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.
Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma. Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.
Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in patients with an acute ST elevation MI. In particular we plan to assess the relationship between regions with early hypoperfusion and/or late hyperenhancement, and myocardial viability.
Patients will be treated for 2 consecutive chemo cycles with the study drug for one and placebo for the other. In addition, patients will receive an injection before the chemo, either ondansetron (if receiving placebo inhalation) or normal saline) if receiving active study drug. They will take study medication for 3 days, 4 times daily and fill out VAS scores before and after doses. Patients will be given rescue medication with each dose.
The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by Doppler ultrasound in a selected group of patients suffering from gynecological malignancies.
Human cytomegalovirus (HCMV) has remained a major cause of morbidity and mortality following allogeneic bone marrow or peripheral blood stem cell transplantation (SCT). The most reliable virological predictive marker for disease development is the presence of HCMV viremia. It has been further recognized that viral load, and viral load kinetics are important determinants of pathogenesis. Prior to the preventive use of antiviral agents, CMV disease occurred in 15-45% of at-risk patients and carried a high mortality rate. In the last decade, major advances in the prevention of CMV disease have occurred with the application of pp65 antigenemia and qualitative/quantitative polymerase chain reaction (PCR) assays for the rapid and sensitive diagnosis of HCMV infection, combined with preemptive antiviral treatment targeted to patients with viremia. The prevalence of early CMV disease has declined to 3% to 6% with intense antiviral drug use. All antiviral drugs currently used for the treatment of systemic HCMV infection, including ganciclovir, foscarnet, and cidofovir, target the HCMV DNA polymerase. Ganciclovir is the most widely used drug for preemptive treatment. However, ganciclovir treatment is often complicated by bone marrow toxicity with the occasional development of potentially life-threatening thrombocytopenia, granulocytopenia, and graft failure, associated with secondary bacterial and fungal infection. Another limitation of preemptive ganciclovir therapy is the requirement for intravenous administration. The currently available oral valganciclovir is not yet approved for preemptive therapy in SCT recipients, and is associated with high treatment cost. Additionally, prolonged or repeated ganciclovir treatment may lead to the development of drug resistance. The use of foscarnet and cidofovir is limited by considerable nephrotoxicity, low oral bioavailability, and high cost. Thus, there is an increasing need for new effective non-toxic, low-cost anti-HCMV drugs with high oral bioavailability. Recently, the anti-malaria drug artesunate, which is widely used in the treatment of severe malaria, has been shown to be a highly effective inhibitor of HCMV in vitro. Artesunate exhibited similar antiviral activity (same micromolar range) to that of ganciclovir, while demonstrating no cytotoxicity. Importantly, its antiviral activity has been further demonstrated in vivo in a rat CMV model. No significant side effects were demonstrated in a number of pre-clinical and clinical studies, and artemisinin and its derivatives have been shown to be well-tolerated and safe in adults and children. Several million people have taken artemisinins to date, with no significant adverse or treatment-limiting effects being reported. Although neurotoxicity has been reported with supraphysiological doses in animals, it has not been documented in humans. Meta-analyses of malaria patients treated with artemisinins demonstrated that this drug class is safe. In rare cases, however, slight changes to haematology values have been seen, including a reduction in the number of reticulocytes as well as a slight increase in transaminase levels. These signs, however, do not generally give rise to any noticeable clinical manifestations. In rare cases, a slight but transient reduction in sinus heart rate has been observed. Abdominal cramps and mild diarrhoea have been reported at elevated doses. Thus, one might expect a similarly high degree of safety for the potential use of artesunate as an antiviral drug for HCMV infection. Thus, oral therapy with artesunate could be a beneficial option to the current therapies for the preemptive treatment of HCMV disease in SCT recipients.
Cigarette smoking is a major public health problem causing significant morbidity and mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break their addiction. The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the mesolimbic dopamine systems in both animals and humans. For this reason, we investigated whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex can help people to withdraw smoking in comparison to placebo rTMS. Smokers seeking to quit are recruited through newspaper advertisements. Participants were randomized to 10 days of either real or placebo high frequency rTMS.
This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate - Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) - Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to - Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) - Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: - The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: - To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups - To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. - To evaluate quality of life as measured by the FACT-P questionnaire. Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized. The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.
The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.