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NCT ID: NCT03471637 Completed - Chronic Pain Clinical Trials

Compassion-Focused Therapy for Chronic Pain

Start date: February 27, 2018
Phase: N/A
Study type: Interventional

This research aims to study how Compassion-Focused Therapy (CFT) might work for people with chronic pain. People with chronic pain may feel shameful about their condition and this type of therapy aims to help people to view themselves and their difficulties in a kinder, less critical way (i.e. self-compassion). Currently, no research is available on the effectiveness of CFT in helping people with chronic pain. Participants attending a CFT-incorporated Pain Management Programme will complete a battery of questionnaires at the start of the group (week 1), in the middle of the group (week 5) and at the end of the group (week 11).

NCT ID: NCT03471494 Completed - Gastric Cancer Clinical Trials

GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

GS3
Start date: April 1, 2018
Phase:
Study type: Observational

Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication rates after cancer surgery. The secondary aim is to characterise infrastructure and care processes in the treatment of these cancers worldwide. Primary outcome measure 30-day mortality and complication rates after cancer surgery. Primary comparison Between country groups defined by human development index. Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer. Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent. Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged. Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018). Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.

NCT ID: NCT03471130 Completed - Healthy Volunteer Clinical Trials

Definitive QT Study With MT-8554

MT-8554 DQT
Start date: April 23, 2018
Phase: Phase 1
Study type: Interventional

This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF) from Baseline in healthy adult subjects

NCT ID: NCT03471026 Completed - Cerebellar Mutism Clinical Trials

Advanced MRI for Posterior Fossa Tumours

Start date: April 9, 2018
Phase:
Study type: Observational

Post-operative paediatric cerebellar mutism syndrome (pCMS) is a well-recognised complication of resective surgery for brain tumours of the cerebellum and fourth ventricle in children. Occurring in around 25% of infratentorial craniotomies, it is characterised by a delayed onset of mutism and emotional lability, and may comprise motoric and cognitive cerebellar deficits. Transient mutism gives way to prolonged, and often incomplete, recovery. Neuroimaging studies are beginning to reveal anatomical and functional aberrancies in the brain of children with pCMS. The cerebellar efferent pathways are likely to be implicated as a neuroanatomical substrate in the development of pCMS, as shown by a handful of diffusion tractography studies to date. However, the pathophysiology of this condition still remains unclear. Hypoperfusion of supratentorial cortical and subcortical structures may mediate the speech and behavioural deficits seen in pCMS, and is a candidate for a causal pathophysiological mechanism. This study aims to prospectively image children with pCMS using advanced MRI techniques including diffusion tractography and arterial spin labelling, and to correlate this with clinical descriptions of the syndrome. All children referred to Great Ormond Street Hospital for Children with a posterior fossa brain tumour will be imaged pre-operatively, post-operatively and at delayed follow-up. In tandem with this, clinical assessments will be made of children post-operatively to ascertain which patients develop pCMS. In addition, anonymised advanced MRI data on healthy controls will be used as a comparator group.

NCT ID: NCT03470844 Completed - Major Injury Clinical Trials

Perioperative Research Into Memory: Cognitive Outcome Following Major Burns

PRiMe
Start date: August 5, 2015
Phase:
Study type: Observational

The long term survival of patients who require admission to critical care (CC) following a major burn injury (MBI) continues to improve with advanced clinical management. There has been increasing interest into cognitive dysfunction (CD) due to neuroinflammation (NI) following CC, anaesthesia, surgery, and the association of NI with diseases characterised by CD such as Alzheimer's disease. Patients who suffer a MBI and who subsequently require admission to CC will be at uniquely high risk for CD. MBI produces an exaggerated and prolonged systemic inflammatory response, with NI demonstrated in animal models. Additionally NI can be exaggerated by insults such as sepsis, anaesthesia, and surgical trauma, common and often necessary following MBI. The aim of this study is to identify CD using cognitive tests to examine for deficits in working memory and executive function. Test proposed to use are the Hopkins Verbal Learning and Verbal Fluency tests, and a validated computerised battery (CogState). Neuroinflammation and underlying pathophysiology using fMRI and spectroscopy, known to demonstrate biomarkers for CD and NI. QoL will be assessed using the validated EQ-5D tool. The Inclusion criteria; patients who survive their burns injury (greater than 15% total body surface area) and require mechanical ventilation. Primary exclusion criteria; admission with toxic epidermal necrolysis syndrome, and evidence of head trauma.

NCT ID: NCT03470545 Completed - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

EXPLORER-HCM
Start date: May 29, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

NCT ID: NCT03470441 Completed - Clinical trials for Acute Myocardial Infarction

A Study of Acute Myocardial Infarction Using FDY-5301

Start date: October 27, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.

NCT ID: NCT03469934 Completed - Eosinophilic Asthma Clinical Trials

Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma

Start date: November 14, 2017
Phase: Phase 2
Study type: Interventional

This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This study will also assess the safety and tolerability of etokimab in adult participants with severe eosinophilic asthma.

NCT ID: NCT03469245 Completed - Clinical trials for Abdominal Aortic Aneurysms

Validation of Fenestrations Positioning by Numerical Simulation

FenSim
Start date: April 26, 2018
Phase:
Study type: Observational

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

NCT ID: NCT03468725 Completed - Clinical trials for Healthy Male Volunteers

Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101

Start date: February 13, 2018
Phase: Phase 1
Study type: Interventional

The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study.