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NCT ID: NCT01985009 Completed - Clinical trials for Non-alcoholic Fatty Liver Disease

Prospective, Cross-sectional and Multicenter Study, Evaluating the Diagnosis Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® (Either With M+ or XL+ Probe) in Patient With Non-Alcoholic Fatty Liver Disease Using Liver Biopsy as Reference.

Start date: January 2014
Phase: N/A
Study type: Interventional

The non-alcoholic fatty liver disease (NAFLD) represents the most common cause of liver disease in the western world. It can progress from steatosis to non-alcoholic steatohepatitis (NASH), and then onto cirrhosis where there is a concomitant risk of developing hepatocellular carcinoma (HCC). The prevalence of hepatic steatosis is high, ranging from 16 to 31% in the general population, up to 80% in the obese populationand up to 96% in severely obese patients. Liver biopsy (LB) has traditionally been regarded as the gold standard for the assessment of patients with NAFLD, although it has several limitations. LB has a potential sampling error, is an invasive and often painful procedure. The natural history of patients with NAFLD is generally determined by the extent of liver fibrosis, hence non-invasive assessment of fibrosis with FibroScan® is often sufficient. For patients with proven NASH, changes in hepatic steatosis and serum ALT levels may provide information on the patient's course and/or response to treatment. Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® machine using the M+ probe. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease (ALD) and NAFLD. Recently, Echosens has also developed a novel ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™). Studies comparing CAP with liver biopsies in multi-aetiology cases and patients with Hepatitis C Virus (HCV) have shown that there is a good correlation between steatosis assessed histologically and using CAP. The main objective of this prospective study is to evaluate the diagnosis accuracy of the Controlled attenuation Parameter (CAP) measured by FibroScan® (either with M+ or XL+)in patients with NAFLD to assess liver steatosis using biopsy as a reference. The study involves adults' patients with suspected NAFLD scheduled to have a liver biopsy within 2 weeks of fibroscan examination and followed by the Hepatology service of four centers in United Kingdom. Approximately 450 patients (of which 350 will be evaluable) will be enrolled in this study: Around 100 patients will be measured with the M+ probe and around 250 with the XL+ probe. The inclusion period is from 18 to 24 months. Starting date: January 2014. End of recruitment: June 2017. The duration of the study for a patient is from 1 to 7 days, depending to the exams calendar.

NCT ID: NCT01984827 Completed - Diabetes Clinical Trials

Effect of Glucose on QTc Interval in Type 1 Diabetes

Start date: February 10, 2019
Phase: Phase 1
Study type: Interventional

High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have both been shown independently to affect heart activity in healthy volunteers as recorded by ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, the investigators want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation in Type 1 diabetic patients. The investigators also want to assess whether C-peptide (a fragment if insulin normally found in the blood but not present in the blood of Type 1 diabetics) has the opposite effect on heart activity i.e it shortens the QTc interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful for preventing 'dead in bed' syndrome also known as 'Sudden Cardiac Death' which is more common in diabetic patients compared to healthy volunteers.

NCT ID: NCT01984788 Completed - Clinical trials for Hereditary Angioedema

Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

OPuS-1
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.

NCT ID: NCT01984424 Completed - Hyperlipidemia Clinical Trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

GAUSS-3
Start date: December 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).

NCT ID: NCT01984346 Completed - Clinical trials for Persistent Atrial Fibrillation

CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

CONVERGE
Start date: December 2013
Phase: N/A
Study type: Interventional

This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

NCT ID: NCT01984242 Completed - Clinical trials for Renal Cell Carcinoma

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma

IMmotion150
Start date: January 8, 2014
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.

NCT ID: NCT01984047 Completed - Colitis, Ulcerative Clinical Trials

Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002

Start date: January 10, 2014
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a screening visit and if eligible and consenting, will attend to participate in the study within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing when each subject will receive a single intravenous dose of GSK3050002 or placebo, then remain in house under supervision until discharged on Day 3. Subjects will then return for 7 outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be 7-14 days following the last visit.

NCT ID: NCT01983488 Completed - Uveitis Clinical Trials

Clinical Outcome in Uveitis

Start date: September 2011
Phase:
Study type: Observational

This study is aimed at investigating the long term clinical outcome of patients with uveitis.

NCT ID: NCT01982565 Completed - Diabetic Foot Ulcer Clinical Trials

Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers

ProNOx1
Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 140 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, NOx generating dressing to increase blood flow in DFUs and to improve healing in chronic DFUs compared to standard of care.

NCT ID: NCT01982396 Completed - HIV Infection Clinical Trials

Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children

PENTA 13
Start date: January 2003
Phase: Phase 1
Study type: Interventional

Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.