Nazareth

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating a new cuffless photoplethysmography PPG chest-patch monitor to measure 24-hour blood pressure continuously. The study aims to validate the accuracy and reliability of this PPG-based device compared to the standard ambulatory blood pressure monitoring ABPM method using an upper arm cuff. The trial follows the 2023 European Society of Hypertension ESH guidelines, focusing on both hypertensive and normotensive adults referred for clinical ABPM. Participants will wear the Biobeat PPG-based chest patch and a standard cuff-based ABPM device simultaneously for 24 hours. The PPG device is a single-use, wireless, noninvasive patch applied to the chest, calibrated with three reference cuff measurements at the start. Blood pressure readings from both devices will be compared during awake, asleep, and total 24-hour periods. The study also assesses device comfort and usability as secondary goals. During the study, participants will be monitored for blood pressure accuracy and device performance, while avoiding vigorous exercise and showering for 24 hours. Researchers will collect data from both devices and evaluate agreement in systolic and diastolic pressures. Safety is monitored for mild skin irritation from the patch. The total participation involves wearing both devices for one day while following study instructions.

Researchers are studying the effects of combining castor oil ingestion with an extra-amniotic single balloon catheter to help with cervical ripening and reduce the time from labor induction to delivery in women who have given birth before. This trial aims to find out if adding castor oil to the balloon catheter shortens labor time, affects other birth outcomes, and whether any side effects from castor oil are tolerable for mothers. The study is randomized and controlled to provide clear comparisons between the methods. Participants will be randomly assigned to one of two groups. The first group will drink a mixture of 60 ml castor oil and 140 ml orange juice, followed 30 minutes later by the insertion of a 22-French Foley catheter filled with 60 ml saline above the cervix. The second group will have the Foley catheter inserted in the same way but without drinking castor oil. The balloon catheter will be removed about 12 hours after insertion, after which membrane rupture and oxytocin infusion may be used if contractions have not begun naturally. During the study, continuous fetal monitoring and routine labor management will be performed. Researchers will assess many outcomes including time to delivery, labor stages duration, mode of delivery, maternal and neonatal complications, side effects related to castor oil, and maternal satisfaction up to 10 days after birth. Follow-up includes monitoring for infections, hemorrhage, neonatal health, and length of hospital stay. The total participation period extends through delivery and postnatal observation up to 30 days for some neonatal outcomes.

Researchers are evaluating whether combining castor oil ingestion with an extra-amniotic single balloon catheter can shorten the time from labor induction to delivery in first-time mothers. This randomized controlled trial focuses on nulliparous women to determine if adding castor oil affects labor duration, other perinatal outcomes, and maternal tolerance to castor oil side effects. The trial seeks to address inconsistent findings on combining mechanical and natural methods for labor induction. Participants are randomly assigned to one of two groups. The study group drinks 60 ml of castor oil mixed with 140 ml of orange juice, followed 30 minutes later by insertion of a Foley catheter filled with 60 mL of saline above the cervical opening. The control group receives the Foley catheter insertion alone, without castor oil ingestion. Both groups undergo labor management according to standard protocols, including membrane rupture and oxytocin infusion if needed. During the study, researchers will monitor labor timing, balloon expulsion, delivery mode, maternal and neonatal health outcomes, side effects, and satisfaction with the delivery process. Assessments include fetal monitoring, Bishop scores, Apgar scores, blood tests, and complications up to 30 days after delivery. The total participation period covers labor and the postpartum hospital stay, with follow-up on maternal and neonatal outcomes.

Postpartum hemorrhage and anemia are major health concerns that can affect a mothers well-being and her bonding with her baby after delivery. This trial evaluates whether using ultrasound to check for blood loss after cesarean delivery can detect anemia earlier than standard care, which relies on blood tests measuring hemoglobin levels. Early detection is important because anemia can affect a mothers cognitive and emotional health, and untreated anemia may lead to complications such as postpartum depression and longer hospital stays. Participants are divided into two groups. One group receives abdominal and transvaginal ultrasound examinations within 24 to 48 hours after cesarean surgery to assess blood loss. The other group receives standard care without routine ultrasound. Ultrasound is a fast, non-invasive imaging method that can measure intra-abdominal fluid volume, which may indicate blood loss. The study compares these approaches to see which detects anemia sooner after delivery. Throughout the study, researchers will monitor hemoglobin drops within 24 to 72 hours postpartum and other ultrasound measurements such as uterine size and fluid volume. Additional assessments include infection rates, blood transfusions, hospital stay length, and maternal discomfort during ultrasound. Follow-up hemoglobin levels will also be checked 4 to 6 weeks after delivery. Participants will be closely monitored during the postpartum period to evaluate the timing and effectiveness of anemia diagnosis methods.

