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Palatability testing of a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children - VALID 0

PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…

An outpatient phase 3 efficacy study of Ecopipam (PSYRX 101) in the symptomatic treatment of self-injurious behavior in subjects with Lesch-Nyhan disease.

The primary objective of this study is to assess the efficacy of Ecopipam to reduce self-injurious behaviors (SIB) in adults and children with Lesch-Nyhan Disease (LND) in an outpatient setting. The secondary objectives of this study are to assess…

Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety

Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…

The effects of long-acting methylphenidate on academic activity and related constructs in children with ADHD: A randomised placebo controlled trial

See page 9Primary Objective:The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore…

Randomized crossover comparison of mask leak between facemask and nasal mask ventilation; a pilot study.

To compare the occurrence of significant mask leak when using a nasal mask versus a facemask in preterm infants needing positive pressure ventilation.

Tolerance of camel*s milk and mare*s milk in cow*s milk protein allergy.

Primary: To establish the tolerance of camel*s milk and mare*s milk in standardized food provocation tests in patients with double-blind placebo-controlled provocation (DBPCP) proven CMA >=3 years of age. Secondary: To determine the minimum…

A Randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein Infant formula in children with cow's milk allergy using amino-based infant formula as a reference.

The primary study objective is to assess the hypoallergenicity of an extensively hydroloyzed whey protein infant formula in children with cow's milk allergy.The second study objective is to assess the long-term effects on growth and tolerance…