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NCT ID: NCT03309332 Recruiting - Stroke Clinical Trials

AMPLATZER PFO Occluder Post Approval Study

PFO PAS
Start date: January 31, 2018
Phase: N/A
Study type: Interventional

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.

NCT ID: NCT03308903 Recruiting - Sarcopenia Clinical Trials

Use of the Sit-To-Stand Task as a Screening Tool for Sarcopenia The

Start date: January 22, 2018
Phase:
Study type: Observational

A common condition associated with ageing is sarcopenia, which is a progressive decrease in muscle mass. Sarcopenia is associated with adverse outcomes including increased mortality, and places a major burden on healthcare spending, with the annual cost of sarcopenia in the United States exceeding that of osteoporosis and hip fracture. In the UK, the prevalence of sarcopenia in community-dwelling older people has been estimated at 5% for men and 8% for women. Current guidelines for sarcopenia diagnosis require muscle mass to be measured using costly devices such as Dual Energy X-ray Absorptiometry (DXA) and Magnetic Resonance Imaging (MRI). Previous research has found strong relationships between the sit-to-stand (STS) test and both muscle mass and muscle strength. This pilot study aims to examine this relationship in community-dwelling older people to develop predictive equations for initial screening of sarcopenia. Forty subjects will be tested using the diagnostic criteria developed by the European Working Group on Sarcopenia in Older People (EWGSOP). Muscle mass will be measured using the DXA and diagnostic ultrasound. Muscle strength will be measured using isokinetic dynamometer, handgrip dynamometry, and hand-held dynamometry. Functional performance will be measured using the Timed-up-and-Go and gait velocity, and the STS. Subjects will perform two variants of the STS; the five times STS (5STS), which requires subjects to perform five consecutive STS movements as quick as possible, and the 30-second STS (30STS), which requires subjects to perform as many STS movements as possible in 30 seconds. All testing will be completed in a single session lasting 90 minutes for each subject. Testing will be performed at the University of Bedfordshire Polhill Campus. Subject recruitment will be recruited using advertisement posters and word of mouth.

NCT ID: NCT03303547 Recruiting - Clinical trials for Adenocarcinoma of the Rectum

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

COMET
Start date: October 16, 2017
Phase: N/A
Study type: Interventional

Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be identified on pre-operative scans and mapped by radiologists then shared with pathologists prior to processing the resected specimen. Patients will be managed at their local hospital with standard follow-up. Patients will be followed up for 5 years.

NCT ID: NCT03302663 Recruiting - Fetal Conditions Clinical Trials

The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice

Start date: August 1, 2013
Phase: N/A
Study type: Interventional

This project is split into 4 sections: 1. Can improvements be made in the Magnetic resonance imaging sequences used to image the fetus in order to improve diagnostic accuracy? 2. Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T 3. Can fetal MRI be used to image the fetal heart? 4. Can fetal MRI be used to image the fetal Bones?

NCT ID: NCT03302013 Recruiting - Clinical trials for Primary Osteoarthritis of Knee Nos

All Ligaments Left In Knee Arthroplasty Trial

ALLIKAT
Start date: September 5, 2016
Phase: N/A
Study type: Interventional

Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.

NCT ID: NCT03301506 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Start date: December 12, 2017
Phase: Phase 3
Study type: Interventional

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

NCT ID: NCT03299569 Recruiting - Clinical trials for Myocardial Infarction

Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

STARR
Start date: July 29, 2016
Phase:
Study type: Observational [Patient Registry]

Acute stress-induced (Takotsubo cardiomyopathy) presents like a heart attack and is triggered by intense emotional or physical stress. Although coronary arteries are unobstructed, it has been suggested that the risk of death is similar to a myocardial infarction. The purpose of the STARR study is to identify all cases of Takotsubo in Scotland since 2010 and assess its epidemiology and outcomes.

