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.
It is well established that CD8 and CD4 T cells reactive against defined islet antigens are associated with initiation and progression of Type 1 Diabetes (T1D). In previous work, we have demonstrated that it is possible to redirect T cells against pathogenic T cells via chimeric peptide/MHC/CD3-zeta receptors in a peptide-specific manner and to prevent, or inhibit diabetes in NOD mice. In this study we intend to extend this approach to T cells of T1D patients. Working hypothesis: Beta cell-reactive CD8 T cells of human T1D patients can be immuno-targeted by their own gene-modified cytotoxic T lymphocytes (CTLs). Aims: Our major aim is to demonstrate, in a set of ex-vivo experiments, such immunotargeting with T cells derived from T1D patients at the Ziv Medical Center. To this end we will stimulate and expand autoreactive CD8 cells in blood samples of T1D patients and target them, ex-vivo, with genetically-reprogrammed CTLs which are present in the same blood samples.
The proposed study aims to explore brain mechanisms mediating the cognitive benefits of aerobic exercise in patients with mild cognitive impairment- a prodromal stage of Alzheimer disease. We will perform FMRI experiments, as well as laboratory and behavioral tests that will advance our knowledge about the nature of these mechanisms. Participants will participate in individual- tailored aerobic training program. Pre and post evaluation will identify brain changes following the training using advanced techniques of brain imaging. Cognitive performance will be assessed prior and at the end of the program, as well as endocrine markers reflecting improvement in learning abilities. Moreover, demonstrating cortical plasticity in subjects with aMCI has tremendous practical significance for these subjects .
Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).
The use of inhaled medications for the treatment of pulmonary diseases allows for the delivery of a high concentration of a drug at the site of disease with reduced systemic absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully used in the maintenance treatment of CF patients with chronic colonization with PA (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung functions, decrease the density of the PA in the sputum, decrease hospitalizations, and reduce the risk of mortality. Non CF Bronchiectasis share many features in common with CF, including frequent colonization with PA that leads to deterioration in lung function and increased morbidity. A recent Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics in the treatment of bronchiectasis, however further randomized controlled trials with adequate power and standardized end points are required. There have been reports in the literature describing the efficacy of inhaled tobramycin the treatment of patients with non CF bronchiectasis with eradication of PA, and significant improvement in respiratory symptoms. There were however patients who discontinued treatment due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest 2005). TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry powder formulation has not yet been trialed in patients with non CF bronchiectasis. The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in patients with non CF bronchiectasis, and to gather more data on the benefit of continuous antibiotic therapy in patients with non CF bronchectais.
Scientific Background: Inherent gaps exist between the worlds of research and clinical therapy, especially in mental-health systems. Developed as an important strategy aimed to bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a method devised for systematic ongoing quantitative measurements used in diverse clinical practices, from psychotherapies to psychiatric management. The efficacy of this approach has been repeatedly demonstrated in various measures, such as satisfaction with treatment by patients and therapists, lower drop-out rates, symptomatic benefits, and more. Objectives: The aim of the current study is to test the feasibility and the clinical benefits of implementation of a Routine Outcome Monitoring System in a public clinical center, as a pioneering project in Israel, at the "Shalvata" Mental Health Center. Working Hypotheses: Incorporation of a ROM system in routine clinical practice is hypothesized to improve patients' and therapists' overall satisfaction, allow for early detection and intervention in therapeutic raptures, decrease drop-out rates, and improve various clinical outcome measures. Methods: The suggested study is a two-stage (implementation and intervention) open trial. 900 new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention (ROM) and control groups. Assessment questionnaires will be filled periodically using 'CORE-NET', a computerized system enabling repeated measurements and feedback in a user-friendly and efficient manner. Data Analysis: The evaluation of the differential influence of monitoring processes on overall efficiency as compared to control group will be tested using Multiple Analysis of Variance (MANOVA). The predictive value of possible variables on process and outcome of therapy will be assessed using stratified regression analyses. The possible causal effects between specific lagged variables will be assessed using Hierarchical Linear Modeling and Time Series Analysis. Contribution: This pioneering study is the first in Israel to offer a routine systematic evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently, a large and meaningful data-set will emerge, enabling significant enrichment of our evidence-based understanding of therapeutic processes.
Emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. These field expedient tests have not been validated in a military setting or across different military occupational specialties. In this prospective study the investigators plan to screen 300 combatants for a 1-year time frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable risk factors which are hypothesized to predict injury risk during the military service.
Purpose: To evaluate the performance of Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung cancer. The study population will include a total of 950 participants, patients with lung cancer before any treatment, and healthy and COPD patients as a control group.
Exposure to heat stress can compromise the physiological and cognitive function and be life threatening, particularly in a military setting. Various strategies of precondition to heat stress that have been explored in the past proved to be inapplicable. We aim to examine the influences of Astaxanthin supplementation as a preconditioning strategy to heat stress in a human model using a heat tolerance test. This will be achieved by a double-blind, placebo controlled supplementation trial, exposing human subjects, before and after consuming Astaxanthin or a placebo, to a controlled heat strain environment, while performing moderate exercise in a heated chamber.
This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes. The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation. The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.
The aim of the current study is to evaluate, in a prospective cross-over, randomized study, the effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficits and cognitive impairment after anterior skull base meningioma tumor removal.