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NCT ID: NCT01352754 Active, not recruiting - Hip Fracture Clinical Trials

Troponin T Elevation in Patient Undergoing Hip Fracture Surgery

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

Background: Patients undergoing hip fracture surgery are elderly and usually have co-morbidities; hence they are at risk for perioperative MI. Troponin is the gold standard for diagnosis of myocardial damage and currently the cornerstone of MI diagnosis. Perioperative troponin elevation is a poor prognosis factor. The significance of minor troponin elevation, detected by highly sensitivity troponin T assay, is unknown. Objectives: To determine the frequency of perioperative troponin T elevation using highly sensitivity troponin T assay, and to determine the clinical significance of this elevation. Methods: Serum Troponin T levels of patients undergoing hip fracture surgery will be tested prior to surgery 48 hrs and 72 hrs after surgery, using highly sensitivity troponin T assay. Patients will be followed for 1 year. Primary outcomes- The number of patients with elevated troponin levels perioperatively and cardiac mortality at 3 months, 6 months and 1 year.

NCT ID: NCT01349322 Active, not recruiting - Breast Cancer Clinical Trials

Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

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

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.

NCT ID: NCT01335100 Active, not recruiting - Cerebral Palsy Clinical Trials

Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study

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

Background: Motor impairment limits social and recreational activities in children with cerebral palsy (CP), compromising participation and impacting on quality of life. Improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. While Botulinum toxin (BTX) injections are effective and safe treatment for spasticity in children with CP, there is insufficient evidence for improvement of motor function and enhanced participation in this population. Objective: To examine outdoor activity as a functional outcome following lower limb BTX in children with CP. Methods: In this pilot study the investigators will use Global Positioning Systems (GPS) to measure walking speed, distances, number of walking events and destinations in ambulatory children with CP following BTX injection to the lower limbs; age and gender matched sibling will be studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires. Significance: Improvement in outdoor activity following BTX injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with CP.

NCT ID: NCT01303770 Active, not recruiting - Multiple Sclerosis Clinical Trials

Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

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

Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age. Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation. The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.

NCT ID: NCT01298323 Active, not recruiting - Clinical trials for Medullary Thyroid Cancer

Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

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Start date: February 25, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib

NCT ID: NCT01282892 Active, not recruiting - Atherosclerosis Clinical Trials

Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis

Start date: February 2009
Phase: N/A
Study type: Observational

Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a condition carrying a high risk of coronary artery disease. The independent role of Visceral Fat in cardiovascular risk remains unclear. Patients with excess of visceral fat and NAFLD patients will have higher prevalence of coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting that the presence of visceral fat and/or fatty liver will be considered an important condition to optimize the cardiovascular risk stratification

NCT ID: NCT01281059 Active, not recruiting - NAFLD Clinical Trials

Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test

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

The Exalenz clinical investigation is a multicenter, non-randomized, blinded, study of the ¹³C-Octanaote breath test (OBT). The OBT is a non-invasive test for evaluation of disease severity in patients with suspected non alcoholic fatty liver disease (NAFLD) The purpose of the study is to demonstrate that the ¹³C-Octanaote Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting non alcoholic steatohepatitis(NASH) with a high probability. Retrospective analysis based on multivariable analysis will determined if and which demographic, clinical and biochemical or imaging techniques data can assist in addition to the data derived from OBT in differentiation of NASH, NAFL and possibly normals.

NCT ID: NCT01221883 Active, not recruiting - Clinical trials for Posttraumatic Stress Disorder

Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam

Start date: May 2013
Phase: Phase 4
Study type: Interventional

PTSD is a pervasive and frequent disorder. Early psychological treatment - but not pharmacology - effectively prevent PTSD. Current pharmacological studies did not include treatment given immediately after trauma exposure. However, a recent study of opiates suggests that their early administration may reduce the likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) - within an adequate window of time. Benzodiazepines are often used to reduce anxiety and agitation during stressful situations - including traumatic event. These compounds may increase the likelihood of developing PTSD when administered few days after the traumatic event - but their effect as an immediate intervention has not been studied - despite their frequent and uninformed use at this stage. This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory following traumatic event in a randomized controlled design. Following the studies of opiates it is hoped that diazepam, administered within hours of the traumatic event, and before the first night sleep (a memory consolidating condition) will reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and thus the investigators posit a bidirectional hypothesis. The importance of this work is that it will provide the necessary evidence to sanction a frequently practiced use of benzodiazepines.

NCT ID: NCT01205074 Active, not recruiting - Healthy Subjects Clinical Trials

¹³C-Methacetin Breath Test (MBT) Methodology Study

Start date: September 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Several factors will be tested to see if they have an influence on the methacetin breath test results. Each one of the factors has been raised as a possible source of distortion of the MBT result. I. Variability between same tests on same subject MBT. Repeatability will be tested in both healthy individuals and patients with chronic liver disease. II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and can potentially have an effect on the MBT since the breath test is based on CO2 production and these subjects may have abnormal CO2 production. III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore, internal preliminary data has shown signs that there is an influence of smoking on the MBT ranges. IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that age is a significant factor in determining the probability of disease severity and preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the effect of age has to be elucidated in an orderly fashion. V. CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the MBT. VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results. VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic blood flow and thereby the outcome of the methacetin breath test.

NCT ID: NCT01178463 Active, not recruiting - Male Infertility Clinical Trials

Spermatogonial Stem Cells in Azoospermic Patients: a Comparison Between Obstructive and Non-obstructive Azoospermia

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

The researchers hypothesized that nonobstructive azoospermia might be associated with a reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia. Testicular sperm specimens that had been previously extracted from azoospermic patients will be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies. Those found to be SSCs will be counted using light microscopy, and compared between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).