Nazareth

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the accuracy and reliability of a new cuffless blood pressure monitoring device, called the Biobeat PPG-based chest-patch monitor, compared with the standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff. This study follows the 2023 European Society of Hypertension (ESH) guidelines for validating cuffless blood pressure devices. The trial includes adults referred for 24-hour ABPM for clinical reasons, including both hypertensive and normotensive individuals. The study also aims to assess the feasibility and convenience of using the new device. Participants will wear both the Biobeat chest patch and a standard cuff-based ABPM device simultaneously for 24 hours. The Biobeat device is a wireless, single-use patch placed on the chest that measures blood pressure continuously using photoplethysmography (PPG) technology. It will be calibrated at the start of monitoring using three reference cuff measurements. Data from both devices will be compared during awake, asleep, and total 24-hour periods to check agreement in blood pressure readings. During the study, participants will be monitored for 24 hours while wearing both devices. Researchers will collect data on blood pressure accuracy, device performance across different blood pressure ranges and demographic groups, as well as participant comfort and usability. The primary outcome is the accuracy of blood pressure measurements over 24 hours. The study poses minimal risk, with only possible mild skin irritation from the adhesive patch. Participants will be asked to avoid vigorous exercise and showering while wearing the device.

Researchers are studying the effects of combining castor oil ingestion with the use of an extra-amniotic single balloon catheter to help ripen the cervix and reduce the time from labor induction to delivery in women who have given birth before. The study aims to find out if adding castor oil shortens the time until birth, whether it influences other childbirth outcomes, and if the side effects are tolerable for mothers. This is a randomized controlled trial involving multiparous women at term pregnancy. Participants are randomly assigned to one of two groups. The study group drinks a mixture of 60 ml of castor oil mixed with 140 ml of orange juice, followed thirty minutes later by insertion of a balloon catheter filled with 60 ml of normal saline above the cervical opening. The control group receives only the balloon catheter without castor oil ingestion. The balloon catheter is removed about 12 hours after insertion, after which the membranes may be artificially ruptured if safe. If contractions do not start spontaneously, oxytocin infusion is given. Labor is closely monitored and managed by healthcare providers. During the study, continuous electronic fetal monitoring is used throughout labor. Researchers track the time from induction to delivery as the primary outcome within 48 hours. They also observe other delivery outcomes and any side effects related to castor oil use. Labor progress and safety are managed following clinical protocols, and the study includes women aged 18 to 60 years with specific pregnancy and cervical conditions. The total number of participants planned is 216 women, divided equally between the two groups.

Researchers are studying how combining castor oil ingestion with the use of an extra-amniotic single balloon catheter affects the time from labor induction to delivery in women having their first baby. This trial focuses on whether adding castor oil can shorten the time until birth and how it impacts other childbirth outcomes and potential side effects. The study includes women at term with a healthy, single baby in the head-down position who need labor induction. Participants are divided into two groups. The study group drinks a mix of 60 ml castor oil with 140 ml orange juice, then after 30 minutes, both groups have a balloon catheter inserted in the cervix and inflated with 60 ml normal saline. After the catheter is removed, if safe, the membranes may be artificially ruptured, and oxytocin infusion started if contractions haven’t begun. Labor is closely monitored with continuous fetal heart monitoring and managed by experienced obstetricians and midwives according to established guidelines. Throughout labor, electronic fetal monitoring is used to track the baby’s wellbeing. Researchers will measure the time from induction to delivery, aiming to see if the castor oil shortens labor by about three hours. Safety and side effects for mothers and babies will be observed. The total number of participants planned is 142 women, with follow-up during the delivery process to assess all maternal and newborn outcomes.

Postpartum hemorrhage and anemia are major health concerns that can affect a mother's quality of life, cognitive function, and emotional well-being, especially during the critical time of bonding with her baby. This study focuses on women who have undergone cesarean delivery and aims to determine if ultrasound exams can detect anemia from blood loss earlier than standard laboratory tests, which typically measure hemoglobin levels 24 hours after delivery but may not capture the lowest point until 48-72 hours later. Participants will receive either an ultrasound examination to assess intra-abdominal fluid and blood loss or standard care, which involves routine management without ultrasound assessment. Ultrasound is a safe, fast, and non-invasive tool that may help in the early diagnosis of anemia by detecting fluid volume more accurately than traditional methods. This study compares these two approaches to see which better identifies anemia after cesarean section. During the study, women will be monitored for hemoglobin drops of 2 g% or more within 24 to 72 hours after delivery. Researchers will evaluate blood loss using ultrasound or standard care procedures and track hemoglobin levels to confirm anemia. The study includes assessments of clinical condition and safety monitoring, aiming to improve early diagnosis and treatment of postpartum anemia after cesarean delivery.

