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NCT ID: NCT01485991 Completed - Hepatitis C Clinical Trials

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

ATTAIN
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

NCT ID: NCT01485315 Completed - Septic Shock Clinical Trials

Transfusion-requirements in Septic Shock Trial

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

Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. The evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in these very sick patients

NCT ID: NCT01484977 Completed - Epilepsy Clinical Trials

eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

VERVE
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

NCT ID: NCT01484743 Completed - Parastomal Hernia Clinical Trials

Risk Factors for Morbidity After Parastomal Hernia Repair

PAHEREP
Start date: January 2007
Phase:
Study type: Observational

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.

NCT ID: NCT01484496 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

BLISS-SC
Start date: November 16, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

NCT ID: NCT01483560 Completed - Clinical trials for Diabetes Mellitus, Type 1

REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)

REMOVAL
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c 7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid intima-media thickness (cIMT), in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease.

NCT ID: NCT01483482 Completed - Clinical trials for Acute, Displaced Midshaft Clavicle Fractures

Treatment of Displaced, Midshaft Clavicle Fractures. Sling or Plate?

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

Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics. There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle fractures. Conservative treatment has, traditionally, been the preferred treatment but recent studies have shown higher incidences of non-union and symptomatic malunion associated with conservative treatment. Primary surgery has in several studies been associated with high success rates and few complications but there is no compelling evidence towards superior results after primary surgery. The objective of this randomized study is to compare conservative treatment (sling) with primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.

NCT ID: NCT01482962 Completed - Clinical trials for Relapsed Peripheral T-Cell Lymphoma

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Start date: June 11, 2012
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

NCT ID: NCT01482663 Completed - Chronic Hand Eczema Clinical Trials

Chronic Hand Eczema - Self-management and Prognosis

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

Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.

NCT ID: NCT01482377 Completed - Neoplasms Clinical Trials

A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Participants With Metastatic and/or Locally Advanced Malignant Human Epidermal Growth Factor Receptor (HER3) Expressing Solid Tumors of Epithelial Cell Origin

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

This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety, pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or erlotinib, in participants with metastatic and/or locally advanced malignant HER3-positive solid tumors. Cohorts of participants will receive escalating doses of intravenous RO5479599 as monotherapy (Part A) or in combination with cetuximab (in Part B) or with erlotinib (in Part C) followed by an extension phase for each part. In an imaging substudy, participants will receive one or two doses of zirconium-89-labeled RO5479599 (89ZrRO5479599) in addition to unlabeled RO5479599 to evaluate the in vivo biodistribution and organ pharmacokinetics of RO5479599.