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Exercise training in congenital heart disease: is it effective and safe and does it improve quality of life

Objectives:Medical: What is the effect of an exercise training program in children and young adults (up to 20 years of age) who have undergone treatment for ConHD (tetralogy of Fallot or Fontan procedure) on: a) aerobic fitness, b) ventricular size…

High frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international randomized controlled trial

Primary objective: -to determine if there is a significant difference in the incidence of oxygen dependency at day 28 and/or death within the first 28 days of life between newborns with congenital diaphragmatic hernia treated with high frequency…

Effect of Fecal transplant harvested from Bariatric surgery subjects on Lipid and Glucose metabolism in subjects with metabolic syndrome;

To investigate whether single dosis of fecal therapy by infusion of allogeneic (post bariatric surgery donor feces in the bowel) or autologous (own feces) have differential effect on lipid-metabolism-mediated insulin resistance.

A 2-Part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of
AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety,
Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial
Hypercholesterolemia
Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to
Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects

Primary ObjectivePart A: To characterize the effect of 12 weeks of subcutaneous (SC) AMG 145 on percentchange from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with homozygousfamilial hypercholesterolemiaPart B: To evaluate…

insulin therapy in non-diabetic adults with cystic fibrosis

To investigate the effect of low-dose long acting insulin therapy on nutritional status in adult CF patients without diabetes.

Initiation of chronic ventilatory support outside the hospital.

We want to investigate if it is possible to set up the entire process of home mechanical ventilation outside the hospital. This means practically that the patients will not be admitted to the hospital. The goal of this study is to answer the…

A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth

In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…

Dendritic cell vaccination in patients with Lynch Syndrome or colorectal cancer with MSI

The primary objective is the safety and feasibility of CEA/frameshift derived neopeptide loaded DC in patient with MSI-positive colorectal cancer and persons who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.…

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia (study 20110117)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous…

Randomized trial to study the efficacy and adverse effects of the subcutaneous ICD in patients with a class I or IIa indication for ICD without an indication for pacing

To determine the efficacy endpoint whether the lack of ATP function will cause more appropriate but unnecessary shock therapy in patients with a S-ICD. Furthermore we will study the complication endpoint whether the S-ICD is superior to the TV-ICD…

A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen
receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer

PrimaryDemonstration of superior efficacy (as measured by PFS time) of L-BLP25 in combination with hormonal treatment (HT) over placebo plus HT, when used for first-line therapy of hormone receptor-positive (ER+ and/or PgR+), inoperable locally…

LEARN 2 MOVE 16-24;Effectiveness of an age specific intervention to stimulate mobility related activity and physical fitness of adolescents with spastic cerebral palsy.

The aim of the research is to evaluate the efficacy and working mechanisms of the "active lifestyle" intervention, which is directed to strategies to prevent low levels of daily activities and poor fitness in adolescents and young adults…

Nasoalveolar Molding with nasal stent to improve nasal symmetry in unilateral cleft patients

Objective: permanent improvement of the symmetry of the external nose in patients with unilateral cleft

Web-based tailored information and question prompt for enhancing counselee participation and outcome; a RCT in breast cancer genetic counselling

This study aims to establish the effectiveness of web-based counselee-tailored information plus question prompt designed to 1) increase realistic expectations of breast cancer genetic counselling, 2) facilitate participation, question asking and…

Towards a new technique for pre-implantation genetic embryo screening in IVF, pilot phase

The objective of this study is to evaluate a new and less invasive method of PGS. The new PGS technique will analyse a nucleus of a blastomere that was obtained by nuclear extraction rather than by biopsy of a whole blastomere.

Transition of care in women with Turner syndrome: Oxandrolone follow-up study

The aim of the study is to assess the long-term effects (at adult age) of the TOS study medication (growth hormone and estrogen with or without Ox), with specific attention to adult height and body proportions, body composition, virilization,…

Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study

The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies with inhaled mannitol have demonstrated improvements in lung function, mucociliary…

A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz 112638 in Patients with Gaucher Disease Type 1 who have been Stabilized with Cerezyme

The primary objective of this study is to assess the efficacy and safety of Genz-112638 compared with Cerezyme after 52 weeks of treatment in patients with Gaucher disease type 1 who have been stabilized with Cerezyme. The secondary objective of…

Circadian Influence on Renal Clearance of Aminoglycosides in cystic fibrosis patients

Main objective: To compare the renal elimination rate constant in CF patients receiving a daily intravenous dose of tobramycin in the morning against patients receiving a daily intravenous dose of tobramycin in the evening. Secondary objective: To…

A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease

Primary objective:* Evaluate long-term effect of tolvaptan in ADPKD through rate of renal volume change(%) for tolvaptan-treated compared to placebo-treated subjects.Secondary objectives:* Evaluate long-term efficacy of tolvaptan in ADPKD through a…