Sde Warburg, Israel

Routine Activity and Preterm Delivery Risk in Women With a Short Cervix

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Influence of CleaRing Open-capsule Device on Refractive Predictability in Cataract Patients (Part 2)

Cataract surgery has undergone significant improvement in terms of surgical technique, instrumentation and the quality of intraocular lenses (IOLs) over the past decades. Although the rate of posterior capsular opacification (PCO) has decreased, it is still the most common complication following uneventful cataract surgery, with the rate of laser capsulotomy ranging from 10% to 37%1-5 ND:YAG capsulotomy is a highly successful treatment, but it is not free of complications, such as increased intraocular pressure (IOP), pitting or dislocation of the IOL, cystoid macular edema, and retinal detachment. PCO also places an economic burden on the healthcare system. The importance of PCO prevention has increased in recent years, due to the expanding popularity of premium IOLs. Patients implanted with a premium IOL usually have high demands with regard to outcome, and PCO can also have an earlier effect on the performance of a premium IOL (i.e., multifocal IOLs). Previous attempts to prevent PCO have included investigations of various IOL materials and designs, surgical techniques, and pharmacological materials. Unexpectedly lower PCO rates were recently noticed in eyes that were implanted with a special type of IOL, e.g., the Synchrony IOL (AMO, Santa Ana, CA, USA)8 and the FluidVision IOL (PowerVision, Belmont, CA, USA). It was hypothesized that the capsular bag stayed open due to the special design of these IOLs, and that this should reduce the PCO rate. Based upon this concept, a special open capsule ring was designed for intracapsular implantation in an attempt to maintain the capsular bag open and to reduce PCO rate. Safety and efficacy of the device was demonstrated through several animal studies. The tested devices were effective in reducing posterior capsule opacification and Soemmering's ring formation by 69% to 77% compared to control group. The Hanita CleaRing device is designed to be implanted in the capsular bag together with a standard posterior chamber IOL in a minimally invasive cataract surgery. The device is intended to reduce posterior capsular opacification leading to reduced Nd:YAG treatment rate. The raw material of the device is a hydrophilic co-polymer, considered to be biocompatible and practically inert to the eye tissue. The objective of this study is to evaluate the safety and the efficacy of CleaRing device in cataract patients.

A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement

Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. Bleeding complications are associated with worse clinical outcomes, including a higher risk of infection, ischemic events attributable to hypo-perfusion (e.g., myocardial infarction, acute kidney injury), in-hospital mortality, and transfusion-related adverse events. Additionally, bleeding complications are an important driver of blood product utilization in cardiac surgery. Coagulopathy and bleeding after cardiac surgery are often a multifactorial problem, thus there is unmet need to find new technologies that can give better care to these bleeding patients. In 2016, it was estimated that one million people throughout the world undergo cardiac surgery each year. Most of these surgeries are Coronary artery bypass grafting and valves replacement. Coronary artery bypass grafting (CABG) is still the most commonly performed cardiac surgery procedure worldwide, representing annual volumes of approximately 200,000 isolated cases in the US and an average incidence rate of 62 per 100,000 inhabitants in western European countries. Aortic valve replacement is procedure that treat diseases affecting the aortic valve, one of four valves that control blood flow through the heart. In the United States, it is estimated that 2.5% of the general population, 8.5% of those 65-74 ≥75 years of age have moderate to severe valvular diseases. These surgeries are commonly done in the western countries, however, the ability to halt the bleed remain challenge for most clinicians. Failed or delayed treatment of a massive bleeding can result in irreversible end-organ damage (e.g., renal failure), cardiovascular events (e.g., stroke, myocardial injury) or death, accompanied by significantly increased costs. Fibrin clot breakdown is actively mediated by plasmin, a serine protease which cleaves fibrin. Administration of plasma depleted of plasminogen, the precursor of plasmin, may shift the balance towards coagulation. PLAS-FREE LTD has developed ClearPlasma™, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.

ABTECT - Maintenance

All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases. This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit. The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2. At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded. Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.

Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

This is a prospective, multi center, multinational, non-interventional observational study. All patients will be managed according to the clinical site's normal clinical practice, i.e., the diagnostic and clinical treatment/practice process that a clinician chooses according to their clinical judgement for an SMA patient. Clinical care will not be driven by the protocol. No additional visits or investigations will be performed beyond normal clinical practice. Patients will be followed for 15 years from enrolment or until death, whichever is sooner.

Remifentanil Versus Fentanyl During Laparoscopic Hysterectomy

Study design- Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. study protocol- 1. anesthesia is induced and maintained with propofol 2. Ventilation is performed with volume/pressure control mode with a tidal volume of 6-8 ml/kg, a frequency of 10-12/min and a positive end-expiratory pressure of 5 cm H2O aiming at normocapnia. 3. Tracheal intubation is performed 2 min after administration of the muscle relaxant 0.6-1.2 mg/kg rocuronium. 4. Patients in the study group will receive 0.2 mcg/kg/min Remifentanil 5. Fentanyl at the dose of 100mcg will be administered to all the patients in the control group 6. The gynecologist, surgical staff and patients will be blinded to group allocation. 7. During surgery additional muscle relaxant will be given only when asked by the gynecologist and will be mentioned in the anesthesiologic chart 8. The investigator managed the insufflation of the abdomen to 12 mmHg pneumoperitoneum. 9. Patients will be placed in the lithotomy position in a 30-degree head-down body position. 10. Antibiotic prophylaxis is given for all patients 11. The gynecologists will evaluate the surgical conditions before a colpotomy is made in a circumferential fashion around the cervix and toward the end of the surgery on four-point rating scale (1: excellent, 2: good, 3: acceptable 4: poor) 12. The gynecologists will also rate surgical space conditions on a numeric rating scale (NRS), where NRS 0 indicated optimal surgical space conditions and NRS 100 indicated unacceptable surgical space conditions and an intervention is needed to secure acceptable surgical space6

The Effect of Exposure to an Informative Video on Maternal Anxiety

A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction