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NCT ID: NCT03532594 Recruiting - Clinical trials for Cardiovascular Diseases

Algorithmic Protamine Dosing for Reversal of Heparin After Cardiopulmonary Bypass

PRODOSE
Start date: April 16, 2018
Phase: N/A
Study type: Interventional

The PRODOSE trial is investigating a bespoke pharmacokinetic algorithm that calculates a tailored dose of protamine, required after cardiopulmonary bypass to reverse the action of heparin, based on individual patients and their actual bypass time. The PRODOSE trial aims to demonstrate that the algorithm can be used to define a protamine dose that will more reliably return coagulation parameters to pre-heparin levels as well as decreasing the risk of post-operative bleeding and transfusion. The trial aims to recruit 200 patients who will be randomised to either a bespoke or standard dose of protamine. The randomisation ratio will be 1:1 in the first instance but the trial uses an adaptive design and an interim analysis will be conducted after 100 patients have been randomised. The randomisation ratio could then be updated after the interim analysis to favour a superior arm whilst preserving statistical power levels.

NCT ID: NCT03532529 Not yet recruiting - Cardiogenic Shock Clinical Trials

Evaluation of Speckle Tracking Parameters as Predictors of Successful VA SPECKLE ECMO

SPECKLE-ECMO
Start date: September 3, 2018
Phase:
Study type: Observational

Purpose of this study is to assess whether measurements obtained through speckle tracking (LV longitudinal and circumferential strain, RV longitudinal strain) can give additional information in identifying patients who develop adverse outcomes 30 days post successfully weaning from VA ECMO (liberation not for palliation). It is a prospective observational non-blinded pilot study. In order to achieve this purpose, speckle tracking analysis will be performed on the recorded images of the transoesophageal echocardiogram performed during the last VA ECMO weaning study of patients defined ready for VA ECMO liberation. VA ECMO liberation will be based according to LVOT VTI increase and clinical judgment during patients' VA ECMO weaning study. It will be assessed whether the population experiencing the outcomes of interest (death within 30 days from VA ECMO liberation, hospital admission for a new episode of cardiogenic shock or heart failure within 30 days from VA ECMO liberation, need for new mechanical circulatory support within 30 days from VA ECMO liberation) and the population not experiencing these outcomes have different values of strain (LV longitudinal and circumferential and RV longitudinal strain) during the weaning study.

NCT ID: NCT03532347 Recruiting - Cancer Clinical Trials

Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

SharkBITE
Start date: May 22, 2017
Phase: N/A
Study type: Interventional

Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and fine needle biopsy (FNB) are the standard methods for obtaining tissue samples from tumours of the pancreas. The diagnostic accuracy by strict criteria is around 75-80%. A non diagnostic sample causes delay and the need for a repeat procedure. To date no significant difference has been found between standard FNA and standard FNB needles. A novel opposing bevel design (SharkCore) needle for FNB may provide better diagnostic performance. The aim of this study is to compare the performance of a standard needle and the Sharkcore needle. Patients attending for routine biopsy of a suspected pancreatic tumour will be invited to participate. All participants will have 3 samples taken with each needle. The samples from each needle will be processed and reported separately with the pathologists blinded as to the report from the other needle. Following the procedure participants will be observed as normal in the recovery area and allowed home later. Further study participation is limited to 1 telephone call at 7 days. Participants will be asked if they have developed any new symptoms since the procedure and whether they have had to seek medical attention for this.The risks of the study procedure are the same as those of a non study procedure. Both needle types are in routine use in our unit. The study will be performed in the endoscopy unit of the Freeman hospital. The study is funded by a grant from Medtronic the company who make the Sharkcore needle. The study is planned to recruit 108 participants over 10 months with a further 6 months of follow up. If the new needle is found to perform better its routine use will potentially reduce the delay experienced by patients as well as the cost incurred by repeat procedures.

NCT ID: NCT03531398 Recruiting - Nutrition Clinical Trials

Postprandial Responses to Typical UK Meal Nutrient Profiles

Pre-PREDICT
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The aim of the current study is to investigate the postprandial metabolic response to typically consumed fat and carbohydrate doses in single meals. An additional aim is to validate the use of dry blood spot (DBS) for triglyceride analysis versus venous blood sampling.

