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Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101.

The objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…

The effect of glycopyrroniumbromide on nocturnal clozapine induced sialorrhea in psychiatric patients: a randomized, cross-over, double blind, placebo controlled trial with an extended open label phase (QUITSPIT study)

Main objective: to determine the effect, defined as the percentage of patients that show a clinical relevant improvement on the severity of complaints of nocturnal sialorrhea, of oral glycopyrroniumbromide in comparison with placebo in psychiatric…

A randomized, double-blind, placebo-controlled, serial-cohort, single ascending dose of Xen2174 with bupivacaine interaction study administered intrathecally in healthy volunteers.

The objectives of the study are:To determine the pharmacokinetic and pharmacodynamic interaction of a single ascending dose of Xen2174 with bupivacaine, and in one cohort of Xen2174 alone, when administered intrathecally to healthy volunteers and…

Sitagliptin prophylaxis for glucocorticoid-induced impairment of glucose metabolism and beta-cell function in males with the metabolic syndrome-X: a randomized, placebo controlled, double blind, 2x2 factorial designed intervention trial.

The objective of this study is to assess whether sitagliptin may prevent prednisolone-induced impairment of glucose metabolism and beta-cell function.

A randomized, double-blind, placebo-controlled, serial-cohort, single ascending dose of Xen2174 PK/PD study administered intrathecally in healthy volunteers.

The objectives of the study are:To determine the pharmacokinetic profile of Xen2174 in plasma and CSF when administered intrathecally to healthy volunteersTo determine which modalities of pain are affected by treatment with Xen2174 when administered…

Preventive Methods for Reduction of Pain associated with Propofol Injection: a randomised controlled trial of commonly used methods

In this randomised controlled trial we compare three commonly used preventive methods to reduce the pain on injection op (PIP) with a control group. Our primary goal is to try and establish the most effective and easy to use method for preventing…

The influence of peroperative dobutamine infusion on the blood flow of the DIEP-flap

Primary Objective: To investigate in a prospective randomized controlled trial whether intravenous infusion of low doses dobutamine solely peroperative or for 18 more hours postoperative in women undergoing a breast reconstruction by means of a DIEP…

Ascending single dose study of the safety, tolerability, and pharmacokinetics of PRM-151 administered to healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF)

PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce fibrosis. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of PRM-151 after administration of ascending…

The peripheral effects of prednisolone on glucose metabolism, metabolic hormones, insulin sensitivity and insulin secretion in healthy young males and males with metabolic syndrome * two randomized, placebo controlled, double blind, dose-response, parallel group intervention studies.

The objective of these studies is to identify the primary mechanisms of GC-induced dysmetabolic effects in humans and to find biomarkers that reflect these side effects of GC treatment and which can be followed during therapy and in future clinical…

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock

To demonstrate that treatment with drotrecogin alfa (activated) 24 mcg/kg/h administered as an intravenous infusion for 96 hours reduces 28 day all-cause mortality in adult patients with septic shock compared with placebo.

Pre-incisional bupivacaine infiltration trocarincions, reduction of postoperative pain?

The purpose of this study is to monitor whether preicncisional bupivacaine (bupivacaïne 0,5% with epinefrine 1:200.000), infiltration in trocarcincisions reduces postoperative wound pain.

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated with Sub-cutaneous Administration of Peginterferon beta-1a

Primary ObjectivesTo evaluate the IRE intensity/color mitigation effect of a single administration of Brimonidine tartrate in comparison with a vehicle gel (placebo).Secondary ObjectiveTo evaluate the IRE intensity/color mitigation effect of a…

Amitriptyline 10% or ketamine 10% cream in neuropatic pain: a randomised doubleblind, placebo-controlled, cross-over multicenter pilot study

The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT

A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy.

PrimaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the frequency of moderate to severe VMSKey secondaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the severity of moderate to severe VMSSecondary• To evaluate…

Anakinra: safety and efficacy of interleukin-1 pathway inhibitor anakinra for the management of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalan - A randomized controlled trial

The primary objective is to evaluate the efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). The primary endpoint is the…