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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

Age: 55Years +All GendersPhase 4
105 locations
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Actively Recruiting

The ICU-related Out-of-Pocket Expenses ICOPE study is a multinational, prospective observational study conducted in African and Asian countries to understand the financial impact of ICU care on patients and their families. The study focuses on measuring out-of-pocket expenses and the occurrence of catastrophic health expenditure among patients who stay in the ICU for more than 24 hours, including those who receive mechanical ventilation and those who do not. The study addresses the rising cost burden related to ICU care in low- and middle-income countries LMICs and aims to identify factors contributing to financial hardship. Participants include all patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. The study compares groups of patients receiving invasive mechanical ventilation with those who do not, tracking their ICU-related expenses. The follow-up period extends from ICU admission to discharge, with additional assessments at 30 days and 6 months, spanning a total study duration of 18 months. During the study, researchers will collect detailed information about direct and indirect costs associated with ICU care, including medical and non-medical expenses. They will also examine how families cope with these costs and identify risk factors for catastrophic health expenditure. The primary outcomes include out-of-pocket cost per patient episode and the relative risk of catastrophic health expenditure by ICU discharge. Secondary outcomes include risk factors for catastrophic expenditure and the frequency of various coping strategies used by families.

All Genders
44 locations
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Actively Recruiting

This research aims to evaluate the use of a lower international normalized ratio INR target range of 1.5 to 2.5 in patients with a mechanical bileaflet heart valve placed in the aortic position. The study seeks to determine whether lowering the INR target can reduce bleeding risks without increasing the chance of blood clots or stroke. This is important because patients with mechanical heart valves require lifelong warfarin Coumadin treatment to prevent clot formation, but managing the right balance between clot prevention and bleeding risk remains challenging. Participants will be randomly assigned to one of two groups. One group will receive warfarin therapy adjusted to a lower INR target range of 1.5 to 2.5, while the other group will have warfarin adjusted to a standard INR target range as currently recommended. Both groups will receive warfarin after their mechanical valve implant, but the INR targets for blood thinning will differ. The study includes follow-up over an expected mean of 2 to 3 years to monitor outcomes. During the study, participants will be regularly monitored for blood clot events such as thrombosis or stroke, as well as bleeding episodes, including major and minor bleeding. Researchers will track various outcomes like mortality, different types of stroke, heart attacks, pulmonary embolism, and kidney function over the study period. Time in the therapeutic INR range and occurrences of extreme INR values will also be recorded. Participants will be followed through the study duration, which will help determine the safety and risk balance of using a lower INR target in this patient group.

Age: 18Years +All GendersPhase 3
35 locations
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Actively Recruiting

Hypertensive disorders during pregnancy HDP and gestational diabetes GDM are common complications that can cause serious health problems for mothers and babies. Researchers are studying the MOM-HD program, a mobile app-based telemonitoring system, to see if it helps women with HDP and GDM manage their blood pressure and blood glucose better. This study is a randomized controlled trial conducted in real-world hospital settings in Nepal, aiming to assess both the effectiveness and how well the program can be implemented in clinical care. The MOM-HD program includes training for patients and their families, provision of blood pressure monitors and glucometers, and a mobile app for uploading daily readings. Participants also have biweekly tele-visits with nurses who review their data and provide counseling. The study compares standard antenatal care alone to standard care plus the MOM-HD program, from enrollment during pregnancy up to 6 weeks after delivery. The program also involves ongoing technical support, financial assistance for home monitoring, and provider feedback to support sustained use. Participants will be followed from 24 to 30 weeks of pregnancy until 6 weeks postpartum. Researchers will monitor clinical outcomes such as blood pressure and blood glucose levels, and adverse perinatal events like neonatal intensive care admissions and cesarean deliveries. The study collects data through the app and provider portal, with regular telehealth check-ins, and evaluates implementation success and costs. Total participation lasts from enrollment in late pregnancy through the postpartum period, allowing comprehensive assessment of both health and program impact.

Age: 18Years +FEMALEPhase Not Applicable
3 locations