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NCT ID: NCT05651347 Recruiting - Clinical trials for Fetal Growth Retardation

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

PROTECTMe
Start date: May 29, 2019
Phase: Phase 3
Study type: Interventional

Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia. This triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.

NCT ID: NCT05650879 Recruiting - Clinical trials for HER2-positive Metastatic Breast Cancer

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

HER2
Start date: March 20, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

NCT ID: NCT05650866 Recruiting - Clinical trials for Erectile Dysfunction Following Radical Prostatectomy

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

Start date: May 19, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: - Is the device safe? - Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: - Come to the hospital for follow-up visits, - Complete questionnaires, - Activate the device every day, - Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

NCT ID: NCT05650554 Completed - Clinical trials for Influenza Immunization

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older

Start date: December 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) [adults ≥ 65 years of age only], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.

NCT ID: NCT05650528 Recruiting - Healthy Volunteers Clinical Trials

QG101-23-0 Capsules SAD and MAD Study in Healthy Subjects

Start date: February 20, 2023
Phase: Phase 1
Study type: Interventional

The study will consist of three parts: a single-dose ascending (SAD) phase (Part A) enrolling a total of five ~ six cohorts of healthy participants, a multiple-dose ascending (MAD) phase (Part B) enrolling 3 cohorts of healthy participants, and a food effect study (Part C).

NCT ID: NCT05649722 Recruiting - Clinical trials for Pulmonary Hypertension

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Start date: May 11, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.

NCT ID: NCT05649384 Recruiting - Clinical trials for NSTEMI - Non-ST Segment Elevation MI

Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

PRESC1SE-MI
Start date: December 1, 2020
Phase:
Study type: Observational

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.

NCT ID: NCT05648968 Recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

VAYHIA
Start date: December 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.

NCT ID: NCT05648110 Active, not recruiting - Clinical trials for COVID-19, SARS-CoV-2

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

SUPERNOVA
Start date: December 16, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061. Sub-study: This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

NCT ID: NCT05647746 Completed - Clinical trials for Sleep-Disordered Breathing

Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

Start date: December 10, 2022
Phase: N/A
Study type: Interventional

To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing