Search Bar & Filters
Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the long-term safety and effectiveness of etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassemia. These disorders affect hemoglobin, the protein responsible for carrying oxygen in the body. This phase 3 study aims to monitor how well etavopivat works and its safety profile over an extended period. Participants will receive one of three forms of etavopivat (A, B, or C) as oral doses. The study is open-label and multicenter, involving adults, adolescents, and children who have previously completed treatment in an etavopivat parent study and continue to benefit clinically. The treatment period can last up to 264 weeks but may end earlier if etavopivat is approved in the participant's country. During the study, researchers will track the number of treatment-emergent adverse events and adverse reactions for each participant by indication and age group from baseline through the end of the study, which can last up to 316 weeks. Participants' safety and response to long-term treatment will be closely monitored throughout this period.
Actively Recruiting
Researchers are evaluating a multimedia social and behavior change intervention in Kano and Kaduna states, Nigeria, to study its impact on family planning and reproductive decisions among women and couples. This study aims to assess the intervention's effectiveness, cost-efficiency, and sustainability over three years (2025-2028) using a mixed-methods, prospective longitudinal cohort design. The intervention targets low modern contraceptive use, which remains a challenge in Nigeria, especially in Kano and Kaduna, compared to the national average. The intervention, led by BBC Media Action in collaboration with partners, uses multiple media channels including TV drama, radio shows, public service announcements, social media, mobile interactive voice response drama, and community engagement activities. Additionally, family planning services supported by Marie Stopes International provide supply-side measures like provider training and commodity supply to improve service quality. The evaluation includes comparison with Nasarawa state, which does not receive the intervention. Participants will be women aged 15 to 44 years residing in the selected areas, surveyed at baseline before the intervention and followed up two years after implementation begins. Assessments include surveys on current family planning use, intent to use methods, and attitudes towards family planning. Qualitative interviews with women, their partners, program implementers, and key stakeholders will explore behavioral pathways and sustainability. Cost data will be collected to analyze cost efficiency. The study monitors the intervention's impact and supports evidence for family planning and mass media behavior change programs.
Actively Recruiting
Researchers are evaluating the effects of pre-operative chlorhexidine mouthwash and perioperative oxygen levels on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This Phase 3, multi-center, randomized controlled trial is conducted across hospitals in low and middle-income countries, focusing on adults and children aged 10 years or older having elective or emergency midline laparotomy. The study aims to reduce serious postoperative complications that significantly contribute to mortality and healthcare burden, especially in these resource-limited settings. Participants will be randomly assigned to one of four groups combining the use or non-use of chlorhexidine mouthwash before surgery and different oxygen concentrations during surgery: (a) mouthwash with high oxygen (80-100% FiO2), (b) no mouthwash with high oxygen, (c) mouthwash with low oxygen (21-30% FiO2), or (d) no mouthwash with low oxygen. The trial includes a 6-month internal pilot phase to assess recruitment and compliance, followed by a main phase enrolling approximately 12,924 participants. During the study, researchers will monitor participants for pneumonia and surgical site infections within 30 days after surgery using CDC definitions. Data on treatment adherence and participant outcomes will be collected and assessed by blinded outcome assessors. The study will track complications and follow patients through their recovery to evaluate how these interventions might reduce postoperative infections and improve surgical outcomes.
Actively Recruiting
Researchers are investigating how genetic modifiers influence hemoglobinopathies, including sickle cell disease and beta-thalassemia. These diseases vary widely in severity, and while some genetic factors have been identified, more are believed to exist that impact disease outcomes. This large-scale, multi-ethnic genome-wide association study (GWAS) aims to discover new genetic modifiers, validate known ones, pool existing genetic data, standardize disease descriptions, and develop risk scores to better classify patients. The study will perform GWAS using SNP chips on blood samples collected during routine clinical visits or existing biobank DNA samples. Participants with various hemoglobinopathy genotypes will be included without restrictions on gender or ethnicity. The research will analyze genetic factors related to survival, complications like stroke, renal impairment, pain syndromes, and responses to treatments such as hydroxyurea and iron chelation. Data collected will contribute to a comprehensive research resource combining genomic, phenotypic, and functional information. Participants will provide consent and contribute blood samples if DNA is not already available. Researchers will gather worldwide demographic and clinical data from multiple centers. The primary outcome measured over five years is the identification of genetic modifiers influencing disease traits and treatment responses. This extensive monitoring and data collection aim to improve understanding and risk stratification of hemoglobinopathies globally.