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NCT ID: NCT02579889 Terminated - Sinus Node Disease Clinical Trials

Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease

B3
Start date: September 2015
Phase: N/A
Study type: Interventional

The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.

NCT ID: NCT02468661 Terminated - Clinical trials for Non-Small Cell Lung Cancer

A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

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

The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

NCT ID: NCT02409238 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Insulin Resistance and Mild Cognitive Impairment (IRMCI) Study

IRMCI
Start date: March 11, 2015
Phase: Phase 4
Study type: Interventional

Dementia (Alzheimer's Disease) is sometimes called "Type 3 Diabetes" because of the strong connection between Type 2 diabetes (a function of insulin resistance) with Dementia. The investigators therefore hypothesize that Reducing Insulin Resistance using Intensive Lifestyle Intervention (Exercise and Weight loss) + Metformin Treatment in Prediabetic & diet-control-only Diabetic overweight and mildly cognitively impaired individuals 55 years or older would lead to better Cognitive Function (compared to standard care) after 2 years. Subjects will be monitored and assessed using a battery of Cognitive and psychological tests and PET scans to demonstrate glucose utilization in the relevant areas of the brain. This 3-year open-label study aims to recruit 360 subjects with 50% (180 subjects) randomized to receiving Intensive lifestyle intervention with Metformin (if diabetic) vs the other 50% who would receive only the usual standard level of care in the primary care setting.

NCT ID: NCT02368951 Terminated - Medical Oncology Clinical Trials

Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

Start date: March 24, 2015
Phase: Phase 1
Study type: Interventional

To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

NCT ID: NCT02365493 Terminated - Clinical trials for Methicillin-Resistant Staphylococcus Aureus

Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus Infection

CAMERA2
Start date: August 26, 2015
Phase: Phase 3
Study type: Interventional

The aim of this clinical trial is to determine whether a novel combination antibiotic treatment (vancomycin/daptomycin + beta-lactam) is superior to the standard antibiotic treatment (vancomycin/daptomycin) for hospitalised adults with Methicillin Resistant Staphylococcus aureus bacteraemia. The hypothesis is that the addition of beta-lactam antibiotics (these are antibiotics from the penicillin family) to the standard therapy will lead to more efficient bacterial killing and hence lead to faster clearance of bacteria from the blood stream and other areas of infection, thereby reducing the risk of the spread of infection and death. The study design is an investigator-initiated, multi-centre, open-label, randomised controlled trial. This will include 440 participants diagnosed with Methicillin Resistant Staphylococcus aureus bacteraemia recruited over a period of 4 years (July 2015 - June 2019) from within Infectious Diseases inpatient units across 21 hospital sites including 18 from within Australia and 3 located in Singapore. Participation will be voluntary and subject to informed consent. The participants will be randomised 1:1 to either the standard therapy group or combination therapy group. The combination therapy will include a treatment of intravenous beta-lactam for the first 7 days of treatment, in addition to the standard treatment (either vancomycin or daptomycin). The primary outcome measure will be complication-free survival 90 days post randomisation.

NCT ID: NCT02341560 Terminated - Clinical trials for Non Arteritic Anterior Ischemic Optic Neuropathy

Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Start date: February 24, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.

NCT ID: NCT02335944 Terminated - Clinical trials for Non Small Cell Lung Cancer

Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.

Start date: January 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of nazartinib (EGF816) in combination with capmatinib (INC280) and to estimate the preliminary anti-tumor activity of nazartinib in combination with capmatinib in participants with advanced non-small cell lung cancer (NSCLC) with documented EGFR mutation.

NCT ID: NCT02325427 Terminated - Stroke Clinical Trials

Changes in Brain Activity Associated With Upper Limb Motor Recovery

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

This study is to investigate changes in brain activities in acute stroke patients , and to correlate findings with clinical outcome measures. Another aim of the study is to investigate whether transcranial direct current stimulation (tDCS) could improve motor function in subjects with poor brain activity after stroke. The brain activity will be measured by single and paired pulse TMS (transcranial magnetic stimulation). The study hypothesizes that: 1. The neural mechanisms employed in patients who have different response to TMS stimulation are different. It is hypothesized that patients with no response upon TMS stimulation might have poorer motor function outcome, compared with patients with response upon TMS stimulation. 2. The result of clinical outcome measures is related with TMS measurement. 3. tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome measures will include a battery of upper limb motor tests such as upper extremity component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and block test, and manual muscle testing. Clinical outcome and TMS measurement will be assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.

NCT ID: NCT02323126 Terminated - Clinical trials for Non Small Cell Lung Cancer

Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

Start date: February 9, 2015
Phase: Phase 2
Study type: Interventional

To determine the efficacy and safety of nivolumab in combination with EGF816 and of nivolumab in combination with INC280 in previously treated NSCLC patients

NCT ID: NCT02318368 Terminated - Clinical trials for Non-small Cell Lung Cancer

A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

FOCAL
Start date: November 2014
Phase: Phase 2
Study type: Interventional

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.