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NCT ID: NCT05395195 Not yet recruiting - Encephalopathy Clinical Trials

Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)

EMBRACE
Start date: December 1, 2022
Phase: Phase 3
Study type: Interventional

One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year. Cooling therapy in the context of modern tertiary intensive care improves outcome after NE in high-income countries. However, the uptake and applicability of cooling therapy in LMICs is poor, due to the lack of intensive care and transport facilities to initiate and administer the treatment within the six-hours window after birth as well as the absence of safety and efficacy data on hypothermia for moderate or severe NE. Erythropoietin (Epo) is a promising neuroprotectant with both acute effects (anti-inflammatory, anti-excitotoxic, antioxidant, and antiapoptotic) and regenerative effects (neurogenesis, angiogenesis, and oligodendrogenesis),which are essential for the repair of injury and normal neurodevelopment. Pooled data from 5 small randomized clinical trials (RCTs) (n=348 babies), suggests that Epo (without cooling therapy) reduce the risk of death or disability at 3 months or more after NE (Risk Ratio 0.62 (95% CI 0.40 to 0.98). Hence, a definitive trial (phase III) for rigorous evaluation of the safety and efficacy of Epo monotherapy in LMIC is now warranted.

NCT ID: NCT05109611 Recruiting - Clinical trials for SARS-CoV-2 Infection

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

Start date: November 20, 2021
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection.

NCT ID: NCT05051774 Recruiting - Clinical trials for Coronary Heart Disease

Effectiveness of a Motivated, Action-based Intervention on Health Outcomes of Coronary Heart Disease Patients

Start date: August 15, 2021
Phase: N/A
Study type: Interventional

Coronary heart disease (CHD), the major group of cardiovascular disorders, is the leading cause of cardiac-associated mortality, causing >9 million death in 2016. American Heart Association (AHA) and the American College of Cardiology Foundation (ACCF) recognized that lifestyle modification including physical activity is the class one-level recommendation for secondary prevention and risk reduction therapy for patients with CHD. The assessment of physical activity and confidence in performing exercise for patients with CHD will help healthcare professionals to develop and implement the appropriate intervention to enhance patients' confidence in performing exercise and physical activity to promote and maintain their health. With the increasing morbidity and mortality from CHD, especially in low and middle-income countries, secondary prevention including exercise-based cardiac rehabilitation (CR) plays an important role to improve the prognosis of CHD patients. High prevalence of physical inactivity, unhealthy dietary practices, poor control of blood glucose, blood pressure (BP), blood lipid, and body weight (BW) was found among CHD patients in the world as well as in Sri Lanka. Therefore, it is important to design and implement an appropriate intervention to improve the physical activity level, exercise self-efficacy, and cardiovascular risk factors in CHD patients in Sri Lanka. This study aims to develop and examine a culturally specific motivated, action-based intervention for improving physical activity level, exercise self-efficacy, and cardiovascular risk factors of CHD patients in Sri Lanka. The participants will be patients who admitted to the coronary care unit (CCU) and medical wards of the Teaching Hospital Batticaloa, Sri Lanka with CHD for the first time confirmed by electrocardiogram with aged 18 years or above, able to reads and speak Tamil, able to attend clinic follow-up, obtain a medical clearance from a cardiologist to perform the exercise and, able to understand and give informed consent. The medical records of the CHD patients will be reviewed to screen for their eligibility. In addition, the cardiologist of the participants will be consulted for their suitability to perform the exercise of the intervention. The purpose of the study, the data collection procedures, the potential risk and benefits, the maintenance of confidentiality, and the voluntary basis of participation will be clearly explained to the participants, and informed written consent will be obtained before data collection. Ethical approval was obtained from The Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee and Ethics Review Committee, Faculty of Health Care-sciences, Eastern University, Sri Lanka. The Statistical Package for Social Science version 22.0 software (SPSS 22.0) will be used to analyze the data and the p-value less than 0.5 will be considered as significant. This study will provide evidence on the effectiveness of a motivated, action-based intervention on the physical activity level, cardiovascular risk factors, and exercise self-efficacy of CHD patients in Sri Lanka. Findings from this study could be useful to promote healthy lifestyle behaviors in CHD patients in a low-resource setting. Furthermore, this study will provide information on which level this intervention could be applied and possible constraints that hinder the outcomes of the results.