NCT ID: NCT03531229 Recruiting - Healthy Clinical Trials

Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

Start date: April 17, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men

NCT ID: NCT03531177 Recruiting - Type2 Diabetes Clinical Trials

Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial

HEAL-D
Start date: April 26, 2018
Phase: N/A
Study type: Interventional

The HEAL-D feasibility trial is a randomised control study to determine the feasibility of conducting an effectiveness trial of the Healthy Eating & Active Lifestyles for Diabetes programme; a culturally-tailored diet and lifestyle intervention for the management of type 2 diabetes in African and Caribbean communities. In this feasibility study HEAL-D will be evaluated against usual care in 80 patients with type 2 diabetes. HEAL-D is a programme of culturally-tailored diabetes self-management education and support, delivered over 7 sessions. Key outcomes are the acceptability of the programme; and recruitment and retention of the research participants. The current study will also pilot the feasibility and acceptability to participants of measuring proposed primary and secondary outcomes including HbA1c, blood lipids (triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol), body weight, waist circumference, diabetes knowledge, diabetes and dietary competence, diabetes empowerment, perceived social support, quality of life, dietary intake, and physical activity.

NCT ID: NCT03531125 Not yet recruiting - Pancreatic Cancer Clinical Trials

Gene Expression in Resectable Pancreatic Cancer

NEOPANC-01
Start date: June 2018
Phase:
Study type: Observational

Pancreatic cancer is a lethal disease. The 1-year and 5-year survival rate is approximately 20% and <5% respectively. The treatment options available are limited. Only around 10-20% of patients present early enough to undergo surgical resection. Furthermore, chemotherapy for more advanced pancreatic cancer leads to limited survival benefit and can cause significant side effects. One of the main obstacles to developing new treatments for pancreatic cancer is our limited understanding of how pancreatic cancer cells change/evolve/adapt following treatment. This study is a pilot study to assess whether we can track gene expression (using a technique called RNA sequencing) in pancreatic cancer cells between two separate time points. We intend to take a tissue sample (biopsy) of the cancer using endoscopy ultrasound (EUS) and compare it with samples taken at the time of surgery in those patients with resectable disease. The interval between endoscopy and surgery will be approximately 2 to 3 weeks and reflects the standard period of time that patients wait from the time point at which the cancer is deemed to be operable (in the multi-disciplinary team meeting) to the actual operation. If we find that the samples (biopsies) taken at EUS and surgery are comparable we plan to develop future clinical trials of similar design but with the addition of drug therapy. Here we will use RNA sequencing to interrogate the effects of novel cancer drugs on gene expression within the tumour. This will give us information on how to select patients for therapy, how resistance develops to these treatments, and allow us to better understand what treatments can be combined on a rational basis. However, prior to undertaking such studies it is important to understand much variability there is in gene expression between sampling at 2 different time points at which two different techniques are used.

NCT ID: NCT03531073 Recruiting - Psoriatic Arthritis Clinical Trials

Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis

MONITOR
Start date: April 18, 2018
Phase:
Study type: Observational

MONITOR is a cohort study recruiting patients with a new diagnosis of psoriatic arthritis (PsA) which will establish outcomes using a pragmatic feasible 'treat to target' approach in a real-life clinic population. It is the central cohort for a planned Trials Within Cohorts (TWiCs) design which will test alternative therapies and interventions in embedded clinical trials comparing outcomes to those receiving "standard care" in the cohort.

NCT ID: NCT03531047 Not yet recruiting - Keratoconus Clinical Trials

Refractive Corneal Cross-linking

Start date: June 2018
Phase: N/A
Study type: Interventional

Young patients with keratoconus face two problems: disease progression and corneal shape irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required to maintain useful vision. Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease progression. The aim is to strengthen the cornea to prevent further shape deterioration. For patients whose quality of vision has already suffered, standard CXL can generally only prevent further deterioration, rather than improving vision. Refractive CXL, a new iteration of CXL in which a bespoke treatment pattern is applied to the cornea, aims to smooth out surface irregularities thereby improving vision. This primary objective of this study is to compare the visual outcome in patients with progressive keratoconus treated with refractive CXL, as compared with historical controls treated with standard CXL.

NCT ID: NCT03530995 Recruiting - Autoimmune Diseases Clinical Trials

Drug-drug Interaction Study Between KD025, Itraconazole, Rifampicin and Rabeprazole in Healthy Volunteers

Start date: April 28, 2018
Phase: Phase 1
Study type: Interventional

This is a single centre, non-randomised, 4-period sequential dose study in healthy male subjects.