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NCT ID: NCT04501666 Completed - Prurigo Nodularis Clinical Trials

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Start date: September 11, 2020
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.

NCT ID: NCT04501263 Completed - Constipation Clinical Trials

Educational Intervention for Management of Constipation

DEMCON
Start date: October 1, 2018
Phase:
Study type: Observational

The overall aim of the study is to develop and test the feasibility and acceptability of a novel educational intervention for HCPs to help them manage constipation experienced by people in the hospice setting. This stage aims to establish the feasibility of, and to pilot, a novel educational intervention for HCPs. Additionally, it also originally aimed to test the feasibility of the chosen measures of change in patient care, however this was not undertaken. In order to achieve this aim, the objectives are to: - Implement the educational intervention across Marie Curie sites. - Evaluate the likely effectiveness of the educational intervention on the knowledge and self-efficacy of HCPs. - Explore the feasibility and acceptability of the educational intervention with HCPs, and identify factors associated with feasibility/acceptability - Explore the feasibility and acceptability of research procedures, and identify factors associated with feasibility/acceptability - Examine the effect of contextual factors upon the implementation and sustainability of the educational intervention in the hospice. - Examine the suitability of outcome measures for HCPs

NCT ID: NCT04499872 Completed - Clinical trials for Advance Care Planning

Planning for Future Care With Patients With Advanced Cancer

Start date: July 10, 2019
Phase:
Study type: Observational

Advance Care Planning (ACP) is a process where patients (and their families if appropriate) discuss with their doctors and nurses what may happen as their illness progresses, including how they (and their family) would like to be supported and cared for. The discussion of expectations and choices for care can then be formally recorded and used to guide and inform future care. Well documented benefits of ACP include empowering patients and their families to better understand available choices and make informed decisions regarding future care; This ensures care is based on what is important to that patient (and their family) and prepares all for the end of life. However, few people with a life limiting illness (such as cancer) have an ACP. Patients and families often find future and end of life care a difficult subject to discuss, as do doctors/nurses, who fear upsetting patients and families and who may have limited training/experience in how to prompt and record ACP discussions. This project aims to overcome the barriers in discussing ACP by using the Trajectory Touchpoint Technique. The technique utilises a range of existing service evaluation and service design methods found in "service management" and "design systems". Rich pictures are used in the form of cartoons on an electronic tablet or printed card, to enable patients/families to lead discussions. The images are simple and enable people to raise sensitive and potentially distressing topics at a pace they are comfortable with, rather than responding to numerous pre-determined questions. The technique was originally designed to explore the experiences of patients (and their families) of Hospice Care and has been successfully used in over 200 interviews, demonstrating an ability to sensitively facilitate difficult conversations whilst enabling rich and detailed discussion.

NCT ID: NCT04499677 Completed - COVID-19 Clinical Trials

FLARE: Favipiravir +/- Lopinavir: A RCT of Early Antivirals

FLARE
Start date: September 24, 2020
Phase: Phase 2
Study type: Interventional

The current pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. Antiviral medications are most likely to be effective when administered soon after infection. There is therefore an urgent need to study subjects who have recently developed symptoms, or have recently been tested positive with or without symptoms, and who can be sampled frequently to understand changes in viral load. This cohort will allow us to collect detailed trajectory data on early disease and understand how pharmacological interventions may affect this. The objective of the FLARE trial is to assess whether early antiviral therapy with either favipiravir + Lopinavir/ritonavir (LPV/r), LPV/r or favipiravir is associated with a decrease in viral load compared with placebo. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.

NCT ID: NCT04495530 Completed - Cancer Clinical Trials

Information Needs Around Parenteral nUTrition in Cancer

INPUT
Start date: January 19, 2021
Phase:
Study type: Observational

This study will explore the information needs of patient's with advanced cancer, and their carers, when making a decision to commence or discontinue parenteral nutrition. Interviews will be conducted with both patients with advanced cancer, and their carers to determine the information they need to make a shared decision with the healthcare team.

NCT ID: NCT04495062 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

The Use of Wearable Technology to Acquire Signals for COPD Research

Start date: September 1, 2020
Phase:
Study type: Observational

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition which affects approximately 3 million people in the UK and 210 million worldwide. The disease is characterized by progressive air flow obstruction and decline of lung function. COPD is currently the fourth leading cause of death in the world. The main reason for hospitalisations associated with COPD is exacerbations (chest infections or a worsening of the underlying symptoms). Severe COPD exacerbations are the second largest cause of emergency admissions in the UK. Mild and moderate exacerbations can be managed in the community but if they are not identified promptly they may progress to breathlessness and in some patients to respiratory failure. Thus, finding modalities for early detection and diagnosis of exacerbations is clearly a priority for current and future COPD research. However, these still do not exist. The aim of this study will be to acquire acoustic respiratory signals from COPD patients with a small wearable device. These signals will be subsequently used to carry out engineering research with the objective of trying to find "fingerprints" in them which could be early indicators of disease exacerbations. If those "fingerprints" were found, subsequent research could focus on trying to create software methods which, together with the use of a small wearable device, would aim at automatically detecting exacerbations when they are at very early stages- prior to the symptoms being evident to the patient- so that clinical intervention could be triggered, in order to optimize the disease outcomes.

NCT ID: NCT04494594 Completed - Mental Health Issue Clinical Trials

Drinks:Ration - Combat Stress Randomized Controlled Trial

Drinks:Ration
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. The main objective of this participant blinded (single-blinded) Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing weekly self-reported alcohol consumption between baseline and 3-month follow-up among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting. Methods: In a two-arm single-blinded Randomised Controlled Trial (RCT), a smartphone app which includes interactive features designed to enhance participant motivation and personalised messaging is compared to a smartphone app which only provides Government guidance on alcohol consumption. The trial will be conducted in a veteran population who have sought help through Combat Stress; a UK veteran's mental health charity. Recruitment, consent and data collection is performed automatically through the Drinks:Ration platform. The primary outcome is change in self-reported weekly alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption; secondary outcome measures include 1) change in baseline to 3-month follow-up (day 84) Alcohol Use Disorder Identification Test score, and 2) change in baseline to 3-month follow-up (day 84) World Health Organisation Quality of Life-BREF score to assess Quality of Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability ratings as measured by the mHealth App Usability Questionnaire. The primary and secondary outcomes will also be re-assessed at 6-month follow-up (day 168) to assess the longer-term benefits of the intervention and reported as a secondary outcome. The study will begin recruitment in September 2020 and is expected to require 12 months to complete. Study results should be published in 2022.

NCT ID: NCT04493866 Completed - Quality Improvement Clinical Trials

Quality Improvement Study on Operative Consent Forms

Start date: January 6, 2020
Phase:
Study type: Observational

A Quality Improvement Project was undertaken to improve the completion of operative consent forms within a UK hospital plastic surgery department. Four weekly interventions were made which were accompanied by four further data collection cycles.

NCT ID: NCT04493593 Completed - Insomnia Clinical Trials

Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility

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

The principal objective of the study is to assess the feasibility and preliminary efficacy of an online-delivered CBT-I intervention for those with insomnia or reporting sleep difficulties. The program will be offered to service users of IAPT to establish criteria for the planning of a future large scale RCT study.

NCT ID: NCT04493255 Completed - Healthy Volunteers Clinical Trials

A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants

Start date: September 9, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants. Also, to assess the safety and tolerability of a single dose of E7090 in healthy male participants.