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NCT ID: NCT05904470 Recruiting - Hepatitis C Clinical Trials

A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

NCT ID: NCT05904145 Recruiting - Clinical trials for Pregnancy, High Risk

PRISMA Maternal and Newborn Health Study

PRiSMA-MNH
Start date: August 1, 2022
Phase:
Study type: Observational

Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions. Additionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change. The Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.

NCT ID: NCT05899491 Recruiting - GERD Clinical Trials

Role of ARMA in Selective Subset of Refractory GERD Patients.

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

NCT ID: NCT05898048 Recruiting - Clinical trials for Acute Necrotizing Pancreatitis

CMV Reactivation in Acute Necrotizing Pancreatitis

Start date: June 5, 2023
Phase:
Study type: Observational

Patients with the diagnosis of acute necrotizing pancreatitis (ANP) present with a wide spectrum of severity. These patients frequently require intensive care management. According to the revised Atlanta classification (2012), acute pancreatitis is divided into distinct subtypes, based on the presence or absence of necrosis. The mortality rates for sterile necrosis though comparatively low (5%-10%), but superinfection of the necrotic pancreas and peri-pancreatic tissue/ fluid collections increases the mortality rate considerably (up to one-third). The most common organisms isolated from the infected pancreatic necrosum are gram-negative bacteria mainly Escherichia coli and Klebsiella pneumoniae followed by gram-positive bacteria; however, with the increased use of antibiotic therapies in the ICU, the incidence of pancreatic fungal infections is also on a rise. Traditionally, critically ill patients have been considered immunocompetent but the immunomodulatory effects of sepsis may lead to reactivation of dormant viral infections. In recent years, Cytomegalovirus (CMV) reactivation in critically ill patients has been recognized with as high as 71% incidence with associated higher mortality, organ failure rates, duration of mechanical ventilation, nosocomial infections, and ICU length of stay. CMV reactivation had been studied in various cohorts in the ICU population, such as acute respiratory distress syndrome (ARDS) and septic shock exhibiting their impact on mortality. However, currently, no study is available investigating the role of CMV reactivation in patients with acute necrotizing pancreatitis. Therefore, the investigators aimed to study the prevalence of CMV reactivation and its viral load kinetics in critically ill patients with acute necrotizing pancreatitis.

NCT ID: NCT05895786 Recruiting - Myositis Clinical Trials

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Start date: May 20, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: - Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater - Have active DM or active PM. - Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. - Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

NCT ID: NCT05894239 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Start date: July 28, 2023
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

NCT ID: NCT05893277 Recruiting - Clinical trials for Alcohol Use Disorder

Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India

Harmony
Start date: October 12, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to test an intervention consisting of a combination of behavioral couples therapy and motivational interviewing to improve communication and reduce conflicts between couples and decrease harmful drinking among spouses in urban primary health centers, South India. The intervention will be delivered by nurses in primary health centers who will be supervised by a clinical psychologist. The main question[s] it aims to answer are: - Do the wives of the couples in the intervention report less intimate partner violence (IPV) after 12 months, compared to wives in couples in a control group? - Do the husbands of the couples in the intervention show less alcohol consumption after 12 months, compared to husbands in couples in a control group? Husbands will participate in Motivational Interview (MI) sessions targeted at reducing their alcohol use. Husband and wife will participate in Behavioral Couples Therapy (BCT) targeted at improving their marital relationship. These intervention participants will be compared to a control group who will receive only referral information for intimate partner violence and an educational session and referral for alcohol use disorder. All participants will participate in quantitative interviews at baseline, and every three months thereafter, for a period of one year. In-depth qualitative interviews will be done with a subgroup of couples to try to understand how the intervention led to the observed outcomes.

NCT ID: NCT05891249 Recruiting - Anemia Clinical Trials

A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India

Start date: June 5, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of luspatercept in participants who require regular blood cell transfusions due to b-thalassemia and myelodysplastic syndromes in India

NCT ID: NCT05890222 Recruiting - Depression Clinical Trials

IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion

IMPRESS
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.

NCT ID: NCT05885022 Recruiting - Clinical trials for Glaucoma, Open-Angle

Feasibility Clinical Evaluation of the Calibreye System

Start date: May 31, 2023
Phase: N/A
Study type: Interventional

To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.