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Found 6 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate and improve how appendicitis, the most common emergency surgery, is managed worldwide. Appendicitis requires timely diagnosis and treatment to prevent complications and reduce healthcare costs. By using appendicitis as a "tracer condition," the study examines emergency care systems across different countries, focusing on access to care, treatment quality, and efficiency. The goal is to find gaps in emergency surgical care, especially in low- and middle-income countries, to guide future improvements. The study will collect data from about 500 hospitals globally between February 3 and May 25, 2025. Each hospital will gather information over 14 days on patients undergoing appendicectomy, which includes open, laparoscopic, and robotic surgeries, as well as cases converted from minimally invasive to open surgery. The study also includes two sub-studies: one exploring sustainability and waste management in operating rooms, and another examining the financial impact of appendicectomy on patients, particularly in lower-income settings. Participants include all patients having appendicectomy for suspected or confirmed appendicitis during the study period. Data will be collected from routine health records without additional follow-up. Researchers will measure key outcomes such as time to surgical assessment, rates of laparoscopic surgery, postoperative complications, length of hospital stay, and financial costs to patients. The study aims to capture data on about 14,000 patients to understand how differences in hospital resources affect care and outcomes worldwide.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a new short 6-week daily rifapentine treatment compared to the standard 12-16 week rifamycin-based treatments for latent tuberculosis infection (LTBI). This trial focuses on people at higher risk of developing active tuberculosis and is conducted in various settings with different TB incidence rates. The study aims to test if the shorter treatment is not worse than the longer standard treatments in terms of safety and effectiveness. Participants are randomly assigned to either the experimental group receiving 600 mg of rifapentine daily for 6 weeks or to a control group receiving one of three standard treatments: 12 weeks of once-weekly rifapentine and isoniazid, 12 weeks of daily rifampin and isoniazid, or 16 weeks of daily rifampin. Dosage adjustments are made based on patient weight according to established guidelines. A total of 1,120 participants will be assessed for safety and 3,400 for effectiveness, followed for 24 months after enrollment. During the study, participants will be monitored for treatment discontinuation due to adverse drug reactions and for the development of tuberculosis. Safety and effectiveness will be evaluated by comparing the rates of drug discontinuation and new TB cases between the two groups. Follow-up includes clinical assessments and laboratory tests over a 24-month period to ensure comprehensive monitoring of participant health and treatment outcomes.
Actively Recruiting
This research investigates whether wearable wireless sensors can help detect early signs of patient deterioration after surgery. Patients who become critically unwell after operations often experience delayed recognition of complications, which can lead to harm or death. The study focuses on surgical inpatients undergoing major open surgery across various countries and aims to see if data from wearable monitors is acceptable to patients and healthcare staff while potentially improving early detection of problems. Participants will wear wireless sensors placed on their chest and fingers before, during, and after surgery for up to 10 days. These sensors record vital signs like heart rate, oxygen levels, and body temperature continuously but do not affect patient care, as clinical teams will not have access to the sensor data during the study. The study is device-agnostic but initially uses the Sibel ANNE ae One device, a wireless dual sensor system that stores real-time physiological data. During the study, researchers will collect and analyze physiological data alongside clinical event information to explore links between vital sign changes and patient deterioration. Participants will be monitored through wearable sensors for up to 10 days postoperatively, with no changes to standard care. The study takes place in general surgery departments in several countries and includes usability assessments and baseline monitoring practice evaluations in earlier stages.
Actively Recruiting
Healthy Volunteer
The GR-Ex program, supported by the French Ministry of Higher Education and Research, focuses on improving understanding of red blood cell physiology, erythropoiesis, iron metabolism, and related disorders. The research aims to develop innovative therapeutic protocols to add value in these areas. It involves exploring pathophysiological aspects of red blood cells and related diseases. Participants will undergo biological sampling, including blood, surgical remnants, and urine collection, to support these investigations. This sampling is part of the program's efforts to gather data and study various markers related to red blood cell function, inflammation, and metabolism. Throughout the program, researchers will monitor multiple long-term outcomes such as spleen functionality, inflammation in sickle cell disease, post-artesunate hemolysis, transfusion yield, neutrophil adhesion efficiency, mitochondria removal during erythropoiesis, and iron metabolism in patients with specific blood disorders. The study involves extended follow-up and thorough laboratory assessments over a 20-year period to evaluate these markers and improve therapeutic approaches.
Actively Recruiting
The trial investigates delivery strategies to improve how post-discharge malaria chemoprevention (PDMC) is given to children under 10 years old in Benin who were hospitalized with severe anaemia or severe malaria. PDMC aims to reduce hospital readmissions and deaths by providing a monthly 3-day malaria drug regimen three times after hospital discharge. This research addresses the lack of a clear delivery method for PDMC and the challenge of ensuring caregivers follow the dosing schedule. The study follows a cluster randomized design to compare different community delivery approaches and adherence support methods, with the goal of informing national health policies in malaria-endemic areas. Children in the study receive three courses of dihydroartemisinin-piperaquine at 2, 6, and 10 weeks after leaving the hospital. The trial compares three groups: one where caregivers receive all PDMC drugs at discharge plus monthly home visit reminders from community health workers (CHWs); another where CHWs deliver the drugs at home with SMS/phone reminders from qualified officers; and a control group where caregivers get the drugs at discharge without additional reminders. All children receive standard hospital care including blood transfusions and malaria treatment. The study also includes economic and acceptability evaluations of the delivery methods. Participants will be followed for 14 weeks post-discharge with clinic visit monitoring, unannounced home visits to check drug adherence, and an end-of-study visit. Data collected will include hospital readmissions, clinic visits, mortality rates, and adherence to the 9-dose PDMC regimen. Researchers will assess the effectiveness, feasibility, acceptability, and cost-effectiveness of the delivery strategies while monitoring safety events. The entire study spans 36 months, including preparation, recruitment, follow-up, and data analysis phases.
Actively Recruiting
Researchers are evaluating shorter and safer treatment options for latent tuberculosis infection in adults and children aged 5 years and older. This Phase 2 randomized open-label trial aims to identify at least one tuberculosis preventive treatment (TPT) regimen lasting two months or less that matches or exceeds the safety, completion, and tolerability of the standard 4-month rifampin 10 mg/kg regimen. The study will eventually select the best regimen to move forward into a Phase 3 trial for effectiveness and efficacy testing. Participants will be randomly assigned to one of three daily self-administered treatments: the standard 4 months of rifampin at 10 mg/kg, 2 months of rifampin at 20 mg/kg, or 1 month of levofloxacin and rifapentine. A third experimental regimen, such as 1 month of isoniazid plus rifapentine or a novel regimen, may be added later based on ongoing studies. Treatment completion, safety, and tolerability will be monitored closely, with early safety analyses planned after 100 participants complete each new regimen. Enrollment will continue for up to 24 months to assess all regimens. Participants will have scheduled in-person visits and telephone follow-ups during and after treatment to monitor symptoms, adverse events, and adherence. Blood tests and pharmacokinetic sampling will be done at 2 weeks for all. After treatment, participants will be contacted every 3 months for up to 26 months to check for active tuberculosis disease. Safety will be the primary outcome, focusing on severe treatment-related adverse events from the start of treatment until two weeks after completion. The study will also assess regimen completion, tolerability, acceptability, and tuberculosis incidence.