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NCT ID: NCT00781391 Completed - Stroke Clinical Trials

Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

EngageAFTIMI48
Start date: November 2008
Phase: Phase 3
Study type: Interventional

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

NCT ID: NCT00781248 Completed - Clinical trials for Intubation, Nasogastric

Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage

Start date: September 2008
Phase: Phase 2
Study type: Interventional

The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations

NCT ID: NCT00781209 Not yet recruiting - Neoplasm Metastasis Clinical Trials

The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. Patterns of failure following treatment of metastases that arise in the posterior fossa have not been reliably defined. Although most would agree that radiosurgery alone is not sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver less than WBI as an "expanded port" beyond the SRS volume. The current study acknowledges that at least two therapeutic modalities are requisite for patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In so doing, it is hoped that the putative advantage derived from foregoing whole brain irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of excessive surpratentorial failure.

NCT ID: NCT00780884 Completed - Schizophrenia Clinical Trials

Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

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

Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning and quality of life. Although insomnia is most often treated with medication, a growing number of studies have demonstrated the efficiency of a variety of relaxation techniques, cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims to restore and maintain health through the stimulation of specific points on the body. Previous studies have demonstrated that acupuncture has a positive influence on a number of diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the aim of the present study is to examine the effects of acupuncture as a treatment for insomnia in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period, followes by an 8-week experimental period. During the experimental period, subjects receive acupuncture treatments twice a week. During the first week of the study (no-treatment period) and the last week of the experimental period, subjects' sleep is monitored with a wrist actigraph, and subjects complete a wide spectrum of questionnaires.

NCT ID: NCT00778492 Recruiting - Bleeding Clinical Trials

Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Start date: May 2008
Phase: N/A
Study type: Observational

Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.

NCT ID: NCT00776841 Completed - Healthy Clinical Trials

A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers

Start date: September 2008
Phase: Phase 1
Study type: Interventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers. Primary Objectives: 1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B) 2. To assess the pharmacokinetics of Aramchol at the administered doses

NCT ID: NCT00776451 Completed - Clinical trials for Age Related Macular Degeneration

Usability of the PreView PHP for Home Use in Intermediate AMD Patients

Start date: November 2008
Phase: N/A
Study type: Observational

To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

NCT ID: NCT00775723 Completed - Clinical trials for Melatonin Production

Melatonin Production Delay in Preterm Infants

Start date: January 2008
Phase: Phase 1/Phase 2
Study type: Observational

Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months of age. This might be related to exposure of preterm infants to continuous lighting in the NICU during a critical period of pineal gland development. The investigators aimed to test the profile of melatonin production in these infants at 9-12 months of age. Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks) were studied. The investigators tested nocturnal urinary melatonin excretion, within a repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by ELISA assay.

NCT ID: NCT00774982 Completed - Crohns Disease Clinical Trials

Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients

Start date: December 2008
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC) of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard 6MP (100 mg Purinethol) in 12 patients with Crohn's Disease. The study is being undertaken to prove that the new test formulation is indeed delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following local absorption are lower than that seen following standard Purinethol dosing. This should result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer side effects.

NCT ID: NCT00774345 Completed - Clinical trials for B-cell Chronic Lymphocytic Leukemia

A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

Start date: January 27, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.