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NCT ID: NCT01163019 Completed - Clinical trials for Coronary Artery Disease

2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room

2DSPER
Start date: September 2010
Phase: N/A
Study type: Observational

Background: Chest pain (CP) and suspected heart attack is the second most frequent complaint among patients presenting to the emergency department (ED). Present workup involves in-hospital observation for 6 - 48 hours and requires significant resources including imaging tests, some of which are invasive and involve radiation and radio-contrast agents, which can be toxic to the kidney. CP can result from impaired blood supply to the heart muscle, which may result in impaired contraction of the heart that persists for several days. Bedside echocardiography with semi-automated speckle tracking strain analysis (2D strain) is a novel promising noninvasive tool for the evaluation of heart muscle contraction. 2D strain can be useful for evaluating patients with CP, since it can accurately detect minor impairment in heart muscle contraction that can identify patients with coronary artery disease (CAD) and impending heart attack (coronary arteries are the arteries supplying blood to the heart muscle). Working hypothesis and aims: The investigators hypothesize that a bedside echo study with normal 2D strain may allow quick and safe ruling out of a heart attack and significant CAD disease as the cause of CP. The main aim of the study is to validate the investigators preliminary findings in a large number of patients in order to establish whether a normal 2D strain can safely rule out a heart attack or life threatening CAD. Methods: In a large multi-center study 1200 patients presenting to the ED with acute CP of an unclear cause will undergo echocardiography as close as possible to presentation and not more than 24 hours from cessation of pain. Patients will undergo standard workup by the ED physicians. Standard echocardiographic findings, but not the 2D strain analysis, will be made available to the attending physician. Data from discharge letters, ECGs, blood tests, stress tests, nuclear imaging, heart CT and heart catheterization will be collected. A 6-month follow-up telephone interview will be performed to collect data on survival, heart attacks, re-hospitalization and revascularization (opening heart vessels blockages). 2D strain analysis will be performed off-line in a central laboratory to evaluate the ability of 2D strain to distinguish between patients with CP from heart disease and patients without life threatening heart disease that can be early released home safely. Expected results: The investigators expect, based on the investigators previous experience, that patients with normal 2D strain will have a very low probability of a heart attack and significant CAD. The investigators further expect these patients to have an excellent 6-month prognosis. This will allow their early and cost-effective discharge. Importance and Probable implications to Medicine: Reduction in ED patient load and a decrease in unnecessary hospitalizations for CP. Cost and resource savings and elimination of unnecessary imaging studies, some of which are invasive or involve radiation and contrast agents.

NCT ID: NCT01162928 Completed - Critical Illness Clinical Trials

Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.

NCT ID: NCT01162148 Not yet recruiting - Clinical trials for Lung Transplantation

Pulmonary Rehabilitation and Inspiratory Muscle Training (IMT) for Patients Following Lung Transplantation

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

Lung transplantation (LT) is now an established treatment option for patients with a wide variety of end-stage lung diseases- aims to improve quality of life and survival. Pulmonary rehabilitation (PR) is widely recognized as an important component of care of patients with chronic obstructive pulmonary disease (COPD), it improves dyspnea, exercise tolerance, quality of life, and reduces healthcare resource utilization. The goal of pulmonary rehabilitation following lung transplantation is to enhance the physiological and functional benefits resulting from surgery. Inspiratory muscle Training (IMT) is defined as any intervention with the goal of training the inspiratory muscles. IMT can improve inspiratory muscles strength, endurance and exercise capacity in adults with COPD. IMT provides additional benefits to patients undergoing PR program and is worthwhile even in patients who have already undergone a general exercise reconditioning (GER) program. IMT will provide additional benefits (together or without) PR to patients following lung transplantation. No formal guidelines exist regarding the optimal methods of exercise training component of pulmonary rehabilitation for patients recovering from lung transplantation. This study will evaluate the unique influence of IMT in Patients Following Lung Transplantation.

NCT ID: NCT01162044 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)

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

PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.

