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NCT ID: NCT02159794 Withdrawn - Clinical trials for Severe Aortic Stenosis

HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA

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

The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

NCT ID: NCT02158832 Withdrawn - Lymphedema Clinical Trials

Acupuncture for Lymphedema Secondary to Breast Cancer Treatment

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

This study is being conducted to determine if electro-acupuncture can reduce swelling of the arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research conducted on animals suggests that such treatment might be used to improve circulation leading to reductions in swelling. Previous research in humans with lymphedema suggests that treatment may be safe to use, although results regarding its efficacy in the reduction of swelling have not yet been established. This research will use sophisticated, non-invasive assessment methods to determine if a single session of electro-acupuncture treatment can be effective for reducing lymphedema. Results may be used to further develop our understanding of how electro-acupuncture can be used in the management of this condition. Electro-acupuncture may provide a promising complement or alternative to conventional lymphedema treatments such as compression bandaging, massage therapy or surgery.

NCT ID: NCT02152059 Withdrawn - Clinical trials for Small Cell Lung Cancer

A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy

Start date: July 2014
Phase: Phase 2
Study type: Interventional

This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be more effective and better tolerated than standard therapy. The purpose of this study is to: - Find out the proportion of patients with their small small cell lung cancer controlled for at least 90 days after treatment with BIBF1120 - Compare the response rate, survival and side effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients - Identify a group of patients who will benefit the most from BIBF1120 In this study, patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21 days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if patients do not tolerate it well or if the doctors are concerned about the side effects of BIBF1120 on individual patients.

NCT ID: NCT02144831 Withdrawn - Clinical trials for Transient Ischemic Attacks

The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack

MENA-TIA
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The primary goal of the research is to determine if 10 days of dual anti-platelet treatment is as effective as 30 days of similar treatment in the prevention of stroke, myocardial ischemia (MI) and death in patients with TIAs and minor stroke.

NCT ID: NCT02139852 Withdrawn - Metabolism Clinical Trials

Capsaicinoid Ingestion, Human Metabolism and Exercise

Phase 1
Start date: June 2014
Phase:
Study type: Observational

Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking. The investigators seek to understand the effect of 3 months capsaicinoid ingestion on alterations in body composition, traditional cardiovascular risk factors and cardiovascular function Hypotheses: 1) Continued use of capsaicinoids will alter resting metabolism substrate use, which will result in moderate (but clinically meaningful) alterations in body composition manifested as a decrease in adiposity. 2) Blood lipids will be unaffected by capsaicinoid use, as will brachial blood pressure. 3) Levels of systemic inflammation may increase slightly, and this could have an effect on vascular reactivity to hyperemic flow or baseline vascular tone. However, previous research suggests that these alterations will not be manifested in autonomic nervous tone assessed by changes in heart rate variability.

NCT ID: NCT02139709 Withdrawn - Clinical trials for Inflammatory Bowel Disease

Milk-derived Gangliosides for Inflammatory Bowel Disease

Start date: January 2007
Phase: Phase 1
Study type: Interventional

The overall objective of this study is to demonstrate how dietary ganglioside may protect the gut attenuate inflammatory signals in the intestinal mucosa. Gangliosides are dietary fats found in milk and are important constituents of intestinal cells. Our previous studies have shown that inflamed intestinal mucosal cells have reduced ganglioside content compared to normal mucosal cells. Gangliosides are glycolipids found on the surface of the intestinal mucosa and in lipid rafts in enterocytes and lymphocytes. Gangliosides influence microbial attachment, cell division, differentiation, signaling and mucosal integrity. Preclinical studies show that provision of ganglioside in cell culture and in animal diets increase ganglioside content in mucosal cells and down regulates signals caused by pro-inflammatory stimuli. In subjects with active Crohn's disease, consumption of ganglioside remarkably improved the Crohn's Disease Activity Index. In healthy control subjects, dietary ganglioside improved intestinal permeability and decreased production of pro-inflammatory prostaglandin E2. It is proposed that ganglioside degradation is elevated in the inflamed gut of IBD patients. Provision of ganglioside in the diet replaces ganglioside in the gut, consequently restoring proper structure and function to the diseased intestine and inducing disease remission. Insight into diet-based treatment would allow IBD patients to live healthy and happy lives. The main research objective is to characterize how ganglioside catabolism is associated with increased signaling from pro-inflammatory mediators and how reduction in ganglioside levels can be ameliorated by ganglioside supplementation during active inflammatory disease. This study will assess molecular mechanisms by which ganglioside alters gut permeability, inflammatory mediators and cell signaling.

