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NCT ID: NCT01078402 Completed - Clinical trials for Ankylosing Spondylitis (AS)

EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

EviraEAST
Start date: April 2009
Phase: N/A
Study type: Observational

This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.

NCT ID: NCT01077154 Terminated - Breast Cancer Clinical Trials

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

Start date: June 2, 2010
Phase: Phase 3
Study type: Interventional

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

NCT ID: NCT01076764 Completed - Clinical trials for Acute Coronary Syndrome

Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

TAO
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: - To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide - To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide - To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide - To document the safety of Otamixaban as compared to UFH + eptifibatide - To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

NCT ID: NCT01075906 Completed - Clinical trials for Familial Mediterranean Fever

Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients

Start date: August 2010
Phase: Phase 1
Study type: Interventional

Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or crushing adult-dose tablets. An age-appropriate sprinkle formulation will allow for more accurate dosing in pediatric patients. The primary objective of this study is to evaluate and compare the steady-state pharmacokinetics of multiple oral doses of colchicine sprinkle capsules administered to pediatric and adult FMF patients. Secondary objectives include evaluation of the safety and tolerability of this regimen in pediatric and adult FMF patients and measurement of the levels of acute phase reactants (i.e, serum amyloid A [SAA], erythrocyte sedimentation rate [ESR], C-reactive protein [CRP]) at baseline and after dosing.

NCT ID: NCT01075581 Not yet recruiting - Hypertension Clinical Trials

Intranasal Injection Versus Topical Administration of Epinephrin During Endoscopic Sinus Surgery

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

Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied by cardiovascular side effects during the early postinjection period, putting in risk patients with cardiovascular morbidity. Evidence indicate that topical administration of epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while avoiding systemic adverse effects. We wish to conduct a prospective controlled trial assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects. We hypothesize that topical administration of epinephrine provides a hemostatic effect not inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.

NCT ID: NCT01075568 Not yet recruiting - Healthy People Clinical Trials

The Satiety Effect After Okara Compared to Porridge Eating

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

To examine the satiety effect after eating of Okara.

NCT ID: NCT01075438 Not yet recruiting - Clinical trials for Ataxia Telangiectasia

Immunogenicity of Pneumococcal Vaccines in Ataxia-telangiectasia Patients

Start date: March 2010
Phase: N/A
Study type: Observational

Ataxia-telangiectasia (AT) is a rare genetic disorder characterized by gait disorders, neuromotor dysfunction, eye abnormalities and immune deficiency. AT patients are vulnerable to cancer and infection and usually die during their 2nd or 3rd decade due to these complications. The main cause of death is respiratory infections because these patients are known to have severe type of immunodeficiency. Consequently, pneumonia is the most common infection seen in AT patients, and is usually caused by S. pneumoniae. Therefore, a routine schedule of pneumococcal vaccine is highly recommended in AT cases where immunoglobulin replacement therapy was not already initiated. Until recently, AT patients were immunized with the pneumococcal polysaccharide vaccine (PPV23, Pneumovax® Aventis Pasteur MSD). However, data have shown that they do not respond well to these vaccines. Recently, the Israeli Ministry of Health has approved the pneumococcal 7-valent conjugate vaccine (PCV7, Prevenar®, Wyeth Lederle) for AT patients of all ages. This conjugate vaccine is known to stimulate the immune system through a different mechanism and the response is expected to be higher. The approved Israeli schedule for immunization of AT patients includes children older than 2 years that are entitled to receive 2 doses of PCV7 (8 weeks apart) boosted by PPV23, eight weeks after the second dose of PCV7. Assessment of the antibody response of such pneumococcal vaccination protocol in AT patients has never been performed. The "Safra" Children's Hospital is the national multi-disciplinary center caring for AT patients. Approximately 50 patients from all over the country (including Jewish, Druze, Bedouin and other Muslim patients - 3 of whom are Palestinians) are followed in the clinic on a monthly basis. Approximately 20 AT patients are not receiving IVIG replacement therapy, therefore are entitled to receive pneumococcal vaccination as stated above (mean age 10.6, 3 -23 years, 3 less than 5 years) The aim of this study is to evaluate the responsiveness, determined by specific antibody production, of AT patients receiving this new vaccine protocol.

NCT ID: NCT01075334 Recruiting - Male Infertility Clinical Trials

Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?

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

Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.

NCT ID: NCT01074788 Active, not recruiting - Clinical trials for Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic Surgery

Mind Body Therapy During Geriatric Rehabilitation

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

The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary methods that can improve the care of elderly people who had suffered an acute illness. The aim of this prospective study is to assess the effect of mind-body therapy(including guided imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and physical rehabilitation in geriatric patients.

NCT ID: NCT01074658 Completed - Clinical trials for Severe Aortic Stenosis

CoreValve Advance International Post Market Study

Start date: March 2010
Phase: N/A
Study type: Observational

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.