This research aims to compare two methods of epidural analgesia for pain relief during labor in women who are giving birth for the first time. The study focuses on the impact of programmed intermittent bolus epidural analgesia PIBEA combined with patient-controlled epidural analgesia PCEA versus continuous epidural infusion CEI combined with PCEA on reducing breakthrough pain. The trial also looks at labor outcomes such as the duration of labor stages, delivery methods, and womens satisfaction. Participants will be randomly assigned to one of two groups during labor. The study group receives a programmed intermittent bolus of 10 ml of 0.1% Bupivacaine and 2 microgramsml Fentanyl every hour until delivery and repair of any lacerations. The control group receives a continuous infusion of the same dose of medication at 10 ml per hour until delivery and suturing. Both groups can self-administer additional doses under specific limits if breakthrough pain occurs. During the study, participants will be monitored closely with pain assessments, medication use tracking, labor progress evaluation, and safety checks. Researchers will measure breakthrough pain, labor duration, delivery method, maternal satisfaction, and newborn health indicators over 48 to 96 hours following delivery. The study includes follow-up for blood tests, side effects, and any complications related to epidural analgesia.

This research aims to evaluate how programmed intermittent bolus epidural analgesia affects the occurrence of breakthrough pain during labor in women who have given birth before. The study compares this method to continuous epidural infusion, focusing on pain relief and labor outcomes. Epidural analgesia is a widely used method for labor pain relief, and this trial explores whether programmed bolus dosing combined with patient-controlled analgesia reduces breakthrough pain and improves satisfaction compared to continuous infusion methods. Participants are randomly assigned to one of two groups during labor. The study group receives a programmed intermittent bolus of 10 ml of 0.1% Bupivacaine with 2 microgramsml Fentanyl every hour, while the control group receives a continuous infusion of the same medication and dose. Both groups can self-administer additional boluses of 5 ml every 30 minutes, up to a maximum of 20 ml per hour. Treatment continues until delivery and suturing of any lacerations. Women in the study will be closely monitored for pain levels using a visual analogue scale and for any breakthrough pain episodes. Researchers will assess a variety of outcomes including pain scores, labor duration, mode of delivery, medication consumption, maternal satisfaction, and newborn health indicators within 48 hours after delivery. Safety and side effects related to epidural analgesia will also be recorded, with follow-up extending up to 96 hours for some measures.

This research aims to assess intra-abdominal blood volume and hemodynamic status in women after gynecological surgery by measuring the diameter of the inferior vena cava IVC using 3D and Doppler ultrasound within 24 hours post-surgery. The study focuses on women undergoing laparotomy, laparoscopy, or vaginal surgery and examines how ultrasound findings relate to postoperative outcomes such as hemoglobin drop, blood transfusion needs, pain, infection, and hospital stay length. It also seeks to define normal postoperative fluid volume and IVC parameters and to evaluate if ultrasound-guided care can improve recovery and avoid unnecessary treatments. Participants will receive abdominal and transvaginal ultrasound imaging within 24 to 48 hours after their gynecological surgery. The study involves measuring intra-abdominal fluid volume, IVC diameter, and its collapsibility index. Researchers will monitor these parameters alongside clinical outcomes to better understand their relationship. This cohort study includes about 250 women and does not involve any treatment interventions, focusing on diagnostic evaluation. During the study, participants will undergo ultrasound assessments shortly after surgery and have their clinical outcomes tracked, including hemoglobin levels, transfusion needs, infection signs, pain, and hospital stay duration. Data will be collected up to 7 days post-operation, with postoperative fever and patient discomfort after ultrasound also recorded. This observational study provides important information on postoperative fluid status and recovery in women having gynecological surgery.