Asdod, Israel

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

An Ophthalmic Safety Study in Patients With Breast Cancer

This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. An approximate total of eligible 207 participants will be randomized to one of the three treatment groups - 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. Placebo The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM

Two periods: Run-In period will be a period in which patients will submit daily recordings, baseline creation Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

MISOPROSTOL FOR THE TREATMENT OF SUSPECTED POSTPARTUM RETAINED PRODUCTS OF CONCEPTION

Misoprostol (Cytotec) is used widely in Obstetrics and Gynecology, whether for labor induction (1), prevention (2), and treatment (3) of early postpartum hemorrhage (ePPH), induced and missed abortions (4) and for cases suspected for having retained products of conception postabortion and postpartum (RPOC, residua). While it has been shown in previous studies that misoprostol is efficacious for most of the above-mentioned indications, it is less well-established that the treatment for suspected postpartum RPOC alters the natural course of events and reduces the number of patients requiring surgical intervention and actually having RPOC. RPOC is estimated to complicate about 1% of term pregnancies and is more prevalent than after miscarriages and termination of pregnancy (5). The diagnosis and treatment of RPOC might be challenging, as there are no clearly determined diagnostic criteria, evidence-based guidelines or treatment protocols (6). Different protocols for the follow-up and treatment of cases suspected of RPOC are in use worldwide, including expectant management, administrating uterotonics, performing suction curettage (6), and performing hysteroscopy (7, 8). Evidence in the literature supports the treatment of RPOC with operative hysteroscopy since curettage seems to increase the risk for intrauterine adhesions and Asherman syndrome (9, 10) with the possibility for menstrual abnormalities, infertility or subfertility, recurrent pregnancy losses, preterm labor, and preterm premature rupture of membranes (11). Chambers et al published in 2009 a 6-year trial (12), which shows that treatment with 200 mcg SL / PO misoprostol 3 times daily for 2 days may effectively treat RPOC and reduce repeat curettage rate by 79.6%. There was also the complete resolution of symptoms in 93%, and 77% of women reported a high level of satisfaction. The trial was retrospective and RPOC was not confirmed by hysteroscopy or histology. The main tool for diagnosis and follow-up in cases of RPOC is postpartum ultrasound, showing low, medium, and high probability for residua, with the clinical symptoms of abnormal bleeding pattern, abdominal tenderness, and persistently dilated cervix. We've decided to set the categories according to the study by Smorgick (13), although we chose to name them and treat them differently. The categories are: 1. Low probability for residua - ultrasound shows thin regular endometrial line 10 mm and below, with no intrauterine mass or Doppler vascular flow. In effect a normal ultrasound scan. 2. Medium probability for residua - ultrasound shows a cavity over 10 mm, intrauterine hypo / hyperechogenic mass, or irregular endometrial line without Doppler flow. With this group, PROC cannot be excluded. 3. High probability for residua - with the addition of Doppler vascular flow to the cavity. The natural course of the ultrasonic appearance of the uterine cavity postpartum (14) was shown to take roughly 56 days for the cavity to appear empty in 95% percent of cases not suspected of having RPOC. This study aims to test prospectively expectant management compared to misoprostol administration for a certain duration of time of cases with risk factors for RPOC, including cases undergoing revision of the uterine cavity or manual lysis of placenta postpartum, early postpartum hemorrhage, cases with a history of treated postpartum residua, having placental pathology (succenturiate, bilobed placenta), a pregnancy that started as multifetal with only one fetus reached advanced pregnancy, and patients undergoing Bumm curettage post-delivery. 2. Aims Since the literature data on this subject is scarce and the treatment is challenging, the primary aim of this study is to assess prospectively and randomly expectant management vs. misoprostol administration (PV, PO, SL) on the treatment for suspected RPOC postpartum in women with risk factors for residua along an 8-week duration as characterized by ultrasound follow-up every 2-3 weeks and divided to a 3 tier system of the low, medium and high probability of residua and the cases requiring hysteroscopy for suspected residua. Secondary aims include side effects of treatment, late postpartum hemorrhage, blood transfusion, and endomyometritis / PID and complications. 3. Hypothesis In this study, we hypothesize that the treatment with misoprostol, compared to expectant management, will be able to reduce the number of cases at medium and high probability of residua as described by ultrasound and by that reduce the number of cases requiring hysteroscopy and treatment of residua.

Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)

This is a prospective, binational, single-blind, multicenter, randomized control trial, conducted according to international good clinical practice (GCP) ethical and quality standards. Critically ill, mechanically ventilated patients aged >=50 years with Richmond Agitation Sedation Scale (RASS) score of -3 to +1 (at time of screening) who are anticipated to require ventilation for >=24 hours will be eligible for recruitment. The study will be conducted simultaneously at Beth Israel Deaconess Medical Center (BIDMC) Boston, USA, Assuta Ashdod Medical Center (Ashdod, Israel) and Rabin Medical Center (Petah Tikvah, Israel) with BIDMC contributing up to 50% of the total enrollment. Participants will be randomized to either a) sham device or b) active intervention arm (details described below). Legally appointed representatives, patients and caregiver teams will be administered an optional questionnaire to assess their experience with the study device at the conclusion of the study protocol. Study subjects will be administered the telephone-Montreal Cognitive Assessment (t-MoCA); total score of 22 - missing 8 points present in Montreal Cognitive Assessment (MoCA) pertaining to drawing/executive function not feasible over phone) or MoCA (if still in-hospital; assessed out of total score of 30) and Hospital Anxiety and Depression Scale (HADS) questionnaire 30 days post-randomization. Hebrew versions of these questionnaires will be used at Israeli sites.