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.
This is a single-center, prospective study in subjects visiting TASMC for various indications. This study will be divided into two arms: First Arm - Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects). Second Arm - subjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm). Hence, total number of subjects for the study will be up to N=50. All subjects will be enrolled to the study only after signing an informed consent form. Specifically for the second arm, subjects will undergo proper training by the sponsor's representatives prior to being discharged from the hospital. Training will focus on proper operation of the device, which is also designed for autonomous use in a simple and user-friendly manner. Subjects will be asked to monitor themselves periodically for a duration of up to a week. Ongoing support will be provided by the sponsor upon subject request, either by phone, or on-premise via a dedicated support team. For both arms, device users (either study staff in first arm or subjects in the second arm) will be requested to answer questionnaires in order to assess usability with the investigational device. In both cases, a dedicated sponsor representative will observe the users to gather objective usability data, and aid in the questionnaire filling process.
This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications. The study will be conducted in two stages. The first stage will comprise a pilot study with 10 subjects, which will be completed and analyzed prior to initiation of the second stage. The two studies are independent and are included in the same protocol for logistical reasons. The second stage of the study, which will include 120 subjects, is pivotal and intended to validate the Gili BioSensor System. Testing procedure will include seating the subject in either a steady chair in front of a table, or in bed with the bedrest raised in front of a cardiac table (or similar). The subject will be seated for 5 minutes to reach a physiological steady state. During this time, the subject will be connected to the reference device according to the manufacturer's guidelines. The investigational device will be placed on a stable surface in front of the subject (table / cardiac table or similar) and will point to the left side of the subject's chest. Both the investigational and reference devices will be temporally synchronized to maintain coordinated recording. Following the 5-minute resting period, both investigational and reference devices will be activated for a comparative recording session to acquire at least 180 seconds (3 minutes) of evaluable data. Each 60-sec interval will be used separately for comparative analyses.
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
The incidence of cesarean deliveries (CD) worldwide is increasing, around 30% in United States. Although very common surgery women undergoing non emergent CD still experience fear and anxiety. It is known that increased levels of stress can negatively affect pain perception and the usage of analgesics postoperatively as well as lactation. this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of plasminogen-depleted plasma (PDP) or fresh-frozen plasma (FFP). In case of transfusions needing more than two units, the third unit and above will consist in regular plasma for both treatment groups. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30+/-3 days after transfusion.
MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability and routine disease progression measures (ALSFRS-R and Vital Capacity).
The present study examined the effect of a short Mindfulness-based intervention emphasizing a 'decentering' component on elderly seniors. Methods: 30 community seniors (Mage= 74.7) performed either 'decentering' intervention, guided imagery intervention, or control care as usual. The 8-week interventions included weekly 20-minute sessions and daily 10-minute home practice. Participants underwent a cognitive and emotional assessment before and after the interventions, which included filling out questionnaires and performing the Simon task. Trial registration: The study follows the principles of the Declaration of Helsinki, approved by the committee in Beer-Yaacov Hospital, Israel (number 579) on 24 Oct. 2017.