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NCT ID: NCT04193735 Recruiting - Clinical trials for Chronic Intestinal Pseudo-Obstruction

Pseudo-obstruction Assessment With MRI

POM
Start date: January 17, 2020
Phase:
Study type: Observational

This study will explore the potential for a standardized MRI scan after a liquid meal to be used in diagnosis of the rare but debilitating chronic intestinal pseudo-obstruction (CIPO).

NCT ID: NCT04193475 Recruiting - Clinical trials for Cardiovascular Diseases

Machine Learning in Quantitative Stress Echocardiography

MLQSE
Start date: November 22, 2019
Phase:
Study type: Observational

Greater diagnostic accuracy is required to find out who is at risk of a heart attack as this can reduce the requirement of more invasive downstream tests and thereby improve the patient experience and also reduce their exposure to risk. Stress echocardiography is a routine clinical test that involves using ultrasound to image the heart whilst it is under stress to assess the risk of a heart attack. This study will focus on developing more accurate analysis tools to interpret the results of these stress echocardiographic scans. New methods will be tested to measure the function of each part of the heart muscle, using advanced analysis of the information obtained when high-frequency sound waves are bounced off the heart inside the chest. The researchers will measure and report exact heart function during stress, so that they will be able to recognise normal hearts and those with any disease. New computer methods will be developed to display any abnormality, which will make it easier for doctors to choose the best treatment for patients who are at risk. The goals and potential benefits of this research proposal are to update the interpretation of a routinely used clinical test (stress echocardiography) to produce a reliable new method for diagnosing the precise effects of diseased arteries on the function of the heart muscle; to develop new computer graphics that adapt to show individual risks for each patient; and to implement new computer models that can be constantly updated

NCT ID: NCT04192422 Recruiting - Hypoglycemia Clinical Trials

DiGESTnewborn Study

DiGESTnewborn
Start date: September 1, 2020
Phase:
Study type: Observational

We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.

NCT ID: NCT04191304 Recruiting - Clinical trials for Hypereosinophilic Syndrome

A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

NATRON
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur. Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.

NCT ID: NCT04191122 Recruiting - Depression Clinical Trials

Community Outpatient Psychotherapy Engagement Service for Self-harm

COPESS
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Background: Self-harm (SH) is any act of intentional self-injury or self-poisoning, with or without the intention to die. People who SH are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who SH and may be an underlying driver of self-harm behaviour. Treating depression in people who SH has the potential to reduce the risk of further SH and suicide. Self-harm is often repeated, and risk of repetition is highest immediately after an act of self-harm. Readily accessible brief talking therapies show promise in helping people who SH, but further evaluation of these approaches is needed. The Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) is a brief talking therapy intervention for depression and self-harm. This intervention was shown to be feasible and acceptable in hospital emergency department settings, but accessibility was limited; thus, the investigators wish to develop and test a community-based version of this intervention. The COPESS project moves this therapy into a community setting, thereby increasing the number of people who can be helped, especially those in hard-to-reach groups and from disadvantaged areas. Aim: To assess the feasibility of conducting a trial of the COPESS intervention in a community setting, for people with depression who self-harm, in relation to participant recruitment and retention. Therapy, acceptability and safety of the intervention will also be assessed. Methods: Using a Single Blind Randomised Control Trial (RCT) design, the investigators will recruit a sample of n=60 participants with a history of SH within the last six months, who are also currently depressed. Recruitment will take place via GP practices for patients who: 1) seek consultation for self-harm; 2) have consulted for self-harm in the previous 6 months (determined by GPs' search of their own data-systems); or 3) self-refer via their GP. Following baseline assessment participants will be randomly allocated to either receive COPESS plus Treatment as Usual [TAU; n = 30)] or TAU alone (n=30). Follow-up assessments will take place at one, two and three months. Recruitment rates, attrition and data completeness will be monitored. Qualitative interviews with participants and stakeholders will further investigate feasibility.

NCT ID: NCT04190849 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)

EU-PNAFLD
Start date: November 14, 2017
Phase:
Study type: Observational [Patient Registry]

The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry ("EPoS", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.

NCT ID: NCT04188509 Recruiting - Sickle Cell Disease Clinical Trials

Open-Label Extension of Voxelotor

Start date: November 18, 2019
Phase: Phase 3
Study type: Interventional

Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.

NCT ID: NCT04187911 Recruiting - Mental Health Clinical Trials

Relationships in Good Hands - Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy

RIGHT
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The research question is: Can the research recommend better ways for social care and health services to work work together to help adoptive and foster families? Can a therapy called DDP improve the mental health of 5-12 year old fostered or adopted children? Is DDP worth the commitment families need to give to it - and the extra cost to the services that deliver it? More than half of adopted or fostered children in the UK have mental health problems including ADHD (i.e. hyperactivity, impulsive behaviour and poor concentration), antisocial behaviour and problems with relationships. Abused and neglected children are more likely than others to have problems in school, become homeless, get involved in crime and even die young (e.g. from suicide), yet there are no fully tested treatments for such complex mental health problems. This is a huge problem because early treatment could greatly improve children's life chances - and reduce strain on health and social care budgets. There is a Dyadic Developmental Psychotherapy (DDP) a parent-child therapy that takes around 20 sessions and focusses on "Playfulness, Acceptance, Curiosity and Empathy". There is not yet available really good evidence for or against it: many UK therapists like DDP, but it is a big commitment for families: once a week for about six months children will need time off school, the parents will need time off work - and this can be hard to explain to school friends, colleagues and bosses. Research team doesn't just need to know if DDP improves children's mental health - they also need to know if the commitment needed is worth it for families and whether the costs to services outweigh the benefits. In PHASE 1 the research team will find out whether DDP can work smoothly in the three different settings where it is usually delivered: the NHS, Social Care and Private Practice. Many abused children need other medical and psychiatric support so, the research will assess whether children can get any additional assessments or referrals they may need . In PHASE 2, the research team plans to find out if it is practically possible to run a high quality trial of DDP. This phase will involve 60 families to find out if they are happy to take part (whether offered DDP or usual services). If all goes to plan, these 60 families will contribute to the final results, along with the 180 families involved in the next PHASE 3 when the research team will test whether DDP is better than usual services and, if it is, whether the improvements in child mental health outweigh the costs. What impact will the research have? This study will make recommendations about how services should work together to help abused and neglected children and their families. If the researcher team finds that DDP is worth the time and money, it could improve the mental health of abused and neglected children across the world.

NCT ID: NCT04187859 Recruiting - Frailty Clinical Trials

Prompting And encouRaging Community Hydration Through EDucation

PARCHED
Start date: January 6, 2020
Phase: N/A
Study type: Interventional

PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty. PARCHED will randomise four areas in Cwm Taf University Health Board to receive one of four different interventions. Individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.

NCT ID: NCT04185883 Recruiting - Clinical trials for Advanced Solid Tumors

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.