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NCT ID: NCT00712413 Withdrawn - Clinical trials for Helicobacter Pylori Infection

Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori

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

The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.

NCT ID: NCT00687583 Withdrawn - Clinical trials for Intubation, Intratracheal

Head Movement Effect on Different Tracheal Tubes

Start date: April 2007
Phase: Phase 4
Study type: Observational

A breathing tube, which is used to secure the airway and allow ventilation of the lungs during general anaesthesia, is inserted into the windpipe either through the nose or mouth. In children, different formulas exist to determine the appropriate size of the tube according to age, and how far it should be advanced into the airway. Head movement can alter the position of the breathing tube, making it go in or come out too far. Different types of breathing tubes may also differ in their change of position with head movement. The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tubes.

NCT ID: NCT00686530 Withdrawn - Brain Malformation Clinical Trials

Comparison of Abnormal Cortical Development in Brain Malformations on Postmortem Imaging With Autopsy

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

Examination of the fetal brain at autopsy is technically challenging because of marked fragility of the brain tissue. Studies have found postmortem fetal MR to be particularly useful in examining gross structural abnormalities in fetal brain and spine. We have recently included postmortem MR as part of the radiological studies for fetal autopsy workup. Using the same MR data, the development of normal layering of the brain, also called laminar organization, can also be assessed. This laminar organization of the brain is often disturbed in congenital malformations. Our aim is to study the disturbance in laminar organization of the postmortem brain with MR, using structural MR and a type of MR sequence called diffusion tensor imaging, which is well suited for assessing the organization of the developing brain. The postmortem MR findings will be compared with gold standard of histopathology. This will help us understand the abnormal development of gray and white matter in brain malformations. Knowledge gained from studying the abnormal laminar organization in brain malformations will serve as a reference for future studies of fetal brain malformations in-utero using MRI.

NCT ID: NCT00686478 Withdrawn - Burn Clinical Trials

Intron A for the Treatment of Hypertrophic Scar

Start date: n/a
Phase: Phase 3
Study type: Interventional

This study assesses the intervention with antifibrotic agents, specifically interferon (IFN) to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic scar are randomly assigned to either an intervention IFN group or a placebo control group by subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter, standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability, itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six month treatment period.

NCT ID: NCT00679744 Withdrawn - Clinical trials for Sandhoff Disease Ganglioside

A Phase I Study of Pyrimethamine in Patients With GM2 Gangliosidosis

Start date: May 2008
Phase: Phase 1
Study type: Interventional

Adult Tay-Sachs disease and Sandhoff diseases are caused by deficiency of an enzyme called β-hexosaminidase A, or Hex A in short. This enzyme is located in a particular cellular component, called lysosomes, inside the brain cells. The reason that Hex A of patients with Adult Tay-Sachs disease or Sandhoff disease is deficient is because this enzyme had gone through mutation, resulting in it not working very well. In healthy people, Hex A efficiently breaks down GM2-ganglioside, which is a by-product from cells of our body. However, patients with Adult Tay-Sachs disease or Sandhoff disease cannot efficiently break down GM2-ganglioside in the body. Therefore, these patients have high levels of this by-product in the brain cells, which causes the brain to be unable to function normally. There is a drug called Pyrimethamine. This drug is used by doctors to treat specific types of infections called malaria and toxoplasmosis. Our laboratory test tube studies have shown that Pyrimethamine can help the Hex A enzyme to function in a normal manner. If Hex A can function normally in presence of Pyrimethamine, this drug should be able restore the brain malfunction of these patients since Hex A can now efficiently break down GM2-ganglioside with Pyrimethamine treatment. Although results from laboratory test tube studies are promising and Pyrimethamine should theoretically restore brain function of these patients, we do not know if Pyrimethamine is safe or if it would actually work in patients. This study is the first study (a Phase I study) of testing Pyrimethamine to treat Adult Tay-Sachs and Sandhoff diseases. The objective of this study is to see if Pyrimethamine is safe in these patients and to see if it can restore the brain function of these patients.

NCT ID: NCT00671281 Withdrawn - Chronic Sinusitis Clinical Trials

The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery

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

Sinus surgery is a common, day surgery procedure performed by general and subspecialty trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of complications. When there is significant bleeding or enough bleeding to obscure important anatomical landmarks, there is a higher chance of complications. These complications can include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients taking oral tranexamic acid three days before surgery and six days after, there will be less intraoperative bleeding, better surgical visualization and less postoperative bleeding events.

NCT ID: NCT00665964 Withdrawn - Osteoarthritis Clinical Trials

Comparing X-3 To N2vac Polyethylene With the Triathlon Total Knee System

Start date: May 2008
Phase: Phase 4
Study type: Interventional

Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system. Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration Multi-centre study Objectives Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used. Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups. Number of Subjects 384 cases (197 each group)

NCT ID: NCT00664690 Withdrawn - Pain Clinical Trials

Effect of Celecoxib on Transitional Pain After Outpatient Surgery

Start date: n/a
Phase: Phase 4
Study type: Interventional

Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain

NCT ID: NCT00664651 Withdrawn - Joint Contracture Clinical Trials

Joint Stiffness Following Knee Replacement Surgery

Start date: December 2006
Phase: N/A
Study type: Observational

Our primary research question is to find out whether there is a genetic component to the development of joint contractures following knee surgery, through the application of lab techniques.

NCT ID: NCT00627835 Withdrawn - Clinical trials for Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses) and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib, cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck (SCCHN)patient population.