75 results
This proposal entails a proof-of-concept study into the neuropsychological effects of memantine augmentation in a random cross-over comparison to placebo, as add-on treatment to ongoing clozapine in severely mentally ill (SMI) patients with…
The purpose of this trial is primarily to assess the efficacy of inhaled mannitol compared with a true placebo in subjects with cystic fibrosis aged 6 to 17 years.We hypothesize that inhaled mannitol will improve the overall health and hygiene of…
The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…
The main objective is to assess the efficacy of the closed loop system at the home of the patient. Secondary objectives are to assess the safety of the new prototype while the telemonitoring intensity is being reduced during the trial; to…
- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…
In the current study we want to further explore the predictability of pre-treatment pain variability on the probability to experience pain relief. Knowledge on the understanding of individual differences in analgesic properties of a drug is of…
To assess the impact of treatment with Lanreotide versus current standard of treatment on output reduction in patients with high output enterocutaneous fistula or high-output stoma.
Primary Objective: To study the change on performance on executive function and memory function (as measured on Neurocart), after an active challenge with methylphenidate (monoaminergic) and galantamine (cholinergic), compared to placebo, in…
With the proposed study we aim to gain insight into the effects of oxytocin (OT) on both parents* and grandparents* sensitive, empathic, and protective responses to their (grand)children, and in the neural origins of these responses.The primary…
The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical and conservative treatment of non-obstructive meniscal injuries in older patientsHypothesis: We assume equal improvement of physical function in both…
Study Rationale and ObjectivesThe objective of the study is to determine the efficacy and safety of lacosamide, a sodium channel blocker, in patients with pain due to SCN9A-associated SFN. The proposed study plans to recruit patients with clinically…
To test the hypothesis that metabolic inflexibility in pre-diabetic subjects and diabetic patients is due to a reduced capacity to form acetylcarnitines: We aim to investigate whether glucose intolerant subjects have a lower capacity to form acetyl-…
Primary Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…
Our primary aims are 1) to test with observational and electrophysiological techniques whether intranasal oxytocin administration to mothers of young infants increases their defensive reactivity and protective approach responses in mildly…
Primary objective: To assess the mean difference in time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), expressed as hours/day, between the two 16-week intervention periods, i.e. RT-CGM versus masked CGM, in…
The objective of this study is to examine whether a serious game using Cognitive Bias Modification is effective on anxiety symptoms and self stigma regarding patients with a psychotic disorder or a developmental disorder.
To this end, two study protocols have been developed, one concerning the *target group* of overweight children (aged 12-16), only including non-invasive measurements, and one targeting adult overweight participants (aged 18-45), allowing for…
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
We hypothesize that hypertonic saline nebulizations improve respiratory symptoms and quality of life in PCD patients.
To examine the impact of an exercise bout on the ability to protect endothelial damage in response to ischaemia reperfusion injury in healthy humans. A secondary objective is to explore the potential difference in efficacy to prevent ischaemia…