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NCT ID: NCT02492009 Completed - Depression Clinical Trials

Patient Decision Aid for Antidepressant Use in Pregnancy

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

The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient decision aid (PDA) for antidepressant use in pregnancy. The overall aim of this pilot RCT is to establish the feasibility of future large international RCT of the PDA's effectiveness.

NCT ID: NCT02491983 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

PARSIFAL
Start date: August 2015
Phase: Phase 2
Study type: Interventional

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

NCT ID: NCT02491944 Completed - Oncology Clinical Trials

A Phase I, Open-label Study to Assess Bioavailability of a Single Oral Dose of AZD9291 vs an IV Dose of [14C]AZD9291

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

The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall cell lung cancer. Lung cancer has been the most common cancer in the world for several decades and represents 12.8% of all new cancer cases in 2008. The purpose of this study is to see how much AZD9291 is taken up by the body when dosed by mouth (tablet) compared to when the study drug is dosed once by injection directly into the vein (intravenously). The dose given directly into the vein will be radiolabelled. This means that the test drug has a radioactive component which helps us to track where the drug is in the body. This allows us to detect the differences between the tablet and the intravenous dose. The study will be performed in 12 healthy male subjects aged 18-65 years. On Day 1, subjects will be dosed with a single oral dose of 80 milligrams AZD9291 tablet followed by 100 micrograms [14C] AZD9291 dosed as an intravenous microdose beginning 5 hours and 45 minutes after the oral dose has been administered. Subjects will remain in the study centre until after the 120 hour post-dose blood sample is obtained and will return to the clinic for further visits on Day 8, 10, 15 and 22 for pharmacokinetic and safety assessments.

NCT ID: NCT02491892 Completed - Breast Cancer Clinical Trials

A Study of Pertuzumab in Participants With Metastatic Breast Cancer

Start date: February 2003
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.

NCT ID: NCT02491684 Completed - Asthma Clinical Trials

A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection

INEXAS
Start date: July 21, 2015
Phase: Phase 2
Study type: Interventional

A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza

NCT ID: NCT02491463 Completed - Clinical trials for Respiratory Synctial Virus Infections

A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults

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

The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

NCT ID: NCT02491424 Completed - Clinical trials for Traumatic Amputation of Lower Extremity

Intraosseous Transcutaneous Amputation Prosthesis

(ITAP)
Start date: January 2007
Phase: N/A
Study type: Interventional

Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).

NCT ID: NCT02491164 Completed - Clinical trials for Respiratory Infections

Exploratory Study of Intrapulmonary Microdosing of Gram-negative Optical Imaging Detection Probe

BAC TWO
Start date: April 2016
Phase: Early Phase 1
Study type: Interventional

Critically ill patients are often ventilated in dedicated critical care units to provide respiratory support. Despite best practice patients can often develop a condition called adult respiratory distress syndrome (ARDS), which is characterised by deterioration in their respiratory function, and changes on chest x-ray. The correct management for ARDS is identifying the underlying condition causing the deterioration and identifying appropriate targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs of a ventilated patient. The patients may have been ventilated due to pneumonia but they may also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has significant mortality. Despite all the clinical and laboratory data at the investigators' disposal there remains great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often given empirically. Therefore, there is an urgent clinical need for accurate methods to diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As such, the investigating team have developed and synthesised an imaging agent called BAC TWO. BAC TWO will be instilled directly into the lungs of 12 patients to assess whether it can label gram-negative bacteria in the human lung.

NCT ID: NCT02490865 Completed - Clinical trials for Systemic Bioactivity of Nebulized RNS60

Systemic Bioactivity of Inhaled Nebulized RNS60

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

The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the circulation.

NCT ID: NCT02490800 Completed - Neoplasms Clinical Trials

Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma

Start date: June 23, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

First in human, open-label, sequential dose escalation and expansion study of oral BAL101553 in adult patients with advanced solid tumors and adult patients with recurrent or progressive glioblastoma or high-grade glioma.