Clinical Trials Logo

Filter by:
NCT ID: NCT03126279 Recruiting - Pain Clinical Trials

fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study

Start date: August 2015
Phase: N/A
Study type: Observational

Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop persistent post-operative pain. To test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain and function will be performed 6 months post TKR surgery

NCT ID: NCT03118037 Recruiting - Uterine Fibroid Clinical Trials

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry

SAGE
Start date: June 14, 2017
Phase:
Study type: Observational [Patient Registry]

SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.

NCT ID: NCT03117543 Recruiting - Clinical trials for Diabetes, Gestational

Diagnostic Approaches in Gestational Diabetes and Impact of Ethnicity

Start date: March 2016
Phase:
Study type: Observational

Gestational diabetes (GDM) means raised blood glucose found for the first time in pregnancy. GDM is common, particularly in women from minority ethnicities. GDM does not cause any symptoms in the mother. GDM is associated with adverse pregnancy outcomes which can be improved with treatment of GDM. The United Kingdom National Institute for Health and Care Excellence (NICE) recommend pregnant women with one or more risk factors should have a 75g oral glucose tolerance test (OGTT). The OGTT is performed in a clinic with venous plasma glucose measured fasting and at 2 hours. This is resource-intensive, and some women with GDM may be missed by this risk-factor based approach. The International Association of Diabetes and Pregnancy Study Groups (IADPSG 2010) recommends screening all pregnant women with 2-hour, 3 sample (fasting, 1 and 2 hour), 75g OGTT, which is even more resource intensive. Developing more cost-effective and convenient approaches to screening for GDM is a priority. The researchers will validate a new home-use OGTT system (hOGTT), which measures whole blood glucose in capillary blood ('finger-stick' sample), against the gold standard venous plasma glucose in pregnancy. The researchers will also investigate the performance of glycated haemoglobin (HbA1c) in screening for GDM. HbA1c is used for diagnosis of diabetes outside of pregnancy, but is currently not recommended for screening for GDM. The researchers will also investigate relationships between glucose measured in different samples (venous versus capillary), different fractions (plasma versus whole blood), and using different methods in pregnancy. In a substudy the researchers will investigate: ethnic differences in HbA1c and other glycaemic markers; the contribution of fasting and postprandial glucose handling, diet and ethnicity on HbA1c; and ethnic differences in insulin responses to 75g OGTT in pregnancy. The researchers will invite pregnant women between 16-34 weeks gestation to participate. The research involves one hospital visit for an OGTT. Participants will have venous blood samples taken fasting and at 1-hour and 2-hours, and at the same times finger-stick blood samples will be tested. The researchers will invite women of Black African, Black Caribbean and White European ethnicity to participate in a substudy in which participants will have extra blood taken and a diet assessment. If the hOGTT provides accurate results in pregnancy, using it to perform OGTTs at home would make screening for GDM less expensive and more convenient and may facilitate universal screening for GDM. Understanding ethnic differences in HbA1c will help determine if HbA1c is a reliable screening tool for GDM in our ethnically diverse local population.

NCT ID: NCT03116256 Recruiting - Clinical trials for Overweight and Obesity

The Effect of Very Low Calorie Diet With and Without Exercise on Muscle Synthesis in Middle-aged Overweight Male.

VLCDex
Start date: January 9, 2017
Phase: N/A
Study type: Interventional

The aims of this project are: to investigate the impact of VLCD on control of muscle protein synthesis, muscle structure and function, cardiac function (ejection fraction), vascular function (blood flow and capillary function), overall physiology status (cardiopulmonary function) and metabolic status (insulin sensitivity) in overweight and obese middle-aged male with or without exercises. There are 3 groups for the study, to which each participant will be randomly assigned into one of either: 1. VLCD only 2. VLCD with resistance exercise training (RET) 3. VLCD with high intensity interval training (HIIT) The total duration of the intervention is six weeks, with exercises taking place three times per week at the research unit under close supervision by trained staff.

NCT ID: NCT03116217 Recruiting - Clinical trials for Posterior Urethral Valves

Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

Antenatal
Start date: June 26, 2017
Phase:
Study type: Observational

Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

NCT ID: NCT03114813 Recruiting - Liver Cirrhosis Clinical Trials

Can MRI Evaluate Beta-blocker Response in Portal Hypertension?

