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NCT ID: NCT02926508 Enrolling by invitation - Behaviour Clinical Trials

Oxford Study of Prebiotics in Children

OxPiC
Start date: July 2016
Phase: N/A
Study type: Interventional

Recently, there has been an emerging interest in how manipulating gut microbiota (which is composed by microorganisms living in our digestive system) can influence learning, memory and cognition. This influence is thought to primarily occur via the gut endocrine and immune systems, and the vagus nerve, all of which influence brain function and are modulated by intestinal microorganisms. One way to manipulate the microbiota is to ingest dietary compounds, such as prebiotics. Prebiotics are non-digestible dietary fibres that enhance the growth of "healthy" bacteria in the intestines when given in adequate amounts. Prebiotics are relatively stable, can be stored at room temperature and can be easily added to foods or drinks. They are not degraded by enzymes and acids in the digestive tract; therefore they reach the colon relatively unchanged, where they are metabolised by specific bacteria, thus promoting their beneficial effects. Prebiotics can be found in very small proportions in vegetables and fruits such as leeks, onions, tomatoes, garlic, etc., but this naturally occurring quantity is generally insufficient to promote a significant growth of beneficial bacteria. Therefore, large quantities of purified prebiotics are available as powder supplements and sold in packages of the appropriate dose. Pre-clinical studies in animals have shown that prebiotics modulates brain expression of key molecules involved in cognition and brain health in rats. These findings therefore highlight the potential of influencing cognition through the manipulation of gut microbiota (in this case, via the ingestion of a prebiotic). Building on this evidence, the aim of this study is to investigate how manipulating gut microbiota can influence reading, learning and behaviour in a group of children whose reading scores suggest there is room for improvement.

NCT ID: NCT02905097 Enrolling by invitation - Arthritis Clinical Trials

Post-marketing Surveillance Study of the Triathlon Tritanium Baseplate

Start date: January 5, 2018
Phase:
Study type: Observational

The aim of the study is to assess the performance of the cementless Triathlon Tritanium tibial baseplate for total knee replacement, with a minimum follow up of 5 years.

NCT ID: NCT02875548 Enrolling by invitation - Clinical trials for Advanced Solid Tumors

A Study to Assess the Long-term Safety of Tazemetostat

TRuST
Start date: August 30, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat.

NCT ID: NCT02721797 Enrolling by invitation - Clinical trials for Ehlers-Danlos Syndrome

Origins and Impact of EDS in Connective Tissues and Skin

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

Ehlers-Danlos Syndrome (EDS) is an inherited disease of collagen, found in connective tissues, such as skin. EDS patients suffer from joint and skin problems (skin hyperextensibility, joint hypermobility) along with a large range of other disorders, including, delayed wound healing with atrophic scarring, easy bruising, tissue fragility, gastrointestinal and gum problems. There are many different types of EDS, with different mechanisms of action, and not all of these are well understood. This study will used advanced microscopy techniques called atomic force microscopy (AFM) and scanning electron microscopy (SEM) to analyse the changes in collagen as a result of EDS, compared to normal collagen. These changes will be viewed at the micron and nanoscale level (between 1,000 to 100,000 x magnification), and will focus on the differences in collagen construction through a process called cross-linking. These changes could potentially help clinicians understand the root cause of EDS symptoms, and provide a deeper knowledge of cross-linking disorders in collagen. Increasing our knowledge of how collagen is affected in EDS patients, may lead to improved treatment options for patients.

NCT ID: NCT02721394 Enrolling by invitation - Clinical trials for Intellectual Disability

FCT With Young Children With ID in the UK: A Feasibility Project V.1

Start date: February 2016
Phase: N/A
Study type: Interventional

The current project aims to assess the feasibility of conducting Functional Communication Training in the UK with a small sample of young children (aged under 9) in an NHS setting. Three delivery formats will be assessed in order to demonstrate the feasibility of conducting FCT via different delivery methods within an NHS context. Participants will be four children aged under 9 who have an identified intellectual / developmental disability and display either self-injury, property destruction, or aggression at home. In addition, one family carer per child will be coached to implement the intervention, either following researcher intervention, or from the beginning. Data will be collected on challenging behaviour, communication responses, family carer confidence in managing behaviour, fidelity of intervention implementation, family quality of life, and acceptability of the intervention.

NCT ID: NCT02699736 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV

EuroSIDA
Start date: January 1994
Phase:
Study type: Observational [Patient Registry]

The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994. The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes. Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects. All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website. In general terms, the objective of the EuroSIDA study is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to (1) assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.

NCT ID: NCT02666495 Enrolling by invitation - Anorexia Nervosa Clinical Trials

Individual Schema-mode Therapy for Anorexia Nervosa: a Pilot Case Series

Start date: January 2016
Phase: N/A
Study type: Interventional

A reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is therefore a need to test new treatments to find more effective treatments. Clinical trials of Schema Therapy have shown low rates of dropout, which is often a problem in the treatment of anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30 sessions, has been shown to be effective for other complex mental health problems.This pilot study is therefore designed to pilot the use of individual Schema Therapy for people with Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer the principal research question: Does individual Schema mode Therapy, adapted for eating disorders, have the potential to improve symptoms, quality of life and weight in people with moderate-severe anorexia nervosa? It will also address secondary research questions: Can people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study of iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome? Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional medical or dietetic management required. Standard outcome measures will be collected at 6 month intervals. The research team have expertise in eating disorders research, schema therapy for severe anorexia nervosa and are all members of the local clinical service. The study will take place over a 3 year period.

NCT ID: NCT02653001 Enrolling by invitation - Clinical trials for Human Gut Microbiota

The QIB Colon Model

Start date: December 18, 2015
Phase: N/A
Study type: Interventional

The aim of this project is to establish a list of volunteers willing and able to donate stool samples for use in the model colon so as to facilitate research directed toward understanding the basic science underlying the interactions between the gut microbiome, potential external modifiers, and health.

NCT ID: NCT02637388 Enrolling by invitation - Obesity Clinical Trials

Effects of Beta-glucan on Energy Intake and Satiety

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to address the effect of consuming 4g of soluble fibre beta-glucan at breakfast on satiety and food intake.

NCT ID: NCT02615444 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

The Effects of Beta-glucan Enriched Oatcake Consumption on Metabolic Disease Risk Factors

Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether daily consumption of soluble fibre, oat beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.