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NCT ID: NCT03479866 Recruiting - Healthy Clinical Trials

Personalised Responses to Dietary Composition Trial

PREDICT
Start date: June 4, 2018
Phase: N/A
Study type: Interventional

The foods we eat - our diet - can affect whether we develop diseases during our lives, such as diabetes or heart disease. This is because the amount and types of foods we eat can affect our weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in our guts (the gut microbiome) affects our metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often, there's a greater chance of developing diseases such as diabetes. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in our guts are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18 years or over from the TwinsUK cohort to take part in a study that aims to answer the questions above. The participants will need to come in for a clinical visit where they will give blood, stool, saliva and urine samples. The participants will also be given a standardised breakfast and lunch and fitted with a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. After the visit, the participants will be asked to eat standardised meals at home for breakfast for a further 12 days. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record constantly their appetite, food, physical activity and sleep using apps and wearable devices.

NCT ID: NCT03474965 Recruiting - Clinical trials for Sickle Cell Disease (SCD)

Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.

NCT ID: NCT03474094 Recruiting - Sarcoma,Soft Tissue Clinical Trials

Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

RT-Immune
Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients. Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive: - Arm A: Radiotherapy followed by atezolizumab then surgery. - Arm B: Atezolizumab followed by surgery then radiotherapy. - Arm C: Radiotherapy then surgery followed by atezolizumab. The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same: - Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W). - Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy. - Surgery will be performed as per institutional practice. Randomisation will be stratified according to histological subtypes as follows: Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.

NCT ID: NCT03471052 Recruiting - Barrett Esophagus Clinical Trials

Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch

Start date: March 6, 2018
Phase: N/A
Study type: Interventional

Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner (GP) referral to Ear Nose & Throat departments. There is no recognised treatment. Drugs that reduce acid may help but do not block mucus production. Argon Plasma coagulation has been shown to be successful but limited to a few expert centres. The investigators have previously shown a device that uses radiofrequency energy to remove the patch to be highly effective in a ten patient pilot study, with 80% response rate that was durable over 1 year. The purpose of this trial is to demonstrate the previous study was not due to placebo effect alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months after sham. All males and non-pregnant females over 18 years old with previously diagnosed inlet patch causing symptoms of globus, with > 50% severity on a visual analogue score, are eligible.

NCT ID: NCT03468881 Recruiting - Breast Cancer Clinical Trials

A Communication Skills Package to Prevent Fear of Cancer Recurrence

FORECAST2
Start date: September 1, 2018
Phase:
Study type: Observational

This study (FORECAST 2) builds upon the work of the successful pilot study (FORECAST) that found some evidence that breast cancer patients' fears of cancer recurrence (FCR) were sensitive to the communication exchange with therapeutic radiographers during weekly review appointments. The aim of FORECAST 2 is to co-design and pilot a communication training package for therapeutic radiographers to help them manage emotional talk with breast cancer patients who are undergoing treatment, with the intention to minimise patients' development of FCR during this trajectory.

NCT ID: NCT03467958 Recruiting - Crohn Disease Clinical Trials

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Start date: August 24, 2018
Phase: Phase 3
Study type: Interventional

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

NCT ID: NCT03467568 Recruiting - Mood Clinical Trials

Does Salt Intake Improve Mood

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Humans display a preference for salt although the reasons remain unclear. The aim was to examine the hypothesis that salt may enhance mood. The study compares the drinking of water with and without electrolytes (either dissolved in water or by capsule). Mood was rated over a period of 155 minutes

NCT ID: NCT03466944 Recruiting - Leukaemia Clinical Trials

PUMA (Paediatric Osseous Marrow Assessment)

PUMA
Start date: March 5, 2018
Phase:
Study type: Observational

This is a pilot cancer imaging study investigating change in the apparent diffusion coefficient (ADC) at a single time point post-transplantation in patients. The treatment is bone marrow transplant as per standard patient care, without change for trial purposes. Its main aim is to evaluate the engraftment of bone marrow after transplantation performing functional Magnetic Resonance Imaging (MRI) of the lumbar spine and pelvis at baseline and after 2-3 weeks after the transplantation (according to the appearances of raised white blood cells).This will enhance the understanding of bone marrow features on imaging at engraftment and improve the management of children/young adults who suffer acute leukaemia. Following allogenic haemopoietic stem cell transplantation, changes in bone marrow apparent diffusion coefficient (ADC) are measurable at the point of engraftment and in conjunction with peripheral blood counts may provide a future biomarker of successful clinical outcome.

NCT ID: NCT03465761 Recruiting - Essential Tremor Clinical Trials

Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor

Start date: January 3, 2019
Phase: N/A
Study type: Interventional

The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety. This study is designed as a prospective, open-label, single arm, multi-site study design.

NCT ID: NCT03465280 Recruiting - Clinical trials for Human Papilloma Virus

Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)

AIR:RRP
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment. Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.