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.
An Open-label, Phase II, Two-stage, Study of Xantrene® (Bisantrene) in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) Lead-in stage: up to 12 (up to 2 cohorts in a 3+3 dose escalation design) Efficacy stage: up to 17 (Simon 2-stage design 9+8) Study Objectives: - Confirm safety and tolerability of the combination regimen - Time to response with combination treatment - Overall survival The treatment regimen will comprise daily IV infusion of Fludarabine (Flu), Clofarabine (Clo) and Bisantrene (Xan) administered via central venous line and controlled-rate infusion pump with a 1-hour break between each agent infusion, amounting to a total of 6 hours for each daily FluCloXan treatment in the following sequence: - First, infusion over 60 minutes of Fludarabine (Flu) at 10 mg/m2 - Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes - Followed by infusion of Bisantrene (Xan) at 250 mg/m2 over 2 hours. One cycle will comprise daily IV infusion of the combination treatment course for 4 or 5 consecutive days and rest period to between Day 30 and Day 42, based on patient performance and disease status.
Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12 months post-surgery. Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered 30 min prior to skin incision. A surgical assistant will be selected by the PI from the surgical staff of the department. The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura® approximation device and fixation of mesh with tacks over the closed defect in an IPOM fashion. Based on surgeon consideration, primary umbilical hernia defects under 2 cm will be repaired with or without mesh. Study follow-up visits will take place 14 days, 3 months and 12 months post-surgery.
Opioid-based sedation as a first line in mechanically ventilated patients has been considered the "gold standard" in intensive care unit patients around the world for several decades. Advantages of opiate-based sedation, compared to benzodiazepine-based sedation, which has been used in the past, include a reduction in delirium scores, better pain control, decreasing the time between cessation of sedation and patient awakening, and decreasing the time between cessation of sedation and extubation, with decreased ICU admission times. In most Western European countries, as well as in the United States, there are almost no mechanically ventilated patients hospitalized outside the intensive care unit. In a few countries, including Japan and Israel, mechanically ventilated patients are also hospitalized outside of intensive care units, as part of internal or surgical wards. Contrary to the vast knowledge accumulated regarding different sedation methods in ventilated patients in intensive care units, there are almost no studies that have evaluated different sedation methods in ventilated patients hospitalized in non-intensive care wards. Thus, while there is consensus on the benefits of opioid-based sedation in intensive care units, there is insufficient information to recommend the preferred sedation method in non-ICU wards. For various reasons, in a large number of the internal medicine wards of hospitals in Israel, the common sedation practice for ventilated patients is still benzodiazepine-based sedation. In the past year, a pilot program was initiated in Internal Medicine Department A at Meir Hospital in Kfar Saba, in which a new protocol for opioid-based sedation in ventilated patients was implemented. The protocol is based on the continuous intravenous infusion of fentanyl as the first line of treatment for sedation in ventilated patients only. If the sedation-agitation level (as measured by the RASS score) did not match the target RASS score set by the attending physician, a dose up to a maximum limit could be increased according to the protocol. Second-line sedation drugs were addition of continuous intravenous infusion of midazolam (in addition to fentanyl) in hemodynamically stable patients, or addition of continuous intravenous infusion of ketamine in unstable patients. In stable patients who did not reach the desired RASS level under continuous infusion of fentanyl and midazolam, ketamine could be added as a third line drug, in addition to fentanyl and midazolam.
The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.
The study will comprise of three groups of children (n=40): 1. A group receiving a novel short-term dynamic play therapy. 2. Dyadic therapy 3. Control group who will not receive therapy. All children will be assessed for psychopathology (anxiety, depression and behavioral problems) using standardized instruments such as semi-structured interview and self-reported questionnaires; EEG recordings will be performed from child and parents in order to asses brain synchrony; Cortisol (CT), Dehydroepiandrosterone (DHEA), Oxytocin (OT) and Secretory Immunoglobulin A (SIgA) will be assessed by using saliva sampling; and father-mother-child interactions will be videotaped and analyzed. Narrative descriptions will be obtained from parents, and the interviews recorded for voice analysis. Assessment will be made at baseline and then bi-monthly for six months.
The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
GnRH agonist triggering is used during ART in order to reduce the risk of OHSS. Some studies described that in up to 5% of the cycles triggered with GnRH agonist, a lack of respone or suboptimal response was displayed. The investigators aim to asses the possibility to predict the respone to ovulation triggering by the response to decapeptyl in the follicular phase of the same cycle.
Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in combination with dexamethasone and carfilzomib intravenously across two cohorts with a monotherapy component as well.
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.