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NCT ID: NCT03238040 Completed - Critical Illness Clinical Trials

Biomarkers of Acute Serious Illness in Children

BASIC
Start date: April 1, 2014
Phase:
Study type: Observational

This study is a large multi-centre collaboration between a busy regional paediatric intensive care transport service (Children's Acute Transport Service, CATS), four large paediatric intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of Paediatrics at Imperial College, London. CATS transports over 800 sick children on life support to the three PICUs each year. We aim to improve our understanding of the genetic basis and biological pathways by which children with acute infection or injury become critically ill and develop failure of vital organs, and how these factors influence outcome. We will establish well-characterised cohorts of sick children with diverse pathologies, in whom blood, urine and other samples will be collected at an early stage of critical illness. Samples will be analysed using genomic, transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will be used to identify biomarkers for early diagnosis and robust risk stratification. We will focus on biomarkers to help distinguish between serious bacterial infections, viral infections and other causes of critical illness; diagnose incipient organ failure; and accurately identify, early on, children at high risk of developing a poor outcome. We will recruit critically ill children at first contact with the CATS team, during emergency transport to PICU. Due to the emergency nature of the research, and minimal risk associated with the study procedure, we will seek deferred, written informed consent from parents/guardians once their child has been stabilised, within 24-48 hours following PICU admission. By studying these important questions, we aim to better understand how we can diagnose and provide early life-saving treatments to critically ill children. The research team have an established track record of successful completion of several large clinical studies in critical care as well as validation of biomarkers in other diseases.

NCT ID: NCT03237741 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants

Start date: August 7, 2017
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female volunteers of non-childbearing potential. The first part of the study will compare the bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference capsule (Periods 1 and 2). The second part of the study will assess the effect of GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).

NCT ID: NCT03237325 Completed - Oral Mucositis Clinical Trials

DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

Start date: December 4, 2017
Phase: Phase 3
Study type: Interventional

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

NCT ID: NCT03236974 Completed - Clinical trials for Postmenopausal Women With ER+ HER2- Primary Breast Cancer

Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.

D6090C00002
Start date: October 5, 2017
Phase: Phase 1
Study type: Interventional

This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2) negative (HER2-) primary breast cancer. Patients will receive AZD9496 or fulvestrant and will have an on-treatment image -guided core biopsy after 5-14 days of commencing treatment.

NCT ID: NCT03236857 Completed - Neuroblastoma Clinical Trials

A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Start date: November 8, 2017
Phase: Phase 1
Study type: Interventional

An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

NCT ID: NCT03236506 Completed - Hepatitis C Clinical Trials

A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study

ADVANCE
Start date: January 19, 2018
Phase: Phase 2
Study type: Interventional

Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000 Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV infection is intravenous drug use. As HCV is highly infectious by the blood borne route through needle sharing, it can infect the person who injects drugs (PWID) early in their habit. Around two thirds of people who are infected are unaware of it, and often show no symptoms over a long period of time. While there is presently no vaccination for Hepatitis C, improved treatments with shorter duration are now available. This raises the possibility of using therapy as prevention, turning the epidemic off at source, by targeting active PWID who are the main source of new infections. Modelling work illustrates the startling possibility and impact of treating drug users to reduce the prevalence of HCV. The focus of this trial will be to ascertain whether oral treatment regimens are effective in the treatment as prevention scenario in an active PWID population where illicit drug taking and poor adherence may reduce treatment efficacy. The investigators will trial 3 different methods of delivering treatment and will trial an unlicensed combined treatment against HCV genotype 3 infection of shortened duration since current regimens for this genotype are limited. The investigators will recruit 135 participants and randomise them to one of three arms: daily, directly observed therapy; fortnightly dispensing of drugs; fortnightly dispensing of drugs with a psychological adherence intervention. Randomisation will be stratified according to HCV genotype. Participants will be treated for 12 or 8 weeks depending on genotype and followed up 12 weeks post treatment for the measurement of sustained viral response (SVR). The primary outcome measure will be SVR at 12 weeks post treatment (SVR12), as this measure of cure is the determinant of sufficient compliance and efficacy within the 3 treatment arms. Analysis will be by modified intention to treat of all participants who receive one dose of therapy, to show non-inferiority fortnightly dispensing is easier to deliver than daily dispensing.

NCT ID: NCT03236233 Completed - Clinical trials for Respiratory Syncytial Virus (RSV)

A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786

Start date: June 21, 2017
Phase: Phase 1
Study type: Interventional

This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.

NCT ID: NCT03235726 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug

Start date: July 13, 2017
Phase: Phase 1
Study type: Interventional

This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.

NCT ID: NCT03235115 Completed - Myopia Clinical Trials

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Start date: June 23, 2017
Phase: N/A
Study type: Interventional

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

NCT ID: NCT03232944 Completed - Heart Failure Clinical Trials

Personalized CRT - MPP Post Approval Study

Start date: July 5, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).