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NCT ID: NCT01546532 Completed - Clinical trials for Chronic Heart Failure (CHF)

Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

Start date: February 2012
Phase: Phase 2
Study type: Interventional

This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

NCT ID: NCT01546051 Completed - Healthy Clinical Trials

A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers

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

This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its metabolite BCI-632 and several new pro-drugs in healthy male subjects.

NCT ID: NCT01545076 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

NCT ID: NCT01544790 Completed - Esophageal Cancer Clinical Trials

Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy

ROBOT
Start date: April 2012
Phase: Phase 3
Study type: Interventional

This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy will result in a lower percentage of postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).

NCT ID: NCT01543854 Completed - Acute Heart Failure Clinical Trials

Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure

Start date: March 2012
Phase: Phase 2
Study type: Interventional

This study will assess the hemodynamic effect of RLX030 infusion in subjects with acute heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

NCT ID: NCT01543672 Completed - Lung Cancer Clinical Trials

Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

VOLUMES
Start date: November 22, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

NCT ID: NCT01543373 Completed - Stable Angina Clinical Trials

Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS

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

The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.

NCT ID: NCT01543256 Completed - Biliary Stricture Clinical Trials

WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

Start date: September 18, 2012
Phase: N/A
Study type: Interventional

The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months. Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.

NCT ID: NCT01542762 Completed - Pulmonary Embolism Clinical Trials

Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation

Pot-Cast
Start date: March 2012
Phase: N/A
Study type: Interventional

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment. Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.

NCT ID: NCT01542723 Completed - Pulmonary Embolism Clinical Trials

Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy

Pot-Kast
Start date: May 2012
Phase: N/A
Study type: Interventional

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment. Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.