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NCT ID: NCT03495297 Active, not recruiting - Clinical trials for Ventricular Arrythmia

A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

PRAETORIAN-DFT
Start date: May 7, 2018
Phase: N/A
Study type: Interventional

This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

NCT ID: NCT03494322 Active, not recruiting - Clinical trials for Head and Neck Cancer

EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer

EACH
Start date: July 20, 2018
Phase: Phase 2
Study type: Interventional

Head & neck (H&N) cancer is the eighth most common cancer in the UK. Advanced H&N cancer which has come back after treatment or has spread to other parts of the body is incurable and the average life expectancy of these patients is less than a year. New drugs called immune checkpoint inhibitors work with the patient's own immune system to fight cancer. They are used in the clinic to treat a number of cancers, including H&N cancer. It may be possible to make immune checkpoint inhibitors more effective by combining drugs that work in different ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established drug that works by blocking signals that tell cancer cells to grow and divide into more cells. It also engages with the immune system within the tumour. The trial aims to see if giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at treating advanced H&N cancer than giving avelumab on its own. These two drugs have not been given together before, so to start with, the investigator plans to enrol a small number of patients and give the patients avelumab + cetuximab to make sure the combination is safe at the doses chosen. After this, the investigator plans to enrol 114 patients with advanced H&N cancer. Half the patients will be treated with avelumab alone and the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital once every 2 weeks. Treatment lasts for up to a year and patients will be followed up for up to 2 years from the time they enter the study. Patients will be recruited from around 15 hospitals in the UK. Recruitment would be expected to start in the second quarter of 2018 and it will take about 29 months (Safety run-in: 5 months; Phase II: 24 months) to recruit all the patients.

NCT ID: NCT03493685 Active, not recruiting - Clinical trials for Focal Segmental Glomerulosclerosis

Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

DUPLEX
Start date: April 17, 2018
Phase: Phase 3
Study type: Interventional

To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

NCT ID: NCT03492177 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

Start date: July 23, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

NCT ID: NCT03485677 Active, not recruiting - Clinical trials for Gaucher's Disease Type III

Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3

ELIKIDS
Start date: April 11, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: Evaluate the safety and pharmacokinetics of eliglustat in pediatric patients (≥2 to <18 years old). Secondary Objective: Evaluate the efficacy of eliglustat and quality of life in pediatric patients (≥2 to <18 years old).

NCT ID: NCT03485378 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

ASPIRE-ILD
Start date: September 20, 2018
Phase: N/A
Study type: Interventional

This is a prospective phase II study of Stereotactic Ablative Radiotherapy (SABR) in patients with Non-Small Cell Lung Cancer (NSCLC) and co-existent Interstitial Lung Disease (ILD), to determine oncologic and toxicity outcomes. Patients will be divided into 3 separate cohorts based on the ILD-GAP index.

NCT ID: NCT03482700 Active, not recruiting - COPD Clinical Trials

Impact of Specialist Led Integrated Care in COPD

INTEGR-COPD
Start date: December 6, 2017
Phase: N/A
Study type: Interventional

This study will look at the impact of care delivery by a specialist respiratory doctor compared to general practitioners for patients with COPD in East Birmingham. The primary outcome will be to compare the rates of provision of guideline-based care in intervention and control practices.

NCT ID: NCT03480347 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The BLF Early COPD Development Partnership Grant

Start date: January 17, 2018
Phase:
Study type: Observational

Most existing medical research has focused on patients with well-established COPD and poor lung function. Whilst this is important because such patients have lots of symptoms and problems, in some respects a better way of reducing health problems in the future would be to develop a strategy which focuses on patients with milder disease, and identifies which ones will go on to develop more severe problems and why these problems occur. The research in this application is designed to investigate these issues. The main objective of the Partnership is to study the very early stages of the development of COPD. The investigators will do this by recruiting a novel cohort of smokers (age 30-45), in whom the investigators will follow the trajectories of lung function decline to identify prospectively those at risk of excess decline. This programme forms a unique UK consortium of 8 academic centres with excellent high quality publication records and broad experience in mechanistic, translational, clinical and epidemiological studies in COPD with key capabilities including primary care.

NCT ID: NCT03477890 Active, not recruiting - Angina, Stable Clinical Trials

Coronary Microvascular Function and CT Coronary Angiography (CorCTCA)

CorCTCA
Start date: August 31, 2017
Phase: N/A
Study type: Interventional

Angina in patients without obstructive coronary artery disease (CAD) is a clinical conundrum and patient management is heterogeneous. Hypothesis: Abnormal coronary function is common and clinically relevant in this population. Design: An observational cohort study and nested randomised controlled diagnostic strategy trial. Methods: 250 patients with known or suspected angina informed by validated questionnaires but without obstructive CAD (<70% stenosis) in an artery >=2.5 mm or structural heart disease, as revealed by CT coronary angiography (CTCA), will be invited to undergo coronary function testing (FFR, CFR, IMR; intra-coronary ACh) during invasive angiography. Patients will be randomised following angiography but before testing coronary function to disclosure of the coronary function test results or not. Treatment decisions by the attending cardiologist will be recorded before and after disclosure of results. Outcomes: Primary: The between-group difference in the reclassification rate of the initial diagnosis using logistic regression, adjusted for baseline factors associated with the likelihood of reclassification of the initial diagnosis. Secondary: Prevalence of microvascular or vasospastic angina; health status reflected by the EuroQol group 5-Dimensions (EQ-5D), Seattle Angina Questionnaire, Illness perception, treatment satisfaction questionnaires and functional status questionnaires; angina medication and adherence. Value: This research will provide new insights into the conundrum of angina in patients without obstructive CAD or structural heart disease.

NCT ID: NCT03474653 Active, not recruiting - Clinical trials for Urinary Incontinence

LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®

Start date: June 12, 2017
Phase:
Study type: Observational

Latitude is an observational study exploring how effective Bulkamid ® is as a first line treatment for women with stress urinary incontinence. Women who choose to have Bulkamid as part of their standard clinical care will be asked to complete questionnaires before and after their surgery so that we can assess how their urinary symptoms change. As a second part of the study, we are asking all patients having any first line treatment for stress incontinence to complete a short questionnaire telling us how they decided what treatment to have. A small number of these women will be contacted via telephone and asked whether they would mind being interviewed to tell us more about this. We will also interview a number of doctors taking part in Latitude to find out how they counsel patients about different treatment options for stress urinary incontinence.