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NCT ID: NCT01427673 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Continuous Positive Airway Pressure Versus Noninvasive Ventilation in Patients With Overlap Syndrome

OS
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if Bipap should assume a standard-of-care role in the management of overlap syndrome.

NCT ID: NCT01405482 Not yet recruiting - Clinical trials for Thoracic Outlet Syndrome

Botulinum Toxin Injections for Thoracic Outlet Syndrome

Start date: August 2011
Phase: Phase 1
Study type: Interventional

Botulinum toxin type A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.

NCT ID: NCT01373034 Not yet recruiting - Clinical trials for Diarrhea Predominant Irritable Bowel Syndrome

The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome

Start date: July 2011
Phase: N/A
Study type: Interventional

The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.

NCT ID: NCT01357382 Not yet recruiting - Metabolic Syndrome Clinical Trials

The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome

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

Current obesity prevention emphasizes caloric restriction and avoidance of high fat foods. The result is an approach that replaces dietary fat with carbohydrates. There has, however, since been an obesity epidemic with an increased prevalence of metabolic syndrome (MetS) and type II diabetes. Negative results from trials of low fat diets for weight loss, prevention of heart disease and malignancies are consistent with the inadequacy of low fat/high carbohydrate approach. One of the findings of trials comparing low fat, calorie reduced diets to ad lib carbohydrate restricted diets is that subjects randomized to a low carbohydrate intake lose more weight despite equivalent intake. This equates to a 200 kcal/day greater weight loss on a carbohydrate restricted diet. Some investigators have speculated the metabolic advantage of carbohydrate restriction is due to increased energetic costs of gluconeogenesis. Alternatively, carbohydrate restriction is associated with increases in spontaneous physical activity. This protocol has three aims. First, adherence to a carbohydrate restricted diet in subjects with metabolic syndrome will cause an increase in spontaneous physical activity, independent of weight changes. Second, cardiometabolic risk factors (ApoB, TG, HDL, blood pressure, CRP) will show greater improvement on a carbohydrate restricted diet compared to a low-fat, high carbohydrate diet. Finally the investigators will interview a sub-sample of participants to better understand quality of life issues with respect to the dietary assignment or lifestyle intervention. The investigators will recruit 72 participants with MetS, from the Metabolic Syndrome Program at St. Paul's Hospital, Vancouver. Individuals will be randomized to either a low-carbohydrate diet or a calorie restricted, low fat diet and followed for 6 months. The investigators will measure body composition with bioelectrical impedance at baseline, 3 and 6 months. The investigators will also examine cardiometabolic changes due to the standard lifestyle intervention compared to the carbohydrate restricted treatment. The investigators will examine blood pressure, triglycerides, LDL-chol, HDL-chol, C-reactive protein, apolipoprotein B, glucose, insulin, hemoglobin A1c and leptin at baseline, 3 and 6 months. The investigators will use accelerometers to assess changes in physical activity. The investigators will use three-way repeated-measures ANOVA, with changes in body weight and insulin levels as covariates in the model with time as the repeated factor for statistical analyses.

NCT ID: NCT01356875 Not yet recruiting - Clinical trials for Myelodysplastic Syndrome

Treatment of Myelodysplastic Syndromes Comparing Hydralazine/Ac. Valproic and Supportive Care in Patients Not Candidates, Refractory and/or Intolerant to Intensive Chemotherapy

Start date: September 2011
Phase: Phase 2
Study type: Interventional

Transfusional dependence has been associated closely and independently with low survival in patients with myelodysplastic syndrome (MDS), especially in patients at low risk according to IPSS. Treatment of patients with hydralazine + valproic acid as an alternative to treatment with 5-azacytidine has lower cost and possibly as effective with fewer side effects. The objective of this phase II study is to determine the effectiveness of combination therapy with hydralazine + Ac. Valproic compared with best supportive care. The investigators will select 42 patients per group, and after 14 weeks of treatment the investigators will study in both groups the hematological response (transfusion-dependent, hemoglobin, cytogenetics and morphology) and treatment safety (adverse reactions and vital signs) to 1 year after starting treatment. The concentration of hemoglobin, the number of transfusions, platelets, neutrophils and other continuous variables in both groups will be compared by Student t or Mann-Whitney, as appropriate. For comparison of cytogenetic and morphological response and other categorical variables between groups Chi square will be used. And within each group the investigators will compare each of these variables before and after treatment by t-test for paired data or Wilcoxon test.

