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Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.

1. To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin.2. To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.3. To…

European survey of cardiovascular disease prevention and diabetes (EuroAspire) - IV

The objectives of EUROASPIRE IV are:1. To determine in patients with established CHD (acute myocardial infarction and ischaemia and patients following revascularisation by angioplasty orcoronary artery surgery) and in high multifactorial risk…

A Randomised Controlled Trial of Nonoperative Treatment versus Open Reduction and Internal Fixation for Mason type-II Fractures Of the Radial Head

The primary objective of this study is to compare the DASH (Disabilities of the Arm, Shoulder, and Hand) after conservative treatment versus ORIF in adult patients who sustained a Mason type-II fracture of the radial head. Secondary aims are to…

Facial and hand analysis, sleep apnea and speech in patients with acromegaly: a prospective study to investigate changes in craniofacial and hand characteristics, sleep apnea and speech during treatment and after remission.

To investigate the changes in facial- and hand analysis in patients with acromegaly as a result of medical treatment and pituitary surgery, and to investigate the changes in relational proportions between facial- and hand structures, incidence and…

Prospective, multicenter Tack Optimized Balloon Angioplasty (TOBA) study for femoropopliteal arteries using the Tack-IT Endovascular Stapler.

De Tack-IT Endovascular Stapler consists of a very short stent-like frame (Tack ring or endovascular ring) which has the properties of a stent (to prevent elastic recoil and to treat intimal damage), but lacks the disadvantages of the usual longer…

The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral* Drug-Eluting Balloon

To prospectively collect and assess global safety and efficacy data on the IN.PACT Admiral* Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries in *real world* patient population.

Identification of predictive parameters for colitis in melanoma patients treated with immunotherapy.

To identify predictive parameters for colitis in melanoma patients treated with immunotherapy

Distal Radius Plaster Immobilization Period I; A randomized trial comparing three weeks of plaster cast immobilization versus five weeks of plaster cast immobilization in adult patients with distal radius fractures.

The aim of the study is to compare the functional outcome of distal radial fractures after three weeks of plaster cast immobilization with five weeks of plaster cast immobilization. We think that a shorter immobilization period of distal radial…

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.

Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already…

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Primary Efficacy Objectives:To ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).Secondary Efficacy…

High-dose baclofen for the treatment of alcohol addiction * A double-blind, randomized, placebo-controlled study

The primary goal of the present study is to examine the efficacy of high dose baclofen for the treatment of patients with AD in a double-blind, randomized, placebo controlled study. Therefore high dose baclofen will be compared with placebo.…

Presence of Sub-Clinical Atrial Fibrillation using an implantable cardiac monitor in patients with cardiovascular risk factors (ASSERT II)

To determine the rate of detection of sub-clinical atrial AF (* 5 minutes) within an average of 12 months following implant of the Confirm® Implantable Cardiac Monitor in patients with known cardiovascular risk factors and left atrial enlargement,…

A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

The study is designed to evaluate the efficacy and safety of fingolimod in the treatment of CIDP compared with placebo. Data from this study will be used to support the registration of fingolimod in the indication of CIDP.

Beneficial effects of caloric and protein restriction on markers of the stress response and postoperative recovery

To investigate the feasibility and safety of a diet containing 30% caloric and 70% protein restriction given during five days in healthy kidney donors planned to undergo a live kidney donation as well as persons awaiting bariatric surgery.…

Neurophysiological Basis of Rehabilitation in Patients with Complex Regional Pain Syndrome-Type I (CRPS-I) and chronic Low Back Pain (LBP)

The goal of this study is to investigate the effect of Exposure in vivo on the brain areas involved in the processing of harmless tactile stimuli in CRPS-I and LBP patients (touch or warmth in CRPS; touch in LBP) and the processing of visual…

*The primary uncemented Delta III Reversed Shoulder Prosthesis * A longterm follow-up study*

The goal of our study is to determine long-term follow up results of the uncemented primairy Delta Reversed Shoulder Prosthesis placed on basis of a non-traumatic etiology, such as rheumatoid arthritis, cuffarthopathy and osteoarthritis of the…

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn*s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study.

To evaluate the efficacy and safety of eASCs compared to placebo for the treatment of complex fistulas in Crohn*s disease over a 24- and 104-week period.

An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy.

*Run-in* part: The *run-in part* primary objective:• To determine a safe light dose for PC-A11 with interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and…

Translation, cross-cultural adaptation and validation of questionnaires for Turkish and Moroccan Dutch patients with mood, anxiety and/or somatoform disorders and a comparison between native Dutch and Turkish and Moroccan immigrant patients

Our aim is to make ROM suitable for patients of Moroccan or Turkish origin. In order to achieve this, necessary steps need to be taken: (1) translate and cross cultural adapt ROM questionnaires; (2) validate the translated questionnaires; and (3)…