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NCT ID: NCT00699751 Completed - Bone Metastases Clinical Trials

A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

ALSYMPCA
Start date: June 2008
Phase: Phase 3
Study type: Interventional

ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.

NCT ID: NCT00699582 Completed - Clinical trials for Refractory Partial Seizures

To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Start date: May 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

NCT ID: NCT00699569 Not yet recruiting - Clinical trials for Head and Neck Cancer

Hyperimmune Colostrum and Oral Mucositis

Mucositis
Start date: July 2008
Phase: N/A
Study type: Interventional

To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.

NCT ID: NCT00699127 Withdrawn - Anxiety Clinical Trials

Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety

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

Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

NCT ID: NCT00697645 Completed - Stroke Clinical Trials

Use of Deep Transcranial Magnetic Stimulation After Stroke

tmstroke
Start date: December 2010
Phase: N/A
Study type: Interventional

This study will determine the safety and efficacy of transcranial magnetic stimulation (TMS) in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). TMS was found to be effective and safe in the set up of depression. TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotrophic factor (BDNF). This is followed by positive effects of these growth and survival factors on neuronal sprouting, re-organization and also potentially on neurogenesis. Hence it is postulated that TMS will have a positive effect on the recovery rate and extent of recovery after stroke. Brainsway innovative project involves the development and use of deep Transcranial Magnetic Stimulation in humans to treat a host of behavioral disorders, including depression and addiction. Brainsway developed a novel coil design for stimulation of deep structures in the human brain and conducted several safety and efficacy studies and recently completed a large study (70 subjects) demonstrating effectiveness in depressive patients. Deep TMS produces directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, and no need of hospitalization or anesthesia. Consistent with animal studies using brain stimulation deep TMS of the prefrontal cortex was found to exert potent antidepressant effects on patients not previously responsive to antidepressant drugs in two different studies. Therefore, it is expected that TMS will also be safe in patients with stroke. Patients between 18 and 80 years of age who have had a mild or moderate acute stroke may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) or a magnetic resonance (MRI) scan of the head. CT involves the use of specialized X-rays and MRI involves a magnetic field to obtain images of the brain. All participants will receive standard medical and rehabilitation therapy for stroke. In addition, patients recruited for the study will receive x sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Each session will last for y minutes. Sessions will begin on day 3 after stroke onset and will be given on an alternate day basis for 14 days (7 treatments). Patients will be monitored daily until discharge from the hospital, or until day 17, whichever is earlier. Assessments will include physical examinations and safety evaluations including blood tests to and MRI or CT scans to evaluate both the response to treatment and side effects if needed. Patients will return for a follow-up examination 30 and 90 days after treatment conclusion to evaluate their recovery rate and functional status.

NCT ID: NCT00697021 Recruiting - Clinical trials for Acute ST SEgment Elevation Myocardial Infarction

Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

TEG
Start date: June 2008
Phase: Phase 3
Study type: Interventional

TEG is an established technique to assess the quality of clot formation' used mainly in surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be used in cardiology, where it can be a valuable tool to assess a response to antiplatelet therapy and its association with the outcome. However, there is a few data about use of TEG in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and the correlation of this response with the long term outcome, and ability to dose adjustment according to a specific measurement by TEG in order to prevent future MACE.

NCT ID: NCT00696982 Recruiting - Diabetes Mellitus Clinical Trials

The Effect of Sitagliptin on Hypertension, Arterial Stiffness, Oxidative Stress and Inflammation

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

Recently a new category of antihyperglycemic therapy aiming to modulate the incretin system has emerged. These drugs induce insulin secretion without inducing hypoglycemia. The effect of the incretin modulators drugs on hypertension, arterial stiffness, inflammation and oxidative stress parameters have not been fully investigated yet.GLP-1 analogue has been suggested to have an effect on endothelium and the development of hypertension. Nystrom et al have demonstrated that GLP-1 improves endothelial dysfunction in a small group of type 2 diabetes subjects, with coronary heart disease. We hypothesize that DPP-4 inhibitor will have an effect on hypertension and arterial stiffness by effect on the NO pathway.The aim of this study is to investigate the effect of two insulin inducers drugs, sulfonyl urea and DPP-4 inhibitor on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and inflammation.

NCT ID: NCT00696332 Completed - ALS Clinical Trials

Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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

The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

NCT ID: NCT00694382 Completed - Cancer Clinical Trials

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

SAVE-ONCO
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

NCT ID: NCT00693485 Completed - Clinical trials for Glaucoma, Open-Angle

Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

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

A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.