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NCT ID: NCT04904549 Active, not recruiting - COVID-19 Clinical Trials

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 purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows: - For participants who initially received vaccine: 12 months post-booster (ie, approximately 18 to 24 months) - For participants who initially received placebo: ≥ 4 months post-last dose of the primary series + 12 months post-booster (ie, approximately 28 to 34 months) - For participants who do not consent to continue in the unblinded Crossover / Booster part of the study, all study procedures will be stopped and participants will be discontinued from the study.

NCT ID: NCT04518306 Completed - Hypertension Clinical Trials

Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension

GMRx2_PCT
Start date: June 6, 2021
Phase: Phase 3
Study type: Interventional

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to placebo.

NCT ID: NCT04518293 Completed - Hypertension Clinical Trials

Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

GMRx2_ACT
Start date: June 26, 2021
Phase: Phase 3
Study type: Interventional

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

NCT ID: NCT04287985 Completed - 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).

NCT ID: NCT03382470 Completed - Clinical trials for Resistance Bacterial

Impact of Antimicrobial Stewardship Programs in the Global Setting

PEARL
Start date: March 12, 2018
Phase:
Study type: Observational

Antimicrobial resistance is one of the greatest threats to human health, and is driven by inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials in hospitals. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania.

NCT ID: NCT03347136 Completed - Clinical trials for Respiratory Distress of Newborn

Comparison of Continuous Positive Airway Pressure and Non Invasive Positive Pressure Ventilation

Start date: January 10, 2015
Phase: N/A
Study type: Interventional

The objective of the study is to compare the effectiveness of treatment with Non Invasive Positive Pressure Ventilation (NIPPV) and continuous positive airway pressure (CPAP) in decreasing the requirement for endotracheal ventilation in neonates with respiratory distress within the first hours of birth.Primary outcome is the non invasive respiratory support failure and the need for intubated ventilatory support during the first 72 hours of life. Randomized control , single center trial. Eighty neonates admitted to Neonatal Intensive Care Unit (NICU) were randomly allocated to NIPPV and CPAP. Outcomes of respiratory support were observed and information on risk factors were obtained by going through bed head ticket.

NCT ID: NCT03305939 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Lifestyle Intervention IN Gestational Diabetes (LIVING)

LIVING
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Investigators have taken the learning from various programs to develop a new lifestyle program (LIVING) that has a high probability of being feasible, acceptable and cost-effective in the South Asian context for women with prior Gestational Diabetes Mellitus (GDM). Investigators will optimize this intervention using an iterative, systems-based and user-centered approach. The intervention will be delivered by auxiliary nurse midwives or their equivalent in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. Investigators will then evaluate this in a Randomised Controlled Trial (RCT) to determine whether it will reduce the incidence of Type 2 Diabetes Mellitus (T2DM), in a manner that is affordable, acceptable and scalable. This project focuses on generating new knowledge around implementation of a preventive strategy embedded within existing health systems, using mixed-methods evaluation to inform on cost-effectiveness, acceptability and scalability. It represents a case study into "Integrated Innovation TM" incorporating a science component (a program based on behavior change theory that supports a multi-level approach to prevention by combining individually targeted strategies with social support), a social component (an innovative workforce strategy) and a sustainability component (a systems perspective for integration with existing health system infrastructure).