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NCT ID: NCT02496390 Completed - Diabetes Mellitus Clinical Trials

Transplantation of Microbes for Treatment of Metabolic Syndrome & NAFLD

FMT
Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is deposited in the liver. Almost all patients also have obesity and insulin resistance (the inability of the body to effectively use insulin). Obesity and NAFLD are intricately intertwined and are increasing in incidence. While weight loss is the most effective therapy for NAFLD, the investigators' efforts are failing and in the next generation it will become the most common cause of liver failure in Canada. Recently, researchers have focused on the potential use of altering the composition of bacteria in the gut (microbiome) to alter absorption of energy from food, deposition of fat and resistance to insulin. This study will determine if transplantation of bacteria from the stool of a healthy volunteer into an individual with metabolic syndrome and NAFLD (i.e. fecal microbiota transplant/FMT) can alter insulin resistance and reduce the amount of fat deposited in the liver. FMT is being studied to treat several clinical conditions and is now standard of care for the treatment of refractory Clostridium difficile infection. Investigators are proposing a randomized controlled pilot study of FMT in 21 patients to determine the feasibility and to inform us of changes needed for a larger study.

NCT ID: NCT02495077 Completed - Kidney Transplant Clinical Trials

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Start date: November 2, 2015
Phase: Phase 2
Study type: Interventional

During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha). The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.

NCT ID: NCT02495051 Completed - Clinical trials for Gastroesophageal Reflux

Esophageal Atresia: Metaplasia, Barrett

Oesophagix
Start date: February 2010
Phase: N/A
Study type: Observational

The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.

NCT ID: NCT02494037 Completed - Breast Neoplasms Clinical Trials

The Canadian/US Integrative Oncology Study

CUSIOS
Start date: January 1, 2015
Phase:
Study type: Observational

This study describes the survival outcomes of advanced stage breast, colorectal, ovarian and pancreatic cancer patients receiving advanced integrative oncology (AIO) treatment at participating North American integrative oncology clinics. This study also aims to describe the integrative treatments recommended by naturopathic doctors (NDs) for these participants alongside their conventional care treatments. Sub-studies will evaluate health-related quality of life, cost of cancer care, and qualitative experience of care in a subset of Canadian participants.

NCT ID: NCT02493868 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression

SUSTAIN-1
Start date: October 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.

NCT ID: NCT02493660 Completed - Clinical trials for Rotator Cuff Syndrome

A Pivotal Study to Assess the InSpaceā„¢ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

Start date: June 26, 2015
Phase: N/A
Study type: Interventional

A pivotal study to assess the safety and effectiveness of the InSpaceā„¢ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

NCT ID: NCT02493348 Completed - Fibromyalgia Clinical Trials

A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia

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

Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patient's quality of life. The present research aims to determine the effectiveness of Rhythmic Sensory Stimulation with rhythmic gamma-frequency (30 - 120 Hz) acoustic-driven stimulation of mechanoreceptors in the body on the treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at gamma range, 5 days per week, for 5 weeks. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression, will be compared before and after treatment between the treatment and control groups. The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of chronic pain disorders, such as fibromyalgia, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.

NCT ID: NCT02493244 Completed - Dry Eye Clinical Trials

Lipid Layer Thickness Pre and Post Lid Scrubs With Cliradex

HONDA
Start date: June 2015
Phase: N/A
Study type: Interventional

Tears play a vital role in vision. A thin layer of tears is always present to cover the surface of the eye for optimal comfort and vision. There are several layers to the tear film, and the outer most layer is comprised of lipids. This lipid layer prevents evaporation of the tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning eyelids with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients, and the purpose of this study is to evaluate the tear film lipid layer thickness before and after one months treatment with Cliradex Wipes.

NCT ID: NCT02493049 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis (RRMS)

Start date: August 2015
Phase: Phase 2
Study type: Interventional

The first major objective of this pilot trial is to demonstrate that it is possible to study myelin repair in relapsing-remitting multiple sclerosis (RRMS) patients with enhancing lesions on MRI by using advanced imaging techniques. To demonstrate that this is possible the investigators will recruit 24 RRMS patients who are being treated with standard disease modifying therapy (DMT) and have new lesions identified on clinically indicated brain MRI scans and measure myelin repair at 16 and 32 weeks using MRI measures of myelin repair. The second major objective is to determine how much repair occurs in participants treated with domperidone compared with those who are not treated. This will allow us to design larger trials to confirm that domperidone improves repair. The study will also confirm the safety and tolerability of domperidone in RRMS, determine circulating prolactin levels during dosing with domperidone 10mg three times daily in people with RRMS, and explore the impact of other clinical factors (such as age) on lesion repair. In addition, blood will be collected to test for metabolomics and the investigators will bank blood for future study of biomarkers that can help the investigators better understand MS. Metabolomics is an experimental test where changes in the pattern of the chemicals in blood cells are compared at different time points (during and after inflammation). There will be random changes but changes that are common in most study participants may help identify chemicals that signal stages in injury or repair. The investigators will also compare the pattern of change in those with the best repair to those with the worst repair. This may help identify a chemical that is associated with better or worse repair and help develop new treatment strategies. There are currently no blood tests that help in the diagnosis of MS, help determine which drug a person will respond to, or help determine a person's expected MS outcome. Any such tests would be considered biomarkers.

NCT ID: NCT02492711 Completed - Clinical trials for HER-2 Positive Breast Cancer

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

SOPHIA
Start date: August 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.