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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the long-term safety and effects of etavopivat, a new oral medicine being developed for inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein responsible for carrying oxygen in the blood. This phase 3 study involves participants who have already completed treatment in a prior etavopivat study and aims to understand how etavopivat performs over an extended period of up to 264 weeks, though the study may end earlier if the drug gains approval locally. Participants will receive oral doses of etavopivat, with different forms A, B, or C given based on their age and condition. Those aged 12 years and older will receive etavopivat A or C, while children under 12 years will receive etavopivat B. The study includes several groups covering various sickle cell disease and thalassaemia categories, including transfusion-dependent and non-transfusion-dependent cases. Treatment is continuous during the study period. Throughout the study, participants will undergo regular monitoring for side effects and treatment responses, including tracking treatment emergent adverse events, hospitalizations, vaso-occlusive crises, hemoglobin concentration changes, and blood transfusion needs. These assessments will help evaluate the drugs safety and efficacy across age groups and disease types. The study is open-label and non-randomized, with follow-up lasting up to about six years.
Actively Recruiting
This research aims to evaluate a multimedia social and behavior change SBC intervention in Kano and Kaduna states, Nigeria, focusing on its impact on womens and couples ability to make reproductive and family planning decisions. The study targets unintended pregnancy prevention by assessing how this intervention influences the use and intention to use modern contraception. It also examines cost-efficiency and sustainability, using a mixed-methods, prospective longitudinal cohort design over three years from 2025 to 2028, including comparison with a non-intervention state. The intervention, led by BBC Media Action, uses multiple media channels such as TV drama, radio drama, discussion shows, public service announcements, social media, mobile interactive voice response drama, and community engagement activities to encourage family planning. The study compares three groups areas receiving both the multimedia intervention and supply-side family planning services by Marie Stopes International MSI, areas with only the multimedia intervention, and areas with only MSI supply-side interventions but no multimedia exposure. Participants are women aged 15 to 44 who are sexually active and live in the selected areas. Data collection includes baseline and follow-up surveys two years after intervention start, in-depth interviews with participants and their partners, program monitoring interviews, and key informant interviews with implementing partners. Researchers will measure family planning use, intent to use, attitudes, confidence, communication frequency, and planning related to contraception. The study also collects cost data and evaluates sustainability over the course of the intervention and follow-up period.
Actively Recruiting
Researchers are investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups pre-operative chlorhexidine mouthwash combined with high oxygen levels 80-100% FiO2, no mouthwash with high oxygen levels, mouthwash with low oxygen levels 21-30% FiO2, or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.
Actively Recruiting
Researchers are studying genetic modifiers in hemoglobinopathies, including sickle cell disease and beta-thalassemia, through a large-scale, multi-ethnic genome-wide association study GWAS. These diseases vary widely in severity, influenced partly by genetic factors. The study aims to discover new genetic modifiers, validate known ones, pool existing genomic data, standardize disease descriptions, create a comprehensive research resource, and develop risk scores to help stratify patients based on disease severity and treatment response. The study will collect blood samples during routine clinical visits to perform GWAS experiments on individuals with hemoglobinopathies. Participants include those with various genotypes of sickle cell disease, beta-thalassemia, and alpha-thalassemia, without restrictions on gender or ethnicity. All participants will provide consent, and DNA samples may be collected if not already available in existing biobanks. Participants will contribute data including genetic, phenotypic, and functional information. The study will analyze worldwide patient demographics, genotypes, and disease severity. Researchers will investigate genetic modifiers related to survival, neurological function, renal impairment, pain syndromes, pulmonary hypertension, and treatment responses. This observational study involves data collection over five years, with no investigational treatments administered.