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NCT ID: NCT02537223 Completed - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer

Start date: September 2015
Phase: Phase 1
Study type: Interventional

This is a phase 1 study (the first step in testing a new drug or combination, to see how safe the drug and/or combination are) of investigational agent BYL719 in patients with locally advanced head and neck cancer (LA-SCCHN) in combination with standard radiation and chemotherapy (cisplatin). BYL719 is a new drug that is able to bind (attach to) and block a protein called PI3K-alpha. PI3K-alpha is part of an important pathway called EGFR/PI3K/Akt. A pathway is a series of chemical reactions among proteins in the cells that are involved in the support of normal cellular function. If the pathway is too active, due to changes in those proteins, the pathway can lead to tumor cell growth, survival and invasion. BYL719 has been shown to stop cancers in laboratory and animal studies. This study is the first time BYL719 will be combined with radiation and chemotherapy.

NCT ID: NCT02537197 Completed - Gambling Clinical Trials

The Effect of Regular Naltrexone Dosing on Disordered Gamblers

Start date: April 2016
Phase: Phase 1
Study type: Interventional

This study examines the effect of regular naltrexone dosing on disordered gamblers. Gamblers will also be scanned pre- and post-treatment where we will investigate the functional changes to tasks designed to engage brain region associated with gambling and addiction. These changes will be correlated with treatment outcomes and urge scores.

NCT ID: NCT02536755 Completed - Gaucher Disease Clinical Trials

Phase 3b Study to Evaluate Skeletal Response to Eliglustat in Adult Patients Who Completed Phase 2 or Phase 3 Studies

EXOSKEL
Start date: October 27, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: Evaluate long term skeletal response to eliglustat in adult participants who successfully completed one of the Phase 2 or Phase 3 eliglustat studies. Secondary Objective: Evaluate the safety of eliglustat (by serious adverse event continuous monitoring), the quality of life (Short Form-36 Health Survey [SF-36]) and biomarkers of Gaucher disease type 1 (GD1) (chitotriosidase, plasma glucosylceramide [GL-1] and lyso glucosylceramide [lyso-GL-1]) in adult participants who successfully completed one of the Phase 2 or Phase 3 studies.

NCT ID: NCT02536534 Completed - Clinical trials for Hypertension, Pulmonary

Electronic Activity Level Monitoring Pilot in Pulmonary Hypertension

e-MOTION PH
Start date: June 30, 2015
Phase: N/A
Study type: Observational

Evaluate the correlation between activity level (monitored by Fitbit Flex remote activity tracker) and 6-minute walk distance (6MWD) (performed by investigator) in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) over 6 months in routine clinical practice settings.

NCT ID: NCT02536417 Completed - Delirium Clinical Trials

Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients

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

The purpose of this study is to determine if melatonin administration to end-of-life patients is effective in preventing the development of delirium compared with those who do not receive this treatment. Delirium is a difficult to control symptom commonly seen in patients at the end-of-life. A person who is delirious is unable to think clearly and cannot make sense of what is going on around him/her.

NCT ID: NCT02536404 Completed - Ulcerative Colitis Clinical Trials

Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

Start date: January 25, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

NCT ID: NCT02536248 Completed - Clinical trials for Type 2 Diabetes Mellitus

Sitagliptin Therapy and Kinetics of Inflammatory Markers

Start date: August 1, 2015
Phase: Phase 3
Study type: Interventional

Inflammatory processes are increasingly being recognized as a critical step in the pathogenesis of both diabetes and heart disease and may constitute a biological link between the two diseases. Inflammatory cytokines increase vascular permeability, change vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important step in the development of atherosclerosis, and adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore, identifying novel therapeutic approaches that would favorably affect inflammation, endothelial function, and glucose is of significant interest. Investigators have recently demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The results also suggest that the beneficial effects of sitagliptin on both inflammation and endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the beneficial effects of sitagliptin on these markers remain to be fully elucidated. The proposed study will address this key issue.

NCT ID: NCT02535754 Completed - Health Behavior Clinical Trials

Interventions to Increase Workplace Wellness

Start date: April 2010
Phase: N/A
Study type: Interventional

Behaviour changes such as improving nutrition, increasing physical activity, and decreasing obesity are linked with lower mortality and morbidity and fewer cancers. Health promotion programs in the workplace are a promising way to reach a large segment of the population. This project evaluated the efficacy of three approaches - all of which were based on previous research and programs with demonstrated positive benefits - on cancer-related outcomes (healthy eating, physical activity, normal body weight) and work-related outcomes (absenteeism, presenteeism).

NCT ID: NCT02535390 Completed - Depression Clinical Trials

Action-Based Cognitive Remediation to Improve Vocational Outcomes in Depression

ABCR
Start date: December 2014
Phase: N/A
Study type: Interventional

Major depressive disorder places a tremendous burden on workplace disability each year. Its diagnosis is based on the presence of characteristic symptoms that include disturbances in mood regulation, maladaptive beliefs, and behaviour. Impairment in neurocognitive functions (e.g., information processing speed, attention, memory, problem solving skills) is absent from current diagnostic criteria and off the radar in most clinical treatment settings, yet increasingly recognized as a primary cause of poor work functioning and outcomes. This disconnect between the root causes of poor vocational outcomes and targets of treatment has resulted in a failure to return to work following illness, job underproductivity, and work-related stress, which contribute to indirect costs to society each year. The investigators seek to expand scientific support for treating neurocognitive impairments in order to increase occupational productivity and reduce job-related stress associated with depression. The investigators developed a novel group cognitive remediation (CR) treatment, Action-Based Cognitive Remediation (ABCR). It builds on procedural learning skills with explicit work-related role-plays to facilitate immediate and salient abstraction of drill and practice remediation techniques. The activities were developed in collaboration with a community rehabilitation partner in this study through systematic interviews with job placement specialists and supervisors from employment sites used by the agency. The props match those used in work settings and include miniature versions of a cash register, filing system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The activities capitalize on procedural learning skills through roleplays and props that simulate a work environment. ABCR maintains important aspects of drill and practice, strategic monitoring to enhance flexible problem solving approaches, and bridging. The role-plays follow computerized drill and practice exercise and therapists facilitate group discussions of how cognitive skills and flexibility in thinking from drill and practice can be effective while directly engaged in an everyday work environment. Thus, bridging used in ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the treatment from standard CR, where the discussion-based approach is limited by the auditory learning, memory, and abstraction deficits observed in depression.

NCT ID: NCT02535065 Completed - Clinical trials for Abdominal Aortic Aneurysms

Zenith® Low Profile AAA Endovascular Graft

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

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.