NCT ID: NCT04904549 Recruiting - Clinical trials for COVID-19 (Healthy Volunteers)

Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older

VAT00008
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are: - To assess, in participants who are severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) naïve, the clinical efficacy of the SARS-CoV-2 vaccines for the prevention of symptomatic COVID-19 occurring ≥ 14 days after the second injection. - To assess the safety of the SARS-CoV-2 vaccines compared to placebo throughout the study. The main secondary objectives of the study are to assess, in SARS-CoV-2 naïve participants, the efficacy of the SARS-CoV-2 vaccines against: - SARS-CoV-2 infection occurring ≥ 14 days after the second injection. - Severe disease occurring ≥ 14 days after the second injection. - Asymptomatic infection and symptomatic COVID-19 occurring ≥ 14 days after the first injection.

NCT ID: NCT04381936 Recruiting - Clinical trials for Severe Acute Respiratory Syndrome

Randomised Evaluation of COVID-19 Therapy

RECOVERY
Start date: March 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

RECOVERY is a randomised trial investigating whether treatment with Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Infliximab, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) prevents death in patients with COVID-19.

NCT ID: NCT04341662 Recruiting - Clinical trials for Post-Partum Haemorrhage

A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth

E-MOTIVE
Start date: October 13, 2020
Phase: N/A
Study type: Interventional

Every six minutes a mother dies from postpartum haemorrhage (PPH) in low-resource countries, in the prime of her life and often leaving behind a young family. In many settings, when a mother dies in childbirth, her infant has less than a 20% chance of surviving past the first month. PPH, defined as a blood loss of more than 500 ml, is the leading cause of maternal death worldwide, accounting for 27% of maternal deaths. The WHO published "Recommendations for the Prevention and Treatment of Postpartum Hemorrhage" in 2012 to provide evidence-informed recommendations for managing PPH. However, adherence to these recommendations is currently limited by a number of challenges. This primary aim of this multi-country, parallel cluster randomised trial with a baseline control phase, along with mixed-methods and health economic evaluations, is to evaluate the implementation of early detection and the use of the World Health Organisation (WHO) MOTIVE 'first response' treatment bundle for postpartum haemorrhage (PPH) on clinical, implementation and resource use outcomes. The investigators will evaluate the implementation through mixed-methods and carry out a health economic evaluation from the public healthcare system perspective.

NCT ID: NCT04287985 Active, not recruiting - Clinical trials for Immunoglobulin A Nephropathy

Safety and Efficacy Study of VIS649 for IgA Nephropathy

Start date: July 20, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)

NCT ID: NCT04098198 Completed - Biomarker Clinical Trials

Biomarkers for Inborn Errors of Metabolism

BioMetabol
Start date: August 1, 2019
Phase:
Study type: Observational

International, multicenter, observational, longitudinal study to identify or monitor Inborn Error of Metabolism disease biomarkers and to explore the clinical robustness, specificity, and long-term variability of these biomarkers

NCT ID: NCT03922594 Terminated - Microcephaly Clinical Trials

Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia

Start date: May 20, 2019
Phase:
Study type: Observational [Patient Registry]

This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia. This will inform regional public health strategies, such as vaccination of women of child-bearing age. It will also demonstrate the public health impact of ZIKV infection and increase the understanding of other regional infectious (e.g. cytomegalovirus) causes of microcephaly.

NCT ID: NCT03588026 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576

CAPSTONE
Start date: June 7, 2018
Phase: Phase 3
Study type: Interventional

rVA576 for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).