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NCT ID: NCT00703118 Completed - Clinical trials for Hepatitis C, Chronic

A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

NCT ID: NCT00702286 Not yet recruiting - Clinical trials for Urinary Tract Infection

Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters

NV-US-04-001
Start date: August 2008
Phase: N/A
Study type: Observational

Catheter associated urinary tract infection is one of the most common types of catheter acquired infections and adds greatly to patient morbidity, mortality and medical cost. Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains in place, the greater the tendency of these organisms to develop biofilms and result in urinary tract infections, which are difficult to treathe UroShield System is intended to prevent bacterial biofilm formation by means of the Active NanoShield technology it has developed. A number of scientific concepts and principles shown in prior studies have shown some promising results in the treatment of biofilm based sequele using ultrasound energy. The NanoShield technological basis of the UroShield System has taken these concepts to a level where acoustical waves in the ultrasound range can be created by low cost disposable actuators which actually create a physical coating on all of the surfaces of the catheter thereby interfering with the attachment of bacteria which is the initial step in biofilm formation.

NCT ID: NCT00702169 Completed - Clinical trials for Mechanical Ventilation

Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation

Start date: December 2007
Phase:
Study type: Observational

Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages. Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen. Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.

NCT ID: NCT00702065 Completed - Multiple Sclerosis Clinical Trials

A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

MusiQoL
Start date: November 2007
Phase: N/A
Study type: Observational

This is a multi-center, multi-regional observational,24 month study. Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

NCT ID: NCT00701701 Terminated - Pompe Disease Clinical Trials

Immune Tolerance Induction Study

Start date: December 14, 2008
Phase: Phase 4
Study type: Interventional

An exploratory, open-labeled study of participants with Pompe disease, who had previously received Myozyme® (alglucosidase alfa) treatment, to evaluate the efficacy, safety and clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme®. Eligible participants who were then receiving Myozyme® therapy were enrolled into the study, and were followed for a minimum of 18 months on-study (a 6-month ITI treatment module and a 12-month follow-up module on Myozyme® alone). Eligible participants were followed for a minimum of 18 months on treatment or, if a participant was <6 months of age at the time of enrollment, until the participant was 2 years of age. Both cross-reacting immunologic material (CRIM)-negative and CRIM-positive participants were eligible for Regimen A depending if they met the required criteria. Regimen B, however, was limited to CRIM-negative participants.

NCT ID: NCT00701610 Recruiting - Clinical trials for Von Willebramd Factor

Levels of Von Willebrand Factor Multimers and VWF-Cleaving Protease (ADAMTS-13) in Preterm and Neonate

Start date: August 2007
Phase: N/A
Study type: Observational

Von Willebramd Factor (VWF) is an adhesive glycoprotein synthesized by megakaryocytes and endothelial cells.VWF has a central role in primary hemostasis and is a critical ligand for platelets adhesion and aggregation (1, 2).VWF is the carrier of circulating factor 8 as well. VWF is stored in Wiebel-Palade bodies in endothelial cells and in platelets alfa granules in a form of Ultra-large (UL) multimers. The VWF multimers are composed from subunits which are linked by disulfide bonds that alternate between 2 C- terminal ends and 2 N- terminal ends in a head-to-head and tail-to-tail fashion (3, 4). The biological activity of VWF has been shown to be related to the size of the multimers. VWF is released from endothelial cells toward the plasma as a multimers ranging from 500-20,000 kD. The UL multimers are hemostaticallly more effective than the smaller forms. They spontaneously bind to platelets which lead to the formation of microthrombi in the circulation. This mechanism is downregulated by the plasma protease ADAMTS-13(A Disintegrin And Metalloprotease with ThromboSpondin motif).If the proteolysis become defective the ULVWF will bind to platlets resulting in systemic thrombotic microangiophaties (TMA) such as thrombotic thrombocytopenic purpura(TTP)(5,6). ADAMTS-13 belongs to the ADAMTS family of metalloproteases.The structure of ADAMTS-13 is conserved throughout vertebrates, indicating its important function (7).The metalloprotease function was first describe 11 years ago and has been cloned and characterized (8-13).The ADAMTS family of metaloploproteases is required in other systems such as genitourinary system (ADAMTS1), collagen system (ADAMTS2) and as a cleaving protease of VWF (VWFCP) - ADAMTS13. When VWF multimer is subjected to sufficient fluid shear stress ADAMTS-13 cleaves VWF at a unique 842Tyr- 843Met bond in domain A2 (14,15).This cleavage produce VWF subunit fragments of 176 kDa and 140 kDa. The activity of ADAMTS-13 depends on both Zn+2 and Ca+2 ions (16). Low levels or deficiency of ADAMTS-13 is seen in patient with TTP(17,18). Mannuccio et al (19) showed that low levels of ADAMTS-13 are seen in other conditions such as healthy adults older than 65 years, patients with cirrhosis, uremia, acute inflammation, postoperative period. In neonate and preterm infants the data is limited. Few studies have shown that levels of ADAMTS-13 are low in neonate (19-21).Tsai et al (22) observed that ADAMTS-13 activity is normal in cord blood compared to adults. In preterm infants a pilot study showed that preterm have low levels of ADAMTS-13(23). The aim of our study is to check ADAMTS-13, VWF multimers, VWF antigen and VWF collagen binding activity in healthy and sick neonate and in preterm infants.

NCT ID: NCT00701467 Completed - Clinical trials for Ventricular Tachyarrhythmia

Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients

HRV
Start date: March 2008
Phase: N/A
Study type: Observational

To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.

NCT ID: NCT00701181 Terminated - Clinical trials for Diabetic Retinopathy

Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema

DEGAS
Start date: June 2008
Phase: Phase 2
Study type: Interventional

To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema

NCT ID: NCT00700323 Not yet recruiting - ADHD Clinical Trials

PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children

ADHD-3
Start date: July 2008
Phase: Phase 2
Study type: Interventional

To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.

NCT ID: NCT00699998 Completed - Clinical trials for Acute Coronary Syndrome

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

TRILOGY ACS
Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).