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A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease

We propose to conduct a study in patients with mild to moderate AD where a cholinergic challenge is given in a placebo-controlled, cross-over fashion, prior to onset of treatment with a CEI. Patients will be followed over a period of 6 months to…

A clinical study to evaluate the safety, tolerability, and pharmacokinetics of the MMP 12 inhibitor FP- 025 after multiple oral ascending dose administration, and to evaluate the effect of food after a single oral dose administration in healthy subjects

Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…

A single dose, randomized, four-way cross-over, bioavailability and food interaction study of PedPRM (Pediatric Prolonged Release Melatonin, Neurim Pharmaceuticals Ltd) and Circadin® tablets in healthy male and female volunteers.

Primary Objective- To demonstrate dose proportionality between 1 mg and 5 mg of PedPRM (Neurim Pharmaceuticals Ltd.) following a single oral dose in healthy male and female volunteers (treatment A and C), under fed conditions.Secondary Objectives-…

PARROT-2: Postprandial plasma amino acid concentrations after dairy consumption

To compare postprandial plasma amino acid concentrations over time after ingestion of a fixed amount of protein from different dairy products in healthy adults.

Influence of Oral Processing Behaviour and Yogurt Properties on Satiation (Meal Termination)

The overall objective of this study is to understand how consumers adapt their oral processing behaviours in response to small texture variations of yogurts and how changes in oral processing behaviour of yogurts impact the amount of food eaten and…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

The effect of oral ingestion of casein protein versus whey protein on plasma amino acids, satiety and anorexigenic hormones after gastric bypass surgery

To investigate whether a test meal in gastric bypass patients with supplemented casein protein results in higher concentrations of satiety-related plasma amino acids and satiety-related hormones and leads to more postprandial satiety and less hunger…

Pilot study to determine clock-related nonvisual effects of light on alertness and metabolism

To test whether a short FD protocol can be used to test whether effects of light on alertness, sleep, metabolism and temperature are under circadian control.

Randomized, double-blind, double-dummy, placebo-controlled, four-way crossover single dose
study to determine the test-retest reliability of, and the effect of oral valproic acid, levetiracetam and
lorazepam on, cortical excitability measurements in healthy volunteers as measured by TMS-EEG and TMS-EMG.

Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…

Bilateral vs. unilateral transcranial magnetic stimulation of the primary motor cortex to treat chronic orofacial pain: a pilot study with a randomized controlled design

In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect…

Acute effects of 40 mg cortisol on emotion and cognition.

To investigate acute effects of a single 40 mg dose hydrocortisone, compared with placebo, on stress and various aspects of attention and other cognitive processing of emotionally relevant stimuli in healthy anxious young females. The main question…

The acute effects of the nutrition method "Breinspijs" (Brainfood) on cognitive functioning - a pilot intervention study

The primary objective of this study is to investigate the acute effects of a Breinspijs meal on the cognitive domains attention, processing speed, working memory and episodic memory. Secondary objectives are the effects of a Breinspijs meal on…

An open label, randomized, single inhaled dose, three-way cross over pilot study to compare the pharmacokinetic profiles of different dry powder inhalers with tiotropium bromide in healthy volunteers.

Primary objective:* To compare the bioavailability of different dry powder formulations of tiotropium bromide in healthy volunteersSecondary objectives:* To compare the safety and tolerability of different dry powder formulations of tiotropium…

A randomized, double-blind, repeat dose cross-over study
to assess the bronchodilator effects of once daily QVM149
following morning or evening dosing for 14 days compared
to placebo in patients with asthma

To investigate the potential influence of time of dosing (morning or evening)on the bronchodilator effect of once daily orally inhaled QVM149 compared toplacebo.

Open label, randomized, cross-over study to explore the pharmacokinetics of BAY 1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY 1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent BAY 1834845 is absorbed and eliminated from the body (this is called pharmacokinetics). In both study parts it will also be investigated to what extent BAY 1834845 is…

An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjects

During the study, an oral solution of JZP-507 produced on a commercial scale will be compared with a JZP-507 oral solution produced on a pilot scale (an oral solution of JZP-507 which is manufactured locally at PRA). The purpose of the study is to…

The Effects of Transcutaneous Vagus Nerve Stimulation on the Pupil Diameter, Heart Rate and Heart Rate Variability in Epilepsy Patients and Healthy Subjects.

Primary objective: The main objective of this pilot study is to gain more insight into the effects of tVNS: to assess if the ABVN and consecutively the NTS are really stimulated by tVNS. Therefore this study investigates the effects of tVNS on the…

Oro-sensory exposure, eating rate and satiation

The primary objective of this study is to determine the independent and additive effects of oro-sensory exposure (mastication effort) and ingestion rate (bite interval) on satiation in relation to the cephalic endocrine and metabolic hormonal…

Double blind, randomized, 2-way cross-over, placebo controlled study to evaluate the therapeutic and preventive effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model in healthy male subjects

PrimaryTo assess the preventative effect of GLPG1205 on nociceptive and inflammation/sensitization induced pain in the UVB sunburn model using HPTol upon multiple dosing of GLPG1205 versus placebo.SecondaryTo further assess the preventative effect…