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NCT ID: NCT03921723 Completed - HIV Infections Clinical Trials

Dolutegravir Pediatric Liquid Formulation Study

Start date: May 7, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult subjects. The study will contain 6 periods with five prototype liquid formulations for evaluation in fasted state. In period 1, 2 and 3 single reference dose of 2 dispersible tablets of 5 milligram DTG will be administered and at least 2 liquid prototype DTG formulations (containing a target total dose of 10mg DTG). There will be a wash-out period of 7 days between each period. In period 4 through 6, there would be options to evaluate additional prototype liquid formulations. The total duration of study will be up to 17 weeks. DTG has been found to be safe and effective in adults infected with human immunodeficiency virus (HIV). DTG dispersible tablets have been developed primarily for use in children from 4 weeks to 6 years of age, and a DTG liquid formulation are is being developed to study the appropriate dose needed for the HIV-exposed and infected neonatal population in the first four weeks of life. Approximately 18 subjects will be enrolled in this study.

NCT ID: NCT03921541 Completed - Hyperargininemia Clinical Trials

Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency

Start date: April 10, 2019
Phase: Phase 3
Study type: Interventional

CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.

NCT ID: NCT03921268 Completed - Asthma Clinical Trials

Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402

Start date: March 25, 2019
Phase: Phase 1
Study type: Interventional

To evaluate and compare the pharmacokinetics profiles of AZD1402 after oral inhalation as an inhalation powder and a nebuliser solution. To further assess the safety and tolerability of single doses of AZD1402 in healthy volunteers. To evaluate the taste characteristics of the test formulations.

NCT ID: NCT03920384 Completed - Psychosis Clinical Trials

Improving Psychological Therapy for Psychosis: A Case Series

Start date: March 27, 2018
Phase: N/A
Study type: Interventional

Standard psychological therapy for psychosis (Cognitive Behavioural Therapy) is made up of different 'ingredients', also called treatment components. In therapy, different treatment components can be included or excluded depending on the needs of the individual. In this study, the investigators want to find out if standard psychological therapy for psychosis can be improved by including new treatment components. Therefore, participants in this study will be offered psychological therapy for psychosis with new treatment components included or standard psychological therapy for psychosis without new treatment components included. Which of these two options participants are offered will be decided by chance, and during the study neither the study participants nor the researcher will know which of these two variations of psychological therapy are given. Researchers call this a randomized double-blind study. The investigators are aiming to use the results from this study to guide the improvement of psychological therapies for psychosis.

NCT ID: NCT03920371 Completed - Tumour Clinical Trials

Evaluation of a Prototype Hand Held Hybrid Gamma Camera

BIVISTA
Start date: June 13, 2017
Phase: N/A
Study type: Interventional

The aim of the project is to undertake clinical development of a hybrid compact gamma camera that combines gamma ray and optical imaging. It is an extension of the previous pilot study using a newly developed handheld hybrid compact gamma camera in clinical arena.

NCT ID: NCT03920124 Completed - Bronchiectasis Clinical Trials

Feasibility of Interval Exercise in Bronchiectasis

Start date: June 5, 2019
Phase: N/A
Study type: Interventional

Research to date suggests that encouraging increased physical activity and exercise engagement may be an effective way to improve symptoms, fitness, quality of life, and reduce time spent in hospital for bronchiectasis sufferers. However, relatively few patients continue to engage with exercise programs that are of benefit to their health and symptoms. Barriers to exercise are thought to include time constraints and the use of specialist equipment (e.g. cycle ergometers) which may not be available or accessible in the home (or hospital) setting. With these points in mind, there is growing interest in brief, relatively intense, interval exercise interventions for chronic lung disease sufferers as they require minimal equipment and may more easily translate back into the home setting. Of the types of approach this might include, both stair-based and walk-based interval exercise appear to be relatively safe, practical, and time-efficient ways to improve physical fitness and quality of life in previously untrained and clinical populations. However, the feasibility and effectiveness of their use by chronic lung disease patients, particularly those with bronchiectasis, is yet to be properly examined. The investigators therefore intend to recruit 10 bronchiectasis patients to explore the feasibility and effectiveness of minimal-equipment interval exercise interventions in this population. More specifically, the investigators would like to observe patients' acute physical and perceptual responses to four different step and walk-based protocols which have been established for other clinical populations. The investigators also wish to explore whether these protocols are engaged with, and enjoyed, during a six week unsupervised exercise intervention (in the home), as well as the effects of this six week unsupervised exercise period on physical fitness. This project will hopefully make a valuable contribution to the limited research to have examined the real-world application and impact of interval-type exercise interventions on exercise behaviour, health, and symptoms in bronchiectasis sufferers.

NCT ID: NCT03920111 Completed - Clinical trials for Japanese Encephalitis

Flavivirus Cross-priming Potential of IMOJEV

FlaviPrime
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

There is a pressing need for a better experimental system to understand flavivirus antibody responses, beyond dengue, to make sure the investigators are using current vaccines to greatest effect and to inform the development of next-generation vaccines. This study will use live chimeric JE vaccine IMOJEV® as a tool for flavivirus epitope discovery. This will allow experimental JEV infection using replication competent, live, attenuated virus as a model, in a setting where the flavivirus infection history of humans can be tightly controlled.

NCT ID: NCT03920085 Completed - Diabetes Mellitus Clinical Trials

Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

Start date: January 8, 2019
Phase: N/A
Study type: Interventional

Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

NCT ID: NCT03920072 Completed - Clinical trials for X-linked Hypophosphatemia

Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

Start date: March 7, 2019
Phase: Phase 3
Study type: Interventional

This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).

NCT ID: NCT03919890 Completed - Clinical trials for Venous Thromboembolism

A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers

Start date: January 17, 2019
Phase: Phase 1
Study type: Interventional

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-7684 in healthy adult volunteers. This study will be conducted in 2 parts: Part A is a single-ascending dose and Part B is a multiple-ascending dose.