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NCT ID: NCT04760964 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis

MUSIC
Start date: January 27, 2021
Phase:
Study type: Observational

The MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed). This new biomarker approach will study a panel of molecular signs in IBD patients' blood, stools and biopsies that will be correlated to the current gold standard of direct gut visual examination using ileo-colonoscopy and flexible sigmoidoscopy tests (a fibre-optic examination of the lower small bowel and large bowel). Here, the state and appearances of IBD patients' gut lining will be assessed over one year in response to treatment given to them by their NHS IBD consultant. This approach will focus on the role of damage associated molecular patterns (DAMPs), also known as 'danger signals'. DAMPs are found in our own cells and are released during tissue stress or injury. Like signals from bacteria, they can trigger inflammation. In the MUSIC study, blood, stool, saliva and gut samples obtained from participants during active IBD and in clinical remission will be used in order to understand how DAMPs contribute to the development of gut inflammation.

NCT ID: NCT04758559 Recruiting - Weight Loss Clinical Trials

Usability of myfood24 in Clinical Populations

Start date: February 1, 2021
Phase: Early Phase 1
Study type: Interventional

Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations. Primary objective: test usability and acceptability of 'myfood24 Health' for monitoring dietary intake in a group of patients. Recruit 60 gastroenterology surgery patient (Leeds) and 60 Tier 3 Weight Management patients (30 Leeds/ 30 York). Randomise to 3 groups 1. usual care 2. myfood24Health 3. myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods During a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times. HCPs will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (N.B. not all participants will have a scheduled clinic appointment during the study). 2 months after recruitment, all participants will receive a link to an online feedback questionnaire. At end of study, HPCs will be invited to provide feedback during a 30 minute interview.

NCT ID: NCT04757610 Recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)

ShORe
Start date: March 12, 2021
Phase: Phase 3
Study type: Interventional

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

NCT ID: NCT04757116 Recruiting - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Post-Market Study to Assess iTind Safety in Comparison to UroLift

MT-08
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

The study objective is to evaluate the safety of the iTind device comparied to UroLift.

NCT ID: NCT04755933 Recruiting - Child Anxiety Clinical Trials

Parenting With Anxiety: Helping Anxious Parents Raise Confident Children

PWA
Start date: February 15, 2021
Phase: N/A
Study type: Interventional

This is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. The parents will be randomised to the intervention or a control group with no intervention. The intervention itself will undergo a component analysis to determine whether some modules are more effective than others.

NCT ID: NCT04754217 Recruiting - Clinical trials for Aortic Valve Disease

Valved Graft PMCF Study

Start date: July 13, 2021
Phase:
Study type: Observational

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

NCT ID: NCT04754087 Recruiting - Osteoarthritis, Hip Clinical Trials

G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.

NCT ID: NCT04752982 Recruiting - Stroke Clinical Trials

Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors' Homes?

c-SIGHT
Start date: February 25, 2021
Phase: N/A
Study type: Interventional

Spatial neglect is a common post-stroke condition in which people may not be aware of anything on one side of the world (usually the same side they lost their movement). Currently, there is no effective treatment for spatial neglect. A therapy called SIGHT (Spatial Inattention Grasping Home-based Therapy) has shown early evidence of improving stroke survivors' spatial neglect (Rossit et al., 2019). SIGHT involves individuals picking-up and balance wooden rods with their less affected hand, independently, without the need for a therapist present at all times. Working with stroke survivors, carers and clinicians we have developed of a computerized version of SIGHT (c-SIGHT; Morse et al., in press). The present trial aims to: 1) investigate the feasibility of a blinded randomized controlled trial of c-SIGHT (active intervention) vs. an attentional control training version of c-SIGHT (sham intervention) in the homes of stroke survivors with spatial neglect; 2) Explore participant's experience using c-SIGHT independently at home; and 3) Explore the potential effects and effect size of c-SIGHT active intervention compared to the attentional control training to inform a future Phase II trial.

NCT ID: NCT04752826 Recruiting - Clinical trials for Advanced Malignancies

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Start date: January 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors (where iRECIST can be applied for efficacy assessment) and subjects with cutaneous T-cell lymphoma (CTCL), specifically Sézary Syndrome (SS) and mycosis fungoides (MF). The study will consist of 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B. All subjects participating in the trial will complete a follow-up portion of the trial and an End of Treatment (EOT) Visit 30 days (±3 days) after their last dose of BI-1808.

NCT ID: NCT04752072 Recruiting - Clinical trials for Complex Post-Traumatic Stress Disorder

RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD

Start date: February 25, 2021
Phase: N/A
Study type: Interventional

Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (DSO). DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (AR), negative self-concept (NSC), and disturbances in relationships (DR). There are no effective interventions for CPTSD. It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD. The present study will be one of the first to investigate the effectiveness of a novel, modular intervention for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms). The overall aim of this study is to establish the feasibility, acceptability and preliminary effects of ESTAIR in treating CPTSD. To achieve these aims, the investigators will conduct a pilot randomised controlled trial (RCT), with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD, and with two treatment arms: ESTAIR vs. a treatment-as-usual (TAU) condition.