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NCT ID: NCT04289961 Completed - Clinical trials for Pancreatic Adenocarcinoma

PDAC Peripheral and Portal Vein Sampling

Start date: June 12, 2019
Phase: N/A
Study type: Interventional

This is a research study in which bio-specimens (whole blood, plasma and serum from peripheral circulation and portal vein) will be collected from patients with pancreatic adenocarcinoma for translational research. These samples will be used for (but not limited to) identification and characterisation of blood-borne biomarkers at the genomic and protein expression level. Examples of such biomarkers are circulating tumour cells (CTCs), CTC clusters and circulating DNA (which can be tumour derived, or from unaffected/normal cells). CTC-enriched blood samples may also be used to generate CTC-derived tumour explant (CDX) models in immunocompromised mice in order to produce suitable disease models in which to test novel therapies and identify new molecular targets. In addition, permission will be sought from study participants for the research team to access clinical information from medical notes to aid in determining the clinical relevance of biomarkers identified during the course of this study. Validated biomarkers are anticipated to be used in designing future biomarker-directed clinical trials in these disease groups.

NCT ID: NCT04289714 Completed - Asthma in Children Clinical Trials

Novel Electronic Monitoring Devices (NEMD) to Monitor Adherence in Children With Asthma

NEMD
Start date: October 12, 2018
Phase: N/A
Study type: Interventional

This is a feasibility study to assess novel electronic monitoring devices for monitoring adherence in children with asthma who are on inhaled corticosteroids (ICS) It is a mixed method (quantitative and qualitative) open label, pragmatic randomised feasibility study with two main aims: 1. To assess the feasibility of 4 novel electronic monitoring devices in children aged 6-16 years with asthma, in terms of usability and acceptability by patients/ guardians and healthcare professionals (qualitative study) 2. To evaluate the accuracy of these devices and assess whether they impact on asthma control (quantitative study). The duration of study is 16 weeks.

NCT ID: NCT04289272 Completed - Body Image Clinical Trials

Evaluating Dove Confident Me in India

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Body image is one of the leading concerns for young people. Such concerns can have serious health consequences, including unhealthy weight control and exercise behaviours, depression and self-harm, low self-esteem and substance abuse. Emerging approaches for improving body image are effective among adolescent girls and boys in the school setting. However, the vast majority of trials in this area are conducted in high-income westernised countries, despite body image concerns increasingly being recognised as a global concern. As such, it is important to develop and disseminate interventions to promote positive body image among adolescents in in low-to-middle income countries, too. 'Confident Me' has been found to be effective in improving body image and related outcomes among adolescent girls and boys in the UK up to 12-months later, and thus, could undergo adaptations for the Indian context. The aim of the present study is two-fold: - To conduct a small-scale acceptability study of a 'Confident Me', a body image intervention, among 11-13-year olds in New Delhi, India, to understand its acceptability, feasibility, and preliminary efficacy in a metropolitan area of India. - To refine 'Confident Me' based on the acceptability study, and to conduct a randomised controlled trial to evaluate its efficacy at improving body image and related outcomes among 11-13-year olds in New Delhi, India. The first aim will be fulfilled by recruiting two schools, of which one will be randomised to the intervention and the other to the control arm. We will compare the body image and well-being of students who take part in the programme to students in the control group. The investigators will also gather in-depth feedback from students, teachers and the interventionist via focus groups and interviews, in order to inform future improvement of the programme. The second aim will be fulfilled by randomising six schools to either the revised body image programme (3 schools) or the control arm (3 schools). Students will complete questionnaire assessments of body image and well-being before and after the 5-week programme period, and again 12 weeks later to assess longer-term benefits.

NCT ID: NCT04289233 Completed - Oral Lichen Planus Clinical Trials

Molecular & Cellular Characterisation of Oral Lichen Planus

Start date: October 26, 2016
Phase:
Study type: Observational

The principal research objective is to provide enhanced understanding of the cellular and molecular events important in the pathogenesis of Oral Lichen Planus to enable improved diagnosis and development of novel treatments for patients.

