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A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

Volar Internal Plate Fixation versus Plaster in Extra-articular distal Radial fractures (VIPER)

To compare the functional outcome of ORIF with a volar locking plate to closed reduction and plaster immobilisation in patients with dislocated extra-articular distal radius fractures.

Characterization and localization of microstructural changes in brain tissue in Neuropsychiatric Systemic Lupus Erythematosus (NPSLE)

• To increase the sensitivity of the current MRI methods for detecting the changes caused by NPSLE through the scans made on the 7 Tesla scanner, since the higher field strength will lead to a higher signal to noise ratio and higher resolution. • To…

Stress and childhood epilepsy

The overall aim of this project is to elucidate the interaction between stress and epileptic seizures in childhood epilepsy. The specific aim of this study is to compare the possible differences in stress hormone regulation, hippocampal function and…

Treatment of Central Sleep Apnea Syndrome with low-pressure nasal continuous positive airway pressure and rebreathing.

Primary objective:To show that addition of dead space to low-pressure nCPAP (which is usually not effective but can be relatively well tolerated) makes the therapy effective and diminishes the apnea hypopnea index with >10/hour in patients…

Betacel dysfunction induced by impaired pancreas anatomy and insulin sensitivity in subjects with heterozygous EXT1 or EXT2 Mutations

Assessment of glucose homeostasis and pancreas size (MRI) in 10 subjects with heterozygous mutations in EXT-1, in 10 subjects with heterozygous mutations in EXT-2 and 10 unaffected related controls as well as 10 subjects with known type 2 diabetes…

The real distribution of microbiota along the colonic mucosa using a novel device capable of taking *protected* biopsies

Primary Objective: to show the differences in distribution of microbial DNA proximal versus distal in the colon as well as luminal composition versus mucosa adherent. Secondary Objective: to test whether bowel lavage has influence on the microbial…

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

Undercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.

The objective of the study is to study the effect of Teripratide (rhPTH 1-34) on undercarboxylated osteocalcin levels, testosterone concentrations, glucose tolerance and insulin sensitivity in male subjects with primary osteoporosis.

Immunological causes of recurrent miscarriages.

Does humoral and/or cellular rejection play a role in recurrent miscarriage of unknown etiology?Can biomarkers of humoral and/or cellular rejection be used for the detection of patients who are likely to suffer a miscarriage in a next pregnancy?

Infusion of IL-15 activated NK cells after allogeneic stem cell transplantation in children transplanted for relapsed/refractory leukemia: a feasibility study

Primary: The main objective of the study is to evaluate the feasibility, safety and tolerability of allogeneic IL15-activated NK cell infusions in children transplanted for refractory or relapsed leukemia.Secondary: To document immune reconstitution…

Varenicline, a partial nicotinic receptor agonist, for the treatment of excessive daytime sleepiness in Parkinson*s disease: a placebo-controlled cross-over study

This study is aimed to determine the efficacy of varenicline in reducing EDS in PD patients.

ROBot-aided system Identification: a novel tool for diagnosis and assessment in Neurological rehabilitation: *ROBIN*

Primary objective of this study is to assess the reliability, validity, and diagnostic value of the neuromechanical parameters of joint impedance estimated by nonlinear SIPE technology in patients with a spastic paresis.

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…

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…

ADOLESCE-NT: More rapid deterioration of renal function after renal transplantation in adolescence: effect of the endocrine system on immunological and pharmacokinetic factors

Answering the question if there are any associations between hormonal status in adolescence on the one hand, and immunological reactivity and pharmacodynamics on the other hand; and if such associations can explain the more rapid deterioration of…

Change of body composition in breast cancer: All-in Assessment

The aims of this project are to:1. Assess what percentage of breast cancer patients experience accelerated gain in fat mass, loss of muscle mass and muscle strength as induced during chemotherapy2. Assess whether changes in energy intake, protein…

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…

Prevalence of signs of abuse in children with functional defecation disorders

The aim of our study is to measure 1) the prevalence of signs of child abuse and neglect in children with functional defecation disorders, 2) whether signs of child abuse and neglect are more common in children with functional defecation disorders…

Age-related changes of the immune system leading to hyporesponsiveness; a major player and predictor for biological behaviour of metastasized melanoma?

To study the frequencies and differentiation status of CD4 and CD8 T cell populations (Tnaive, TCM, TEM, TEMRA) in young (18-50) and old (>65) treatment naive metastasized melanoma patients at baseline and after treatment.