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NCT ID: NCT03391778 Recruiting - Neoplasms Clinical Trials

Adoptive Cell Therapy Long-term Follow-up (LTFU) Study

Start date: April 9, 2018
Phase: Phase 1
Study type: Interventional

This trial will evaluate long term safety of participants who have received GlaxoSmithKline (GSK) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.

NCT ID: NCT03386201 Recruiting - Bile Duct Injury Clinical Trials

FLuorescence Cholangiography Using Methylene Blue

FLoCaMB
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.

NCT ID: NCT03376438 Recruiting - Atrial Flutter Clinical Trials

Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

FAST Registry
Start date: June 8, 2017
Phase:
Study type: Observational

The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.

NCT ID: NCT03373500 Recruiting - Hypertension Clinical Trials

Effect of Dietary Salt Reduction on Blood Pressure in Kidney Transplant Recipients

Start date: October 11, 2017
Phase: N/A
Study type: Interventional

Cardiovascular morbidity and mortality is increased in kidney transplant patients. High blood pressure (BP) contributes significantly to this risk and is also associated with shortened allograft survival. Salt reduction lowers BP in the general population and there is emerging data that salt reduction also effectively lowers BP in chronic kidney disease (CKD). Kidney transplant patients, by definition have CKD, but they differ fundamentally from the general CKD population in that they are on medications which can predispose to high blood pressure, their kidneys are denervated, and they often have reasonable excretory kidney function. The proposed study will be an eight-week randomised, controlled trial assessing the effect of intensive dietary salt advice on cardiovascular risk factors in kidney transplant patients. The primary outcome is office BP readings, with the effect on 24-hour ambulatory blood pressure, proteinuria, arterial stiffness and endothelial function being studied as secondary outcomes.

NCT ID: NCT03369821 Recruiting - Clinical trials for Type1 Diabetes Mellitus

EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)

EXE-T1D
Start date: September 1, 2017
Phase:
Study type: Observational

Type 1 diabetes (T1D) results from destruction of insulin-producing beta cells in the pancreas by the body's own immune system (autoimmunity). It is not fully understood what causes this type of diabetes and why there is variation in age of onset and severity between people who develop the disease. The aim of this work is to study very unusual people who develop T1D extremely young, as babies under 2 years of age (EET1D). The investigators think that, for the condition to have developed that early, they must have an unusual or extreme form of autoimmunity. Studying people with EET1D will enable us to look at exactly what goes wrong with the immune system because they have one of the most extreme forms of the disease. Much may be learned about the disease from a small number of rare individuals. The investigators aim to confirm that they have autoimmune type 1 diabetes and then try to understand how they have developed diabetes so young by studying their immune system genes, the function of their immune system, and environmental factors (such as maternal genetics) that may play a role in their development of the disease. People with diabetes diagnosed under 12 months are very rare, live all over the world. and are usually referred to Exeter for genetic testing. Individuals will be contacted via their clinician to ask for more information about their diabetes and their family history. Samples will be collected to study whether they still make any of their own insulin and whether they make specific antibodies against their beta cells in the pancreas. Separately, their immune system will be studied in depth using immune cells isolated from a blood sample. These cells will undergo cutting edge techniques by Dr Tim Tree at King's College London, by Professor Bart Roep at Leiden University Medical Center, Netherlands, and Dr Cate Speake, Benaroya Research Institute, Seattle (USA). Some of these tests have never been used in people of young ages around the world, so an aim of this project will be to develop methods that can be used to study people even if they live far away. Additional funding extends the study for a further 3 years (Phase 2) to include recruitment of infants without diabetes, aged 0-6 years, as controls to enable assessment of how the abnormalities found in autoimmune and non-autoimmune diabetes compare to normal early life development of the immune system.

NCT ID: NCT03369548 Recruiting - Healthy Clinical Trials

CABALA Diet & Health Study

CABALA
Start date: December 4, 2017
Phase: N/A
Study type: Interventional

During digestion of fatty foods, the liver produces a substance called bile which helps with the absorption of fat in the gut (small intestine). Some research studies have shown that friendly bacteria that live in our gut can change the makeup of bile (referred to as bile acids) leading to a lowering of blood cholesterol levels, an important risk factor for developing heart disease. This finding has been found in people who consume diets high in dietary fibers and probiotics that enhance the growth of friendly gut bacteria, and also plant rich foods high in polyphenols (such as apples). At present, very little is known about how the makeup of bile acids can regulate blood cholesterol levels and if their measurement in blood, urine or stool samples can be used as an indicator of human health. The aim of this study is to explore how consumption of foods which enhance the growth of friendly gut bacteria (such as probiotics, prebiotics, and plant rich foods high in polyphenols) can change the makeup of bile acids after 8 weeks. Changes in the bile acids measured in blood and stool samples will then be related to markers of health, such as blood cholesterol, glucose, insulin, vascular health and inflammatory markers.

NCT ID: NCT03366545 Recruiting - Heart Failure Clinical Trials

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

BIO|STREAM HF
Start date: May 14, 2018
Phase:
Study type: Observational [Patient Registry]

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

NCT ID: NCT03364114 Recruiting - Clinical trials for Barrett's Esophagus With Dysplasia

Endorotor Resection In Refractory Barrett's Dysplasia Patients

Start date: February 9, 2018
Phase: N/A
Study type: Interventional

The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

NCT ID: NCT03363373 Recruiting - Neuroblastoma Clinical Trials

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Start date: April 3, 2018
Phase: Phase 2
Study type: Interventional

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

NCT ID: NCT03363087 Recruiting - Atrial Fibrillation Clinical Trials

High Density Scar Guided Atrial Fibrillation Mapping

HD-SAGA
Start date: August 27, 2019
Phase: N/A
Study type: Interventional

HD SAGA: There is increasing evidence that having AF is associated with some scarring of the upper chamber of the heart, the left atrium. There is also evidence that the amount of scarring can predict ablation success rates. Recently, rapid ultra high density mapping equipment has become available and this has the capability of defining the electrical scar in the atrium in detail. The equipment used to do this is standard approved equipment for the procedure but its use for making scar maps has not been fully assessed. In the mapping phase of the study therefore, the aim will be to collect high density scar maps in AF and normal rhythm to see how they compare. Maps will be collected in different ways to see if that changes their accuracy. The study will also assess if the values previously suggested as representing scar with lower density mapping systems are still appropriate where high density mapping equipment is used. The results from this study will help to improve the understanding of scar in the atrium and help demonstrate the most efficient way to collect scar information using this high density mapping equipment. In the future, clinicians may be able to use these very detailed scar maps to tailor and refine the way they ablate patients with AF, though the focus of the current study is just on collecting the scar information. While identifying areas requiring ablation is important to an ablation procedure, the other important aspect is the efficacy of ablation. Until now, we have been reliant on assessing our inputs into an ablation (such as the level of contact and the power delivered) but have been limited in the assessment of the output of an ablation in terms of lesion characteristics. New ablation catheter technology is now available which can assess the localised impedance drop with ablation. This is likely a better surrogate for lesion parameters than what we have previously had available and merits further study. Based on such study, we may be able to define targets for ablation which would help to guide future ablations. HD SAGA S: Approval amendment March 2021 In addition to the above, using new catheter technology incorporating contact force into the assessment of ablation lesion efficacy. HD SAGA H: Approval amendment March 2021 Using new mapping catheter (HD Grid) and algorithms (HD Wave) to compare scar maps between AF and SR and pre-establish pulmonary vein isolation lines.