NCT ID: NCT04289077 Completed - Desmoid Tumor Clinical Trials

Quality of Life of Patients With Desmoid-type Fibromatosis

QUALIFIED
Start date: August 6, 2020
Phase:
Study type: Observational

Rationale: Desmoid-type fibromatosis (DTF) is a rare, histologically benign, soft tissue tumour. Although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. Various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. Nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. Health-related quality of life (HRQL) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. Additionally, HRQL can be in important endpoint for future clinical trials. Today, no HRQL-tools are available which capture the needs of DTF patients. The hypothesis is that patients with DTF have issues on several HRQL domains including physical, social and emotional well-being. For this reason we developed a list of items based on previous research. This study aims to evaluate HRQL issues experienced by DTF patients. Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.

NCT ID: NCT04289025 Completed - Clinical trials for Arthroplasty Complications

Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement

MAPREHAB
Start date: September 23, 2020
Phase: N/A
Study type: Interventional

This study aims to determine a volunteer's gait objectively after surgery, when signed off from the consultant and physiotherapist. This will identify any gait deficiencies using simple traffic light coding, using GaitSmart, a CE Marked Class 1M Medical Device. Volunteers chosen for the intervention programme, a set of exercises to improve gait deficiencies identified in the report. All the exercises will be standard one already used within the NHS. The objectives are to compare the outcomes from the intervention group with the Standard of Care group, in terms of gait and PROMS and from this determine the clinical and economic benefits of the intervention.

NCT ID: NCT04288557 Completed - Sleep Clinical Trials

Sleep Measurement Study

Start date: January 23, 2020
Phase:
Study type: Observational

Sleep behaviour has critical importance to health and wellbeing. A large body of evidence has implicated poor sleep in all-cause mortality, and in cardiovascular and cardiometabolic risk factors. Given the importance of sleep to health, the importance of accurately monitoring sleep duration and quality is becoming more evident. Polysomnography (PSG) is considered the gold standard for sleep assessment. Nevertheless, PSG is impractical, expensive and labour-intensive. Another method to quantify indices of sleep is based on actigraphic measures. Wrist worn actigraphy devices provide an indirect measure of sleep parameters e.g. total sleep time, sleep onset latency and waking time. However, the data is in the form of manufacturer-specific activity 'counts', making it difficult to compare the data with different accelerometer brands. Recently wrist-worn accelerometers have become increasingly used for objective measurement of physical activity in large population studies where participants are often asked to wear them for 24 hours continuously. These devices therefore collect data that could be used to estimate sleep parameters, and now there is a sleep algorithm that can be applied to raw data from accelerometers. The three widely used raw-data accelerometer brands are the Axivity, ActiGraph and GENEActiv and ActivPAL which is a thigh-worn accelerometer that provides a measure of posture. Studies that examined accuracy of estimating sleep parameters from different brands of accelerometers compared to PSG have reported conflicting results which could be due to the use of different sleep algorithms and accelerometer placement (dominant vs. non-dominant wrist vs. hip). Therefore this study will aim to validate automated sleep algorithms for research grade accelerometers against PSG in a clinical and healthy adult population.

NCT ID: NCT04287985 Completed - Clinical trials for Immunoglobulin A Nephropathy

Safety and Efficacy Study of VIS649 for IgA Nephropathy

Start date: July 20, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)

NCT ID: NCT04287296 Completed - Mental Wellbeing Clinical Trials

A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

The aim of Wakey! is to increase access to wellbeing support to lower socio-economic groups who have traditionally been excluded from the design and evaluation of digital mental health interventions. This feasibility study is designed to explore engagement, initial efficacy and experience of using Wakey! in the underserved populations in the United Kingdom. This will be used to further adapt and refine the intervention, so it is appealing and effective in the target populations.

NCT ID: NCT04285827 Completed - Sickle Cell Disease Clinical Trials

Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease

Start date: May 20, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics (PD), and biomarkers of target engagement of CSL889 following single intravenous (IV) doses in subjects with sickle cell disease (SCD). The study involves sequential dose escalation of cohorts with between-group assessments of key safety and PK variables.