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NCT ID: NCT04063631 Recruiting - Asthma Clinical Trials

Pulmonary Epithelium, Immunology and Development of Asthma: Breathing Together

Start date: February 20, 2017
Phase:
Study type: Observational

The investigators want to know why some babies wheeze and some of these go on to develop asthma. The investigators are going to find out if babies who develop wheeze and asthma have abnormal airway lining cells (taken from the nose) when they are born and what happens to these cells as they get older. The study will last three years. Parents will be asked to fill in a monthly health questionnaire. The tests on the babies are all in routine clinical use: a urine sample, a blood test from a heel or finger prick, swabs from the nose and throat to look at the microbiome, and a brushing of cells from the inside of the nose. These tests will be performed at 5-10 days old, and at one and three years. Parents will be asked to fill in online monthly health questionnaire. Some babies will have the swabs repeated at 3 and 6 months, and those who wheeze in the first 3 years of life, samples during the illness and after recovery.

NCT ID: NCT04061512 Recruiting - Clinical trials for Waldenstrom Macroglobulinemia

Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia

RAINBOW
Start date: February 3, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Waldenström's macroglobulinaemia (WM) is a rare type of slow growing lymphoma. It develops when white blood cells grow abnormally. Typically a disease of the elderly, the median age of presentation is >70 years and the current treatment for WM is unsatisfactory, with incomplete responses and inevitable recurrence. Therefore there is a need to find alternative treatments that are more effective, leading to lasting responses and improved quality of life. The RAINBOW study is a phase 2-3 trial assessing 'chemotherapy free' treatment as primary therapy for WM which can potentially improve response outcome, durability and importantly, reduce toxicity for WM patients. This approach will be done using the drug Ibrutinib, which in combination with rituximab (RI) will be the experimental arm. As there is no agreed standard on first-line therapy for WM, the control arm is the current treatment based on the most recently published clinical trial results. The control arm consists of rituximab, cyclophosphamide and dexamethasone (DCR), and is widely recommended by international consensus as appropriate treatment for first-line therapy for WM. In this study, 148 adults (aged ≥ 18 years) with treatment naïve WM will be randomised on a 1:1 ratio to either the treatment or control arm. Randomised treatment lasts for a maximum of 6 cycles and response will be assessed following 3 cycles of treatment and completion of randomised treatment at approximately 24 weeks after commencing treatment. RI patients may then have up to 5 years of Ibrutinib monotherapy. Patients will be seen regularly during treatment and then every 3 months for 5 years after treatment discontinuation. Patients will enter annual follow up for survival until the end of trial (including progressed patients). The study will be conducted at NHS hospitals and is expected to last 9 years and 6 months.

NCT ID: NCT04060706 Recruiting - Cancer Clinical Trials

Heuristics, Algorithms and Machine Learning: Evaluation & Testing in Radiation Therapy

Hamlet rt
Start date: September 11, 2019
Phase:
Study type: Observational [Patient Registry]

The Hamlet.rt study is a prospective data collection and patient questionnaire study for patients undergoing image-guided radiotherapy with curative intent. The aim of the study is to use novel machine learning and mathematical techniques to build a model that can predict the risk of significant side effects from radiotherapy treatment for an individual patient: using calculations of normal tissue dose from radiotherapy treatment planning and patient baseline characteristics derived from image and non-image data, continuously updated as the patient is reviewed both during and after treatment. A secondary goal of the project is to facilitate research in machine learning and medical image processing for radiation therapy through the creation of a discoverable and shared data resource for research use.

NCT ID: NCT04059640 Recruiting - Inguinal Hernia Clinical Trials

PMCF Study of LiquiBand FIX8® OHMF Device

LBF8-Open
Start date: December 7, 2021
Phase: N/A
Study type: Interventional

Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.

