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NCT ID: NCT02438826 Completed - Clinical trials for Chronic Cluster Headache

A Study of Galcanezumab in Participants With Chronic Cluster Headache

Start date: June 18, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

NCT ID: NCT02438579 Completed - Common Cold Clinical Trials

Hypertonic Saline Nasal Irrigation and Gargling for the Common Cold.

ELVIS
Start date: August 2014
Phase: N/A
Study type: Interventional

Viral upper respiratory tract infections (URTI), one of the commonest infection faced by humans, have a significant impact on individuals, families, health service and economy. Though rhinoviruses are called the "common cold virus", numerous viruses can cause URTI. Hence virus specific remedy for URTI is impractical. There are currently no evidence-based interventions that reduce the severity, symptom duration or viral shedding. Preliminary evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the duration of symptoms. With this pilot randomised controlled trial (RCT), the investigators aim to assess the feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses on recruitment rate, willingness to be randomised, acceptability, compliance and likely effect size of the intervention. This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured by a validated symptom score. A questionnaire based participant feedback will help assess intervention and trial procedures. This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost intervention that has the potential of substantial health and societal benefits.

NCT ID: NCT02437799 Completed - Hypotension Clinical Trials

Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia

DINOCS
Start date: September 2015
Phase: N/A
Study type: Observational

BACKGROUND: Hypotension occurs commonly during spinal anaesthesia for caesarean section and may result in detrimental effects to the mother and foetus. A previous pilot study where images of the pulse oximeter waveform study were taken, found that the dicrotic wave moved away from the systolic wave during the onset of hypotension. AIMS: The investigators wish to download electronic data which describe the pulse oximeter pulse wave to more accurately assess movement of the diastolic wave relative to the systolic wave during spinal anaesthesia for caesarean section. METHODOLOGY: 20 women undergoing caesarean section under spinal anaesthesia will be recruited by informed consent for this observational study. Data downloaded from the pulse oximeter will be analysed to identify movement of the dicrotic wave relative to the systolic wave and this will be related to changes in blood pressure. EXPECTED OUTCOMES: The investigators will establish best way to analyse changes in the pulse oximeter waveform and the relationship between changes in pulse oximeter waveform morphology and the onset of hypotension during spinal anaesthesia for caesarean section. IMPLICATIONS: Analysis of movement of the dicrotic wave could be used to anticipate and thus avoid severe hypotension during spinal anaesthesia for caesarean section.

NCT ID: NCT02437734 Completed - Clinical trials for Coronary Artery Disease

Virtual Coronary Physiology: an Angiogram is All You Need

Start date: August 13, 2013
Phase: N/A
Study type: Interventional

Disease in coronary arteries kills more people in the UK than any other cause. The investigators have developed a computer system ('VIRTU') which predicts blood pressure changes inside coronary arteries. This is important because; - Doctors make better decisions regarding when and how to treat patients with coronary artery disease if they have these blood pressure measurements - Currently, Doctors have to insert a metal wire inside the heart to measure artery pressures which is time-consuming and requires special equipment, staff, training and medicines. Although this invasive technique saves lives and money, more than 95% of patients do not receive the procedure or the benefits it provides. VIRTU provides a solution to this problem since it only needs X-ray pictures and does not require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and works but needs improving before it can be used in all patients. GOALS: Following, and compared with, our pilot project ((Modelling the significance of coronary artery disease, STH 15740) to: 1. Improve VIRTU's accuracy. 2. Improve VIRTU's speed. 3. Test VIRTU in patients with more complicated coronary disease. One hundred patients will be recruited from angiography waiting lists and consented before attending for their angiography. The patients will be asked whether their angiogram pictures and pressure measurements maybe used as part of the data collection for this study. The data will be used to validate and develop VIRTU to make it 'patient-ready'. VIRTU will deliver all the advantages of the current invasive technique (i.e. reduced deaths, heart attacks and cost) but, is less invasive and usable in 100% patients.

NCT ID: NCT02437591 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

PROFILE
Start date: August 13, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

NCT ID: NCT02437227 Completed - Cancer Clinical Trials

A Phase I, First in Man Study to Evaluate the Safety and Tolerability of a panRAF Inhibitor (CCT3833/BAL3833)in Patients With Solid Tumours

PanRAF
Start date: April 15, 2015
Phase: Phase 1
Study type: Interventional

The study is a first in man, dose escalation study to evaluate the safety, tolerability and how the drug works in the body in patients with all solid tumours. The aim of this study is to determine the most effective dose of the study drug that can then be further investigated in patients with advanced melanoma.

NCT ID: NCT02436668 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.

NCT ID: NCT02436577 Completed - Pharmacokinetics Clinical Trials

Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects

Start date: June 2015
Phase: Phase 1
Study type: Interventional

This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre. The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD) tablets when administered with water and without water and ticagrelor immediate-release (IR) tablets.

NCT ID: NCT02436278 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

The Predictive Ability of 4MGS in IPF

IPFMORT
Start date: March 2015
Phase: N/A
Study type: Observational

This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis.