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NCT ID: NCT01630980 Completed - Obesity Clinical Trials

Meta-analyses of the Effect of Tree Nuts on Glycemic Control and Features of the Metabolic Syndrome

Start date: May 2012
Phase: N/A
Study type: Observational

Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable protein, and fibre, as well as minerals, vitamins, and phytonutrients. Although heart disease risk reduction claims for nuts have been permitted in the U.S. and general dietary guidelines and recommendations from heart associations recommend the consumption of nuts for heart protection, diabetes associations have not addressed nuts in their most recent recommendations. This omission is despite heart disease being a major cause of death in diabetes. There remains insufficient information on the usefulness of these foods in diabetes. To improve evidence-based guidance for tree nut recommendations, the investigators propose to conduct a systematic review of the effect of tree nuts on diabetes control and features of the metabolic syndrome. The systematic review process allows the combining of the results from many small studies in order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The investigators will be able to explore whether eating tree nuts has different effects between men and women, in different age groups and background disease states, and whether or not the effect of tree nuts depends on the dose and background diet. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing diabetes association recommendations and heart association recommendations where they relate to diabetes.

NCT ID: NCT01629459 Completed - Barth Syndrome Clinical Trials

Resistance Exercise in Barth Syndrome

Start date: June 2012
Phase: N/A
Study type: Interventional

Barth syndrome (BTHS) is a disorder that is characterized by heart failure, exercise intolerance and skeletal muscle weakness. Preliminary evidence demonstrates that endurance exercise training does not significantly improve exercise tolerance in BTHS. Because endurance exercise training targets a metabolic pathway that is adversely affected by BTHS, the investigators hypothesized that resistance training may improve exercise tolerance in BTHS because this type of training targets a different metabolic pathway than does endurance exercise. Therefore, the overall objective of the pilot/feasibility/proof-of-concept proposal is to collect preliminary data on the following hypothesis: Supervised resistance exercise training (3x/wk, 45min, 12 wks) will improve exercise tolerance, heart function, muscle strength and quality of life, and will be found safe in adolescents and young adults with BTHS.

NCT ID: NCT01629212 Recruiting - Clinical trials for Irritable Bowel Syndrome

Comparison of the Efficacy and Safety of Tiropramide and Octylonium in the Treatment of Irritable Bowel Syndrome

Start date: December 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study was to compare the Efficacy and Safety of Tiropramide HCl and Octylonium bromide in the Treatment of Irritable Bowel Syndrome.

NCT ID: NCT01629082 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

Start date: June 6, 2012
Phase: Phase 1
Study type: Interventional

Background: - Several types of blood cancer are associated with poor outcomes including high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for standard treatments. New types of treatment are needed for these cancers. - Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the body. The second can alter blood supply to abnormal cells or affect how the immune system attacks these cells. These drugs have been previously tested as treatments for MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and AML. Researchers want to see if these drugs are safe and effective for these types of cancer. Objectives: - To test the safety and effectiveness of clofarabine and lenalidomide for people with high-risk MDS, CMML, and AML. Eligibility: - Individuals at least 18 years of age who have high-risk MDS, CMML, and AML. - Participants must not be candidates for standard treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and bone marrow samples will be collected. - Participants will have 5 days of treatment with clofarabine. It will be given through a vein during an inpatient hospital stay. If there are no serious side effects after the infusion, participants will continue treatment as outpatients. - After 28 days, participants will have a bone marrow biopsy to check their response to treatment. - After the biopsy, participants will start lenalidomide treatment. Half of the participants will take the drug for 28 days (one treatment cycle). The other half will take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor treatment. - If there are no serious side effects and the disease does not become worse, participants may keep taking lenalidomide at lower doses for up to 12 more cycles.

NCT ID: NCT01626781 No longer available - Clinical trials for the Treatment Hand-foot Syndrome Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine

A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer

PROCAPP
Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®. Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS. Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected for the standard arm, because it is used commonly, is accepted by patients, and seems to have a positive influence on the severity of the HFS in the experience of many oncologists.