NCT ID: NCT03298763 Recruiting - Clinical trials for Adenocarcinoma of Lung

Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer

TACTICAL
Start date: March 5, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the safety and anti-tumour activity of MSCTRAIL in addition to chemotherapy in metastatic Non-small cell lung cancer (NSCLC) patients in a Phase I/II clinical trial. In the phase I study, patients will receive cisplatin and pemetrexed on day one followed by MSCTRAIL cells on day 2. This constitutes one cycle of treatment. Each patient will receive 3 cycles of treatment at 21 day intervals. The aim of phase 1 is to estimate the recommended Phase II dose (RP2D) of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy. During the phase II study patients will be randomised to either the intervention or the control arm of the study. All patients in both arms will receive cisplatin and pemetrexed on day one of treatment. Patients randomised to the intervention arm will receive the recommended dose of MSCTRAIL from Phase I on day 2 whilst those in the control arm will receive a placebo. As this is a double blind trial both patients and the clinical team will not know whether they are receiving MSCTRAIL or a placebo product. The aim of phase 2 is to assess tolerability and preliminary efficacy of MSCTRAIL in combination with pemetrexed/cisplatin chemotherapy.

NCT ID: NCT03289884 Recruiting - Hydatid Disease Clinical Trials

MR Assessment of Hepatic Hydatid Disease

Start date: August 14, 2017
Phase:
Study type: Observational

Hydatid disease is a major healthcare problem worldwide caused by infection that commonly affects the liver. Treatments for hydatid disease depend on how advanced the disease is and if the infection is active or not. Currently, doctors decide what stage the disease is at by looking at the appearance of liver on scans and by performing blood tests. It is however still very difficult to be certain if a treatment is working and when is the right moment to start and stop medication. Magnetic Resonance Imaging (MRI) scanning is a safe and non-invasive way of imaging the liver that can provide detailed information not just about what the liver looks like but also other information about the chemical composition of normal and diseased liver tissue. MRI is already widely used in the NHS for many liver conditions but it is unknown whether analysing the chemical composition will help decide on the stage and activity of hydatid liver disease. This study will allow comparison between MRI information about liver structure and composition with existing methods of assessing disease stage. If fluid is later obtained from the liver as part of usual clinical care (either using a needle with ultrasound or at the time of surgery), this study will also compare information about the fluid composition obtained from MRI scanning, with the results obtained when analysing the fluid in the lab. This will help to develop a more accurate way of non-invasively assessing hydatid disease in the liver, in the future.

NCT ID: NCT03288532 Recruiting - Clinical trials for Renal Cell Carcinoma

Renal Adjuvant MultiPle Arm Randomised Trial

RAMPART
Start date: July 19, 2018
Phase: Phase 3
Study type: Interventional

RATIONALE: The current global standard of care after nephrectomy for localised RCC therefore remains active monitoring (i.e., observation by clinical and radiological means). 30-40% patients with initially localised RCC develop metastatic disease following nephrectomy. Need for adjuvant therapy is most marked in the high risk population where outcomes are predictably poor. However, the risk of recurrence in patients who are of intermediate risk of recurrence is not insignificant. Unfortunately, despite showing efficacy in advanced RCC, the results in the adjuvant setting, so far, are inconclusive. AIM: RAMPART is a phase III Multi-Arm Multi-Stage randomised controlled platform trial, initiated with three arms. The trial is assessing if durvalumab monotherapy or the combination of durvalumab and tremelimumab can improve Disease Free Survival (DFS) or Overall Survival (OS) compared to the current global standard-of-care (active monitoring). At the start of recruitment, patients with Leibovich scores 3 to 11 will be eligible for randomisation. Accrual of intermediate risk patients (Leibovich scores 3 5) will stop after 3 years or when intermediate risk patients contribute 25% of the total accrual target, whichever is earlier. Recruitment of patients with Leibovich scores 6 to 11 will continue until the accrual target is reached.