NCT ID: NCT01161017 Completed - Migraine Clinical Trials

Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Start date: July 2008
Phase: N/A
Study type: Interventional

Mechanism-based choice of therapy for pain: Can successful prevention of migraine be coupled to a psychophysical pain modulation profile?

NCT ID: NCT01160211 Completed - Neoplasms, Breast Clinical Trials

A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

Start date: May 5, 2011
Phase: Phase 3
Study type: Interventional

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

NCT ID: NCT01159613 Completed - Clinical trials for Chronic Hepatitis C Viral Infection

Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?

Start date: April 2008
Phase: N/A
Study type: Observational

The working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.

NCT ID: NCT01159457 Recruiting - Celiac Disease Clinical Trials

Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients

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

Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.

NCT ID: NCT01158352 Completed - Growth Clinical Trials

Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children

Formula
Start date: November 2010
Phase: N/A
Study type: Interventional

Study design: Double blind, randomized, placebo controlled study.The proposed study will consist of two main segments: 1. Segment 1 is aimed to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean prepubertal children on weight SDS, height SDS, BMI SDS and growth velocity 2. Segment 2 is aimed to explore the eating behavior of idiopathic short stature and lean prepubertal children against their sibling who have a normal height and body weight and to find out whether there is a difference in eating patterns and quality of life between idiopathic short stature and lean prepubertal children and children with normal height and body weight Segment 1 Population: 200 subjects and controls will be recruited to segment 1 of the proposed study, 100 at each group. Participants will be recruited from healthy children who will be referred to either the institute for endocrinology or the gastroenterology unit, at Schneider Children's Medical Center for growth assessment, due to low height and weight, in whom, no gastrointestinal morbidity or other underlying cause was found. Methods: Randomization & Blinding: Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the first 6 months of the study. Treatment: Participants in the intervention group will be treated with a nutritional supplementation standardized formula.Participants in the control group will be instructed to consume the same volume of formula as was calculated if they were in the intervention group. Treatment duration: The study will be divided into two treatment periods: 6 months of intervention versus active placebo followed with additional 6 months (an extension period), in which participants at the intervention group will be offered to extend the intervention period and participants at the control arm will be offered to switch to the intervention group. Study Schedule: Follow up visits will take place at 0, 3, 6, 9 and 12 months and will include: 1. Demographic data, medical history and growth data (month 0): Demographic parameters, including birth date, gender, birth weight and length for gestational age, medical history and growth data, including height velocity, parent's and sibling's weight and height will be documented from patient's file. 2. Nutritional assessment 3. Anthropometric assessment (months 0, 3, 6, 9 12): 1. Height without shoes 2. Length 3. Weight with light cloths and without shoes 4. MAC 5. Body mass index (BMI) will be calculated from children's weight and height and age and gender specific BMI SDS will be calculated 6. Body composition assessment using the method of bioelectrical impedance 4. Laboratory parameters (months 0, 6 and 12): 5. Sleeping Questionaire Segment 2: 86 subjects and controls will be recruited to segment 2 of the proposed study Population: Short and lean prepubertal children participating at segment 1 of the study and who are at study entry under 10th percentile in height, when the weight percentile is equal or smaller to the height percentile. Only participants from segment 1 who have siblings with normal height and body weight for age and gender, will be able to participate in segment 2 of the study Control group 1: Sibling of participants in segment 1 of the study, who have a normal height- above 25th percentile and normal BMI for age and gender- above 5th percentile and under 85th percentile. Control group 2: Healthy children from the community who have a normal height above 25th percentile and normal BMI for age and gender above 5th percentile and under 85th percentile Segment 2 of the study will be designed as a case- control study and will focus on the eating patterns, sleeping patterns and quality of life of participants at segment 1 at time 0 month of the study, before the beginning of the nutrition intervention. These findings will be compared to data of a control group, which will be comprised of siblings of participants in segment 1, with normal height and body weight which are matched in age.

NCT ID: NCT01158066 Not yet recruiting - Clinical trials for Coronary Artery Calcification

Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification

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

Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial