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NCT ID: NCT00992784 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

Start date: October 15, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

NCT ID: NCT00992589 Completed - Clinical trials for Gastroesophageal Reflux

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

NCT ID: NCT00992576 Completed - Constipation Clinical Trials

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

HMX3501
Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

NCT ID: NCT00991978 Completed - Breast Cancer Clinical Trials

VEGF Early Imaging for Breast Cancer

Start date: March 2010
Phase: Phase 0
Study type: Interventional

Breast cancer is the most common cause of cancer death among women. Yearly around 12,500 Dutch women are diagnosed with breast cancer and 3,500 die of this disease. One of the problems leading to such striking effect refers to late tumor detection due to inadequate sensitivity of current imaging techniques. Current screening is performed by means of mammography, consisting of traditional film-screen mammograms of digital mammograms. These digital mammograms offer digital enhancement to aid interpretation, which is especially helpful in women with dense breast tissue. Screening mammography is nowadays the single most effective method of early breast cancer detection. For screening of high risk individuals, increasingly the magnetic resonance imaging (MRI) technique is emerging. However, none of the above mentioned techniques has an optimal sensitivity and specificity, leading for instance to a significant portion of false positive results. The clinical consequence of this error is that additional tests and procedures are performed in women who may not have cancer. In the United States, for example, 11% mammograms require additional evaluation; the lesion turns out to be benign in more than 90% of cases [1]. False-positive readings False positive readings are more common in younger women, both because the tests are less specific and because breast cancer is less common [2,3]. As a result, more follow-up procedures, including invasive procedures such as biopsies, will be done in younger women even though fewer cancers will be found. Furthermore, because breast cancer screening occurs repeatedly, the risk of a false-positive study is likely to rise with repeated screening [4]. Emerging adjuncts to mammography include ultrasonography, which is helpful for further assessment of known areas of interest, and magnetic resonance imaging. Image-guided biopsy - directed by ultrasonography or stereotactic mammography views - plays a critical role in histological confirmation of suspected breast cancer.

NCT ID: NCT00991614 Completed - Clinical trials for Gastric Outlet Obstruction

EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms

Start date: December 2009
Phase: N/A
Study type: Observational

The objective of this investigation is to compile clinical experience on the use of the Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. It is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. Patients will be treated as per usual medical practices.

NCT ID: NCT00991523 Completed - Exercise Clinical Trials

Overnight Post-Exercise Recovery After Protein Ingestion Prior to Sleep

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

The purpose of this study is to examine the effects of post-exercise protein ingestion prior to sleep on overnight protein kinetics and muscle recovery.

NCT ID: NCT00991237 Completed - Clinical trials for Lumbosacral Radicular Syndrome

PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management

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

The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS). Prospective, single blinded, multicenter clinical trial.

NCT ID: NCT00989677 Completed - Clinical trials for Rheumatoid Arthritis

Rheumatoid Arthritis Disease Activity Monitor

RADAM
Start date: January 2009
Phase: N/A
Study type: Observational

Background of the study: Rheumatoid Arthritis (RA) is an autoimmune disease. There are four stages of the disease: 1. Synovial inflammation 2. Swelling of synovium 3. Pannus formation 4. Advanced bone and cartilage destruction Currently, there is no cure for RA, making the disease a chronic condition. RA is more prevalent in elderly and women. With medication it is possible to delay the onset of complications. Over the last decade, the treatment of RA has changed. Where treatment was palliative until pain medication was ineffective, the treatment is now more aggressive with early administration of disease modifying drugs (DMARDs). The treatment for RA is staged. First, the patient receives generic, low-cost drugs. If this treatment becomes ineffective, the treatment is adjusted with different and usually more advanced drugs. Biologics are a category drugs that are considered most advanced and most expensive. For effective treatment, there are two unmet needs. - A tool to aid early diagnosis, as this allows early treatment and delay of complications and physical restrictions for patients. - A safe, simple and cheap tool to monitor disease progress to allow traceable, operator-independent informed decisions on treatment adjustments. Non-invasive optical methods offer several advantages over existing modalities. Optical contrast can be related to physiological parameters in the body, such as blood concentration and oxygenation. At relevant wavelengths and intensities, optical radiation is completely harmless. The cost of optical methods is low compared to other modalities. An important application, where optical methods can help diagnosis and treatment is detection of inflammation of joints in patients suffering from rheumatoid arthritis (RA). Due to the highly scattering nature of tissue, non-invasive optical methods for medical imaging are limited to the extremities of the human body. For application in joint diseases, this is acceptable, because imaging of hands can provide sufficient clinical information. Objective of the study: Primary objectives: This is a retrospective, nonrandomized controlled observational study, conducted in a single center to evaluate the potential of optical attenuation measurements to establish disease activity for rheumatoid arthritis patients. Secondary objectives: Establish parameters from transient optical transmission measurements of the joint that relate to clinical evaluation results of individual joints Evaluate relation between disease activity (DAS-28 score) and the optical attenuation spectra of the fingers of a patient. Study design: This is a cross sectional, nonrandomized controlled observational study, conducted in a single center to evaluate the potential of optical attenuation measurements to establish disease activity for rheumatoid arthritis patients. Study population: The subject population will be patients visiting the Regionaal Reuma Centrum Eindhoven for rheumatoid arthritis. Patient visiting this center will represent a cross section of RA patients that are taken care of in an outpatient setting. Primary study parameters/outcome of the study: Primary endpoint is a successful measurement of optical attenuation of a joint and the part of the finger next to the joint before, during and after two consecutive restrictions of venous blood flow by means of a pressure cuff. Secondary study parameters/outcome of the study (if applicable): Secondary endpoints are unsuccessful measurements related to early termination of the measurement related to patient discomfort or safety and equipment or software failure.

NCT ID: NCT00989261 Completed - Clinical trials for Acute Myeloid Leukemia

Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)

ACE
Start date: November 2009
Phase: Phase 2
Study type: Interventional

AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).

NCT ID: NCT00988325 Completed - Influenza Clinical Trials

A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection

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

This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.