B-SMaRT
Start date: January 2017
Phase:
Study type: Observational

Aim: To test if MRI can detect meaningful changes in portal pressure in the liver to assess whether treatment with beta-blockers has worked. Liver Disease: Most people with liver disease do not have symptoms. Over time they develop 'cirrhosis' - severe liver scarring. In the United Kingdom deaths due to cirrhosis have doubled over the last decade, because of increasing rates of alcohol consumption and obesity, while heart, kidney, lung diseases, strokes and cancer fatalities have fallen. Portal pressure: Cirrhosis causes increased pressure within the liver and changes in the circulation leading to the development of varicose veins in the gullet and stomach called 'varices'. Varices bleed easily, leading to emergency situations that can be life threatening. However, if the increased pressure within the liver (portal pressure) is detected early, then treatment can prevent variceal bleeding. The only test we have to predict prognosis and treatment success in someone with cirrhosis is by measuring the portal pressure. Measuring portal pressure: Currently the only existing test to measure portal pressure is to pass a pressure sensor through a vein in the neck, down into the liver. This is called the hepatic venous pressure gradient (HVPG) measurement. The HVPG measurement is disliked by patients because it is an invasive procedure. It is also expensive and not widely available. Hence, patients with cirrhosis need to have regular camera tests (endoscopies) to look for varices. How can you treat varices? Two options; 1. With tablets to lower the pressure (beta-blockers) 2. Endoscopy treatment (banding) Both have advantages and disadvantages; - Beta-blockers only lower the portal pressure in about half of those that take them, with some evidence they may also have a protective effect against infections from the bowel by increasing the speed of bowel motion - Treating the varices with endoscopy requires several endoscopies and can lead to life-threatening bleeding. Most patients are therefore given beta-blockers and monitored closely to see if they work. Why does it matter? Beta-blockers can cause side effects (e.g. fainting) that are unpleasant enough to make up to one third of patients stop taking them. Beta-blockers only reduce the portal pressure in half of patients. The remaining patients are exposed to potential side effects and possible harm in those with the most advanced liver disease. These patients may still have a life-threatening bleed as the varices have not been adequately treated. There is a desperate need to discover whether the portal pressure changes with treatment (such as with beta-blockers) without invasive tests across the NHS. Proposed study: Researchers in Nottingham have shown MRI can be used as an accurate marker of portal pressure with just one scan. To be useful to patients, doctors and researchers, this study will investigate whether MRI can detect meaningful changes in portal pressure after treatment with beta-blockers. This study has been designed with patient and public involvement (PPI) integrated throughout. A focus group shaped the study design and committed to collaborate in developing patient materials, recruitment, retention and dissemination. All patients who have HVPG will be given information about the study. Study Visit 1 - One hour MRI scan - Endoscopy to identify varices - If varices are present the patient will be started on beta-blockers and invited to visit 2 - If there are no varices, patients will return to regular follow up with the liver team Study Visit 2 (after one week) - Assess side effects, blood pressure and pulse - Increase dose of beta-blocker as appropriate Study Visit 3 (after 4-12 weeks) - One hour MRI scan - Repeat HVPG measurement Treatment success is determined by the second HVPG measurement. If beta-blockers are working they will be continued. If not, the patient will have treatment with endoscopy. This represents the ideal pathway which is more personalised than current standard care.

NCT ID: NCT03110796 Recruiting - Diabetic Foot Ulcer Clinical Trials

Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers

DISCOVERY
Start date: July 31, 2017
Phase: N/A
Study type: Interventional

Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.

NCT ID: NCT03109925 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

Start date: June 2, 2017
Phase: Phase 2
Study type: Interventional

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.

NCT ID: NCT03108495 Recruiting - Cervical Carcinoma Clinical Trials

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

Start date: June 22, 2017
Phase: Phase 2
Study type: Interventional

Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma

NCT ID: NCT03104517 Recruiting - Clinical trials for Stress Urinary Incontinence

Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

CELLEBRATE
Start date: April 23, 2019
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.