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Sleep problems in children with Angelman syndrome: the effect of a behavioral treatment.

Primary Objective:To evaluate the effect and sustainability over time of behavioural treatment for sleep problems in children with AS on the actual hours of sleep and sleep behaviour of the children.Secondary Objectives:To evaluate the effect and…

Dietary treatment of children with Angelman Syndrome and refractory epilepsy

Primary objective: - 50% seizure reduction or more at 3 months of dietary treatment .Secondary objectives: -level of ketosis on KD and MAD.-number of patients maintaining >50% seizure reduction on MAD.-number of withdrawals (not able to…

A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)

Primary:To evaluate the clinical activity of GSK525762 in NUT Midline Carcinoma and other solid tumors.Secondary:Effect of treatment with GSK525762 on tumor growth and survival. Pharmacokinetics of GSK525762. Safety.

Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

This is a follow-up (FU) study for subjects who completed Study ALX0681-C301 (HERCULES) according to the protocol (i.e., completed the Final [28 day] FU visit). Subjects who completed Study ALX0681-C301 will be given the option to participate in…

Closure after small skin incisions and excisions with a new closing system

compare the SoClose system with traditional skin wound closure with intracutaneous suturs of small skin excision on: cosmetics, wound healing, closing time, patient comfort and costs.

Examining the difference between healthy and pathological narcissism: the role of empathy

The present research proposal aims at investigating the distinction between healthy and pathological narcissism. In particular, the role of empathy is studied.The present study is the first in which patients with narcissistic personality disorder…

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter
Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects who are
Asymptomatic At Risk for Developing Alzheimer*s Dementia

Primary Objective:The primary objective of this study is to determine whether treatment with JNJ-54861911 slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive…

Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group and the Polish Lymphoma Research Group

The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (BEACOPP) in case of a positive FDG-PET after one cycle of ABVD, has non-inferior efficacy…

Op Volle Kracht: An intervention to increase emotional resilience among youth in residential treatment centers

Main: 1. To investigate whether a short term CBT-based group program is more effective in reducing symptoms of depression and anxiety than treatment as usual (TAU), among adolescents aged 10-16 within residential treatment settings in the youth…

A phase I study on Dendritic cells loaded with allogeneous cell lysate (Alloys) in patients with mesothelioma as maintenance treatment (AlloDen)

The objective of the present trial is to investigate the safety of an allogenic tumor cell lysate loaded onto autologuous dendritic cells (AlloDen) in patients with malignant mesothelioma (MM). Heretoo we will perform a phase I study with a…

Melanoma, artificial reproductive therapy and pregnancy; is there an increased risk of recurrence?

The aim of this study is to evaluate if a recurrent melanoma is more common after ART or pregnancy after a previous history of stage I or II melanoma. Other forms of hormonal therapy will be examined. Also, anxiety about pregnancy or hormonal…

The effect of dietary nitrate (beetroot juice) on the microcirculation in healthy adults; A pilot study

The primary objective is to determine the effects of dietary nitrate (beet root juice) on the microcirculatory profile in healthy adults. The secondary objectives are 1) to determine the effects of dietary nitrate on macrocirculatory parameters, 2)…

Stop or Go?
Tapering antidepressants in pregnancy: A pragmatic multicenter RCT to investigate risk and benefits for mother and child.

The aim of this study is to investigate the effect of guided tapering in early pregnancy as compared to continuation of SSRIs during pregnancy. We will study effects on both mother and child with a pragmatic approach.

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine

Primary:• To prove the superiority of a 12-week add-on treatment with 3.2 g/daygastro-resistant phosphatidylcholine granules (LT-02) in at least one of twodifferent dosing regimens versus LT-02 placebo for the induction ofremission in patients with…

Multiproblem Young Adults: a study on service use trajectories, neurobiological mechanisms and treatment effect in young adults with severe criminal, psychiatric and social problems.

With this integrative research project we will expand the knowledge on factors associated with problematic behavior in young adults. To elucidate why multiproblematic behavior in young adults exists in a persistent way we will explore the underlying…

Follow up MISSION!: Optimization of chronic care for patients with acute myocardial infarction and long term course of cholesterol.

Primary Objective:- To assess lipid levels of STEMI patients over a long course. Secondary Objectives:- To assess the association between poorly controlled cholesterol and (apo) lipoprotein levels for the long term outcome in STEMI patients.- To…

A Study of Respiratory Muscle Strength, including Effort-Independent Measures, in Subjects with Late-Onset Pompe Disease

The primary objective of this study is to compare respiratory muscle strength values obtained using volitional techniques with values obtained using non-volitional techniques. The secondary objective is to compare the change for these two sets of…

Proof-of-concept study on treating cognitive side-effects of Tamoxifen with guanfacine in postmenopausal women with E2/Pg receptor-positive breast cancer.

Provide proof-of-concept for the hypothesis that guanfacine diminishes cognitive side-effects in ER+ BC patients treated with adjuvant hormonal therapy. Secondary, provide data for power calculations in later studies.

Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study

To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the
Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged
12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a
Second Allele With a CFTR Mutation Predicted to Have Residual Function

To evaluate the efficacy of VX-661 in combination with ivacaftor and ivacaftormonotherapy through 8 weeks of treatment in subjects with cystic fibrosis (CF)who are heterozygous for the F508del mutation on the CF transmembraneconductance regulator (…