NCT ID: NCT01626534 Completed - Clinical trials for Acute Coronary Syndrome

Evaluation of Ticagrelor Anti Platelet and Pleiotropic Effects in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome

Start date: March 2012
Phase: Phase 3
Study type: Interventional

Ticagrelor is a new P2Y12 ADP receptor antagonist. This drug demonstrated a faster onset of action and a higher potency compared to clopidogrel standard regimen. Consistently these properties were associated in the PLATO trial, and particularly in the percutaneous coronary intervention (PCI) arm of the study, with a lower incidence of thrombotic complications at one year follow-up but at a price of increased major bleedings (7,8). The major finding of the trial was a significant reduction in one year mortality in patients treated with ticagrelor. This reduction in mortality may not be related to the anti-platelet effect of the drug since another potent anti-platelet agent which was recently commercialized a did not exhibit any improvement in death compared to clopidogrel. Therefore there may be non anti platelet directed properties, or pleiotropic effects, of ticagrelor that could be involved in a reduction in mortality in acute coronary syndrome (ACS) patients. In fact together with its anti platelet properties, ticagrelor, has been shown to inhibit the uptake of adenosine by red cells, leading to an increase in adenosine plasma level and then activating the low affinity adenosine receptor thus potentially affecting the vascular homeostasis including endothelial cells. Therefore, it is hypothesis that the side effects and its benefit on mortality may be related to its interaction with adenosine metabolism. In line with this hypothesis, some adverse effects of ticagrelor (bradycardia and modulation of bronchoconstriction) are compatible with the activation of low affinity A1 or A2A adenosine receptors. In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact the endothelial compartment during PCI (9). In fact the investigators have observed that the level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of endothelial damage during PCI. More potent anti platelet drugs such as ticagrelor may thus be associated with reduced peri-procedural endothelial lesion which could further improve the clinical prognosis of patients. The investigators have previously observed that endothelial marker of lesion and regeneration could be measured in the blood post PCI (10). Finally, in the response trial no patients in the ticagrelor arm had HTPR compared to 50% in the clopidogrel arm (7). This finding is surprising since recent data suggest that some patients still exhibit HTPR following the use of the very potent third generation thienopyridine prasugrel. This may be related to the fact that in the response trial only stable patients were included. The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary intervention.

NCT ID: NCT01626430 Completed - Metabolic Syndrome Clinical Trials

Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome

Start date: January 2012
Phase: N/A
Study type: Interventional

Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome. Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.

NCT ID: NCT01625663 Completed - Barth Syndrome Clinical Trials

Heart and Muscle Metabolism in Barth Syndrome

Start date: June 2012
Phase:
Study type: Observational

Barth syndrome (BTHS) is an X-linked disorder caused by abnormal cardiolipin metabolism and is characterized by skeletal and cardiomyopathy and high mortality rates. Through clinical metabolism and imaging studies and pluripotent stem cell induction and molecular techniques on skin biopsy samples, this project will produce novel translational information regarding the pathogenesis of BTHS, reveal potential targets for interventions and provide unique data regarding nutrient metabolism and abnormal cardiolipin and mitochondrial function. This project has the potential to provide information that could significantly improve morbidity and mortality in children and young adults with BTHS and may have relevance to other non-BTHS related conditions such as aging and adult heart failure.

NCT ID: NCT01625455 Terminated - Pruritus Clinical Trials

Effect of Neurokinin-1 Receptor (NK1R) Antagonism on Pruritus in Patients With Sezary Syndrome

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The purpose of this randomized, double-blinded, placebo-controlled study is to test the hypothesis that administration of aprepitant will decrease the severity of pruritus in patients with Sèzary Syndrome.

NCT ID: NCT01625442 Completed - Metabolic Syndrome Clinical Trials

Crocus Sativus (Saffron) and Berberis Vulgaris (Barberry Fruit) in Metabolic Syndrome

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The metabolic syndrome is associated with increased risk of cardiovascular disease and diabetes mellitus. The age-adjusted prevalence of the metabolic syndrome in the United States is 34% for men and 35% for women. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of Crocus sativus (Saffron) and Berberis Vulgaris (barberry fruit) in treatment of metabolic syndrome. Serum total cholesterol, serum LDL cholesterol, serum HDL cholesterol, serum triglyceride, Fasting Blood Sugar and hematocrit measured before and after 45 days of treatment.