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NCT ID: NCT04638738 Recruiting - Sepsis Clinical Trials

Outcomes of Digital Alerting Systems in Secondary Care

Start date: October 1, 2017
Phase:
Study type: Observational

Why? The investigators are trying to find out if participants that suddenly deteriorate on the ward can be identified sooner by wearing a wearable sensor. This is an important study to see if the sensor works correctly in recording continuous vital observations of heart rate, respiratory rate and temperature. This information can help doctors and nurses identify un-well participants. What? The investigators will ask the participants to wear a light wearable sensor on the chest that can be worn for 5 days. If the participants are still in hospital after this time the sensor can be changed. All sensors are disposable. The participants would not have to actively do anything to the sensor. We will also participants to complete a short questionnaire about the sensor. Who? All participants on the ward that are admitted with a new medical or surgical problem can take part in the study. Participants undergoing a surgical procedure that require at least one overnight stay are eligible to take part in this study. Where? This study is being conducted at West Middlesex University Hospital and St Marys Hospital Paddington. Only certain wards are being included at both sites, if the participant moves wards the sensor will be removed. How? The study will last around 5 years and we aim to recruit 1000 participants.

NCT ID: NCT04637165 Recruiting - Sarcoidosis Clinical Trials

Exploring the Immunology of Sarcoidosis

Start date: November 11, 2019
Phase:
Study type: Observational

In sarcoidosis, over activity of parts of the immune system drives the accumulation of granulomas (collections of immune cells) in affected parts of the body. To facilitate development of effective and safe treatment options in the future it will be vital to understand how and why the immune system becomes over active. The aim of this research is to work towards this goal by studying cells of the immune system and the molecular pathways inside these cells that control how they behave. This will be achieved by analysing patterns of proteins and RNA (the code used to tell cells which proteins to produce) in immune cells present in blood samples and tissue biopsies from people with sarcoidosis.

NCT ID: NCT04636814 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

PILLAR
Start date: July 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.

NCT ID: NCT04636801 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

PILASTER
Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

NCT ID: NCT04635891 Recruiting - FSHD Clinical Trials

Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

MOVE FSHD
Start date: December 15, 2020
Phase:
Study type: Observational

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and muscle biopsy.

NCT ID: NCT04635449 Recruiting - PTSD Clinical Trials

Psycho-educational Tool to Prevent Psychological Sequelae Following Paediatric Intensive Care Unit Admission

4PICU
Start date: July 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

- To systematically evaluate an innovative directed psycho-educational intervention consisting of written specific, age-appropriate information, complemented by a follow-up targeted telephone call in order to reduce psychological sequelae in the child and their parents/guardians after PICU discharge. - To confirm the effects of the psycho-educational tool on parent and child emotional adjustment 6 months after PICU discharge; and to explore whether these outcomes are associated with the child's age; with receipt of the targeted telephone call; and/or with parental levels of stress during the child's admission. - To obtain detailed feedback from parents/guardians and children about the different aspects of the psycho-educational intervention (the written information and the targeted telephone call) and the utility of these two psycho-educational interventions. The study team will perform a randomised controlled trial of the intervention vs treatment as usual in children 0-16 years, stratified according to age (< 4 years and > 4 years). It is estimated that 288 children will be required to show a difference in outcome which is PTSD in parents and children.

NCT ID: NCT04635410 Recruiting - NO CONDITIONS Clinical Trials

Improving Ultrasound Based Prediction of Delivery Mode

Start date: February 3, 2020
Phase:
Study type: Observational [Patient Registry]

The progress of labour is traditionally determined by regular vaginal examinations (VEs) to assess the cervix (neck of the womb) and the baby's head position. Such examinations can be uncomfortable and risk causing infection to the baby or mother's womb. The findings are subjective, can be unreliable and cannot be recorded for later review and analysis. The novel, non-intrusive "transperineal ultrasound" technique has been developed utilising existing scanning machines normally found on a delivery unit, with the ultrasound probe placed outside the woman's vagina. This allows objective, recordable measurements creating images that can be captured and stored electronically. This is a prospective longitudinal observational cohort study in nulliparous term (37-42 weeks) labouring women. This study aims to improve the prediction of intrapartum Caesarean Delivery (ICD). The study contains ultrasound and clinical assessments: Transabdominal Ultrasound to measure: Umbilical and Middle Cerebral Artery Doppler, fetal head position and Amniotic Fluid Index (AFI). Transperineal Ultrasound to assess: Head Perineum Distance (HPD), Caput Succedaneum and moulding. Digital vaginal examination by a caregiver: to measure cervical dilatation. Primary outcome: • Mode of delivery Secondary outcome: • Time to delivery Neonatal outcomes: • Apgar score, cord pH level, gender, fetal birth weight, neonatal unit admission within 24 hours, neonatal morbidity.

NCT ID: NCT04635345 Recruiting - Vaginismus Clinical Trials

Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus)

ViTaDiVa
Start date: August 11, 2021
Phase: N/A
Study type: Interventional

The acceptability of vulvar vibration therapy has been evaluated in women with vulvodynia, and found to be acceptable, however has not been assessed in women with a primary complaint of vaginismus. This proposed study looks at the feasibility and acceptability of using clitoral vibration therapy, alongside current therapy, for women with vaginismus. It is likely that many, if not most, of these women will also have an element of vulvodynia. The investigators propose that the use of external clitoral or vulval vibration therapy is likely to be acceptable in most women with vaginismus, based on acceptability of vulvar vibration therapy in women with vulvodynia. It is proposed that vibrator therapy may help women with female sexual dysfunction to use vaginal dilators.

NCT ID: NCT04633681 Recruiting - Eating Behavior Clinical Trials

Impact of Sweeteners on Behaviour, Physiology & Health

SWEET-WP2-P2
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners & Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.

NCT ID: NCT04632394 Recruiting - Clinical trials for Ventricular Tachycardia

Multimodality Assessment of Ventricular Scar Arrhythmogenicity.

Start date: March 1, 2021
Phase:
Study type: Observational

We aim to improve our understanding of a life-threatening heart rhythm disorder known as ventricular tachycardia (VT). This is a disorder which originates from the lower chamber of the heart and frequently is associated with heart disease. We will use an MRI scan to generate a computer based model of the heart which can predict areas of the heart which are important in generating this rhythm disorder. We intend to assess how accurate this computer model is compared to traditional invasive assessment of the heart muscle. We also aim to assess the electrical characteristics of those areas which were predicted by the computer model in order to see why they were thought to be so important. All patients seen at St George's Hospital with VT will be eligible. As is routine for these patients, they will have an MRI scan of the heart. We will then use this scan to create a virtual reconstruction of the heart from which predictions of the critical areas of the heart which are generating the rhythm problem will be made. Then we will perform a VT ablation (studying the electrical properties and if necessary making a burn to treat the rhythm problem) - as per standard of care, however during the ablation we will spend extra time collecting information comparing the accuracy of the computer-generated model to the traditional invasive signals which guide ablation. We will study the electrical properties of those predicted areas to see what is special about them. The study will last up to three years.