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Edwards SAPIEN periprosthetic leakage evaluation versus Medtronic CoreValve in tranfemoral aortic valve implantation: the ELECT trial

The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on periprosthetic aortic regurgitation and additional focus on other clinical and…

The effect of the exposure to a photo series of unaltered vulva's on the genital self image of women who are considering a labial reduction

1. What is the effect of a photo series of unaltered vulvas on genital self image in women who consider a labial reduction.2. Does the diagnosis BDD; the reason to consider a labial reduction (aesthetic or functional); sexual functioning; sexual…

A good start: An early intervention to prevent the development of antisocial behavior in infants

The first objective of this study is to gain insight in which neurocognitive and neurobiological processes underlie the development of externalizing behavior (in specific aggressive behavior) in the first two years of life. The second objective is…

Long-term efficacy and safety of microwave ablation in the treatment of mild axillary hidradenitis suppurativa: a randomized intra-patient controlled trial

Primary objective: To prospectively evaluate the lesion (AN-)count, i.e. abscesses, inflammatory nodules, and draining sinuses, in the axilla treated with MWA compared to the untreated contralateral axilla after six months.Secondary objectives: - To…

A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis combined with standard anticoagulant therapy versus standard anticoagulant therapy alone for acute primary iliofemoral deep vein thrombosis (IFDVT).

Primary Objective: Can catheter directed thrombolytic therapy, for the treatment of primary IFDVT, safely and effectively reduce post thrombotic morbidity after one year?Secondary Objective: Does catheter directed thrombolytic intervention have a…

Fractional CO2 laser assisted delivery of topical anesthetics: a randomized controlled pilot study

The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser assisted delivery of two topical anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) and eutectic mixture of…

Multi-centre, randomized, investigator-blind, intra-individual active and vehicle-controlled study, comparing Metvix® Natural Daylight Photodynamic Therapy versus Metvix® conventional Photodynamic Therapy in subjects with actinic keratosis

Primary efficacy objective:To show the non-inferior efficacy of Metvix® Natural Day Light Photo Dynamic Therapy (NDL-PDT) versus Metvix® conventional Photo Dynamic Therapy (c-PDT) in Subjects with mild and moderate AKs at Week 12 in terms of percent…

A prospective, randomized, intra-patient, comparative, open, multi-centre study to evaluate the efficacy of a Single-Use Negative Pressure Wound Therapy (NPWT) System (PICO) on the prevention of postsurgical incision healing complications in patients undergoing reduction mammoplasty

Primary Objective:To assess the difference in healing complications up to and 21 days post-operatively between postsurgical incisions treated with PICO compared with standard of care Incision healing complications will include;* Skin necrosis*…

Lifestyle Interventions for Severe Mentally Ill Outpatients in the Netherlands.

The aim of the current proposal is to compare the (cost)effectiveness of a 12-month multidimensional lifestyle approach for SMI outpatients to usual care to reduce cardiometabolic risk factors in SMI patients. Secondary research questions include…

Effect of high-frequency chest wall oscillation and manual hyperinflation on the resolution of atelectasis in ventilated patients

Studies provide statistically significant evidence of the effectiveness of high-frequency chest wall oscillation administered via The Vest* System.St. Elisabeth Ziekenhuis Tilburg wants to demonstrate the effectiveness of HFCWO on ventilator-…

A randomized, double masked, active controlled, phase 3 study of the efficacy, safety, and tolerability of repeated doses of intravitrial VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD)

Primary objectiveTo assess the efficacy of intravitreally (ITV) administered VEGF Trap-Eye compared to ranibizumab (in a non-inferiority paradigm) in preventing moderate vision loss in subjects with all subtypes of neovascular AMD Secondary…

Effect of postoperative negative pressure wound therapy (Prevena TM) in clean closed surgical incisions on the incidence of wound dehiscence in low and high risk patients: a rondomized controlled pilotstudy.

The aim of this study is to compare the effect of a postoperativenegative pressure dressing (Prevena (TM) IMS) with a standardwound dressing (care as usual) in clean closed surgical wounds on the prevention of wounddehiscence in low riks and high…

Parameters in fractional laser assisted delivery of topical anesthetics: role of laser type, laser settings, type of anesthetic and occlusion time

The primary objectives of the present study are to compare the effect of pretreatment with two different fractional laser modalities (CO2 and Er:YAG laser) on topical anesthesia and to compare the anesthetic effect of two different topical…

Continuation of Metformin during surgery in patients with diabetes mellitus type 2

The objective of the study is to investigate the glucose lowering potential and safety of continuation of Metformin during non-cardiac surgery, compared to discontinuation of Metformin 24 hours before surgery.

Advanced lung ultrasound to differentiate pneumonia and atelectasis in ICU patient

Advanced lung utltrasound, c.q. color doppler imaging and dynamic air bronchograms can aid in differentiating pneumonia from atelectasis

Efficacy and tolerability of ixazomib, daratumumab and low dose dexamethasone (IDd) followed by ixazomib and daratumumab maintenance therapy until progression for a maximum of 2 years in unfit and frail newly diagnosed multiple myeloma patients; an open-label phase II trial

This study aims to assess: - the efficacy of 9 cycles of ixazomib, daratumumab and low dose dexamethasone in newly diagnosed unfit and frail multiple myeloma patients. - the value of geriatric assessments to predict both feasibility and efficacy…

Immediate implant placement and implant placement after alveolar ridge preservation in the aesthetic region: an evaluation after 5 years

Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.

De waarde van echo en MRI bij de evaluatie van gewrichtsschade bij hemofilie

- The diagnostic accuracy of ultrasound assessment regarding the synovium in patients with haemophilia is > 70%. - Soft tissue changes on initial MRI are associated with osteochondral changes on re-examination after 5 years…

Estetrol Therapy in Sjögren’s Syndrome: An Open Proof of Concept

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Clinical differences between atopic and atopiform dermatitis.

We hypothesize that atopiform dermatitis is a separate entity with specific characteristics, which needs recognition in order to be diagnosed and treated appropriately.