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A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy

The primary objective of this study is to compare the overall survival (OS) of ramucirumab DP administered in combination with docetaxel versus docetaxel with placebo as therapy for patients with Stage IV non-small cell lung cancer (NSCLC) who have…

Prevention of CF exacerbation in childhood (PREVEC-study): early recognition by non-invasive biomarkers in exhaled breath (condensate) and early antibiotic treatment

To assess the efficacy of an intervention directed towards prevention of clinical CF exacerbations by means of early recognition and early antibiotic treatment.

Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 µg versus placebo.

* To investigate the effect of roflumilast 500 µg tablets once daily versus placebo on exacerbation rate, and pulmonary function and major adverse cardiovascular events (MACE) in COPD patients who are concomitantly treated with a fixed combination…

A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of
Inhaled JNJ-49095397 (RV568) in Subjects With Moderate to Severe Chronic Obstructive
Pulmonary Disease

Primary ObjectiveThe primary objective is to assess the efficacy (as measured by change from baseline in prebronchodilator [preBD] percent predicted forced expiratory volume in one second [FEV1]) of JNJ-49095397 compared with placebo in subjects…

An explorarory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…

AMB115811: A randomised, multicentre, double-blind, placebo-controlled study of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Primary: to assess the efficacy of ambrisentan 5mg after treatment period of 16 weeks, in subjects with inoperable CTEPH. Secondary: safety and tolerability.

Effect of pre-surgical pulmonary rehabilitation on outcomes of bariatric surgery in morbidly obese patients with asthma

To determine whether pulmonary rehabilitation prior to bariatric surgery leads to improved and sustained asthma control (ACQ) as compared to bariatric surgery alone in patients with morbid obesity and not optimally controlled asthma.Secondary aims…

A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.

2.1 Primary study objectiveThe primary objective of this study is to investigate the therapeutic effect of an extensively hydrolyzed protein based infant formula with a synbiotic mixture on the severity of atopic dermatitis in infants.2.2 Secondary…

A double blind randomized placebo controlled study on the efficacy of intralymphatic immunotherapy in the treatment of grasspollen induced allergic rhinitis.

In this study we will compare the effect of intra nodal allegen injection with grass pollen to the intra nodal injection with placebo on symptome scores of allgic rhinitis (hay fever) in grass allergic patients.

Improvement of physical endurance and motor function performance in children with anatomical congenital anomalies and/or following neonatal extracorporeal membrane oxygenation; a randomized study

The main objective is to improve exercise tolerance. Secondary objectives are: 1) improvement of motor function development, daily physical activity, quality of life, self perception of motor competence, and participation; 2) evaluation of cost…

A randomised controlled trial of Dabigatran Etexilate on airway inflammation and coagulation in severe corticosteroid dependent asthma.

To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.

The influence of the addition of rinsing with a 0.05% chlorhexidine-containing solution to usual daily oral hygiene care on the incidence of aspiration pneumonia in physically-impaired care home residents with dysphagia.

Primary objective: To assess the influence of the addition of rinsing with a 0.05% chlorhexidine-containing solution to usual daily oral hygiene care on the incidence of pneumonia in physically-impaired care home residents with dysphagia.Secondary…

A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment (CAUY922A2207)

Primary: Progression Free Survival (PFS) in patients treated with AUY922 versus pemetrexed or docetaxel.Secondary: Overall response rate, disease control rate, overall survival, safety and tolerability, PK.

A 3-month Multicenter randomized trial to evaluate the efficacy of a Physical Activity Promotion Program on the experience of physical activity in patients with COPD (Mr PAPP)

The purpose of this study is to test the impact of a physical activity promotion program which is a personalized, semi-automated, coaching program utilizing an smartphone on which an app is installed and coaching by the investigator. The automated…

Positional therapy with the Sleep Position Trainer versus oral appliance therapy with the MRA in patients with position dependent Obstructive Sleep Apnea; A Randomised Controlled Trial

Objective: To compare the effect of positional therapy with the SPT versus OAT on polysomnographic (PSG) parameters, to evaluate the compliance and measuring the possible learning effect that might occur with POSA patients using the SPT for…

A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia (CBYM338X2204)

Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…

Reducing exacerbations in patients with chronic obstructive pulmonary disease with physiotherapy

This study aims to investigate the potential of guideline driven physiotherapy treatment as a supportive measure to postpone or prevent acute exacerbations in COPD patients. So, the primary research question is: *What is the efficacy of adding…

The effects of self-treatment on duration of exacerbations, health status and costs of health care in patients with Chronic Obstructive Pulmonary Disease (COPD) and common co-morbidities.

To investigate whether complex COPD patients are trained in the use of an individualised action plan for self-treatment have fewer COPD exacerbation days over 12 months compared to a control group. Secondary objectives are defined to investigate the…

Respiratory, hemodynamic and inflammatory effects of induced HypothermiA using NoVAtherm with extra corporeal membrane ventilator iLA-Activve in patients with acute respiratory distress syndrome (ARDS)

Primary Objective: Does induced hypothermia using NovathermTM combined with the iLA-Activve MinilungTm result in a reduction in minute volume ventilation and work of breathing by reducing positive peak inspiratory pressure levels in patients with…

*Does maintaining endotracheal tube cuff pressures at 20 mm Hg prevent dysphagia and hoarseness after anterior cervical spine surgery?*
A randomised controlled trial.

To determine if adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery prevents postoperative dysphagia. Furthermore laryngo-tracheal complaints (hoarseness and sore throat) will be scored.