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NCT ID: NCT02538666 Completed - Lung Cancer Clinical Trials

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

CheckMate 451
Start date: October 13, 2015
Phase: Phase 3
Study type: Interventional

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

NCT ID: NCT02535546 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Seasonal Trends in Pneumococcal Carriage in COPD Patients

Helios
Start date: July 2014
Phase: N/A
Study type: Observational

Patients suffering from chronic obstructive pulmonary disease (COPD) commonly get exacerbations of their illness which have many potential triggers including infection. The most common cause of lung infection/pneumonia is an organism named Streptococcus pneumoniae. In Ireland a 13-valent pneumococcal conjugated vaccine (PCV-13) was recently introduced into the childhood vaccination programme. This study aims to investigate the carriage rate of S. pneumoniae in COPD patients over one year and to determine if isolates of S. pneumoniae found within the COPD population would be covered by the PCV-13 vaccine.

NCT ID: NCT02527317 Completed - Breast Cancer Clinical Trials

Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

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

This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.

NCT ID: NCT02526160 Completed - Clinical trials for X-linked Hypophosphatemia

Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

Start date: October 22, 2015
Phase: Phase 3
Study type: Interventional

The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.

NCT ID: NCT02526004 Completed - Cystic Fibrosis Clinical Trials

Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified

CFMATTERS
Start date: October 1, 2013
Phase: N/A
Study type: Interventional

Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary use of antibiotics is a key driver in the development of antibiotic resistance. Cystic Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore therapeutic strategies for same, as chronic lung infection overlaps with acute lung exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent infections and treatments result in increasing antimicrobial resistance, and alterations in pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy that can be compared with standard empirical antibacterial therapy currently used. Cystic Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of microbiome-derived antimicrobial treatments versus current empirical therapy.

NCT ID: NCT02525523 Completed - Pouchitis Clinical Trials

Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics

Start date: December 3, 2015
Phase: Phase 3
Study type: Interventional

A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed. Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.

NCT ID: NCT02521532 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease

Start date: January 2015
Phase: N/A
Study type: Interventional

Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.

NCT ID: NCT02520128 Completed - Ewing Sarcoma Clinical Trials

A Study of IMRT in Primary Bone and Soft Tissue Sarcoma

IMRiS
Start date: March 2016
Phase: N/A
Study type: Interventional

IMRiS is a phase II trial which aims to assess the feasibility, efficacy and toxicity of Intensity Modulated Radiotherapy (IMRT) in three different cohorts of patients with primary bone and soft tissue sarcoma and to demonstrate whether IMRT can improve on current clinical outcomes. Cohort 1 of the trial is now closed to recruitment.

NCT ID: NCT02515071 Completed - Clinical trials for Obstructive Sleep Apnoea Syndrome

A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).

Start date: January 2015
Phase: N/A
Study type: Interventional

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.

NCT ID: NCT02508922 Completed - Autism Clinical Trials

Trial of Vitamin D3 Supplementation in Paediatric Autism

Start date: September 2015
Phase: N/A
Study type: Interventional

To build on a recent case study and open label trial, the investigators want to find out if vitamin D supplementation can influence behavioural and core symptoms of autism.