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NCT ID: NCT01290679 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

QUEST-2
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

NCT ID: NCT01290653 Completed - Neck Pain Clinical Trials

Dry Needling Versus Strain-counterstrain on the Upper Trapezius

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

This study investigates the effect of two different techniques (dry needling and Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP). Subjects with active or latent MTP in this location of the muscle will be identified and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain or placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck disability and electromyography (EMG) activity of the upper trapezius will be registered before and after six sessions of treatment.

NCT ID: NCT01290497 Completed - Clinical trials for Osteoarthritis of the Knee

Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)

Start date: November 2010
Phase: Phase 4
Study type: Interventional

The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.

NCT ID: NCT01290250 Completed - Obesity Clinical Trials

Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans

BIONAOS
Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of a new orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones) on features of metabolic syndrome and cardiovascular disease risk factors related to inflammation and antioxidant defense system in overweight and obese adult humans. This study hypothesizes that consumption of an orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure and the Homeostatic Model Assessment (HOMA) index.

NCT ID: NCT01289951 Completed - Hepatitis C Clinical Trials

Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis

LIVERAL
Start date: December 2010
Phase: Phase 1
Study type: Interventional

Raltegravir is the first integrase inhibitor used in humans. It has been shown to be highly efficacious and well tolerated in phase III clinical trials in multidrug experienced human immunodeficiency virus(HIV)-infected patients, as well as initial therapy in untreated patients. Pharmacokinetic studies in healthy adult subjects indicate that the major mechanism of clearance of the drug is glucuronidation mediated by UGT1A1, with a minor contribution of renal excretion of unchanged parent compound. Unlike CYP-based metabolism, glucuronidation is generally found to be relatively unaffected by hepatic disease. A single dose pharmacokinetic study of raltegravir in patients with mild to moderate hepatic insufficiency (Steigbigel et al. 2008) found no clinically important effect on the drug pharmacokinetic profile, with no dosage adjustment being necessary. The liver safety and tolerability of boosted atazanavir (ATV/r) has been evaluated in human immunodeficiency virus and hepatitis C virus (HIV/HCV) coinfected patients with advanced liver disease (decompensated cirrhosis) (Hermida JM et al. 4th IAS: Sidney, 2007). Similar to Raltegravir, ATV is also mainly metabolized by conjugation through UGT1A1. There is an urgent need for potent and efficacious ARV drugs with a clean safety liver profile even in patients with severe liver disease. The investigators hypothesized that pharmacokinetics will not be altered in HIV/HCV patients with advanced (Child-Pugh grade C) cirrhosis or in those with no histologic liver damage.

NCT ID: NCT01289821 Completed - Clinical trials for Colorectal Neoplasms

First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

Start date: February 2011
Phase: Phase 2
Study type: Interventional

This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.

NCT ID: NCT01289782 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

QUEST-1
Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

NCT ID: NCT01289041 Completed - Clinical trials for Advanced Endometrial Cancer

BKM120 as Second-line Therapy for Advanced Endometrial Cancer

Start date: February 2011
Phase: Phase 2
Study type: Interventional

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

NCT ID: NCT01289002 Completed - Clinical trials for Coronary Artery Disease

e-BioMatrix PostMarket Registry

eBMX-PMR
Start date: April 2008
Phase:
Study type: Observational

The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

NCT ID: NCT01288573 Completed - Neuroblastoma Clinical Trials

A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone

Start date: March 3, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages: - Stage 1 is a dose-escalation study. - Stage 2 is an open-label, randomized, comparative study using the appropriate dosing regimen identified in the Stage 1 dose-escalation study. All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative). Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.