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NCT ID: NCT02387606 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

Start date: May 7, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral effect of repeated oral dosing of JNJ 53718678 compared to placebo in healthy adult participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b virus.

NCT ID: NCT02387580 Completed - Malaria Clinical Trials

Bioavailability Study of Oral OZ439 Prototype Granule Formulations Administered With Piperaquine Phosphate (PQP) Tablets

Start date: April 2015
Phase: Phase 1
Study type: Interventional

This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male subjects and female subjects of non-childbearing potential.

NCT ID: NCT02386839 Completed - Clinical trials for Retinopathy of Prematurity (ROP)

Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

PEDAL
Start date: March 26, 2015
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).

NCT ID: NCT02386761 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001

CHF6001Ext
Start date: November 2014
Phase: Phase 1
Study type: Interventional

A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

NCT ID: NCT02386436 Completed - Clinical trials for Scleroderma, Systemic

A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects

Start date: April 21, 2015
Phase: Phase 1
Study type: Interventional

GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is being developed for the treatment of inflammatory and fibrotic diseases. This first time in human study will evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profile of single ascending subcutaneous (s.c.) doses of GSK2330811, in healthy subjects. This study will be a randomised, double-blind (sponsor open), placebo-controlled, single centre, single dose escalation study of s.c. administrations of GSK2330811 in healthy subjects. Approximately 40 subjects will be enrolled in the study, across 5 cohorts. Each cohort is planned to consist of 8 subjects, randomised such that 6 subjects will receive GSK2330811 and 2 subjects will receive placebo. The starting dose for the study will be 0.1 milligram (mg)/kilogram (kg) s.c. single dose and the highest dose will be 6 mg/kg s.c. single dose. Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). On Day 1, each subject will receive a s.c. dose of GSK2330811 or placebo. Subjects will then remain as an in-patient until discharged on Day 8, after assessments have been performed. The duration of the study, including screening, is approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5.

NCT ID: NCT02385513 Completed - Clinical trials for Streptococcus Pneumoniae

PCV10 Immunogenicity Study Nepal 2015

Start date: August 21, 2015
Phase: Phase 4
Study type: Interventional

A single centre open-label, parallel group, randomised controlled trial, recruiting healthy Nepalese infants aged 40-60 days, who present to the immunisation clinic at Patan Hospital, Kathmandu, Nepal, randomised to receive a 10-valent pneumococcal conjugate vaccine (PCV10) at either; 1. 6+10 weeks and 9 months OR 2. 6+14 weeks and 9 months The study will enroll 152 healthy Nepalese infants in each treatment arm (304 in total). Demographic and clinical data will be collected on an electronic case report form to allow monitoring remotely. Participants will receive the study vaccine according to their allocated treatment arm in addition to their other routine vaccines. The investigators will collect 3 blood samples for analysis of serum antibody responses to the PCV10 vaccine serotypes throughout infancy (see Table 1). The data collected will be analysed in order to determine whether the 6+10 schedule is non-inferior to the 6+14 schedule in generating immune responses against the vaccine serotypes above the ≥0•35μg/mL threshold. These data will then be used to inform decision-making around augmenting the currently recommended 6+14 schedule to a 6+10 schedule in Nepal. The investigators will collect a nasopharyngeal swab at 2 time points to look at carriage of pneumococcus over time and to assess differences between the 2 groups. This is of critical importance because much of the programmatic impact of PCV is ultimately conferred by reductions in carriage at the community level and indirect effects resulting from that nasopharyngeal (NP) protection.

NCT ID: NCT02385344 Completed - Clinical trials for Coronary Artery Bypass

Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery

REQUEST
Start date: April 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.

NCT ID: NCT02385175 Completed - Clinical trials for Eustachian Tube Dysfunction

The Accuracy of Tests of Eustachian Tube Function

Start date: February 2016
Phase:
Study type: Observational

The Eustachian tube links the middle ear to the back of the nose and is designed to open to allow the pressure in the air-filled middle ear to be equal to external (atmospheric) pressure. In some people this system fails to work properly leading to abnormal pressure in the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'. An affected person may feel pressure, pain or other symptoms in their ear, and their hearing can be temporarily or permanently reduced. This study is designed to find out which of a number of simple tests is best at detecting if the Eustachian tube is performing normally. Both patient-completed questionnaires and clinical tests using specialist machines will be compared as a way of diagnosing Eustachian tube dysfunction. A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a similar group of people that are already known to have Eustachian tube dysfunction, will both take six different tests and complete four different questionnaires. The differences in the results between the group with ETD and the healthy group will be compared. The results for each test or questionnaire will be compared to see which is best at telling the healthy and Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube dysfunction. The investigators will also look to see if a combination of one or more of the tests or questionnaires is best at diagnosing the disease. The results of this study hope to provide a test or combination of tests that can be used on a daily basis by ENT doctors. The assessment technique would also be helpful in researching and comparing new treatments for ETD.

NCT ID: NCT02385071 Completed - Healthy Clinical Trials

A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants

Start date: April 28, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV following single dose administration of a selected age-appropriate oral formulation candidate.

NCT ID: NCT02385045 Completed - Gastritis Clinical Trials

i-Scan for the Detection of Helicobacter Pylori

Start date: October 2014
Phase: N/A
Study type: Interventional

This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.