NCT ID: NCT02138630 Withdrawn - Exercise Clinical Trials

Capsaicinoid Ingestion, Human Metabolism and Exercise (Phase 2)

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

Capsaicinoids (the active ingredient in hot peppers) have been shown to cause a moderate increase in energy expenditure (50 kcal/day) as well as reductions in appetite, energy intake, and (visceral) adiposity. As such, there is considerable interest in capsaicinoid for weight loss supplements. Owing to the fact that these changes are believed to be driven by catecholamine release and alterations in fat oxidation, there is growing belief that capsaicin may also offer potential ergogenic benefits (performance enhancement) during exercise, similar to the affect of caffeine, which works through similar pathways. Of particular interest are the recent findings that free-fatty acids in the blood are elevated 2-2.5hrs post ingestion, yet changes in typical cardiovascular or sympathetic nervous tone indicators (heart rate, blood pressure) were unaffected, suggesting some of the negative consequences of other stimulants may be avoided. At present, however, more in depth investigations of the effects on endothelial function, vascular autonomic tone and inflammation are lacking. Although there are some indications that capsaicinoid ingestion may alter factors associated exercise performance (such as increased fat oxidation for glucose sparing), to date these studies have primarily used very low exercise intensities wherein these effects are typically unnecessary, and results are not generalizable to the typical race intensities of endurance sport competition. Performance measures have also been a noticeably absent outcome from research to date. Hypotheses: 1), Exercise performance will improve, at a level similar to those demonstrated for caffeine ingestion 2) ratings of perceived exertion will go down with the effect of causing intensity to go up 3) During sustained aerobic activity approaching the aerobic threshold alterations in substrate use will be minimal (but possibly meaningful in regard to performance); alterations at rest will be more pronounced. 4) acute alterations (6o min post single dose) in blood pressure, HRV, arterial stiffness and RMR will mirror the effects observed for more prolonged exposure in phase 1.

NCT ID: NCT02137811 Withdrawn - Cancer Clinical Trials

Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)

Start date: April 2014
Phase: N/A
Study type: Observational

Recently an automated test for measuring cancer cell death in the presence of chemotherapy has been developed. This test has been called the MiCK assay during the ten year development phase and is now called Correct Chemo. CorrectChemo provides the medical community and patients a way to determine the effects of different chemotherapies on individual cancer cells. MiCK assay has been proven to have clinical usefulness in two studies. In one study using multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the physician used the results to prescribe the chemotherapy treatment, the patients' response rate, time to the disease getting worse, and overall survival were all significantly better compared to patients whose physicians did not use the results. In another study of breast cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used when planning chemotherapy, response rate and time to the disease started getting worse were all significantly better compared to patients whose physicians did not use the results of the MiCK assay The purpose of this study is to compare the outcomes of patients who have had the MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and how the physicians used the test. This study will be gathering this data by reviewing medical charts.

NCT ID: NCT02126020 Withdrawn - Clinical trials for Stevens-Johnson Syndrome

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several causes of corneal blindness. Some categories of patients, including those with auto-immune diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous membrane pemphigoid, have a higher risk of failure for the KPro. Because of chronic inflammation, the cornea supporting the KPro may melt, leading to a higher risk of infection, loss of the KPro and loss of the eye. Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to control inflammation in several diseases. It has been used in some cases of corneal melting with significant success. This study's hypothesis is that infliximab can be successfully used as an eye drop (instead of the usual administration through veins) and that its regular use may prevent melt in eyes with a Boston Keratoprosthesis type I and underlying auto-immune disease.

NCT ID: NCT02118116 Withdrawn - Clinical trials for Applied Suicide Intervention Skills Training

The Safety and Effectiveness of Gatekeeper Training in First Nations Communities

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

Gatekeeper training is where people in the community are trained to recognize and identify those who are at risk for suicide and assist them in getting care. Gatekeeper training has been widely implemented around the world. There are two types of gatekeepers: 1) Designated gatekeepers - individuals who have been trained in helping professions (medicine, psychology, social work, nursing), and 2) Emergent gatekeepers - individuals who are not in caregiving roles (family members, police, teachers, clergy). Applied Suicide Intervention Skills Training (ASIST) has been implemented in Manitoba. However, a recent randomized controlled trial in First Nations community members (emergent gatekeepers) from the Swampy Cree Tribal Council (Northwestern Manitoba) demonstrated that the training had no positive impact on self-reported gatekeeper skills or behavior. Also, compared to a resilience retreat, the ASIST training was associated with a slightly higher likelihood of reporting suicidal ideation. The demonstrated lack of efficacy and the possibility of adverse effects associated with this training program in this vulnerable group have raised concerns about the safety and efficacy of ASIST. There were several key limitations of the previous study. First, the study only recruited community members (emergent gatekeepers), therefore findings may not be generalizable to designated gatekeepers (clinicians, nurses, counselors). Second, the study had a small sample size (n=55) and may have not been large enough to detect small effects that are often associated with educational interventions. Finally, the increase in distress in the ASIST trained group may not have been directly related to the training. To overcome the above limitations, we aim to conduct a larger evaluation of the safety and effectiveness of gatekeeper training that is occurring in Manitoba First Nations, Inuit and Metis communities. Based on previous work that suggests designated gatekeepers are more likely to benefit from gatekeeper training than emergent gatekeepers, we will examine these groups separately. Hypotheses: 1) ASIST will be associated with an increase in gatekeeper skills and behaviors; 2) ASIST will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3) ASIST will not be associated with an increase in suicidal ideation or distress.