There are about 9745 clinical studies being (or have been) conducted in Israel. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The mechanisms responsible for the development of hormonal refractory prostate cancer (HRPC) have been elusive. Genetic inactivation/loss of the PTEN tumor suppressor gene occurs in 30-60% of advanced prostate cancers and in 20% of the localized form. Researchers hypothesize that PTEN loss is a landmark genetic event in prostate cancer progression into the fatal HRPC form. One consequence of PTEN loss is activation of the oncogenic Akt and phosphorylation of downstream Akt targets including mTOR. mTOR controls many important cellular processes including cell cycle regulation. We propose to evaluate pharmacodynamic assessments of the mTOR inhibitor RAD001 in intermediate and high risk prostate cancer patients in the neoadjuvant setting. Patients will be admitted to 6 weeks treatment with RAD001 10 mg/day followed by either radical prostatectomy or radiotherapy combined with hormonal treatment. Immunohistochemistry with antibodies for phosphorylated p70S6K , pS6, Akt as well as antibodies for VEGF, BCL2 and PTEN in prostate cancer tissues before and after 6 weeks RAD001 treatment will be performed. Additionally, Patients will be evaluated by FDG-PET scan before (as baseline) and after RAD001 treatment. A link between mTOR signaling and glycolysis regulation was established and may provide a mechanism to assess drug-target interaction of RAD001 in prostate cancer. The secondary endpoint of the trial will be to determine the response proportion to RAD001 treatment by assessing time to biochemical failure followed by radiation therapy or radical prostatectomy. The data will be compared to a matched cohort of high and intermediate-risk prostate cancer patients admitted to the same treatments modalities without receiving RAD001.
The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy
Fractures of an elbow are common in children. Accurate initial diagnosis is crucial for the management of the fractures of an elbow. In young children the fractures may be suspected clinically but missed on x-rays due to mostly non-ossified cartilage that is not visible on a regular x-ray. We propose that every x-ray negative, but clinically suspicious elbow trauma in children can be additionally evaluated using high resolution US.
To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.
We propose to develop a personalized pharmacogenetic approach including the major genetic markers of warfarin (coumadin) dosing and patients' age and weight. The known genetic determinants include several functional and common polymorphisms in CYP2C9 and VKORC1 genes, which explain the low-end of warfarin dosing range and mostly occur in patients of Caucasian and Chinese origins. We identified a new VKORC1 polymorphism that is specifically indicative of the high dose requirements and is dominant over the dose-reducing effect of the known CYP2C9 and VKORC1 markers. This marker is significantly over-represented in Jews of Ethiopian origin, but is also common in Ashkenazis, it is also linked to the VKORC1 genetic markers characteristic of the Afro-American population (published in Blood 2007, 109:2477-80). This information prompts the development of a more inclusive and universal diagnostic approach to the individualized warfarin therapy. The present study aims at evaluation of our novel pharmacogenetic model for predicting warfarin (coumadin) dose response on the basis of patient's genetic markers of warfarin sensitivity and resistance, and other patient specific factors. To this end, we proposes to re-evaluate our previously developed pharmacogenetic model in stabilized warfarin treated patients (N=200) and then to implement it in a prospective study of patients new on warfarin as compared to the "traditionally" treated patients (N=500).
Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.
The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins & De Luca, 1993). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible. In addition step execution test and Late life function and disability questionnaires will be also examined.