skeletal muscle through exercise or other activities performed intense enough or long enough to cause minor damage(Cheung et al., 2003). DOMS usually begins to show symptoms 24 hours post-activity, becomes most intense 48-72 hours post-activity and can sometimes last up to 5-10 days in ordinary cases(Cheung et al., 2003; Dutto and Braun 2004). Typical less severe cases still can cause an individual to alter proper movement mechanics - this alteration in mechanics can lead to the further injuring of the involved or compensating skeletal muscle tissues and the associated joints and skeletal structures. DOMS-related muscular pain can lead to functional deficits and altered movement mechanics that can lead to a greater risk of further injury or sources of pain. The body does this by trying to avoid the initial source of pain by adopting some form of compensation (such as a limp when walking) which may help reduce pain at the initial source but lead to another source of pain or risk injury at another joint or limb. DOMS is a common complaint of many runners from novice to expert and due to the increased forces in running, a compensatory pattern in walking is exaggerated in running and can affect the compensating structures to an even greater extent, further increasing the risk of injury. Biofreeze®, a topical analgesic, is used to block the pain signal from the affected structures to the brain when applied to muscles experiencing delayed onset muscle soreness. Blocking the pain signal from DOMS should allow an individual to restore their natural movement mechanics. The purpose of this study is to assess the interaction between Biofreeze® and delayed onset muscle soreness and how it affects movement mechanics and muscle function. Hypothesis: The application of a topical analgesic (Biofreeze®) on muscles experiencing delayed onset muscle soreness (DOMS) will increase force production and return running biomechanics to pre-DOMS values.

NCT ID: NCT03515837 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)

Start date: June 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.

NCT ID: NCT03515811 Completed - Thoracic Diseases Clinical Trials

A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

Start date: January 22, 2019
Phase:
Study type: Observational

The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.

NCT ID: NCT03515590 Completed - Satiety Clinical Trials

Emulsion Droplet Physical State on Postprandial Lipemia and Satiety

Start date: July 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of oil-in-water emulsions in which the droplets are in either the liquid or solid (i.e. crystalline) states.