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NCT ID: NCT03180840 Completed - Fabry Disease Clinical Trials

Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks

BRIGHT
Start date: July 10, 2017
Phase: Phase 3
Study type: Interventional

This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3 years. Safety and efficacy exploratory endpoints will be evaluated throughout the study period and pharmacokinetics will be obtained on Day 1 and Week 52.

NCT ID: NCT03180801 Completed - Influenza Clinical Trials

Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model

Start date: August 18, 2016
Phase: Phase 2
Study type: Interventional

FLU-v is a broad spectrum influenza vaccine that targets regions conserved among multiple influenza strains. FLU-v adjuvanted with Montanide ISA-51 was shown to be safe in previous trials. This study aims to assess efficacy of adjuvanted FLU-v vaccine in protecting healthy volunteers against an influenza challenge delivered intranasally under quarantine. Efficacy of FLU-v will be assessed by measuring the incidence and severity of the disease in the treatment groups compared to the placebo group. In addition, the immune responses of the volunteers to FLU-v will also be explored.

NCT ID: NCT03180619 Completed - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)

Start date: June 29, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.

NCT ID: NCT03179267 Completed - Vital Signs Clinical Trials

Detection of Deterioration by SNAP40 Versus Standard Monitoring in the ED

SNAP40ED
Start date: September 25, 2017
Phase: N/A
Study type: Interventional

In recent years there has been increasing focus on the earlier detection of deterioration in the clinical condition of hospital patients with the aim of instigating earlier treatment to reverse this deterioration and prevent adverse outcomes. This is especially important in the ED, a dynamic environment with large volumes of undifferentiated patients, which carries inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the upper arm that continuously monitors patients' vital signs including relative changes in systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and temperature. It uses automated risk analysis to potentially allow clinical staff to easily and quickly identify high-risk patients. The aim of this study is to investigate whether the SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient earlier than current standard monitoring and observation charting techniques.

NCT ID: NCT03179072 Completed - Clinical trials for End Stage Renal Disease

Dehydr8 and Deactiv8

Start date: July 19, 2017
Phase:
Study type: Observational

Managing fluid status is a complex but fundamental part of the clinical care of people receiving haemodialysis (HD). Day-to-day fluid management is usually based on the concept of 'target weight' - the weight used to determine how much fluid should be removed during each dialysis session. However, the focus of this approach is usually on avoiding fluid overload (hypervolaemia), since this is associated with a higher incidence of cardiovascular and pulmonary events, in addition to increased morbidity and morbidity. As a consequence, a significant proportion of people on maintenance HD spend a great deal of time in a dehydrated state. Although dehydration is known to be associated with a number of unwanted consequences (e.g. headaches, severe fatigue, impaired cognitive and physiological function), there has been little research focusing on the impact dehydration has on the physical and psychosocial well-being of this patient group. Considering the short life expectancy of individuals with end-stage renal disease (ESRD) reliant on maintenance HD, particularly those who are unable to receive a renal transplant, we should be focused on improving their function and quality of life (QoL). Key issues that need addressing prior to developing interventions in this cohort are 1) investigating the best and alternative measures to assess hydration status and 2) documenting the biopsychosocial impact of typical target weight driven HD in a well-designed study.

NCT ID: NCT03178487 Completed - Clinical trials for Ankylosing Spondylitis (AS)

A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis

SELECT-AXIS 1
Start date: October 24, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

NCT ID: NCT03178318 Completed - Clinical trials for Difficult Intubation

Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position

ULOC
Start date: June 19, 2017
Phase: N/A
Study type: Interventional

Ability to provide oxygen to patients undergoing general anaesthesia is crucial. This is traditionally provided using face mask, supraglottic airway (breathing tube above voice box) or endotracheal tube (breathing tube in wind pipe). However in some patients it may be impossible to provide oxygen through any of these above means which can be life threatening and lead to permanent brain damage/death. One of the ideal ways of managing this emergency situation is to pass a breathing tube through a membrane in the front of the neck called cricothyroid membrane with the neck in extension position where permitted. Many studies have recommended identifying the cricothyroid membrane before general anaesthesia in high risk patients but with their head in neutral position. This study will be a pilot study to check if the cricothyroid membrane remains in the same place in neutral and extended positions.

NCT ID: NCT03178279 Completed - Schizophrenia Clinical Trials

The Evaluation of the Use of a New Physical Health Plan

Start date: December 6, 2017
Phase: N/A
Study type: Interventional

People suffering from psychotic illnesses (e.g. schizophrenia) have poorer physical health than the general population. The reasons include a lack of service user motivation to attend physical health checks and the tendency of health professionals to focus mainly on the mental disorder thus delaying the detection of physical health conditions. Identifying people who have physical health needs is increasingly recognised as a priority. The investigators have developed a Physical Health Plan (PHP) which is completed by service users and identifies areas of physical health need. An action plan is then completed by the service user and care co-ordinator to address these issues. The PHP is designed to be very simple to use and there will be 3 versions, 1. paper version, 2. 1 version implemented via the 'IMPARTS' computerised 'tablet' based system that has been separately evaluated (REC Ref 12/SC/0422) and 3. 1 version on an iPad via the MHL2 system via Mindwaves. The investigators wish to pilot the use of this PHP in two community teams in the South London and Maudsley (SLaM) Trust. The pilot will be done in three stages. Stage One: The investigators will undertake an initial qualitative study to refine the process of using the PHP using focus group consultations with staff and service users. Stage Two: The investigators will then undertake a six month study to evaluate the uptake and use of the PHP. This will involve collecting data on how many people complete the PHP and what actions are taken following the completion of the PHP. Stage Three: At the end of this six month period the investigators will undertake qualitative interviews with a selection of service users and staff to understand their experience of using the PHP. The investigators hope to be able to use the results of this pilot study to introduce the use of the PHP into routine care.

NCT ID: NCT03178214 Completed - Clinical trials for Adrenal Insufficiency

Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration

Start date: May 22, 2017
Phase: Phase 1
Study type: Interventional

This is a single centre, open-label, randomised, single dose, three-period, crossover study to evaluate the bioavailability of Infacort® administered as 'sprinkles' with soft food and yoghurt compared with direct administration to the back of the tongue in dexamethasone-suppressed healthy adult male subjects. The study will comprise of a pre-study screen, followed by 3 treatment periods and a post-study follow-up.

NCT ID: NCT03177395 Completed - Clinical trials for Paracetamol Overdose

PP100-01 (Calmangafodipir) for Overdose of Paracetamol

POP
Start date: June 8, 2017
Phase: Phase 1
Study type: Interventional

Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.