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.
High-dose chemotherapy and autologous stem-cell transplantation have an established role in the treatment of aggressive Non-Hodgkin's lymphoma (NHL) when refractory to first line chemotherapy or after relapse. The PARMA study randomized 109 patients, with chemo-sensitive relapse and no marrow involvement to receive, following the initial salvage regimen, high-dose chemotherapy versus continuous standard dose chemotherapy. 5-year progression-free survival was 46% in the transplant group compared with 12% in the chemotherapy group. Results are significantly inferior in patients with multiply relapsed or chemo-refractory disease with only 0-20% of patients achieving long-term disease control with autologous transplantation. Thus a large proportion of patients with refractory and relapsing disease are not cured with currently available transplantation methods and newer approaches are required. Rituximab is the first monoclonal antibody approved for clinical use. It is an anti CD20 antibody with high response rate in the treatment of follicular lymphoma and increases response rate in aggressive lymphoma when combined with chemotherapy. It is well tolerated with minimal side effects. However tumors may escape rituximab sensitivity by loss of antigen, poor access of antibody to bulky or poorly vascularized tumors, or failure of host effectors to eliminate antibody binding tumor cells. Lymphoma cells are inherently and exquisitely sensitive to radiation. Radioimmunotherapy uses monoclonal antibodies conjugated with a radioactive isotope to target radiation directly to tumor cells. Ibritumomab is the parent murine anti CD20 antibody witch targets the same epitope as rituximab. Tiuxetan is a chelator covalently linked to the antibody which chelates the isotope 90Yttrium to form the active radioconjugate Zevalin. 90Yttrium is a pure high-energy beta emitter with a relatively short half time (64 hours) and a path length of 5 mm. These properties make it an ideal isotope for radioimmmunotherapy. The high energy and long beta path are advantageous in treating bulky, poorly vascularized tumors, and tumors with heterogeneous antigen expression as neighboring tumor cells can be hit by cross fire from tumors binding the radioconjugate. Pure beta emission limits radiation to the patient body and is safe for the surrounding allowing simple outpatient care, no need for patient isolation or shielding. Biodistribution is predictable, eliminating the need for dosimetry. Initial studies showed that Zevalin has a favorable toxicity profile and is more effective than rituximab in patients with follicular and transformed non-Hodgkin's lymphoma, and studies are currently performed in aggressive lymphoma. There are initial phase I-II studies combining radioimmunotherapy with high-dose chemotherapy and autologous stem-cell transplantation with promising results. We conducted a phase II study of fixed-dose Zevalin at 0.4 mCi/kg with BEAM high-dose chemotherapy in patients with chemo-refractory disease. So far, 23 patients were included. With a median follow-up of 17 months the estimated progression-free survival was 52% compared with 0-20% expected in patients with multiply relapsed and chemo-refractory disease. Based on these data and data from other groups we expect that the addition of Zevalin to standard high-dose chemotherapy will improve transplantation outcomes in patients with standard-risk chemosensitive disease, as well. This study will randomize patients to Zevalin-BEAM versus BEAM alone to determine the potential of Zevalin radioimmunotherapy to improve outcome of autologous stem-cell transplantation.
Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events. Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone. The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.
occult hip fractures present to the emergency room with a history of trauma,a painful hip and normal X-ray. these patients usually undergo other imaging modalities such as CT scans, MRI, or bone scans. In this study we check the sensitivity and specificity of a directed ultrasound examination of the hip joint in diagnosing or excluding a hip fracture. We also compare the results of ultrasound examination by the orthopedic surgeon in the emergency room versus the consultant radiologist. The patients undergo bone scans or CT to make the diagnosis.
Hip fractures are usually classified according to their X-ray as subcapital, pertrochanteric. We examine hip fractures with ultrasound in order to characterize the fractures with several parameters.
Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results
This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.
The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.
Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain. We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments). The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.