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NCT ID: NCT04570657 Completed - Asthma Clinical Trials

Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma

FRONTIER-3
Start date: September 17, 2020
Phase: Phase 2
Study type: Interventional

Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.

NCT ID: NCT04563208 Completed - Covid19 Clinical Trials

Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19

DuACT
Start date: December 9, 2020
Phase: Phase 2
Study type: Interventional

This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 72 hours prior to testing.

NCT ID: NCT04561063 Completed - Covid19 Clinical Trials

COVID-19 Prophylaxis South Africa (COVER HCW)

COVER
Start date: December 8, 2020
Phase: Phase 2
Study type: Interventional

This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.

NCT ID: NCT04556981 Completed - Clinical trials for Human Immunodeficiency Virus

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV

MESA-TB
Start date: November 17, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).

NCT ID: NCT04551898 Completed - Covid19 Clinical Trials

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19

NCT ID: NCT04550832 Completed - Clinical trials for Pulmonary Tuberculosis

PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)

DECODE
Start date: October 22, 2021
Phase: Phase 2
Study type: Interventional

This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose Bedaquiline, Delamanid and Moxifloxacin alone

NCT ID: NCT04536818 Completed - Clinical trials for Penetrating Abdominal Trauma

Outcomes After Laparotomy for Penetrating Abdominal Trauma

Start date: April 1, 2019
Phase:
Study type: Observational

The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.

NCT ID: NCT04534816 Completed - Abdominal Injuries Clinical Trials

Feasibility and Usability of Intraoperative Fluorescent Angiography With Indocyanine Green in Penetrating Abdominal Trauma

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

The surgical management of penetrating bowel and intestinal injuries, inflicted via a gunshot or knife stabbing, has long been a topic of debate [1-3]. The surgical management principally consists of: (i) primary repair; (ii) primary diversion or (iii) an initial abbreviated so called "damage control" operation followed by a definitive surgical intervention once the patient is stabilized [4-9] . Different classifications systems have been proposed to help determine the best operative option [2,3,10-14], but intestinal injuries can be difficult to manage and despite improvements in the diagnostics and treatment of penetrating abdominal trauma, high mortality and morbidity rates are prevalent [15,16]. In order to determine the correct surgical option an accurate determination of intestinal viability is essential. But clinically assessing regional perfusion is challenging and surgeons' clinical risk assessment of anastomotic leaks have shown a low predictive value [17]. Hence, there is a need for more precise diagnostic tool helping the surgeon in assessing intestinal viability the extent of intestinal injury. Indocyanine green (ICG) fluorescence angiography (ICG-FA) is an applied method for to assessing visceral perfusion worldwide. The obtained fluorescent signal after intravenous injection, is considered proportional to blood flow, thus aiding the surgeon to detect and address inadequate regional perfusion, despite satisfactory macroscopic appearance, intraoperatively [18-21]. Hence, the use of perioperative ICG-FA, has reduced the risk of anastomotic leaks after esophageal and colorectal surgery [22-25] and in the setting of acute mesenteric ischemia, significantly reduced the extent of intestinal resection [26]. In retrospective review of 186 war related trauma cases the use of ICG-FA was deemed useful however only 9 of these cases were truncal/abdomen/gastrointestinal and no objective definition of usability was provided [27]. Hence, data on the usability and feasibility of ICG-FA for in penetrating abdominal trauma is limited and to our knowledge has not been investigate in a civilian population previously. The present study aimed to investigate the usability and feasibility of ICG-FA in patients undergoing open abdominal exploration for penetrating abdominal trauma

NCT ID: NCT04533529 Completed - Clinical trials for Depressive Disorder, Major

A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant and Long-term Safety Extension Treatment With Seltorexant

Start date: September 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.

NCT ID: NCT04533399 Completed - COVID-19 Clinical Trials

A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults

Start date: August 17, 2020
Phase: Phase 2
Study type: Interventional

This is a study to evaluate the effectiveness and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in a minimum of approximately 2,960 to a maximum of approximately 4,164 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 15 sites across South Africa. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in these study populations. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study.