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NCT ID: NCT02991469 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)

Start date: August 9, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population. Secondary Objective: To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.

NCT ID: NCT02991300 Recruiting - Cartilage Disease Clinical Trials

BioPoly® RS Partial Resurfacing Patella Registry Study

Start date: September 2016
Phase:
Study type: Observational [Patient Registry]

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit

NCT ID: NCT02989480 Recruiting - Sarcoidosis Clinical Trials

PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC

Start date: August 2015
Phase:
Study type: Observational

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the heart patches of inflammation can result in scarring, especially of the ventricles. Both conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated with inflammation suppressing treatment (steroids), as well as pacemakers and implantable defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with implantable defibrillators. The diagnosis of either condition can be difficult and indeed distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are used to identify inflammation in the heart in patients suspected of having cardiac sarcoid. It is not known whether patients with ARVC have abnormal PET scans.

NCT ID: NCT02989207 Recruiting - Clinical trials for Primary Open Angle Glaucoma

Surgical Approaches in Treating Uncontrolled Glaucoma in Black African and African-Caribbeans

PEACE
Start date: August 2016
Phase: N/A
Study type: Interventional

The aim is to perform a randomised feasibility trial preceding a large prospective randomised controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London. The UK Office of National Statistics estimated that among the population of England in 2007, approximately 4.3% were of African/African-Caribbean background, while in large cities such as London and Birmingham about 20% of the population is of African/African-Caribbean origin. For eye units in these cities, managing glaucoma in this population is challenging and we need to identify a better alternative to our current standard surgical treatment. There is now evidence from one RCT which shows better overall outcomes from tube surgery in comparison to trabeculectomy for glaucoma. However, this study did not address black populations specifically and did not address the potential role of MMC in tube surgery. This feasibility study will enable us to design a fully powered RCT with the aim of determining how best to optimise the surgical treatment of POAG in black populations, by comparing outcomes in three types of glaucoma surgery.

NCT ID: NCT02988128 Recruiting - Stroke, Ischemic Clinical Trials

Neurovascular Product Surveillance Registry

INSPIRE
Start date: December 2016
Phase:
Study type: Observational [Patient Registry]

Post market surveillance registry

NCT ID: NCT02987608 Recruiting - Clinical trials for Emotional Difficulties

A Feasibility Trial of Power Up

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

There is an increasing demand for digital tools to empower young people with mental health difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are increasingly being used to support child mental health. Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision making tools available to support young people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to participate more in decisions around their care. The project will involve two phases: - Development Phase -Developing Power Up according to the views and ideas expressed by young people, their parents/ carers, and clinicians in Patient and Public Involvement (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS, 10 parents/ carers and 10 clinicians to review the acceptability of the content and format of Power Up. - Feasibility testing Phase -Conducting a feasibility trial with 120 young people with emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will receive treatment as usual and 60 will use Power Up alongside treatment as usual. Participant's ratings of empowerment, activation, and symptoms will be measured soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later. The findings will inform the planning of a prospective cluster controlled trial. More broadly this trial will contribute an understanding of the feasibility and acceptability of developing and implementing a shared decision making app into CAMHS.

NCT ID: NCT02986516 Recruiting - Chordoma Clinical Trials

Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

SACRO
Start date: March 16, 2017
Phase: N/A
Study type: Interventional

Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

NCT ID: NCT02984410 Recruiting - Clinical trials for Oropharyngeal Cancer

Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

Best Of
Start date: November 27, 2017
Phase: N/A
Study type: Interventional

Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are usually cured. Treatment of early stage OPSCC can be successfully achieved with primary surgery including neck dissection, as indicated, or with definitive radiotherapy. The current standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both associated with comparable, high tumor control rates but with different side effects profiles and technical constraints. In order to decrease the potential morbidity of surgery, transoral approaches have been developed within the last decades, including transoral robotic surgery (TORS), transoral laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients with head and neck cancer treated with IMRT experienced significant improvements in cause specific survival (CSS) compared with patients treated with non-IMRT techniques thus suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile. It is as yet unclear however, which one of the new techniques is superior to the other in terms of function preservation. Given that the functional outcome of most importance is swallowing function, the preservation of swallowing is thus of major importance. The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC.

NCT ID: NCT02981511 Recruiting - Clinical trials for Preoxygenation, Apnoea, Anaesthesia

Optiflow Preoxygenation

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

Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood oxygen saturation. This study is designed to assess whether the Optiflow system can efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it could be used in emergency anaesthesia. If so, it would be then be in place in the case of difficult or failed intubation to maintain oxygenation ie: it could preoxygenate and then maintain oxygenation seamlessly.

NCT ID: NCT02980367 Recruiting - Clinical trials for Anterior Cruciate Ligament Injury

ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients

ACL SNNAP
Start date: December 2016
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine in patients with non-acute Anterior Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management [Rehabilitation] (with option for later ACL reconstruction, only if required) is more clinically effective and cost effective than a strategy of surgical management [Reconstruction].