NCT ID: NCT01311323 Not yet recruiting - Clinical trials for Acute Coronary Syndrome

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

MILESTONE
Start date: January 2021
Phase: N/A
Study type: Interventional

MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS). Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction. In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.

NCT ID: NCT01301872 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Effect of Mechanical Ventilation Strategy on Lung Injury in Patients With Less Severe Acute Respiratory Distress Syndrome: Targeted on RAGE

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

During the past two decades, there current concept has evolved significantly that ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and subsequent injury to the lungs, but may also induce local as well as systemic inflammation responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine response compared with conventional ventilation with high tidal volume.3 Stuber et al found an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within 1 hour after switching the patients from a protective to non-protective ventilator strategy.4 The receptor for advanced glycation end-products (RAGE) was recently identified as a marker of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal volume strategy ventilation accelerated the decline in plasma RAGE levels. These results suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in acute lung injury and may associated with ventilator induced lung injury6. Although, current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower plateau pressures to avoid causing lung overdistension and ventilator associated lung injury (VILI)7; however, in the real world, some studies showed that strictly reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30 cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury to alveolar epithelial cells. Of these potentially promising markers, the receptor for advanced glycation end-product (RAGE) is of great interest. We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI patients with good compliance may be beneficial to this patient population. Therefore, we wish to propose a prospective single-center study to investigate the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.

NCT ID: NCT01297556 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome

Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.

IBS
Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination.

NCT ID: NCT01242163 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples

Start date: December 2010
Phase: N/A
Study type: Observational

Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD), especially with mild disease activity, is common clinical challenge. Most of the patients with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to avoid invasive investigations, there is a search for noninvasive markers with the capacity to distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering, Technion) developed a system that combines nano-metals produced in his laboratory with electrical devices (transistors). The combination between a nanomaterial and an electrical transistor induces a change in its electrical behavior upon exposure to the material being examined; that is, a change in its electrical properties. The change in its electrical behavior is translated into a computerized graphic signal. The electronic nose is composed of an air pump, a filter for filtering external contaminants and an array of sensors. Each sensor transmits a signal according to the materials it "knows" how to identify. Thus, it is possible to characterize most of the substance families characteristic of a certain disease, and the same system is designed for differential diagnosis of different diseases. The purpose of the investigators study is to use the "electronic nose" to find bio-markers that will help to diagnose IBD and IBS without using invasive procedures. The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire. The samples will analyzed in the laboratory of Dr. Haick.

NCT ID: NCT01196715 Not yet recruiting - Clinical trials for Myelodysplastic Syndrome

Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes

REGIME
Start date: November 2010
Phase: Phase 3
Study type: Interventional

REGIME is comparing two treatments, with Darbepoetin Alpha (DA) and Filgrastim (Granulocyte Colony Stimulating Factor, G-CSF), to the standard treatment for Myelodysplastic Syndrome (MDS). After giving Informed Consent patients will undergo a number of tests to confirm eligibility. Once eligibility is confirmed patients will be randomly assigned to one of the three treatments group: A: Darbepoetin Alpha (DA), B: Darbepoetin Alpha and Filgrastim (DA+G-CSF), C: Blood transfusion only. Patients will be required to attend the clinic once a month for 24 weeks. After 24 weeks if a patient has reacted favorably to the treatment they may continue on the treatment regime up to 52 weeks. After week 24 all patients will be required to attend the clinic twice more, at week 36 and 52. Patients will be followed for a further 5 years to record loss of response, transformation to Acute Myeloid Leukaemia and/or Refractory Anemia with Excess Blasts and death.