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Treatments for auditory verbal hallucinations in patients with borderline personality disorder: Cognitive Behavioural Therapy for hearing voices (CBT) and treatment with Flupentixol

The aim of the study is to observe the changes in severity of AVH symptoms during standard treatment of CBT or antipsychotics in patients with BPD.

Study on the pharmacokinetic interaction between diclofenac and tamoxifen in patients with breast cancer. "the DICLOTAM study"

Primary objective1. To compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without diclofenac.Secondary objectives1. To compare the Area under the Curve (AUC) of tamoxifen and endoxifen-…

P2y12-receptOr antagonist therapy in patients with coronary artery disease undergoing Percutaneous coronary intervention using an genotype-guided treatment STRATEGY

To evaluate if an individualized antithrombotic P2Y12-inhibitor monotherapy in comparison to an individualized DAPT treatment is superior regarding bleeding events and non-inferior regarding ischemic events in patient with CCS after PCI.

A single-center, prospective, placebo-controlled, double-blind, randomized, cross-over mechanistic intervention study to investigate the effect of empagliflozin on kidney function in people with either preserved or impaired kidney function with or without type 2 diabetes

We aim to investigate the renal hemodynamic effects of empagliflozin in people with either preserved or impaired renal function with T2DM and people with impaired renal function without T2DM, all with and without adenosine blockade.

Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial.

What is the (cost-)effectiveness of salbutamol inhalations (4x200*g for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing?

AN OPEN-LABEL MULTICENTER PHASE 2 CLINICAL SAFETY INVESTIGATION OF THE ENDOART® IMPLANTATION IN SUBJECTS WITH CHRONIC CORNEAL EDEMA

To evaluate the safety of EndoArt® in subjects with chronic corneal edema.

Post-market Clinical Investigation of High-Volume Anesthesia (Local Tumescent Anesthesia) used with the miraDry Treatment for Axillary Hyperhidrosis

To collect safety and efficacy data from study participants that have been treated with the miraDry System using High Volume Anesthesia (HVA, also known as LTA or Local Tumescent Anesthesia) method as the local anesthesia delivery method.

Slowly-resorbable TIGR® Matrix mesh (Novus Scientific, Uppsala Sweden) for totally extraperitoneal (TEP) endoscopic reinforcement of inguinal-related groin pain.

The objective of this study is to collect additional data on the performance and safety of the slowly-resorbable TIGR® mesh in patients undergoing TEP for IGRP. The study endpoints are described below.

RE-DUAL PCI Real life Registry: Dual Therapy with dabigatran/clopidogrel versus Triple Therapy with dabigatran/clopidogrel/aspirin in ACS patients with indication for NOAC undergoing PCI.

A real world registry to compare dual therapy with Dabigatran/Clopidogrel to Usual care (Triple Therapy) with Dabigatran/Clopidogrel/Aspirin in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with…

A strategy of bacterial eradication to prevent exacerbations of COPD in the frequent exacerbator phenotype population (GOAL study), a prospective randomized controlled pilot study

Investigation of the impact of a treatment consisting of inhalation antibiotics and prolonged oral antibiotic course during a bacterial exacerbation on the prevention of further exacerbations.

Methylprednisolon Pulse Therapy vs Methylprednisolon Pulse Therapy combined with Radiotherapy for Moderately Severe and Active Graves* Orbitopathy

In this study, we want to demonstrate that MPP is no less effective than MPP plus XRT.

Transcatheter Repair of Mitral Regurgitation with Cardioband System Post Market Study (MiBAND): A European prospective, multicenter study to assess transcatheter mitral valve repair with Edwards Cardioband System in patients with symptomatic mitral regurgitation.

The objectives of the study are to describe:1. The efficacy of the Edwards Cardioband Mitral System in improving mitral regurgitation, functional status, and quality of life.2. The safety of the Edwards Cardioband Mitral System.

What is the optimal antithrombotic strategy in patients presenting with acute coronary syndrome having atrial fibrillation with indication for anticoagulants?

1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)…

Pharmacokinetics of Paracetamol before and after Roux-en-Y gastric bypass

To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol

An open-label, randomised, Phase IV study, to assess the efficacy and safety of tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy.

Primary objectiveTo assess the efficacy of tildrakizumab treatment (as assessed by PASI 75) in moderate-to-severe plaque psoriasis patients who are non-responders to DMF. Secondary objectivesTildrakizumab- To assess the efficacy of tildrakizumab…

A phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with early, oligoarticular psoriatic arthritis despite initial stable treatment with either non-steroidal anti-inflammatory drugs (NSAIDs) and/or <=1 conventional synthetic disease-modifying antirheumatic drugs (DMARD).

Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…

Clinical investigation of the Qmedics EXIST NiTi Stent type Flex & Pull in adults with Peripheral Artery Disease (PAD) (of the Q-medics NiTi Stent Family.

The objective of the HORIZON trial is to demonstrate and provide long-term clinical data on safety and performance of the Qmedics EXIST NiTi Stent System type FLEX &amp; PULL for treating de novo or re-stenotic symptomatic atherosclerotic…

New treatment strategy for patients with multiple recurrent Clostridioides difficile infection with bezlotoxumab as first option

To investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with initial FMT. Strategy A includes bezlotoxumab as…

CONNected Electronic Inhalers Asthma Control Trial 3 (*CONNECT 3*), a 24-Week Treatment, Multicenter, Open Label, Randomized, Parallel Group Comparison Study of Standard of Care Treatment Versus the Budesonide/Formoterol Digihaler Digital System, to Optimize Outcomes in Adult Patients with Asthma

The primary objective of this study is to demonstrate the effectiveness of the DS compared to the SoC group. The secondary objectives:(#1) is to describe the asthma management actions by HCPs for all patients in both groups. (#2) is to evaluate…

VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target

The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target…