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NCT ID: NCT00946062 Completed - Aged Clinical Trials

Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision

Start date: November 2007
Phase: N/A
Study type: Interventional

The purpose of this study is: 1. to develop a standardised orientation and mobility training (O&M-training) in the use of an identification/symbol cane by older adults with low vision, and; 2. to evaluate this newly developed standardised O&M-training with respect to effectiveness and feasibility in a randomised controlled trial.

NCT ID: NCT00945997 Completed - Clinical trials for Termination of Pregnancy Second Trimester

Misoprostol for Second Trimester Termination of Pregnancy

MIMIS
Start date: October 2000
Phase: N/A
Study type: Interventional

To compare the efficacy of two different dose regimens of misoprostol administered vaginally in combination with mifepristone in second trimester termination of (non)viable pregnancy.

NCT ID: NCT00945165 Completed - Clinical trials for Diabetes Mellitus, Type 2

Exercise and Glycemic Control in Type 2 Diabetes

Start date: July 2009
Phase: N/A
Study type: Interventional

Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated. This study aims to assess the effect of several exercise characteristics on hyperglycemia in various subgroups of type 2 diabetes patiënts.

NCT ID: NCT00943826 Completed - Glioblastoma Clinical Trials

A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma

Start date: June 29, 2009
Phase: Phase 3
Study type: Interventional

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.

NCT ID: NCT00943540 Completed - HIV Infections Clinical Trials

Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients

PRADA
Start date: July 2009
Phase: Phase 2
Study type: Interventional

The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is metabolized predominantly through glucuronidation by UGT1A1. Atazanavir increases the plasma concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of UGT 1A1. This suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once daily for example, is possible. Another reason why raltegravir most likely can be applied is that its pharmacodynamic effect is not related to Cmin but to AUC which is expected to be similar for an 800mg QD dose when compared to 400mg BD. Phase III clinical trials evaluating QD dosing of raltegravir are currently ongoing and interim results are expected to be published in mid 2009. A regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may be a well tolerated and effective NNRTI-, and ritonavir-sparing regimen that could be an attractive option for both first and second line (after NRTI/NNRTI failure) treatment regimens.

NCT ID: NCT00943267 Completed - Pneumonia Clinical Trials

Effect of Intrapulmonary Recombinant Human Activated Protein C (APC) on Coagulation and Inflammation After Lipopolysaccharide (LPS)

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

Recombinant human Activated Protein C (rhAPC) has been shown to reduce the mortality of patients with severe sepsis. The biological effects of APC are pleiotropic, and can be roughly divided in anticoagulant and cytoprotective effects. Lung infection and inflammation are associated with reduced bronchoalveolar levels of endogenous APC. Recent evidence derived from animal studies indicates that local administration of rAPC into the lungs exerts local anti-inflammatory and anticoagulant effects. In this study we propose to study the potential of locally administered APC, within a lung subsegment, to inhibit lipopolysaccharide (LPS) induced lung inflammation and coagulation in humans.

NCT ID: NCT00943059 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cross-over Study on Effect of Lipid Lowering by Acipimox on Cardiac and Skeletal Muscle Mitochondrial Function

ACP
Start date: March 2010
Phase: N/A
Study type: Interventional

Accumulation of lipid in skeletal and cardiac muscle has been associated with insulin resistance and diabetic cardiomyopathy. In skeletal muscle, lipotoxic damage has been suggested to lead to dysfunction of mitochondria. It remains unknown whether lipotoxicity leads to mitochondrial dysfunction in heart as well, and if so, whether this also leads to cardiomyopathy (failure of the heart). Although it has been shown that lipid lowering agents can improve insulin sensitivity, the effect of lowering free fatty acids on cardiac and skeletal muscle mitochondrial function remains unknown. In this study the investigators want to investigate whether lowering cardiac and muscular lipid content will improve mitochondrial and cellular function in type 2 diabetic patients. To this end, type 2 diabetic patients and body mass index (BMI)-matched controls will be included in a blinded cross-over design, in which subjects will receive a lipid lowering agent (Acipimox) or placebo for 2 weeks in random order. During treatment, diabetes medication will be stopped. Baseline measurements will be performed prior to the study and after each treatment to assess cardiac and muscular lipid accumulation, cardiac function, mitochondrial function and insulin sensitivity.

NCT ID: NCT00943007 Completed - Clinical trials for Glioblastoma Multiforme

Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors

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

The treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the presence of residual tumor that can be removed. This study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative MRI.

NCT ID: NCT00942968 Completed - Cancer Clinical Trials

Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer

Start date: June 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.

NCT ID: NCT00942903 Completed - Total Laryngectomy Clinical Trials

Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

N08HME
Start date: July 2009
Phase: Phase 1
Study type: Interventional

This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.