NCT ID: NCT04059510 Recruiting - Clinical trials for Group B Streptococcus

Developing a Controlled Human Infection Model for Group B Streptococcus (CHIM_GBS)

TIMING
Start date: November 4, 2019
Phase:
Study type: Observational

Group B Streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis. In 2015, it was estimated that worldwide there were at least 320,000 infants with invasive GBS disease, 90,000 infant deaths and 10,000 cases of children with disability related to GBS meningitis. Maternal rectovaginal colonization with GBS is the biggest risk factor for neonatal GBS sepsis and meningitis within the first 6 days of life, with transmission of the bacteria from mother to baby occurring around the time of birth. An estimated 20-35% of pregnant women are colonised with GBS. 1-2% of neonates born to GBS-colonised women develop invasive GBS disease in the absence of intrapartum antibiotic prophylaxis (IAP). The current strategy to prevent neonatal GBS is to give antibiotics during labour, called IAP. This has various limitations and is not easily achieved outside of high income settings. Additionally, widespread antibiotic use raises concerns about antibiotic resistance. A better approach would be a vaccine for GBS however in order to test any vaccines it would be necessary to develop a controlled human infection model whereby healthy female volunteers are artificially colonised with GBS to test the vaccines efficacy. Before developing these human infection models researchers need to better understand how women become colonised with GBS and whether antibodies in the blood and at the mucosal surfaces provide protection. This study will be observational and will test the antibody levels at the vaginal mucosa and in the blood of a group of women who are naturally colonised with GBS at the start of the study and a group who are not colonised. Investigators will follow women up over 12 weeks to observe how colonisation changes and the effect that this has on the mucosal and blood stream antibody concentrations. This will inform the development of human infection studies.

NCT ID: NCT04058821 Recruiting - Brain Injuries Clinical Trials

Novel MRI for Diagnosing Traumatic Brachial Plexus Injuries

Start date: January 29, 2019
Phase: N/A
Study type: Interventional

The aims are: 1. Investigate new magnetic resonance imaging (MRI) scans for diagnosing severe nerve injury in the arm. 2. Understand how the brain and spinal cord respond to severe nerve injury using MRI. The nerves which control movement and feeling in the arm can be severely damaged in eg. motorbike crashes, sporting or work-related injuries. Every year 500 adults sustain life-changing major nerve injuries, causing 1) disability needing constant care, 2) life-long pain and 3) mental illness. In England, major nerve injuries cost £250million every year in hospital treatments, unemployment and social care. Injured nerves can be repaired with surgery. To decide if nerves need repairing, exploratory surgery is needed. Instead, we have developed a new MRI scan which could diagnose nerve injuries, meaning that exploratory surgery could be avoided, nerve injuries could be diagnosed sooner and reconstructive surgery performed sooner. Some people with nerve injuries develop lifelong pain - if we could understand how the brain adapts, we could learn how to prevent nerve pain. Also, some people don't recover movement in their hand - if we could understand how the brain reorganises nerves controlling movement, we could predict who would benefit from surgery.

NCT ID: NCT04058457 Recruiting - Parkinson Disease Clinical Trials

DBS and Respiration

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

Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease. The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.

NCT ID: NCT04057976 Recruiting - Clinical trials for Vestibular Schwannoma

Use of DTT to Define Facial Nerve Position in Vestibular Schwannomas

Start date: June 27, 2019
Phase: N/A
Study type: Interventional

Vestibular schwannomas (VS) arise from the vestibulocochlear (hearing and balance) nerve, located at the base of the brain. Although benign, VS can enlarge over time, resulting in debilitating symptoms; therefore, surgical removal is frequently offered. One significant risk of surgery is inadvertent injury to the facial nerve, which lies adjacent to the vestibulocochlear nerve. Currently, the nerve's course is only revealed during surgical dissection and injury can cause permanent facial weakness. It would therefore be useful for the surgeon to know the course of the nerve before operating. To this end, a new MRI technique known as probabilistic diffusion tensor tractography (DTT) has shown potential in revealing the course of the facial nerve pre-operatively. However, its clinical reliability remains uncertain. This study aims to investigate the reliability of DTT in identifying the course of the facial nerve preoperatively in patients undergoing surgery for VS. The future benefit would be to enable surgeons to operate with more confidence and potentially reduce the chance of nerve injury. The study will recruit adult patients due to have surgery for VS. The only change to the participants' clinical pathways will be the addition of a DTT sequence to their pre-operative MRI scans (increasing scanning time by approximately 10 minutes).

NCT ID: NCT04056247 Recruiting - Clinical trials for Stage IV Non-small Cell Lung Cancer

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

PROPHETIC
Start date: October 1, 2019
Phase:
Study type: Observational

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

NCT ID: NCT04054362 Recruiting - Pancreatic Cancer Clinical Trials

Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

PINBALL
Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

This is a phase II pilot trial of Paclitaxel Protein Bound and Gemcitabine based chemotherapy and the addition of Paricalcitol upon attainment of stable or progressive disease in eligible patients with untreated metastatic pancreatic ductal adenocarcinoma.