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NCT ID: NCT02834429 Completed - Celiac Disease Clinical Trials

Pre-endoscopy Serological Testing for Coeliac Disease; a Novel Approach Using Rapid Antibody Testing

Start date: February 2010
Phase: N/A
Study type: Observational

The aim of this study is to assess the clinical utility of the whole blood transglutaminase-based rapid test against current serological tests and the gold standard of duodenal biopsy. The investigators will recruit patients (n=1000) from the endoscopy department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK). The patients recruited for this study will already have been referred for a consultation and gastroscopy. In addition, these patients will already have been serologically tested for IgA TTG, EMA and a total IgA immunoglobulin level (as per normal clinical practice). All duodenal biopsy specimens will be fixed in buffered formalin and embedded in paraffin wax. Standard, 3μm thick sections at three levels will be stained with haematoxylin and eosin and reported routinely. Additionally, biopsies demonstrating increased intraepithelial lymphocytes only (changes compatible with but not diagnostic of coeliac disease) will be stained with KiRAS or CD4/CD8 which are markers for coeliac disease.

NCT ID: NCT02833974 Completed - Asthma Clinical Trials

Effect of the GSK2245035 on the Allergen-induced Asthmatic Response

Start date: December 5, 2016
Phase: Phase 2
Study type: Interventional

This study will assess whether Toll like receptor 7 (TLR7)-mediated pharmacology, with intranasal (i.n.) GSK2245035 20 nanogram (ng) administered weekly for a period of 8 weeks, will lead to reduced allergic reactivity in the lower airways in subjects with mild allergic asthma. This will be a randomised, double-blind (sponsor open), placebo-controlled, parallel group, 8-week treatment study. The study will consist of a screening period of up to approximately 4 weeks (involving two screening visits), a blinded treatment period of 8 weeks, followed by a follow-up period of up to 3 months. The total duration of the study for each subject will therefore be a maximum of approximately 6 months.

NCT ID: NCT02833857 Completed - Clinical trials for Chronic Kidney Disease, Secondary Hyperparathyroidism

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

Start date: March 14, 2017
Phase: Phase 1
Study type: Interventional

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.

NCT ID: NCT02833844 Completed - Clinical trials for Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection

Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia

Start date: May 22, 2017
Phase: Phase 3
Study type: Interventional

The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM. The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.

NCT ID: NCT02833558 Completed - Clinical trials for Gastrointestinal Haemorrhage

Purastat® vs Standard Therapy for Haemostasis During Endoscopic Submucosal Dissection

Start date: May 4, 2016
Phase: N/A
Study type: Interventional

Endoscopic submucosal dissection (ESD) is an endoscopic resection technique used to treat superficial neoplasia in the gastrointestinal tract. Bleeding is a commonly encountered problem during submucosal dissection and is usually managed with electrocautery. However, this does carry a risk of deep thermal injury and perforation. PuraStat® is a novel extracellular scaffold matrix of amino acids that forms a transparent adherent barrier when applied to a bleeding point. The aim of this trial is to study the use of PuraStat® in reducing the need for thermal haemostasis during ESD.

NCT ID: NCT02833389 Completed - Clinical trials for Neuropathic Diabetic Foot Ulcers

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

Start date: November 14, 2016
Phase: Phase 1
Study type: Interventional

This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.

NCT ID: NCT02832648 Completed - Osteoporosis Clinical Trials

Selenium for Musculoskeletal Health

Start date: January 2017
Phase: Phase 3
Study type: Interventional

This research aims to determine whether selenium supplements improve bone and muscle health in older women at risk of osteoporosis (low bone density or weak bones) and fracture (broken bones). Osteoporosis is a major public health problem. One in two women and one in five men over age 50 will have a fracture. Fractures cause pain, disability and reduce life-expectancy. Women with below-average bone density around the time of the menopause might have previously taken hormone replacement (HRT) to prevent osteoporosis, but HRT is much less used now due to side effects. Therefore there is a need for safe, effective and inexpensive preventative interventions for women at risk of osteoporosis. Selenium is a chemical nutrient present in several human proteins, including anti-oxidants. Anti-oxidants may protect against ageing of tissues, including bone, by mopping up damaging reactive oxygen molecules (sometimes called 'free radicals'). Selenium is present in soil, and so is obtained from many foods. However, soil selenium levels are low in Europe, and dietary intake in the UK is below recommended levels. We previously found that women with higher blood selenium levels have stronger bones, but this doesn't prove that giving selenium will improve bone strength. The investigators propose a randomised controlled trial to compare selenium supplements with a placebo (dummy treatment) in women with below-average bone density. The investigators will give selenium (at two different doses) or placebo to 120 women for six months and use blood and urine tests and bone density scans to see if giving selenium does have any effect on bone. The investigators will also do muscle function tests and measurements of free radical molecules.

NCT ID: NCT02832427 Completed - Clinical trials for Postoperative; Dysfunction Following Cardiac Surgery

Is Six Weeks Too Long for First Outpatient Review After Cardiac Surgery?

FORCAST6
Start date: June 2016
Phase:
Study type: Observational

Although the first outpatient review following cardiac surgery is conventionally scheduled for six weeks after hospital discharge, there is no evidence to support this practice. Thirty-day mortality and morbidity rates, which are now widely used as indicators of the quality of surgical care, reveal rates that are higher than corresponding in-hospital rates. Secondly, the rates for mortality and morbidity occurring up to 6 weeks after surgery are not known. The objectives of our study are to determine the postoperative mortality and morbidity rates in the 6-week interval between hospital discharge and the first planned specialist review after cardiac surgery, and to assess the level of patient satisfaction with current practice. The study will enrol eligible patients who are undergoing elective and urgent coronary artery bypass and/or valve surgery at our institution over a 6-month period and provide them with study information. Prior to discharge after surgery, prospective participants will be consented and given a questionnaire to take home, complete and bring along to the outpatient appointment. The investigators will analyse the data to determine the rates and timing of the complications, and the impact on postoperative recovery. The investigators will also assess the level of patient satisfaction with the current practice. Appropriate conclusions either in support of current practice or, a change in practice would be drawn..

NCT ID: NCT02832128 Completed - Hearing Loss Clinical Trials

Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)

Start date: May 2016
Phase: Phase 2
Study type: Interventional

The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.

NCT ID: NCT02832037 Completed - Schizophrenia Clinical Trials

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Start date: July 25, 2016
Phase: Phase 2
Study type: Interventional

The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.