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Tidal ventilation distribution and patient-ventilator synchrony during Proportional Assist Ventilation with load-adjustable gain factors

To compare the tidal volume distribution and other ventilator parameters between PAV+ and NAVA.

TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral
Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic
Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer
(NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase
Inhibitor (TKI) and Platinum-doublet Chemotherapy

Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…

A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) (CLDK378A2112)

Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…

A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)

The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…

Temporal fluctuations of biomarkers in patients with asthma and controls: Proof of concept for predicting loss of control.

1). To compare temporal fluctuations of lung function and inflammatory biomarkers in blood, nasal lavage, exhaled air and urine between patients with asthma and controls.2). To investigate the change in variations of these biomarkers upon…

A novel class of regulators: the potential of IL-10 producing B cells in decreasing allergic inflammation in asthmatic patients.

Conditions that promote IL-10 producing B cells in humans are still ill defined. In this project our aim is to investigate the frequnecy of IL-10 producing B cells in healthy volunteers. Next, we aim to compare this to the frequency of IL-10…

An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

The main aim of this study is to find out if the continuation of bevacizumab, in addition to standard 2nd & 3rd -line treatment, can help patients with NSCLC that has progressed to live longer. The study also aims to find out if continued…

Ammendment of protocol: Intravenous iron treatment in iron deficient patients with idiopathic pulmonary arterial hypertension. Title amendment: Skeletal muscle strength in healthy persons and patients with pulmonary hypertension

To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls

The effects of mild prematurity on asthma-like symptoms, Lung Clearance Index and exercise performance at the age of 12.

Main question: What is the lung function of late preterm births compared with children born at term at age 12? Sub-questions: - Which respiratory symptoms in late preterm infants at age 12?

Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study

The REDUQ II study will be conducted to help us to complete data on the secondary endpoints of the REDUQ study (P09-22) and arrange and examine relationships occurring between and among intervention elements of the REDUQ study, behavioural and…

Gait patterns in patients with COPD during the 6-minute walk test

The main objective of this study is to assess more thoroughly the differences in gait patterns between COPD patients and healthy controls. Other objectives are to assess differences in gait patterns between GOLD stages and two age groups in healthy…

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

Effect on bone mineral density.

The reliability of new point-of-care instruments for breath analysis in children with asthma and cystic fibrosis (CF), and healthy controls

Research questions: Primary questions:* Are the new point-of-care instruments for the measurement of VOCs in exhaled breath feasible for use in children and adolescents aged 6 to 20 years?* Are these techniques able to differentiate between healthy…

Economic evaluation of treatment modalities for position dependent obstructive sleep apnea patients

To evaluate the effect and cost-utility of positional therapy, comparing the SPT and MRA versus CPAP in patients with moderate positional obstructive sleep apnea.

The role of the pulmonary vasculature in the Fontan circulation

Primary Objectives:- Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise.- Characterization of structural properties of small pulmonary arteries.Secondary Objectives: - Investigate the effect of…

Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients - The PROBESE Randomized Controlled Trial

To compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.We hypothesize that an intra-…

A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib

The primary objective of this study is to compare PFS with LY2875358 plus erlotinib therapy with erlotinibmonotherapy as first-line treatment in metastatic NSCLC patients with activating EGFR mutations who havedisease control after an 8-week lead-in…

eVita COPD; Patient Centered Care through eHealth Solutions

The main aim is to investigate clinical effects of different implementation methods of online supported self-management for COPD patients in primary care. Secondary objectives include effects on well-being, health care use and actual use of the…

A comparison between two different oral appliance therapies: Somnodent vs Herbst appliance in patients with mild and moderate OSA; a Randomised Controlled Trial

To compare the effect of two different types of mandibular advancement device (MAD) on polysomnographic (PSG) parameters, to evaluate the compliance and to evaluate the outcome of the different Quality of Life scales, eg general health with the…