Researchers are evaluating the effects of programmed intermittent bolus epidural analgesia compared to continuous epidural infusion on breakthrough pain during labor in first-time mothers. This randomized controlled trial aims to determine if the programmed intermittent bolus technique, combined with patient-controlled epidural analgesia, can reduce breakthrough pain, shorten the second stage of labor, decrease instrumental deliveries, and improve women's satisfaction. Epidural analgesia is considered the most effective pain relief method during labor, and this study focuses on nulliparous women with term, single pregnancies in early labor. 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 and 2 mcg/ml fentanyl every hour, with the option to self-administer additional doses every 30 minutes, up to a maximum of 20 ml per hour. The control group receives a continuous infusion of the same anesthetic solution at the same dose and schedule. If breakthrough pain occurs, an additional bolus dose is given in both groups. Pain levels are checked 30 minutes after the initial epidural loading dose to decide eligibility for continued treatment. Women will be closely monitored throughout labor with pain assessments using the Visual Analogue Scale. Data collected includes incidence of breakthrough pain within 48 hours, labor duration, delivery outcomes, and patient satisfaction. If pain relief is inadequate 30 minutes after the loading dose, a repeat epidural may be performed, and those cases are excluded from final analysis. The study continues until delivery and suturing of any lacerations, aiming to provide insights into pain management during labor for nulliparous women.

Researchers are studying the effect of programmed intermittent bolus epidural analgesia on breakthrough pain during labor in women who have given birth before (multiparous women). The goal is to compare this method to the traditional continuous epidural infusion to see which better controls pain during labor. Epidural analgesia is a common and effective way to relieve labor pain, and this trial explores if giving boluses at set intervals can reduce pain episodes and improve outcomes. In this study, multiparous women in labor will be randomly assigned to one of two groups. The study group will receive a programmed intermittent bolus of a mixture of bupivacaine and fentanyl every 60 minutes. The control group will receive a continuous infusion of the same mixture over one hour until delivery. Both groups can self-administer additional doses every 30 minutes if needed, with a maximum dose limit per hour. If pain remains high after the initial loading dose, a new epidural may be required. Participants will report their pain levels about 30 minutes after the initial epidural dose and throughout labor. Researchers will monitor breakthrough pain episodes within 48 hours and assess labor outcomes such as pain relief effectiveness, labor duration, and satisfaction. The study includes monitoring of anesthetic doses, pain scores, and any need for additional interventions until delivery and suturing. Data from women requiring a new epidural due to failed analgesia will not be included in the final analysis.

Researchers are evaluating the effectiveness of ravulizumab compared to a placebo in reducing proteinuria and improving kidney function in adults with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression. This Phase 3 study involves participants who have a confirmed diagnosis of IgAN and are receiving stable standard treatments for their condition. The study aims to provide important information about the impact of ravulizumab on kidney health over time. About 510 eligible participants will join the study. Around 450 will be randomly assigned to receive either ravulizumab or a placebo through weight-based intravenous infusions. Participants will continue their stable IgAN treatments during the study. An additional group of approximately 60 participants with more advanced kidney disease will also be enrolled. After Week 106, all participants have the option to enter an open-label phase to receive ravulizumab. Participants will be monitored through urine tests measuring protein levels and kidney function assessments over the course of the study. Key outcomes include changes in proteinuria at Week 34 and kidney filtration rate at Week 106. Safety and treatment effects will be closely observed throughout the study and during any extended access periods. The study includes thorough screening and follow-up assessments to track progress and ensure participant well-being.

Researchers are evaluating the use of ultrasound imaging to measure intra-abdominal blood volume and the diameter of the inferior vena cava (IVC) within 24 hours after gynecological surgery. This prospective cohort study aims to explore the connection between these ultrasound measurements and postoperative outcomes such as hemoglobin drop, need for blood transfusion, pain, infection, and length of hospital stay. The study also seeks to establish normal reference ranges for postoperative fluid volume and IVC parameters to potentially improve postoperative care and reduce unnecessary interventions. Women undergoing laparotomy, laparoscopy, or vaginal gynecological surgery at Holy Family Hospital will have transabdominal and transvaginal ultrasound imaging performed within 24 to 48 hours after their surgery. This advanced ultrasound assessment includes 3D volumetric measurements of intra-abdominal fluid and Doppler-based evaluation of the IVC diameter and collapsibility index. The study does not involve experimental treatments but focuses on diagnostic ultrasound to assess postoperative blood loss and fluid status. Participants will be monitored closely during the postoperative period with ultrasound scans, and clinical outcomes including hemoglobin levels, transfusion needs, pain, infections, and hospitalization duration will be recorded. The main outcome measured is the presence of intra-abdominal free fluid within 24-48 hours after surgery. The study involves about 250 women and includes detailed assessments to understand how ultrasound findings relate to recovery and complications after gynecological surgery.