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.
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice. The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Richter's syndrome (RS) is a life-threatening complication of chronic lymphocytic leukemia (CLL). It is associated with a switch in histopathology and biology, generally with a transformation of the original CLL clone to diffuse large B-cell lymphoma (DLBCL). The development of RS is accompanied by the onset of B symptoms, rapid growth of lymphadenopathy, extra-nodal disease, significant elevations of lactate dehydrogenase (LDH), and associated multi-organ dysfunction from invasive or obstructive processes RS occurs in 2-10% of CLL patients with an incidence rate of 0.5% per year. The molecular pathogenesis of RS involves inactivation of the tumor protein p53 (TP53) tumor suppressor gene in 50-60% of cases and activating aberrations of NOTCH1 and myelocytomatosis oncogene (MYC) in about 30% of cases. . These distinct molecular footprints of RS are chemoresistance leading to an aggressive clinical course with low response rates and poor outcomes.Taking into consideration that in addition to the underlying aggressive disease, most RS patients are often at an advanced age and suffer from numerous other comorbidities. Additionally, intensive chemotherapy regimens are highly toxic to this population group and lead to excessive treatment-related morbidity. Enrolling DLBCL-RS patients in clinical trials is therefore justifiable, particularly those with RS that is clonally related to the predisposed underlining CLL disease. Due to the poor activity of immunochemotherapy, the possibility of using novel agents in the treatment of RS is of great interest. The toxicity and the efficacy of the combination of cluster of anti differentiation antigen 20 (anti-CD20) antibody (e.g. Obinutuzumab or Rituximab) with Ibrutinib and/or Venetoclax have been already reported in both relapsed and naïve patients with CLL. The use of these three agents in combination is highly active in CLL and has manageable side effects. In addition, recent reports showed that treatment with Ibrutinib or Venetoclax as a single drug are active in RS. Herein the investigators propose a phase 2, open-label, non-randomized, single arm, multi-center study aiming to assess the safety and efficacy with the combination of Ibrutinib, Venetoclax and Obinutuzumab in patients with RS .
This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.
The main purpose of this study is to evaluate the efficacy of 3 multiple doses of VIT-2763 as measured by the reduction in red blood cell (RBC) transfusion burden from Week 13 to Week 24, to identify the most efficacious and safe dose.
The purpose of this telemedicine 24-person open-label study is to evaluate the safety and usability of a proprietary wearable microcurrent electroceutical (a device that delivers micro-ampere electronic pulses) made by Healables, Ltd. to promote healing of chronic mild to moderate knee osteoarthritis as shown by decreased disability and relief of pain. In this study, subjects treat themselves at home once/day for an hour using a smart phone to activate the device worn on an e-textile sports knee sleeve. Microcurrent signals are transmitted from a device thru built in conductive pathways to strategic electrodes placed above and below the knee. A proprietary App both activates therapeutic protocols to transmit microcurrent signals as well as allows user-generated recording of the status of knee pain & function prior to and following each treatment. These records are then transmitted to health professionals using software compliant with human use data transmission regulations including subject anonymity. The rationale that the device would be effective is supported by microcurrent treatment for osteoarthritis at several US clinics including the prestigious Cleveland Clinic as well as by data of published randomized controlled clinical trials. One reason that more persons do not avail themselves of microcurrent therapy is that treatment usually requires several trips to a clinic often requiring considerable travel by a patient who may be in considerable pain. The health provider typically administers therapy in a clinic using electrodes with a desktop sized instrument. Our miniaturization of a microcurrent device and its use with wearable e-textiles such as a knee compression sleeve is a distinct advantage that enables regular use of effective therapy in home-based self-treatment to provide pain relief and improved knee function. Microcurrent electrotherapy represents a significant improvement in pain control and healing since it employs current in the microampere range, 1000 times less than that of Transcutaneous Electrical Nerve Stimulator (TENS) devices that transmit millicurrent electrical signals. This study is designed to demonstrate use of a wearable microcurrent electroceutical at home for subjects to self-treat at their leisure in a comfortable environment that facilitates healing. Moreover, data communication via a smart phone App to health providers enables digital telemedicine for rapid collation and interpretation of relevant data.
The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
Trace elements are micronutrients that are of vital important importance to human health and are involved in the process of many key human functions including the immune response, antioxidant defense and wound healing. Deficiency in a single element can manifest with multiple systems and can have significant organ impact. Research has shown correlation between deficiencies in trace elements and increased risk for infections, sepsis, multi organ failure and mortality. However relatively few studies examined the impact of perioperative changes in trace elements and patients' postoperative outcomes. In this prospective observational cohort study, we aim to examine the impact of perioperative changes in trace elements on postoperative outcomes, morbidity and mortality. This study will include patients aged 18 and above undergoing elective surgeries under general anesthesia at Rabin Medical Center. In the operating room blood samples will be collected from all study participants in the beginning of surgery and at the end of surgery. Collected samples will be sent for analysis of periodic table elements to assess the perioperative period changes in trace elements measured in whole blood. Participants intraoperative and postoperative data will be collected. All postoperative complications will be documented. Perioperative changes will be correlated with participants' postoperative outcomes using computer analytical correlations.
The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Follicular lymphoma (FL) is a chronic indolent malignancy, where treatment with 6 cycles of bendamustine obinutuzumab (BO) is highly effective but at a cost of increased adverse events. Tumor specific DNA can be traced in blood and bone marrow of follicular lymphoma patients even after therapy, and when detected after lymphoma treatment it is referred to as minimal residual disease (MRD). MRD elimination after effective lymphoma treatment is a marker for deep response and correlates with prolonged remission. In this study we aim to omit chemotherapy after 4 cycles of treatment in patients achieving MRD elimination after 3 months of therapy, as well as complete metabolic response on positron emission computed tomography (PET-CT), hoping to preserve treatment effectiveness while reducing adverse events.