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Grumpy or depressed? Disentangling normative irritability from early signs of depression among adolescents with cell-phone micro-measures of daily mood swings.

Objective: We would like to differentiate *normative mood swings*. in adolescence from early signs of depression. A comparison between low-risk adolescents and an at risk and a clinically referred sample is needed to detect an unrecognized subsample…

Posttraumatic osteoarthritis following perilunate dislocations and perilunate fracture dislocations in young patients and the correlation with subjective and objective outcome measures. A descriptive cohort study.

To determine the prevalence of posttraumatic osteoarthritis following a PLD-PLFDs in a cohort of young non-osteoporotic patients and correlation with objective and subjective outcome measures.

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

To evaluate the efficacy of NEOD001 plus standard of care vs. placebo plus standard of care when administered intravenously in subjects with AL amyloidosis by assessing time to all-cause mortality or cardiac hospitalizationSecondary ObjectivesIn…

Shifting pain modulation towards anti-nociceptivity: Mechanism-specific pharmacological prevention of post sternotomy pain

In this research project we explore anti-nociception as a state of pain modulation. Our main objectives in utilizing the plasticity of the central pain pathways are to: (i) Shift individuals from a pro-nociceptive pain modulation profile to an anti-…

Sexual functioning in women with the Mayer-Rokitansky-Küster-Hauser syndrome (MRKH syndrome) and their partners and physiological sexual arousal responses in these women with a surgical or non-surgical created neovagina

The study comprises 2 parts.Part 1: Primary: to assess sexual functioning, sexual self image and psychological and relational functioning in MRKH women with surgical or non- surgical created neovaginas and their partners and make a comparison with…

TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe Asthma.

To evaluate long term safety, efficacy and airway remodelling effects of BT in patients with severe asthma.

A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…

Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes

To evaluate the feasibility, safety and efficacy related endpoints for the Fractyl Revita System for the treatment of uncontrolled type 2 diabetes.

Quantitative Sensory Testing in Failed Back Surgery Syndrome and Complex Regional Pain Syndrome Patients during Dorsal Root Ganglion stimulation

The primary objective of this study is to investigate attenuation of pain and sensory thresholds during dorsal root ganglion stimulation using QST. The secondary objectives of this study are to investigate 1) To assess changes in pain intensity (NRS…

Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

Primary Objective To compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice over 6 months following de novo renal transplantation in a real-life setting in different European Countries.…

The association between Sleep bruxism and Temporomandibular disorder Pain

1. How does muscle overloading expressed by pain effect SB characteristics?2. What SB characteristics are associated with jaw-muscle pain?3. Are SB and psychological stress contributing factors for TMD pain?

A randomised, open-label clinical trial assessing the efficacy of octreotide to decrease iron infusion and blood transfusion requirements in patients with refractory anaemia due to gastrointestinal bleeding from angiodysplasias.

To assess the efficacy of octreotide in decreasing the need for iron infusions or blood transfusions in patients with refractory gastrointestinal bleedings due to small bowel angiodysplasias despite endoscopic intervention.

A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy

To assess the efficacy as well as the safety and tolerability of an investigational drug called UCB0942 that will be given in addition to the current epilepsy treatment of the patient.

Analysis of Predictive Parameters of Evident Anastomotic Leakage II

ObjectiveTo identify biomarkers for CAL in drain fluid and serum, in addition to RT-PCR for E. faecalis, that increase specificity and positive predictive value.

OPEN-LABEL, RANDOMIZED STUDY TO ASSESS THE SAFETY AS WELL AS THE PHARMACOKINETIC PROFILE AND TO INVESTIGATE THE EFFICACY TRENDS ON BIOMARKERS IN TYPE 2 DIABETES MELLITUS PATIENTS OF A SUSTAINED RELEASE FORMULATION OF EXENATIDE BASED ON MEDUSA* TECHNOLOGY

The purpose of the study is to investigate to what extent Exenatide MPF is tolerated.It will also be investigated how quickly and to what extent Exenatide, when administered as Exenatide MPF, is absorbed and eliminated from the body (this is called…

High-resolution ultrasonography of peripheral nerves in neurofibromatosis

The aim of this study is to further explore ultrasonographic abnormalities of peripheral nerves in patients with NF and their relation with symptoms, findings in neurological examination and electrophysiological characteristics.Primary objective:…

MCL-laxity in valgus knee deformity before and after closing wedge high tibial osteotomy

1. To assess the effects of a CWHTO on the MCL and LCL laxity.2. To assess the effects of a CWHTO on the patient*s experience of collateral ligament instability.

A Phase 1 Study of DCR-PH1 in Patients with Primary Hyperoxaluria Type 1 (PH1)

Primary Objective:- To determine the safety and tolerability of DCR-PH1 administered via intravenous (IV) infusion to patients with PH1.Secondary Objective:- To study the pharmacokinetics (PK) of DCR-PH1- To study the pharmacodynamics (PD) effects…

Pilot study added value intermittent vacuum therapy (IVT)

To determine the effect of IVT on walking distance after 6 and 12 weeks, 6 months and 1 year in patients with IC who are treated with a SET program. To determine the optimal timing for IVT within the SET program.

A decision model for the management of acute exacerbation chronic obstructive pulmonary disease in the emergency department: flowchart for treatment allocation.

The primary objective is to validate a previously established prognostic instrument in the form of an algorithm (flowchart) in patients that present with AECOPD to the department of emergency medicine for classifying for out- or inpatient treatment…