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NCT ID: NCT01729208 Completed - Myopia Clinical Trials

An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

NCT ID: NCT01728805 Completed - Clinical trials for Cutaneous T-Cell Lymphoma

Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

NCT ID: NCT01728558 Completed - Clinical trials for Critical Illness and Mechanical Ventilation

Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients

SPICE III RCT
Start date: November 2013
Phase: Phase 3
Study type: Interventional

The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol. The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers: 1. Early randomization after intubation or arrival in the ICU (intubated). 2. Early Adequate analgesia after randomization. 3. Goal directed sedation titrated to achieve light sedation. 4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines. The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients. The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation.

NCT ID: NCT01728532 Completed - Clinical trials for Root Canal Obturation

Open, Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer

PA0903
Start date: June 2012
Phase: N/A
Study type: Interventional

TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer SPONSOR: SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91 Reference protocol: 11/001 PRODUCT NAME: PA0903 MEDICAL DEVICE: Class III: Root canal sealer Dose: not applicable Application : one single time DEVELOPMENTAL PHASE: not applicable (medical device class III)

NCT ID: NCT01728324 Completed - Clinical trials for Hepatitis C, Chronic

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

NCT ID: NCT01727765 Completed - Asthma Clinical Trials

Inspiratory Muscle Training and Asthma

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

This is a pilot study which will assess the feasibility of a follow on main study. This study will examine the impact of inspiratory muscle training on quality of life, rescue drug medication usage, and other markers of asthma in adult asthmatics in the UK.

NCT ID: NCT01727609 Completed - Premature Birth Clinical Trials

Speed of Increasing Milk Feeds Trial

SIFT
Start date: June 2013
Phase: N/A
Study type: Interventional

Survival of preterm infants has increased greatly over the years, so a major aim now is to improve the long term outlook for these babies and to avoid serious complications. The way babies are fed in early life affects short and long-term health and survival. Because the bowels of preterm infants have not matured, they cannot digest large volumes of milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip while the amount of milk given is gradually increased over time. Increasing the amount of milk rapidly may increase the risk of gut complications. Increasing the amount of milk given more slowly means that intravenous nutrition is needed for longer; there is an associated risk of infection proportional to the time the intravenous line is present in the bloodstream of these infants. Despite the importance of milk feeding preterm infants, there have been few studies to inform how best to balance these risks, and what the best way to increase feeds in these infants is - this study sets out to address this missing information. The study will compare two different speeds of milk feed increase, one 'faster' and one 'slower', both within rates currently used in United Kingdom neonatal units. The study aims to find out if either speed of milk feed increase gives better outcomes for the infants. Investigators will measure a variety of outcomes, such as survival without disability, infection, bowel problems, growth and long-term physical and mental development, as well as the impact on families and the National Health Service, including costs. The study is being led by an established team of researchers who have run similar studies before, and uses an established network of neonatal units that have taken part in previous studies.

NCT ID: NCT01726452 Completed - Oesophageal Cancer Clinical Trials

NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS)

Start date: January 24, 2013
Phase: Phase 3
Study type: Interventional

This is a multicentre phase III open-labelled, randomised controlled trial. Eligible patients will be randomised in a 1:1 fashion between neoadjuvant and adjuvant chemotherapy (Investigator's choice modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen) and surgery or Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal protocol). Primary Objective: To evaluate one, two and three year survival of patients treated with resection plus neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy. Secondary Objective(s): To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate (in particular relief of dysphagia, improvement in health related quality of life (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression grade, node-positivity, post-operative pathology, disease-free survival, time to treatment failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL). Exploratory Objective(s): Translational Research: The collection of blood and tissue samples for storage in the bio bank for future research.

NCT ID: NCT01726413 Completed - Clinical trials for Painful Diabetic Peripheral Neuropathy

A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Start date: November 2012
Phase: Phase 2
Study type: Interventional

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

NCT ID: NCT01726257 Completed - Clinical trials for Abdominal Aortic Aneurysm (AAA)

Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

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

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).