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Families in the frontline;An evaluation study of parenting interventions for veteran families

The main objective is to investigate the effectiveness of parenting programs addressing family functioning and PTSD within the Dutch veteran population. A secundary objective is to unravel and identify the role of emotion regulation and…

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (minocycline) for Injection in Healthy Adult Subjects

* The primary objective is to assess the safety and tolerability of single and multiple intravenous doses of Minocin IV when administered to healthy adult subjects.* The secondary objective is to assess the pharmacokinetics of single and multiple…

Protein supplementation to augment the training adaptations to endurance-type exercise training.

Primary Objective: The primary objective of the current study is to assess the impact protein supplementation during long-term endurance-type exercise training on VO2max. Secondary Objective(s): The secondary objective of the current study is to…

A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

To demonstrate that treatment with avelumab in combination with standard of care (SOC) CRT is superior to SOC CRT alone in prolonging progression-free survival (PFS) in front-line patients with high-risk (as defined in Inclusion Criterion 2),…

A phase I, randomized, placebo-controlled, double blind, first time in human, escalating single-dose study to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of Neu-P12 in healthy male volunteers

Primary objectiveTo assess safety and tolerability of Neu-P12 in four different single doses of the drug. Secondary objectiveTo compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of different single doses of Neu-P12.

Ultrasound guided fascia iliaca block: a comparison with the landmark method

Percentage of accurate guessed blocks

A phase 1, randomized, placebo-controlled study to assess the safety and pharmacokinetics of multiple ascending dose regimens of TP-6076.

The purpose of the study is to investigate how safe TP-6076 is and how well TP-6076 is tolerated. It will also be investigated how quickly and to what extent TP-6076 is absorbed and eliminated from the body (this is called pharmacokinetics). This…

The role of the cerebellum in response inhibition and error processing: A transcranial direct current stimulation study

To demonstrate a direct relation between the cerebellum and electrophysiological and behavioural indices of response inhibition and error processing in healthy volunteers.

Inhibition of Neointimal hyperplasia with Paclitaxel-eluting balloon angioplasty in haemodialysis shunts.
A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in patients with haemodialysis access stenoses.

This study is designed to test the hypothesis that obstructed shunts will function longer after PTA whenever DEB is used instead of the standard balloon used nowadays.

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI*PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY

This is a phase III, open-label, multicenter, randomized study to investigate the efficacy and safety of atezolizumab (anti PDL1 antibody) compared with chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer after…

Substance use and violence: development and validation of a test battery

Objective: To investigate whether persons under the influence of alcohol tend to be more aggressive (as measured by Point Subtraction Aggression Paradigm (PSAP) job and an attention task) than those receiving a placebo.In addition, the psychometric…

A Mobile-Health application for follow-up treatment of primary closed wounds in an outpatient setting -
A randomized controlled trial

The objective of this study is four-fold:1)To investigate the safety and effectiveness of a mobile-health system intended to promote wound monitoring and sutures removal of primary closed uncomplicated wounds by the patients at home. The system is…

Pilot study: postoperative pain reduction by pre emptive N-Acetylcysteine

Primary Objective: To evaluate the efficacy of intravenous NAC in comparison with placebo in terms of pain relief after unilateral inguinal hernia repair measured by a visual analogue scale (VAS 0-100) at day 1 after surgery.Secondary Objective(s):…

The Role of the Parietal Cortex in Familiarity and Recollection: A Transcranial Alternating Current Stimulation Study

To investigate contributions of parietal theta oscillations in recollection processes.

A multicentre, randomised, dose-confirmation, factorial phase II study to evaluate the optimal dose of 68Ga-OPS202 as a PET imaging agent in subjects with gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Primary Study Objective:*To define the optimal dose range for peptide mass and radioactivity of 68Ga-OPS202 based on detected lesions in adult subjects with somatostatin receptor 2 (sstr2) positive gastroenteropancreatic neuroendocrine tumour (GEP-…

The role of working memory in language comprehension and production: A transcranial direct current stimulation study

To investigate the direct role of DLPFC suppression in language comprehension and production performance

Amnioninfusion or expected management after midtrimester PPROM * what are the long-term effects on offspring*s general health and neurobehavioral development?

The long-term follow-up of the PPROMEXIL-III trial is designed to evaluate the effect of amnioninfusion on offspring*s neurological development, lung function and general health.

Gastrointestinal tolerance in ICU patients after administration of an energy and protein enriched peptide formula as compared to an isocaloric standard tube feed

The objective of this study is to compare gastrointestinal tolerance in ICU patients during administration of an upgraded peptide based tube feed product to an isocaloric standard tube feed during a period of maximal two weeks.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

The primary objective of the study is To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF.The secondary objectives of the study are:* To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF as…

A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)

The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…