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NCT ID: NCT01480830 Completed - Colonoscopy Clinical Trials

The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

SCOPE GUIDE
Start date: January 2012
Phase: N/A
Study type: Interventional

Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient. This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen. We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.

NCT ID: NCT01480596 Completed - Myasthaenia Gravis Clinical Trials

The Evaluation of Belimumab in Myasthenia Gravis (MG)

Start date: April 2013
Phase: Phase 2
Study type: Interventional

Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with MG. The study will enroll male and female outpatients (> or equal to 18 years of age) with a diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle specific kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3) continue to exhibit signs of MG. The study will include 3 phases: a 4 week screening period, a 24 week treatment period, and a 12 week follow-up period. IP will be administered intravenously on Days 0, 14, 28 and then every 28 days through and including Week 20. At Week 24, primary outcomes will be obtained. Follow up evaluations will be conducted at Weeks 28, 32 and 36 for all subjects. The primary objective of this study is to assess the efficacy of belimumab as evaluated by the change in the quantitative myasthenia gravis (QMG) score.

NCT ID: NCT01480479 Completed - Glioblastoma Clinical Trials

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

ACT IV
Start date: November 2011
Phase: Phase 3
Study type: Interventional

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

NCT ID: NCT01480401 Completed - Heart Failure Clinical Trials

Study of Dietary Intervention Under 100 MMOL in Heart Failure

SODIUM-HF
Start date: March 2012
Phase: N/A
Study type: Interventional

This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.

NCT ID: NCT01480349 Completed - Clinical trials for Post-Hemorrhagic Hydrocephalus

Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

SOPHH
Start date: January 10, 2011
Phase: N/A
Study type: Observational

This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

NCT ID: NCT01480310 Completed - Healthy Volunteer Clinical Trials

Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers

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

This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study site in Canada.

NCT ID: NCT01480063 Completed - Multiple Sclerosis Clinical Trials

An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

LIBERATE
Start date: April 16, 2012
Phase:
Study type: Observational

The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

NCT ID: NCT01479868 Completed - Clinical trials for Hepatitis C Virus Genotype-1

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

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

The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

NCT ID: NCT01479283 Completed - Infection Clinical Trials

Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

PARITY
Start date: January 2013
Phase: Phase 3
Study type: Interventional

The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever international multi-center randomized controlled trial in bone cancer surgery. In order to avoid amputation for bone cancer in the leg, complex limb-saving operations are performed. However, infections with devastating complications following surgery are common. Surgeons from across the world will randomize patients to receive either short- or long-duration antibiotic regimens after surgery with the goal of identifying the best regimen to reduce these infections.

NCT ID: NCT01479244 Completed - Clinical trials for Breast Cancer With Low to Intermediate HER2 Expression

Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence

PRESENT
Start date: November 2011
Phase: Phase 3
Study type: Interventional

Purpose of this trial: 1. To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF). 2. To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.